Clinical Efficacy and Tolerability of Praziquantel for Intestinal and Urinary Schistosomiasis—A Meta-analysis of Comparative and Non-comparative Clinical Trials

Extensive use of praziquantel for treatment and control of schistosomiasis requires a comprehensive understanding of efficacy and safety of various doses for different schistosoma species.a systematic review and meta-analysis of comparative and non-comparative trials of praziquantel at any dose for any schistosoma species assessed within two months post-treatment. of 273 studies identified,55 were eligible (19,499 subjects treated with praziquantel,control treatment or placebo). most studied were in school-aged children (64%),s. mansoni (58%),and the 40 mg/kg dose (56%); 68% of subjects were in africa. efficacy was assessed as cure rate (cr,n=17,017) and egg reduction rate (err,n=13,007); safety as adverse events (ae) incidence. the who-recommended dose of praziquantel 40 mg/kg achieved crs of 94.7% (95%ci 92.2–98.0) for s. japonicum,77.1% (68.4–85.1) for s. haematobium,76.7% (95%ci 71.9–81.2) for s. mansoni,and 63.5% (95%ci 48.2–77.0) for mixed s. haematobium/s. mansoni infections. using a random-effect meta-analysis regression model,a dose-effect for cr was found up to 40 mg/kg for s. mansoni and 30 mg/kg for s. haematobium. the mean err was 95% for s. japonicum,94.1% for s. haematobium,and 86.3% for s. mansoni. no significant relationship between dose and err was detected. tolerability was assessed in 40 studies (12,435 subjects). on average,56.9% (95%ci 47.4–67.9) of the subjects receiving praziquantel 40 mg/kg experienced an ae. the incidence of aes ranged from 2.3% for urticaria to 31.1% for abdominal pain.the large number of subjects allows generalizable conclusions despite the inherent limitations of aggregated-data meta-analyses. the choice of praziquantel dose of 40 mg/kg is justified as a reasonable compromise for all species and ages,although in a proportion of sites efficacy may be lower than expected and age effects could not be fully explored. © 2014 zwang,olliaro.