Introduction

Simiao Xiaobi decoction (SXD) is a traditional Chinese medicine (TCM) formula that has been clinically applied for rheumatoid arthritis (RA). This meta-analysis aimed to systematically assess the therapeutic efficacy and safety of SXD compared to conventional therapy.

Methods

Twelve worldwide databases were searched for randomized controlled trials (RCTs) of treating RA with SXD and comparing non-operative conventional treatments (e.g., medication) from inception to August 2023. Primary outcomes for disease activity were effective rate (ER), joint pain score (JPS), joint swelling score (JSS), and morning stiffness (MS), and secondary outcome measures were laboratory inflammation markers and adverse events. The efficacy was presented as the risk ratio (RR) or mean difference (MD) with 95 % confidence interval (CI) using Review Manager. Risk of bias and the quality of evidence were assessed by using Cochrane “risk of bias” tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE).

Results

A total of 16 RCTs involving 1,749 patients were included. Compared with conventional treatments, SXD monotherapy significantly improved the ER (RR = 1.34, 95 % CI [1.26, 1.43], 14 RCTs, n = 1,578), JPS (MD = -1.00, 95 % CI [–1.33, –0.68], 4 RCTs, n = 327), JSS (MD = -1.59, 95 % CI [–2.12, –1.05], 4 RCTs, n = 327), MS (MD = -0.39, 95 % CI [–0.59, –0.18], 6 RCTs, n = 525), and laboratory results, and SXD add-on therapy significantly improved the ER (RR = 1.22, 95 % CI [1.00, 1.49], 1 RCT, n = 70). Due to some concerns with risk of bias, small sample sizes, and/or inconsistency, the certainty of evidence for SXD monotherapy was moderate for ER, low for JPS and JSS, very low for MS, and very low for SXD add-on therapy. There were fewer cases of adverse events in the SXD group.

Conclusion

Our findings suggest that SXD can be a complementary treatment option. However, the methodological quality of the included RCTs was unsatisfactory, so further high-quality research is needed to confirm our results.

中文翻译：

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四妙消痹汤治疗类风湿性关节炎的疗效和安全性：系统评价和荟萃分析

介绍

四妙消痹汤（SXD）是临床应用于治疗类风湿性关节炎（RA）的中药方剂。这项荟萃分析旨在系统评估 SXD 与传统疗法相比的治疗功效和安全性。

方法

检索了全球 12 个数据库，寻找从开始到 2023 年 8 月用 SXD 治疗 RA 的随机对照试验 (RCT)，并比较非手术常规治疗（例如药物治疗）。疾病活动性的主要结局是有效率 (ER)、关节疼痛评分（JPS）、关节肿胀评分（JSS）和晨僵（MS），次要结果指标是实验室炎症标志物和不良事件。使用 Review Manager 将疗效表示为风险比 (RR) 或平均差 (MD)，置信区间 (CI) 为 95%。使用 Cochrane“偏倚风险”工具和建议评估、制定和评估分级 (GRADE) 评估偏倚风险和证据质量。

结果

总共纳入了 16 项随机对照试验，涉及 1,749 名患者。与传统治疗相比，SXD 单药治疗显着改善 ER（RR = 1.34，95 % CI [1.26，1.43]，14 项 RCT，n  = 1,578）、JPS（MD = -1.00，95 % CI [–1.33，–0.68]） , 4 个 RCT, n  = 327), JSS (MD = -1.59, 95 % CI [–2.12, –1.05], 4 个 RCT, n  = 327), MS (MD = -0.39, 95 % CI [–0.59, – 0.18]，6 个随机对照试验，n  = 525）和实验室结果，SXD 附加治疗显着改善了 ER（RR = 1.22，95% CI [1.00, 1.49]，1 个随机对照试验，n  = 70）。由于对偏倚风险、小样本量和/或不一致的担忧，SXD 单一疗法的证据质量对于 ER 为中等，对于 JPS 和 JSS 为低，对于 MS 为非常低，对于 SXD 附加治疗为非常低。SXD 组的不良事件较少。

结论

我们的研究结果表明 SXD 可以作为一种补充治疗选择。然而，纳入的随机对照试验的方法学质量并不令人满意，因此需要进一步的高质量研究来证实我们的结果。