The RCT of Acupuncture on PCOS Combined With IR

Summary

The objectives of this randomized controlled trial are to compare insulin sensitivity following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR.

Timeline

Start

2015-08

Primary completion

2018-10

Completion

2018-10

Publications

• Background Lakkakula BV, Thangavelu M, Godla UR. Genetic variants associated with insulin signaling and glucose homeostasis in the pathogenesis of insulin resistance in polycystic ovary syndrome: a systematic review. J Assist Reprod Genet. 2013 Jul;30(7):883-95. doi: 10.1007/s10815-013-0030-1. Epub 2013 Jun 22.
• Background Nestler JE. Role of hyperinsulinemia in the pathogenesis of the polycystic ovary syndrome, and its clinical implications. Semin Reprod Endocrinol. 1997 May;15(2):111-22. doi: 10.1055/s-2007-1016294.
• Background Farrell K, Antoni MH. Insulin resistance, obesity, inflammation, and depression in polycystic ovary syndrome: biobehavioral mechanisms and interventions. Fertil Steril. 2010 Oct;94(5):1565-74. doi: 10.1016/j.fertnstert.2010.03.081. Epub 2010 May 14.
• Background Bhathena RK. Insulin resistance and the long-term consequences of polycystic ovary syndrome. J Obstet Gynaecol. 2011;31(2):105-10. doi: 10.3109/01443615.2010.539722.
• Background Hernandez-Valencia M, Hernandez-Rosas M, Zarate A. [Care of insulin resistance in polycystic ovary syndrome]. Ginecol Obstet Mex. 2010 Nov;78(11):612-6. Spanish.
• Background Franks S. When should an insulin sensitizing agent be used in the treatment of polycystic ovary syndrome? Clin Endocrinol (Oxf). 2011 Feb;74(2):148-51. doi: 10.1111/j.1365-2265.2010.03934.x.
• Background Pauli JM, Raja-Khan N, Wu X, Legro RS. Current perspectives of insulin resistance and polycystic ovary syndrome. Diabet Med. 2011 Dec;28(12):1445-54. doi: 10.1111/j.1464-5491.2011.03460.x.
• Background Zhou G, Myers R, Li Y, Chen Y, Shen X, Fenyk-Melody J, Wu M, Ventre J, Doebber T, Fujii N, Musi N, Hirshman MF, Goodyear LJ, Moller DE. Role of AMP-activated protein kinase in mechanism of metformin action. J Clin Invest. 2001 Oct;108(8):1167-74. doi: 10.1172/JCI13505.
• Background Hwang KR, Choi YM, Kim JJ, Chae SJ, Park KE, Jeon HW, Ku SY, Kim SH, Kim JG, Moon SY. Effects of insulin-sensitizing agents and insulin resistance in women with polycystic ovary syndrome. Clin Exp Reprod Med. 2013 Jun;40(2):100-5. doi: 10.5653/cerm.2013.40.2.100. Epub 2013 Jun 30.
• Background Legro RS, Arslanian SA, Ehrmann DA, Hoeger KM, Murad MH, Pasquali R, Welt CK; Endocrine Society. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013 Dec;98(12):4565-92. doi: 10.1210/jc.2013-2350. Epub 2013 Oct 22.
• Background Chang CT, Chen YC, Fang JT, Huang CC. Metformin-associated lactic acidosis: case reports and literature review. J Nephrol. 2002 Jul-Aug;15(4):398-402.
• Background Triggle CR, Ding H. Cardiovascular impact of drugs used in the treatment of diabetes. Ther Adv Chronic Dis. 2014 Nov;5(6):245-68. doi: 10.1177/2040622314546125.
• Background Dunaif A. Drug insight: insulin-sensitizing drugs in the treatment of polycystic ovary syndrome--a reappraisal. Nat Clin Pract Endocrinol Metab. 2008 May;4(5):272-83. doi: 10.1038/ncpendmet0787. Epub 2008 Mar 25.
• Background Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, Ali F, Sholley C, Worrall C, Kelman JA. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA. 2010 Jul 28;304(4):411-8. doi: 10.1001/jama.2010.920. Epub 2010 Jun 28.
• Background Mamtani R, Haynes K, Bilker WB, Vaughn DJ, Strom BL, Glanz K, Lewis JD. Association between longer therapy with thiazolidinediones and risk of bladder cancer: a cohort study. J Natl Cancer Inst. 2012 Sep 19;104(18):1411-21. doi: 10.1093/jnci/djs328. Epub 2012 Aug 9.
• Background Betteridge DJ. Thiazolidinediones and fracture risk in patients with Type 2 diabetes. Diabet Med. 2011 Jul;28(7):759-71. doi: 10.1111/j.1464-5491.2010.03187.x.
• Background Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.
• Background Stener-Victorin E, Jedel E, Janson PO, Sverrisdottir YB. Low-frequency electroacupuncture and physical exercise decrease high muscle sympathetic nerve activity in polycystic ovary syndrome. Am J Physiol Regul Integr Comp Physiol. 2009 Aug;297(2):R387-95. doi: 10.1152/ajpregu.00197.2009. Epub 2009 Jun 3.
