How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study

Yanhua Zheng, Elisabet Stener-Victorin, Ernest H Y Ng, Juan Li, Xiaoke Wu, Hongxia Ma, Yanhua Zheng, Elisabet Stener-Victorin, Ernest H Y Ng, Juan Li, Xiaoke Wu, Hongxia Ma

Abstract

Introduction: Hyperinsulinaemia and insulin resistance (IR) are key features of polycystic ovary syndrome (PCOS) and metabolic syndrome. The effect of 5 weeks of acupuncture treatment has been investigated in a completed prospective pilot trial (Clinicaltrials.gov: NCT01457209), and acupuncture with electrical stimulation applied to insulin-resistant rats with dihydrotestosterone-induced PCOS was shown to improve insulin sensitivity. Therefore, we now aim to conduct a prospective pilot study to evaluate whether using the same acupuncture treatment protocol given over a longer period of time (6 months) than in the previous pilot trial will improve insulin sensitivity in women with PCOS and IR. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles will improve insulin sensitivity in women with PCOS and IR.

Methods/analysis: This is a prospective pilot trial. A total of 112 women with PCOS and IR will be recruited and categorised according to their body mass index (BMI) as normal weight (BMI=18.5-23 kg/m(2)) or as overweight/obese (BMI>23 kg/m(2)). Acupuncture will be applied three times per week for 6 months at 30 min per treatment. The primary outcome will be the change in insulin sensitivity before and after 6 months of acupuncture treatment, as measured by an oral glucose tolerance test.

Ethics/dissemination: Ethical approval of this study has been granted from the ethics committee of the First Affiliated Hospital of Guangzhou Medical University (No. 2013039). Written and informed consent will be obtained from each patient before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal and presented at international congresses.

Trial registration numbers: NCT02026323 and ChiCTR-OCH-13003921.

Keywords: acupuncture; insulin resistance; polycystic ovary syndrome.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
(IR, insulin resistance; PCOS, polycystic ovary syndrome).

