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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
 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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