Wang Qianqian, Zhou Jian, Gong Guanwen
Department of Preventive Treatment of Diseases, Nantong Hospital of Traditional Chinese Medicine, Nantong, China.
Department of General Surgery, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Front Pharmacol. 2025 Feb 6;16:1496774. doi: 10.3389/fphar.2025.1496774. eCollection 2025.
Xiaoyao San (XYS) has been increasingly used in China for treating chronic fatigue syndrome (CFS), but its efficacy and safety remain unclear.
To systematically evaluate the efficacy and safety of XYS compared to standard biomedical treatments (SBT) in CFS patients.
A comprehensive search of English and Chinese databases was conducted up to December 2024. Eligible studies included randomized controlled trials comparing XYS or XYS + SBT to SBT alone. Primary outcomes were effective rate (ER) and fatigue scale-14 (FS-14). Secondary outcomes included self-rating anxiety scale (SAS), self-rating depression scale (SDS), and adverse events (AEs). Data were analyzed using Review Manager 5.4, and evidence quality was assessed using the GRADE approach.
Six studies involving 623 patients were included. The meta-analysis showed that XYS-based interventions significantly improved ER (RR = 1.27, 95% CI: 1.18-1.37, I = 0%) and FS-14 (MD = 1.77, 95% CI: 1.49-2.06, I = 54%). Subgroup analyses confirmed consistent efficacy for both XYS vs. SBT and XYS + SBT vs. SBT. Anxiety and depression improved significantly in the XYS + SBT group, with SAS (MD = 5.16, 95% CI: 3.84-6.48, I = 24%) and SDS (MD = 4.62, 95% CI: 3.15-6.09, I = 0%). Additionally, the risk of AEs was significantly reduced in the XYS + SBT group compared to SBT alone (RR = 0.48, 95% CI: 0.32-0.72, I = 0%). However, the quality of evidence was rated "low" due to risk of bias and potential publication bias among the studies.
XYS, whether alone or with SBT, is effective and safe for improving ER, fatigue, anxiety, and depression in CFS patients. However, due to the low quality of the evidence, results should be interpreted cautiously. High-quality RCTs with larger sample sizes and longer follow-up are needed to provide stronger evidence for the clinical use of XYS in managing CFS.
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=493084, identifier CRD42023493084.
逍遥散（XYS）在中国越来越多地用于治疗慢性疲劳综合征（CFS），但其疗效和安全性仍不明确。
系统评价逍遥散与标准生物医学治疗（SBT）相比在CFS患者中的疗效和安全性。
截至2024年12月，对英文和中文数据库进行了全面检索。符合条件的研究包括将逍遥散或逍遥散+SBT与单纯SBT进行比较的随机对照试验。主要结局为有效率（ER）和疲劳量表-14（FS-14）。次要结局包括自评焦虑量表（SAS）、自评抑郁量表（SDS）和不良事件（AE）。使用Review Manager 5.4进行数据分析，并使用GRADE方法评估证据质量。
纳入6项研究，共623例患者。荟萃分析表明，以逍遥散为基础的干预措施显著提高了有效率（RR = 1.27，95%CI：1.18 - 1.37，I² = 0%）和FS-14（MD = 1.77，95%CI：1.49 - 2.06，I² = 54%）。亚组分析证实逍遥散与SBT以及逍遥散+SBT与SBT相比疗效一致。逍遥散+SBT组的焦虑和抑郁明显改善，SAS（MD = 5.16，95%CI：3.84 - 6.48，I² = 24%）和SDS（MD = 4.62，95%CI：3.15 - 6.09，I² = 0%）。此外，与单纯SBT相比，逍遥散+SBT组不良事件的风险显著降低（RR = 0.48，95%CI：0.32 - 0.72，I² = 0%）。然而，由于研究中存在偏倚风险和潜在的发表偏倚，证据质量被评为“低”。
逍遥散单独使用或与SBT联合使用，对于改善CFS患者的有效率、疲劳、焦虑和抑郁是有效且安全的。然而，由于证据质量较低，结果应谨慎解释。需要开展样本量更大、随访时间更长的高质量随机对照试验，为逍遥散在管理CFS中的临床应用提供更有力的证据。
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=493084，标识符CRD42023493084 。
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