Guidelines for Clinical Research on Acupuncture

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CONTENTS Foreword 1.

vii

Introduction Background Research on acupuncture Need for guidelines for the clinical evaluation of acupuncture

1 1 1

Glossary Terms relating to evaluation methodology Terms relating specifically to acupuncture Studies

3 3

3.

Goals and objectives of the guidelines Goals Objectives

5 5 5

4.

General considerations Legal considerations Ethical considerations Considering the character of acupuncture Clinical research Laboratory studies Animal research Education

6 6 6 6 7 8 8 8

5.

Research methodology Literature review Terminology and technology Investigators Clinical research design and rational use of acupuncture Randomized controlled clinical trial design

2.

2

3

9 9 9 10 11 13

6.

Protocol development Research knowledge Case report forms Data management Ethics review board Statistical analysis Monitoring of studies Reporting Implementation Conclusions

16 18 23 23 24 24 25 26 26 27

Using the guidelines

28

Annexes Annex 1

Strategic approaches to randomized controlled clinical trials

31

Annex 2

World Medical Association Declaration of Helsinki

Annex 3

Report of the working group on Clinical Research Methodology for Acupuncture, Aomori, Japan, 1-4 June 1994

41

List of members, observers and secretariat of the working group on Clinical Research Methodology for Acupuncture, Aomori, Japan, 1-4 June 1994

57

Annex 4

Bibliography

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35

61

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