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CONTENTS
Foreword 1. Introduction Background Research on acupuncture Need for guidelines for the clinical evaluation of acupuncture Glossary Terms relating to evaluation methodology Terms relating specifically to acupuncture Studies Goals and objectives of the guidelines Goals Objectives General considerations Legal considerations Ethical considerations Considering the character of acupuncture Clinical research Laboratory studies Animal research Education Research methodology Literature review Terminology and technology Investigators Clinical research design and rational use of acupuncture Randomized controlled clinical trial design vii 1 1 1 2 3 3 3 5 5 5 6 6 6 6 7 8 8 8 9 9 9 10 11 13

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3.

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5.

Protocol development Research knowledge Case report forms Data management Ethics review board Statistical analysis Monitoring of studies Reporting Implementation Conclusions 6. Using the guidelines

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Annexes Annex 1 Annex 2 Annex 3 Strategic approaches to randomized controlled clinical trials World Medical Association Declaration of Helsinki Report of the working group on Clinical Research Methodology for Acupuncture, Aomori, Japan, 1-4 June 1994 List of members, observers and secretariat of the working group on Clinical Research Methodology for Acupuncture, Aomori, Japan, 1-4 June 1994 31 35

41

Annex 4

57 61

Bibliography

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