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한의약융합데이터센터


근거중심한의약 DB

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Title

Chuanhu anti-gout mixture versus colchicine for acute gouty arthritis: a randomized, double-blind, double-dummy, non-inferiority trial.

Authors

Wang Y, Wang L, Li E, Li Y, Wang Z, Sun X, Yu X, Ma L, Wang Y, Wang Y.

Journal

Int J Med Sci.

Year

2014

Vol (Issue)

11(9)

Page

880-5.

doi

10.7150/ijms.9165.

PMID

25013367

Url

http://www.ncbi.nlm.nih.gov/pubmed/25013367

MeSH

Adult
Aged
Arthritis, Gouty/drug therapy*
C-Reactive Protein/metabolism
Colchicine/administration & dosage
Drug-Related Side Effects and Adverse Reactions/pathology*
Female
Gout Suppressants/administration & dosage*
Gout Suppressants/adverse effects
Humans
Male
Medicine, Chinese Traditional*
Middle Aged
Treatment Outcome

Keywords

Chuanhu; acute gouty arthritis

한글 키워드

천호; 급성 통풍 관절염

KMCRIC
Summary & Commentary

KMCRIC 비평 보기 +

Korean Study

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.

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