Complementary and Alternative Medicine

EVERNORTH Coverage Policy: EN0086 1

Behavioral Health Coverage Policy

Effective Date 02/15/2024

Next Review Date 02/15/2025

Coverage Policy Number EN0086

Complementary and Alternative Medicine

Table of Contents

Overview .............................................................. 2

Coverage Policy ................................................... 2

General Background ............................................ 4

Medicare Coverage Determinations .................. 36

Coding Information ............................................ 37

References ........................................................ 39

Revision Details ................................................. 57

Related Coverage Resources

Acupuncture

Atherosclerotic Cardiovascular Disease Risk

Assessment: Emerging Laboratory Evaluations

Attention-Deficit/Hyperactivity Disorder (ADHD):

Assessment and Treatment

Autism Spectrum Disorders/Pervasive Developmental

Disorders: Assessment and Treatment

Biofeedback

Chiropractic Care

Drug Testing

Hyperbaric and Topical Oxygen Therapies

Physical Therapy

INSTRUCTIONS FOR USE

Coverage Policies are intended to provide guidance in interpreting benefit plans administered by Evernorth

Behavioral Health, Inc. Please note, the terms of a customer’s particular benefit plan document [Group Service

Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan

document] may differ significantly from the standard benefit plans upon which these Coverage Policies are

based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic

addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always

supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage

mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage

determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan

document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source

materials including Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request

should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment where

appropriate and have discretion in making individual coverage determinations. Where coverage for care or

services does not depend on specific circumstances, reimbursement will only be provided if a requested

service(s) is submitted in accordance with the relevant criteria outlined in the applicable Coverage Policy,

including covered diagnosis and/or procedure code(s). Reimbursement is not allowed for services when billed for

conditions or diagnoses that are not covered under this Coverage Policy (see “Coding Information” below).

When billing, providers must use the most appropriate codes as of the effective date of the submission. Claims

submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will

be denied as not covered. Coverage Policies relate exclusively to the administration of health benefit plans.

Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines.

Page 2 of 57

Medical Coverage Policy: EN0086

Overview

This Coverage Policy addresses complementary and alternative medicine diagnostic testing methods, systems,

therapies and treatments that are proposed to reduce disease-based clinical symptoms and improve health and

wellness.

Coverage Policy

Coverage for complementary and alternative testing and therapies varies across plans. Please refer to

the customer’s benefit plan document for coverage details.

For information on Acupuncture and Biofeedback, refer to the applicable Cigna Coverage Policies.

Each of the following complementary or alternative medicine diagnostic testing methods, systems,

therapies or treatments is considered experimental, investigational or unproven:

Category

Therapy

• meridian therapy

• millimeter wave therapy

• moxibustion therapy

• Qigong Longevity

• Reiki

• therapeutic touch

Manipulative and body-based methods

• Alexander’s technique

• AMMA Therapy

• Bio Photonic Lymphatic Drainage

Treatment (BELD)

• colonic irrigation, colonic lavage, colonic cleansing

• craniosacral therapy

• ear candling

• Feldenkrais therapy

• inversion therapy

• myotherapy

• neural therapy

• Pfrimmer Deep Muscle Therapy

• Pilates

• reflexology (zone therapy)

• remedial massage

• Rolfing

• Trager

• Tui Na

• visceral massage

Mind-body medicine

• art therapy

• bioenergetics’ analysis

• color therapy

• dance movement therapy

• equestrian therapy (hippotherapy)

• faith healing

• guided imagery interactive

• Hellerwork

• humor therapy

• hypnosis

• Martial Arts including Chung Moo Doe therapy

• meditation/Transcendental Meditation (TM

)

• mirror box therapy

• music therapy

• outdoor youth programs

• pet therapy

• primal therapy

• psychodrama

• recreational therapy

• wilderness therapy

• yoga

Prescription medications are generally subject to a separate pharmacy benefit. Many pharmacy and

medical benefit plans specifically exclude coverage of over-the-counter (OTC) medications, including

OTC vitamins and nutritional and dietary supplements.

EVERNORTH Coverage Policy: EN0086 4

General Background

Complementary and alternative medicine (CAM), also called unconventional, nonconventional, or nontraditional

healthcare, is a group of diverse medical and healthcare systems, practices and products that are not typically

considered to be part of traditional Western medicine (i.e., conventional medicine). CAM assessments and

therapies are proposed to reduce disease-based clinical symptoms and improve health and wellness.

Complementary medicine may be used in conjunction with Western medicine, as opposed to alternative

medicine which may be used in place of Western medicine. Integrative medicine, as defined by the National

Center for Complementary and Alternative Medicine (NCCAM), combines conventional medical therapies and

CAM therapies for which there is scientific evidence of safety and effectiveness (NCCAM, 2016; updated 2018).

Classifications of CAM practices include the following:

• Whole Medical Systems: Whole medical systems are built upon complete systems of theory and

practice. Often, these systems have evolved apart from, and earlier than, the conventional medical

approach used in the United States.

• Biologically-Based Practices: Biologically-based practices, also referred to as natural products, in

CAM use substances found in nature including herbs, foods, and vitamins. Examples of these

substances include dietary supplements, herbal products, and other natural products that have not been

scientifically proven (e.g., using shark cartilage to treat cancer).

• Energy Medicine: Energy medicine involves the use of energy fields and consists of two types of

therapies:

 Biofield therapies are intended to affect energy fields that purportedly surround and penetrate

the human body. The existence of such fields has not yet been scientifically proven. Some forms

of energy therapy are proposed to manipulate biofields by applying pressure, heat or body

manipulation.

 Bioelectromagnetic-based therapies involve the unconventional use of electromagnetic fields,

such as pulsed fields, magnetic fields, or alternating current or direct current fields.

• Manipulative and Body-Based Methods: Manipulative and body-based methods are based on

manipulation and/or movement of one or more parts of the body.

• Mind-Body Medicine: Mind-body medicine uses a variety of techniques designed to enhance the mind's

capacity to affect bodily function and symptoms.

Some CAM therapies are supported by some degree of scientific evidence, but most of the other CAM therapies

lack data in the peer-reviewed published evidence supporting the safety and efficacy of these therapies for

specific conditions and are not yet considered an established treatment option.

U.S. Food and Drug Administration (FDA)

The Federal Food and Drug Act of 1906, The Wiley Act, empowers the FDA Center for Food Safety and Nutrition

to remove unsafe food substances and botanicals from the market, and gives the FDA regulatory oversight for

substances added to food, including monitoring safe use. The FDA maintains that a drug is any substance or

mixture of substances intended for the cure, mitigation, diagnosis or prevention of disease (FDA, 2009; updated

2019).

Dietary supplements are regulated differently than prescription and over-the-counter drug products.

Manufacturers of dietary supplements are responsible for ensuring that their products are safe. While the FDA

monitors adverse effects after dietary supplement products are on the market, newly marketed dietary

supplements are not subject to premarket approval or a specific post-market surveillance period. Per the Dietary

Supplement Health and Education Act of 1994 (DSHEA), the burden of proof rests on the FDA to show that a

product is unsafe. Manufacturers are not required to submit substantiation of benefit data to the FDA. The

Federal Trade Commission (FTC) is charged with accurate marketing and advertising claims (FDA, 2015;

updated 2019).

EVERNORTH Coverage Policy: EN0086 5

According to the FDA, dietary supplements in today’s market include one or a combination of: vitamins, minerals,

herbals, botanicals, amino acids, any dietary substance used to supplement the diet by increasing total dietary

intake, and a concentrate, metabolite, constituent or extract. The FDA states that, while some supplements may

help ensure that the individual consumes adequate amounts of essential nutrients needed for optimal health and

performance, dietary supplements cannot be promoted as a treatment or a cure.

In December 2006, the FDA issued a draft guidance document for the regulation of CAM products. The draft was

issued because increased use of CAM in the United States had caused confusion regarding which products are

subject to regulation under the Federal Food, Drug, and Cosmetic Act (Act) or the Public Health Service Act

(PHS Act) and because the number of CAM products being imported into the United States had increased. The

document provides guidance as to when a CAM product is subject to the Act or the PHS Act. The FDA cites the

NCCAM’s definition and categories of CAM in the draft. According to the new guidance, if the labeling of a

dietary supplement includes the term “to treat,” that supplement will be regulated as a drug under the Act.

Biological products (e.g., virus, therapeutic serum, toxin, antitoxin, vaccine) will be regulated under the PHS Act

(FDA, 2006; updated 2020).

Diagnostic Testing Methods

Applied Kinesiology (AK): AK is a form of diagnostic testing that uses muscle testing as a type of functional

neurological evaluation. According to their guidelines on allergy diagnostic testing, the American Academy of

Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology stated there is

“no evidence of diagnostic validity” of AK (Bernstein, et al., 2008).

Chemical Hair Analysis: Chemical hair analysis is a test in which a person’s hair is analyzed for mineral

content. Hair analysis has been proposed to aid in the evaluation of a person’s general state of health, mental

and physical conditions (e.g. autism, cancer, hypertension, myocardial infarction, kidney disease, osteoarthritis

and diabetes mellitus), skin diseases (e.g., alopecia), detect heavy metals (e.g., lead, mercury, arsenic) and

pesticides, identify nutritional/mineral deficiencies, analyze deoxyribonucleic acid (DNA), and identify the

presence of illegal drugs (e.g., cocaine, marijuana) (Guo, et al., 2019; Wolowiec, et al., 2013; Caprara, et al.,

2006; Balíková, 2005). However, evidence to support the accuracy and clinical utility of hair analysis is lacking.

Greek Cancer Cure: Greek cancer cure also known as METBAL

, Cellbal

, and Alivizatos, consists of a blood

test that allegedly diagnoses the location and extent of cancer in a person's body. Following diagnosis, treatment

consists of intravenous injections of a serum containing sugars, vitamins, amino acids, and other factors.

Available scientific evidence does not support claims that the Greek Cancer Cure is effective in preventing,

detecting, or treating cancer.

Iridology: Iridology sometimes referred to as iris diagnosis, is based on the belief that each area of the body is

represented by a corresponding area in the iris of the eye. According to their guidelines on allergy diagnostic

testing, the American Academy of Allergy, Asthma and Immunology and the American College of Allergy,

Asthma and Immunology stated there is “no evidence of diagnostic validity” of iridology (Bernstein, et al., 2008).

Live Blood Cell Analysis: Live blood cell analysis by dark field microscopy is an unproven means to study the

"biologic terrain" and offer practical, nutritional, herbal, and lifestyle solutions for various medical conditions. It

involves taking a drop of blood and viewing it under a microscope using a dark field condenser, allowing the

viewer to see all components of the blood and tiny particles to enable early detection of disease. There is

insufficient evidence to support the accuracy and clinical utility of live blood cell analysis.

Nutrient Panel Testing: Nutrient panel testing assesses the level of multiple nutrients in the body. These panels

may include measurement of numerous vitamins, minerals, amino acids, fatty acids, oxidation products, organic

acids, toxins and antioxidants. The test results are proposed to help determine the cause of various symptoms,

such as hair loss and fatigue, and various disease processes. Antioxidant function testing (e.g., Spectrox™) has

been proposed as a method to evaluate the ability of cells to resist damage caused by free radicals and other

forms of oxidative stress. SpectraCell Laboratories, Inc., (Houston, TX) offers a micronutrient testing panel

proposed to measure how micronutrients function within the white blood cell. The Individual Optimal Nutrition

(ION) (Genova Diagnostics, Asheville, NC) is a blood test that measures levels of vitamins, minerals,

antioxidants, and organic, fatty and amino acids. ExaTest

, offered by IntraCellular Diagnostics, Inc

(Bedford,

EVERNORTH Coverage Policy: EN0086 6

OR) is an intracellular tissue analysis of mineral electrolytes. The test is proposed to provide information on

mineral electrolyte deficiencies or imbalances not available by blood testing. The analysis is made from an

epithelial cell scraping from the sublingual area. The sample is analyzed using high energy photos (x-rays).

At this time, there is insufficient evidence in the published, peer-reviewed, scientific literature to establish the

clinical utility of nutrient panel testing or antioxidant function testing or to demonstrate that the use of such testing

results in improved health outcomes.

In their practice parameter for the screening and diagnosing of autism, the American Academy of Neurology and

the Child Neurology Society stated that there is insufficient evidence to support testing for micronutrients such as

vitamin levels (Filipek, et al., 2000; posted 2013).

Ream's Testing: Ream's Testing is promoted as a noninvasive investigation of the body's overall metabolic

function, utilizing urine and saliva samples. An individual’s pancreatic function, blood sugar control, pH levels,

digestive function, liver function, hydration status, mineral status, kidney and adrenal function, and systemic

inflammation are reviewed with recommendations made for diet, specific pH and supplementation of other

nutrients. It is used by proponents to monitor progress with various treatment regimes. There is insufficient

evidence to support the accuracy and clinical utility of Ream’s testing.

Salivary Hormone Panels: Salivary testing for various hormones in the form of hormone panels (i.e., testing

several different hormone levels in one test at the same time) has been proposed for numerous indications

including screening and monitoring of menopause, aging and various other conditions. Diagnos-Techs

™

, Inc.

(Kent, WA) offers several different types of these hormone panels including Post- and PeriMenopausal Hormone

Panels

™

. The Postmenopause Panel

™

(PostM

™

) is a diagnostic study that measures estrone (E1), estradiol (E2),

estriol (E3), progesterone (P), testosterone (T), dehydroepiandrosterone (DHEA), and dehydroepiandrosterone–

sulfate (DHEA-S). The Perimenopause Panel™ (PeriM™) measures the same six hormones as the PostM Panel

but two samples are analyzed 13-15 days apart. The initial sample is obtained, frozen and sent for analysis with

the second sample. The expanded Postmenopause Panel (ePostM™) and the expanded Perimenopause Panel

(ePeriM™) include analyses of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) in addition to the

six hormones offered in the nonextended panels. Proposed clinical applications of these tests include: to monitor

women who are perimenopausal, postmenopausal or have had a total hysterectomy; to aid in risk assessment of

breast/uterine proliferative diseases; to detect early disruption in the hypothalamic pituitary ovarian axis in

women approaching menopause; to monitor FSH and LH and/or investigate libido changes and emotional

vulnerability problems (Diagnos-Tech, 2019).

Diagnos-Techs also offers Male Hormone Panels

™

performed on saliva samples. The regular Male Hormone

Panel

™

(MHP

™

) is proposed to evaluate the androgen pathway by measuring progesterone, DHEA, DHEA-S,

androstenedione, estrogens, dihydrotestosterone (DHT) and testosterone. The Expanded Male Hormone Panel

™

(eMHP

™

) includes the seven hormones plus follicle stimulating hormone (FSH) and luteinizing hormone (LH).

The proposed clinical utility of the test is to diagnose andropause and hypogonadism; monitor hormone

replacement therapy and balancing of hormones; investigate prostate hypertrophy, thinning of hair and hirsutism;

and evaluate low-libido.

The Adrenal Stress Index

™

(ASI), which analyzes five saliva samples, is proposed for evaluation of chronic

stress and fatigue, glycemic dysregulation, and chronic pain and inflammation. The ASI test includes cortisol,

DHEA-S, 17-Hydroxyprogesterone, two insulin tests (fasting and after meals), total secretory IgA (SigA), and

wheat gluten sigA for grain intolerance. The proposed indications for ASI are to evaluate stress and conditions

associated with adrenal disturbances such as chronic pain/fibromyalgia, chronic fatigue syndrome, glycemic

dysregulation, allergies, autoimmune disorders, depression and attention deficit disorders.

The Bone Health Panel

™

(BHP

™

) saliva test includes progesterone, estradiol, testosterone, cortisol, FSH and

DHEA and as a bone marker, Pyrilinks-D in urine. The panel is proposed for screening and monitoring for

osteoporosis, identifying high risk hip fracture patients and screening for metabolic bone diseases, rheumatoid

arthritis and other connective tissue diseases, Paget’s disease and bone malignancies.

There is insufficient evidence in the published peer-reviewed literature to support the clinical utility (e.g.,

appropriate medication dosage, diagnosis and monitoring menopause, risk assessment) of salivary hormone

EVERNORTH Coverage Policy: EN0086 7

panels. Studies comparing salivary hormone panels to established individual hormone serum testing and impact

on health outcomes are lacking.

In 2011 guidelines on the diagnosis and treatment of menopause, The American Association of Clinical

Endocrinologists (AACE) stated that salivary hormone level testing is recommended by many bioidentical

hormone proponents as a means of providing patients with “individualized” therapy, but the methods are not

approved by either the FDA or the Clinical Laboratory Improvement Amendments (CLIA). AACE noted that

“accurate studies have revealed large intrasubject variability in salivary sex hormone concentrations which

fluctuate depending on numerous variables (e.g., diet, hydration, circadian rhythm).” This guideline was

reaffirmed in 2017.

In a 2023 Committee Opinion on compounded bioidentical hormones (e.g., dehydroepiandrosterone,

pregnenolone, testosterone, progesterone, estrone, estradiol, and estriol), the American College of Obstetricians

and Gynecologists (ACOG) stated, “salivary testing does not offer accurate or precise assessment of hormone

levels”. ACOG goes on to explain that salivary levels do not consistently provide a reasonable representation of

endogenous, circulation serum hormones because of the large variability in salivary hormones depending on

diet, time of testing and the hormone being tested. Because the pharmacokinetics of exogenously administered

compounded hormones cannot be known, it is not possible to estimate with reliability how and when to test

saliva to obtain a representative result. Lastly, saliva contains far lower concentrations of hormone than serum

and is prone to contamination with blood, infections agents, and epithelia cells which may affect the level of

hormone to be measured. “Hormone levels should not be titrated to hormone levels (serum, urinary, or salivary).”

Currently, there are no FDA-approved salivary or urinary tests for steroid hormone measurement (ACOG, 2023).

Whole Medical Systems

Ayurveda: Ayurveda provides an integrated approach to preventing and treating illness through lifestyle, based

upon the premise that all disease begins with an imbalance or stress in the individual's consciousness. Lifestyle

interventions are a major Ayurvedic preventive and therapeutic approach and include diet and herbal remedies.

This approach emphasizes the use of body, mind and spirit in disease prevention and treatment.

Ng et al. (2019) conducted a systematic review of Withania somnifera (Ashwagandha), a popular herb in

Ayurvedic medicine, in managing cognitive dysfunction. Five randomized, placebo-controlled, double-blind

studies (n=267) were reviewed, but meta-analysis was unsuitable due to small number of trials and dissimilar

study designs and outcome measures. The studies’ diverse populations included children with intellectual

disabilities, healthy adults, older adults with mild cognitive impairment, and adults with schizophrenia,

schizoaffective disorder, or bipolar disorder. Withania somnifera was found to improve performance on cognitive

tasks and be well tolerated, with good adherence and minimal side effects in almost all of the studies. Limitations

of the studies included: heterogeneous small patient populations, limited clinical data and lack of follow-up.

