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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

<< Back to Publications >> Go to Table of Contents

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