special subjects
Overview of Integrative, Complementary, and Alternative Medicine
Efficacy of Alternative Therapies
In 1992, the Office of Alternative Medicine in the National Institutes of Health (NIH) was formed to study the efficacy and safety of alternative therapies. In 1998, this office became the National Center for Complementary and Alternative Medicine (NCCAM), and in 2015, it became the National Center for Complementary and Integrative Health (NCCIH). Other NIH offices (eg, National Cancer Institute) also fund some CAM research. The NCCIHmaintains a list of research outcomesin this field. There are 3 types of support for CAM therapies: Efficacy on clinical outcomes as shown in controlled clinical trials (considered the strongest evidence for clinical uses) Evidence of established physiologic mechanisms of action (eg, modification of gamma-aminobutyric acid [GABA] activity in the brain byvalerian), although evidence of a validated physiologic mechanism of action does not necessarily indicate efficacy on clinical outcomes Use over periods of time ranging from decades to centuries (considered lower quality evidence) A substantial amount of information about CAM is available in peer-reviewed publications, evidence-based reviews, expert panel consensus documents, and authoritative textbooks; much of it has been published in languages other than English (eg, German, Chinese). Many CAM therapies have been studied and found to be effective and/or comparable to conventional treatment, but some have been found to be ineffective or subject to conflicting and inconsistent results. Some CAM therapies have not been tested in definitive clinical trials. Factors that limit such research include the following: Holistic, or whole system, modalities (eg, healthy diet pattern) encompass a large number of variables, many or all uncontrolled. In contrast, evidence-based medicine emphasizes one or a small number of variables, ideally controlled interventions (eg, medications or procedures). CAM therapies tend to be low cost and inadequately reimbursed, limiting financial incentive to fund research. Regulation of CAM products and therapies does not require proven disease-specific efficacy. The U.S. Food and Drug Administration (FDA), under the Dietary Supplement Health and Education Act (DSHEA) of 1994, allows marketing of Overview of Dietary Supplements and use of CAM devices but significantly restricts efficacy claims. Generally, manufacturers of dietary supplements can claim, without having to provide evidence for safety or efficacy to the FDA, benefit to the body’s structure or function (eg, improves cardiovascular health) but cannot claim benefit for treating disease (eg, treats hypertension). In 2022, the FDA updated the Designing studies of CAM therapies poses challenges beyond those faced by researchers of conventional therapies: Therapies may not be standardized. For example, there are different systems of Acupuncture , and the contents and biologic activity of extracts made from the same plant species vary widely. Diagnoses may not be standardized. Use of many CAM therapies (eg, traditional herbal medicine, homeopathy, acupuncture) is based on the patient’s unique characteristics or experiences rather than on a conventional medicine diagnosed disease or disorder. CAM treatments may emphasize the whole person and thus include patients who may be excluded from evidence-based medicine randomized controlled trials because they have comorbidities. Double- or single-blinding is often difficult or impossible. For example, patients cannot be blinded as to whether they are practicing meditation. Reiki practitioners cannot be blinded as to whether or not they are using Energy Medicine . Outcomes are difficult to standardize because they are often specific to the individual or focused on general health rather than based on objective and uniform measurements (as mean arterial pressure, HbA1C level, and mortality). Placebos or control interventions may also be difficult to devise in complementary therapies. For example, in massage, the effective component could be touching, the specific area of the body massaged, the particular massage technique used, or time spent with the patient. From a conventional research perspective, use of a Placebos is important. Placebo effect is complex, particularly when considering self-healing in the concept of care. CAM systems, however, recognize and interpret placebo effect as neurobiologic with mind-body implications, often with significant impact on symptoms and experience of disease ( In practice, CAM therapies are intended to enhance the quality of the healing environment and therapeutic relationships and thus optimize the patient’s capacity for healing. Studying the effective components of a CAM therapy against an inert placebo or control in a research setting remains a methodologic challenge. Despite these challenges, many high-quality studies of CAM therapies (eg, Acupuncture , 