The effectiveness of acupuncture in the treatment of primary dysmenorrhea

386 Pages·2015·2.41 MB·English

The effectiveness of acupuncture in the
treatment of primary dysmenorrhea: A
mixed methods study

Michael John Armour

A thesis submitted in fulfilment of the requirements for the degree
of Doctor of Philosophy, National Institute of Complementary
Medicine, School of Science and Health, University of Western
Sydney.

May 2015
Dedication
This thesis is dedicated to three very special people who have shaped my life
and put my feet upon the path that has ended up here.
My father, Graeme Armour, who passed away before I was ever an
acupuncturist, my mother Patsy Armour, who has always showered me with
love and supported my academic endeavors, no matter how left field, and most
recently my wife, Susanne, whose period pain inspired me to start looking for
alternatives to the medication which never really worked for her.
Acknowledgements
No thesis is the product of one person. Without the love, support and
understanding of others, I would never have been able to finish this study.
Firstly, I would like to thank my primary supervisor Professor Caroline Smith,
who has helped guide, shape and most importantly prune this thesis from
rambling to readable. Thank you for your support and encouragement, your
confidence in my ability, and most importantly sharing your vast wealth of
experience and knowledge with me.
Secondly, thank you to my other supervisors, Professor Hannah Dahlen, Dr
Xiaoshu Zhu and Professor Cindy Farquhar. Hannah, you always asked the right
questions to get me thinking, and gently nudged me back on track when I was
veering off. Thank you! Xiaoshu and Cindy, thank you for your expertise, it was
vital to helping me talk to the right people or understand the right path.
Thirdly, my thanks to everyone who has given up their time and experience to
help make this thesis possible. All the practitioners who answered the survey
and came to the focus groups, all the professional bodies who worked with me
on the survey and especially all the women who took part in the trial and
subsequent interviews. It would be a very thin thesis without your
contributions! The New Zealand Register of Acupuncturists and the NZ School of
Acupuncture have both been especially supportive both financially and also
with words of encouragement and support. Special thanks to Kate Roberts and
Serena Joe who helped as practitioners in the RCT and to Dr Debra Betts, who
helped with the focus groups, interviews and in general provided all round
support and encouragement. Micki and Narelle and everyone else at NICM, who
put up with a Kiwi coming in and didn’t really make too much fun of my accent.
Thanks to Dr Avinesh Pilay and Dr Kingsley Agho for assistance and guidance
with the statistical analysis.
My extra special gratitude to my best friend and business partner Brendon who
supported me during this thesis with clinic space and materials for my trial and
with chats for my mental health. Likewise my editor Sue Lewis, who came in at
the last minute and helped add a consistent style to this thesis.
Lastly, but definitely not least, the wonderful woman in my life who has put up
with me sitting glued to a computer for days and days at a time, mumbling
about menstruation, my wonderful, understanding and thoughtful wife Susanne.
I honestly couldn’t have done it without you.
Statement of Authentication
I declare that this thesis does not incorporate without acknowledgement any
material previously submitted for a diploma or degree in any university, and
that to the best of my knowledge it is original and does not contain any
materials previously published or written by another person except where due
reference is made in the text.

Michael Armour
May 2015
LIST OF FIGURES ............................................................................................................................ IX
LIST OF TABLES ................................................................................................................................ X
ABBREVIATIONS ...........................................................................................................................XII
ABSTRACT ..................................................................................................................................... XIII
CHAPTER ONE: INTRODUCTION AND BACKGROUND ......................................................... 1
1.1 DYSMENORRHEA ..................................................................................................................................... 1
1.2 PREVALENCE OF PRIMARY DYSMENORRHEA ...................................................................................... 2
1.2.1 Factors influencing the prevalence of primary dysmenorrhea .................................... 3
1.3 PHYSIOLOGICAL BASIS OF PRIMARY DYSMENORRHEA ...................................................................... 4
1.4 THE IMPACT OF PRIMARY DYSMENORRHEA ....................................................................................... 9
1.5 CURRENT BIOMEDICAL INTERVENTIONS FOR THE MANAGEMENT OF PRIMARY DYSMENORRHEA
......................................................................................................................................................................... 10
1.6 COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) INTERVENTIONS FOR PRIMARY
DYSMENORRHEA ........................................................................................................................................... 13
1.6.1 Prevalence of CAM in New Zealand and Australia ...........................................................13
1.6.2 Predictive factors for CAM usage .............................................................................................14
1.6.3 CAM usage in primary dysmenorrhea ...................................................................................15
1.7 ACUPUNCTURE: A PROMISING CAM THERAPY FOR PRIMARY DYSMENORRHEA ........................ 17
1.7.1 TCM physiology of the menstrual cycle .................................................................................19
1.7.2 Pathophysiology of dysmenorrhea according to TCM ...................................................22
1.7.3 Acupuncture treatment of primary dysmenorrhea: mechanisms of action .........22
1.8 PARADOXES IN THE LITERATURE ....................................................................................................... 24
1.9 COMPLEX INTERVENTIONS .................................................................................................................. 26
1.9.1 Acupuncture as a complex intervention: implications for trial design ..................26
1.10 ACUPUNCTURE PRACTICE IN NEW ZEALAND AND AUSTRALIA .................................................. 28
1.11 DESIGNING CLINICALLY RELEVANT TRIALS: THE IMPORTANCE OF PRACTITIONER
INVOLVEMENT .............................................................................................................................................. 29
1.12 INDIVIDUALISATION OF TREATMENT IN TCM: THE IMPORTANCE OF FLEXIBILITY IN
DIAGNOSIS, POINT SELECTION AND CO-INTERVENTIONS ....................................................................... 32
1.13 SELF-CARE: A CHARACTERISTIC COMPONENT OF ACUPUNCTURE TREATMENT ....................... 34
1.14 SUMMARY AND RESEARCH RATIONALE .......................................................................................... 36
