Li Ming, Zhou Boyang, Zhou Lihong, Li Linfeng
Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Evid Based Complement Alternat Med. 2021 Mar 17;2021:6693268. doi: 10.1155/2021/6693268. eCollection 2021.
Runzao Zhiyang capsule (RZC), an oral Chinese herbal medicine, has been widely used for chronic eczema in China for many years. This study aims to evaluate the efficacy and safety of RZC as an add-on therapy to conventional treatment for chronic eczema.
Randomized controlled trials (RCTs) assessing the efficacy and safety of RZC as an add-on therapy for chronic eczema were retrieved from eight literature databases from their inception to 31 August, 2020, including CNKI, WanFang, VIP, Sinomed, PubMed, Cochrane Library, Web of Science, and Embase. The Cochrane risk of bias tool was used to assess the methodological quality of the included studies. The data were analyzed by RevMan5.3 software.
A total of 18 RCTs involving 1896 patients with chronic eczema were included. Compared with no oral treatment, RZC was superior on the total efficacy rate (TER) (RR = 1.45, 95% CI: 1.23 to 1.72, < 0.0001), Eczema Area and Severity Index (EASI) (MD = -0.73, 95% CI: -0.90 to -0.56, < 0.00001), and Visual Analogue Scale (VAS) for pruritus (MD = -2.76, 95%CI: -4.53 to -0.99, =0.002). Similar results were also seen in a randomized, placebo-controlled trial. Compared with the antihistamine (AH) group, TER in the RZC combined with AH group was significantly higher (RR = 1.32, 95% CI: 1.21 to 1.43, < 0.00001), and the EASI score (MD = -0.29, 95% CI: -0.38 to -0.20, < 0.001), the VAS score (MD = -0.19, 95% CI: -0.23 to -0.15, < 0.00001), and the level of serum total IgE (MD = -9.83 ng/ml, 95% CI: -11.66 to -8.00 ng/ml, < 0.00001) decreased more significantly in the RZC combined with AH group. In terms of safety, mild gastrointestinal diseases occurred more frequently in the RZC group, and no serious adverse effect was reported.
RZC as an add-on therapy to conventional treatment shows good effects on chronic eczema, and there is no severe side effect from short-term use of RZC. However, due to suboptimal quality of the included studies, more large-sample and high-quality RCTs are needed to improve the evidence quality.
润燥止痒胶囊(RZC)是一种口服中药,多年来在中国已广泛用于治疗慢性湿疹。本研究旨在评估RZC作为慢性湿疹常规治疗附加疗法的疗效和安全性。
从8个文献数据库(包括中国知网、万方、维普、中国生物医学文献数据库、PubMed、考克兰图书馆、科学引文索引和Embase)中检索自数据库建库至2020年8月31日评估RZC作为慢性湿疹附加疗法疗效和安全性的随机对照试验(RCT)。采用考克兰偏倚风险工具评估纳入研究的方法学质量。数据采用RevMan5.3软件进行分析。
共纳入18项RCT,涉及1896例慢性湿疹患者。与未进行口服治疗相比,RZC在总有效率(TER)(RR = 1.45,95%CI:1.23至1.72,P < 0.0001)、湿疹面积和严重程度指数(EASI)(MD = -0.73,95%CI:-0.90至-0.56,P < 0.00001)以及瘙痒视觉模拟量表(VAS)(MD = -2.76,95%CI:-4.53至-0.99,P = 0.002)方面更具优势。在一项随机、安慰剂对照试验中也观察到了类似结果。与抗组胺药(AH)组相比,RZC联合AH组的TER显著更高(RR = 1.32,95%CI:1.21至1.43,P < 0.00001),且RZC联合AH组的EASI评分(MD = -0.29,95%CI:-0.38至-0.20,P < 0.001)、VAS评分(MD = -0.19,95%CI:-0.23至-0.15,P < 0.00001)以及血清总IgE水平(MD = -9.83 ng/ml,95%CI:-11.66至-8.00 ng/ml,P < 0.00001)下降更显著。在安全性方面,RZC组轻度胃肠道疾病发生频率更高,未报告严重不良反应。
RZC作为常规治疗的附加疗法对慢性湿疹显示出良好效果,且短期使用RZC无严重副作用。然而,由于纳入研究质量欠佳,需要更多大样本、高质量的RCT来提高证据质量。