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Chinese Herbal Medicine for the Treatment of People with Impaired Glucose Tolerance and Insulin Resistance

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Chinese Herbal Medicine for the Treatment of People with Impaired Glucose Tolerance and Insulin Resistance Chinese herbal medicine for the treatment of people with impaired glucose tolerance and insulin resistance Suzanne J Grant Doctorate of Philosophy The University of Western Sydney 2010 Acknowledgements I would like to thank all the men and women who participated in the clinical trial without whom the questions of science and medicine would remain unanswered. I am thankful to my wonderful supervisors, Associate Professor Dennis Chang, Professor Alan Bensoussan and Dr Vincent Wong for their persistence in nudging me toward completion, their guidance and sharing of invaluable knowledge. In each of their roles, they inspired and sustained my passion for complementary and alternative medicine research. I would like to extend my thanks to Nerida Klupp, Suzannah Bouchier, Bridget Carmady and Ros Priest for their guidance, support and ever-present reassuring good humour. Ben Colagiuri and Mark Chatham I thank for helping me to bring together the numbers. Thank you to Micki McDonald for all the little (and sometimes big) things. I am indebted to Professor Jianping Liu and Xun Li (Tina) for their contribution to my research, for teaching me how to make the best jiaozi (dumplings), for their kind hospitality and practical assistance while I was in Beijing, and after. This research would not have been possible without the in-kind and financial support of the Xiyuan Hospital in Beijing who developed the medication, University of Western Sydney, the Cochrane Collaboration, and the Australian Acupuncture and Chinese Medicine Association. I am also grateful to Professor Hosen Kiat and the Cardiac Health Institute for their funding and assistance with the Cochrane review and their collaboration as part of the Cardiovascular Research Group. The informal support, interest and encouragement of my family and friends has been indispensable, words of wisdom poured forth when the journey seemed long: “when there is no wind – row.” Thank you to all for listening, babysitting, and in so many i thoughtful ways, supporting my pursuit of a passion. To my sister, proof reader, child-minder and coach Jenny, thank you. Your turn next. This thesis would not have been possible without the unfailing unquestioning unconditional support of my partner, Chris. It is Chris who has made the greatest sacrifice of time and opportunities. I owe you my deepest gratitude and then some. Perhaps a foot massage. Or ten. To my two delightful little ones, I thank you for your remarkable patience (most of the time). Remember when as toddlers, you would shuffle me back into the office with an admonishing “finish your PhD mummy so you can come and play”? I’m ready. ii STATEMENT OF AUTHENTICATION The work presented in this thesis is, to the best of my knowledge and belief, original except as acknowledged in the text. I hereby declare that I have not submitted this material, either in full or in part, for a degree at this or any other institution. ................................................................................... (Signature) iii Table of Contents Acknowledgements ................................................................................................ i Statement of Authentication ............................................................................... iii Table of Contents .................................................................................................iv List of Tables ........................................................................................................ xi List of Figures .................................................................................................... xiii List of Appendices ............................................................................................. xv Abbreviations .................................................................................................... xvii Abstract .................................................................................................. 1 Chapter 1 Overview and chapter outline ............................................. 5 1.1 Thesis title ............................................................................................... 5 1.1.1 Research rationale .................................................................. 5 1.2 Research outline ...................................................................................... 8 1.2.1 Systematic review .................................................................. 8 1.2.2 Patterns of disharmony and TCM treatment principles in people with prediabetes .................................................. 9 1.2.3 Randomised controlled trial ................................................... 9 1.2.4 Reliability of Traditional Chinese Medicine (TCM) diagnosis10 1.3 Significance of the study ....................................................................... 10 1.4 Thesis outline ........................................................................................ 11 Chapter 2 Prediabetes: Definitions and Current Management ......... 14 2.1 Definition and diagnosis ....................................................................... 14 2.2 Testing for prediabetes .......................................................................... 17 2.3 Epidemiology ........................................................................................ 19 2.4 Pathophysiology of prediabetes ............................................................ 23 2.5 Aetiology .............................................................................................. 27 2.6 Current management ............................................................................. 29 2.6.1 Intensive lifestyle modifications .......................................... 30 2.6.2 Pharmaceutical interventions ............................................... 32 2.7 Impact on quality of life & economic cost ........................................... 35 2.8 Conclusion ............................................................................................ 36 Chapter 3 Traditional Chinese Medicine: Theory, Treatment and Herbal Medicine for prediabetes .................................... 38 3.1 Rationale .............................................................................................. 38 3.2 Method .............................................................................................. 42 3.2.1 Inclusion criteria ................................................................... 42 3.3 Findings of the review .......................................................................... 42 3.3.1 Description of the literature .................................................. 42 3.3.2 TCM differential diagnosis and patterns of disharmony in people with IGT .............................................................. 43 iv 3.3.3 The prevalence of TCM patterns of IGT and correlation to biochemical markers ....................................................... 46 3.3.4 Treatment principles and formulations ................................ 49 3.4 Discussion ............................................................................................. 53 Chapter 4 Chinese Herbal Medicines for IGT or IFG - A Systematic Review .............................................................................. 59 4.1 Background ........................................................................................... 59 4.2 Objectives ............................................................................................. 60 4.3 How the intervention might work ......................................................... 60 4.4 Adverse effects of the intervention ....................................................... 61 4.5 Method 4.5.1 Types of studies ...................................................................... 61 4.5.2 Types of participants............................................................... 61 4.5.3 Types of interventions ............................................................ 61 4.5.4 Types of outcome measures ................................................... 62 4.5.5 Covariates, effect modifiers and confounders ........................ 63 4.5.6 Search methods for identification of studies .......................... 63 4.5.7 Searching other resources ....................................................... 64 4.5.8 Data collection and analysis ................................................... 65 4.5.9 Measures of treatment effect .................................................. 67 4.5.10 Time-to-event data .................................................................. 67 4.5.11 Unit of analysis issues ............................................................ 68 4.5.12 Dealing with missing data ...................................................... 68 4.5.13 Assessment of heterogeneity .................................................. 69 4.5.14 Assessment of reporting biases ............................................... 67 4.5.15 Data synthesis ......................................................................... 68 4.5.16 Subgroup analysis and investigation of heterogeneity ........... 68 4.5.17 Sensitivity analysis ................................................................. 69 4.6 Results - Description of studies ............................................................ 69 4.6.1 Results of the search ............................................................... 69 4.6.2 Included studies .....................................................................
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