Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.
Department of Dermatology, the Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang 330000, Jiangxi Province, China.
J Integr Med. 2024 May;22(3):270-278. doi: 10.1016/j.joim.2024.03.008. Epub 2024 Mar 16.
Acute gouty arthritis (AGA) is an inflammatory joint disease with a high prevalence. Typical medical interventions, including nonsteroidal anti-inflammatory drugs, colchicine and glucocorticoids, can have serious adverse reactions. Huzhang Granule (HZG), a compound Chinese herbal medicine, has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions. However, the efficacy and safety of HZG in AGA patients remains unknown.
The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: The current study was conducted as a noninferiority, randomized controlled clinical trial on 180 eligible enrolled participants. Participants were randomly assigned into the HZG and etoricoxib groups. Treatments were administered for 5 d, during which the HZG group received HZG and placebo etoricoxib, while the etoricoxib group received etoricoxib and placebo HZG in the same ratio (1:1).
The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window. The pain level was measured via a visual analogue scale, ranging from 0 mm to 100 mm. The secondary outcomes comprised joint tenderness and swelling, reduction of inflammatory biomarkers, and the patient's and investigator's global evaluations of therapeutic response.
The mean reduction in pain was -51.22 mm (95% confidence interval [CI], [-53.42, -49.03] mm) for the HZG and -52.00 mm (95% CI, [-54.06, -49.94] mm) for the etoricoxib groups. The mean difference between the two groups was 0.78 mm (95% CI, [-2.25, 3.81] mm). All additional efficacy endpoints, covering decreased inflammation and pain relief, yielded compelling proof of noninferiority. Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group (4.44% vs 13.33%; P ≤ 0.05).
HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness. The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.
Chinese Clinical Trial Registry (ChiCTR2000036970). Please cite this article as: Wang H, Chen ST, Ding XJ, Kuai L, Hua L, Li X, Wang YF, Zhang M, Li B, Wang RP, Zhou M. Efficacy and safety of Huzhang Granule, a compound Chinese herbal medicine, for acute gouty arthritis: A double-blind, randomized controlled trial. J Integr Med. 2024; 22(3): 270-278.
急性痛风性关节炎（AGA）是一种高发的炎性关节疾病。典型的医学干预措施，包括非甾体抗炎药、秋水仙碱和糖皮质激素，可能会产生严重的不良反应。虎杖颗粒（HZG）是一种复方中药，用于治疗 AGA 已有 30 多年，疗效满意，无明显不良反应。然而，HZG 在 AGA 患者中的疗效和安全性仍不清楚。
本研究旨在评估 HZG 治疗 AGA 患者的疗效和安全性。
设计、地点、参与者和干预措施：本研究是一项非劣效性、随机对照临床试验，共纳入 180 名符合条件的参与者。参与者被随机分为 HZG 组和依托考昔组。治疗持续 5 天，HZG 组给予 HZG 和安慰剂依托考昔，依托考昔组给予依托考昔和等量安慰剂（1:1）。
主要疗效指标为治疗窗第 2 至 5 天患者受累关节的疼痛程度。疼痛程度采用视觉模拟评分法（VAS）测量，范围为 0 至 100 毫米。次要疗效指标包括关节触痛和肿胀、炎症生物标志物的减少以及患者和研究者对治疗反应的总体评估。
HZG 组疼痛缓解均值为-51.22 毫米（95%置信区间[CI]，[-53.42，-49.03]毫米），依托考昔组为-52.00 毫米（95%CI，[-54.06，-49.94]毫米）。两组间的平均差异为 0.78 毫米（95%CI，[-2.25，3.81]毫米）。所有其他疗效终点，包括减轻炎症和疼痛，均证明了非劣效性。HZG 组不良反应发生率明显低于依托考昔组（4.44%比 13.33%；P≤0.05）。
HZG 组和依托考昔组的镇痛效果相似。HZG 的安全性和疗效表明，它可以作为治疗 AGA 的一种潜在治疗选择。
中国临床试验注册中心（ChiCTR2000036970）。请引用本文：Wang H, Chen ST, Ding XJ, Kuai L, Hua L, Li X, Wang YF, Zhang M, Li B, Wang RP, Zhou M. Efficacy and safety of Huzhang Granule, a compound Chinese herbal medicine, for acute gouty arthritis: A double-blind, randomized controlled trial. J Integr Med. 2024; 22(3): 270-278.
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