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
Close this folder2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
View the document2.1 Types of Traditional Procedure-Based Therapies
View the document2.2 Evaluation of Safety and Efficacy
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
 

2.2 Evaluation of Safety and Efficacy

Theories and concepts

The theories and concepts of the various systems of traditional medicine are very important for the research and evaluation of traditional procedure-based therapies. These are discussed in Part 1 (section 1.3).

Safety

In general, traditional procedure-based therapies are relatively safe, if they are performed properly by well-trained practitioners. But accidents do occasionally occur, most probably when practitioners are not fully trained. Therapies should be performed within accepted parameters, and the indications for a therapy should be evidence based when possible. Serious adverse effects of therapies are rare, but supportive data on adverse effects are not readily available. Accordingly, the evaluation of adverse effects should be considered a priority area for systematic evaluation of safety of these therapies.

One problem in ensuring safety of a therapy is variable quality control in the manufacture of therapy equipment. The most effective safety measures, therefore, are to ensure that the equipment used is of good quality, as well as ensuring that the practitioners who use it have had sound and well supervised theoretical and practical training. These are the appropriate ways to minimize incompetent examination of patients, incorrect diagnoses and errors of technique, and to ensure that patients are properly selected for traditional procedure-based therapy. It should also ensure that the practitioner knows how to deal with accidents when they do occur, and knows how to refer the patient to an appropriate physician if the patient does not respond to therapy or if there is a medical emergency. The WHO Guidelines on basic training and safety in acupuncture5 promote the safe use of acupuncture to prevent adverse effects occurring in patients who have been incorrectly selected for treatment. Similar guidelines could be prepared by WHO Member States. WHO can provide technical assistance to facilitate such efforts.

Efficacy

Many kinds of traditional procedure-based therapies, such as acupuncture and manual therapies, have already been widely used in health care systems in a number of countries. However, there is an increasing demand to study and evaluate the efficacy of these therapies.

The efficacy of most forms of traditional procedure-based therapies depends heavily upon the proficiency of the practitioners, including their skills and experience. This may partly explain the disparity or inconsistency of results reported by different authors, even though the methodologies of the studies were equally sound. Non-specific effects of the therapy can also contribute to efficacy, but these are difficult to measure or quantify. Therefore, clinical trials and other research methodologies are extremely important in the evaluation of the efficacy of traditional procedure-based therapies (see Part 3).

 

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