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Dr. C. E. Danforn LIM J.P.

Dr. C. E. Danforn LIM J.P. Conjoint Associate Lecturer, Faculty of Medicine, University of New South Wales, Sydney Australia B.Sc (Medicine), M.B.B.S. (UNSW), B.Hlt Sc (Complementary Medicine) (CSU), Grad Dip Acup, M.App Sc (Acupuncture) (RMIT), M.App Mgt (Health) (N’Castle)

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Dr. C. E. Danforn LIM J.P.

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  1. Dr. C. E. Danforn LIM J.P. Conjoint Associate Lecturer, Faculty of Medicine, University of New South Wales, Sydney Australia B.Sc (Medicine), M.B.B.S. (UNSW), B.Hlt Sc (Complementary Medicine) (CSU), Grad Dip Acup, M.App Sc (Acupuncture) (RMIT), M.App Mgt (Health) (N’Castle) RCMP (CMRBVic), MACNEM, MAMAC, MANTA, MATMS, AAIMS

  2. Female Infertility - PCOS • Current Western Thearpies • Need for alternative therapies • Acupuncture studies • Proposed study • Q & A

  3. Female Infertility • 3.5% (Webb 1992); 15.8% (Hirsch 1987); 14.1% (Templeton 1990); 26.4% (Gunnell 1994) • PCOS • 5-10% of women of reproductive age (Hull 1987; Polson 1988) • Farquar et al (1994) suggested the prevalence of PCO to be 21%

  4. 針灸對多囊卵巢綜合征的臨床治療作用及其機制研究針灸對多囊卵巢綜合征的臨床治療作用及其機制研究

  5. 7 cases in 1935 • Association between the presence of bilateral polycystic ovaries (雙側卵巢增大或呈多囊性) and signs of amenorrhoea (閉經), oligomenorrhoea (月經稀小), hirsutism (多毛) and obesity (肥胖)

  6. Axelord & Goldzieher, 1963 (from 187 references and 1079 cases with proven Stein Leventhal Syndrome)

  7. Hyperandrogenemia 高雄激素症 • Testosterone (Total or Free) • Free Androgen Index (T x 100 / SHBG) • Androsteredione • Other Androgens • Polycystic Ovaries 多囊性卵巢 • Elevated LH 促黄體生成激素偏高 • Insulin Resistance 胰島素抵抗 and Hyperinsulinemia 高胰島素症

  8. Insulin Resistance 胰島素抵抗 / Obesity 肥胖 Insulin sensitisers Endocrine 內分泌 Metabolic 代謝性 Liver Ovary Adrenals 肝 卵巢 腎上腺 SHBG Androgen Glucose intolerance 糖耐量異常 Dyslipidaemia 血脂異常 Vascular function Vascular Disease 血管性疾病 Infertility 不育/ Menstrual problem 月經紊亂/ Hirsutism 多毛 Harborne et al Lancet 8th April, 2003

  9. Hyperandrogenemia 高雄激素症 PCOS PCO 多囊性卵巢 Oligo/anovulation 少/不排卵 Norman, Wu and Stankiewicz MJA 2004

  10. Oral anti-oestrogens e.g., clomiphene citrate • 15% of patients remain anovulatory (Hammond 1983) • 50% of patients fail to conceive (Zarte 1971; Raj 1977) • Exogenous gonadotrophin preparations • higher risk of overstimulation • ovarian hyperstimulation syndrome • multiple pregnancy (Farhi 1996 ) • Gonadotrophin-releasing hormone analogues (GnRH-a) • Reduced Complications (Tartagni 1995)

  11. Laparoscopic Surgery • anaesthetic, postoperative adhesion formation (Greenblatt 1993); premature ovarian failure, duration of effect • recombinant FSH (r-FSH) • Cost Effective ? More expensive than u-FSH • Insulin sensitising agents, e.g., Metformin, Rosiglitazone and pioglitazone • Effects proven but indications not yet (Lords et al 2003, Cochrane review 2003) • Data on Safety use • Tolerability may varied • Prediction of response to treatment has not been determined • Unproven use in IVF, Recurrent Miscarriages, CVD reductions

  12. Nil RCTs performed • Relative small population size • Unclear Diagnosis of PCOS • Non-standardised TCM Syndrome Differentiation of PCOS • Nil identified mechanism of acupuncture towards PCOS

  13. To standardise the TCM syndromes differentiation in PCOS • To evaluate the clinical efficacy of Body/Auricular Acupuncture in the clinical management of PCOS by comparing the results obtained from the acupuncture treatment groups to the sham acupuncture groups • To elucidate the biological / endorcrinological mechanism of Acupuncture in the management of PCOS

  14. Significant clinical or laboratory difference between the pre and post treatment measurement in each group of subjects • Significant endocrinological and physical improvement detected by clinical or laboratory measurements between the treatment & control groups

  15. Systemic Literature Review 系統性文獻分析 • Development of a TCM Syndrome Differentiation Diagnostic Questionnaire (Instrument) 中醫症候鑒別診斷表格 • Prospective, randomised, single blinded, sham controlled clinical acupuncture trials 前瞻性随機單盲針灸試驗,以安慰針為對照 • 112 subjects – Inclusion Criteria as defined as Rotterdam Consensus 2003