1.15 RESEARCH AIM AND RESEARCH QUESTIONS .................................................................................. 37
1.16 OVERVIEW OF THESIS ........................................................................................................................ 38
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CHAPTER TWO: ACUPUNCTURE FOR THE TREATMENT OF PRIMARY
DYSMENORRHEA: A NARRATIVE REVIEW OF THE LITERATURE ON DOSAGE AND
CLINICAL RELEVANCE ................................................................................................................. 40
2.1 INTRODUCTION ..................................................................................................................................... 40
2.2 ISSUES WITH CURRENT RESEARCH ON ACUPUNCTURE FOR PRIMARY DYSMENORRHEA ........... 40
2.2.1 Clinical applicability of research ..............................................................................................42
2.2.2 Components of an acupuncture dose .....................................................................................42
2.2.3 The presence of a dose-response relationship in acupuncture ..................................43
2.2.4 Purpose of this review ...................................................................................................................44
2.3 SEARCH STRATEGY ............................................................................................................................... 45
2.4 FINDINGS OF RECENT SYSTEMATIC REVIEWS ................................................................................... 46
2.5 FINDINGS OF RCTS UNDERTAKEN SINCE THE COCHRANE SYSTEMATIC REVIEW ...................... 51
2.5.1 Electro-acupuncture at fixed points versus wait-list control .....................................51
2.5.2 Electro-acupuncture versus herbal medicine ....................................................................52
2.5.3 Manual acupuncture at different treatment times .........................................................55
2.5.4 Manual acupuncture versus manual acupuncture without stimulation...............55
2.5.5 Manual acupuncture versus non-acupuncture interventions ....................................56
2.5.6 Summary of trials undertaken since the systematic review ........................................57
2.6 THE EFFECT OF ACUPUNCTURE DOSAGE ON THE OUTCOMES OF PRIMARY DYSMENORRHEA ... 58
2.6.1 Study location ...................................................................................................................................58
2.6.2 Treatment frequency and timing .............................................................................................58
2.6.3 Number of treatments ...................................................................................................................59
2.6.4 Mode of stimulation .......................................................................................................................59
2.6.5 Point number and selection ........................................................................................................60
2.6.6 Needle retention ..............................................................................................................................60
2.7 CLINICAL CONSIDERATIONS ON DOSING: .......................................................................................... 63
2.7 INDIVIDUALISATION OF DIAGNOSIS, POINT SELECTION AND USE OF CO-INTERVENTIONS ........ 65
2.8 CONCLUSION .......................................................................................................................................... 69
CHAPTER THREE: METHODOLOGY ........................................................................................ 72
3.1 INTRODUCTION ..................................................................................................................................... 72
3.2 AIMS ........................................................................................................................................................ 72
3.3 RESEARCH DESIGN: MIXED METHODS ................................................................................................ 73
3.4 PARADIGM CHOICE IN MMR ............................................................................................................... 75
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3.4.1 A pragmatic stance .........................................................................................................................76
3.5 MULTI-PHASE DESIGN .......................................................................................................................... 77
3.6 ANALYSIS AND INTEGRATION OF MULTIPLE PHASES ...................................................................... 78
3.7 SURVEY OF THE TREATMENT OF WOMEN’S MENSTRUAL HEALTH BY ACUPUNCTURISTS.......... 82
3.7.1 Study design .......................................................................................................................................83
3.7.2 Self-completed questionnaire ....................................................................................................85
3.7.3 Participants ........................................................................................................................................86
3.7.4 Sampling ..............................................................................................................................................87
3.7.5 Pilot ........................................................................................................................................................87
3.7.6 Survey administration...................................................................................................................87
3.7.7 Data management and data analysis ....................................................................................90
3.7.8 Ethical approval...............................................................................................................................90
3.8 FOCUS GROUPS AND SEMI-STRUCTURED INTERVIEWS ................................................................... 90
3.8.1 Sampling ..............................................................................................................................................92
3.8.2 Practitioner data forms: patterns of disharmony and acupuncture point
selection ..........................................................................................................................................................94
3.8.3 Interview schedule for focus groups and interviews .......................................................95
3.8.4 Data analysis .....................................................................................................................................95
3.9 FACTORIAL DESIGNED RCT: THE EFFECT OF TIMING AND MODE OF STIMULATION IN
ACUPUNCTURE TREATMENTS ON PRIMARY DYSMENORRHEA ............................................................... 97
3.9.1 Study design .......................................................................................................................................98
3.9.2 Group design ......................................................................................................................................98
3.9.3 Rationale for a pragmatic study ..............................................................................................99
