Evaluating the therapeutic efficacy of the Chinese herbal medicine Yishen Tongbi decoction in patients with active rheumatoid arthritis: protocol for a randomized, controlled, noninferiority trial
Evaluating the therapeutic efficacy of the Chinese herbal medicine Yishen Tongbi decoction in patients with active rheumatoid arthritis: protocol for a randomized, controlled, noninferiority trial
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评价中草药益肾痛痹汤对活动性类风湿关节炎患者的治疗效果：随机、对照、非劣效性试验方案
DOI：
10.1186/s13063-019-4005-0
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发表时间：
2019-12
期刊：
影响因子：
2.5
通讯作者：
Chen Guangxing
中科院分区：
文献类型：
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作者：
Zhao lianyu;Li Meiling;Xu Yanping;Zhang Mingying;Chen Guangxing
背景类风湿性关节炎（RA）是一种常见的慢性自身免疫性疾病，因关节损伤而严重影响患者的生活质量。目前，类风湿性关节炎的治疗主要是疾病缓解抗风湿药物（DMARDs）或生物制剂;然而，它们在某些患者中的疗效有限。因此，需要开发额外的治疗策略。益肾通痹汤是目前国内广泛应用于治疗类风湿关节炎的中药方剂。然而，目前还没有足够的证据推荐其用于治疗RA。因此，我们的目的是验证益肾通痹汤治疗类风湿关节炎的疗效的非劣效性试验，并提供了一个全面的临床试验，其使用的依据。方法/设计100例符合条件的RA患者将被随机分为两组，每组50例。一组用益肾通痹汤和安慰剂代替甲氨蝶呤（MTX），另一组用MTX和安慰剂代替益肾通痹汤。疼痛视觉模拟量表评分大于40 mm的患者将接受非甾体抗炎药（如肠溶双氯芬酸钠，25 mg，每日三次）给药;将记录所有药物给药情况。将在基线和治疗开始后4、12和24周评估患者的临床指标及其疾病活动。疗效的主要结局将是治疗后24周根据临床疾病活动指数评分显示良好缓解的患者比例。讨论中医理论和现代西医研究均证实了益肾通痹汤治疗类风湿关节炎的疗效。以往的临床观察和动物模型药效试验均证明益肾通痹汤治疗类风湿关节炎疗效显著。鉴于益肾通痹汤治疗类风湿关节炎的潜在益处，我们设计了这项双盲、前瞻性、随机对照试验，试验结果和结论将在研究完成后发表。于2019年8月3日注册。
BackgroundRheumatoid arthritis (RA) is a common chronic autoimmune disease that seriously affects the quality of life of patients because of damage to joints. Presently, RA is mainly treated with disease-modifying antirheumatic drugs (DMARDs) or biological agents; however, they offer limited efficacy in some patients. Therefore, additional therapeutic strategies need to be developed. Yishen Tongbi decoction is a traditional Chinese medicine formulation widely used to treat RA in China. However, currently, there is insufficient evidence to recommend its use for the treatment of RA. Therefore, we aim to verify the efficacy of Yishen Tongbi decoction to treat RA by a noninferiority trial, and to provide a basis for its use with a full-scale clinical trial.Methods/designOne hundred eligible patients with RA will be randomized into two groups of 50 patients. One group will receive Yishen Tongbi decoction and placebo replacing methotrexate (MTX), while the other group will receive MTX and placebo replacing Yishen Tongbi decoction. Patient’s whose visual analogue scale score for pain is greater than 40 mm will be administered nonsteroidal anti-inflammatory drugs (such as enteric-coated diclofenac sodium, 25 mg three times a day); administration of all medications will be recorded. The clinical indicators of patients and their disease activity will be assessed at baseline and at 4, 12 and 24 weeks after treatment initiation. The primary outcome of efficacy will be the proportion of patients who demonstrate a favourable response based on their Clinical Disease Activity Index score at 24 weeks after treatment. All adverse events will be reported.DiscussionTraditional Chinese medicine theory and modern western medicine research have identified the efficacy of Yishen Tongbi decoction to treat RA. Previous clinical observation and efficacy trials of Yishen Tongbi decoction in animal models for the treatment of RA has demonstrated significant effect. Because of the potential benefits of Yishen Tongbi decoction in the treatment of patients with RA, we designed this double-blind, prospective, randomized controlled trial; the results and conclusions of the trail will be published after the completion of the study.Trial registrationChinese Clinical Trials Registry, ChiCTR1900024902. Registered on 3 August 2019.
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DOI：
10.3390/molecules22091469
发表时间：
2017-09-05
期刊：
Molecules (Basel, Switzerland)
影响因子：
--
作者：
Chen B;Wang L;Li L;Zhu R;Liu H;Liu C;Ma R;Jia Q;Zhao D;Niu J;Fu M;Gao S;Zhang D
通讯作者：
Zhang D
影响因子：
5.3
作者：
通讯作者：
--
影响因子：
27.4
作者：
T.N. Somasinghe-;B. Clarke;S. Panthakalam
通讯作者：
T.N. Somasinghe-;B. Clarke;S. Panthakalam
影响因子：
5.4
作者：
Wang, Jian-Ying;Yuan, Ying;Yang, Yong-Qing
通讯作者：
Yang, Yong-Qing
影响因子：
10.7
作者：
通讯作者：
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