Minimal Hepatic Encephalopathy Clinical Trial
Official title:
Professor of Tropical Medicine
Minimal hepatic encephalopathy (MHE) can have a far-reaching impact on quality and ability to function in daily life and may progress to overt Hepatic Encephalopathy. Patients with MHE were missed in clinical follow up and are more exposure to work accident. The aim of the present study was to assess the effects of oral supplementation of antioxidant and zinc gluconate Versus Lactulose inTruck driver cirrhotic patients with MHE.
The aim of the present study was to assess the effects of oral supplementation of
antioxidant and zinc gluconate in patients with MHE. Zinc, may be considered as a cofactor
of urea cycle enzymes, that deficient in cirrhotic patients; especially if associated, with
malnutrition or encephalopathy . Zinc is essential for the synthesis of coenzymes that
mediate biogenic amine synthesis and metabolism. Data from studies sustain that, there is a
synergistic combined effect between systemic oxidative stress, and ammonia that is
implicated in the pathogenesis of hepatic encephalopathy, so that the present study was
designed to assess the effects of oral supplementation of antioxidant and zinc gluconate in
cirrhotic Truck drivers patients with MHE.
A prospective randomized controlled study comparing the effect of zinc and antioxidant
supplementation plus lactulose on MHE versus lactulose alone. Patients who were diagnosed as
having MHE were randomly assigned either to receive zinc and antioxidant plus lactulose
(group A) or lactulose alone (group B, the control). Patients in group A received 175 mg
zinc gluconate, 50000 iu vitamin A, 500 mg vitamin C and 100 mg vitamin E once daily plus
lactulose (30-60 ml in 2 or 3 divided doses), while patients in group B received 30-60 ml
lactulose in 2 or 3 divided doses so that the patient passed 2-3 semi soft stools per day.
The therapy was taken daily for 3 months or until the patients discontinued the study drugs
for any reason (e.g. non compliance). All patients were followed up every month for
treatment compliance and for development of any complications. The compliance with the
therapy was assured primarily by ensuring increased stool frequency and a change to a softer
consistency and by counting the number of bottles of lactulose consumed. None of the study,
patients were specifically treated by other therapy for MHE within the study period (e.g.
rifaximin).
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Observational Model: Case-Only, Time Perspective: Prospective
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