Efficacy of acupuncture on menstrual frequency in women with polycystic ovary syndrome: Protocol for a randomized, controlled trial.

BACKGROUND: Acupuncture may improve the menstrual frequency of women with polycystic ovary syndrome (PCOS). However, more sufficient data are needed to improve the efficacy of acupuncture.

METHODS: A total of 172 participants diagnosed with PCOS would be randomly assigned to either the acupuncture group or sham-acupuncture group, at a ratio of 1:1. Participants in both groups will receive treatment for 12 weeks, 3 times a week. The primary outcome will be the proportion of participants with at least a 50% increase from baseline in the monthly menstrual frequency from baseline after 12 weeks intervention, while secondary outcomes will be the difference in anthropometrics, serum hormone level, ovarian morphology, anxiety and depression, and quality of life from baseline to after 12 weeks intervention and to 12 weeks postintervention follow-up between groups.

DISCUSSION: The aim of this study is to evaluate the efficacy and safety of acupuncture for improving menstrual frequency and other symptoms of patients with PCOS. The limitation of this trial is that it would be difficult to blind the acupuncturists. In addition, these findings may not be suitable for women with PCOS who are seeking pregnancy.