General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contents1. Methodologies for Research and Evaluation of Herbal Medicines
Open this folder and view contents2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Open this folder and view contents3. Clinical Research
Open this folder and view contents4. Other Issues and Considerations
View the documentReferences
Open this folder and view contentsAnnexes
Open this folder and view contentsAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Open this folder and view contentsAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Open this folder and view contentsAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Close this folderAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
View the documentClaims Based on Evidence of Traditional Use
View the documentWhat Kinds of Claims Does the Evidence Support?
View the documentRegistrable Diseases List
View the documentClaims Based on Evidence of Traditional Use
Open this folder and view contentsAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Open this folder and view contentsAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Open this folder and view contentsAnnex VIII. Guideline for Good Clinical Practicea
Open this folder and view contentsAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
View the documentAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

Claims Based on Evidence of Traditional Use

Traditional medicines are used by some 60% of the world’s population and in some countries are extensively incorporated into the public health system. They are based on an extensive history of use, often measured over thousands of years. This history provides an accumulated repository of systematic observation that underpins the use of these traditional medicines.

Traditional use may infer community knowledge of the existence and application of a substance but does not necessarily carry with it any scientific assessment or scrutiny. For many products and substances there has been little quantifiable scientific research undertaken into their mode of action and effect. Evidence of traditional use may be used to support claims for therapeutic goods. The Complementary Medicines Evaluation Committee (CMEC) has adopted the following definition of “traditional use” for regulatory purposes.

Traditional use refers to documentary evidence that a substance has been used over three or more generations of recorded use for a specific health related or medicinal purpose.b

b Where tradition of use has been recorded as an oral rather than written history, then evidence of such should be obtained from the appropriate practitioner or indigenous group(s), who maintain such a history.

In assessing traditional use the context of the claim is important. Most traditional forms of medicine are likely to use a mixture of substances, and certain behavioural rules promoting healthy diets and habits are likely to apply to them. In those cases, holistic principles are part of the therapy. Thus the theories, concepts and cultural context of the therapy need to be considered.

In forming a claim based on traditional use, products and substances that form part of traditional therapies should identify the therapy to which they belong as well as the product description/name and the symptom/indication/condition for which the product or substance is claimed to be beneficial. Traditional therapies are considered to include Traditional Chinese Medicine (TCM), traditional Ayurvedic medicine, traditional western herbal medicine, traditional homeopathic medicine, aromatherapy and other indigenous medicines. Where multi-component products are comprised of active ingredients from different traditional therapies, the therapy from which each ingredient is derived needs to be described in the claim.

Modification of the classic formulations in Traditional Chinese Medicine (TCM) and Ayurvedic medicine must be based on the classical theory associated with the therapy and on traditional methods of preparation, in order for these products to make a traditional claim. For example, to meet the criteria for a traditional claim using evidence of traditional use, the overall formulation of a TCM needs to reflect the classical methods of combination. Claims for combinations in Western Herbal formulations must be based on evidence linking the particular formulation (including methods of preparation) with traditional preparations, and must reflect the traditional knowledge about each individual herb in the product.

With respect to multigenerational use of homeopathic medicines, it is recognised that homeopathic medicine represents a special case where the manufacturing process of serial dilution is a major component of the tradition of use of the therapy. Providing that a new substance is prepared according to principles described in (Therapeutic Goods Administration [TGA]-approved) homeopathic pharmacopoeia, and satisfies safety requirements, claims may be assessed on an “evidence of traditional use” basis. Evidence of traditional use includes independent written histories of use in traditional or contemporary homeopathic literature, multigenerational use, homeopathic proving, records of clinical use and records of the set of symptoms provoked by a “crude” substance. Claims made in relation to homeopathic products must be consistent with the homeopathic picture of the remedy or remedies on which the claim is based.

Substances that have been altered significantly in their constituent profile from the classical traditional medicine for which the claim is being made, require scientific evidence in order to substantiate their claimed action.

Combinations of substances, some of which have a history of traditional use, and others which do not but are supported by scientific evidence, may make claims based both on their traditional-use components and the scientific evidence, thus allowing a mixed claim. Should scientific evidence be contrary to the evidence based on traditional use, the claim used must reflect the truth, on balance of the evidence available.

For Listable multi-component products, traditional claims can be based on the evidence of traditional use for the product itself, or on evidence for an individual component or components about which claims are made. However, the dose of the component or components mentioned in the claim must be consistent with the evidence, and the composition and preparation of the product must be consistent with the holistic principles of the tradition about which the claim is made.

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