3.9.4 Participants ..................................................................................................................................... 100
3.9.5 Recruitment .................................................................................................................................... 101
3.9.6 Screening .......................................................................................................................................... 104
3.9.7 Randomisation............................................................................................................................... 105
3.9.8 Sample Size ..................................................................................................................................... 105
3.9.9 Manualised acupuncture protocol ....................................................................................... 106
3.9.10 Treatment schedule .................................................................................................................. 109
3.9.11 Practitioner training and quality control ...................................................................... 110
3.9.12 Treatment group: manual acupuncture ......................................................................... 110
3.9.13 Treatment group: electro-acupuncture .......................................................................... 111
3.9.14 Endpoints ....................................................................................................................................... 111
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3.9.14 Data collection tools ................................................................................................................. 112
3.9.15 Data management .................................................................................................................... 115
3.9.16 Statistical analysis .................................................................................................................... 115
3.9.17 Blinding of participants and researchers ....................................................................... 116
3.9.18 Ethics approval ........................................................................................................................... 116
3.10 PARTICIPANT SEMI-STRUCTURED INTERVIEWS ......................................................................... 117
3.10.1 Sampling ........................................................................................................................................ 117
3.10.2 Interview guide ........................................................................................................................... 118
3.10.3 Interview format ........................................................................................................................ 118
3.10.4 Data analysis ............................................................................................................................... 119
3.11 SUMMARY ......................................................................................................................................... 119
CHAPTER FOUR: HOW ACUPUNCTURISTS TREAT DYSMENORRHEA IN CLINICAL
PRACTICE: FINDINGS FROM A SURVEY, FOCUS GROUPS AND SEMI-STRUCTURED
INTERVIEWS .................................................................................................................................120
4.1 SURVEY OF NEW ZEALAND AND AUSTRALIAN ACUPUNCTURE PRACTITIONERS ..................... 120
4.1.1 Demographics and responders .............................................................................................. 120
4.1.2 Treatment of gynaecological conditions ........................................................................... 121
4.1.3 Different practice characteristics between New Zealand and Australian
practitioners .............................................................................................................................................. 125
4.1.4 Referral and professional networks..................................................................................... 125
4.2 THEMATIC ANALYSIS OF FOCUS GROUPS AND INTERVIEWS ........................................................ 125
4.3 A COMPLEX PARTNERSHIP ................................................................................................................ 128
4.4 PRACTICAL OBSTACLES OF MONEY, TIME AND SPACE .................................................................. 130
4.4.1 The ideal treatment approach ............................................................................................... 130
4.4.2 Money ................................................................................................................................................. 133
4.4.3 Time .................................................................................................................................................... 135
4.4.4 Space .................................................................................................................................................. 136
4.4.5 Bridging the treatment gap .................................................................................................... 137
4.5 TEXTBOOKS ARE JUST PART OF THE DIAGNOSIS ........................................................................... 138
4.5.1 Textbooks as a foundation ....................................................................................................... 138
4.5.2 Limitations of textbooks ............................................................................................................ 139
4.5.3 The importance of multiple sources .................................................................................... 141
4.5.4 Intuition ............................................................................................................................................ 142
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4.6 FINDING WHAT IS EFFECTIVE .......................................................................................................... 143
4.7 TREATING WOMEN HOLISTICALLY .................................................................................................. 144
4.8 A PARTNERSHIP IN UNDERSTANDING PATTERNS AND CONNECTIONS...................................... 148
4.8.1 Lead them back to balance ...................................................................................................... 148
4.8.2 Introducing women to a new normal ................................................................................. 154
4.8.3 Reframing the narrative around period pain ................................................................. 157
4.9 ITS NOT CUT AND DRIED ................................................................................................................... 158
4.10 PROTOCOL DEVELOPMENT ............................................................................................................ 164
4.10.1 Clinical considerations ............................................................................................................ 164
4.10.2 High and low frequency of treatment .............................................................................. 165
4.10.3 Common treatments between groups .............................................................................. 165
4.10.4 Duration of treatment ............................................................................................................. 166
