Clinical trial of triclabendazole on human fascioliasis: long term follow-up

ABSTRACT

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