Efficacy and safety of acupuncture for breast cancer-related insomnia: a systematic review and meta-analysis

Clinical Snapshot

Key Findings

• P Value: PSQI: P<0.00001; Overall efficacy rate: P<0.00001; ISI: not significant (P value not specified)

• Effect Size: PSQI: MD = -2.74 points; Overall efficacy rate: RR = 1.51; ISI: non-significant (effect size not specified in abstract)

• Primary Outcome: Acupuncture significantly reduced PSQI scores compared to control (MD = -2.74 points), indicating improved sleep quality. The overall efficacy rate was significantly higher in the acupuncture group (RR = 1.51). ISI scores did not show statistically significant improvement.

• Nnt Or Sensitivity: NNT not calculable from abstract data. The PSQI MD of -2.74 approaches the commonly cited MCID of approximately 2.5–3 points, suggesting borderline clinical significance. The RR of 1.51 for overall efficacy rate implies a 51% relative increase in treatment responders, but absolute risk difference and NNT cannot be derived without baseline event rates.

• Confidence Interval: PSQI: 95% CI [-3.92, -1.55]; Overall efficacy rate: 95% CI [1.27, 1.81]; ISI: not reported as significant

Clinical Application

Acupuncture is widely available in integrative oncology and private practice settings. Treatment frequency and duration vary across included trials, limiting protocol standardisation. Adverse events were infrequent and mild (consistent with the established safety profile of acupuncture), supporting feasibility in cancer care settings. Cost and access remain barriers for some patient populations. In Australia, acupuncture is not currently listed on the Pharmaceutical Benefits Scheme (PBS) and is not a Medicare Benefits Schedule (MBS) item for insomnia management. Patients typically access acupuncture through private health insurance extras cover or out-of-pocket payment. The Therapeutic Goods Administration (TGA) regulates acupuncture needles as medical devices (Class IIa). The RACGP supports integrative approaches to cancer-related symptom management but emphasises evidence quality; current GRADE low-to-very-low certainty ratings would not support a strong RACGP recommendation for acupuncture as a first-line BCRI treatment. Cognitive Behavioural Therapy for Insomnia (CBT-I) remains the recommended first-line treatment per Australian clinical guidelines. Acupuncture may be considered as a complementary option for patients who decline or do not respond to CBT-I or pharmacotherapy, particularly given its favourable safety profile. Clinicians should counsel patients regarding the current evidence limitations. Adult women with confirmed breast cancer diagnosis experiencing clinically significant insomnia, particularly those who have not responded to or declined first-line pharmacological or psychological interventions. Applicability is most direct for patients already engaged with integrative oncology services.

Abstract

Breast cancer-related insomnia (BCRI) is a common and burdensome sequela. Acupuncture is frequently used, but robust evidence is limited, and previous systematic reviews included few trials yielding imprecise estimates. This updated systematic review and meta-analysis evaluated the efficacy and safety of acupuncture for BCRI. We systematically searched eight databases for randomized controlled trials (RCTs) up to July 1, 2025. RCTs comparing acupuncture with any control for BCRI were eligible. Methodological quality was assessed using the Cochrane Risk of Bias tool (RoB 2.0) and the modified Jadad scale. Meta-analyses employed a random-effects model. Subgroup analyses explored heterogeneity sources, and the GRADE framework rated evidence certainty. Twenty-seven RCTs (n=2,025) were included. Acupuncture significantly reduced Pittsburgh Sleep Quality Index (PSQI) scores (MD= -2.74, 95% CI [-3.92, -1.55], P<0.00001) and increased the overall efficacy rate (RR=1.51, 95% CI [1.27, 1.81], P<0.00001) compared to control, but did not significantly improve Insomnia Severity Index (ISI) scores. Subgroup analyses identified control intervention type and treatment frequency as significant sources of heterogeneity. Adverse events were infrequent and typically mild. GRADE assessments rated the certainty of evidence as low or very low, primarily due to risk of bias and substantial heterogeneity. Current evidence suggests acupuncture may improve sleep in patients with BCRI, with effects moderated by comparator type and treatment frequency. However, conclusions are limited by methodological weaknesses and heterogeneity. Future rigorous RCTs using validated sham controls, standardized protocols, and objective outcomes are needed to confirm efficacy and guide practice. PROSPERO Registration number (ID: CRD42024559828).

References

1. 1.Zhang, H., Ren, K., & Wang, S. (2026). Efficacy and safety of acupuncture for breast cancer-related insomnia: a systematic review and meta-analysis. BMJ Supportive & Palliative Care. https://doi.org/10.1136/spcare-2025-006052