Department of Rheumatism, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200021, China.
Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Trials. 2021 Nov 3;22(1):764. doi: 10.1186/s13063-021-05579-w.
Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with the primary clinical symptoms of joint swelling and pain. Early detection of erosion and synovial inflammation at an active stage resulting from RA can prevent damage to the joints and activity restriction. However, there are still many patients who do not respond to these treatments; the development of newer, safer drugs is urgently needed. Compared to Western medicine, Guizhi-Shaoyao-Zhimu decoction has equal or higher efficacy and safety for RA patients. With the widespread use of musculoskeletal ultrasound (MSUS), this technology holds great value for the degree of joint damage in RA patients, guiding the clinical selection of treatments, and assessing of prognosis. Therefore, we designed a double-blinded randomized controlled clinical trial to measure the safety and efficacy of Guizhi-Shaoyao-Zhimu decoction in treating early-stage RA using MSUS.
This study is a randomized, double-blinded, parallel group, placebo-controlled trial. A total of 152 adult participants with early RA will be enrolled, with balanced treatment allocation (1:1). The experimental intervention will be Guizhi-Shaoyao-Zhimu decoction plus the conventional medicine methotrexate and the control intervention will be placebo plus the conventional drug methotrexate for 3 months. In addition, both groups will receive folic acid during treatment to prevent side effects from methotrexate. The primary outcomes are the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), hepatic and renal function, visual analog scale, disease activity score in 28 joints, measurement scale for TCM symptoms, and 7-joint ultrasound score.
We designed this double-blinded randomized controlled clinical trial to evaluate the efficacy and safety of Guizhi-Shaoyao-Zhimu decoction in RA patients using MSUS. The results of this trial may provide insights into how to improve the clinical symptoms of RA patients and delay further joint destruction. We hope that this trial may provide preliminary evidence of the efficacy of Guizhi-Shaoyao-Zhimu decoction in treating RA patients and that these results aid researchers, practitioners, and patients alike.
The main aim of the study is to clarify the efficacy and safety of Guizhi-Shaoyao-Zhimu decoction in patients with early RA.
Chinese Clinical Trials Register ChiCTR2000036141 . Registered on 21 August 2020 (retroactively registered).
类风湿关节炎（RA）是一种慢性炎症性自身免疫性疾病，其主要临床症状为关节肿胀和疼痛。早期发现 RA 引起的侵蚀和滑膜炎症的活动期，可预防关节损伤和活动受限。然而，仍有许多患者对这些治疗无反应，因此迫切需要开发更新、更安全的药物。与西药相比，桂枝芍药知母汤治疗 RA 患者具有同等或更高的疗效和安全性。随着肌肉骨骼超声（MSUS）的广泛应用，该技术对 RA 患者关节损伤程度具有重要价值，可指导临床治疗选择和预后评估。因此，我们设计了一项双盲随机对照临床试验，使用 MSUS 测量桂枝芍药知母汤治疗早期 RA 的安全性和疗效。
本研究为随机、双盲、平行分组、安慰剂对照试验。共纳入 152 例成人早期 RA 患者，采用均衡治疗分配（1:1）。实验组为桂枝芍药知母汤联合常规药物甲氨蝶呤，对照组为安慰剂联合常规药物甲氨蝶呤，治疗 3 个月。此外，两组在治疗过程中均给予叶酸以预防甲氨蝶呤的副作用。主要结局指标为红细胞沉降率（ESR）、C 反应蛋白（CRP）、肝肾功能、视觉模拟评分、28 关节疾病活动评分、中医症状测量量表和 7 关节超声评分。
我们设计了这项双盲随机对照临床试验，使用 MSUS 评估桂枝芍药知母汤治疗 RA 患者的疗效和安全性。该试验结果可能为改善 RA 患者的临床症状和延缓进一步关节破坏提供思路。我们希望该试验能为桂枝芍药知母汤治疗 RA 患者的疗效提供初步证据，并为研究人员、临床医生和患者提供参考。
本研究的主要目的是明确桂枝芍药知母汤治疗早期 RA 患者的疗效和安全性。
中国临床试验注册中心 ChiCTR2000036141 [注册号]。于 2020 年 8 月 21 日注册（追溯注册）。
