THE CLINICAL EFFECTS OF NITAZOXANIDE IN HEPATIC ENCEPHALOPATHY PATIENTS: A PILOT STUDYAbstract
Background: Hepatic encephalopathy (HE) is a brain dysfunction caused by liver insufficiency and/or portosystemic shunting. It is associated with poor survival and high risk of recurrence along with reduced quality of life (QOL) of patients and their caregivers. Nitazoxanide (NTZ) is an oral antimicrobial that improved mental status and QOL score in HE patients and is well-tolerated. Aim: To evaluate the efficacy and safety of NTZ compared to metronidazole and rifaximin in patients with grade II-III HE and to evaluate its effect on patients’ QOL. Patients and Methods: A Prospective, Randomized, Controlled, Open-Label, Pilot study. Thirty four patients were randomly assigned to receive either Nitazoxanide (n=12), Metronidazole (n=11) or Rifaximin (n=11) for 7 days. Serum ammonia level, Clinical Hepatic Encephalopathy Staging Scale (CHESS) and Chronic Liver Disease Questionnaire (CLDQ) for QOL was measured at baseline and at end of treatment. Results: Baseline and after 1 week serum ammonia levels and CHESS scores, showed no significant difference among the 3 groups. There was no significant difference in serum ammonia level in each group for the 3 groups while it showed significance in CHESS score. Regarding QOL, there was a significant difference between baseline and after 1 week CLDQ total (p-value= 0.01) and fatigue scores (p-value= 0.01) for Nitazoxanide group. Conclusion: Administration of 500 mg of NTZ twice daily over 7 days showed the same efficacy on HE as standard treatment. However, it was superior in improving patients’ QOL.
A. A. Elrakaybi *, A. T. Abd ElMoez and O. A. Badary
Department of Clinical Pharmacy, Faculty of Medicine Ain-Shams University, Cairo, Egypt
24 April, 2015
26 June, 2015
28 August, 2015
01 November, 2015