Chuanhu anti-gout mixture versus colchicine for acute gouty arthritis: A randomized, double-blind, double-dummy, non-inferiority trial – Full Text
International Journal of Medical Sciences , 07/14/2014 Evidence Based Medicine
Clinical Article
Wang YG, et al. – 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. 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.
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).
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).
Int J Med Sci. 2014 Jun 14;11(9):880-5. doi: 10.7150/ijms.9165. eCollection 2014.
Chuanhu Anti-Gout Mixture versus Colchicine for Acute Gouty Arthritis: A Randomized, Double-Blind, Double-Dummy, Non-Inferiority Trial.
Wang Y
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.