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WHO/EDM/TRM/2000.1

Distr.: General

Original: English


General Guidelines for Methodologies on Research and Evaluation of
Traditional Medicine





World Health Organization

Geneva

Acknowledgements


WHO acknowledges its indebtedness to the more than 100 experts, and national health authorities, who provided comments and advice during the preparation of these guidelines. Thanks are also due to those who participated in a WHO informal discussion on research methodology for evaluation of traditional medicine, which took place in Rockville, MD, USA in 1997, where the first draft of the guidelines was prepared.

In particular, we thank those who participated in the WHO Consultation held in Hong Kong Special Administrative Region of China (Hong Kong SAR) in 2000 (see Annex X), to review and finalize the draft guidelines. We also thank Professor Johan Karlberg, Director of the Clinical Trial Centre of the University of Hong Kong, who revised Part 3; and Dr Williamina Wilson, who edited the final draft.

Appreciation is also extended to the National Center for Complementary and Alternative Medicine – a WHO Collaborating Centre for Traditional Medicine – at the National Institutes of Health, Bethesda, MD, USA, for their support to initiate this endeavour in 1997; and to the Department of Health of the Government of Hong Kong SAR, the Federation of Hong Kong Industries, and the Innovation and Technology Fund of Hong Kong SAR, for their generous support in hosting the WHO Consultation and for their financial contribution to publication of the guidelines.

© World Health Organization 2000



This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced and translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes.

The views expressed in documents by named authors are solely the responsibility of those authors.

Acknowledgements iii

Foreword vi

Introduction 1

Definitions 1

General considerations 1

Purpose of the guidelines 2

Use of the guidelines 2

1. Methodologies for research and evaluation of herbal medicines 3

1.1 Definitions 3

1.2 Botanical verification and quality considerations 4

1.3 Research and evaluation of safety and efficacy 4

2. Methodologies for research and evaluation of traditional
procedure-based therapies 9

2.1 Types of traditional procedure-based therapies 9

2.2 Evaluation of safety and efficacy 9

3. Clinical research 11

3.1 General considerations 11

3.2 Literature review 11

3.3 Selection of study design 12

4. Other issues and considerations 17

4.1 Pragmatic research issues 17

4.2 Ethics 17

4.3 Education and training 18

4.4 Surveillance systems 18

References 19

Annexes 20

Note 20

Annex I. Guidelines for the assessment
of herbal medicines 21

Introduction 21

Assessment of quality 22

Assessment of safety 23

Assessment of efficacy 24

Intended use 25

Utilization of these guidelines 25

Annex II. Research guidelines for evaluating the safety and
efficacy of herbal medicines 26

Definition of terms 26

Guidelines for toxicity investigation of herbal medicines 27

Acute toxicity test 27

Long-term toxicity test 28

Annex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Products 33

Preclinical considerations 33

Clinical considerations 35

Recommendations 36

Annex IV. Definition of levels of evidence and grading of recommendations 38

Levels of evidence 38

Grading of recommendations 39

Annex V. Guidelines for levels and kinds of evidence to support claims
for therapeutic goods 41

Claims based on evidence of traditional use 41

What kinds of claims does the evidence support? 42

Registrable diseases list 44

Claims based on evidence of traditional use 46

Annex VI. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products 49

Ethical principles 49

Annex VII. Guidance for industry: significant scientific agreement in the review of health claims for conventional foods and dietary supplements 51

Identifying data for review 51

Annex VIII. Guideline for Good Clinical Practice 55

Clinical trial protocol and protocol amendment(s) 55

ANNEX IX. WHO QOL (quality of life) user manual: facet definitions
and response scales 59

Introduction 59

Overall Quality of Life and Health 59

DOMAIN I - PHYSICAL DOMAIN 59

DOMAIN II - PSYCHOLOGICAL 60

DOMAIN III - LEVEL OF INDEPENDENCE 61

DOMAIN IV - SOCIAL RELATIONSHIPS 63

DOMAIN V - ENVIRONMENT 64

DOMAIN VI - SPIRITUALITY/RELIGION/PERSONAL BELIEFS 66

Response scales 66

Annex X. Participants in the WHO Consultation on Methodologies
for Research and Evaluation
of Traditional Medicine 69

Hong Kong Special Administrative Region of China (Hong Kong SAR), 11–14 April 2000 69
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