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Background  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.    Methodology/Principal Findings  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.    Conclusions/Significance  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.

plos neglected tropical diseases

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