Evaluation of Effectiveness and Safety of Acupuncture in the Treatment of Migraine

334 Pages·2008·2.69 MB·English

Evaluation of Effectiveness and Safety of Acupuncture in
the Treatment of Migraine: A Systematic Review and
A Randomised Controlled Trial

Yanyi Wang

(A thesis submitted in fulfilment of the requirements for
the degree of Doctor of Philosophy)

Division of Chinese Medicine
School of Health Sciences
RMIT University
August 2008
Declaration

I certify that except where due acknowledgement has been made, the work is that of the
author alone; the work has not been submitted previously, in whole or in part, to quality for
any other academic award; the content of the thesis is the result of work which has been
carried out since the official commencement date of the approved research program; and, any
editorial work, paid or unpaid, carried out by a third party is acknowledged.

Yanyi Wang ___________________________

Date ___________________________

I
Acknowledgements

I am most grateful to my supervisors, Dr. Zhen Zheng, Professor Charlie Changli Xue and Dr.
Lin Dong for their inspiration, outstanding intellect, encouragement, guidance, and support
during my study for this degree. Sincere thanks also go to my consultants, Professor Robert
Helm (Western Health, Melbourne) and Associate Professor Clifford Da Costa (School of
Mathematic & Geospatial Sciences of RMIT) for their invaluable advice on the study design
and data analysis. Without all my supervisors’ support, the thesis would not have been
possible.

I would like to express my appreciation to Dr. Yamashita Hitoshi (Morinomiya University of
Medical Sciences), Dr. Junchul Seo (Daegu Haany University, Korean) and Dr. Myeong Soon
Lee (Korean Institute of Oriental Medicine, Korea), for their valuable assistance in searching
Japanese and Korean databases and Mira An for translating the Korean data. My appreciation
also goes to Mr. David Lu, Dr. Ye Shen and Mr. Xinyu Hao for data collection and data entry.
The collaboration with Dr Charlotte Paterson (Universities of Exeter & Plymouth, UK)
enables me to see the trial from participants’ eyes. Thank you!

I would like to greatly thank Dr. Thomas Cheung and Mr. Daniel Townsend (Deakin
University) for kindly commenting on the manuscripts,

The help from all staff and other research students in the Division of Chinese Medicine,
School of Health Sciences, RMIT, have also been most helpful. The support and
encouragement of many friends has been indispensable. I would like particularly to
acknowledge the contribution of Dr Lin Zhang, Mrs. Sandy Ebell, Ms. Shuiqing Zhang, Ms.
Wenyu Zhou and Ms. Xuedong An.

II
Most of all I would like to dedicate this thesis to my family, Mr. Qiushi Wang, Ms. Jing Sun
and Mr. Jinqun Wu. Without their support, nothing would have happened.
III
Table of Contents

