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
Close this folderAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
View the documentPreclinical Considerations
View the documentClinical Considerations
View the documentRecommendations
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Open this folder and view contentsAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
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
 

Recommendations

A place for traditional herbal remedies in the health care system will be established only if recommendations for their use are based on studies that make them credible and acceptable. Thus, studies with herbal medicines must satisfy the same criteria of efficacy and safety as do the drugs that are products of the modern pharmaceutical industry.

In this context, the consultation drew up a series of guidelines for clinical trials with traditional medicine products used in the treatment of AIDS and AIDS-related diseases.

The consultation also made the following recommendations:

1. This report should be given wide distribution so that the guidelines can be readily and immediately applied in countries where potential remedies may exist.

2. The guidelines should be used as the basis for the development of clinical trials for the evaluation of traditional medicines and natural products.

3. WHO should monitor the impact of the use of the guidelines at the country level to determine any needs for revision.

4. A second consultation should be convened in two years’ time to revise the guidelines on the basis of experience in their use.

5. The WHO Traditional Medicine Programme, together with the WHO Global Programme on AIDS, should jointly identify appropriate institutions in developing countries where clinical evaluation of traditional medicines and natural products for AIDS could be carried out.

6. Other consultations should be convened by the WHO Traditional Medicine Programme, in collaboration with appropriate WHO programmes, to adapt the guidelines for the clinical evaluation of traditional medicines for other primary disease states that are of concern in developing countries, such as malaria and other parasitic diseases.

 

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