General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAcknowledgements
Ver el documentoForeword
Abrir esta carpeta y ver su contenidoIntroduction
Abrir esta carpeta y ver su contenido1. Methodologies for Research and Evaluation of Herbal Medicines
Abrir esta carpeta y ver su contenido2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Cerrar esta carpeta3. Clinical Research
Ver el documento3.1 General Considerations
Ver el documento3.2 Literature Review
Ver el documento3.3 Selection of Study Design
Abrir esta carpeta y ver su contenido4. Other Issues and Considerations
Ver el documentoReferences
Abrir esta carpeta y ver su contenidoAnnexes
Abrir esta carpeta y ver su contenidoAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Abrir esta carpeta y ver su contenidoAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Abrir esta carpeta y ver su contenidoAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Abrir esta carpeta y ver su contenidoAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Abrir esta carpeta y ver su contenidoAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Abrir esta carpeta y ver su contenidoAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Abrir esta carpeta y ver su contenidoAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Abrir esta carpeta y ver su contenidoAnnex VIII. Guideline for Good Clinical Practicea
Abrir esta carpeta y ver su contenidoAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
Ver el documentoAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

3.1 General Considerations

Normally, clinical research of all types of conventional and traditional medicine considers both efficacy and safety, and is conducted according to WHO’s guidelines for good clinical practice and the Declaration of Helsinki (see Annex VI). Safety evaluation, however, may not be the main focus of clinical research in traditional medicine, because of the long history of traditional medicine. The information here provides further details to the relevant sections dealing with clinical trials in the assessment of herbal medicines (Part 1) and traditional procedure-based therapies (Part 2).

In addition to evaluating the safety and efficacy of traditional medicine through clinical trials, there may be a number of different objectives when evaluating traditional medicine through clinical research, as when using clinical research to evaluate conventional medicine. Some of the objectives specific to the assessment of traditional medicine through clinical research are to:

• evaluate traditional medicine in its own theoretical framework (e.g. mechanistic studies);

• evaluate traditional medicine in the theoretical framework of conventional medicine (e.g. mechanistic studies);

• compare the efficacy of different systems of traditional medicine and/or conventional medicine; and

• compare the efficacy of different traditional practices within a system of traditional medicine.

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