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
Close this folderIntroduction
View the documentDefinitions
View the documentGeneral Considerations
View the documentPurpose of the Guidelines
View the documentUse of the Guidelines
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
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
 

General Considerations

Practices of traditional medicine vary greatly from country to country, and from region to region, as they are influenced by factors such as culture, history, personal attitudes and philosophy. In many cases, their theory and application are quite different from those of conventional medicine. Long historical use of many practices of traditional medicine, including experience passed on from generation to generation, has demonstrated the safety and efficacy of traditional medicine. However, scientific research is needed to provide additional evidence of its safety and efficacy. In conducting research and evaluating traditional medicine, knowledge and experience obtained through the long history of established practices should be respected.

Despite its existence and continued use over many centuries, and its popularity and extensive use during the last decade, traditional medicine has not been officially recognized in most countries. Consequently, education, training and research in this area have not been accorded due attention and support. The quantity and quality of the safety and efficacy data on traditional medicine are far from sufficient to meet the criteria needed to support its use worldwide. The reasons for the lack of research data are due not only to health care policies, but also to a lack of adequate or accepted research methodology for evaluating traditional medicine. It should also be noted that there are published and unpublished data on research in traditional medicine in various countries, but further research in safety and efficacy should be promoted, and the quality of the research should be improved.

The methodologies for research and evaluation of traditional medicine should be based on the following basic principles. On the one hand, the methodologies should guarantee the safety and efficacy of herbal medicines and traditional procedure-based therapies. On the other hand, however, they should not become obstacles to the application and development of traditional medicine. This complex issue has been a concern for national health authorities and scientists in recent years.

The discussion of methodologies for research and evaluation of traditional medicine is divided into two parts: herbal medicines and traditional procedure-based therapies. However, successful treatment is often the consequence of both types of treatment acting synergistically. Thus, the efficacy of traditional medicine has to be evaluated in an integrated manner, taking into account both treatment types. Consequently, efficacy assessment of traditional medicine may be quite different to that of conventional medicine. As traditional medicine relies on a holistic approach, conventional efficacy assessment measures may not be adequate.

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