(2004; 109 pages)
4.4.1 Therapeutic claims
Statements about the efficacy and/or benefits of a TM/CAM therapy made by manufacturers, health care providers or TM/CAM practitioners may or may not be supported by an evidence base. The claims on legally registered TM/CAM products can be expected to be reliable. However, in most countries, TM/CAM has not been integrated into mainstream health care and there is a lack of research information and, in particular, a lack of clinical studies. The efficacy of TM/CAM could be divided into different categories based on research data and studies.
For example, in the WHO monographs on selected medicinal plants, the information on medicinal use has been divided into the following three categories (25, 26):
Use supported by clinical data
This category includes medical indications which are well established in some countries and which have been validated by clinical works documented in the world’s scientific literature. Clinical trials may be controlled, randomized, double-blind studies, open trials, cohort studies, or well-documented observations on therapeutic applications.
Uses described in pharmacopoeias and in traditional systems of medicine
This category includes medicinal uses which have been well established in many countries and are included in official pharmacopoeias or governmental monographs. Uses having a pharmacologically plausible basis are included as well as information resulting from clinical studies which clearly need to be repeated because of conflicting results.
Uses described in traditional medicine, not supported by experimental or clinical data
This category refers to indications described in non-official pharmacopoeias and other literature or traditional uses. Their appropriateness could not be assessed because sufficient data to support the claims could not be found in the literature.
Consumers need to be aware of the different levels of efficacy and the different legal status of medicinal products, which have a major impact on the safety, efficacy and quality of the products and treatment.
Claims for TM/CAM medication therapies should be appropriately stated on the label. Statements about claims for TM/CAM procedure-based therapies may be provided by bodies such as approved TM/CAM professional organizations. In addition, it is important to ensure that when a product is claimed to be marketed for its traditional use, it is used in accordance with the traditional method of use (e.g. the same dosage, duration of treatment and dosage instructions).
Many Member States have regulatory agencies or licensing boards for certain types of TM/CAM practitioners and therapies that may also provide information about evidence and claims (43, 44). In addition, licensing, accreditation and regulatory laws for TM/CAM practices help ensure that TM/CAM practitioners are competent and provide services that correspond to stated claims.
When it is possible to have access to conventional medicines, it is widely agreed by doctors and medical researchers that certain serious diseases or disorders cannot or should not be diagnosed or treated except under medical advice, and that claims for the treatment of such diseases/disorders must be specially evaluated by conventional health care providers and TM/CAM practitioners (3). In countries where such circumstances apply, consumers need to know where to find proper information. The WHO document Acupuncture: Review and analysis of reports on controlled clinical trials, for example, lists symptoms and diseases for which acupuncture may be used (30). It also emphasizes that some symptoms and diseases may only be treated provided that the practitioner has special knowledge in conventional medicine and access to adequate monitoring equipment.