title: Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients with co-infection of Clonorchis sinensis and other helminths.
abstract: BACKGROUND
  Both tribendimidine and mebendazole are broad-spectrum drugs for anti-intestinal nematodes. We aim to assess the efficacy and safety of tribendimidine and mebendazole in patients with co-infection of Clonorchis sinensis and other helminths.
  
  
  METHODS
  We performed a randomized open-label trial in Qiyang, People's Republic of China. Eligible participants were randomly assigned to one of four groups: (i) a single dose of 400 mg tribendimidine, (ii) 200 mg tribendimidine twice daily, (iii) 75 mg/kg praziquantel divided in four doses within 2 days, and (iv) a single dose of 400 mg mebendazole. Cure rates and egg reduction rates were assessed, and adverse events were monitored after treatments. Uncured patients accepted the second treatment with the same drugs after the first treatment.
  
  
  RESULTS
  156 patients were eligible for the study. Results from the first treatment showed that the cure rates of single-dose tribendimidine and praziquantel against C. sinensis were 50% and 56.8%, respectively; the single-dose tribendimidine achieved the cure rate of 77.8% in the treatment for hookworm, which was significantly higher than that of praziquantel; Low cure rates were obtained in the treatment of single-dose tribendimidine against Ascaris lumbricoides and Trichuris trichiura (28.6% and 23.1%). Results of the second treatment illustrated the cure rates of tribendimidine and praziquantel against C. sinensis were 78.1% and 75%, respectively. Most adverse events were mild and transient. Adverse events caused by tribendimidine were significantly less than praziquantel.
  
  
  CONCLUSIONS
  Single-dose tribendimidine showed similar efficacy against C. sinensis as praziquantel with less adverse events, and achieved significantly higher cure rate in the treatment for hookworm than those of praziquantel and mebendazole. Low cure rates, which were still higher than other drugs, were obtained in the treatment of single-dose tribendimidine against Ascaris lumbricoides and Trichuris trichiura.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN55086560.
authors.affiliation: National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China; WHO Collaborative Center for Malaria, Schistosomiasis and Filariasis, Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, People's Republic of China.
authors.forename: Li-Li
authors.initials: LL
authors.lastname: Xu
authors.affiliation: National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China; WHO Collaborative Center for Malaria, Schistosomiasis and Filariasis, Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, People's Republic of China.
authors.forename: Bin
authors.initials: B
authors.lastname: Jiang
authors.affiliation: Hunan Center for Disease Control and Prevention, Changsha, People's Republic of China.
authors.forename: Ji-Hui
authors.initials: JH
authors.lastname: Duan
authors.affiliation: Hunan Center for Disease Control and Prevention, Changsha, People's Republic of China.
authors.forename: Shi-Feng
authors.initials: SF
authors.lastname: Zhuang
authors.affiliation: Qiyang Center for Disease Control and Prevention, Yongzhou, People's Republic of China.
authors.forename: Yong-Chun
authors.initials: YC
authors.lastname: Liu
authors.affiliation: Qiyang Center for Disease Control and Prevention, Yongzhou, People's Republic of China.
authors.forename: Shi-Qiao
authors.initials: SQ
authors.lastname: Zhu
authors.affiliation: Sichuan Center for Disease Control and Prevention, Chengdu, People's Republic of China.
authors.forename: Li-Ping
authors.initials: LP
authors.lastname: Zhang
authors.affiliation: National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China; WHO Collaborative Center for Malaria, Schistosomiasis and Filariasis, Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, People's Republic of China.
authors.forename: Hao-Bing
authors.initials: HB
authors.lastname: Zhang
authors.affiliation: National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China; WHO Collaborative Center for Malaria, Schistosomiasis and Filariasis, Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, People's Republic of China.
authors.forename: Shu-Hua
authors.initials: SH
authors.lastname: Xiao
authors.affiliation: National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China; WHO Collaborative Center for Malaria, Schistosomiasis and Filariasis, Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, People's Republic of China.
authors.forename: Xiao-Nong
authors.initials: XN
authors.lastname: Zhou
mesh_terms: D000328:Adult; D000818:Animals; D000871:Anthelmintics / Q000627:therapeutic use*; D001196:Ascariasis / Q000188:drug therapy; D003003:Clonorchiasis / Q000188:drug therapy*; D060085:Coinfection / Q000188:drug therapy*; D005260:Female; D006373:Helminthiasis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008463:Mebendazole / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010655:Phenylenediamines / Q000009:adverse effects / Q000627:therapeutic use*; D011223:Praziquantel / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000871:Anthelmintics; D010655:Phenylenediamines; C056017:tribendimidine; D011223:Praziquantel; D008463:Mebendazole