RATIONALE: Insomnia is a common issue affecting people with cancer. Although acupuncture is widely used as a treatment option for insomnia, its effects on cancer patients require a rigorous and up-to-date evaluation. OBJECTIVES: To evaluate the benefits and harms of acupuncture for insomnia in people with cancer. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, PsycINFO, and five other databases or trial registries in January 2024. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) with a minimum duration of four weeks that evaluated acupuncture (defined as needle insertion at specific acupoints) for treating insomnia in patients with cancer. OUTCOMES: Our outcomes were insomnia severity measured by the Insomnia Severity Index (ISI), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), adverse events, and sleep diary outcomes including sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE). RISK OF BIAS: We assessed the risk of bias using the RoB 2 tool. SYNTHESIS METHODS: We performed random-effects meta-analysis to calculate risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CIs). We assessed the certainty of evidence with GRADE and interpreted findings for continuous outcomes against minimally important differences (MIDs). INCLUDED STUDIES: We included five studies with 402 participants. The participants were predominantly females with breast cancer, and most were people following primary cancer treatment. SYNTHESIS OF RESULTS: We identified three comparisons with outcomes assessed at the end of the interventions. We rated the certainty of the evidence as very low-to-moderate, mainly due to risk of bias and the imprecision of effect estimates from the small studies. Acupuncture versus sham acupuncture We are very uncertain about all results due to very low-certainty evidence. Compared to sham acupuncture, acupuncture may have little to no effect on post-intervention ISI scores (MD -3.17, 95% CI -10.39 to 4.05; MID -4.7 points; 2 studies, 152 participants; very low-certainty evidence) and PSQI scores (MD -1.16, 95% CI -3.53 to 1.22; MID -3 points; 2 studies, 152 participants; very low-certainty evidence). Acupuncture may increase the risk of adverse events (RR 2.60, 95% CI 0.98 to 6.90; 1 study, 138 participants; very low-certainty evidence), but this result is very uncertain. Regarding sleep diary outcomes, acupuncture compared with sham acupuncture may improve post-intervention SOL (MD -10.02 min, 95% CI -19.09 to -0.94; MID 20 minutes; 2 studies, 152 participants; very low-certainty evidence) and SE (MD 4.90%, 95% CI 1.98 to 7.82; MID 10%; 2 studies, 152 participants; very low-certainty evidence) very slightly. It may have a large effect on TST (MD 45.94 min, 95% CI -0.93 to 92.80; MID 15 minutes; 2 studies; 152 participants; very low-certainty evidence), but this result is very uncertain. Data on WASO were unavailable. No outcome both exceeded its MID and was statistically significant. Acupuncture versus inactive control We are very uncertain about all results due to very low-certainty evidence. Compared to an inactive control, acupuncture may reduce post-intervention ISI scores (MD -3.88, 95% CI -7.25 to -0.52; MID -4.7 points; 2 studies, 46 participants; very low-certainty evidence) and PSQI scores (-2.20, 95% CI -3.35 to -1.04; MID -3 points; 3 studies, 98 participants; very low-certainty evidence) slightly, but may increase the risk of adverse events (RR 15.49, 95% CI 2.12 to 113.10; 2 studies, 76 participants; very low-certainty evidence). With respect to sleep diary outcomes, acupuncture may slightly improve post-intervention SOL (MD -15.61 min, 95% CI -29.23 to -1.99; MID 20 minutes; 2 studies, 46 participants; very low-certainty evidence), TST (MD 34.61 min, 95% CI 12.54 to 56.69; MID 15 minutes; 2 studies, 46 participants; very low-certainty evidence) and SE slightly (MD 5.65, 95% CI 0.99 to 10.32; MID 10%; 2 studies, 46 participants; very low-certainty evidence). However, it may result in little to no difference in post-intervention WASO (MD 5.70 min, 95% CI -17.25 to 28.65; 1 study, 30 participants; very low-certainty evidence). Only the TST improvement surpassed the MID. Acupuncture versus cognitive behavioural therapy for insomnia (CBT-I) Compared to CBT-I, acupuncture probably results in slightly higher (worse) post-intervention ISI scores (MD 2.60, 95% CI 1.13 to 4.07; 1 study, 160 participants; moderate-certainty evidence) and PSQI scores (MD 1.51, 95% CI 0.51 to 2.51; 1 study, 160 participants; moderate-certainty evidence). However, it may have little to no effect on adverse events (RR 1.68, 95% CI 0.59 to 4.79; 1 study; 160 participants; low-certainty evidence). Regarding sleep diary outcomes, acupuncture compared with CBT-I probably slightly worsens post-intervention SOL (MD 16.33 min, 95% CI 8.22 to 24.44; MID 10 minutes; 1 study, 160 participants; moderate-certainty evidence) and SE (MD -5.00%, 95% CI -8.48 to -1.52; MID 5%; 1 study, 160 participants; moderate-certainty evidence) but probably increases TST (MD 26.80 min, 95% CI 3.87 to 49.73; MID 15 minutes; 1 study, 160 participants; moderate-certainty evidence). It probably has little to no effect on WASO (MD 8.94 min, 95% CI -1.47 to 19.35; MID 15 minutes; 1 study, 160 participants; moderate-certainty evidence). The effects on SOL, TST, and SE reached the MIDs. AUTHORS' CONCLUSIONS: Based on very low-certainty evidence, acupuncture may have little to no effect on insomnia severity or sleep quality compared to sham acupuncture, though it may offer slight improvements in some sleep diary metrics. In contrast, when compared to an inactive control, acupuncture may alleviate insomnia severity and improve sleep quality and most sleep diary metrics, but adverse events should be taken into consideration. These findings are derived primarily from studies of female adults with breast cancer. Based on low- to moderate-certainty evidence, when compared with CBT-I, acupuncture is likely less effective at reducing insomnia severity, improving sleep quality, SOL and SE. Conversely, acupuncture probably improves TST. Larger, methodologically robust, long-term trials that include diverse cancer populations are required to provide definitive conclusions.

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