Ear-acupressure for allergic rhinitis Shuiqing Zhang, BMed A thesis submitted in fulfilment of the requirement for the degree of Doctor of Philosophy Discipline of Chinese Medicine School of Health Sciences RMIT University August 2011 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. Shuiqing Zhang ______________________ Date ______________________ I To my dearest father and mother with deepest gratitude and love 献给我亲爱的父亲张广明和母亲夏秀萍 II Acknowledgement I am most grateful to my supervisors, Professor Charlie Changli Xue, Dr Angela Weihong Yang and Dr Anthony Lin Zhang for their inspiration, intellect, encouragement, guidance, support and friendship during my study for this degree. Sincere appreciation also goes to my consultants Professor Francis Thien (Department of Respiratory Medicine, Eastern Health and Box Hill Hospital, Victoria, Australia) and Associate Professor Cliff DaCosta (School of Mathematical & Geospatial Sciences, RMIT University) for their invaluable assistance and statistical advice. Without the support of all my supervisors and consultants, this thesis would not have been possible. I would like to thank Mr Alan Xinyu Hao and Ms Xuedong An for data entry and data checking, Dr Brian May for thesis proof reading. The help from all staff and other research students in the Discipline of Chinese Medicine, School of Health Sciences, RMIT University, has also been most valuable. I would like to particularly acknowledge the contribution of Mrs Sandy Ebell, Dr Joyce Ye Shen and Dr Yanyi Wang. Most of all, I would like to express my deepest gratitude to my father Professor Guangming Zhang, my mother Professor Xiuping Xia, my brother Mr Dajian Zhang and my husband Professor Mike Yi-Min Xie for their enormous love, patience and encouragement throughout these years. III Table of contents Declaration ................................................................................................................... I Acknowledgement ...................................................................................................... III Table of contents ....................................................................................................... IV List of Tables ............................................................................................................ XV List of Figures ......................................................................................................... XVII Publications .............................................................................................................. XX Journal articles ...................................................................................................... XX Conference papers ............................................................................................... XX Abbreviations .......................................................................................................... XXII Summary ..................................................................................................................... 1 Chapter 1: General Introduction .................................................................................. 5 1.1 Background ........................................................................................................ 5 1.2 Study design ...................................................................................................... 8 1.3 Aims and Objectives ........................................................................................ 12 1.4 Location of the study ........................................................................................ 13 1.5 Organisation of the thesis ................................................................................ 13 Chapter 2: Literature review on allergic rhinitis from the Western medicine perspective ................................................................................................................ 16 2.1 Definition of AR ................................................................................................ 16 2.2 Epidemiology of AR ......................................................................................... 17 2.2.1 Prevalence in global general population.................................................... 17 2.2.2 Increase of AR prevalence ........................................................................ 19 2.2.3 AR prevalence in Australia and China ....................................................... 20 2.2.4 Factors impacting on AR prevalence ........................................................ 22 2.3 Mechanisms of AR ........................................................................................... 24 IV 2.3.1 Nasal mucosa ........................................................................................... 26 2.3.2 Nasal inflammation .................................................................................... 26 2.3.3 Neurotransmitters ...................................................................................... 28 2.3.4 The IgE immune response ........................................................................ 28 2.3.5 From nasal challenge to chronic rhinitis .................................................... 29 2.4 Allergens and other risk factors ....................................................................... 31 2.4.1 Allergens ................................................................................................... 31 2.4.1.1 Inhalant allergens ............................................................................................ 31 2.4.1.2 Food allergens ................................................................................................ 34 2.4.1.3 Occupational agents ....................................................................................... 35 2.4.2 Pollutants .................................................................................................. 35 2.4.3 Other risk factors of AR ............................................................................. 36 2.5 Classification of AR .......................................................................................... 36 2.5.1 SAR/PAR classification ............................................................................. 37 2.5.2 IAR/PER classification ............................................................................... 38 2.6 Co-morbid conditions of AR ............................................................................. 40 2.6.1 Asthma ...................................................................................................... 