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

Hou, Xun-Ya; McManus, Donald P; Gray, Darren; Balen, Julie; Luo, Xin-Song; He, Yongkang; Ellis, Magda; Williams, Gail; Li, Yue-Sheng

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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...[Show more]

dc.contributor.authorHou, Xun-Ya
dc.contributor.authorMcManus, Donald P
dc.contributor.authorGray, Darren
dc.contributor.authorBalen, Julie
dc.contributor.authorLuo, Xin-Song
dc.contributor.authorHe, Yongkang
dc.contributor.authorEllis, Magda
dc.contributor.authorWilliams, Gail
dc.contributor.authorLi, Yue-Sheng
dc.date.accessioned2015-12-10T23:06:52Z
dc.identifier.issn0042-9686
dc.identifier.urihttp://hdl.handle.net/1885/62847
dc.description.abstractObjective: 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 x 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).
dc.publisherWorld Health Organization (WHO Press)
dc.sourceBulletin of the World Health Organization
dc.subjectKeywords: artemether; placebo; praziquantel; prednisone; blood; chemotherapy; comparative study; drug development; enzyme; health monitoring; health services; health survey; hemoglobin; schistosomiasis; temporal analysis; abdominal discomfort; adolescent; adult; al
dc.titleA randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China
dc.typeJournal article
local.description.notesImported from ARIES
local.identifier.citationvolume86
dc.date.issued2008
local.identifier.absfor111706 - Epidemiology
local.identifier.ariespublicationU3488905xPUB743
local.type.statusPublished Version
local.contributor.affiliationHou, Xun-Ya, Hunan Institute of Parasitic Diseases
local.contributor.affiliationMcManus, Donald P, Queensland Institute of Medical Research
local.contributor.affiliationGray, Darren, College of Medicine, Biology and Environment, ANU
local.contributor.affiliationBalen, Julie, Queensland Institute of Medical Research
local.contributor.affiliationLuo, Xin-Song, Hunan Institute of Parasitic Diseases
local.contributor.affiliationHe, Yongkang, Hunan Institute of Parasitic Diseases
local.contributor.affiliationEllis, Magda, Queensland Institute of Medical Research
local.contributor.affiliationWilliams, Gail, University of Queensland
local.contributor.affiliationLi, Yue-Sheng, Queensland Institute of Medical Research
local.description.embargo2037-12-31
local.bibliographicCitation.issue10
local.bibliographicCitation.startpage788
local.bibliographicCitation.lastpage795
local.identifier.doi10.2471/BLT.08.053041
dc.date.updated2016-02-24T10:13:10Z
local.identifier.scopusID2-s2.0-54249153209
CollectionsANU Research Publications

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