Highlights
– A Cochrane systematic review (Ma et al., 2025) pooled five RCTs (402 participants, mostly women with breast cancer) evaluating acupuncture for insomnia in cancer populations.
– Evidence quality ranged from very low to moderate. Compared with sham or inactive controls, acupuncture produced small, uncertain improvements in some sleep diary measures but did not consistently exceed minimally important differences (MIDs) for standard patient-reported scales (ISI, PSQI).
– Compared with cognitive behavioural therapy for insomnia (CBT‑I), acupuncture was probably less effective for insomnia severity and sleep quality (moderate-certainty evidence from one trial), though it may modestly increase objective/diary total sleep time.
Background and clinical context
Insomnia is common in people with cancer, affecting sleep initiation, maintenance, and daytime function. Prevalence estimates vary with cancer type and stage but can be substantially higher than in age-matched populations without cancer. Insomnia in cancer survivors is associated with fatigue, poorer quality of life, and may interfere with cancer recovery and treatment adherence.
CBT‑I is recommended as first-line therapy for chronic insomnia in adults by major guideline bodies and has demonstrated efficacy in cancer populations when adapted to the clinical context. Nonetheless, access barriers (long waiting lists, limited trained providers, patient preference) drive interest in complementary therapies such as acupuncture as alternative or adjunctive options.
Study design and methods (review overview)
The 2025 Cochrane review (Ma Q et al., CD015177) searched major bibliographic databases and trial registries through January 2024 and included randomized controlled trials (RCTs) of acupuncture (needle insertion at specific acupoints) for insomnia in people with cancer. Trials had to have at least four weeks’ duration. Primary outcomes were insomnia severity (Insomnia Severity Index, ISI) and sleep quality (Pittsburgh Sleep Quality Index, PSQI). Secondary outcomes included adverse events and sleep diary measures: sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE).
Risk of bias was assessed with the RoB 2 tool. Random-effects meta-analyses estimated mean differences (MDs) or risk ratios (RRs) with 95% confidence intervals (CIs). The review judged clinical importance against pre-specified minimally important differences (MIDs) and rated evidence certainty using GRADE.
Included trials and population
Five RCTs (total n = 402) were included. Key characteristics:
- Most participants were female and had breast cancer; most were post-treatment (survivorship setting).
- Comparators included sham acupuncture, inactive controls (wait-list or usual care), and one trial comparing acupuncture directly with CBT‑I.
- Trial sizes were small to moderate (range single small trials to one larger trial of n=160 comparing acupuncture versus CBT‑I).
- Intervention specifics (acupoints, number/timing of sessions) varied across trials.
Key findings — detailed results
Certainty of evidence
Overall certainty ranged from very low to moderate. Most comparisons versus sham or inactive controls were downgraded for risk of bias (blinding and randomization concerns) and imprecision (small sample sizes and wide CIs). The acupuncture versus CBT‑I comparison (one trial, n=160) provided moderate-certainty evidence for several outcomes.
Acupuncture versus sham acupuncture (2 trials, 152 participants)
Evidence certainty: very low.
Patient-reported outcomes at end of intervention:
- Insomnia Severity Index (ISI): MD −3.17 (95% CI −10.39 to 4.05); prespecified MID −4.7 points. The CI includes both clinically important benefit and no effect — overall very uncertain.
- Pittsburgh Sleep Quality Index (PSQI): MD −1.16 (95% CI −3.53 to 1.22); MID −3 points. No clear clinically meaningful benefit.
Sleep diary outcomes:
- Sleep onset latency (SOL): MD −10.02 minutes (95% CI −19.09 to −0.94); MID 20 minutes. Small improvement that did not meet the MID.
- Sleep efficiency (SE): MD 4.90% (95% CI 1.98 to 7.82); MID 10%. Small improvement below MID.
- Total sleep time (TST): MD 45.94 minutes (95% CI −0.93 to 92.80); MID 15 minutes. Point estimate large but CI wide and crosses no-effect; very imprecise.
Adverse events: One trial reported increased adverse events with acupuncture (RR 2.60, 95% CI 0.98 to 6.90; 138 participants), but precision was poor and certainty very low.
Acupuncture versus inactive control (2–3 trials; small samples, pooled where possible)
Evidence certainty: very low.
- ISI: MD −3.88 (95% CI −7.25 to −0.52); MID −4.7 points. Slight reduction in ISI but did not surpass the MID; imprecise.
- PSQI: MD −2.20 (95% CI −3.35 to −1.04); MID −3 points. Small improvement not reaching MID.
- TST: MD 34.61 minutes (95% CI 12.54 to 56.69); MID 15 minutes. Improvement exceeded MID; however, evidence is very low certainty and comes from small trials (n≈46 pooled).
- SOL and SE showed small improvements that typically did not meet their MIDs.
- Adverse events: pooled signal of higher events with acupuncture (RR 15.49, 95% CI 2.12 to 113.10; 2 trials, 76 participants) — wide CI, very imprecise, and likely driven by low event counts.
Acupuncture versus CBT‑I (1 trial, 160 participants)
Evidence certainty: moderate for many outcomes.
- ISI: acupuncture worse than CBT‑I — MD 2.60 (95% CI 1.13 to 4.07), indicating higher (worse) insomnia severity in the acupuncture arm. This difference reached statistical significance and is likely clinically relevant.