Additional rigorous clinical trials with large, well-defined patient populations are needed to support meaningful

clinical outcome of Ashwaganda.

Homeopathy: Homeopathy is a complementary and alternative medicine system that has been proposed to

assist the body's efforts to heal physically, mentally, and emotionally. This system encompasses the belief that

"like cures like", meaning that small, highly diluted quantities of medicinal substances are given to cure

symptoms, when the same substances given at higher or more concentrated doses would actually cause those

symptoms. There are over 3000 homeopathic remedies. Homeopathic intravenous (IV) therapy or IV nutrient

therapy is the intravenous administration of multiple minerals, vitamins, amino acids, chelating agents, botanical

and/or herbal supplements to allow maximum concentrations of these substances in the body. IV therapy has

been proposed for the treatment of cancer, malabsorption syndromes (e.g., Crohn’s, colitis), metal toxicities,

infectious diseases (e.g., Epstein Barr, Lyme disease), and neurological disorders.

A Cochrane systematic review (Hawke, et al., 2018) of randomized controlled trials investigating oral

homeopathic medicinal products for the prevention and treatment of acute respiratory tract infections in children

(age <16 years) concluded that the evidence did not show any benefit of homeopathic medicinal products

compared to placebo. Eight randomized controlled trials (n=1562) met inclusion criteria. Limitations of the studies

included: methodological inconsistencies, high attrition rates, selective reporting, protocol deviations and unclear

or high risk of bias. Methodological inconsistencies and significant clinical and statistical heterogeneity precluded

robust quantitative meta-analysis.

EVERNORTH Coverage Policy: EN0086 8

Banerjee et al. (2017) conducted a systematic review of randomized controlled trials evaluating homeopathy for

allergic rhinitis. Eleven studies (n=1654) met inclusion criteria and ten were placebo-controlled trials. Six trials

used isopathy (i.e., the causal agent is used for the cure), but they were unsuitable for meta-analysis due to

problems of heterogeneity and data extraction. Patient populations ranged from 34–142. Due to the high level of

heterogeneity across studies in terms of medical condition and outcome measures and the poor quality of results

reported, only three studies could be used for meta-analysis. Meta-analysis of the three studies using Galphimia

glauca showed that relief of nasal and ocular symptoms favored homeopathy. A homeopathic and a conventional

nasal spray produced equivalent improvements in nasal and ocular symptoms. Due to the overall low or

uncertain quality of the evidence, firm conclusions could not be drawn about the clinical benefit of homeopathy

medicine for the treatment of allergic rhinitis.

Posadzki et al. (2012) conducted a systematic review of case series and case reports to evaluate adverse

effects (AEs) of homeopathy. Thirty-five case studies (n=1159) met inclusion criteria. Direct AEs included

abdominal pain, acute pancreatitis, severe allergic reactions, and nausea and vomiting. Occasionally

homeopathy was reported to result in serious outcomes (e.g., cancer, cardiac arrest, coma, death). Multiple

indirect AEs (e.g., hypertension, seizures, organ failure) were also reported. The duration of AEs ranged from 22

hours to seven months with four reported deaths.

Davidson et al. (2011) conducted a systematic review of randomized placebo-controlled trials (n=25) of

homeopathy for psychiatric conditions (i.e., anxiety, depression, sleep problems, attention-deficit/hyperactivity

disorder [ADHD], premenstrual syndrome [PMS], mild traumatic brain injury [TBI] and somatic spectrum

disorders). Efficacy was reported for fibromyalgia and chronic fatigue syndrome, but not for anxiety or stress.

Mixed effects were reported for the other disorders. No studies were found for depression. Meta-analysis could

not be performed due to the limited number of studies and heterogeneity of the data sets. The authors concluded

that firm conclusions about the safety and efficacy of homeopathy for any of these conditions could not be made.

Traumeel (Tr14) injection solution is a homeopathic combination formula consisting of 12 botanical and 2 mineral

substances with proposed anti-inflammatory, anti-edematous, anti-exudative properties (Vanden Bossche and

Vanderstraeten, 2015). Schneider et al. (2008) conducted an observational cohort study of 133 patients with

various musculoskeletal injuries, 69 treated with Traumeel injections and 64 conventionally treated. A greater

number of patients reported complete resolution of the principal symptom with no adverse events. Physician-

assessed tolerability was significantly better in the patients that received Traumeel. In addition to the small

patient population, the studies were limited by the heterogeneous selection of type of injuries. Additional studies

with larger patient populations and long-term evaluations are needed to establish the safety and effectiveness of

Tr14.

Macrobiotics: Macrobiotics is the art and science of health and longevity through the study and understanding

of the relation and interactions between oneself, foods, lifestyles, and the environment. The clinical utility of

macrobiotics has not been established.

Naprapathy: Naprapathy or naprapathic medicine is a system that employs manual medicine (e.g., spinal

manipulation), nutritional counseling and therapeutic modalities (e.g., heat, cold, ultrasound, electrical

stimulation) for the treatment of pain caused by connective tissue disorders. Naprapaths are connective tissue

specialists who propose to have a specialized, holistic approach to address connective tissue problems

(American Naprapathic Association, 2020).

Naturopathy: Naturopathy is a system of healing that views disease as a manifestation of alterations in the

processes by which the body naturally heals itself. It emphasizes health restoration as well as disease treatment.

The core modalities utilized include diet modification, nutritional supplements, herbal medicine, acupuncture,

Chinese medicine, hydrotherapy, massage, joint manipulation, and lifestyle counseling.

Cochrane systematic reviews of randomized or quasi-randomized controlled trials have reported on the effects of

Chinese herbal medicine (CHM) for various conditions including the treatment of subfertile women with

polycystic ovarian syndrome (Zhou, et al., 2016). Analysis of five studies (n=414) revealed that there is

insufficient evidence to support the use of CHM for women with this syndrome and subfertility. No data were

available on live births, and there was no consistent evidence to indicate that CHM influenced fertility outcomes.

EVERNORTH Coverage Policy: EN0086 9

The effectiveness of Chinese herbal medicine (CHM) for relief of menopausal symptoms in women over 18 years

of age was reviewed by Zhu et al. (2016) in this Cochrane review. Twenty-two randomized controlled trials

(n=2902) met inclusion criteria. CHM was compared to placebo, hormone therapy (HT), pharmaceutical drugs,

acupuncture, or another CHM formula. There was insufficient evidence that CHMs were any more or less

effective than placebo or HT for the relief of vasomotor symptoms. Effects on safety were inconclusive. The

quality of the evidence ranged from very low to moderate. Li et al. (2016) reported that analysis of nine

randomized controlled trials (n=861) showed limited evidence to assess the effectiveness of CHM for

unexplained recurrent miscarriage. No data were available to assess the safety of the intervention for the mother

or her baby. There were no data relating to any of the secondary outcomes including obstetrical and other

complications for the mother, infant death, perinatal complications, and congenital malformations.

Chen et al. (2016) assessed the efficacy and possible adverse effects of the addition of Chinese herbal medicine

to treatment with radiotherapy or chemotherapy for esophageal cancer. Nine randomized controlled trials

(n=490) were included in this Cochrane review and the authors found no evidence to determine whether

traditional Chinese medicine (TCM) was an effective treatment for esophageal cancer. The effect of TCM on

short-term therapeutic effects was uncertain.

Two Cochrane systematic reviews of randomized or quasi-randomized controlled trials reported on the effects of

Chinese herbal medicine (CHM) for the treatment of endometriosis and threatened abortion. Although two

studies (n=158) suggested that CHM might be useful in relieving endometriosis pain, the trials were of poor

methodological quality and the authors noted that the outcomes “must be interpreted cautiously” (Flower, et al.,

2012). Li et al. (2012) investigated the effects of CHM for the treatment of threatened abortion. A total of 44 trials

(n=5100) met inclusion criteria. There was insufficient evidence to assess the effectiveness of CHM alone for this

indication.

Polarity Therapy: Polarity therapy is a comprehensive health system involving energy-based bodywork, diet,

exercise, and self-awareness. It works with the human energy field and the electro-magnetic patterns expressed

in mental, emotional, and physical experience. Claims that polarity therapy is an effective treatment for cancer

and other serious diseases have not been proven.

Biologically-Based Practices

Antineoplastons: Antineoplastons are a group of synthetic compounds originally isolated from human blood

and urine. They include five urinary antineoplastons (i.e., A–1 to A–5) that have been theorized as having

antineoplastic activity against cancer. Antineoplastons are not approved for use by the FDA. The National

Cancer Institute (NCI) (2019) stated that antineoplastons are an experimental cancer therapy proposed to

provide a natural biochemical substance that is lacking in the body in people with cancer. According to NCI

(2019), no randomized controlled trials showing the effectiveness of antineoplastons have been published in the

peer-reviewed scientific literature.

Auto Urine Therapy: Auto urine therapy purports to purge embedded toxins and parasites from the colon,

bloodstream, arteries, and internal organs simply by drinking one’s own urine. There is insufficient evidence to

support the effectiveness of this therapy.

Cellular Therapy: Cellular therapy, also called live cell therapy, cellular suspensions, glandular therapy, fresh

cell therapy, sicca cell therapy, embryonic cell therapy and organotherapy, refers to various procedures in which

processed tissue from animal embryos, fetuses or organs is injected or taken orally. Those who practice cell

therapy believe that cell therapy acts like an organ transplant, having a rejuvenation effect.

Zhang et al. (2017) conducted a systematic review and meta-analysis to evaluate the safety and efficacy of

cellular therapy for the treatment of diabetic foot ulcer. Six randomized controlled trials (n=241) met inclusion

criteria. Outcomes included ankle-brachial index (ABI), amputation-free survival (AFS), transcutaneous oxygen

tension pressure (TcPO2), ulcer healing rate at 12 to 24 weeks post transplantation, pain scales and adverse

events. Two studies used mesenchymal stem cells from bone marrow or umbilical cord, three used mononuclear

cells (MNCs) from bone marrow or peripheral blood, and one study used bone marrow-derived mesenchymal

stem cells (BMMSCs) and bone marrow-derived MNCs (BMMNCs). The outcomes revealed that significant

improvements were seen in the ABI (five studies), TcPO2 (three studies), pain scores (three studies), AFC (four

EVERNORTH Coverage Policy: EN0086 10

studies) and ulcer healing rate (three studies). No serious complications were reported. Limitations of the studies

include: the limited number of studies, small patient populations (n=6–74), short-term follow-ups (12-24 weeks),

heterogeneity of cells used, variability of measurements and criterion of ulcer healing and baseline ulcer

conditions that would affect outcomes were not reported in some studies, and lack of information on allocation

concealment.

Chahla et al. (2016) conducted a systematic review to assess the safety and efficacy of cellular therapy as an

intra-articular injection of the knee for the treatment of osteoarthritis (n=124 knees) and focal cartilage defects

(n=176 knees). Four randomized controlled trials without blinding, one prospective cohort study, and one

retrospective therapeutic case-control study met inclusion criteria. Although some of the data suggested modest

improvement, a placebo effect could not be disregarded. The overall quality of the literature was poor, and the

methodological quality was fair. The data did not support cellular therapy for these indications.

Coley's Toxin: Coley's Toxin, also known as mixed bacterial vaccine (MBV) and Issel’s fever therapy, is a

treatment for cancer devised by Dr. William Coley. The toxins are the fluids derived from a bacterial culture of

two microorganisms, streptococcus pyogenes and serratia marcescesn, and are injected into affected tissue to

initiate a high fever, causing necrosis of cancer tissue. A major problem reported with bacterial therapy is their

toxicity when used at the dose required for therapeutic efficacy, including the risk of systematic toxicities (Patyar,

et al., 2010).

Hydrogen Peroxide: Hydrogen peroxide given intravenously is proposed to kill or inhibit bacteria and viruses,

precluding the need for antibiotic therapy. It may be given as a treatment for the common cold, influenza, and

sinus infections. It is also proposed by some as a treatment modality for acquired immune deficiency syndrome

(AIDS) and cancer.

Immunoaugmentative Therapy (IAT): IAT is an experimental form of cancer immunotherapy consisting of daily

injections of processed blood products. It is a developing treatment for mesothelioma that seeks to strengthen

the body's natural immune system by balancing four blood proteins.

Kelley-Gonzales Therapy: Kelley-Gonzales Therapy is based on belief in a relationship between diet and

detoxification with coffee enemas. According to Kelley, all cancers are one disease caused by a deficiency of

protein digestive enzymes which allows cancer cells to grow.

Laetrile: Laetrile is the trade name for laevo-mandelonitrile-beta-glucuronoside. The compound is chemically

related to amygdalin, a substance found naturally in the pits of apricots and various other fruits. Laetrile is

proposed for the treatment of cancer due to its ability to selectively kill cancer cells without being toxic to normal

cells. According to NCI (2017, updated 2019), Laetrile/Amygdalin is not approved for use in the United States

and has shown little anticancer activity in animal studies and no anticancer activity in human clinical trials. NCI

notes that inappropriate advertisement of laetrile as a cancer treatment has resulted in a U.S. Food and Drug

Administration investigation that culminated in charges and conviction of one distributor.

Milazzo and Horneber (2015) conducted a Cochrane systematic review of the literature to assess the proposed

anti-cancer effect and adverse effects of laetrile and amygdalin. Sixty-nine randomized controlled trials (RCTs)

and quasi-RCTs were identified but none met the inclusion criteria. Therefore, beneficial effects of laetrile for

cancer patients could not be recommended. According to the authors, there is a considerable risk of serious

adverse effects from cyanide poisoning after laetrile, especially after oral ingestion. The risk-benefit balance of

laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

Megavitamin Therapy: Megavitamin therapy, orthomolecular medicine, megamineral therapy, intravenously or

orally, is the use of vitamins, minerals, or hormones in amounts considerably greater than the recommended

daily allowance in the belief that abundant use of vitamins can prevent or cure various ailments. An example of

megavitamin therapy is the Myers’ Cocktail, which is the intravenous infusion of a combination of Vitamins B1,

B2, B3, B5, B6, B12, Vitamin C, magnesium, and calcium. The solution is proposed for the treatment of fatigue,

fibromyalgia, migraines, allergies, and many other conditions (Ali, et al., 2009). There is a lack of evidence that

megavitamin therapy improves health outcomes.

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MTH-68: MTH-68 (i.e., more than hope-68) vaccine is a nonpathogenic virus (i.e., Newcastle disease virus

[NDV]) that is believed to interfere with cancer growth in humans. The virus is reported to enhance the immune

system and selectively kill cancer cells. According to the NCI, NDV-based anticancer therapy has been reported

to be of benefit in more than a dozen clinical studies, but the results of these studies must be considered

inconclusive because the study designs were weak, and the study reports were generally incomplete (NCI,

2018).

Over-the-Counter Biologics: Although proposed for a variety of conditions, over-the-counter biologics are not

supported by the peer-reviewed evidence to have a positive impact on health care outcomes. Over-the-counter

biological products include the following (this list may not be all inclusive):

• Actra-Rx (Yillshen)

• Apitherapy

• Aromatherapy

• Bilberry

• Black Cohosh (cimicifuga racemosa, rattle root, snake root)

• Bovine Cartilage Products

• Cancell/Entelev (Sheridan’s Formula, Jim’s Juice, Crocinic Acid, JS–114, JS–101, 126–F, Cantron)

• Cat’s Claw (uncaria tomentosa)

• Coenzyme Q10 (CoQ10, Q10, vitamin Q10, ubiquinone, ubidecarenone)

• Coriolus (versicolor, trametes versicolor, Yun Zhi)

• Echinacea

• Essiac

• Fish Oil

• Flower Essence

• Gerson Therapy

• Ginkgo Biloba (maidenhair tree)

• Glucosamine

• Hoxsey Herbal Therapy

• Hydrazine Sulfate (sehydrin)

• Kava (piper methysticum)

• Lorenzo’s Oil

• Milk Thistle (silybum marianum; silymarin)

• Mistletoe (Iscador

)

• Saw Palmetto

• 714-X

• Shark Cartilage Products

• St. John’s Wort

• Valerian (Valeriana officinalis)

• Yohimbe

Ozone Therapy: Ozone therapy is also known as oxygen therapies or oxidative therapies. The delivery method

of ozone traditionally takes one of three forms: gaseous ozone exposure within a hyperbaric chamber, ozonated

oils, and ozonated water. Ozone therapies include the following: autohemotherapy, auricular insufflation,

colonics, intramuscular, intra-arterial, ozonated olive oil, ozonated steam, ozonated water, rectal insufflation, and

hydrogen peroxide. It is proposed that the extra oxygen increases the body's ability to destroy disease-causing

cells but scientific evidence supporting this claim is lacking. Ozone therapy has been proposed for the treatment

of various conditions including painful temporomandibular joint (TMJ) disorder (TMD), diabetic foot ulcers, acute

back pain, lumbar disc herniation, back pain, and hearing loss. However, there is insufficient evidence to support

the clinical benefit of ozone therapy.

Sconza et al. (2021) conducted a systematic review of randomized controlled trials for the application of oxygen-

ozone therapy in the treatment of lower back pain. Fifteen studies (n=2,597) met the inclusion criteria of

randomized controlled trials published in the last 20 years dealing with oxygen-ozone therapy in patients with

lower back pain and herniated disc, comparing the results with those of other treatments. Patients in the control

groups received different treatments including corticosteroids, analgesic therapy, placebo, microdiscectomy,

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laser-therapy, TENS and postural rehabilitation, percutaneous radiofrequency intradiscal thermocoagulation, and

psoas compartmental block. The primary outcome of the present review was the analysis of patient’s reported

subjective scores and pain at six months’ follow-up. Looking at the quality of the literature, none of the studies

included reached “good quality” standard. Comparison of oxygen-ozone therapy results with other approaches

showed that, in the majority of studies, oxygen-ozone therapy was superior to the control treatment, and also

when compared to microdiscectomy, ozone showed non inferiority in terms of clinical outcomes. No major

complications or serious adverse events were reported in any of the trials included. Limitations of the studies

include heterogeneity of the treatment regimen, heterogeneity of the assessment methods, lack of comparison

with sham or consistent comparator, and unclear or high risk of bias in most categories. Although oxygen-ozone

therapy appears to be a safe treatment with beneficial effects, the quality of the evidence is poor.

Fitzpatrick et al. (2018) conducted a systematic review and meta-analysis of randomized controlled trials to

evaluate the safety and efficacy of ozone therapy for the treatment of chronic wounds. Nine studies (n=453) met

inclusion criteria and investigated the use of ozone therapy in the topical treatment of chronic wounds (e.g., war

wounds, burns, and non-healing diabetes, venous, or arterial ulcers). Primary outcomes included: the number of

ulcers completely healed, change in wound size, presence, or absence of biomarkers in favor of healing, and for

diabetic foot ulcers the general appearance of the wound as assessed by Wagner’s ulcer classification scale.