41 2.6.2 Allergic conjunctivitis ................................................................................. 43 2.6.3 Sinusitis and nasal polyposis .................................................................... 43 2.6.4 Otitis media with effusion .......................................................................... 44 2.6.5 Chronic cough ........................................................................................... 44 2.7 Impacts of AR .................................................................................................. 44 2.7.1 Impacts on quality of life ............................................................................ 45 2.7.2 Economic burden of AR ............................................................................ 46 2.7.3 Cost-effectiveness study ........................................................................... 47 2.8 Diagnosis of AR ............................................................................................... 47 2.8.1 Symptoms ................................................................................................. 47 V 2.8.2 Case history .............................................................................................. 48 2.8.3 Family history ............................................................................................ 49 2.8.4 General ENT examination ......................................................................... 49 2.8.5 Skin tests ................................................................................................... 49 2.8.6 IgE tests .................................................................................................... 50 2.8.7 Nasal challenge tests ................................................................................ 51 2.9 Current management of AR ............................................................................. 51 2.9.1 Allergen avoidance .................................................................................... 52 2.9.2 Pharmacotherapy ...................................................................................... 52 2.9.2.1 Antihistamines ................................................................................................. 53 2.9.2.2 Glucocorticosteroids ....................................................................................... 54 2.9.2.3 Chromones ..................................................................................................... 55 2.9.2.4 Decongestants ................................................................................................ 55 2.9.3 Allergen-specific immunotherapy .............................................................. 60 2.9.4 Anti-IgE ..................................................................................................... 61 2.9.5 Surgical treatment of rhinitis ...................................................................... 61 2.9.6 Alternative therapies for AR ...................................................................... 62 2.10 Assessment of treatment effects .................................................................... 62 2.10.1 Instruments for assessing symptom severity ........................................... 63 2.10.1.1 Simple rating scale ........................................................................................ 63 2.10.1.2 Visual Analogue Scale (VAS) ....................................................................... 64 2.10.2 Questionnaires for assessing quality of life ............................................. 65 2.10.2.1 Generic quality of life questionnaires ............................................................ 66 2.10.2.2 Specific quality of life questionnaires ............................................................ 66 2.10.3 Other assessment ................................................................................... 67 Chapter 3: Literature review on allergic rhinitis from Chinese medicine perspective . 68 3.1 The fundamental theory of Chinese medicine .................................................. 69 VI 3.1.1 Key concepts of Chinese medicine theory ................................................ 69 3.1.1.1 Yin and Yang .................................................................................................. 69 3.1.1.2 Five-Elements theory ...................................................................................... 70 3.1.1.3 Vital substances (Qi, Blood, Fluid and Humour) ............................................. 71 3.1.1.4 Meridian system .............................................................................................. 71 3.1.2 Occurrence of disease and treatment principles of CM ............................. 72 3.2 AR in Chinese medicine ................................................................................... 73 3.2.1 Definition of AR in Chinese medicine ........................................................ 73 3.2.2 Aetiology and pathogenesis of AR in Chinese medicine ........................... 74 3.2.2.1 Fei (Lung) Qi deficiency .................................................................................. 75 3.2.2.2 Pi (Spleen) Qi deficiency ................................................................................. 76 3.2.2.3 Shen (Kidney) Qi deficiency ............................................................................ 76 3.2.3 Differential diagnosis of AR in Chinese medicine ...................................... 77 3.3 CHM and acupuncture management for AR .................................................... 78 3.3.1 CHM for AR ............................................................................................... 79 3.3.2 Acupuncture for AR ................................................................................... 80 3.4 Existing reviews on CHM and acupuncture for AR .......................................... 82 3.4.1 CHM for AR ............................................................................................... 86 3.4.2 Acupuncture for AR ................................................................................... 90 3.4.3 Acupuncture combined with CHM for AR .................................................. 95 3.4.4 Discussion ................................................................................................. 97 Chapter 4: Literature review on ear-acupressure for AR ......................................... 100 4.1 Background .................................................................................................... 