Efficiency and safety of acupuncture for women with premature ovarian insufficiency: study protocol for a randomized controlled trial.

Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency (POI) in China. However, research to date has not shown that acupuncture is effective for POI compared with hormone replacement therapy (HRT). We will conduct a randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on POI. Seventy-six patients with POI will be randomly assigned to two groups. The treatment group will receive twenty-eight one-hour sessions of acupuncture treatments, and the control group will receive 12-week HRT. The whole study will consist of a 12-week treatment plan and a 12-week follow-up session. The primary outcome is measured by changes in serum anti-Müllerian hormone and follicle-stimulating hormone (FSH) levels at weeks 12 and 24. Secondary outcome measures include estradiol, luteinizing hormone (LH), LH/FSH ratio, Kupperman index, and menstrual condition. This trial is expected to clarify whether or not acupuncture is effective and safe for POI compared with HRT.