References

    1. Li R, Zhang Q, Yang D et al. . Prevalence of polycystic ovary syndrome in women in China: a large community-based study. Hum Reprod 2013;28:2562–9. 10.1093/humrep/det262
    1. Norman RJ, Dewailly D, Legro RS et al. . Polycystic ovary syndrome. Lancet 2007;370:685–97. 10.1016/S0140-6736(07)61345-2
    1. Legro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv 2004;59:141–54. 10.1097/01.OGX.0000109523.25076.E2
    1. Yin Y, Hong-mei X, Guang-xiu L. Analysis of insulin resistance and metabolism characteristic of the Hans PCOS women. China J Mod Med 2007;17:1625–30.
    1. Chang RJ, Nakamura RM, Judd HL et al. . Insulin resistance in nonobese patients with polycystic ovarian disease. J Clin Endocrinol Metab 1983;57:356–9. 10.1210/jcem-57-2-356
    1. Stepto NK, Cassar S, Joham AE et al. . Women with polycystic ovary syndrome have intrinsic insulin resistance on euglycaemic-hyperinsulaemic clamp. Hum Reprod 2013;28:777–84. 10.1093/humrep/des463
    1. Fauser BC, Tarlatzis BC, Rebar RW et al. . Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Fertil Steril 2012;97:28–38.e25 10.1016/j.fertnstert.2011.09.024
    1. Moran L, Teede H. Metabolic features of the reproductive phenotypes of polycystic ovary syndrome. Hum Reprod Update 2009;15:477–88. 10.1093/humupd/dmp008
    1. Ciaraldi TP, Aroda V, Mudaliar S et al. . Polycystic ovary syndrome is associated with tissue-specific differences in insulin resistance. J Clin Endocrinol Metab 2009;94:157–63. 10.1210/jc.2008-1492
    1. Ehrmann DA, Liljenquist DR, Kasza K et al. . Prevalence and predictors of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab 2006;91:48–53. 10.1210/jc.2005-1329
    1. Dunaif A, Wu X, Lee A et al. . Defects in insulin receptor signaling in vivo in the polycystic ovary syndrome (PCOS). Am J Physiol Endocrinol Metab 2001;281:E392–99.
    1. Corbould A. Effects of androgens on insulin action in women: is androgen excess a component of female metabolic syndrome? Diabetes Metab Res Rev 2008;24:520–32. 10.1002/dmrr.872
    1. Alvarez-Blasco F, Botella-Carretero JI, San Millan JL et al. . Prevalence and characteristics of the polycystic ovary syndrome in overweight and obese women. Arch Intern Med 2006;166:2081–6. 10.1001/archinte.166.19.2081
    1. Lee H, Oh JY, Sung YA et al. . The prevalence and risk factors for glucose intolerance in young Korean women with polycystic ovary syndrome. Endocrine 2009;36:326–32. 10.1007/s12020-009-9226-7
    1. Hollinrake E, Abreu A, Maifeld M et al. . Increased risk of depressive disorders in women with polycystic ovary syndrome. Fertil Steril 2007;87:1369–76. 10.1016/j.fertnstert.2006.11.039
    1. Jones GL, Balen AH, Ledger WL. Health-related quality of life in PCOS and related infertility: how can we assess this? Hum Fertil (Camb) 2008;11:173–85. 10.1080/14647270802078179
    1. Johansson J, Redman L, Veldhuis PP et al. . Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab 2013;304: E934–43. 10.1152/ajpendo.00039.2013
    1. Jedel E, Labrie F, Oden A et al. . Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab 2011;300:E37–45. 10.1152/ajpendo.00495.2010
    1. Stener-Victorin E, Baghaei F, Holm G et al. . Effects of acupuncture and exercise on insulin sensitivity, adipose tissue characteristics, and markers of coagulation and fibrinolysis in women with polycystic ovary syndrome: secondary analyses of a randomized controlled trial. Fertil Steril 2012;97:501–8. 10.1016/j.fertnstert.2011.11.010
    1. Johansson J, Yi F, Shao R et al. . intense acupuncture normalizes insulin sensitivity, increases muscle GLUT4 content, and improves lipid profile in a rat model of polycystic ovary syndrome. Am J Physiol Endocrinol Metab 2010;299:E551–9. 10.1152/ajpendo.00323.2010
    1. Manneras L, Jonsdottir IH, Holmang A et al. . Low-frequency electro-acupuncture and physical exercise improve metabolic disturbances and modulate gene expression in adipose tissue in rats with dihydrotestosterone-induced polycystic ovary syndrome. Endocrinology 2008;149:3559–68. 10.1210/en.2008-0053
    1. Liang F, Chen R, Nakagawa A et al. . Low-frequency electroacupuncture improves insulin sensitivity in obese diabetic mice through activation of SIRT1/PGC-1α in skeletal muscle. Evid Based Complement Alternat Med 2011;2011:735297 10.1155/2011/735297
    1. Johansson J, Manneras-Holm L, Shao R et al. . 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:e54357 10.1371/journal.pone.0054357
    1. Chang SL, Lin JG, Chi TC et al. . An insulin-dependent hypoglycaemia induced by electroacupuncture at the Zhongwan (CV12) acupoint in diabetic rats. Diabetologia 1999;42:250–5. 10.1007/s001250051146
    1. Chang S-L, Lin K-J, Lin R-T et al. . Enhanced insulin sensitivity using electroacupuncture on bilateral Zusanli acupoints (ST 36) in rats. Life Sci 2006;79:967–71. 10.1016/j.lfs.2006.05.005
    1. Shi Y, Guo M, Yan J et al. . Analysis of clinical characteristics in large-scale Chinese women with polycystic ovary syndrome. Neuro Endocrinol Lett 2007;28:807–10.
    1. Zhao X, Ni R, Li L et al. . Defining hirsutism in Chinese women: a cross-sectional study. Fertil Steril 2011;96:792–6. 10.1016/j.fertnstert.2011.06.040
    1. Balen AH, Laven JSE, Tan S-L et al. . Ultrasound assessment of the polycystic ovary: international consensus definitions. Hum Reprod Update 2003;9:505–14. 10.1093/humupd/dmg044
    1. Chen X, Yang D, Li L et al. . Abnormal glucose tolerance in Chinese women with polycystic ovary syndrome. Hum Reprod 2006;21:2027–32. 10.1093/humrep/del142
    1. Misra A, Chowbey P, Makkar BM et al. . Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. J Assoc Physicians India 2009;57:163–70.
    1. Moher D, Schulz KF, Altman D. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY) 2005;1:40–5. 10.1016/j.explore.2004.11.001
    1. MacPherson H, Altman DG, Hammerschlag R et al. . Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med 2010;7:e1000261 10.1371/journal.pmed.1000261
    1. Lai MH, Ma HX, Yao H et al. . [Effect of abdominal acupuncture therapy on the endocrine and metabolism in obesity-type polycystic ovarian syndrome patients]. Zhen Ci Yan Jiu 2010;35:298–302.
    1. Matthews DR, Hosker JP, Rudenski AS et al. . Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985;28:412–19. 10.1007/BF00280883
    1. Iwata M, Maeda S, Kamura Y et al. . 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;35:1763–70. 10.2337/dc11-2006
    1. Kahn SE, Prigeon RL, McCulloch DK et al. . Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes 1993;42:1663–72. 10.2337/diab.42.11.1663
    1. McHorney CA, Ware JE Jr, Lu JF et al. . The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994;32:40–66. 10.1097/00005650-199401000-00004
    1. Cronin L, Guyatt G, Griffith L et al. . Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS). J Clin Endocrinol Metab 1998;83:1976–87.
    1. Leung KF, Liu FB, Zhao L et al. . Development and validation of the Chinese Quality of Life Instrument. Health Qual Life Outcomes 2005;3:26 10.1186/1477-7525-3-26
    1. Marone J, Lubin B. Relationship between set 2 of the Depression adjective check lists (DACL) and Zung self-rating depression scale (SDS). Psychol Rep 1968;22:333–4. 10.2466/pr0.1968.22.1.333
    1. Craig CL, Marshall AL, Sjostrom M et al. . International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003;35:1381–95. 10.1249/01.MSS.0000078924.61453.FB

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