Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, 11 Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, 102499, China.
Trials. 2022 May 12;23(1):387. doi: 10.1186/s13063-022-06338-1.
Acute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. The use of recommended first-line treatment agents for AGA may be limited by adverse events. There has been a traditional use of alternative therapies for AGA. Tibetan medicine Qingpeng ointment is one of the on-market herbal products used for symptom relief of AGA. Previous clinical studies indicated that Qingpeng ointment can relieve pain, swelling, redness, and dysfunction of joints in patients with AGA. However, there is no rigorous randomized trial to demonstrate its benefit for AGA. In order to evaluate the efficacy and safety of Qingpeng ointment for AGA, we designed a randomized controlled trial.
This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Two hundred and six adults with acute flare of gout, and visual analogue scale (VAS) score of joint pain ≥ 3 points will be recruited. Participants will be randomly assigned to herbal treatment or placebo group at a ratio of 1:1. Qingpeng ointment, or equal placebo ointment, will be applied topically at involved joints twice a day for consecutive 7 days. Patients in both groups would be allowed giving diclofenac sodium sustained-release tablets as rescue therapy when VAS score of joint pain ≥ 7 points during the treatment. The primary outcomes will be joint pain measured by VAS score, and joint swelling measured using width and thickness of affected joints and VAS score. Other outcome measures will be joint mobility, joint redness, C-reactive protein, serum uric acid, and the use of rescue medicine as well as adverse effect.
To the best of our knowledge, this study is the first multi-center, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy of Tibetan medicine Qingpeng ointment for AGA. The findings of this study would provide evidence for its use to relieve symptoms of AGA.
ISRCTN ISRCTN34355813 . Registered on 25 January 2021.
急性痛风性关节炎（AGA）是一种炎症性关节炎，其临床特征为关节剧烈疼痛、肿胀和活动受限，可能导致身体残疾和生活质量下降。由于不良反应，AGA 的推荐一线治疗药物的使用可能会受到限制。传统上也有替代疗法用于 AGA。藏药青鹏软膏是一种市售的草药产品，用于缓解 AGA 的症状。先前的临床研究表明，青鹏软膏可以缓解 AGA 患者关节的疼痛、肿胀、发红和功能障碍。然而，目前尚无严格的随机试验来证明其对 AGA 的益处。为了评估青鹏软膏治疗 AGA 的疗效和安全性，我们设计了一项随机对照试验。
本研究设计为多中心、随机、双盲、安慰剂对照试验。将招募 206 名急性痛风发作且关节疼痛视觉模拟评分（VAS）≥3 分的成年人。参与者将按 1:1 的比例随机分配到草药治疗组或安慰剂组。青鹏软膏或等量安慰剂软膏将每天两次涂于受累关节，连续 7 天。在治疗过程中，如果 VAS 评分的关节疼痛≥7 分，两组患者均可给予双氯芬酸钠缓释片作为解救治疗。主要结局指标为 VAS 评分测量的关节疼痛，以及使用受累关节的宽度和厚度以及 VAS 评分测量的关节肿胀。其他结局指标包括关节活动度、关节发红、C 反应蛋白、血清尿酸以及解救药物的使用情况和不良反应。
据我们所知，这是第一项评估藏药青鹏软膏治疗 AGA 的多中心、随机、双盲、安慰剂对照临床试验。该研究的结果将为其缓解 AGA 症状提供证据。
ISRCTN ISRCTN34355813。于 2021 年 1 月 25 日注册。
