Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial

Kyoung Sun Park, Weijuan Gang, Pyung-Wha Kim, Changsop Yang, Purumea Jun, So-Young Jung, Ojin Kwon, Jin Moo Lee, Hye Jeong Lee, Su Jeong Lee, Xianghong Jing, Ning Zhang, Jing Hu, Jiping Zhao, Ran Pang, Chunlan Jin, Jun-Hwan Lee, Kyoung Sun Park, Weijuan Gang, Pyung-Wha Kim, Changsop Yang, Purumea Jun, So-Young Jung, Ojin Kwon, Jin Moo Lee, Hye Jeong Lee, Su Jeong Lee, Xianghong Jing, Ning Zhang, Jing Hu, Jiping Zhao, Ran Pang, Chunlan Jin, Jun-Hwan Lee

Abstract

Background: Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive endocrinology affecting women of reproductive age. Our study aims to explore the feasibility of a full-scale trial to evaluate the efficacy and safety of acupuncture for PCOS.

Methods: This study is a two-armed, parallel, multi-country, multi-center, pilot randomized controlled trial (RCT) for PCOS with oligomenorrhea. We will recruit 60 women aged 20 to 40 years with oligomenorrhea due to PCOS. The participants will be randomly assigned to acupuncture and control groups. The acupuncture group will undergo a total of 40 sessions for 16 weeks with usual care. The control group will be managed with usual care (regular meals, sufficient sleep, and appropriate exercise) only. The primary clinical outcome is mean change in menstrual frequency from baseline to 16 weeks and 32 weeks (follow-up) after the start of the trial. The secondary outcomes are menstrual period, levels of estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone, LH/FSH ratio, antral follicle count and ovarian volume, body mass index, waist hip ratio, acne severity, and health-related quality of life questionnaire scores at 16 and 32 weeks after the start of the trial.

Discussion: This is the first protocol for multi-country, multi-center RCTs for PCOS in Korea and China. The control group in this study will be subjected to usual care (regular meals, enough sleep, and appropriate exercise). The results of this study will provide evidence for future clinical decisions and guidelines.This trial has been registered at ClinicalTrials.gov (Identifier: NCT04509817).

Conflict of interest statement

The authors have no conflicts of interests to disclose.

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Figure 1
Figure 1
Flowchart of the trial.

