Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, 11 Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Affiliated Hospital of Shaanxi University of Chinese Medicine, Shaanxi University of Chinese Medicine, Xianyang, China.
BMC Complement Med Ther. 2024 Jan 4;24(1):21. doi: 10.1186/s12906-023-04328-7.
This study aims to assess the efficacy and safety of Qingpeng ointment (QPO), a Tibetan medicine for alleviating symptoms in individuals with acute gouty arthritis (AGA).
This study was a randomized, double-blind, placebo-controlled trial that involved individuals with AGA whose joint pain, as measured on a visual analog scale (VAS) from 0 to 10, was equal to or greater than 3. The participants were randomly assigned to either the QPO or the placebo group and received their respective treatments twice daily for seven consecutive days. In case of intolerable pain, the participants were allowed to use diclofenac sodium sustained-release tablets as a rescue medicine. The primary outcomes measured were joint pain and swelling, while the secondary outcomes included joint mobility, redness, serum uric acid levels, C-reactive protein levels, and the amount of remaining rescue medicine. Any adverse events that occurred during the trial were also recorded.
A total of 203 cases were divided into two groups, with balanced baselines: 102 in the QPO group and 101 in the placebo group. For joint pain, differences between the groups were notable in the VAS scores [1.75 (0, 3.00) versus 2.00 (1.00, 3.50); P = 0.038], changes in VAS [5.00 (3.00, 6.00) versus 4.00 (2.00, 6.00); P = 0.036], and disappearance rate [26.47% compared to 15.84%; P = 0.046] after treatment. Concerning joint swelling, significant between-group differences were observed in the VAS scores [1.00 (0, 2.30) versus 2.00 (0.70, 3.00); P = 0.032] and disappearance rate [33.33% compared to 21.78%; P = 0.046] at treatment completion. The QPO group exhibited a statistically significant mobility improvement compared to the placebo group (P = 0.004). No significant differences were found in other secondary outcomes. Five patients, four from the QPO group and one from the other, encountered mild adverse events, primarily skin irritation. All of these cases were resolved after dosage reduction or discontinuation of the medication.
Compared to the placebo, QPO exhibits positive effects on AGA by alleviating pain, reducing swelling, and enhancing joint mobility, without causing significant adverse effects.
ISRCTN34355813. Registered on 25/01/2021.
本研究旨在评估青鹏软膏（QPO）治疗急性痛风性关节炎（AGA）患者症状的疗效和安全性。
这是一项随机、双盲、安慰剂对照的临床试验，纳入了关节疼痛评分（VAS）≥3 的 AGA 患者。VAS 评分范围为 0 至 10 分。患者被随机分配至 QPO 组或安慰剂组，每天接受两次治疗，连续治疗 7 天。如果疼痛难以忍受，患者可以使用双氯芬酸钠缓释片作为解救药物。主要结局指标为关节疼痛和肿胀，次要结局指标包括关节活动度、红肿、血尿酸水平、C 反应蛋白水平和剩余解救药物的量。记录试验期间发生的任何不良事件。
共有 203 例患者被分为两组，基线平衡：QPO 组 102 例，安慰剂组 101 例。在 VAS 评分方面，两组之间的关节疼痛差异具有统计学意义[1.75（0，3.00）与 2.00（1.00，3.50）；P=0.038]，VAS 评分变化[5.00（3.00，6.00）与 4.00（2.00，6.00）；P=0.036]，以及治疗后缓解率[26.47%对比 15.84%；P=0.046]。在关节肿胀方面，两组之间 VAS 评分[1.00（0，2.30）与 2.00（0.70，3.00）；P=0.032]和缓解率[33.33%对比 21.78%；P=0.046]存在显著差异。QPO 组与安慰剂组相比，关节活动度改善具有统计学意义（P=0.004）。其他次要结局无显著差异。5 例患者，4 例来自 QPO 组，1 例来自安慰剂组，出现轻度不良反应，主要为皮肤刺激。所有这些病例在减少剂量或停止用药后均得到缓解。
与安慰剂相比，QPO 对 AGA 具有积极作用，可缓解疼痛、减轻肿胀、改善关节活动度，且无明显不良反应。
ISRCTN34355813。注册于 2021 年 1 月 25 日。
