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SYSTEMATIC REVIEW article

Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1496774

Efficacy and safety of Xiaoyao San in the treatment of chronic fatigue syndrome: A systematic review and meta-analysis

Provisionally accepted
Qianqian Wang Qianqian Wang 1Guanwen Gong Guanwen Gong 2*Jian Zhou Jian Zhou 1*
  • 1 Nantong Hospital of Traditional Chinese Medicine, Nantong, China
  • 2 Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Liaoning Province, China

The final, formatted version of the article will be published soon.

    Background: Xiaoyao San (XYS) has been increasingly used in China for treating chronic fatigue syndrome (CFS), but its efficacy and safety remain unclear.Objective: 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.Results: 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, I² = 0%) and FS-14 (MD = 1.77, 95% CI: 1.49-2.06, I² = 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 = 4.99, 95% CI: 3.43-6.55, I² = 23%) and SDS (MD = 4.36, 95% CI: 2.64-6.07, I² = 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, I² = 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. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=493084], identifier [CRD42023493084].

    Keywords: Chronic fatigue syndrome, Traditional Chinese medicine, XiaoYao San, Standard biomedical treatments, Systematic review, Meta-analysis CFS, chronic fatigue syndrome, TCM, traditional Chinese medicine, XYS, Xiaoyao San, SBT, standard biomedical treatments, PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, RCT, randomized controlled trial, CDC, the Center for Disease Control, ER, effective rate

    Received: 15 Sep 2024; Accepted: 07 Jan 2025.

    Copyright: © 2025 Wang, Gong and Zhou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Guanwen Gong, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Liaoning Province, China
    Jian Zhou, Nantong Hospital of Traditional Chinese Medicine, Nantong, China

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