Secondary outcomes included the complications of pain, toxicity, amputation, infection, and developed

pathologies. Meta-analysis revealed a significant (p<0.05) improvement in wound closure (wound healing and

percent wound closure). However, there was no conclusive evidence that ozone therapy was superior to

standard treatments. No adverse events from the ozone therapy were reported. Limitations of the studies include

heterogeneous small patient populations; heterogeneity of the treatment regimen (e.g., ozone concentration,

treatment duration, frequency of treatment) and type of wounds; and moderate to high risk of bias in the majority

of studies. Due to the heterogeneity of the studies, firm conclusions could not be made regarding the

effectiveness of ozone therapy for the treatment of chronic wounds.

Li et al. (2018) conducted a systematic review and meta-analysis to investigate the safety and efficacy of intra-

articular hyaluronic acid (HA) and oxygen-ozone for the treatment of knee osteoarthritis (OA). Four randomized

controlled trials (RCTs) met the following criteria: age 18 years or older; diagnosis of end-staged knee OA;

intervention groups received intra-articular HA for pain management; control groups received intra-articular

oxygen-ozone therapy; outcomes were pain, stiffness, and function using the visual analog scale (VAS), the

Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire; and adverse effects. There

was no significant difference between the groups regarding VAS at three months follow-up (p=0.202). There was

significant heterogeneity of the studies (p<0.0001). Four studies showed no significant difference in VAS

between the groups at six months (p=0.255). There was no significant difference in WOMAC pain scores at six

months (p=0.380). Based on four RCTs the outcome of WOMAC for stiffness at six months was significantly

improved in favor of HA (p=0.013), but there were no significant differences in WOMAC function (p=0.037) and

adverse events (p=0.837). Limitations of the analysis include: the limited number of studies, small patient

populations; heterogeneity of the studies (e.g., doses of medication, patient characteristics) and short-term

follow-ups. This meta-analysis does not support ozone therapy for the treatment of knee OA.

Liu et al. (2015) conducted a Cochrane systematic review to assess the effectiveness of ozone therapy for the

treatment of foot ulcers in diabetics. Three (n=212) randomized controlled trials “with unclear methodology” met

inclusion criteria. Ozone treatment was compared to antibiotics, and usual care vs. usual care plus ozone

therapy. The use of ozone did not appear to affect the number of ulcers healed or make a difference in the

reduction of the ulcer area.

Magalhaes et al. (2012) conducted a systematic review and meta-analysis to evaluate the effectiveness of

percutaneous injections of ozone for the treatment of low back pain secondary to disc herniation. Four

randomized controlled trials (n=306) and eight observations studies (n=6699) met inclusion criteria. From the

randomized studies, intervention was found to be superior to the control (e.g., sham, steroid, or steroid with local

anesthetic) (p<0.00001). Overall, the observational studies revealed positive results for short- and long-term

relief of pain. Complications were rarely documented. The indicated level of evidence for long-term pain relief

(≥ 6 months) was II-3 (evidence from diagnostic studies of uncertainty); for ozone therapy applied intradiscally, II-

1 (evidence from at least one properly conducted diagnostic accuracy study of adequate size); for ozone therapy

applied paravertebrally; 1C (strong recommendation, low-quality or very low quality evidence) for intradiscal

ozone therapy; and 1B (strong recommendation, moderate quality evidence) for paravertebral ozone therapy.

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Limitations of the studies included a lack of precise diagnosis, use of mixed therapeutic agents, and short-term

follow-up.

Revici’s Guided Chemotherapy: Revici's guided chemotherapy, also known as biologically guided

chemotherapy, Revici’s cancer control, lipid therapy, or Revici’s method, is a chemical therapy given by mouth or

injection. It is promoted as an alternative cancer treatment, as well as treatment for heart disease, arthritis, AIDS,

chronic pain, drug addiction, injury from radiation, and schizophrenia. The therapy varies for every patient but

can include a chemical formulation consisting of lipid alcohols, caffeine, zinc and iron, or a formulation consisting

of fatty acids, selenium, magnesium, and sulfur.

Trichuris Suis Ova Therapy: Trichuris suis ova, T suis ova, ova worm, or porcine whipworm, therapy is a form

of helminth immunomodulation or ova therapy. Helminths (i.e., worms) have the capacity to prevent excessive

inflammatory responses and inhibit immune responsiveness, including gastrointestinal inflammation as seen in

ulcerative colitis and Crohn’s disease (Schölmerich, et al., 2017; Summers, 2007). Ova therapy is also being

evaluated for the treatment of multiple sclerosis, allergic rhinitis, and autism spectrum disorders (Rosche, et al,

2013; Siniscalco and Antonucci, 2013). Evidence supporting the safety and clinical effectiveness of this therapy

is lacking.

Huang et al. (2018) conducted a systematic review and meta-analysis of randomized controlled trials to assess

the effectiveness of Trichuris suis ova (TSO) for the treatment of inflammatory bowel disease (IBD). Six

randomized controlled trials (RCTs) that compared TSO therapy with placebo were included. Three of the

included studies were registered clinical trials. Outcomes included efficacy and safety. There was no significant

difference (p>0.26) in remission and response rates for the treatment of ulcerative colitis (3 RCTs; n=74). Nine

patients in each group experienced one adverse event. Three studies (n=538) investigated TSO for the

treatment of Crohn’s disease study. There was no significant difference in remission and response rates

between the two groups. Studies were limited by the small patient populations and short-term follow-up of 12

weeks and sparse data were lacking on adverse events (gastrointestinal signs and symptoms). Meta-analysis

could not draw a conclusion regarding TSO dosage due to the limited data. There was no statistically significant

clinical benefit using TSO for the treatment of IBD.

Bager et al. (2010) conducted a randomized controlled trial to determine the efficacy of T suis ova for the

treatment of allergic rhinitis (n=100). No therapeutic effect was reported and significant gastrointestinal adverse

events (p=0.007) (e.g., diarrhea and abdominal pain) occurred in 76% of the T suis group compared to 49% in

the placebo group. Summers et al. (2005) (n=54) reported at 12-weeks follow-up that a significant improvement

(p=0.4) was seen with ova therapy compared to placebo in patients with active ulcerative colitis. The placebo

group showed significant improvement in stool frequency (p=0.0488) compared to baseline. Limitations of the

study include the small patient population and the short-term follow-up.

Energy Medicine

Acupressure: Acupressure is an ancient Chinese technique based on the principles of acupuncture, and

involves the use of finger pressure, without needles, on specific points along the body. It is a proposed way of

accessing and releasing blocked or congested energy centers in the body. Chinese cultures believe the points to

be junctures of meridian pathways that carry energy called “chi.” Teishin, also called needleless acupuncture, is

an example of an acupressure therapy.

Clinical trials have been conducted investigating acupressure for various conditions including weight loss

(Huang, et al., 2019), chronic low back pain (Godley and Smith, 2020), allergic rhinitis, labor pain, initiation of

labor, cancer-related pain, nausea and vomiting, dysmenorrhea, glaucoma, insomnia, cognitive function of older

adults, uremic pruritus, and end-stage renal disease. Limitations of the studies included: small patient

populations, short-term follow-ups, conflicting outcomes, no significant improvement, or some improvement but

concluding that additional research is needed comparing acupressure to sham for definitive conclusions.

Chen et al. (2021) performed a systematic review and meta-analysis of randomized controlled trials to evaluate

acupressure in combination with standard procedures during labor and delivery, compared with standard

procedures with/without sham acupressure. Thirteen RCTs (n=1586) met criteria resulting in moderate evidence

indicating that acupressure may have promising effects on labor pain and duration. There were no adverse

events, but the data was inconclusive on how acupressure affects Cesarean sections rates. Makvandi et al.

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(2016) previously conducted a systematic review and meta-analysis (n=13 studies) of randomized controlled

trials (RCTs) to assess the evidence regarding the effects of acupressure on duration of labor and mode of

delivery. Studies were included if they examined the effect of acupressure at any acupoint during childbirth for

these indications. The results were that acupressure increased the chance of vaginal delivery when compared

with placebo/no intervention (p=0.002) and decreased the duration of the active phase by 1.310 hours (p=0.001)

and the second stage of labor by 5.808 minutes (p=0.001). However, there were several limitations to the studies

including: high risk of bias; inadequate and/or unclear allocation concealment; and significant heterogeneity

between the studies regarding the research questions, study design, intervention protocols, and outcome

measures. Conclusions from Chen et al. and Makvandi et al. were that more high-quality trials are needed to

support these findings.

In a randomized controlled trial (n=162), Torkzaharni et al. (2017) reported that the use of acupressure vs.

acupressure sham and control showed no significant differences between the groups in spontaneous initiation of

labor.

Hmwe et al. (2016) conducted a systematic review of the literature to evaluate the effectiveness of acupressure

in promoting sleep quality in adults. Eight randomized controlled trials met inclusion criteria. The studies were

conducted in hemodialysis units, long-term care facilities, nursing homes, psychogeriatric inpatients, and in a

cardiology outpatient department. Comparators were routine care or conventional medical treatment, sham,

transcutaneous electrical acupoints stimulation or acupressure with light touch. The results showed that the

quality of sleep was significantly improved in the acupressure group compared with usual care, but there was no

difference between the acupressure and sham acupressure groups. The studies were limited by the small patient

populations, heterogeneity of acupoints and methodological limitations and unclear risk of bias. Further studies

with well-designed trials are needed to confirm the efficacy and safety of acupressure for sleep.

Matthews et al. (2014; reviewed 2015) conducted a systematic review of randomized controlled trials to assess

the safety and effectiveness of various types of interventions for nausea, vomiting and retching in early

pregnancy. Of the 41 trials that met inclusion criteria, five studies used acupressure. Four of the studies

compared P6 acupressure to placebo and there were no statistically significant effects with acupressure.

Biofield Therapeutics: Biofield therapeutics, also called energy healing or “laying on of hands” (e.g., healing

touch, spiritual touch), is one of the oldest forms of untested healing known to humankind. It involves the transfer

of energy from healer to patient and the manipulation of the human body’s energy fields (Jain and Mills, 2010).

Crystal Healing: Crystal healing is the belief that certain stones and crystals contain special healing energy that

can be transferred into people to provide protection against illness and disease and provide spiritual guidance.

Multiple types of crystals are proposed for healing of all types of conditions and diseases (e.g., amethyst for

headaches and balancing blood sugar and aquamarine for heart and immune system problems).

Cupping: Cupping uses one of several types of cups (e.g., glass, bamboo) placed on the desired acupoints of

the skin to make a local place of hyperemia or hemostasis for the purpose of curing disease (e.g., fibromyalgia,

knee osteoarthritis, low back pain, urticaria, asthma, cough, herpes zoster). There are several types of cupping

including: retained cupping, flash cupping, water cupping, bleeding or wet cupping, moving cupping, needle

cupping, medicinal or herbal cupping, and combined cupping (Li, et al., 2017; Al Bedah, et al. 2016; Cao, et al.,

2012).

Ma et al. (2018) conducted a systematic review and meta-analysis of five randomized controlled trials (n=564) to

assess the effectiveness of cupping for the management of ankylosing spondylitis (AS). Studies were included if

cupping therapy was used as the sole intervention or as an adjunct therapy in conjunction with Western medicine

therapy and patients were diagnosed with AS using definitive modified New York criteria. The primary outcome

was the functional condition measured by recognized scales including the Bath Ankylosing Spondylitis

Functional Index (BASFI). Other outcomes were disease activity as measured on the Bath Ankylosing Disease

Activity Index (BADAI), and serum levels of erythrocyte sedimentation rate (ESR) and C reactive protein (CRP).

Four studies (n=294) showed cupping plus Western medicine had a significantly better response rate than

Western medicine alone (p<0.001). Three RCTs (n=242) showed significantly better BASFI (p<0.001), BASDAI

(p<0.01), ESR (p<0.01), and CRP (p<0.01) outcomes with Western medicine plus cupping. Limitations of the

analysis include the limited number of studies with small patient populations, high risk of bias, and lack of

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blinding to the intervention. The authors noted that caution must be taken when attempting to generalize the

results of this systematic review due to the low quality of the studies and that the power of the analysis based on

small sample size effects may be exaggerated. Most of included RCTs were conducted on Chinese populations

making it difficult to apply the result to the general population.

Al Bedah et al. (2016) conducted a systematic review to evaluate the safety and efficacy of wet cupping.

Fourteen randomized controlled trials (n=863) met inclusion criteria. The included studies evaluated wet cupping

for multiple conditions including: nonspecific low back pain (three studies), hypertension (one study), brachialgia

(one study), carpal tunnel syndrome (one study), chronic neck pain (two studies), metabolic syndrome (one

study), migraine headaches (one study), oxygen saturation in smokers with chronic obstructive pulmonary

disease (one study), physiologic and biochemical parameters of healthy individuals (two studies) and oral and

genital ulcers due to Behcet disease (one study). Outcomes were conflicting with nine studies favoring cupping

for various conditions and five studies reporting no statistically significant difference was seen when cupping was

used. Adverse effects included fainting, discomfort, headache, skin laceration, whole body itching, pain,

generalized body pain, circulatory instability, migraine attack, repeating tinnitus, and wound-healing itch.

Limitations of the studies included the heterogeneity of the conditions, limited number of studies per condition,

variable risk of bias, small patient populations (n=20–126) with no power of calculations, heterogeneity of

treatment regimens (e.g., number of sessions, length of each session; frequency of sessions) and comparators

(e.g., acetaminophen; conventional treatment, no treatment), lack of blinding and no control for placebo effect.

Due to the limitations of the studies and poor overall methodology, firm conclusions could not be made regarding

the clinical effectiveness of wet cupping.

In a systematic review of 135 randomized controlled trials (RCTs) (Cao, et al., 2012) cupping therapy (mainly wet

cupping) was used for the treatment of “herpes zoster, facial paralysis (Bell’s palsy), cough and dyspnea, acne,

lumbar disc herniation, and cervical spondylosis”. Data on cupping therapy combined with other treatments, such

as acupuncture or medications, showed significant benefit (e.g., p<0.00001) over other treatments used alone in

the treatment of herpes zoster, acne, facial paralysis, and cervical spondylosis. Despite the number of RCTs

included in this analysis, the authors stated that there was a lack of well-designed studies and 84.4% of the

studies were at high risk of bias. Additional limitations of the studies included: lack of blinding, especially of

outcome assessors and statistics; lack of reporting of methodology details; and heterogeneity of treatment

regimens.

Gemstone Therapy: Gemstone therapy is an alternative technique proposed for strengthening the body and

resolving issues and patterns. It is based on the theory that gemstones carry vibrational rates and, when placed

within a person’s aura, can change the person’s vibrational rates.

Magnet Therapy: Magnet therapy may also be referred to as biomagnetic therapy, magnetherapy,

magnotherapy, static magnetic field therapy, or therapeutic magnets. The therapy involves static (unmoving)

magnets and is claimed to have healing powers. These therapeutic magnets are typically integrated into

bracelets, rings, shoe inserts, magnetic mattresses and clothing. Some health care providers claim that magnets

can help broken bones heal faster, but most proponents advocate that the magnets relieve pain.

Arabloo et al. (2017) conducted a technology assessment of systematic reviews of randomized and non-

randomized studies that compared magnet therapy with other conventional therapies for the treatment of local

pain. Eight studies met inclusion criteria. Magnet therapy was investigated for the treatment of pain in various

organs, arthritis, myofascial muscle pain, lower limb muscle cramps, carpal tunnel syndrome and pelvic pain.

Comparators included placebo, weak magnet, sham, chiropractic therapy, and traditional therapies. According to

the results, magnet therapy was not an effective treatment for relieving different types of pain.

Magnetic Resonance Therapy (MRT): MRT, based on nuclear magnetic resonance imaging (MRI), uses low

frequency, nuclear electromagnetic fields to redirect molecular activity in the body. The electromagnetic fields

generated by an MRT device are around 10,000 times weaker than those used in MRI. MRT is based on the

theory that the human body is controlled by electric and magnetic fields. When there is tissue damage there is

interference with the normal body healing signals, inhibiting healing and tissue repair. MRT is proposed to

redirect the abnormal signals into normal, healthy signals by exposing and acting on the nuclei of hydrogen

atoms. This in turn is proposed to stimulate the regeneration and repair of cartilage and bone tissue. MRT is

proposed for the treatment of multiple conditions including arthritis, osteoporosis, ligament and tendon injuries,

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sports injuries, degenerative spine disease, autism, and posttraumatic stress syndrome. Specific devices have

been developed to treat different areas of the body and to treat specific conditions. Examples of these external

devices include MBST

Nuclear Magnetic Resonance Therapy, MBST

OpenSystem 350, and MBST

OpenSystem 700 (MedTec Medizintechnik, Germany). Other devices include the Magnesphere

™

and Halo

™

Home Unit (Pico-Testa Magnetic Therapies, LLC, Clearwater, FL). MRT is a patented technology. Treatment is

typically given daily in one-hour sessions for 5–10 consecutive days (Kernspin MBST, 2019).

There is insufficient evidence in the published, peer-reviewed literature to support the effectiveness of MRT for

any indication. Published studies have primarily been in the form of retrospective reviews, case reports and case

series with small, heterogeneous patient populations (e.g., n=21-103) and short-term follow-ups (≤12 months)

(Krpan, et al., 2015; Taghva, et al., 2015; Kullich, et al., 2013). Overall, randomized controlled trials have

reported no significant difference in outcomes with MBST vs. placebo.

Goksen et al. (2016) conducted a randomized controlled trial (n=97) to evaluate the efficacy of therapeutic

nuclear magnetic resonance (MRT) for the treatment of mild to moderate osteoarthritis (OA) of the knee.

Inclusion criteria included: age 35–75 years, symptomatic OA of a single knee, and radiological stage II or III

according to Kellgren and Lawrence scale. Patients received ten, one-hour daily sessions of MRT on weekdays.

Follow-ups occurred at two weeks and 12 weeks. Pain outcomes were measured by Visual Analogue Scale

(VAS), quality of life by the SF-36 and physical function by the Western Ontario and McMaster Universities

Arthritis Index (WOMAC). Ultrasound, magnetic resonance imaging and radiography were also used for knee

evaluation. At weeks two and 12 following treatment, significant improvements were reported in both groups

regarding pain, stiffness, physical functions and quality of life scores, but there were no significant differences

between the groups. There were no significant differences in ultrasonographic measurements and MRI Whole-

Organ Magnetic Resonance Imaging Scores (WORMS) or acetaminophen usage between the groups. No

adverse events were reported. This study showed that MRT was not superior to placebo in the treatment of OA

of the knee. Author-noted limitations included failure to use objective measurements like gait analysis, walking

distance, number of steps without pain and lack of evaluation of pre- and post-range knee joint motions. It was

also questioned if a ten-day course was the correct dosage to assess benefits and harms of MRT.

