A randomised, double-blind, placebo-controlled trial on the safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China

File Size Format
72465_1.pdf 833Kb Adobe PDF View
Title A randomised, double-blind, placebo-controlled trial on the safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China
Author Hou, Xun-Ya; McManus, Donald P; Gray, Darren; Balen, Julie; Luo, Xin-Song; He, Yong-Kang; Ellis, Magda; Williams, Gail M; Li, Yue-Sheng
Journal Name Bulletin of the World Health Organization
Year Published 2008
Place of publication Switzerland
Publisher World Health Organization
Abstract Objective To evaluate the safety and efficacy of combining artemether (AM) and praziquantel (PZQ) in different regimens for treating acute schistosomiasis japonica. Methods We undertook a randomized, double-blind, placebo-controlled trial within four specialized schistosomiasis hospitals in the Dongting Lake region, Hunan province, China, between May 2003 and December 2005. Study participants were randomized into one of four treatment regimes: group A received 60 mg/kg PZQ + 6 mg/kg AM; group B received 60 mg/kg PZQ + AM placebo; group C received 120 mg/kg PZQ + 6 mg/kg AM; and group D received 120 mg/kg PZQ + AM placebo. All participants were followed up over a 45-day period. The primary endpoint of the trial was human infection status (determined by positive stool examination). Secondary endpoints involved clinical observations and blood biochemistry, including monitoring haemoglobin and alanine aminotransferase levels over time. Findings Treatment efficacies of the four different treatment regimens were 98.0%, 96.4%, 97.7% and 95.7% for group A, B, C, and D respectively (P > 0.05). The group B had a greater treatment efficacy (96.4%) than the group D (95.7%) (P > 0.05). Group A treatment was better for clearance of fever (P < 0.05) and resulted in a shorter hospitalization time (P < 0.05). Conclusion This is the first report of a randomized, double-blind, placebo-controlled trial for evaluating combined chemotherapy with AM and two different dosages (60 mg/kg and 120 mg/kg) of PZQ in the treatment of acute schistosomiasis japonica in China. The combination of AM and PZQ chemotherapy did not improve treatment efficacy compared with PZQ alone. PZQ given as a dosage of 60 mg/kg (1 day, 3 × 20 mg/kg doses at 4–5 hour intervals) may be as effective as a dosage of 120 mg/kg (6 days, 20 mg/kg for each day split into 3 doses at 4–5 hour intervals).
Peer Reviewed Yes
Published Yes
Alternative URI http://dx.doi.org/10.2471/BLT.08.053041
Copyright Statement Copyright 2008 World Health Organization. The attached file is reproduced here in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version.
Volume 86
Issue Number 10
Page from 788
Page to 795
ISSN 0042-9686
Date Accessioned 2011-07-26
Date Available 2011-08-30T06:21:55Z
Language en_AU
Faculty Griffith Health Faculty
Subject Epidemiology
URI http://hdl.handle.net/10072/40482
Publication Type Journal Articles (Refereed Article)
Publication Type Code c1x

Show simple item record

Griffith University copyright notice