Efficacy and safety of tribendimidine against Clonorchis sinensis

Background. Clonorchiasis is of considerable public health importance, particularly in the People's Republic of China (P.R. China), where most of the 15 million individuals infected with Clonorchis sinensis are currently concentrated. Praziquantel is the drug of choice, but tribendimidine might be an alternative.Methods. We performed a randomized open-label trial in Guangxi, P.R. China to assess the efficacy and safety of 400 mg tribendimidine once, 400 mg tribendimidine daily for three days, and 75 mg/kg praziquantel in one day divided in three doses against parasitological confirmed C. sinensis infections. Cure and egg reduction rates were determined 3 weeks post-treatment using available case analysis. Clinical symptoms were documented at baseline, and adverse events were recorded and graded 3 and 24 h after each dose.Results. A total of 74 patients were included in the final analysis. Single-dose tribendimidine achieved a cure rate of 44%, while cure rates of 58% and 56% were obtained for tribendimidine administered for 3 days and praziquantel, respectively. High egg reduction rates (97.6-98.8%) were observed for all treatment regimens. Single-dose tribendimidine was the best-tolerated treatment scheme. Patients treated with praziquantel experienced significantly more adverse events than tribendimidine recipients (P >0.05).Conclusions. Tribendimidine has an efficacy comparable to praziquantel in the treatment of C. sinensis infection and resulted in fewer adverse events compared to praziquantel. Larger clinical trials are warranted among C. sinensis-infected patients to determine the potential of tribendimidine against clonorchiasis and other helminthiases.Trial registration. Controlled-Trials.com, identifier: ISRCTN80829842.