References

    1. Grou TREA-SPCW. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril 2004;81:19–25.
    1. McCartney CR, Marshall JC. CLINICAL Practice. Polycystic ovary syndrome. N Engl J Med 2016;375:54–64.
    1. Gorry A, White DM, Franks S. Infertility in polycystic ovary syndrome: focus on low-dose gonadotropin treatment. Endocrine 2006;30:27–33.
    1. Teede HJ, Misso ML, Deeks AA, et al. . Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline. Med J Aust 2011;195:S65–112.
    1. Brown J, Farquhar C, Beck J, Boothroyd C, Hughes E. Clomiphene and anti-oestrogens for ovulation induction in PCOS. Cochrane Database Syst Rev 2009;CD002249.
    1. Legro RS, Barnhart HX, Schlaff WD, et al. . Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med 2007;356:551–6.
    1. Morley LC, Tang T, Yasmin E, Norman RJ, Balen AH. Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Cochrane Database Syst Rev 2017;11:CD003053.
    1. Legro RS, Arslanian SA, Ehrmann DA, et al. . Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2013;98:4565–92.
    1. Rocca ML, Venturella R, Mocciaro R, et al. . Polycystic ovary syndrome: chemical pharmacotherapy. Expert Opin Pharmacother 2015;16:1369–93.
    1. Diamanti-Kandarakis E, Baillargeon JP, Iuorno MJ, Jakubowicz DJ, Nestler JE. A modern medical quandary: polycystic ovary syndrome, insulin resistance, and oral contraceptive pills. J Clin Endocrinol Metab 2003;88:1927–32.
    1. Lim CE, Wong WSJGE. Current evidence of acupuncture on polycystic ovarian syndrome. Gynecol Endocrinol 2010;26:473–8.
    1. Zheng YH, Wang XH, Lai MH, Yao H, Liu H, Ma HX. Effectiveness of abdominal acupuncture for patients with obesity-type polycystic ovary syndrome: a randomized controlled trial. J Altern Complement Med 2013;19:740–5.
    1. 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;297:R387–95.
    1. Qu F, Wu Y, Hu XY, et al. . The effects of acupuncture on polycystic ovary syndrome: a systematic review and meta-analysis. Eur J Integr Med 2016;8:12–8.
    1. Jo J, Lee YJ, Lee H. Acupuncture for polycystic ovarian syndrome: a systematic review and meta-analysis. Medicine (Baltimore) 2017;96:e7066.
    1. Lim CE, Ng RW, Xu K, et al. . Acupuncture for polycystic ovarian syndrome. Cochrane Database Syst Rev 2016;CD007689.
    1. General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China. Nomenclature and Location of Acupuncture Points (GB/T 12346-2006). Beijing: Standards Press of China; 2006.
    1. Pundir J, Charles D, Sabatini L, et al. . Overview of systematic reviews of non-pharmacological interventions in women with polycystic ovary syndrome. Hum Reprod Update 2019;25:243–56.
    1. Lim CED, Ng RWC, Cheng NCL, Zhang GS, Chen HJ. Acupuncture for polycystic ovarian syndrome. Cochrane Database Syst Rev 2019;7:CD007689.
    1. Ko JH, Kim SN. A literature review of women's sex hormone changes by acupuncture treatment: analysis of human and animal studies. Evid Based Complement Alternat Med 2018;2018:3752723.
    1. Dewailly D, Lujan ME, Carmina E, et al. . Definition and significance of polycystic ovarian morphology: a task force report from the Androgen Excess and Polycystic Ovary Syndrome Society. Hum Reprod Update 2014;20:334–52.
    1. World Health Organization. Waist circumference and waist-hip ratio: report of a WHO expert consultation, Geneva, 8-11 December 2008. World Health Organization. 2011. .
    1. Legro RS. Obesity and PCOS: implications for diagnosis and treatment. Semin Reprod Med 2012;30:496–506.
    1. Colonna L, Pacifico V, Lello S, Sorge R, Raskovic D, Primavera G. Skin improvement with two different oestroprogestins in patients affected by acne and polycystic ovary syndrome: clinical and instrumental evaluation. J Eur Acad Dermatol Venereol 2012;26:1364–71.
    1. Han CW, Lee EJ, Iwaya T, Kataoka H, Kohzuki M. Development of the Korean version of short-form 36-item health survey: health related QOL of healthy elderly people and elderly patients in Korea. Tohoku J Exp Med 2004;203:189–94.
    1. Li L, Wang H, Shen Y. Chinese SF-36 health survey: translation, cultural adaptation, validation, and normalisation. J Epidemiol Community Health 2003;57:259–63.
    1. Ware JE. SF-36 health survey update. Spine (Phila Pa 1976) 2000;25:3130–9.
    1. Burnett D. ISO 15189: 2003–quality management, evaluation and continual improvement. Clin Chem Lab Med 2006;44:733–9.
    1. Guzel O, Guner EI. ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I. Clin Biochem 2009;42:274–8.
    1. Witt CM, Pach D, Brinkhaus B, et al. . Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Complement Med Res 2009;16:91–7.
    1. Johansson J, Stener-Victorin E. Polycystic ovary syndrome: effect and mechanisms of acupuncture for ovulation induction. Evid Based Complement Alternat Med 2013;2013:01–16.
    1. MacPherson H, Hammerschlag R, Coeytaux RR, et al. . Unanticipated insights into biomedicine from the study of acupuncture. J Altern Complement Med 2016;22:101–7.
    1. Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med 2009;15:213–6.

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