- PSQI: MD 1.51 (95% CI 0.51 to 2.51) favoring CBT‑I.
- Sleep diary outcomes: acupuncture probably increased SOL (worse) by 16.33 minutes (95% CI 8.22 to 24.44; MID 10 min) and reduced SE by 5.00% (95% CI −8.48 to −1.52; MID 5%), but it probably increased TST by 26.80 minutes (95% CI 3.87 to 49.73; MID 15 min). WASO differences were small and imprecise.
- Adverse events: little to no difference (RR 1.68, 95% CI 0.59 to 4.79; low-certainty evidence).
Interpretation and clinical implications
What clinicians should take away:
- The collective evidence is limited in size, scope, and certainty. Most trials were small, heterogeneous in acupuncture protocols, and enrolled primarily female breast cancer survivors, limiting generalizability.
- Compared with sham or no treatment, acupuncture may provide modest improvements in sleep diary measures (TST, SOL, SE), but the majority of improvements did not consistently exceed established MIDs for patient-centered scales (ISI, PSQI). Confidence in these effects is low to very low.
- When compared directly with CBT‑I in a single adequately powered trial, acupuncture was probably less effective for reducing insomnia severity and improving overall sleep quality, although TST increased modestly. This supports current guidelines that prioritize CBT‑I as first-line therapy for chronic insomnia, including in cancer populations when available.
- Safety signals are unclear: several trials reported adverse events, and pooled estimates had wide CIs. Most reported events were minor (e.g., local discomfort, transient bleeding), but clinicians should counsel patients that acupuncture is not free of risk and evidence on harms in cancer patients is sparse.
- Given limited evidence, acupuncture may be a reasonable option for patients who decline or cannot access CBT‑I, but clinicians should set expectations about modest benefits, uncertainty, and potential for minor adverse effects. Shared decision-making is important.
Mechanistic plausibility
Proposed mechanisms for acupuncture’s effects on sleep include modulation of autonomic balance, endogenous opioid and monoaminergic pathways, and effects on inflammatory mediators and stress hormones. While preclinical and some human mechanistic studies suggest biological plausibility, direct links between acupuncture-induced physiological changes and clinically meaningful improvements in insomnia among cancer patients remain incompletely defined.
Limitations and research gaps
- Population narrowness: trials predominantly enrolled female breast cancer survivors. Data are lacking for men, other cancer types, patients undergoing active oncologic therapies, and for diverse demographic groups.
- Small trial sizes and heterogeneity in acupuncture protocols (acupoint selection, needle depth, session number/frequency) hinder pooled interpretation and reproducibility.
- Short follow-up: most outcomes were assessed at end of treatment; long-term durability of any benefit is unknown.
- Risk of bias: blinding (participant, practitioner) and allocation concealment were concerns in some trials, reducing confidence in estimates.
- Outcomes: objective sleep measures (polysomnography, actigraphy) were rarely reported; reliance on self-report and diaries introduces measurement variability.
Recommendations for clinicians and researchers
Clinicians:
- Advocate CBT‑I as the evidence-based first-line treatment for chronic insomnia in cancer patients when available and acceptable.
- If acupuncture is considered (patient preference, CBT‑I access issues), discuss the limited and low-certainty evidence, potential modest improvements in diary measures, and possible minor harms. Consider acupuncture as adjunctive or palliative for sleep symptoms rather than a replacement for CBT‑I.
- Document treatment plans, monitor sleep outcomes with validated scales (ISI, PSQI) and diaries, and report adverse events.
Researchers:
- Conduct adequately powered, methodologically rigorous RCTs with standardized acupuncture protocols, active comparators (CBT‑I), and longer follow-up to assess durability.
- Include diverse cancer types, sexes, and treatment phases. Report objective sleep measures (actigraphy/polysomnography) alongside validated patient-reported outcomes and adverse events.
- Pre-specify MIDs and patient-centered endpoints; ensure transparent reporting to enable pooled analyses and guideline development.
Conclusion
The Cochrane review (Ma et al., 2025) concludes that current randomized evidence does not provide high-certainty support that acupuncture meaningfully improves insomnia severity or sleep quality in people with cancer when compared with sham acupuncture or inactive controls. Some sleep diary measures show small improvements, but evidence is of low to very low certainty. A single moderate-certainty trial indicates acupuncture is probably less effective than CBT‑I for insomnia severity and sleep quality, supporting CBT‑I as the preferred treatment when available. Well-designed, larger trials across diverse cancer populations are required to draw definitive conclusions about the role of acupuncture in cancer-related insomnia.
Funding and trial registration
This Cochrane review was funded by the Postdoctor Research Fund of West China Hospital, Sichuan University (2025HXBH063) and the Fundamental Research Fund of China Academy of Chinese Medical Sciences (No. ZZ17-XRZ-113). The review protocol is available via DOI: 10.1002/14651858.CD015177.
References
1. Ma Q, Liu C, Zhao G, Guo S, Li H, Zhang B, Li B, Cai Z. Acupuncture for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Dec 5;12(12):CD015177. doi: 10.1002/14651858.CD015177.pub2. PMID: 41347621; PMCID: PMC12679689.
2. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med. 2016 Mar 1;164(3):191-203. doi:10.7326/M15-2175.
Author note
This article summarizes and interprets the findings of the cited Cochrane review for clinicians and researchers. It is intended to support shared decision-making and to highlight priorities for future research in cancer-related insomnia.