DECLARATION......................................................................................................................I
ACKNOWLEDGEMENTS....................................................................................................II
TABLE OF CONTENTS......................................................................................................IV
LIST OF TABLES..............................................................................................................XIII
LIST OF FIGURES.............................................................................................................XVI
PUBLICATIONS.................................................................................................................XIX
ABBREVIATIONS...............................................................................................................XX
SUMMARY......................................................................................................................XXIII
CHAPTER ONE: INTRODUCTION.....................................................................................1
CHAPTER TWO: LITERATURE REVIEW........................................................................6
2.1 Migraine Headache........................................................................................................6
2.2 Diagnosis of Migraine...................................................................................................7
2.3 Mechanisms of Migraine...............................................................................................7
2.3.1 Migraine and Genetics...........................................................................................7
2.3.2 Biochemistry and Migraine...................................................................................8
2.3.3 Mechanisms of Aura in Migraine..........................................................................9
2.3.4 Hypothesis and Mechanisms of Migraine...........................................................10
2.4 Current Western Pharmacotherapy..............................................................................14
2.4.1 Drugs for Acute Pain.........................................................................................14
2.4.2 Migraine-Specific Drugs.....................................................................................16
2.4.3 Drugs for Migraine Symptoms............................................................................17
2.4.4 Prophylactic Drugs for Migraine.........................................................................17
2.4.5 Pharmacotherapy: Strength and Weakness..........................................................18
2.5 Non-pharmacological Treatment Approaches for Migraine........................................19
2.5.1 Psychological Management.................................................................................19
2.5.1.1 Biofeedback (BFB)........................................................................................20
2.5.1.2 Progressive Relaxation Training...................................................................21
2.5.1.3 Autogenic Training and Hypnosis.................................................................21
2.5.1.4 Cognitive - Behavioural Therapy..................................................................22
2.5.2 Physical Management..........................................................................................23
2.5.3 Complementary Therapy.....................................................................................24
IV
2.6 Chinese Medicine’s Understanding of Migraine and Its Treatment............................25
2.6.1 Introduction.......................................................................................................25
2.6.2 Pathogenesis in Traditional Chinese Medicine..................................................26
2.6.2.1 Ascending Hyperactivity of Liver Yang and Liver Wind Up Surge...............26
2.6.2.2 Deficiency of Both Qi and Blood..................................................................26
2.6.2.3 Wind Phlegm Blocking the Meridians..........................................................26
2.6.2.4 Blood Stasis..................................................................................................27
2.6.3 Treatment of Migraine in Chinese Medicine.....................................................27
2.7 Acupuncture for Migraine...........................................................................................28
2.7.1 History of Acupuncture.......................................................................................28
2.7.2 Mechanisms of Acupuncture for Anti-migraine..................................................28
2.7.3 Current Clinical Research of Acupuncture for Headache...................................31
2.8 Assessments of Migraine.............................................................................................32
2.8.1 Pain Dimensions..................................................................................................33
2.8.1.1 Frequency......................................................................................................33
2.8.1.2 Intensity.........................................................................................................33
2.8.1.3 Duration........................................................................................................34
2.8.1.4 Headache Index.............................................................................................35
2.8.2 Pain Quality.........................................................................................................35
2.8.3 Medication Consumption....................................................................................36
2.8.4 Functional Impact................................................................................................36
2.9 Pressure Pain Threshold (PPT)....................................................................................37
2.9.1 Introduction.........................................................................................................37
2.9.2 Thermal Pain Threshold (TPT)............................................................................38
2.9.3 Pressure Pain Threshold (PPT)............................................................................40
2.9.4 Reliability of PPT................................................................................................41
2.10 Research Questions...................................................................................................43
CHAPTER THREE: METHODOLOGY OF SYSTEMATIC REVIEW.........................44
3.1 Search Strategy for Identification of Studies...............................................................46
3.2 Criteria for Considering Studies for Reviews..............................................................47
3.2.1 Language of Studies............................................................................................47
3.2.2 Types of Studies...................................................................................................47
V
3.2.3 Types of Participants...........................................................................................48
3.2.4 Types of Intervention...........................................................................................48
3.2.5 Types of Outcome Measures...............................................................................49
3.3 Data Extraction..............................................................................................................49
3.4 Assessment of Quality.................................................................................................49
3.4.1 Jadad Scale..........................................................................................................50
3.4.2 Internal Validity Scale (IVS)...............................................................................50
3.4.3 Oxford Pain Validity Scale (OPVS)....................................................................52
3.4.4 Allocation Concealment......................................................................................54
3.4.5 Standards for Reporting Interventions in Controlled Trials of Acupuncture
(STRICTA)........................................................................................................................54
3.5 Data Analysis...............................................................................................................56
CHAPTER FOUR: SYSTEMIC REVIEW OF ENGLISH LITERATURES ON
ACUPUNCTURE FOR MIGRAINE....................................................................................57
4.1 Introduction.................................................................................................................57
4.2 Objective......................................................................................................................57
4.3 Methodology................................................................................................................58
4.4 Result...........................................................................................................................58
4.4.1 Identification of Studies.......................................................................................58
4.4.2 Description of the Studies....................................................................................61
4.4.3 Quality Assessment .............................................................................................66
4.4.4 STRICTA.............................................................................................................68
4.4.4.1 Acupuncture Intervention..............................................................................73
4.4.4.2 Control Intervention......................................................................................74
4.4.4.3 Follow-up......................................................................................................75
4.4.5 Outcome Measures..............................................................................................75
4.5 Analysis.......................................................................................................................76
4.5.1 The Effectiveness of Acupuncture in Acute Attacks...........................................77
4.5.1.1 Acupuncture VS. No Treatment.....................................................................77
4.5.1.2 Acupuncture VS. Sham/Placebo Acupuncture...............................................77
4.5.1.3 Acupuncture VS. Western Medication...........................................................77
4.5.1.4 Acupuncture VS. Other Sham Interventions..................................................77
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4.5.2 The Effectiveness of Acupuncture as a Prophylactic Treatment.........................80