• Background Manni L, Rocco ML, Barbaro Paparo S, Guaragna M. Electroacupucture and nerve growth factor: potential clinical applications. Arch Ital Biol. 2011 Jun;149(2):247-55. doi: 10.4449/aib.v149i2.1365.
• Background Liang F, Koya D. Acupuncture: is it effective for treatment of insulin resistance? Diabetes Obes Metab. 2010 Jul;12(7):555-69. doi: 10.1111/j.1463-1326.2009.01192.x.
• Background Johansson J, Manneras-Holm L, Shao R, Olsson A, Lonn M, Billig H, Stener-Victorin E. Electrical vs manual acupuncture stimulation in a rat model of polycystic ovary syndrome: different effects on muscle and fat tissue insulin signaling. PLoS One. 2013;8(1):e54357. doi: 10.1371/journal.pone.0054357. Epub 2013 Jan 18.
• Background Benrick A, Maliqueo M, Johansson J, Sun M, Wu X, Manneras-Holm L, Stener-Victorin E. Enhanced insulin sensitivity and acute regulation of metabolic genes and signaling pathways after a single electrical or manual acupuncture session in female insulin-resistant rats. Acta Diabetol. 2014 Dec;51(6):963-72. doi: 10.1007/s00592-014-0645-4. Epub 2014 Sep 14.
• Background Zhao X, Ni R, Li L, Mo Y, Huang J, Huang M, Azziz R, Yang D. Defining hirsutism in Chinese women: a cross-sectional study. Fertil Steril. 2011 Sep;96(3):792-6. doi: 10.1016/j.fertnstert.2011.06.040. Epub 2011 Jul 18.
• Background Ni RM, Mo Y, Chen X, Zhong J, Liu W, Yang D. Low prevalence of the metabolic syndrome but high occurrence of various metabolic disorders in Chinese women with polycystic ovary syndrome. Eur J Endocrinol. 2009 Sep;161(3):411-8. doi: 10.1530/EJE-09-0298. Epub 2009 Jun 19.
• Background Chen X, Yang D, Li L, Feng S, Wang L. Abnormal glucose tolerance in Chinese women with polycystic ovary syndrome. Hum Reprod. 2006 Aug;21(8):2027-32. doi: 10.1093/humrep/del142. Epub 2006 May 9.
• Background McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247-63. doi: 10.1097/00005650-199303000-00006.
• Background Cronin L, Guyatt G, Griffith L, Wong E, Azziz R, Futterweit W, Cook D, Dunaif A. Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS). J Clin Endocrinol Metab. 1998 Jun;83(6):1976-87. doi: 10.1210/jcem.83.6.4990.
• Background Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Background Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
• Background Leung KF, Liu FB, Zhao L, Fang JQ, Chan K, Lin LZ. Development and validation of the Chinese Quality of Life Instrument. Health Qual Life Outcomes. 2005 Apr 16;3:26. doi: 10.1186/1477-7525-3-26.
• Background Jiang M, Lu C, Zhang C, Yang J, Tan Y, Lu A, Chan K. Syndrome differentiation in modern research of traditional Chinese medicine. J Ethnopharmacol. 2012 Apr 10;140(3):634-42. doi: 10.1016/j.jep.2012.01.033. Epub 2012 Feb 1.
• Background Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005 Jan;1(1):40-5. doi: 10.1016/j.explore.2004.11.001.
• Background MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010 Jun 8;7(6):e1000261. doi: 10.1371/journal.pmed.1000261.
• Background Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
• Background Iwata M, Maeda S, Kamura Y, Takano A, Kato H, Murakami S, Higuchi K, Takahashi A, Fujita H, Hara K, Kadowaki T, Tobe K. Genetic risk score constructed using 14 susceptibility alleles for type 2 diabetes is associated with the early onset of diabetes and may predict the future requirement of insulin injections among Japanese individuals. Diabetes Care. 2012 Aug;35(8):1763-70. doi: 10.2337/dc11-2006. Epub 2012 Jun 11.
• Background Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. doi: 10.2337/diab.42.11.1663.
• Background Zheng Y, Stener-Victorin E, Ng EH, Li J, Wu X, Ma H. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study. BMJ Open. 2015 May 3;5(4):e007757. doi: 10.1136/bmjopen-2015-007757.
• Wen Q, Hu M, Lai M, Li J, Hu Z, Quan K, Liu J, Liu H, Meng Y, Wang S, Wen X, Yu C, Li S, Huang S, Zheng Y, Lin H, Liang X, Lu L, Mai Z, Zhang C, Wu T, Ng EHY, Stener-Victorin E, Ma H. Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial. Hum Reprod. 2022 Mar 1;37(3):542-552. doi: 10.1093/humrep/deab272.
• Li J, Ng EH, Stener-Victorin E, Hu Z, Shao X, Wang H, Li M, Lai M, Xie C, Su N, Yu C, Liu J, Wu T, Ma H. Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial. Trials. 2017 Mar 9;18(1):115. doi: 10.1186/s13063-017-1854-2.

Drugs

Indications