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CONTENTS

Foreword vii

1. Introduction 1

Background 1

Research on acupuncture 1

Need for guidelines for the clinical

evaluation of acupuncture 2

2. Glossary 3

Terms relating to evaluation methodology 3 Terms relating specifically to acupuncture

Studies 3

3. Goals and objectives of the guidelines 5

Goals 5

Objectives 5

4. General considerations 6

Legal considerations 6

Ethical considerations 6

Considering the character of acupuncture 6

Clinical research 7

Laboratory studies 8

Animal research 8

Education 8

5. Research methodology 9

Literature review 9

Terminology and technology 9

Investigators 10

Clinical research design and

rational use of acupuncture 11 Randomized controlled clinical

trial design 13

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Protocol development 16

Research knowledge 18

Case report forms 23

Data management 23

Ethics review board 24

Statistical analysis 24

Monitoring of studies 25

Reporting 26

Implementation 26

Conclusions 27

6. Using the guidelines 28

Annexes

Annex 1 Strategic approaches to randomized

controlled clinical trials 31

Annex 2 World Medical Association Declaration 35 of Helsinki

Annex 3 Report of the working group on Clinical Research Methodology for Acupuncture, Aomori, Japan,

1-4 June 1994 41

Annex 4 List of members, observers and secretariat of the working group on Clinical Research Methodology for Acupuncture, Aomori, Japan,

1-4 June 1994 57

Bibliography 61

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