Wang Fang, Wei Lifang
Qingyunpu Campus, Jiangxi Psychiatric Hospital, Nanchang, Jiangxi Province, China.
Medicine (Baltimore). 2025 Nov 28;104(48):e46207. doi: 10.1097/MD.0000000000046207.
The efficacy of Banxia Shumi decoction (BSD) and its combination with Chinese medicine (acupuncture, formulas, etc) in treating insomnia remains controversial, with varying research conclusions. This study presents a systematic review and meta-analysis of its impact on insomnia.
We conducted a comprehensive search of databases, including PubMed, Embase, Web of Science, and China National Knowledge Infrastructure. Studies meeting the criteria for the insomnia population, intervention, comparison, and outcome were independently screened and data extracted. Fixed- or random-effects models were used to calculate the standardized mean difference and 95% confidence interval (CI). Publication bias and research quality were evaluated to ensure reliability.
BSD was effective in treating method, as shown by improvements in clinical effective rate (risk ratio = 1.16, 95% CI: 1.10-1.23), Pittsburgh Sleep Quality Index (mean standard deviation [MD] = -3.22, 95% CI: -4.41 to - 2.03), Insomnia Severity Index (MD = -5.52, 95% CI: -6.29 to - 4.74), and Athens Insomnia Scale (MD = -1.62, 95% CI: -2.18 to - 1.06) were analyzed. According to the indicators, it has shown good effects in improving the symptoms of patients with insomnia. Compared to Western Medicine, the clinical efficacy of BSD + TCM (MD = 0.16, 95% CI: 0.08-0.24) was more significant than that of BSD alone. For primary insomnia, BSD was more effective (MD=-6.27, 95% CI: -6.43 to - 6.11, P < .0001).
Based on the clinical efficiency index, BSD can effectively improve sleep and quality of life in patients with insomnia, shorten sleep onset time, increase sleep time and efficiency, and alleviate sleep and daytime dysfunction. However, the results should be considered carefully owing to some methodological weaknesses, including study diversity. Future research should employ standardized methods in large-scale, multicenter, randomized controlled trials to confirm these findings.
半夏秫米汤（BSD）及其与中药（针灸、方剂等）联合应用治疗失眠的疗效仍存在争议，研究结论不一。本研究对其治疗失眠的效果进行系统评价和荟萃分析。
我们全面检索了多个数据库，包括PubMed、Embase、Web of Science和中国知网。对符合失眠人群、干预措施、对照和结局标准的研究进行独立筛选并提取数据。采用固定效应或随机效应模型计算标准化均数差和95%置信区间（CI）。评估发表偏倚和研究质量以确保可靠性。
BSD在治疗方法上是有效的，临床有效率提高（风险比=1.16，95%CI：1.10-1.23），匹兹堡睡眠质量指数（平均标准差[MD]=-3.22，95%CI：-4.41至-2.03）、失眠严重程度指数（MD=-5.52，95%CI：-6.29至-4.74）和雅典失眠量表（MD=-1.62，95%CI：-2.18至-1.06）均有改善。根据这些指标，它在改善失眠患者症状方面显示出良好效果。与西药相比，BSD联合中药（MD=0.16，95%CI：0.08-0.24）的临床疗效比单独使用BSD更显著。对于原发性失眠，BSD更有效（MD=-6.27，95%CI：-6.43至-6.11，P<.0001）。
基于临床疗效指标，BSD能有效改善失眠患者的睡眠和生活质量，缩短入睡时间，增加睡眠时间和效率，缓解睡眠及日间功能障碍。然而，由于存在一些方法学上的弱点，包括研究的多样性，这些结果应谨慎考虑。未来的研究应采用标准化方法进行大规模、多中心、随机对照试验以证实这些发现。