Salfinger et al. (2015) conducted a randomized controlled trial to assess the efficacy of therapeutic nuclear

magnetic resonance (tNMR) for lumbar radicular syndrome (LRS) in patients (n=94) with lumbar disc herniation.

Patients were randomized to the treatment group (n=48) or the control group (n=46). In addition to standard,

conservative therapy, the treatment group also received seven sessions of tNMR. Patients were included who

presented with lumbar disc herniation within 12 weeks of inclusion, radiation of pain into one or both legs and

clinical signs of a radicular lesion. Seven treatments on consecutive days were administered. Visual Analogue

Scale (VAS) scores improved significantly in both groups (p<0.000). The intensity of morning and evening pain

decreased significantly in both groups (p<0.000) with a statistically significant difference in pain perception in

favor to the treatment group in week four. Before and after week four, no statistically significant differences were

noted between the groups. There were no significant differences between the groups in the SF-36 physical

component and mental component scores or the Roland Morris Disability Questionnaire (RMDQ) scores. There

was no statistically significant difference in NSAID intake, but there was a significant decrease in the use of

opiates in both groups (p=0.05 in study group; p=0.024 in placebo group). Three months following therapy,

patients in the tNMR group reported a statistically significant lower duration of sick leave (p=0.026) compared to

the control group. Both groups reported fewer absences but there was no significant difference between the

groups. Fourteen patients dropped out of the study (13%). Overall, tNMR did not result in significant

improvements as an adjunctive therapy for this patient population.

Kullich et al. (2006) conducted a randomized controlled trial to evaluate the effects of adjunctive MBST

(n=30)

compared to placebo (n=32) for the treatment of chronic low back pain. Patients had been admitted for three-

weeks of inpatient rehabilitation therapy. Treatment was given for one hour on five consecutive days. Both

groups reported a significant improvement in reduction in the Visual Analogue Scale (VAS) starting at week one

following treatment. The MBST group maintained the improvement in pain under stress at the three-month

follow-up, but the placebo group did not. Neither group maintained significant improvement in pain at rest three

months after therapy. The MBST group showed a signification improvement (p<0.001) in the total Oswestry

score at three months compared to the placebo group. The placebo groups showed a significant improvement at

week one (p<0.05), but the improvement was not maintained. Both groups showed comparable improvement in

the walking and sleeping sections of the Oswestry Questionnaire at the three-month follow-up. No adverse

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events were reported. Limitations of the study include the small patient population, short-term follow-up and

patients were part of an inpatient rehabilitation program with multiple other therapies.

Meridian Therapy: Meridian therapy or the knowledge of meridians, a self-healing system, focuses on

maintaining balance between body organs, and emotional and spiritual elements. Reflexologists propose that

keeping the body’s vital energies flowing aids the body in self-healing. Studies primarily include small patient

populations and short-term follow-up with lack of a sham comparator (Pan, et al., 2016). Evidence supporting the

clinical effectiveness of meridian therapy for the treatment of pain and other conditions is lacking.

Millimeter Wave Therapy: Millimeter wave therapy uses low-power millimeter wave (MW) irradiation to treat a

variety of conditions ranging from skin diseases and wound healing to various types of cancer, gastrointestinal

and cardiovascular diseases and psychiatric illnesses.

Moxibustion Therapy: Moxibustion is a variation of acupuncture and involves the application of heat from the

burning of the herb moxa (i.e., Artemisia vulgaris or mugwort) at the acupuncture point. The ingredients of moxa

smoke include terpene compounds, aliphatic hydrocarbons, alcohols, aromatic hydrocarbons, and their oxides.

Indirect moxibustion involves placing an insulating material (e.g., ginger, salts) between the moxa cone and skin.

Moxibustion has been proposed for the treatment of pain, joint soreness (e.g., osteoarthritis) and for other

conditions such as hypertension and cancer.

Systematic reviews and meta-analysis of randomized controlled trials have investigated moxibustion for the

treatment of heart failure (Liang, et al., 2019), polycystic ovary syndrome (Kwon, et al., 2018), spasticity following

stroke (Yang, et al., 2018), chronic fatigue syndrome (Wang, et al., 2017), primary insomnia (Sun, et al., 2016),

osteoarthritis (Li, et al., 2016; Song, et al., 2016; Choi, et al., 2012), hypertension (Kim, et al., 2010) and

ulcerative colitis (Lee, et al., 2010a), for stroke patients to improve motor and/or urinary function during

rehabilitation (Lee, et al., 2010b), as well as for the relief of chemotherapy side effects in cancer patients (Lee, et

al., 2010c). Firm conclusions regarding significant effectiveness of moxibustion cannot be made due to the

limitation of the studies which included: small patient populations; high risk of bias; lack of reporting of adverse

events (e.g., second degree burns, pruritus); heterogeneity of treatment regimens (e.g. stimulating process,

original materials, duration, frequency, selection of acupoints) and control groups; and the low methodological

quality of the studies. Overall moxibustion is not recommended for these indications.

Qigong Longevity: Qigong longevity exercise, or qigong (alternatively spelled chi gung or chi kung), is a

component of traditional Chinese medicine that combines movement, meditation and regulation of breathing to

enhance the flow of Qi (an ancient term given to what is believed to be vital energy) in the body, improve blood

circulation and enhance immune function. Qigong has been proposed for the prevention of disease (e.g., stroke)

and for treatment of various symptoms, conditions and diseases including fatigue, sleep, cognitive function,

cancer and chemotherapy related symptoms, diabetes mellitus, hypertension, Parkinson disease, infectious

diseases and chronic obstructive lung disease (Meng, et al., 2018; Lauche, et al., 2017; Van, et al., 2017; Wang

et al., 2012). Due to the poor quality of the studies and high risk of bias, the effectiveness of Qigong has not

been established.

Reiki: Reiki is a Japanese word representing universal life energy. Reiki is based on the belief that when

spiritual energy is channeled through a Reiki practitioner, the patient's spirit is healed, which in turn heals the

physical body. Systematic reviews have been conducted to assess the therapeutic effect of Reiki, including pain

control, but firm conclusions regarding its clinical effectiveness have not been established due to the limited

number of studies, small patient populations, poor study methodology, various outcome measures and the

possibility of a high level of bias (Demir, 2018; VanderVaart, et al., 2009).

Therapeutic Touch: Therapeutic Touch assumes the human energy field is abundant and flows in balanced

patterns in health but is depleted or unbalanced in illness or injury. Practitioners believe they can restore health

by sensing and adjusting such fields.

Manipulative and Body-Based Methods

Alexander's Technique: Alexander's technique seeks to rectify learned habits by reteaching the most basic

elements of movement, posture and alignment. Practitioners expect improved coordination and balance, ease of

movement, greater flexibility, reduction of tension and pain relief as the most basic benefits.

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AMMA Therapy

AMMA Therapy,

an integration of Chinese medical principles, is a specialized form of

massage that focuses on the balance and movement of energy within the body. Hand techniques are used to

balance the flow of energy in the channels of the body through which energy passes. The therapist relies on the

sensitivity and strength of hand massage and manipulation of the energy movement.

Bio Photonic Lymphatic Drainage

Treatment (BELD): BELD (Center for Natural & Integrative Medicine,

Orlando FLA) is a proprietary therapeutic technological device proposed for removing blockage from the

lymphatic system by repolarizing proteins throughout the body. The reversal of the polarity is proposed to

remove blockages and allow elimination of toxins from the body through the urine. BELD is recommended for

many conditions including breast lumps, inflammation, chronic pain, joint pain, allergies, sinus pressure and

infections, respiratory problems, headaches, prostate problems, hormone imbalance, chronic female conditions,

dental trauma, heavy metal toxicity, neuromuscular, immune and fatigue syndromes. BELD is proposed to be

more effective than manual massage. There is a lack of evidence in the published, peer reviewed literature to

support the safety and efficacy of Bio-Photonic Lymphatic Detoxification and Drainage for any indication.

Colonic Irrigation, Colonic Lavage, Colonic Cleansing: Colonic irrigation, colonic hydrotherapy, or colonic

lavage involves inserting a tube into the rectum and gently flushing it with water. Colonic cleansing involves

ingesting a variety of powdered or liquid laxative substances. These methods are proposed for cleansing the

colon of waste and toxic materials.

Craniosacral Therapy: Craniosacral therapy, also referred to as cranial osteopathy, cranial therapy, bio-cranial

therapy, bio cranial stretching, craniopathy, or sacro occipital technique, involves intrinsic movements of the

bones of the skull which are believed to reveal different rhythmic tidal motions in the body. These movements

are measured with scientific instruments and are thought to be a direct expression of the health of the system,

linked with physical, mental and emotional health.

Haller et al. (2020) conducted a systematic review and meta-analysis of randomized controlled trials to assess

the effectiveness of craniosacral therapy (CST) for the treatment of chronic pain. Ten RCTs (n=681) met

inclusion criteria which included: adult patients with a chronic, non-malignant pain condition, examining a type of

CST regardless of length or content, and reported at least one primary or secondary outcome assessed at the

end of the intervention period or at a follow-up point closest to six months. The studies included patients with

neck and back pain, migraines, tension-type headaches, fibromyalgia, epicondylitis, and pelvic girdle pain.

Primary outcome measures were pain intensity and functional disability. Secondary outcome measures included:

physical quality of life, mental quality of life, global involvement, and safety. The studies that compared CST to

treatment as usual found small to medium size pooled effects immediately following CST intervention for pain

intensity, functional disability, and physical quality of life. Studies that compared manual and non-manual sham

controls found medium to large, pooled effects directly after, as well as six months after for pain intensity,

functional disability, physical quality of life, and global involvement. Only minor adverse events were reported

across the studies. The results suggested significant effects of craniosacral therapy on pain and function

compared to general treatment. The limitations of the review included the small number of studies in the meta-

analysis, small patient populations, unclear risk of bias profile, lack of subgroup analyses, and patient-reported

outcomes.

Ear Candling: Ear candling is accomplished by a process called convection through which softer waxes and

toxins are drawn out of the ear, oxidized and turned into vapors during the treatment. High-quality ear candles

are hand-made from beeswax and unbleached cotton cloths. These specially fabricated candles are typically

9–12 inches long and will burn for approximately ten minutes.

Feldenkrais Therapy: Feldenkrais is a method of exercise therapy designed to improve coordination. It is a

bodywork system in which the person is viewed as a complex system of intelligence and function and all

movement reflects the state of the nervous system and the individual’s self-awareness. The process of intention,

action, gaining feedback, making decisions, and reenacting with adaptations constitutes the learning framework

(Hillier and Worley, 2015).

Inversion Therapy: Inversion therapy is proposed to relieve back and neck pain by gently stretching the

vertebrae using the person's own body weight by hanging upside down. It is proposed that inversion therapy can

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relieve back pain, decompress the spine, stretch muscles and ligaments, relieve stress, improve circulation and

help maintain overall good health. However, inversion is contraindicated in numerous conditions, including bone

weakness, recent fractures, conjunctivitis, glaucoma, heart disorders, hernias and many others.

Myotherapy: Myotherapy is a method of relaxing muscle spasms, improving circulation and alleviating pain. To

diffuse trigger points, pressure is applied to the muscle for several seconds by means of fingers, knuckles and

elbows. The success of this method is said to depend on the use of specific corrective exercise for the freed

muscles.

Neural Therapy: Neural therapy is an injection technique intended to provide instant relief of pain, increased

motion and return of function. It relies on anesthetic injections to clear up electrical interference causing

problems in the body. The therapy is typically used to treat chronic pain, but proponents say that the people most

likely to benefit are those who have failed to respond to chiropractic care, acupuncture, or physical therapy. It is

recommended if surgery or nerve block treatments fail.

Pfrimmer Deep Muscle Therapy

: Pfrimmer Deep Muscle Therapy involves working across the muscles to

manipulate deep tissues. The goal of treatment is to stimulate circulation and regenerate lymphatic flow to

promote detoxification and oxygenation of stagnant tissues.

Pilates: Pilates is an exercise system that focuses on improving body flexibility, strength, and awareness without

adding bulk. It involves a series of controlled movements performed on exercise equipment and/or on the floor

and resistance training that is proposed to cause spinal cord alignment and build muscle strength. Systematic

reviews and meta-analysis of randomized controlled trials have investigated Pilates for the treatment of the

following: Parkinson’s disease (Suarez-Iglesias et al., 2019); breast cancer; diabetes; chronic stroke; chronic

obstructive pulmonary disease; cystic fibrosis; heart failure; arterial hypertension; obesity (Wang, et al., 2021);

non-specific acute, subacute or chronic low back pain. There is insufficient evidence to support the clinical

effectiveness of Pilates for any condition. Studies primarily include small patient populations, short-term follow-

ups and lack of significant improvement with Pilates.

A systematic review of randomized controlled trials was conducted by Miranda and Marques (2018) to

investigate the effectiveness of Pilates on non-communicable diseases. Twelve studies (n=491) were included.

Diagnoses included: breast cancer (three studies), diabetes (three studies), chronic stroke (two years post

stroke) (two studies), chronic obstructive pulmonary disease (one study), cystic fibrosis (one study), heart failure

(one study) and arterial hypertension (one study). The best-evidence synthesis revealed strong evidence for

improving exercise tolerance, moderate evidence for improving symptoms, muscle strength and health-related

quality of life, and limited or conflicting evidence on vital signs, metabolic parameters, body composition,

respiratory function, functional status, balance, flexibility and social support. Meta-analysis was not possible due

to the paucity of evidence. Limitations of the studies included: small patient populations, 4–16 weeks follow-ups,

heterogeneity of study design, lack of a clear description of usual care in the control groups, and conflicting

outcomes. Patient populations were mainly composed of female participants preventing generalization of results

to both genders. Future studies with homogeneous outcome measures are needed to establish the effects of

Pilates on these subpopulations.

In a Cochrane review of Pilates, Yamato et al. (2015) reported that no high-quality evidence was found for any of

the treatment comparisons, outcomes or follow-up periods investigated for the treatment of non-specific acute,

subacute or chronic low back pain. There was some evidence for the effectiveness of Pilates for low back pain,

but there was no conclusive evidence that Pilates was superior to other forms of exercises. Ten randomized

controlled trials (n=510) met inclusion criteria.

In a systematic review and meta-analysis of five studies (n=139), Pereira et al. (2012) reported no improvement

in functionality or pain with Pilates compared to lumbar stabilization exercises. Lim et al. (2011) conducted a

systematic review and meta-analysis of seven randomized controlled trials and analysis of the pooled data

showed significant pain relief (p=0.04) with Pilates. However, when Pilates was compared to standard exercises

there were no significant differences in pain relief or in disability scores. Studies were limited by small patient

populations, short-term follow-ups, possible publication bias, heterogeneity of Pilates and conventional

interventions, and poor methodological quality.

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Reflexology: Reflexology, or zone therapy, is the study of the reflexes organized around a system of points on

the hands and feet that correspond, or reflex, to every part of the body. The theory is that stimulating and

applying pressure to the feet or hands increases circulation and promotes specific bodily and muscular functions.

Huang et al. (2021) conducted a systematic review and meta-analysis to systematically summarize and quantify

the effects of foot reflexology on improvements in sleep disturbances. Forty-two articles (n=3,928) met the

following inclusion criteria: the target population was adults over 18 years old; the type of foot reflexology was

individual foot reflexology or foot reflexology with other interventions (e.g., foot bath, acupressure, or

acupuncture); the comparison group(s) received routine care, no treatment, prescribed medications, or other

activity controls; outcomes were any changes in sleep disturbances after the intervention; the study design was

limited to randomized controlled trials; and articles were written in the English or Chinese language. Results

revealed that foot reflexology resulted in a greater reduction in the sleep quality score compared with the controls

(Hedges’ g=−1.37; 95% confidence interval (CI)=−1.81~-0.94). As for the therapeutic effect, participants in the

intervention group were less likely to have sleep problems than those in the control group (pooled odds

ratio=0.25; 95% CI=0.19~0.31). Limitations include: all articles were assessed to have a high risk of bias;

heterogeneity in patient populations; lack of detailed descriptions of interventions. The findings suggested that

foot reflexology produced improvements in sleep disturbances, but well-designed, large-scale randomized

controlled trails are needed to assess long-term effects to confirm findings.

In a systematic review of 23 randomized controlled trials, Ernst et al. (2011) concluded that there was insufficient

evidence to support reflexology for the treatment of “any medical condition.” Fourteen studies reported that

reflexology was not an effective treatment compared to eight studies that reported positive outcomes. Positive

outcomes were reported for the treatment of “diabetes, premenstrual syndrome, cancer patients, multiple

sclerosis, symptomatic idiopathic detrusor over-activity and dementia.” Overall, the studies were of poor

methodological quality and included heterogeneous patient populations, various outcome measures, various

treatment regimens and short-term follow-ups.

Remedial Massage: Remedial massage is the rhythmical kneading and stroking of the body's soft tissues to

relieve accumulated tension, restore flexibility to muscles, and offer relief from pain. In addition, holistic massage

is proposed to have a calming effect on the neuromuscular system bringing about deep relaxation and restoring

energy.

A systematic review and meta-analysis of 34 randomized controlled trials concluded that the evidence did not

support infant massage for promoting physical and mental health on low-risk groups of infants under age six

months. Available evidence was of poor quality, and many studies did not address the biological plausibility of

the outcomes being measured or the mechanisms by which change might be achieved (Bennett, et al., 2013).

Rolfing: Rolfing, or structural integration, is a holistic system of soft-tissue manipulation and movement

education that is intended to bring the body’s natural structure into proper balance and alignment. The intent is to

realign the body structurally and harmonize its fundamental movement patterns to enhance vitality and well-

being.

Trager

Bodywork: Trager bodywork is an approach that utilizes gentle, nonintrusive, natural movements to

help release deep-seated physical and mental patterns and facilitate deep relaxation, increased physical

mobility, and mental clarity. These patterns may have developed in response to accidents, illnesses, or any kind

of physical or emotional trauma, including the stress of everyday life.

Tui Na: Tui Na, or Tuina, uses massage and manipulation techniques to establish a more harmonious flow of Qi

through the channels and collaterals in the body, allowing natural healing. Methods include the use of hand

techniques to massage muscles and tendons, acupressure techniques, and manipulation techniques to realign

the musculoskeletal and ligamentous relationships. External herbal poultices, compresses, liniments, and salves

are used to enhance the massage and manipulation. Tui Na is proposed for the treatment of musculoskeletal

disorders and chronic stress-related disorders of the digestive, respiratory and reproductive systems.

