The efficacy and safety of Simiao Xiaobi decoction on rheumatoid arthritis: A systematic review and meta‑analysis

IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Soo-Yeon Chae , Seo-Hyun Park , Joo-Hee Kim , Eun-Jung Kim , Byung-Kwan Seo , Seong-Sik Park , Won-Suk Sung
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引用次数: 0

Abstract

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.

四髎消痹汤治疗类风湿关节炎的疗效和安全性:系统评价和荟萃分析
四髎消痹汤是一种治疗类风湿性关节炎的中药方剂。本荟萃分析旨在系统评估与常规治疗相比,SXD的治疗效果和安全性。方法检索12个全球数据库,检索自成立以来至2023年8月期间,与SXD治疗RA和比较非手术常规治疗(如药物治疗)的随机对照试验(rct)。疾病活动性的主要指标是有效率(ER)、关节疼痛评分(JPS)、关节肿胀评分(JSS)和晨僵(MS),次要指标是实验室炎症标志物和不良事件。使用Review Manager以95%可信区间(CI)的风险比(RR)或平均差(MD)表示疗效。采用Cochrane“偏倚风险”工具和推荐评估、发展和评价分级(GRADE)评估偏倚风险和证据质量。结果共纳入16项随机对照试验,共1749例患者。与常规治疗相比,SXD单一疗法显著提高ER (RR = 1.34,95%可信区间(1.26,1.43),14个相关,n = 1578),译本(MD = -1.00,95%可信区间[-1.33,-0.68],4相关,n = 327),js (MD = -1.59,95%可信区间[-2.12,-1.05],4相关,n = 327),女士(MD = -0.39,95%可信区间(-0.59,-0.18),6个相关,n = 525),和实验室结果,SXD附加疗法显著提高ER (RR = 1.22,95%可信区间(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/或不一致性的一些担忧,对于内质性脑炎,SXD单药治疗的证据确定性为中等,对于JPS和JSS,证据确定性为低,对于MS,证据确定性为低,对于SXD附加治疗的证据确定性为低。此外,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rct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。
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来源期刊
European Journal of Integrative Medicine
European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
4.70
自引率
4.00%
发文量
102
审稿时长
33 days
期刊介绍: The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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