100 4.1.1 The development of auricular therapy ..................................................... 100 4.1.2 Mechanism of auricular therapy .............................................................. 102 4.1.3 Application of auricular therapy ............................................................... 103 4.1.3.1 Needling ........................................................................................................ 103 VII 4.1.3.2 Auricular electroacupuncture stimulation (AES) ........................................... 103 4.1.3.3 Acupressure .................................................................................................. 104 4.1.4 Ear-acupressure for AR ........................................................................... 104 4.2 Ear-acupuncture and ear-acupressure for AR: a systematic review .............. 105 4.2.1 Objectives of the review .......................................................................... 106 4.2.2 Methods .................................................................................................. 106 4.2.2.1 Search strategy ............................................................................................. 106 4.2.2.2 Study selection .............................................................................................. 108 4.2.2.3 Methodological quality assessment, data extraction and data analysis ........ 109 4.2.3 Results .................................................................................................... 110 4.2.3.1 Characteristics of included studies ............................................................... 112 4.2.3.2 Methodological quality of included studies .................................................... 118 4.2.3.3 Clinical effectiveness .................................................................................... 118 4.2.3.4 Adverse events reported in the included studies .......................................... 119 4.2.4 Discussion and conclusion ...................................................................... 120 4.3 Sham control methods used in ear-acupressure RCTs: a systematic review122 4.3.1 Methods of the review ............................................................................. 124 4.3.1.1 Search strategy ............................................................................................. 124 4.3.1.2 Study selection .............................................................................................. 124 4.3.1.3. Classification of sham interventions ............................................................. 125 4.3.1.4 Data analysis ................................................................................................ 126 4.3.2 Results .................................................................................................... 127 4.3.2.1 Description of included studies ..................................................................... 128 4.3.2.2 Sham Interventions ....................................................................................... 136 4.3.3 Discussion ............................................................................................... 145 Chapter 5: General methodology of the ear-acupressure for allergic rhinitis clinical trial .......................................................................................................................... 148 5.1 Trial aims and objectives ............................................................................... 148 VIII 5.2 Trial design .................................................................................................... 149 5.2.1 Randomisation ........................................................................................ 149 5.2.2 Blinding ................................................................................................... 150 5.2.3 Data management ................................................................................... 150 5.2.3.1 Data collection .............................................................................................. 150 5.2.3.2 Data handling ................................................................................................ 150 5.2.4 Sample size ............................................................................................. 151 5.3 Participant selection criteria ........................................................................... 151 5.3.1 Inclusion criteria ...................................................................................... 151 5.3.2 Exclusion criteria ..................................................................................... 152 5.4 Recruitment and withdrawal of participants ................................................... 153 5.4.1 Recruitment strategy ............................................................................... 153 5.4.2 Initial assessment .................................................................................... 154 5.4.3 Withdrawal of participants ....................................................................... 156 5.5 Process of the trial ......................................................................................... 156 5.5.1 Pilot study I (feasibility study) and the main trial ...................................... 156 5.5.1.1 Run-in period ................................................................................................ 157 5.5.1.2 Treatment period ........................................................................................... 157 5.5.1.3 Follow-up period ........................................................................................... 158 5.5.2 Pilot study II (efficacy study) .................................................................... 160 5.6 Real and sham ear-acupressure treatments .................................................. 162 5.6.1 Treatment sessions ................................................................................. 162 5.6.2 Treatment process .................................................................................. 162 5.6.3 Ear-acupressure pellets .......................................................................... 163 5.6.4 Ear-acupressure points selection ............................................................ 163 5.6.4.1 Real ear-acupressure points ......................................................................... 164 5.6.4.2 Sham ear-acupressure points ....................................................................... 164 IX
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