Contraindications include conditions involving fractures, phlebitis, infectious conditions, open wounds, and

lesions. There is a paucity of evidence investigating the clinical effectiveness of Tui Na.

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Wei et al. (2017) conducted a systematic review of the literature to assess the evidence on Tui Na for cervical

radiculopathy. Five randomized controlled trials (n=448) investigated Tui Na alone or Tui Na combined with

cervical traction. The pooled analysis from three studies indicated that Tui Na alone showed a significant

immediate lowering effect on pain scores (p=0.002) compared to cervical traction. Meta-analysis from two trials

revealed significant immediate pain lowering effects using Tui Na plus cervical traction vs cervical traction alone

(p<0.00001). No adverse effects were reported. Limitations of the studies included: small patient populations

(n=60–120), short treatment duration (14–28 days) and variation in treatment regimens and study methodology.

Due to the weak evidence and study limitation, firm conclusions could not be made. Well-designed randomized

controlled trials with large patient populations and long-term follow-ups are needed to support these findings.

Also, the safety of Tui Na could not be determined from the data.

Visceral Massage: Visceral massage, or visceral manipulation, is massage of the internal muscular viscera

proposed to relieve pain anywhere including back, abdomen, legs, as well as relieve migraine headaches. It is

also proposed to improve function by relieving postpartum adhesions and adhesions around the lungs, liver,

pancreas, kidneys and gall bladder.

Mind-Body Medicine

Art Therapy: Art therapy is a creative process utilizing art as a healing and life-affirming technique. The term

typically applies to the use of the visual arts in psychotherapy to improve a feeling of emotional well-being. Art

therapy is used in mental health therapy and other settings to help focus on an individual’s creative process, and

to enhance their use of leisure as a stress reduction activity.

Jiang et al. (2020) conducted a systematic review and meta-analysis of twelve randomized control trials (n=587)

to evaluate the effect of art therapy on cancer patients' quality of life and physical and psychological symptoms.

The results determined art therapy reduced anxiety symptoms, depression symptoms, and fatigue and improved

the quality of life. Wood et al. (2011) previously conducted a systematic review to assess the available evidence

on the effectiveness of art therapy for symptomatic control of patients with cancer. Twelve randomized controlled

trials and case series (n=402) met inclusion criteria. The studies showed that art therapy is most frequently used

by women with breast cancer. Due to the heterogeneity of the studies included in these reviews, variations in the

model and content of the interventions, and various outcome measures, no overall effect was determined.

Schouten et al. (2015) conducted a systematic review of the effectiveness of art therapy in trauma treatment for

adults. Six controlled, comparative studies (n=223) (one randomized controlled trial) met inclusion criteria.

Subjects had to be traumatized adults (independent of type of trauma or type of trauma population), and the

design of the included studies had to be a comparison outcome trial with a control group. Type of trauma

included posttraumatic stress disorder (PTSD), sexual assault and traumatized incarcerated women. Some of

the included studies reported a significant decrease in psychological trauma symptoms in the treatment group

and one study reported a significant decrease in depression. Outcomes were conflicting with studies reporting a

decrease in symptom severity (some significant and some not) and no significant decrease in symptoms. The

most statistically significant decrease in trauma symptom severity was found when art therapy was used with

psychotherapy. Author-noted limitations of the studies included: small patient populations; methodological

weakness with moderate quality at best; heterogeneity of art therapy interventions (type and duration of the

interventions), control conditions, follow-up assessments, and characteristics of the study population; and patient

age primarily less than 22 years. No firm conclusions can be made for the use of art therapy for this patient

population.

Uttley et al. (2015) conducted a systematic review of randomized controlled trials investigating art therapy for

people with non-psychotic (e.g., depression, anxiety, and phobias) mental health disorders. Eleven randomized

controlled trials (n=533 patients) met inclusion criteria. Subjects included children or adolescents with asthma,

sickle cell disease or post-traumatic stress disorder and adults with Alzheimer’s disease, dementia, cancer, or

depression and incarcerated males. Follow-ups occurred from four weeks to 12 months. Control groups

included: no treatment/wait-list, attention placebo controls and psychological therapy comparators. Primary

outcomes included treatment effectiveness, response as determined by changes in mental health rating scales

and a variety of scales and questionnaires. There was a high risk of bias. Some studies reported significant

positive effects compared to controls. Meta-analysis was not possible due to clinical heterogeneity and

insufficient comparable data on outcome. Due to the small patient populations (n=18–111) and the low quality of

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the studies, a definitive statement regarding the clinical effectiveness of art therapy could not be made for people

with non-psychotic disorders.

Bioenergetics’ Analysis: Bioenergetics’ analysis is a somatic psychotherapy that works with both body and

mind to help individuals resolve emotional problems and increase their potential for pleasure and joy in living.

Color Therapy: Color therapy, or chromotherapy, uses energies and sensitivities to color to identify and correct

imbalances in body energies. It is proposed that disorders can be healed by applying color through visualization

or verbal suggestions.

Dance Movement Therapy: Dance movement therapy is the psychotherapeutic use of movement and dance to

engage a person creatively in a process believing to further their emotional, cognitive, physical and social

integration. It is founded on the principle that movement reflects an individual’s patterns of thinking and feeling.

Karkou and Meekums (2017) conducted a Cochrane systematic review to assess the effects of dance movement

therapy on behavioral, social, cognitive and emotional symptoms of patients with dementia. No studies met the

inclusion criteria.

Equestrian Therapy: Equestrian therapy (i.e., horseback riding or hippotherapy) is proposed to offer a person

with a disability a means of physical activity that aids in improving balance, posture, coordination, the

development of a positive attitude and a sense of accomplishment.

Guindos-Sanchez et al. (2020) conducted a systematic review and meta-analysis of ten randomized control trials

(n=452) to analyze the effectiveness of hippotherapy interventions on gross motor function in subjects with

Cerebral Palsy. The studies showed that hippotherapy interventions were effective in improving gross motor

function and had positive effects on balance recovery and muscle spasticity reduction in subjects with Cerebral

Palsy. However, due to the small patient populations, short-term follow-up and heterogeneity of the protocols,

additional randomized control trials with larger sample sizes and specified protocols are needed to support the

effectiveness of these interventions.

Bronson et al. (2010) conducted a systematic review of the literature to evaluate the ability of hippotherapy to

improve balance in multiple sclerosis patients. Three case series with less than 11 patients each met inclusion

criteria. The patients engaged in a mean 7.75 hours of therapy over a mean 11.2 weeks. There is insufficient

evidence to support hippotherapy for this indication.

Faith Healing: Faith healing is the belief that some people are able to channel divine powers to heal injury and

cure disease. Patients who seek the assistance of a faith healer must believe strongly in the healer’s divine gifts

and ability to focus on illness.

Following a systematic review of five randomized controlled trials (n=1130), Candy et al. (2012) found

“inconclusive evidence” that interventions with spiritual or religious components for adults in the terminal phase

of a disease enhanced well-being. Limitations of the studies included: all studies were undertaken in the same

country; in the multi-disciplinary palliative care interventions it was unclear if all participants received support

from a chaplain or a spiritual counselor; it was unclear whether the participants in the comparative groups

received spiritual or religious support, or both, as part of routine care or from elsewhere; and there was a

“paucity of quality research”.

Guided Imagery, Interactive: Guided imagery promotes the use of imagery to help a patient connect with

deeper resources at the cognitive, affective and somatic levels. The guide’s role is to facilitate an enhanced

awareness of the unconscious imagery the patient has and train them to work effectively with this imagery on

their own behalf.

In a systematic review of 15 randomized controlled trials (n=1172), Posadzki et al. (2012) reported that the

evidence for guided imagery for the relief of non-musculoskeletal pain was inconclusive. Overall, the

methodology was poor; outcomes were conflicting; and patient populations, study design, outcome measures

and types of guided imagery were heterogeneous.

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Hellerwork: Hellerwork is a form of deep-tissue bodywork designed to realign and rebalance the body, releasing

chronic tension and stress, producing a more relaxed, youthful state. The central premise is that a structurally

misaligned body experiences gravity as stressful. When movement and flexibility are limited, there is energy

loss, aging and deterioration.

Humor Therapy: Humor therapy targets laughter as a means to lower blood pressure, reduce stress hormones,

increase muscle flexion and boost immune function. It is proposed to raise levels of infection-fighting T-cells,

disease-fighting proteins called Gamma-interferon, and B-cells, which produce disease-destroying antibodies.

Laughter is also thought to trigger the release of endorphins, the body's natural painkillers, and to produce a

general sense of well-being.

Hypnosis: Hypnosis is a psychological condition in which an individual may be induced to show apparent

differences in behavior and thinking. It employs techniques to induce states of selective attentional focusing or

diffusion combined with enhanced imagery. It is often used to induce relaxation. Hypnosis is recognized as a

treatment modality for pain control, weight control, irritable bowel syndrome, and as an adjunct to cognitive

behavioral and other therapies. Hypnosis has also been proposed for reducing fear and anxiety, reducing the

frequency and severity of headaches, and controlling bleeding and pain during dental procedures.

Systematic reviews and randomized controlled trials have reported that there is insufficient evidence to support

hypnosis for insomnia (Chamine, et al., 2018; Lam et al., 2015); burn wound pain and anxiety (Provencal, et al.,

2018); stress reduction (Fisch, et al., 2017); breast cancer (Cramer, et al., 2015); cancer-related anxiety, fatigue,

pain (Chen, et al., 2017); management during labor and childbirth (Madden, et al., 2016); children undergoing

dental treatment (Al-Harasi, et al., 2017) and treatment of irritable bowel syndrome (Webb, et al., 2007).

Although some studies have reported improved outcomes with hypnosis, studies have been limited by small

patient population, short-term follow-ups, and heterogeneity of treatment regimens and controls. Overall, the

authors concluded that the quality of the trials was inadequate to make firm conclusions and outcomes were

conflicting in some studies improvements were reported and in other studies there were no significant

differences in outcomes when hypnosis was used.

Martial Arts: Martial arts are best known as a means of self-defense and are divided into armed and unarmed

sports. Many of the forms and derivatives thereof are practiced as a means of mental and spiritual development

(Cochrane Complementary Medicine, 2020). Many martial arts originate in China with only 20–30% coming from

other East Asian countries. Unarmed combat forms of martial arts include judo, sumo, karate and Chung Moo

Doe. Chung Moo Doe therapy is a martial art that has been practiced for over 1500 years in East Asia under

various names. Along with Tai Chi, Chung Moo Doe includes Kung Fu, Ai-Ki-Do/Hap-Ki-Do, Jujitsu, Tae-Kwon-

Do, Bagwa Chang, Ship Pal Gae/18 weapons and Samurai Sword.

Systematic reviews of randomized and nonrandomized controlled trials have evaluated the effectiveness of Tai

Chi as a supportive treatment for low back pain (Qin, et al., 2019); type 2 diabetes mellitus (n=14 studies) (Chao,

et al., 2018); stroke rehabilitation (n=15 studies) (Ding, 2012) and gait training (n=five studies) (Li, et al., 2018);

the treatment of stress, anxiety, depression and mood disturbance (n=3817) (Wang, et al., 2010); a therapeutic

intervention for the treatment of patients with cardiovascular risk factors or cardiovascular conditions (e.g.,

coronary artery disease, congestive heart failure) (n=29 studies) (Yeh, et al., 2009); and cancer-related fatigue

and quality of life in cancer patients (n=17 studies) (Sur, et al., 2021). Definitive conclusions were limited due to

poor to moderate study quality; possible publication bias; wide variety of Tia Chi styles, frequency, duration and

follow-up; inadequate or no controls; combinations of various treatment activities; and heterogeneity of outcome

measures.

Meditation/Transcendental Meditation (TM

): Meditation/Transcendental Meditation is proposed to be the

single most effective technique available for gaining deep relaxation, eliminating stress, promoting health,

increasing creativity and intelligence and attaining inner happiness and fulfillment. TM is one type of meditation

involving a mantra meditation technique where consciousness is directed towards repetition of a word, or a

phrase, as an object of focus. Meditation has been proposed for the treatment of numerous conditions including

depression (González-Valero, et al., 2019), anxiety, stress (Araujo, et al., 2019), chronic pain, asthma,

posttraumatic stress syndrome, hypertension, headache, dementia, attention deficit disorder, and for smoking

cessation. Systematic review and meta-analysis have reported some benefit from meditation, but based on the

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poor quality of the studies, firm conclusions have not been made regarding the clinical effectiveness of this

modality.

Hilton et al. (2017) conducted a systematic review and meta-analysis of 38 randomized controlled trials

investigating mindfulness meditation for chronic pain (e.g., back pain, headache, fibromyalgia, cancer,

musculoskeletal pain, irritable bowel syndrome). Treatments ranged from 3–12 weeks. Interventions included

mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT) and other types of

meditation. Some interventions were monotherapy while others used meditation as an adjunctive therapy.

Comparators included: treatment as usual, education, support groups, stress management, massage,

multidisciplinary pain interventions, relaxation/stretching, nutritional information/food diaries, and cognitive-

behavioral therapy. These low quality, heterogeneous studies reported some evidence that meditation was

associated with a small decrease in pain. Well-designed, rigorous, and large-scale RCTs are needed to

decisively provide data for the efficacy of mindfulness meditation for chronic pain.

In an analysis of eight systematic reviews (SR) and meta-analyses, Ooi et al. (2017) reported that transcendental

meditation may potentially reduce systolic blood pressure by ∼4 mm Hg and diastolic blood pressure by ∼2 mm

Hg. The SRs included 5–15 studies and follow-ups ranged from six weeks to 18 months. The outcomes were

comparable to those seen with other lifestyle interventions including weight-loss and exercise. However, the

strength of evidence was considered weak due to conflicting findings across reviews and potential risks of bias.

Further research is still needed to validate these findings.

Salhofer et al. (2016) conducted a Cochrane systematic review of randomized controlled trials investigating the

benefits and harms of meditation as an adjunctive therapy for adults with hematological malignancies. One

abstract was found. There is insufficient evidence to support meditation for this patient population.

Mirror Box Therapy: Mirror box therapy is the use of visual illusions created by a mirror and is proposed for the

treatment for phantom limb pain, complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy

syndrome (RSD), stroke, arthritis and carpal tunnel syndrome. Mirror therapy is based on the theory that visual

feedback provides a substitute for missing proprioceptive feedback to reduce pain. The limbs are positioned

inside a box separated by a mirror. The patient looks into the mirror and sees the image of the unaffected limb,

thinking that the affected limb is moving effortlessly. The underlying mechanism accounting for the effectiveness

of the therapy has not been established (Thieme, et al., 2018; Moseley, et al., 2008; Selles, et al., 2008).

Systematic reviews and meta-analysis of randomized controlled trials and case series have evaluated box

therapy for the treatment of stroke patients, phantom limb pain, complex regional pain syndrome (CRPS), and

various upper extremity conditions. Zeng et al. (2018) evaluated the treatment effect of mirror therapy on motor

function of the upper extremity in patients with stroke. Eleven studies (n=347) were included in the meta-

analysis. Although some improvement in motor function was seen, the heterogeneity of the studies, including the

patient (n=15–60) characteristics and treatment regimens, prevented firm conclusions from being drawn

regarding the clinical effectiveness of mirror box therapy.

Thieme et al. (2018) investigated mirror therapy compared to no treatment, placebo/sham therapy, or other

treatments for improving motor function and motor impairment after stroke. Randomized controlled trials (RCTs)

and randomized cross-over trials comparing mirror therapy with any control intervention were included (n=62

studies; 1982 subjects). Mirror therapy was provided 3–7 times a week, for 15–60 minutes for 2–8 weeks

(average of five times a week, 30 minutes a session for four weeks). There was moderate-quality evidence that

mirror therapy had a significant positive effect on motor function and motor impairment. The authors noted that

effects on motor function were influenced by the type of control intervention. Based on moderate-quality

evidence, it was reported that mirror therapy may improve activities of daily living. There was low-quality

evidence for a significant positive effect on pain (n=248) and no clear effect for improving visuospatial neglect

(failure to orientate, to report or to respond to stimuli located on the contralesional side) (n=175). No adverse

effects were reported. The major limitations of the studies included the small patient populations, short-term

therapy and lack of reporting of methodological details, resulting in uncertain evidence quality.

Barbin et al. (2016) conducted a systematic review to evaluate the efficacy of mirror therapy on phantom limb

pain. Five randomized controlled trials and 15 nonrandomized studies met inclusion criteria. Study

methodologies were heterogeneous with low level evidence, patient populations were small, and outcomes were

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conflicting. Meta-analysis was not possible. The data did not support the use of mirror therapy for the treatment

of phantom limb pain.

Music Therapy: Music therapy includes music sessions for individuals and groups based on client needs. Music

therapists assess emotional well-being, physical health, social functioning, communication abilities and cognitive

skills through musical responses, using improvisation, receptive listening, song writing, lyric discussion, imagery,

performance and learning through music.

Systematic reviews of randomized controlled trials have investigated music therapy for individuals with multiple

conditions including: burn injuries (seven trials; n=524) (Wu, et al., 2021); anxiety (32 studies; n=1,924) (Lu, et

al., 2021); dementia (van der Steen, et al., 2018; Gómez-Romero, et al., 2017); depression (nine studies; n=421)

(Aalbers,et al., 2017); substance abuse (40 studies; n=1381) (Hohman, et al., 2017);

schizophrenia and

schizophrenia-like disorders (18 studies; n=1215) (Geretsegger, et al., 2017); acquired brain injuries (29 studies;

n=775) (Magee, et al., 2017); symptoms of cancer (29 trials; n=3731) (Bradt, et al., 2016); and postoperative

pain management after orthopedic surgery (nine studies) (Lin, et al., 2020). Although some studies suggested

that music therapy may be effective for some outcome measures, overall the quality of the studies was very low

to moderate, clinical effectiveness could not be determined, outcomes were inconsistent, treatment regimens

were heterogeneous, and long-term outcomes have not been reported.

In a systematic review of 51 randomized controlled trials (n=3663), Cepeda et al. (2006) concluded that listening

to music reduced the intensity of pain and opioid requirements, but the “magnitude of the benefits was small, and

the clinical importance of music was unclear”.

Outdoor Youth Programs: Outdoor youth programs (outdoor adventure programs, outward bound schools,

outdoor education) are associated with social, recreational, developmental, educational and therapeutic aims. In

general, outdoor education can be described as teaching and/or learning and/or experiencing in an outdoor

and/or out-of-school environment. The content of learning and teaching varies and depends on the general aim

of the program (e.g., gaining of knowledge in natural sciences; increased physical activity, leadership skills,

personal and social development; survival skills; improved skills in relation to nature-oriented sports), the target

group and the outdoor setting. Most programs are designed to fit the needs of a specific target group (e.g.,

substance abuse, school truancy, failing school) and work with teens or at-risk teens. Outdoor adventures are

proposed to have direct positive impacts on well-being and perceived stress, as well as foster the psychological

concepts related to resilience, self-efficacy, mindfulness and subjective well-being. Outdoor activities include

backpacking, climbing, swimming, canoeing, scuba diving, and biking. Programs range from 5–30 days

(Wilderness Adventures, 2020; Becker, et al., 2017; Voyageur 2017; Mutz, et al., 2016). There is insufficient

evidence to support the clinical effectiveness of outdoor youth programs. Studies are primarily in the form of

small case series. Currently, the key components of these programs and the benefits gained by participants

have not been established.

