CLINICAL TRIAL OF TRICLABENDAZOLE ON HUMAN FASCIOLIASIS: LONG TERM FOLLOW UP

Following an outbreak: of human fascioliasis in Gilan province of Iran in 1989, the benzimidazole derivative triclabendazole (TCBZ) was suggested as the drug of choice after finding out that routine drugs were not effective. Two studies were performed: a clinical trial (before/after type) in 1989 and a historical cohort (1989- 1995) to examine the efficacy of the drug. TCBZ was administered to 94 patients in four groups (A, B, C and D) according to the drug's instructions (time, size and frequency of dose). The patients were followed up clinically and paraclinically for 60 days. The highest cure rate, i.e. , omission of eggs and improvement of clinical symptoms (86.6%) was observed in Group A (5 mg/kg-NPO, 3 days). Minor epigastric pain and vomiting and some urticaria was reported a few days after administration of the drug. Just a few developed cholangitis and one toxic hepatitis who were all treated satisfactorily. The second study was a 6-year follow-up survey of 50 of the 94 patients. Five cases had epigastric pain, and eggs were detected in the stool exams of two of them. Thus, by demonstrating up to 94% efficacy in the treatment of human fascioliasis in Iran (p<0.002), TCBZ is recommended as the drug of choice.