International Journal of Medical Sciences

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17 December 2017

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Int J Med Sci 2014; 11(9):880-885. doi:10.7150/ijms.9165

Research Paper

Chuanhu Anti-Gout Mixture versus Colchicine for Acute Gouty Arthritis: A Randomized, Double-Blind, Double-Dummy, Non-Inferiority Trial

YanGang Wang1, Luan Wang1, EnZe Li2, Yang Li1, ZhongChao Wang1, XiaoFang Sun1, XiaoLong Yu1, Lin Ma2, YunLong Wang3✉, YouXin Wang4 ✉

1. Department of endocrinology, The Affiliated Hospital of Medical College Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.
2. Department of pharmacy, The Affiliated Hospital of Medical College Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.
3. Gout laboratory, The Affiliated Hospital of Medical College Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases, Qingdao, 266003, China.
4. Beijing Municipal Key Laboratory of Clinical Epidemiology, School of Public Health, Capital Medical University, Beijing 100069, China.

Abstract

Background The Chuanhu anti-gout mixture has been used for many years in the treatment of gout in Chinese Traditional Medicine, and current methods for treatments for acute gouty arthritis have been either less effective or have had serious side effects.

Methods In this 12-week, double-blind, double-dummy, non-inferiority study, outpatient individuals with newly diagnosed acute gouty arthritis were randomly assigned to receive Chuanhu anti-gout mixture or colchicine. Both the study investigators and the participants were masked to the treatment assignments. The primary outcome was the recurrence rate of acute gouty arthritis, and the secondary outcomes were changes in white blood cells (WHC) and C-reactive protein (CRP). This trial is registered at ISRCTN.org as trial ISRCTN65219941.

Results A total of 176 patients were randomly assigned to receive either the Chuanhu anti-gout mixture or Colchicine. The overall recurrence rates in the Chuanhu anti-gout mixture group (CH group) and the Colchicine group (Col group) were 12.50% vs 14.77% (difference -2.22%, 95% confidence interval (95% CI): -10.78%~6.23%), meeting the predefined non-inferiority criterion of 15%, as did the data for WHC and CRP. The incidence of adverse events (mainly diarrhea) was less in the Col group than in the CH group (2.27% vs 28.41%, 95% CI 0.01~0.26). In addition, changes in blood uric acid, alanine aminotransferase, aspartate aminotransferase and creatinine in the CH group were significantly larger compared to those in the Col group (P<0.05).

Conclusions The Chuanhu anti-gout mixture was non-inferior to colchicine for the treatment of acute gouty arthritis. The study suggested that the Chuanhu anti-gout mixture can be considered an alternative choice for the treatment of acute gouty arthritis because of its lower incidence of adverse events and its protection of kidney and renal function.

Keywords: Chuanhu, acute gouty arthritis

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How to cite this article:
Wang Y, Wang L, Li E, Li Y, Wang Z, Sun X, Yu X, Ma L, Wang Y, Wang Y. Chuanhu Anti-Gout Mixture versus Colchicine for Acute Gouty Arthritis: A Randomized, Double-Blind, Double-Dummy, Non-Inferiority Trial. Int J Med Sci 2014; 11(9):880-885. doi:10.7150/ijms.9165. Available from http://www.medsci.org/v11p0880.htm