Efficacy and safety of acupuncture for perimenopausal insomnia: A systematic review and meta-analysis of randomized controlled trials

Introduction: Acupuncture is widely recognized as an alternative therapy for perimenopausal insomnia (PMI) in China, yet it lacks robust evidence-based support. This systematic review evaluated the efficacy and safety of acupuncture in treating PMI. Methods: We conducted a comprehensive search for randomized controlled trials (RCTs) evaluating acupuncture for PMI across eight databases (PubMed, Cochrane Library, Web of Science, Embase, CNKI, CSPD, CSTJ, and CBM) from their inception until May 17, 2024. We assessed the risk of bias using the Cochrane risk-of-bias tool for randomized trials (RoB). and performed a random-effects meta-analysis and GRADE assessment. Results: The meta-analysis included 16 studies with 1,112 participants. We found evidence supporting the effectiveness of acupuncture in improving several outcomes. Acupuncture significantly improved sleep quality compared to sham-acupuncture or waitlist control (Pittsburgh sleep quality index (PSQI) MD-3.94, 95 %CI [-5.52,-2.35], 6 RCTs, 412 participants, moderate certainty) and medication (PSQI MD-2.62, 95 %CI [- 4.11,-1.12], 7 RCTs, 520 participants, low certainty). Clinical improvement rates were higher for acupuncture compared to medication or waitlist (RR 1.38, 95 %CI [1.12, 1.69], P = 0.002, low certainty). Objective measures using wrist actigraphy monitor or polysomnography favoured acupuncture over sham-acupuncture or medication for improving sleep efficiency (SMD 1.00, 95 %CI [0.70, 1.31], 5 RCTs, 330 participants, moderate certainty), total sleep time (SMD 0.84, 95 %CI [0.61, 1.06], 5 RCTs, 330 participants, moderate certainty) and wake after sleep onset (SMD-0.80, 95 %CI [-1.20,-0.40], 4 RCTs, 281 participants, low certainty), but not sleep awakenings (SMD 0.03, 95 %CI [-0.22, 0.27] 4 RCTs, 256 participants, low certainty). The effects of acupuncture on the Kupperman index and follicle-stimulating hormone (FSH) were inconclusive due to insufficient data. Adverse events were infrequent and symptoms were generally mild. There was a lower risk of adverse events from acupuncture compared to medication (RR 0.05, 95 %CI [0.0, 0.83], 3 RCTs, 183 participants, low certainty) and no difference compared to sham acupuncture (RR 1.25, 95 %CI [0.5, 3.1], moderate certainty). Conclusion: The current body of research suggests acupuncture is an effective and safe treatment option for PMI, offering benefits over Western medication, though the available evidence remains limited. Registration: PROSPERO CRD42023443190