First Clinical Medical School, Shandong University of Traditional Chinese Medicine, Shandong, China.
Shandong University of Traditional Chinese Medicine, Shandong, China.
Medicine (Baltimore). 2021 Oct 29;100(43):e27608. doi: 10.1097/MD.0000000000027608.
Patients with long-term insomnia generally experience anxiety and depression. Traditional sleeping pills and anti-anxiety drugs have certain limitations. Xiao Yao San (XYS), a complementary and alternative therapy, has been widely used to treat insomnia combined with anxiety. This study aims to evaluate the efficacy and safety of XYS in the treatment of insomnia combined with anxiety.
Related literature was retrieved from 8 electronic databases from the establishment time to March 2021. The subjects were diagnosed with insomnia combined with anxiety. We assessed the methodological quality of randomized controlled trials (RCTs) according to the Cochrane Handbook. Data analysis was conducted using RevMan 5.3 software.
The analysis includes 9 RCTs involving 681 patients. Meta-analysis supported that as an auxiliary drug for Western medicine (WM), XYS could enhance the clinical efficacy of insomnia calculated according to the traditional Chinese medicine (TCM) syndrome score scale (risk ratio [RR]: 1.26; 95% confidence interval [CI]: 1.13-1.43; P = .0002) and reduced the scores of Hamilton Anxiety Scale (mean difference [MD]: -5.19; 95% CI: -7.78 to -2.60; P < .001), Pittsburgh Sleep Quality Index (MD: -3.35; 95% CI: -4.86 to -1.84; P < .001), Self-rating Anxiety Scale (MD: -9.38; 95% CI: -10.20 to -8.75; P < .001), TCM syndrome score scale for insomnia (MD: -4.45; 95% CI: -6.65 to -2.24; P < .001), and TCM syndrome score scale for anxiety (MD: -5.54; 95% CI: -9.48 to -1.6; P = .006). The summary analysis also shows that the separate use of XYS was advantageous in reducing the scores of the Hamilton Anxiety Scale (MD: -3.70; 95% CI: -6.31 to -1.09; P = .005), Pittsburgh Sleep Quality Index (MD: -1.82; 95% CI: -2.39 to -1.24; P < .001), and Self-rating Anxiety Scale (MD: -10.79; 95% CI: -14.09 to -7.49; P < .001). The incidence of adverse events with XYS as an ancillary drug or used separately was lower than that in the WM.
Our systematic evaluation and meta-analysis showed that XYS combined with WM or XYS alone was beneficial for improving sleep quality and relieving anxiety. Due to the low methodological quality, small sample size, and significant heterogeneity of RCTs, more rigorous and scientific clinical trials are required to further evaluate the efficacy and safety of XYS.
CRD42020190613.
长期失眠的患者通常会伴有焦虑和抑郁。传统的安眠药和抗焦虑药物存在一定的局限性。逍遥散（XYS）作为一种补充和替代疗法，已被广泛用于治疗伴有焦虑的失眠。本研究旨在评估 XYS 治疗失眠伴焦虑的疗效和安全性。
从 8 个电子数据库中检索了从建立时间到 2021 年 3 月的相关文献。纳入的研究对象均被诊断为失眠伴焦虑。我们根据 Cochrane 手册评估了随机对照试验（RCT）的方法学质量。使用 RevMan 5.3 软件进行数据分析。
该分析纳入了 9 项 RCT，涉及 681 名患者。荟萃分析支持作为西药（WM）的辅助药物，XYS 可以提高根据中医（TCM）证候评分量表计算的失眠的临床疗效（RR：1.26；95%置信区间 [CI]：1.13-1.43；P =.0002），并降低汉密尔顿焦虑量表（MD：-5.19；95% CI：-7.78 至-2.60；P <.001）、匹兹堡睡眠质量指数（MD：-3.35；95% CI：-4.86 至-1.84；P <.001）、自评焦虑量表（MD：-9.38；95% CI：-10.20 至-8.75；P <.001）、失眠中医证候评分量表（MD：-4.45；95% CI：-6.65 至-2.24；P <.001）和焦虑中医证候评分量表（MD：-5.54；95% CI：-9.48 至-1.6；P =.006）的评分。汇总分析还表明，单独使用 XYS 有利于降低汉密尔顿焦虑量表（MD：-3.70；95% CI：-6.31 至-1.09；P =.005）、匹兹堡睡眠质量指数（MD：-1.82；95% CI：-2.39 至-1.24；P <.001）和自评焦虑量表（MD：-10.79；95% CI：-14.09 至-7.49；P <.001）的评分。XYS 作为辅助药物或单独使用的不良反应发生率低于 WM。
本系统评价和荟萃分析表明，XYS 联合 WM 或单独使用均有利于改善睡眠质量和缓解焦虑。由于 RCT 方法学质量低、样本量小且存在显著异质性，需要更多严格和科学的临床试验来进一步评估 XYS 的疗效和安全性。
PROSPERO 注册号：CRD42020190613。
