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

Hou, Xun-Ya, McManus, Donald P., Gray, Darren J., Balen, Julie, Luo, Xin-Song, He, Yong-Kang, Ellis, Magda, Williams, Gail M. and Li, Yue-Sheng (2008) A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for schistosomiasis japonica in China. Bulletin of the World Health Organization, 86 10: 788-795. doi:10.2471/BLT.08.053041


Author Hou, Xun-Ya
McManus, Donald P.
Gray, Darren J.
Balen, Julie
Luo, Xin-Song
He, Yong-Kang
Ellis, Magda
Williams, Gail M.
Li, Yue-Sheng
Title A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for schistosomiasis japonica in China
Journal name Bulletin of the World Health Organization   Check publisher's open access policy
ISSN 0042-9686
1564-0604
Publication date 2008-10
Year available 2008
Sub-type Article (original research)
DOI 10.2471/BLT.08.053041
Open Access Status DOI
Volume 86
Issue 10
Start page 788
End page 795
Total pages 8
Place of publication Geneva, Switzerland
Publisher World Health Organization
Collection year 2009
Language eng
Subject 110803 Medical Parasitology
Formatted 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).
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Published online: 25 August 2008.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Faculty of Health and Behavioural Sciences -- Publications
2009 Higher Education Research Data Collection
 
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Citation counts: TR Web of Science Citation Count  Cited 30 times in Thomson Reuters Web of Science Article | Citations
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Created: Tue, 31 Mar 2009, 10:30:57 EST by Geraldine Fitzgerald on behalf of School of Public Health