Review Efficacy and safety of Xiaoyao San in the treatment of chronic fatigue syndrome: a systematic review and meta-analysis 2025 Wang et al

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.

Methods: 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 = 5.16, 95% CI: 3.84–6.48, I2 = 24%) and SDS (MD = 4.62, 95% CI: 3.15–6.09, 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.

Conclusion: 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.

Open access

 

They should take their own advice for the first sentence.

 

Ah, good old evidence-based medicine, where a completely ridiculous statement like this is not only normal, but almost a universal standard. It's really amazing how health care is the only industry where something like this can occur. Because in all other industries everyone would look at a proposal to use something without any evidence with a concerned "uh, are you OK? do you need an extended vacation?" look and prompt dismissal.

But here? Perfectly normal. And not because it's TCM, actually they are borrowing from the EBM playbook and applying it exactly as it is commonly practiced. In fact this would likely get a moderate rating from applying GRADE, depending on what the people doing the grading think of TCM. Because in the end it's literally the only thing that matters: what people think of the treatment and its rationale. Evidence is entirely irrelevant to the process, it goes whichever way the cultural beliefs go.