4.5.2.1 Acupuncture VS. No Treatment.....................................................................80
4.5.2.2 Acupuncture VS. Sham/Placebo Acupuncture...............................................83
4.5.2.3 Acupuncture VS. Western Medication...........................................................88
4.6 Discussion....................................................................................................................93
4.6.1 Summary of the Findings....................................................................................93
4.6.2 Strengths of This Review.....................................................................................93
4.6.3 Weaknesses of This Review................................................................................94
4.6.4 Reporting of Outcome Measures.........................................................................95
4.6.5 Heterogeneity of the Studies................................................................................97
4.6.6 A Comparison with Other SRs............................................................................97
4.6. 7 Impacts on the Conclusion...............................................................................100
4.7 Conclusion.................................................................................................................100
4.7.1 Implications for Research..................................................................................100
4.7.2 Implication for Clinical Practice.......................................................................101
CHAPTER FIVE: SYSTEMIC REVIEW OF EAST ASIAN LITERATURE ON
ACUPUNCTURE FOR MIGRAINE..................................................................................102
5.1 Introduction...............................................................................................................102
5.2 Objectives..................................................................................................................102
5.3 Methodology..............................................................................................................103
5.4 Results.......................................................................................................................103
5.4.1 Identifying Studies.............................................................................................103
5.4.2 Description of the Studies..................................................................................106
5.4.3 Quality Assessment...........................................................................................110
5.4.4 Acupuncture Intervention..................................................................................116
5.4.5 Control Intervention..........................................................................................116
5.4.6 Outcome Measures............................................................................................117
5.4.7 Follow-up ..........................................................................................................118
5.5 Analysis.....................................................................................................................118
5.5.1 Acupuncture VS. No Treatment........................................................................118
5.5.2 Acupuncture VS. Sham/Placebo Acupuncture..................................................118
5.5.3 Acupuncture VS. Western Medications.............................................................118
5.5.4 Acupuncture plus Western Medication VS. Western Medication .....................121
VII
5.5.5 Acupuncture plus other TCM Therapies VS. Western Medications..................121
5.5.6 Acupuncture plus Other Therapy VS. Western Medication..............................123
5.6 A Comparison of Our Reviews of Literatures Identified in English Databases and
That in Chinese Databases......................................................................................................125
5.7 Discussion..................................................................................................................128
5.8 Conclusion.................................................................................................................131
5.8.1 Implications for Research..................................................................................131
5.8.2 Implication for Clinical Practice.......................................................................131
5.9 Additional Notes........................................................................................................132
CHAPTER SIX: METHOD OF CLINICAL TRIAL........................................................133
6.1 Participants................................................................................................................133
6.1.1 Diagnostic Criteria for migraine........................................................................133
6.1.2 Inclusion Criteria...............................................................................................133
6.1.3 Exclusion Criteria..............................................................................................134
6.2 Procedure of Recruitment..........................................................................................134
6.3 Trial Design...............................................................................................................135
6.3.1 Randomisation...................................................................................................135
6.3.2 Blinding.............................................................................................................135
6.3.3 Drop-Outs..........................................................................................................136
6.4 Materials....................................................................................................................136
6.4.1 Selection of Needles..........................................................................................136
6.4.2 Pressure Algometer............................................................................................137
6.4.3 Real Acupuncture (RA) Treatment....................................................................138
6.4.3.1 Mandatory Acupoints..................................................................................138
6.4.3.2 Supplementary Acupoints............................................................................139
6.4.4 Sham Acupuncture (SA)....................................................................................142
6.5 Outcome Measures....................................................................................................145
6.5.1 Primary Outcome Measures..............................................................................145
6.5.2 Secondary Outcome Measures..........................................................................146
6.6 Procedure of the Trial................................................................................................150
6.6.1 Initial Examination and Assessment..................................................................152
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6.6.2 Run-in Period.....................................................................................................152
6.6.3 Treatment Stage.................................................................................................153
6.6.4 Follow-up Stage.................................................................................................153
6.7 Data Collection and Analysis....................................................................................153
6.7.1 Sample Size Calculation....................................................................................153
6.7.2 Data Collection and Treatment of Missing Data...............................................154
6.7.3 Data Analysis.....................................................................................................155
CHAPTER SEVEN: SHORT TERM EFFECTS OF ACUPUNCTURE ON MIGRAINE
AND DISCUSSION..............................................................................................................156
7.1 Short-term Results.....................................................................................................156
7.1.1 Subject Recruitment..........................................................................................156
7.1.2 Allocation of Participants................................................................................159
7.1.3 Socio-demographic Data.................................................................................161
7.1.4 Clinical Characteristics Between RA and SA Groups at Baseline..................163
7.1.5 Effects of Acupuncture on the Primary Outcomes During the Treatment Period
.........................................................................................................................................166
7.1.5.1 The Effect of Acupuncture on the Frequency of Migraine..........................167
7.1.5.2 The Effect of Acupuncture on the Duration of Migraine.............................170
7.1.5.3 The Effect of Acupuncture on the Intensity of Migraine.............................170
7.1.5.4 The Effect of Acupuncture on the Reduction of Accompanying Symptoms of
Migraine.......................................................................................................................172
7.1.6 The Effect of Acupuncture on the Secondary Outcomes During the Treatment
Period...............................................................................................................................173
7.1.6.1 Pain Assessed with McGill Questionnaire..................................................175
7.1.6.2 Quality of Life.............................................................................................177
7.1.6.3 Medication Consumption............................................................................179
7.1.7 Summary of the Short-term Effects of Acupuncture.........................................181
7.1.8 Adverse Events of Acupuncture........................................................................182
7.1.9 Credibility of Blinding Process.........................................................................183
7.1.10 Results of Media Promotion and Participants Recruitment.............................185
7.2 Discussion..................................................................................................................188
7.2.1 Population Sample.............................................................................................188
7.2.2 Blinding Procedure............................................................................................189
7.2.3 Sham Acupuncture Control...............................................................................190
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