Becker et al. (2017) conducted a systematic review of the literature (n=13 studies) to identify the potential

benefits of regular compulsory school- and curriculum-based outdoor education programs (OEPs) for children

and adolescents. The review concentrated on programs that were embedded within the curriculum and

conducted regularly within the school schedule. These programs focused on student-centered classes and

interdisciplinary subjects, hands-on learning, possibilities to explore and experience oneself and the

environment, and the use of natural and cultural places as a “classroom.” Thirteen studies met inclusion criteria:

nine case series, three quasi-experimental designs and one cross-sectional design. Inclusion criteria were: all

types of study designs; any type of formal school- and curriculum-based outdoor education program involving

children and adolescents (age 5–18 years); regular weekly or bi-weekly classes in a natural or cultural

environment outside the classroom with at least four hours of compulsory educational activities per week over a

period of at least two months; and at least one reported outcome on a student level. Environmental settings

included gardens, local forests, prairies, farmland and sailing. Eight studies described outcomes in terms of

social dimensions, seven studies in learning dimensions, and four studies included physical activity and health.

Sample sizes ranged from 5–230. Eleven studies reported positive results, one study reported positive and

negative results and one study reported negative effects. Tendencies indicated that regular compulsory school-

and curriculum-based outdoor education programs could advance students in the physical, psychological,

learning and social dimensions. However, the wide heterogeneity in the program aims, intervention length (e.g.,

biweekly for eight weeks vs. full weeks for six months), participant groups, age, learning environments,

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methodology and reported effects, prevented any firm conclusions from being made regarding the effectiveness

of these programs. Evidence on the effect of these programs on physical activity and mental health were lacking.

Pet Therapy: Pet therapy (PT) or animal-assisted therapy (AAT) involves the use of animals for therapeutic

purposes. PT is proposed to help people recover from and/or better cope with psychological and/or physical

health problems. The intent is that pet therapy aids in the psychological, educational and physical rehabilitation

of a patient to improve their general sense of well-being and improve their quality of life. Dogs and cats are the

most commonly used animals. Studies have reported that pet therapy decreases cortisol and catecholamine

levels in the blood and increases endorphins, reducing stress and producing a calming effect. Pet therapy has

been proposed for the treatment of dementia, cognitive dysfunction, stroke, mental health disorders (e.g.,

depression, autism spectrum disorder), stress, pain, fatigue, cardiovascular rehabilitation, cancer support,

pregnancy, post-traumatic stress disorder and hospice care. The therapy is used by inpatient facilities, nursing

homes, universities, as well as at home (Zafra-Tanaka, et al., 2019; Fiori, et al., 2018; Ein, et al., 2018; O’Haire

et al., 2013; Moretti, et al., 2011).

There is insufficient evidence in the peer-reviewed literature supporting the clinical effectiveness of pet therapy.

Studies have primarily been in the form of case reports or case series with less than 100 subjects and studied for

a variety of conditions. Outcomes are conflicting with some studies reporting no significant difference with pet

therapies (Gaudet, et al., 2021; Fiori, et al., 2018; O’Haire et al., 2013; Moretti, et al., 2011).

Ein et al. (2018) conducted a systematic review and meta-analysis to examine the efficacy of pet therapy (PT) on

reducing physiological stress levels (i.e., blood pressure and heart rate) and self‐reported stress and anxiety

scores. Studies with the following characteristics were included: subjects all ages, healthy, or had psychological

and/or medical illnesses; used novel living animals (e.g., an animal that was unfamiliar to the subject and not the

subject’s personal pet) as the sole therapeutic tool; used PT programs to create a calming environment with

minimal physical activity (e.g., petting the animal); and incorporated pre- and post-therapy changes in blood

pressure and heart rate and/or changes in self‐reported measures of stress and/or anxiety. A total of 28 studies

(n=1310) met inclusion criteria. All but two studies used dogs for the animal therapy. Overall, analysis of eight

studies showed significantly reduced heart rates (HR) (p<0.001). Subgroup analysis showed that healthy

subjects maintained the significant HR effect (p=0.012) but subjects that had medical and/or psychological

conditions did not show a significant reduction in HR (p=0.68). Significant effects were shown in a group setting

(p=0.007) vs. no effect in individual therapy (p=0.403). PT did not significantly reduce systolic blood pressure

(p=0.149). Overall self-reported anxiety was significantly reduced in adults (p<0.001) and remained significant in

subgroup analysis of healthy adults (p<0.001) and adults with a medical (p<0.001) or psychological condition

(p=0.001). There were an insufficient number of subjects to determine the effect of self-reported anxiety on

children and elderly adults. The authors reported that the majority of medical and psychological subjects had

taken medication (e.g., pain medication) prior to or during PT. Limitations of the studies include the

heterogeneous, small patient populations (n=4–135); lack of self-reported data on stress reduction; use of self-

reported data; use of medication by some of the subjects before and/or during the study; and the use of only

dogs in all but two of the studies.

Primal Therapy: Primal therapy explores, studies, researches and promotes certain forms of psychotherapy and

growth, including those that emphasize uncovering and resolving traumatic experiences. It also aims to develop

a community that is congruent with the principles developed from this work.

Psychodrama: Psychodrama is a method involving improvisational dramatic action under the guidance of a

trained practitioner known as the director. The script is written moment by moment, out of the purposes and

concerns of an individual, or the group where the method is being applied. Group members take an active part in

the dramas so that they bring it as close to life as possible.

Recreational Therapy: Recreation therapy (RT), also call therapeutic recreation, is a therapy that utilizes

recreation and other activity-based interventions to address the needs of individuals with illnesses and/or

disabling conditions. The proposed purpose of RT is to improve or maintain physical, cognitive, social, emotional

and spiritual functioning in order to facilitate full participation in life and maintain optimal levels of independence,

productivity and quality of life. Recreational therapy includes arts and crafts, sports, games, dance and

movement, drama, music, and community outings. RT seeks to reduce depression, stress, and anxiety, recover

basic motor functioning and reasoning abilities, build confidence, and socialize effectively. Services are provided

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or directly supervised by a Certified Therapeutic Recreation Specialist (CTRS). Recreational therapists practice

in various settings including: inpatient and outpatient physical rehabilitation, inpatient and outpatient mental

health, skilled nursing facilities and assisted living, adult day programs, park and recreation, adapted sports

programs, acute care hospitals, and school systems (CTRS) (American Therapeutic Recreation Association,

2019; National Council for Therapeutic Recreation Certification, 2020). There is a lack of evidence investigating

the clinical efficacy of recreational therapy.

Wilderness Therapy: Wilderness therapy (WT), also called wilderness adventure therapy (WAT), is a multi-

faceted program, consisting of outdoor life and various sequenced tasks and challenges. Wilderness therapy is

also used synonymously with other terms including: adventure therapy, wilderness experience programs, bush

adventure therapy, eco-therapy, adventure-based counseling, outdoor adventure intervention, therapeutic

camping, and outdoor behavioral healthcare. The program seeks to enhance the restorative qualities of nature

combined with structured individual and group-based therapeutic work. WT offers a prevention, early

intervention, and treatment modality for individuals with behavioral, psychological, psychosocial and/or

substance abuse issues (Dobud and Harper, 2018; Fernee, et al., 2017; Bowen, et al., 2016). WT has, for the

most part, replaced military style boot camps.

There is a wide diversity of philosophies, theories, and formats being used in WT. Activities often include rope

challenge courses, group games, trust activities, residential camps, and wilderness-based expeditions. The

programs are typically led by a multi-disciplinary therapist team and often serve a heterogeneous population of

adolescent clients. Participants engage in group living with peers and therapists, undergo individual and group

therapy sessions, and learn basic outdoor skills proposed to foster personal, emotional, and social growth.

Typically, WT is a 10-week, part-time program, facilitated by three practitioners for six to eight participants.

Treatment involves seven day-based adventure activities (e.g., bushwalking, cross country skiing, white water

rafting), a two-day overnight training expedition, and a five-day expedition. Parents, teachers, and support

workers also participate in up to eight weekly indoor adventurous problem-solving activities incorporated within

group therapy sessions (Dobud and Harper, 2018; Fernee, et al., 2017; Bowen, et al., 2016).

The wilderness environment is proposed to be a healing place that may facilitate change. After having

experienced difficulties, turmoil and/or loss in their lives, participants may find peace in the wilderness. A primary

sense of despair may gradually be replaced by self-confidence through reflecting on life and managing the basic

tasks of simple outdoor life and the inherent challenges of this approach to treatment. A proposed advantage of

WT over conventional therapy is that the stigma of psychological therapy dissolves former resistance, making

individual and group psychotherapy less intimidating and more natural. The duration and context of the WT

treatment may provide the necessary time and space to address and process emotional upheaval and stimulate

personal issues to surface that have not been revealed in previous treatment settings (Dobud and Harper, 2018;

Fernee, et al., 2017; Bowen, et al., 2016).

Alexander et al. (2016) discussed the safety concerns related to wilderness therapy and the importance of being

prepared for traumatic and minor injuries and illness. Adverse events of WT may occur from contaminated water;

insect and tick bites; heat-related illness; hypothermia; allergic reactions to plants; insects or foods; head injuries;

fractures; sprains; dislocations; burns; lacerations; and blisters.

Studies investigating the effectiveness of wilderness therapy have primarily been in the form of case series with

small heterogeneous patient populations, reporting short-term effects and investigating various outcome

measures. Overall, studies on WT have not provided detailed program descriptions and guiding theories. The

efficacy of WT across programs and populations and how the treatment stimulates change has not been

established (Fernee, et al., 2017).

Dobud and Harper (2018) conducted a systematic review of randomized controlled trials in an effort to identify

the specific activities contributing to adventure therapy (AT) outcomes. Fourteen direct comparison studies met

inclusion criteria. Studies indicating the presence of qualified practitioners working in clinical settings were

included. Studies without a control group or experimental conditions and lacking the presence of a therapeutic

rational or practitioner were excluded. Study groups included: adapted outward bound therapy, wilderness

survival, therapeutic services with AT, integrated wilderness therapy (WT), adventure camp, and outdoor

behavioral healthcare. Comparators included: traditional probation treatment; wilderness survival without family

therapy; treatment as usual; no specific intervention; alternative group therapy; behavior modification, residential

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program, inpatient program, a second outdoor adventure program; and AT plus psychological counseling,

psychological counseling alone and psychological and group counseling. In ten of the 13 studies, intense social

environments were assumed to contribute to positive outcomes. Three studies reported that problem-solving

activities would lead to feelings of success or mastery. Seven studies reported that time in nature and pristine

wilderness environments would provide a more effective setting for therapeutic healing to occur and asserted

that time in nature was an active ingredient contributing to outcomes. However, the differences were not

significant. Studies were limited in number and varied regarding the treatment setting, therapeutic ingredients,

social setting and outcome measures. It was noted that there was limited discussion about the experimental

groups and the treatments provided made it difficult in some cases to determine whether a control group was

designed to be therapeutic. Based on these studies, the authors concluded that the active ingredients regarded

as unique to AT made little difference in outcomes across the 13 studies, and the unique components of AT may

not have greater influence than the factors shared with all other forms of therapeutic interventions.

Fernee et al. (2017) conducted a systematic review of the literature to investigate the effectiveness of WT on

adolescence (aged 12 to 18 years) and to identify the descriptions of the treatment programs and their

outcomes. Seven studies met inclusion criteria and were in the form of case series with small patient populations

(n=4–47). The intent of the studies was heterogeneous and included: 1) understanding how adolescents who

were involuntarily enrolled in the program responded to parents and therapists (n=13); 2) understanding how

backpacking was related to self-reported outcomes for troubled adolescent women (n=9); 3) gaining insight into

the effect of a residential wilderness program on self-evaluation of male adolescents and what specific aspects

of the program caused the changes (n=13); 4) interviewing participants > age 20 years following involvement in a

10-day WT program at age 14–16 years to discover the impact of WT on their lives (n=4) 5) investigating WT

and the outcomes from the intervention (n=4 men); 6) examining WT and identifying the key change agents and

outcomes (n=12); and 7) evaluating youth well-being 24 months after the conclusion of WT treatment (n=47).

Reported outcomes of the studies included: despair was gradually replaced by self-confidence; the wilderness

environment was a healing place and facilitated change; time alone allowed reflection and personal insight;

avoidance of the “stigma” attached to mental health treatment; physical demands of the wilderness lifestyle

contributed to the changes experienced including competence and sense of accomplishment; and enhanced

self-awareness, self-efficacy; and socialization skills with therapists and peers. The authors noted that the lack of

client characteristics in relation to the therapeutic process and to each participant’s specific set of outcomes

prevented conclusion regarding who the best candidates are for WT, as well as the programmatic circumstances

that might facilitate individual change. Another limitation of the studies is the inability to generalize effects to a

larger population due to the limited number of studies and small patient populations. Additional studies are

needed to define a comprehensive and useful framework that is applicable to the general population and who the

ideal candidates are for WT.

Yoga: Yoga is a highly diversified mind-body practice that has evolved into many areas, including fitness

training, a system of healing, a purification program, mind-training, a philosophical system, a religious practice or

a spiritually-based lifestyle. It typically involves physical postures, breathing techniques, and meditation or

relaxation.

Systematic reviews have evaluated peripartum outcomes of yoga, yoga for the prevention of coronary heart

disease, as antihypertensive lifestyle therapy, Parkinson’s, stroke rehabilitation, depression, substance abuse,

posttraumatic stress disorder, treatment of cancer pain and treatment-related side effects, anxiety and stress,

diabetes mellitus, schizophrenia and epilepsy, chronic non-specific low back pain, rheumatic diseases and

asthma, headaches, sleep quality and insomnia (Ban, et al., 2021; Brinsley, et al., 2021; Lenoir Dit Caron, et al.,

2021; Walia, et al., 2021; Wang, et al., 2020; Anheyer, et al., 2020; Gothe, et al., 2019; Sieczkowska, et al.,

2019; Wu, et al., 2019; Kuppili, et al., 2018; Bridges and Sharma, 2017; Broderick, et al., 2017; Lawrence, et al.,

2017; Cramer, et al., 2017; Wieland, et al., 2017; Cui, et al., 2017; Yang, et al., 2016; Panebianco, et al., 2017;

Babbar, et al., 2012; Bussing, et al., 2012; Harder, et al., 2012; Li, et al., 2012; Vancampfort, et al., 2012).

Although some studies suggested improvement in outcomes with yoga, other studies reported that the

effectiveness of yoga remained uncertain. Limitations of the studies included: small patient populations; short-

term follow-ups; and heterogeneity of yoga protocols, number of sessions and length per session; and lack of

blinding. Data are conflicting and studies have not been well designed. Data on adverse events is limited. Large-

scale, well-designed studies using objective measures and long-term follow-up are needed to draw definitive

conclusions regarding the clinical effectiveness of yoga.

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Multi-Therapy Systematic Reviews

Several systematic reviews have evaluated multiple CAM therapies for the treatment of various conditions

including asthma, cancer, dementia, depression, diabetes, hypertension, irritable bowel syndrome, pain

management (Garland, et al., 2019), psoriasis, Raynaud’s phenomenon, rheumatoid arthritis, and rhinitis.

Although some studies reported clinical improvement with some modalities, overall, the authors agreed that

there is insufficient evidence to support CAM for the treatment of these conditions. Studies are limited by small

patient populations, minimal and short-term follow-ups, variability in dosage and unknown quality of oral

supplements, few evaluations of side effects, inconsistent and inconclusive outcomes, and no controls or

comparisons to traditional Western medical therapies.

Abdominal Pain: Abbott et al. (2017) conducted a Cochrane systematic review that included 18 randomized

controlled trials to assess the effectiveness of four types of psychosocial therapy (cognitive behavioral therapy,

hypnotherapy including guided imagery, yoga, written self-disclosure) for the treatment of recurrent abdominal

pain in school-aged children. Regarding four studies on hypnotherapy (n=143), greater treatment success was

reported post-intervention (p=0.0003). Reduced pain intensity (p<0.00001) and frequency (p<0.00001) were

achieved with hypnotherapy compared to controls. Studies were considered low-quality with short term follow-up

and small patient populations. One study reported long-term benefit of hypnotherapy at five years (68%)

compared to control (20%) (p=0.005). For yoga therapy compared to control, there was no evidence of

effectiveness on reduction of pain intensity post-intervention (p=0.09). The three yoga studies included 122

children and were low-quality evidence.

Asthma: Kohn and Paudyal (2017) conducted a systematic review and meta-analysis of 23 randomized

controlled trials to evaluate the safety and efficacy of CAM for the treatment of asthma in adults. CAM therapies

included the following: curcumin; New Zealand green-lipped mussel; solanum xanthocarpum and solanum

trilobatum; coenzyme Q10; selenium; auranofin; vitamins B6, C, D or E; aqueous extract of propolis; AKL1#

(picrorrhiza kurroa, zingiber officinale, ginkgo biloba and apocynin); lactose powder; TJ-96; Pingchuan Yiqi

Granule, magnesium, n-3 polyunsaturated fatty acids; and anti-asthma herbal medicine intervention (ASHMI; a

Chinese herbal formula containing Ku-Shen [Sophora flavescens], Gan-Cao [Glycyrrhiza uralensis] and Ling-Zhi

[Ganoderma lucidum]. Controls included standard asthma treatment, placebo, and pharmacotherapy. The results

of meta-analysis on magnesium, vitamin C and vitamin D, indicated that these supplements were not beneficial

in improving the lung function of asthma patients. Eight single trials showed improvement in lung function and

symptom control but there was no overall trend in one outcome measure across trials. In addition, many of the

trials had a poor methodological quality, restricting the reliability and applicability of these results. The analysis

did not provide sufficient evidence to recommend any of the included CAM compounds for the treatment of

asthma. Limitations of the studies included: short-term duration of treatment (range one day to 36 weeks), small

patient populations (n=14–232), poor methodological quality; heterogeneity of treatment regimens, and the

unclear or high risk of bias in the majority of studies.

