title: Efficacy and safety of tribendimidine against Clonorchis sinensis.
abstract: BACKGROUND
  Clonorchiasis is of considerable public health importance, particularly in the People's Republic of China (PR 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, PR China, to assess the efficacy and safety of 400 mg tribendimidine once, 400 mg tribendimidine daily for 3 days, and 75 mg/kg praziquantel in 1 day divided in 3 doses against parasitological-confirmed C. sinensis infections. Cure and egg reduction rates were determined 3 weeks posttreatment using available case analysis. Clinical symptoms were documented at baseline, and adverse events were recorded and graded 3 and 24 hours after each dose.
  
  
  RESULTS
  A total of 74 patients were included in the final analysis. Single-dose tribendimidine achieved a cure rate of 44%, whereas 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 did tribendimidine recipients (P < .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. Clinical Trials Registration.Controlled-Trials.com, ISRCTN80829842.
authors.affiliation: National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China.
authors.forename: Men-Bao
authors.initials: MB
authors.lastname: Qian
authors.forename: Peiling
authors.initials: P
authors.lastname: Yap
authors.forename: Yi-Chao
authors.initials: YC
authors.lastname: Yang
authors.forename: Hai
authors.initials: H
authors.lastname: Liang
authors.forename: Zhi-Hua
authors.initials: ZH
authors.lastname: Jiang
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.forename: Yu-Guang
authors.initials: YG
authors.lastname: Tan
authors.forename: Hui
authors.initials: H
authors.lastname: Zhou
authors.forename: Jürg
authors.initials: J
authors.lastname: Utzinger
authors.forename: Xiao-Nong
authors.initials: XN
authors.lastname: Zhou
authors.forename: Jennifer
authors.initials: J
authors.lastname: Keiser
mesh_terms: D000328:Adult; D000818:Animals; D000871:Anthelmintics / Q000008:administration & dosage* / Q000009:adverse effects*; D002681:China; D003003:Clonorchiasis / Q000188:drug therapy* / Q000469:parasitology / Q000473:pathology; D003004:Clonorchis sinensis / Q000187:drug effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005243:Feces / Q000469:parasitology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010270:Parasite Egg Count; D010655:Phenylenediamines / Q000008:administration & dosage* / Q000009:adverse effects*; D011223:Praziquantel / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000871:Anthelmintics; D010655:Phenylenediamines; C056017:tribendimidine; D011223:Praziquantel