4.10.5 Mode of stimulation .................................................................................................................. 166
4.10.5.1 Manual Acupuncture ............................................................................................................ 166
4.10.5.2 Electro-acupuncture ............................................................................................................. 166
4.10.6 Co-interventions ......................................................................................................................... 167
4.10.6.1 Moxibustion .............................................................................................................................. 167
4.10.6.2 Self-care advice ....................................................................................................................... 168
4.11 SUMMARY ......................................................................................................................................... 169
CHAPTER FIVE: THE EFFECT OF TIMING AND MODE OF STIMULATION OF
ACUPUNCTURE TREATMENTS ON PRIMARY DYSMENORRHEA — A RANDOMISED
CONTROLLED TRIAL .................................................................................................................171
5.1 INTRODUCTION .................................................................................................................................. 171
5.2 RANDOMISED CONTROLLED TRIAL (RCT) ................................................................................... 173
5.2.1 Eligibility .......................................................................................................................................... 173
5.2.2 Randomisation and participant flow .................................................................................. 174
5.2.3 Characteristics of women at trial entry ............................................................................. 177
5.2.4 Lifestyle characteristics and previous use of acupuncture ....................................... 181
5.2.5 Quality of life .................................................................................................................................. 181
5.2.6 Baseline menstrual pain diary ............................................................................................... 183
5.2.7 TCM patterns .................................................................................................................................. 183
5.2.8 Addressing incomplete randomisation .............................................................................. 184
5.2.9 Statistical conventions ............................................................................................................... 185
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5.2.10 Practitioner group distribution .......................................................................................... 185
5.3 PRIMARY OUTCOME MEASURES ....................................................................................................... 188
5.3.1 Responder rate .............................................................................................................................. 188
5.3.2 Peak pain scores............................................................................................................................ 188
5.3.3 Average pain ................................................................................................................................... 193
5.4 SECONDARY OUTCOME MEASURES .................................................................................................. 196
5.4.1 Worst pain ....................................................................................................................................... 196
5.4.2 Duration of pain ............................................................................................................................ 199
5.4.3 Medication usage ......................................................................................................................... 201
5.4.4 Other menstrual symptoms ..................................................................................................... 203
5.4.5 Absenteeism .................................................................................................................................... 206
5.4.6 Health-related quality of life (SF-36) .................................................................................. 208
5.4.7 Self-rated improvement score and symptom changes ................................................ 209
5.5 ACUPUNCTURE RELATED CONSIDERATIONS .................................................................................. 211
5.5.1 Safety .................................................................................................................................................. 211
5.5.2 Acceptability ................................................................................................................................... 212
5.5.3 Number of treatments by group ............................................................................................ 214
5.5.4 Point selection: .............................................................................................................................. 214
5.6 SUMMARY OF TRIAL FINDINGS ......................................................................................................... 215
CHAPTER SIX: POST-TRIAL INTERVIEWS ..........................................................................218
6.1 PARTICIPANTS .................................................................................................................................... 218
6.2 FINDINGS ............................................................................................................................................. 219
6.3 A CHANGE OF PERSPECTIVE: BECOMING MORE IN TUNE ............................................................ 221
6.4 TREATING MORE THAN JUST CRAMPS ............................................................................................. 223
6.5 PERIOD PAIN, A NORMAL PART OF BEING A WOMAN ................................................................... 226
6.5.1 You’ve just got to live with it ................................................................................................... 227
6.5.2 Can’t let a period stop you ........................................................................................................ 230
6.5.3 Thinking Differently .................................................................................................................... 231
6.6 MAKING SENSE OF MY MENSTRUAL CYCLE .................................................................................... 234
6.6.1 Gaining awareness and making connections .................................................................. 237
6.6.2 Prescribing common sense ....................................................................................................... 241
6.6.3 Continuing to take care of myself ......................................................................................... 245
6.7 SOMEONE YOU CAN TRUST ............................................................................................................... 247
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