Department of Geriatrics of the Affiliated Hospital, North Sichuan Medical College, Nanchong.
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Medicine (Baltimore). 2021 Jan 22;100(3):e23699. doi: 10.1097/MD.0000000000023699.
Gouty arthritis (GA) is a chronic disease caused by monosodium urate crystal deposition. Repeated attacks of arthritis may lead to the deposition of urate to form gout stone, resulting in joint deformity and joint damage. Although GA is not fatal, it causes low work productivity and low quality of life. Western drug, such as febuxostat, colchicine, allopurinol, often cannot get satisfying curative effect, and may even lead to serious side effects, such as exfoliative dermatitis or uremia. However, the therapeutic effect of Traditional Chinese medicine is very satisfactory. The treatment effect of simiao powder, a Chinese patent medicine, combined with acupuncture was widely used on treatment of GA. Although it has been widely used in clinical practice, its relative effectiveness and safety have not been confirmed. Therefore, this study will use meta-analysis to verify the efficacy and safety of simiao powder combined with acupuncture in the treatment of GA.
All randomized controlled trial of simiao powder combined with acupuncture for the treatment of RA from their inception 29 October, 2020 will be searched form the China National Knowledge Infrastructure, Wanfang Database, Chinese Science and Technology Periodical Database, Chinese Biomedical Literature Database, Pubmed, Embase, Web of Science, and the Cochrane library. Two authors will independently select studies, extract data based on pre-designed inclusion and exclusion criteria. Methodological quality assessment and risk of bias will be assessed using Cochrane bias risk tool. All data analysis will be conducted using Revman5.3, WinBUGS 1.4.3, and Stata14.2 software.
We will compare the different outcome indicators of various studies to provide a synthesis of the efficacy and safety of Simiao powder combined with acupuncture for GA patients. The main outcome measures included efficacy, remission rate (no drug symptoms), recurrence rate, clinical absolute score and relative score. Secondary outcome measures included related adverse reactions and uric acid concentration.
The findings of the study will provide helpful evidence for the efficacy and safety of simiao powder combined with acupuncture in the treatment of GA.
This study protocol have been funded through a protocol registry. The registry number is INPLASY2020110028.
痛风性关节炎(GA)是一种由单钠尿酸盐晶体沉积引起的慢性疾病。关节炎反复发作可导致尿酸盐沉积形成痛风石,导致关节畸形和关节损伤。虽然 GA 不是致命的,但会导致工作生产率降低和生活质量下降。西药,如非布司他、秋水仙碱、别嘌醇,往往不能达到满意的疗效,甚至可能导致严重的副作用,如剥脱性皮炎或尿毒症。然而,中药的治疗效果非常令人满意。中药复方四妙散联合针刺治疗 GA 的疗效广泛应用。虽然它已在临床实践中广泛应用,但它的相对疗效和安全性尚未得到证实。因此,本研究将采用荟萃分析验证四妙散联合针刺治疗 GA 的疗效和安全性。
从 2020 年 10 月 29 日起,检索中国知网、万方数据库、中国科技期刊数据库、中国生物医学文献数据库、PubMed、Embase、Web of Science 和 Cochrane 图书馆中所有关于四妙散联合针刺治疗 RA 的随机对照试验。两名作者将根据预先设计的纳入和排除标准独立选择研究,提取数据。采用 Cochrane 偏倚风险工具对方法学质量和偏倚风险进行评估。所有数据均采用 Revman5.3、WinBUGS1.4.3 和 Stata14.2 软件进行分析。
我们将比较各项研究的不同结局指标,为四妙散联合针刺治疗 GA 患者的疗效和安全性提供综合评价。主要结局指标包括疗效、缓解率(无药物症状)、复发率、临床绝对评分和相对评分。次要结局指标包括相关不良反应和尿酸浓度。
本研究结果将为四妙散联合针刺治疗 GA 的疗效和安全性提供有益证据。
本研究方案已在方案注册库中注册。注册号为 INPLASY2020110028。