RATIONALE: Polycystic ovary syndrome (PCOS) is characterised by oligo-amenorrhoea, infertility, and hirsutism. Treatments include pharmacological agents, lifestyle modifications, and surgery. During ovulation in healthy women, the concentration of beta-endorphin, a neuropeptide involved in pain and hormonal regulation, is higher in follicular fluid than in plasma. Acupuncture may improve ovulatory function by stimulating beta-endorphin production, which is hypothesised to enhance gonadotropin-releasing hormone (GnRH) secretion. This is an update of a review first published in 2011 and last updated in 2019. OBJECTIVES: To assess the benefits and harms of acupuncture in managing fertility and symptoms in oligo/anovulatory women with polycystic ovary syndrome. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, and three Chinese databases (CNKI, CBM, and VIP). We also reviewed trial registries and reference lists for related papers. The searches in CENTRAL, MEDLINE, Embase, PsycINFO, and CNKI are current to December 2024. The VIP search is current to November 2024. The CBM database search is current to November 2015. We also performed reference checking and citation searching and contacted study authors to identify additional studies. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) on the efficacy of acupuncture for oligo/anovulatory women with PCOS. OUTCOMES: Our critical outcomes were live birth rate, multiple pregnancy rate, and ovulation rate. Our important outcomes were clinical pregnancy rate, restored regular menstrual period, miscarriage rate, and adverse events. RISK OF BIAS: We used the original Cochrane risk of bias tool (RoB 1) to assess risk of bias. SYNTHESIS METHODS: Two authors independently selected studies, extracted data, and assessed risk of bias. We calculated risk ratios (RRs), mean differences (MDs), and standardised mean differences (SMDs), each with its 95% confidence interval (CI). We used GRADE to assess the certainty of evidence. We considered the possibility of skewed data, particularly in small studies. In such cases, summary statistics may be less reliable. Where transformation or reanalysis was unfeasible due to limited data, we interpreted results cautiously and discussed this limitation. In future updates, we will evaluate whether small, skewed trials should be excluded or analysed using alternative approaches. INCLUDED STUDIES: We included nine RCTs (one added in this update) with 1606 women. The comparisons were acupuncture versus sham acupuncture (3 RCTs), low-frequency electroacupuncture versus exercise/no intervention (1 RCT), acupuncture versus relaxation (1 RCT), acupuncture versus clomiphene (1 RCT), and acupuncture versus Diane-35 (ethinylestradiol/cyproterone acetate tablets; 3 RCTs). Studies comparing acupuncture with Diane-35 focused on symptom control and clinical pregnancy rate. SYNTHESIS OF RESULTS: Overall, the evidence remains uncertain regarding the effectiveness of acupuncture for fertility and symptom control. Larger, well-designed trials are required. Key limitations were the absence of important outcomes and limited data. Acupuncture versus sham acupuncture Compared with sham acupuncture, acupuncture may result in little to no difference in rates of live birth (RR 0.97, 95% CI 0.76 to 1.23; 1 RCT, 1000 women; low-certainty evidence); multiple pregnancy (RR 0.89, 95% CI 0.33 to 2.45; 1 RCT, 1000 women; low-certainty evidence); ovulation, measured as the mean number of ovulations per participant during treatment (SMD 0.02, 95% CI -0.15 to 0.19; 2 RCTs, 1010 women; low-certainty evidence); clinical pregnancy (RR 1.07, 95% CI 0.85 to 1.35; 3 RCTs, 1117 women; low-certainty evidence); and miscarriage (RR 1.10, 95% CI 0.77 to 1.56; 1 RCT, 926 women; low-certainty evidence). Acupuncture may reduce the mean number of days between menstrual periods at 12 weeks' follow-up (MD -312.09 days, 95% CI -344.59 to -279.59; 1 RCT, 141 women; very low-certainty evidence), although the evidence is very uncertain. Adverse events are probably more common with acupuncture (RR 1.16, 95% CI 1.02 to 1.31; 3 RCTs, 1230 women; moderate-certainty evidence). Low-frequency electroacupuncture versus exercise or no intervention The RCT of this comparison reported none of our critical outcomes. We are unsure about the effect of low-frequency electroacupuncture versus exercise or no intervention on restored regular menstrual periods or adverse events, because the evidence is very uncertain. Acupuncture versus relaxation We are unsure about the effect of acupuncture compared with relaxation on ovulation, measured as the mean number of ovulations per participant during treatment (MD 0.35, 95% CI 0.14 to 0.56; 1 RCT, 28 women; very low-certainty evidence). Acupuncture versus clomiphene The RCT of this comparison reported none of our critical outcomes. We are unsure about the effect of acupuncture versus clomiphene on restored regular menstrual periods or adverse events, because the evidence is very uncertain. Acupuncture versus Diane-35 The evidence is very uncertain about the effect of acupuncture compared with Diane-35 on the proportion of women who ovulate during treatment (RR 1.14, 95% CI 0.79 to 1.63; 2 RCTs, 128 women; very low-certainty evidence); clinical pregnancy (RR 1.00, 95% CI 0.22 to 4.56; 1 RCT, 60 women; very low-certainty evidence); and restored regular menstrual period, measured as mean cycle duration (MD 0.90 days, 95% CI -0.77 to 2.57; 1 RCT, 60 women; very low-certainty evidence). AUTHORS' CONCLUSIONS: We found no clear evidence of a difference between acupuncture and sham acupuncture in rates of live birth, multiple pregnancy, ovulation, clinical pregnancy, miscarriage, or restoration of regular menstrual periods. Acupuncture is probably associated with a greater risk of adverse events. It is unclear whether acupuncture improves ovulation rate compared with relaxation or Diane-35. In studies that compared acupuncture with exercise, no intervention, clomiphene, and Diane-35, adverse events reported in the acupuncture group included vaginal bleeding, weight gain, fatigue, dizziness, nausea, and subcutaneous haematoma. The limited number of RCTs and variability in outcome reporting mean that the effectiveness of acupuncture for PCOS remains uncertain.

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