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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.

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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