  16. Hyperandrogenemia 高雄激素症 PCOS PCO 多囊性卵巢 Oligo/anovulation 少/不排卵 Norman, Wu and Stankiewicz MJA 2004

  17. Diagnostic criteria of PCOS set by the 2003 Rotterdam ESHRE & ASRMconsensus will be included in the study (Norman, Wu and Stankiewicz 2004): • Any patient with 2 out of 3 as listed above will be considered as having PCOS : • Presence of Oligo/anovulation • Oligo- or amenorrhoea with cycles ≥ 42 days apart • Presence of hyperandrogenaemia • Biochemical hyperandrogenism with serum testosterone ≥ 3.5 mmol/L and / or free androgen index > 5 • Presence of polycystic ovaries • Polycystic ovaries diagnosed by ultrasound presence of 12 or more follicles in at least one ovary measuring 2-9 mm in diameter and/or increased ovarian volume (>10 ml) • Patients with one or more of the following conditions will be excluded: • Other active ovarian, uterine or pelvic inflammatory diseases • Major systemic diseases • Pregnancy

  18. Kidney Yin or Yang Deficiency 腎陰或陽虧虛 • Phlegm Retention and Internal Heat 痰阻內熱 • Kidney Qi Deficiency 腎氣不足 • Liver Qi Stagnation 肝氣郁滯 • Blood Stasis and Qi Stagnation 血瘀氣滯 • Deficiency of Yin and Internal Heat 陰虛內熱 • Deficiency of Qi and Blood 氣血虧虛 • Blood Cold and Stasis 血寒凝滯 <Criteria of diagnosis and therapeutic effect of disease and syndromes in Traditional Chinese Medicine> - State Administration of Traditional Chinese Medicine of People’s Republic of China – Naning University Press 1995 <中華人民共和國中醫藥行業中醫病症診斷療效標準> - 國家中醫藥管理局 1995 南京大學出版社

  19. TCM Syndromes • Symptoms-assessment scores • Visual Analogue Scale (VAS) • Internal consistency - Cronbach's alpha • Intraclass correlation coefficients • Inter-rater reliability • 95% confidence interval

  20. Kidney Yang Deficiency 腎陽虧虛 • Kidney Yang Deficiency with phlegm and blood stasis 腎陽虧虛並有痰濕血瘀

  21. Body & Auricular Acupuncture 體穴及耳穴針灸 • Acupuncture (Real or Sham) Treatments twice a week for 12 weeks 所有患者每週接受針灸兩次，為期十二週

  22. Primary Measures • Hormonal 內分泌激素類 • Clinical Parameters 臨床類 • Secondary Measures • Biochemistry 生化類 • Radiology 放射影像類

  23. Self-assessment scores & Visual Analogue Scale (VAS) forthnightly for physical symptoms improvements • Daily Basal (Biphasic) Body Temperature Recording • Menstruation Rate • Weight • Height

  24. At Early Follicular Phase • Serum Testosterone • Sex hormone-binding globulin (SHBG) • Androstenedion • Dehydroepiandrosterone Sulphate (DHEAS) • Luteinising Hormone (LH) • Estradiol • Progesterone • 17-HydroxyProgesterone • Follicular Stimulating Hormone (FSH) • LH:FSH Ratio

  25. Fasting Glucose Level • Insulin Level • Leptin • Lipid Profile • Transvaginal Ultrasound on Ovaries

  26. Elucidate the biological / endorcrinological mechanism of Acupuncture on the management of PCOS

  27. Third International Congress on Complementary Medicine Research (IIIth ICCMR) • In collaboration with The International Society for Complementary Medicine Research (ISCMR) • Venue: Darling Harbour, Sydney Australia • Date: 29-31 March 2008

  28. To bring together the world’s leading experts of clinical and basic research in Complementary & Alternative Medicine (CAM) • To provide the state of evidence for the most widespread treatment methods and to present latest results from research • To discuss basic evaluative concepts, methodologies and strategies appropriate to CAM • To evaluate the contribution of meaning/context effects, self regulation and specific effects • To discuss the role of CAM in disease prevention and public health settings • To be a three year rotation meeting of International Society of Complementary Medicine Research (ISCMR) between North America, Europe and Asia Pacific

  29. Major Themes : • Evidence-Based Research in • Women and Child Health • Cancer Management • Aged Care • Pain Relief • Inflammatory Conditions • Endocrinological / Metabolic Disorders • Other Themes include : • Health and Energy • Chinese Medicine • Kampo Medicine • Korean Medicine • Ayurvedic Medicine • Other Traditional Therapies

  30. Chinese Medicine Clinical Research Centre, Department of Obstetrics & Gynaecology, Liverpool Hospital, Liverpool, NSW 2170, Australia • Tel: +612 9828-5677 • Fax: +612 9828-5668 • Email: celim@unswalumni.com • Discounted booking • ISCMR members • Registering early in 2007 • More information about the Congress is on the ISCMR website http:// www.iscmr.org

  31. Q & A 問題及意見 Thank you 謝謝

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