General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine: Annex I. Guidelines for the Assessment of Herbal Medicines a : Assessment of Efficacy

General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish]

Table des matières

	Acknowledgements
	Foreword
	Introduction
		Definitions
		General Considerations
		Purpose of the Guidelines
		Use of the Guidelines
	1. Methodologies for Research and Evaluation of Herbal Medicines
		1.1 Definitions
		1.2 Botanical Verification and Quality Considerations
		1.3 Research and Evaluation of Safety and Efficacy
	2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
		2.1 Types of Traditional Procedure-Based Therapies
		2.2 Evaluation of Safety and Efficacy
	3. Clinical Research
		3.1 General Considerations
		3.2 Literature Review
		3.3 Selection of Study Design
	4. Other Issues and Considerations
		4.1 Pragmatic Research Issues
		4.2 Ethics
		4.3 Education and Training
		4.4 Surveillance Systems
	References
	Annexes
		Note
	Annex I. Guidelines for the Assessment of Herbal Medicines^a
		Introduction
		Assessment of Quality
		Assessment of Safety
		Assessment of Efficacy
		Intended Use
		Utilization of these Guidelines
	Annex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines^a
		Definition of Terms
		Guidelines for Toxicity Investigation of Herbal Medicines
		Acute Toxicity Test
		Long-Term Toxicity Test
	Annex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Products^a
		Preclinical Considerations
		Clinical Considerations
		Recommendations
	Annex IV. Definition of Levels of Evidence and Grading of Recommendation^a
		Levels of Evidence
		Grading of Recommendations
	Annex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goods^a
		Claims Based on Evidence of Traditional Use
		What Kinds of Claims Does the Evidence Support?
		Registrable Diseases List
		Claims Based on Evidence of Traditional Use
	Annex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products^a
		Ethical Principles
	Annex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements^a
		Identifying Data for Review
	Annex VIII. Guideline for Good Clinical Practice^a
		Clinical Trial Protocol and Protocol Amendment(s)
	Annex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scales^a
		Introduction
		Overall Quality of Life and Health
		Domain I - Physical Domain
		Domain II - Psychological
		Domain III - Level of Independence
		Domain IV - Social Relationships
		Domain V - Environment
		Domain VI - Spirituality/Religion/Personal Beliefs
		Response Scales
	Annex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine

Assessment of Efficacy

This should cover all important aspects of efficacy assessment. A review of the relevant literature should be carried out and copies provided of the original articles or proper references made to them. Research studies, if they exist, should be taken into account.

Activity

The pharmacological and clinical effects of the active ingredients and, if known, their constituents with therapeutic activity should be specified or described.

Evidence required to support indications

The indication(s) for the use of the medicine should be specified. In the case of traditional medicines, the requirements for proof of efficacy should depend on the kind of indication. For treatment of minor disorders and for non-specific indications, some relaxation in requirements for proof of efficacy may be justified, taking into account the extent of traditional use. The same considerations may apply to prophylactic use. Individual experiences recorded in reports from physicians, traditional health practitioners or treated patients should be taken into account.

Where traditional use has not been established, appropriate clinical evidence should be required.

Combination products

As many herbal remedies consist of a combination of several active ingredients, and as experience of the use of traditional remedies is often based on combination products, assessment should differentiate between old and new combination products. Identical requirements for the assessment of old and new combinations would result in inappropriate assessment of certain traditional medicines.

In the case of traditionally used combination products, the documentation of traditional use (such as classical texts of Ayurveda, traditional Chinese medicine, Unani, Siddha) and experience may serve as evidence of efficacy.

An explanation of a new combination of well-known substances, including effective dose ranges and compatibility, should be required in addition to the documentation of traditional knowledge of each single ingredient. Each active ingredient must contribute to the efficacy of the medicine.

Clinical studies may be required to justify the efficacy of a new ingredient and its positive effect on the total combination.