DataSheet2_Chinese herbal medicine for the treatment of chronic fatigue syndrome: A systematic review and meta-analysis.pdf

Objectives: This meta-analysis aimed to assess the effectiveness and safety of Chinese herbal medicine (CHM) in treating chronic fatigue syndrome (CFS).
Methods: Nine electronic databases were searched from inception to May 2022. Two reviewers screened studies, extracted the data, and assessed the risk of bias independently. The meta-analysis was performed using the Stata 12.0 software.
Results: Eighty-four RCTs that explored the efficacy of 69 kinds of Chinese herbal formulas with various dosage forms (decoction, granule, oral liquid, pill, ointment, capsule, and herbal porridge), involving 6,944 participants were identified. This meta-analysis showed that the application of CHM for CFS can decrease Fatigue Scale scores (WMD: –1.77; 95%CI: –1.96 to –1.57; p < 0.001), Fatigue Assessment Instrument scores (WMD: –15.75; 95%CI: –26.89 to –4.61; p < 0.01), Self-Rating Scale of mental state scores (WMD: –9.72; 95%CI:–12.26 to –7.18; p < 0.001), Self-Rating Anxiety Scale scores (WMD: –7.07; 95%CI: –9.96 to –4.19; p < 0.001), Self-Rating Depression Scale scores (WMD: –5.45; 95%CI: –6.82 to –4.08; p < 0.001), and clinical symptom scores (WMD: –5.37; 95%CI: –6.13 to –4.60; p < 0.001) and improve IGA (WMD: 0.30; 95%CI: 0.20–0.41; p < 0.001), IGG (WMD: 1.74; 95%CI: 0.87–2.62; p < 0.001), IGM (WMD: 0.21; 95%CI: 0.14–0.29; p < 0.001), and the effective rate (RR = 1.41; 95%CI: 1.33–1.49; p < 0.001). However, natural killer cell levels did not change significantly. The included studies did not report any serious adverse events. In addition, the methodology quality of the included RCTs was generally not high.
Conclusion: Our study showed that CHM seems to be effective and safe in the treatment of CFS. However, given the poor quality of reports from these studies, the results should be interpreted cautiously. More international multi-centered, double-blinded, well-designed, randomized controlled trials are needed in future research.
Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022319680], identifier [CRD42022319680].

研究目的：本项元分析旨在评估中草药（Chinese herbal medicine, CHM）治疗慢性疲劳综合征（chronic fatigue syndrome, CFS）的有效性与安全性。
研究方法：本研究检索了建库至2022年5月的9个电子数据库。由2名研究者独立完成文献筛选、数据提取及偏倚风险评估。采用Stata 12.0软件进行元分析。
研究结果：最终纳入84项随机对照试验（randomized controlled trials, RCTs），涉及69种不同剂型的中草药方剂（包括汤剂、颗粒剂、口服液、丸剂、软膏剂、胶囊剂及中药粥），共纳入6944名受试者。本元分析结果显示，应用中草药治疗慢性疲劳综合征可显著降低疲劳量表（Fatigue Scale）评分（加权均数差WMD：-1.77；95%置信区间CI：-1.96~-1.57；p<0.001）、疲劳评估量表（Fatigue Assessment Instrument）评分（WMD：-15.75；95%CI：-26.89~-4.61；p<0.01）、精神状态自评量表（Self-Rating Scale of mental state）评分（WMD：-9.72；95%CI：-12.26~-7.18；p<0.001）、焦虑自评量表（Self-Rating Anxiety Scale）评分（WMD：-7.07；95%CI：-9.96~-4.19；p<0.001）、抑郁自评量表（Self-Rating Depression Scale）评分（WMD：-5.45；95%CI：-6.82~-4.08；p<0.001）及临床症状评分（WMD：-5.37；95%CI：-6.13~-4.60；p<0.001），同时可提高免疫球蛋白A（IGA）水平（WMD：0.30；95%CI：0.20~0.41；p<0.001）、免疫球蛋白G（IGG）水平（WMD：1.74；95%CI：0.87~2.62；p<0.001）、免疫球蛋白M（IGM）水平（WMD：0.21；95%CI：0.14~0.29；p<0.001）及临床有效率（effective rate）（相对危险度RR=1.41；95%CI：1.33~1.49；p<0.001）。但自然杀伤细胞（natural killer cell）水平无显著变化。纳入研究均未报告严重不良事件。此外，纳入的随机对照试验方法学质量普遍偏低。
研究结论：本研究结果表明，中草药用于慢性疲劳综合征的治疗似乎兼具有效性与安全性。但鉴于纳入研究的报告质量欠佳，需谨慎解读本研究结果。未来仍需开展更多国际多中心、双盲、设计严谨的随机对照试验。
系统评价注册信息：[https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022319680]，注册标识[CRD42022319680]。