Cancer: Duong et al. (2017) conducted a systematic review and meta-analysis of randomized controlled trials

that compared non-physical mind and body practices with control interventions for the management of fatigue in

cancer and hematopoietic stem cell transplant (HSCT) recipients. A total of 55 trials (n=4975) met inclusion

criteria. Interventions included acupuncture or acupressure (n=12 studies), mindfulness meditation (n=11 study),

relaxation techniques (n=10 studies), massage (n=6 studies), energy therapy (n=5 studies), energizing yogic

breathing (n=3 studies) and others (n=8 studies). Mindfulness and relaxation were effective at reducing fatigue

severity, but the authors noted that how to translate these findings into clinical practice had yet to be determined.

Acupuncture, acupressure, massage, energy therapy and yogic breathing were not effective. Limitations of the

studies included: limited number of studies for some modalities; short-term treatment durations; variation in the

definition of fatigue; and heterogeneity of treatment regimens, comparators (e.g., usual care, wait list, sham,

education), types of cancers, and timing of interventions (before, during and/or after treatment).

In a Cochrane systematic review investigating massage therapy with or without aromatherapy for symptom relief

in patients with cancer, Shin et al. (2016) reported that there was a lack of evidence on the clinical effectiveness

of massage therapy for this subpopulation. Nineteen studies (n=1274) met inclusion criteria and were considered

“very low-quality evidence”. Thirteen studies (n= 596 participants) compared massage with no massage. Six

studies (n=561) compared aromatherapy massage with no massage. Two studies (n=117) compared massage

with aromatherapy and massage without aromatherapy. Overall, the patient populations were too small to be

reliable and key outcomes (pain and psychological symptoms) were not reported. From the limited evidence

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available, the authors stated that they were unable to assess the effect of adding aromatherapy to massage on

the relief of pain, psychological symptoms including anxiety and depression, physical symptom distress, or

quality of life.

Leggett et al. (2015) conducted a systematic review of the literature to evaluate the effectiveness of oral CAM

substances for women with breast cancer. Studies of women receiving or who had completed conventional

treatments for breast cancer and reported using oral CAM products (e.g., tablets, capsules, powders, liquids) for

the alleviation of cancer-related symptoms were included. Outcomes of the studies included treatment side

effects, improvement of quality of life, physical and emotional wellbeing, survival, and mortality Twenty-two

randomized and nonrandomized controlled trials met inclusion criteria. The CAM substances included: black

cohosh, a range of Chinese medicinal herbal mixtures, estrogen botanical supplements (EBS), essiac,

Ganoderma lucidum, ginseng, glutamine, grape seed proanthocyanidin extract (GSPE), guarana, herbal

remedies, and soy isoflavones. No more than four studies were found for each modality. Although there was

some weak evidence for support for relief of various symptoms by various substances, the authors advised that

the results should be viewed with caution due to the poor methodological quality of the studies. The overall

strength and quality rating of the body of evidence was considered to be limited. In conclusion, there was little

evidence to make definitive recommendations regarding the effectiveness for individual CAM therapies in women

receiving conventional treatments for breast cancer.

Rada et al. (2010) conducted a systematic review of the literature to assess the efficacy of non-hormonal

therapies for the treatment of hot flushes in women with a history of breast cancer. Sixteen randomized

controlled trials met inclusion criteria and included relaxation therapy (n=2 studies), homeopathy (n=2 studies)

and vitamin E (n=1 study). The vitamin E study reported no beneficial effects and one study on relaxation

therapy showed significant beneficial effects. Homeopathy did not lead to any differences in number and severity

of the hot flushes. Data on continuous outcomes were inconsistent.

Another systematic review evaluated the use of Chinese herbs (e.g., shenmai, pishentang) for the treatment of

chemotherapy side effects in women with breast cancer (n=542 patients) (Zhang, et al., 2007). Bardia et al.

(2006) included acupuncture, support groups, hypnosis, relaxation/imagery, herbal supplements, music therapy,

healing touch, and massage therapy (N=1499 patients) for the relief of cancer pain. Ernst et al. (November–

December 2006) also reviewed CAM for the treatment of breast cancer pain (n=15 studies) including

“psychosocial support, herbal medicine, thymus extract, transfer factor, melatonin, and factor AF2 (xenogenic

peptides)”. Due to the poor quality of the trials (e.g., small patient population without sample size justification,

short-term follow-up, lack of statistical comparison, poor definition of outcomes, and lack of control group), none

of these therapies could be recommended for pain relief in cancer patients.

Depression, Anxiety and/or Sleep Disorders: Asher et al. (2017) conducted a systematic review and meta-

analysis to compare the effectiveness of exercise and CAM therapies for the treatment of major depressive

disorder (MDD). A total of 22 randomized controlled trials were included for direct comparisons and 127 trials

were used for network meta-analyses. CAM studies included acupuncture (three studies), omega-3 fatty acids

(three trials), S-adenosyl methionine (SAMe) (one trial), and St. John’s wort (12 trials; n=1806). Two studies

comparing aerobic exercise monotherapy with SSRIs were also included. The primary outcome measure was

response to treatment on the Hamilton Depression Rating Scale (HAM-D), which was defined as a 50%

improvement of scores from baseline. Overall, there was no significant difference in outcomes with the use of a

CAM therapy and the risk of harms of CAM therapies was not adequately assessed. The studies were limited by

the unclear randomization methods, high loss to follow up, small patient populations, inadequate dosing for the

Selective serotonin reuptake inhibitors (SSRIs), and medium to high risk of bias. The overall quality of the

studies was poor. The authors did caution that SSRIs may lead to more adverse events and treatment cessation

when compared with acupuncture or St. John’s wort.

Lakhan and Vieira (2010) conducted a systematic review to evaluate the effectiveness of herbs and dietary

supplements for the treatment of anxiety and related symptoms. Twenty-one randomized controlled trials and

three open-label, uncontrolled observational studies (n=2619) met inclusion criteria. A total of 1786 patients had

a diagnosis of depression or anxiety disorder and 877 were healthy volunteers with anxiety related to acute

conditions/situations. The authors concluded that nutritional and herbal supplements were an effective method

for the treatment of anxiety but also stated that the positive effects could be due to a placebo effect. Extracts of

passionflower or kava and combinations of L-lysine and L-arginine may be treatment options for anxiety

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symptoms and disorders, but additional studies are needed to evaluate magnesium-containing and other herbal

combinations. There was in sufficient evidence to support St. John’s wort for the treatment of anxiety. Due to the

heterogeneity of the studies and the small patient populations, meta-analysis was not possible.

In a systematic review of randomized controlled trials, Morgan and Jorm (2008) investigated multiple CAM

therapies for the treatment of depression including: herbal remedies or dietary supplements (i.e., borage,

carnitine/acetyl-L-carnitine, chromium, ginkgo biloba, Korean ginseng, Panax ginseng, lavender, lecithin,

melatonin, omega 3 fatty acids, fish oil, S-Adenosylmethionine [SAMe], saffron/cocus sativus L, selenium, St.

John’s wort), vitamins (i.e., B1, B12, C, D, and multivitamins), folate, caffeine, autogenic training, bibliotherapy,

computerized interventions, distraction, meditation, relaxation training, humor, Qigong, Tai Chi, yoga,

aromatherapy, hydrotherapy, light therapy, music, and negative air ionization. There was limited to no evidence

on these therapies, as well as inconsistent reporting of active ingredients and mechanisms, ideal dosages, side

effects and safety issues for herbs and dietary supplements. Some therapies resulted in immediate but not

sustained benefit, and tools for measuring outcomes were inconsistent and/or not well defined. Other limitations

included small patient populations, short duration, and minimal or no follow-up.

Additional systematic reviews of randomized and nonrandomized controlled trials have investigated CAM for the

treatment of depression, anxiety and/or sleep disturbances. Therapies included yoga, meditation, relaxation,

music, various herbs and vitamin supplements, Tai Chi, and Qigong (n=33 randomized controlled trials) (Meeks,

et al., 2007), St. John’s wort, homeopathy, relaxation training, music therapy, aromatherapy massage, and yoga

(n=19 studies) (Thachil, et al., 2007). Although some studies reported a therapeutic effect following a CAM

intervention (e.g., Tai Chi, relaxation techniques, and music for sleep disturbances and acupressure for sleep

and anxiety), the studies had methodological limitations (e.g., small patient populations, lack of use of systematic

psychiatric diagnoses, loss to follow-up, inadequate controls, and lack of inclusion/exclusion criteria and

assessment and reporting of CAM side effects). There is insufficient evidence to support the safety and

effectiveness of CAM for the treatment of depression.

Fibromyalgia: Zech et al. (2017) conducted a systematic review of nine randomized controlled trials (n=457) to

evaluate the efficacy, acceptability and safety of guided imagery/hypnosis (GI/H) in the treatment of fibromyalgia.

Primary outcomes included: ≥ 50% pain relief; ≥ 20% improvement of health-related quality of life; psychological

distress; disability, acceptability and safety at end of therapy; and three-month follow-up. Controls included GI/H

placebo (e.g., education, emotional support, pure relaxation), usual treatment, waiting list and active

pharmacological or nonpharmacological interventions. There was a significant benefit of GI/H compared to

controls on ≥ 50% pain relief and psychological distress at the end of therapy. Acceptability was not significantly

different compared to the control. No study reported on safety. Overall, the quality of evidence was rated as low.

Limitations of the studies included the small patient populations (n=16–100); short-term follow-ups (one week to

six months); heterogeneity of therapies (e.g., home alone therapy, individual therapy, group therapy, non-pain

related suggestions, pain-relation suggestions, number of sessions) and outcome measures. The authors noted

that it was unclear if patients with anxiety and/or depressive disorder, which are frequently associated with

fibromyalgia, were included in most studies. There is insufficient data to support GI/H for the treatment of

fibromyalgia.

Heart Failure: Gok Metin et al. (2018) conducted a systematic review including 24 randomized controlled trials

(n=1314) to evaluate the effectiveness of mind-body interventions for the treatment of high functioning individuals

with heart failure. The analysis included: seven Tai Chi studies; four studies on yoga and relaxation; two studies

each on meditation, acupuncture, and biofeedback; and one study each on stress management, Pilates and

reflexology. Studies ranged from four minutes to 26 weeks in duration. Patient populations ranged from 8–65 per

study group. Small-to-moderate improvements were reported for quality of life (14/14 studies), exercise capacity

(8/9 studies), depression (5/5 studies), anxiety and fatigue (4/4 studies), blood pressure (3/5 studies), heart rate

(5/6 studies), heart rate variability (7/9 studies), and B-type natriuretic peptide (3/4 studies). Due to the limited

number of studies, small patient populations, short duration of the studies, and poor description of the

randomization procedures conclusions could not be drawn regarding the clinical effectiveness of these

interventions for the treatment of heart failure.

Inflammatory Bowel Disease: Langhorst et al. (2015) conducted a systematic review of the literature to

evaluate the safety and effectiveness of CAM for the treatment of inflammatory bowel disease (IBD). A total of 36

randomized controlled trials and three controlled trials met inclusion criteria. CAM interventions included: herbal

EVERNORTH Coverage Policy: EN0086 32

medicine (e.g., aloe-vera gel, andrographis paniculata, artemisia absinthium, barley foodstuff, boswellia serrata,

cannabis, curcumin, evening primrose oil, Myrrhinil intest

, plantago ovata, silymarin, sophora, tormentil,

wheatgrass-juice, wormwood); trichuris suis ovata; mind/body interventions (e.g., lifestyle modification,

hypnotherapy, relaxation training, mindfulness); and acupuncture. Studies were eligible if they assessed at least

one of the following outcomes: induction or maintenance of remission, disease activity or symptom severity,

quality of life, or psychological variables. Overall, the studies included small patient populations and short-term

follow-ups. Due to the low number of trials for each modality and the heterogeneity of the methodology of the

studies, firm conclusions could not be made. Author-noted limitations of the studies included: high risk of bias,

data on compliance was not reported in almost half of the studies, lack of blinding, trials of traditional Chinese

medicine were not considered; and due to the small number of trails, meta-analysis could not be performed.

Because most trials tested interventions for ulcerative colitis, conclusions were mainly limited to patients with this

condition.

Otitis Media: Marom et al. (2016) conducted a systematic review of CAM therapies for the treatment of otitis

media in children. The CAM therapies considered included: acupuncture, homeopathy, herbal

medicine/phytotherapy, osteopathy, chiropractic, xylitol, ear candling, vitamin D supplement, and systemic and

topical probiotics. Overall, limitations of the studies included: small patient populations, short-term follow-ups,

high dropout rates, lack of a control group, and conflicting outcomes. Following review of the data for each CAM

intervention, it was concluded that CAM is not considered a treatment option of otitis media due to the limited

and inconsistent evidence.

Pain Management: A systematic review of data from ten randomized controlled trials (n=1055) compared

manual healing methods (i.e., massage, warm packs, other thermal manual methods, and music) to standard

care, no treatment, other non-pharmacological forms of pain management in labor or placebo. Massage provided

a greater reduction in pain intensity (measured using self-reported pain scales) than usual care during the first

stage of labor (six trials, n=362) and second and third stage of labor (two trials). Other studies showed no clear

benefit of massage over usual care for the length of labor and pharmacological pain relief. One trial reported less

anxiety during the first stage of labor for women receiving massage. One trial found an increased sense of

control from massage and two studies reported higher satisfaction with the childbirth experience with the use of

massage. All evidence was considered low to very low in quality. Very low quality showed reduced pain and

shortened labor with the use of warm packs and other thermal methods. One trial that compared manual

methods with music found very low-quality evidence of reduced pain intensity during labor in the music group

with no evidence of benefit for reduced use of pharmacological pain relief. Further research is needed to support

the clinical benefit of these modalities during labor (Smith, et al., 2018).

Smith et al. (2006) conducted a systematic review and meta-analysis of 14 randomized controlled trials (n=1537)

that compared complementary and alternative medicine (i.e., three acupuncture trials, one audio-analgesia trial,

two acupressure trials, one aromatherapy trial, one massage trial, one relaxation trial, and five hypnosis trials) to

placebo, no treatment or pharmacotherapy for pain management in labor. Acupuncture and self-hypnosis

decreased the need for pain relief and requirements for pharmacotherapy, respectively. There was insufficient

evidence to support the effectiveness of the other therapies. With the exception of the acupuncture and hypnosis

trials, the authors noted that the number of women studied was small, and few complementary therapies had

“been subjected to proper scientific study.”

Pregnancy: In a 2015 Cochrane systematic review, Matthews et al. evaluated the safety and effectiveness of

interventions for nausea, vomiting and retching in early pregnancy (up to 20 weeks’ gestation). A total of 41 trials

(n=5449) met inclusion criteria. Interventions included: acupressure, acustimulation, acupuncture, ginger,

chamomile, lemon oil, mint oil, vitamin B6 and several antiemetic drugs. Acupressure and acustimulation of P6

showed no significant benefit to this subgroup. The evidence for ginger was limited and not consistent. Meta-

analysis was not possible due to the heterogeneity of the patient populations, interventions, comparison groups,

and outcomes measures. Selection bias risk was unclear for many studies and almost half of the studies did not

fully or clearly report all pre-specified outcomes. There is a lack of high-quality evidence to support any one

intervention.

Psoriasis: Smith et al. (2009) conducted a systematic review of randomized controlled trials to identify the

evidence-based information about CAM for the treatment of psoriasis. The studies were categorized as either

vitamins/herbs/minerals; fish oil, climatotherapy, acupuncture/Chinese medicine, or mind/body. The vitamins,

EVERNORTH Coverage Policy: EN0086 33

herbs and minerals category included studies on vitamin D, inositol, zinc, selenium, neem, aloe vera, vitamin

B12 with avocado oil, mahonia aquifolium (i.e., bayberry or Oregon grape), and oleum horwathiensis. The

authors concluded that due to the low quality of the studies and conflicting results, additional studies are needed

to establish the safety and efficacy of these modalities before recommendations for CAM for the treatment of

psoriasis can be made. There is also the potential risk of side effects from aloe vera, Chinese medicine and

climatotherapy, such as allergic contact dermatitis, hepatotoxicity, and increased risk for skin cancer,

respectively.

Rheumatic Diseases: Phang et al. (2018) conducted a systematic review of randomized controlled trials to

evaluate the safety and efficacy of CAM therapies for the treatment of rheumatic diseases including rheumatoid

arthritis, osteoarthritis, fibromyalgia, gout, vasculitides, systemic sclerosis, systemic lupus erythematosus,

ankylosing spondylitis and psoriatic arthritis. A total of 60 studies met inclusion criteria and included the following

CAM therapies: acupuncture (n=9 studies); Ayurvedic treatment (n=3 studies); homeopathic treatment (n=3

studies); electricity (n=2 studies); natural products, nonvitamin and nonmineral (e.g., Dehydroepiandrosterone

[DHEA], traditional Chinese medicine, Chuanhu) (n=31 studies); megavitamin therapies (n=8 studies);

chiropractic or osteopathic manipulation (n=3 studies); and energy healing therapy (n=1 study). Most studies

investigated these therapies for the treatment of rheumatoid arthritis or osteoarthritis. Minor or no adverse events

were reported. Due to the poor quality of the evidence the clinical benefit of these therapies could not be

established. Limitations of the studies included: small patient populations; short-term follow-ups; and

heterogeneity in the study designs, treatment regimens, outcome measures, disease entities, interventions and

statistical analysis.

Rhinitis and Asthma: A systematic review by Passalacqua et al. (2006) on CAM for the treatment of rhinitis and

asthma included randomized controlled trials (n=57) involving acupuncture, herbal medicines, homeopathy,

breathing techniques, yoga, and chiropractic-spinal manipulation. The authors concluded that from a scientific

viewpoint, there was no “definitive or convincing proof of efficacy” for the use of CAM in rhinitis or asthma, and

there was an absence of quantitative measures in the studies. Therefore, it was not possible to provide

evidence-based recommendations for the use of these modalities.

Professional Societies/Organizations

American Academy of Allergy, Asthma & Immunology (AAAAI): In their clinical review of CAM (Mainardi, et

al., 2009) which included vitamins D, E, C and A, magnolol, quercetin, resveratrol, ma huang (ephedrine sinica),

Ayurvedic medicine, Kampo medicine for the treatment of asthma, atopic dermatitis, and allergic rhinitis, the

AAAAI concluded that further studies are needed using larger sample sizes, longer study durations, comparable

absolute measures, and well-constructed study designs that control for biases. They also stated that the

following are unknown: the true efficacy and safety of CAM therapies, the efficacy of CAM therapies alone (as

alternatives) in the treatment of various disorders, the individual CAM therapeutic mechanism of effects (some

may be multiple), the active component of individual CAM therapies, the potential drug-drug and drug-herb-

phytochemical and vitamin interactions.

