OBJECTIVE: To assess the effectiveness and safety of CHM for the treatment of post-viral fatigue.
METHODS: Systematic review and meta-analysis of randomized controlled trials (RCTs).
METHODS: The protocol of this systematic review was registered on PROSPERO (CRD42022380356). Trials reported changes of fatigue symptom, which compared CHM to no treatment, placebo or drugs, were included. Six electronic databases and three clinical trial registration platforms were searched from inception to November 2023. Literature screening, data extraction, and risk bias assessment were independently carried out by two reviewers. Quality of the included trials was evaluated using Cochrane risk of bias tool, and the certainty of the evidence was evaluated using GRADE. The meta-analysis was performed using Review Manager 5.4, mean difference (MD) and its 95% confidence interval (CI) was used for estimate effect of continuous data. Heterogeneity among trials was assessed through I2 value.
RESULTS: Overall, nineteen studies with 1921 patients were included. Results of individual trial or meta-analysis showed that CHM was better than no treatment (MD = -0.80 scores, 95%CI -1.43 to -0.17 scores, P = 0.01, 60 participants, 1 trial), placebo (MD = -1.90 scores, 95%CI -2.38 to -1.42 scores, P<0.00001, 184 participants, 1 trial), placebo on basis of rehabilitation therapy (MD = -14.90 scores, 95%CI -24.53 to -5.27 scores, P = 0.02, 118 participants, 1 trial) or drugs (MD = -0.38 scores, 95%CI -0.48 to -0.27 scores, I2 = 0%, P<0.00001, 498 participants, 4 trials) on relieving fatigue symptoms assessing by Traditional Chinese Medicine fatigue scores. Trials compared CHM plus drugs to drugs alone also showed better effect of combination therapy (average MD = -0.56 scores). In addition, CHM may improve the percentage of CD4 T lymphocytes and reduce the level of serum IL-6 (MD = -14.64 scores, 95%CI 18.36 to -10.91 scores, I2 = 0%, P<0.00001, 146 participants, 2 trials).
CONCLUSIONS: Current systematic review found that the participation of CHM can improve the symptoms of post-viral fatigue and some immune indicators. However, the safety of CHM remains unknown and large sample, high quality multicenter RCTs are still needed in the future.
目的:评估CHM治疗病毒性疲劳的有效性和安全性。
方法:随机对照试验(RCTs)的系统评价和荟萃分析。
方法:本系统综述的方案在PROSPERO(CRD42022380356)上注册。试验报告了疲劳症状的变化,将CHM与不治疗进行比较,安慰剂或药物,包括在内。从成立到2023年11月,搜索了六个电子数据库和三个临床试验注册平台。文学筛选,数据提取,风险偏差评估由两名评审员独立进行。使用Cochrane偏倚风险工具评估纳入试验的质量,并使用GRADE评估证据的确定性。使用ReviewManager5.4进行荟萃分析,平均差异(MD)及其95%置信区间(CI)用于估计连续数据的效果。通过I2值评估试验之间的异质性。
结果:总体而言,19项研究纳入1921例患者.个体试验或荟萃分析的结果表明,CHM优于不治疗(MD=-0.80分,95CI-1.43至-0.17分,P=0.01,60名参与者,1审判),安慰剂(MD=-1.90分,95CI-2.38至-1.42分,P<0.00001,184名参与者,1审判),基于康复治疗的安慰剂(MD=-14.90分,95CI-24.53至-5.27分,P=0.02,118名参与者,1个试验)或药物(MD=-0.38分,95CI-0.48至-0.27分,I2=0%,P<0.00001,498名参与者,4项试验)通过中医疲劳评分评估缓解疲劳症状。将CHM加药物与单独药物进行比较的试验也显示出联合治疗的更好效果(平均MD=-0.56评分)。此外,CHM可以提高CD4T淋巴细胞的百分比并降低血清IL-6的水平(MD=-14.64分,95CI18.36至-10.91得分,I2=0%,P<0.00001,146名参与者,2试验)。
结论:目前的系统评价发现,CHM的参与可以改善病毒后疲劳的症状和一些免疫指标。然而,CHM的安全性仍然未知,样本大,未来仍需要高质量的多中心RCT。