Effect of Acupuncture Plus Usual Care versus Usual Care Alone for Oligomenorrhea in Women with Polycystic Ovary Syndrome: A Pilot Randomized Controlled Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Objectives: This randomized controlled trial evaluated the effects of acupuncture on oligomenorrhea in women with polycystic ovary syndrome (PCOS), and assessed its safety. Design: International, multicenter, parallel, two-arm randomized controlled trial. Setting: Three outpatient centers in China and the Republic of Korea. Participants: Women aged 20-40 years diagnosed with PCOS (Rotterdam criteria) and oligomenorrhea (cycles >35 days or <8 episodes/year). Of 99 screened, 60 were enrolled and randomized (30/group); two control group participants were subsequently excluded from the full analysis set due to baseline misdiagnosis. Twenty-two (73.3%) in the acupuncture group and 25 (83.3%) in the control group completed the trial. Interventions: The acupuncture group received 40 sessions of manual acupuncture over 16 weeks at standardized acupoints, plus usual care (lifestyle advice). The control group received usual care alone. Primary and Secondary Outcome Measures: The primary outcome was the mean change in menstrual frequency (menstruations/month) from baseline to week 16. Secondary outcomes included menstrual cycle length, body mass index (BMI), hormonal profiles, and adverse events, and these were considered exploratory. Results: In the full analysis set (acupuncture, n=30; control, n=28), acupuncture significantly improved menstrual frequency vs control (mean difference: 0.20; 95% CI: 0.11 to 0.28; p=0.002). Significant improvements favoring acupuncture were also observed for menstrual cycle length (mean difference: -19.69 days; 95% CI: -29.42 to -9.97; p<0.001). No serious adverse events occurred. At week 32, the improvement in menstrual frequency was not sustained (mean difference: 0.14; 95% CI: -0.06 to 0.34; p=0.646). Conclusions: Acupuncture was associated with short-term improvements in menstrual frequency and cycle length, with no serious adverse events reported, but these improvements were not sustained at week 32. Given the pilot nature of this study, these findings should be considered preliminary. Trial Registration: NCT04509817 (ClinicalTrials.gov).
DOI: 10.2147/ijwh.s638897
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,836
Awards: G1888231276, G3146574035, G4484048448
OpenAlex ID: W7223105499