American Academy of Neurology (AAN): AAN (2014) conducted a systematic review of the literature to

develop recommendations for CAM for the treatment of multiple sclerosis. Due to the lack of evidence or the

poor quality of the evidence, AAN concluded that the evidence was insufficient to support or refute the use of

Chinese medicine, hippotherapy, massage therapy, hypnosis, mindfulness training, music therapy, naturopathic

medicine, neural therapy, progressive muscle relaxation, tai chi, and yoga. Bases on available studies, AAN

concluded the following: 1) Ginkgo biloba is ineffective for improving cognitive function but possibly effective in

reducing fatigue; 2) low-fat diet with omega-3 fatty acid supplement is probably ineffective for reducing MS-

related relapse, disability, or MRI lesions, or for improving fatigue or quality of life (QOL); 3) reflexology is

possibly effective for reducing MS-associated paresthesia but there is a lack of data to support or refute this

modality for pain, health-related QOL, disability, spasticity, fatigue, cognition, bowel/bladder function, depression,

anxiety, or insomnia. This practice guideline was reaffirmed in February 2023.

American Academy of Pediatrics (AAP): The 2008 AAP Task Force on Complementary and Alternative

Medicine, the Provisional Section on Complementary, Holistic, and Integrative Medicine (Kemper, et al., 2008;

reaffirmed Hyman et al., 2020) published guidance on the use of CAM in pediatrics. The Task Force concluded

that pediatricians and other clinicians who care for children have the responsibility to advise and counsel patients

about relevant, safe, effective, and age-appropriate health therapies including CAM and should routinely inquire

EVERNORTH Coverage Policy: EN0086 34

as to whether or not the patient is using any specific CAM therapies. They advised the clinician to work with the

parents to consider and evaluate all appropriate treatments and monitor the patient’s response to treatments.

They also stated that the physician should be knowledgeable about CAM therapies and evidence-based

information.

In guidelines for the management of autism spectrum disorders (ASDs), the AAP (Myers, et al., 2007; reaffirmed

2020) stated that CAM therapies used to treat ASDs have included “immunoregulatory interventions (e.g., dietary

restriction of food allergens, administration of immunoglobulin or antiviral agents), detoxification therapies (e.g.,

chelation), gastrointestinal treatments (e.g., digestive enzymes, antifungal agents, probiotics, “yeast-free diet,”

gluten/casein-free diet), and dietary supplement regimens (e.g., vitamin A, vitamin C, vitamin B-6, magnesium,

folic acid, folinic acid, vitamin B-12, dimethylglycine, trimethylglycine, carnosine, omega-3 fatty acids, inositol,

various minerals),” “auditory integration training, behavioral optometry, craniosacral manipulation, dolphin-

assisted therapy, music therapy and facilitated communication”. AAP noted that many CAM therapies have been

inadequately evaluated because of methodological flaws, insufficient numbers of patients or lack of replication

and cannot be recommended. Appropriately designed trials have demonstrated no significant benefit from the

use of dimethylglycine (an amino acid), vitamin B-6 and magnesium, auditory integration training, omega-3 fatty

acids, and gluten/casein-free diet.

American College of Chest Physicians (ACCP): The ACCP (Deng, et al., 2013) published evidence-based

clinical practice guidelines on complementary therapies and integrative medicine and suggested that mind-body

modalities could be used as part of a multidisciplinary approach to treating the symptoms of cancer-related pain,

nausea and vomiting associated with chemotherapy, anxiety, and sleep and mood disturbances. Yoga and

massage therapy may be beneficial in reducing fatigue, anxiety and/or pain.

American College of Medical Toxicology (ACMT) and the American Academy of Clinical Toxicology

(AACT): In a 2015 Choosing Wisely statement, ACMT and AACT stated “Don’t use homeopathic medications,

non-vitamin dietary supplements or herbal supplements as treatments for disease or preventive health

measures”. The Societies explained that these therapies are assumed safe and effective because they are

considered “natural” products. Although reliable evidence that these products are effective is often lacking,

substantial evidence exists that they may cause harm. In addition, risks can occur us of these substances delay

or replace known effective forms of treatment or compromise the efficacy of conventional medicines. The

Societies also stated that hair testing for metal poisoning screening should not be performed for screening

purposes. Hair and nail testing are rarely required, frequently unreliable and provide limited utility after metal

exposures.

In a 2015 Choosing Wisely statement, ACMT and AACT stated, “Don’t recommend ‘detoxification’ through colon

cleansing or promoting sweating for disease treatment or prevention.” According to the Societies, there is no

objective evidence or US FDA-approved colonic hydrotherapy systems that support colonic irrigation or cleaning

for detoxification. Doing so may result in cramping, pain, dehydration, electrolyte imbalances, infections and

bowel perforation.

American College of Physicians (ACP): In clinical guidelines on the nonpharmacologic versus pharmacologic

treatment of adult patients with major depressive disorder (Qaseem, et al., 2023), ACP evaluated the use of

complementary and alternative medicines (including acupuncture, w-3 fatty acids, S-adenosyl-L-methionine, St.

John's wort [Hypericum perforatum]), and did not recommend their use. Per the ACP, areas with no evidence for

initial treatment of adults with MDD included: behavior therapy, behavior modification, humanistic therapies, yoga

and meditation. No evidence was found to support any second-line treatment strategies that involved CAM or

exercise. No evidence was available to determine differences in comparative effectiveness and risk for harms of

psychological treatments, CAM, or exercise according to different demographic characteristics, such as age, sex,

race, or ethnicity.

American College of Rheumatology (ACR): The ACR (2022) guideline on complementary and alternative

medicine for rheumatic diseases supports the integration of CAM modalities “proven to be safe and effective by

scientifically rigorous clinical trials published in the biomedical peer review literature” and advised caution in

using those therapies not scientifically studied. For interventions for which randomized controlled trials are not

feasible, “innovative methods of evaluation are needed, as are measures and standards for the generation and

EVERNORTH Coverage Policy: EN0086 35

interpretation of evidence.” The group does not recommend formally defined diet (other than Mediterranean

style), dietary supplements, electrotherapy or chiropractic therapy for the management of rheumatoid arthritis.

American Heart Association (AHA): AHA conducted a systematic review of the literature to review the data on

the potential benefits of meditation on cardiovascular risk. Some studies suggested that meditation could have

long-standing effects on the brain which provides some biological plausibility for beneficial consequences on

cardiovascular risk. Studies of the effects of meditation on cardiovascular risk included stress reduction, smoking

cessation, blood pressure reduction, insulin resistance and metabolic syndrome, endothelial function, inducible

myocardial ischemia, and primary and secondary prevention of cardiovascular disease. Overall, the studies

suggested a possible though not definitively established benefit of meditation on cardiovascular risk reduction.

The overall quality and, in some cases, quantity of study data were modest. AHA stated that given the low costs

and low risks of this intervention, meditation may be considered as an adjunct to guideline-directed

cardiovascular risk reduction by those interested in this lifestyle modification, with the understanding that the

benefits of such intervention need to be better established. Further research on meditation and cardiovascular

risk in the form of randomized controlled trials, adequately powered to meet the primary study outcome, striving

to achieve low drop-out rates, and including long-term follow-up are warranted (Levine, et al., 2017).

American Psychiatric Association: The American Psychiatric Association’s Task Force on Complementary

and Alternative Medicine (Freeman, et al., 2010) conducted a systematic review of randomized controlled trials

to evaluate the evidence on commonly used CAM therapies for the treatment of major depressive disorder

(MDD). Therapies included omega-3 fatty acids, St. John’s wort (Hypericum), folate, S-adenosyl-L-methionine

(SAMe), bright light therapy, exercise, and mindfulness psychotherapies (i.e., mindfulness-based cognitive

therapy, problem-solving therapy, well-being therapy). The Task Force concluded that although some CAM

therapies were promising, more rigorous studies to determine their role in the treatment of MDD were necessary.

It was noted that the greatest risk of pursuing a CAM therapy is the possible delay of other well-established

treatments.

National Cancer Institute (NCI): Per NCI (2023), cancer patients using or considering complementary or

alternative therapy should discuss this decision with their health care provider to ensure coordination of care.

NCI notes that some complementary and alternative therapies may interfere with standard treatment or be

harmful when used with conventional treatment.

National Comprehensive Cancer Network

(NCCN

): In their Clinical Practice Guidelines on Cancer-Related

Fatigue™, NCCN (2020) stated that complementary therapies including muscle relaxation, music therapy,

hypnosis and stress reduction based on mindfulness have been evaluated in some studies and the data

suggested that these therapies may be effective in reducing fatigue and improve sleep quality in cancer patients.

NCCN (2020) noted that yoga, cognitive distraction, relaxation exercises, biofeedback, systemic desensitization

and hypnosis with guided imagery are interventions that may be used for anticipatory nausea and vomiting. For

adult pain, NCCN (2020) lists consideration of cognitive behavioral therapy (CBT), biofeedback, breathing

exercises, distraction techniques, relaxation techniques, guided imagery, graded task assignments, hypnosis,

mindfulness-based stress reduction, cognitive restructuring and behavior activation for pain reduction.

Society for Integrative Oncology (SIO) / American Society of Clinical Oncology (ASCO): In 2022,

SIO/ASCO conducted a systematic review of the literature to develop guidelines on integrative therapies for

supportive care of adult cancer patients. The recommendations were divided into categories which included:

aromatase inhibitor (AI) related joint pain, general cancer or musculoskeletal pain, chemotherapy induced

peripheral neuropathy, procedural or surgical pain, and pain during palliative care. While the group admits many

of the recommendations are weak and based on low-quality evidence, the interventions do have clinical

relevance, with a favorable benefit-to-harm ratio. The group defined intermediate evidence as, “Intermediate

confidence that the available evidence reflects the true magnitude and direction of the net effect. Further

research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect.”

Low quality of evidence was defined as, “Low confidence that the available evidence reflects the true magnitude

and direction of the net effect. Further research may change the magnitude and/or direction of this net effect.”

Moderate recommendations held “moderate confidence” of the intervention reflecting best practice. Weak

recommendations indicated “some confidence” offered of “best current guidance for practice.” SIO/ASCO

recommendations included:

EVERNORTH Coverage Policy: EN0086 36

• Evidence quality: Intermediate; Strength of recommendation: Moderate

 Yoga may be offered to patients experiencing AI-related joint pain in breast cancer.

 Reflexology or acupressure may be offered to patients experiencing pain during systemic

therapy for cancer treatment.

 Hypnosis may be offered to patients experiencing procedural pain in cancer treatment or

diagnostic workups.

 Massage may be offered to patients experiencing pain during palliative and hospice care.

• Evidence quality: Low; Strength of recommendation: Moderate

 Massage may be offered to patients experiencing chronic pain following breast cancer

treatment.

• Evidence quality: Low; Strength of recommendation: Weak

 Hatha yoga may be offered to patients experiencing pain after treatment for breast or head and

neck cancers.

 Guided imagery with progressive muscle relaxation may be offered to patients experiencing

general pain from cancer treatment.

 Reflexology or acupressure may be offered to patients experiencing chemotherapy-induced

peripheral neuropathy from cancer treatment.

 Music therapy may be offered to patients experiencing surgical pain from cancer surgery.

The authors summarize several limitations of the included studies: limited methodologic rigor; inadequate

blinding; variation in dosing and format of interventions; dosing unmonitored and rarely standardized; and

inconsistent methods to assess pain among trials, which created difficulties in interpreting the data. Additionally,

most of the studies failed to report any adverse events from these interventions. The group concludes a large

RCT of a specific intervention (e.g., acupuncture) for a specific outcome (e.g., AI-related joint pain, or massage

for pain in palliative care setting) is often limited to one large trial, which does not allow for adequate replication

of data (Mao, et al., 2022).

Veterans Administration/Department of Defense (VA/DoD): In the clinical practice guideline for major

depressive disorder (MDD) (2022) the VA/DoD addressed the use of some CAM therapies. The

recommendations included the following:

• There is insufficient evidence to recommend for or against yoga, tai chi, or qi gong either as

monotherapy or as an adjunctive treatment to pharmacotherapy.

• For patients with mild MDD who are not pregnant or breastfeeding and who prefer herbal treatments to

first-line psychotherapy or pharmacotherapy, we suggest standardized extract of St. John’s wort (SJW)

as a medication monotherapy (weak evidence). The guideline noted that there is not good evidence that

dosing of SJW is consistent across formulations from different manufacturers.

• Suggested against using omega-3 fatty acids or vitamin D for treatment of MDD (weak evidence).

Medicare Coverage Determinations

Contractor

Policy Name/Number

Revision Effective

Date

NCD

National

Cellular Therapy (30.8)

Longstanding

NCD

National

Colonic Irrigation (100.7)

Longstanding

NCD

National

Hair Analysis (190.6)

8/1/1978

NCD

National

Laetrile and Related Substances (30.7)

Longstanding

NCD

National

Transcendental Meditation (30.5)

11/11/1995

LCD

CGS

Administrators, LLC

Outpatient Physical and Occupational Therapy

Services (L34049)

05/25/2023

LCD

CGS

Administrators, LLC

Outpatient Psychiatry and Psychology Services

(L34353)

05/19/2023

LCD

First Coast Service

Options, Inc.

Allergy Testing (L33261)

07/11/2021

EVERNORTH Coverage Policy: EN0086 37

Contractor

Policy Name/Number

Revision Effective

Date

LCD

First Coast Service

Options, Inc.

Psychiatric Diagnostic Evaluation and

Psychotherapy Services (L33252)

07/01/2020

LCD

National

Government

Services, Inc.

Outpatient Physical and Occupational Therapy

Services (L33631)

01/01/2020

LCD

National

Government

Services, Inc.

Psychiatry and Psychology Services (L33632)

11/28/2019

LCD

Noridian Healthcare

Solutions, LLC

Measurement of Salivary Hormones (L36846 &

L36857)

11/01/2019

LCD

Novitas Solutions,

Inc.

Allergy Testing (L36241)

07/11/2021

LCD

Novitas Solutions,

Inc.

Assays for Vitamins and Metabolic Function

(L34914)

07/01/2020

LCD

Novitas Solutions,

Inc.

Psychiatric Codes (L35101)

07/01/2020

LCD

Palmetto GBA

Outpatient Occupational Therapy (L34427)

04/03/2023

LCD

Wisconsin

Physicians Service

Insurance

Corporation

Allergy Testing (L36402)

10/01/2022

LCD

Wisconsin

Physicians Service

Insurance

Corporation

Psychiatry and Psychology Services (L34616)

10/01/2022

Coding Information

Notes:

1. This list of codes may not be all-inclusive since the American Medical Association (AMA) and Centers for

Medicare & Medicaid Services (CMS) code updates may occur more frequently than policy updates.

2. Deleted codes and codes which are not effective at the time the service is rendered may not be eligible

for reimbursement.

Experimental/Investigational/Unproven

Considered Experimental/Investigational/Unproven:

CPT

Codes

Description

90880

Hypnotherapy

0736T

Colonic lavage, 35 or more liters of water, gravity-fed, with induced defecation, including

insertion of rectal catheter

HCPCS

Codes

Description

A9152

Single vitamin/mineral/trace element, oral, per dose, not otherwise specified

A9153

Multiple vitamins, with or without minerals and trace elements, oral, per dose, not otherwise

specified

G0176

Activity therapy, such as music, dance, art or play therapies not for recreation, related to the

care and treatment of patient's disabling mental health problems, per session (45 minutes or

more)

H2032

Activity therapy, per 15 minutes

EVERNORTH Coverage Policy: EN0086 38

HCPCS

Codes

Description

J3570

Laetrile, amygdalin, vitamin B-17

M0075

Cellular therapy

S8940

Equestrian/hippotherapy, per session

S9451

Exercise classes, nonphysician provider, per session

T2036

Therapeutic camping, overnight, waiver, each session

T2037

Therapeutic camping, day waiver, each session

Considered Experimental/Investigational/Unproven when used to report chemical hair analysis:

CPT

Codes

Description

80178

Lithium

82108

Aluminum

82175

Arsenic

82300

Cadmium

82310

Calcium; total

82525

Copper

83018

Heavy metal (eg, arsenic, barium, beryllium, bismuth, antimony, mercury); quantitative, each,

not elsewhere classified

83540

Iron

83655

Lead

83735

Magnesium

83785

Manganese

83825

Mercury, quantitative

83885

Nickel

84100

Phosphorus inorganic (phosphate);

84255

Selenium

84302

Sodium; other source

HCPCS

Codes

Description

P2031

Hair analysis (excluding arsenic)

Considered Experimental/Investigational/Unproven when used to report a salivary

hormone panel:

CPT

Codes

Description

80426

Gonadotropin releasing hormone stimulation panel This panel must include the following:

Follicle stimulating hormone (FSH) (83001 x 4), Luteinizing hormone (LH) (83002 x 4)

82157

Androstenedione

82530

Cortisol; free

82533

Cortisol; total

82626

Dehydroepiandrosterone (DHEA)

82627

Dehydroepiandrosterone–sulfate (DHEA-S)

82670

Estradiol; total

82677

Estriol

82679

Estrone

82681

Estradiol; free, direct measurement (eg, equilibrium dialysis)

82784

Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each

82787

Gammaglobulin (immunoglobulin); immunoglobulin subclasses (eg, IgG1, 2, 3, or 4), each

83001

Gonadotropin; follicle stimulating hormone (FSH)

83002

Gonadotropin; luteinizing hormone (LH)

EVERNORTH Coverage Policy: EN0086 39

83498

Hydroxyprogesterone, 17-d

84144

Progesterone

84234

Receptor assay; progesterone

84402

Testosterone, free

84403

Testosterone, total

86001

Allergen specific IgG quantitative or semiquantitative, each allergen

HCPCS

Codes

Description

S3650

Saliva test, hormone level; during menopause

S3652

Saliva test, hormone level; to assess preterm labor risk

Other Complementary and Alternative Medicine Diagnostic Testing and Therapies

Considered Experimental/Investigational/Unproven when used to report any complementary or

alternative medicine diagnostic testing methods, systems, therapies or treatments listed in this

Coverage Policy that do not have an assigned code:

CPT

Codes

Description

45399

Unlisted procedure, colon

76498

Unlisted magnetic resonance procedure (eg, diagnostic, interventional)

84999

Unlisted chemistry procedure

86353

Lymphocyte transformation, mitogen (phytomitogen) or antigen induced blastogenesis

86849

Unlisted immunology procedure

90899

Unlisted psychiatric service or procedure

96379

Unlisted therapeutic, prophylactic, or diagnostic intravenous or intra-arterial injection or infusion

96549

Unlisted chemotherapy procedure

97039

Unlisted modality (specify type and time if constant attendance)

97139

Unlisted therapeutic procedure (specify)

97799

Unlisted physical medicine/rehabilitation service or procedure

99199

Unlisted special service, procedure or report

*Current Procedural Terminology (CPT

References

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Revision Details

Type of Revision

Summary of Changes

Date

Annual Review

• No policy statement changes.

02/15/2024

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