GASTROENTEROLGY
A Randomized Clinical End Point Study to Evaluate the Safety and Efficacy of Polyherbal Tablets in Patients with Alcoholic Liver Disease
February 11, 2019 | Ramesh Kannan S, Sivaraman V, Mrinalini C, Sakthibalan M, Jayashree S, Vanangamudi Ss, Nagarajan Km, Arther Paul C
Objective: To evaluate and compare the hepatoprotective effect of herbal tablets with silymarin in patients with alcoholic liver
disease. Material and methods: This was a prospective, randomized, multicenter, open-label, parallel group, interventional
clinical end point study (Phase IIa). Patients attending General Medicine outpatient department were screened for alcoholic liver
disease by using the serum biochemical liver function test, ultrasonogram (USG) abdomen. Investigators tested whether they
satisfied the selection criteria and 24 patients were then enrolled in the study. The study drug was administered to Group A and
tablet silymarin was administered to Group B from Day 1 to Day 56. Patients were reviewed once in 2 weeks. Liver function
test was repeated, and patients were enquired of their well-being and any adverse events. Results: The demographic characters
and body weight of the subjects showed no significant difference between the groups. There was a significant improvement
(p < 0.05) in the aspartate transaminase (AST), alanine transaminase (ALT) and total bilirubin (TB) levels on 28th day and
56th day in both silymarin and herbal tablet groups. Out of the two groups, there was higher significance of improvement in
herbal tablet group (p < 0.001), compared to silymarin group. The herbal tablet group started showing a significant reduction
in AST and ALT levels in the first 14 days of study period. On comparing the mean percentage reduction in the levels of AST
(35.7% vs. 35%), ALT (26.7% vs. 24.3%) and TB (26.7% vs. 25%), it was found that the herbal tablets showed a better percentage
of reduction of the above parameters compared to silymarin. There were reports of adverse effects like loss of appetite and
gastritis in both the groups. Conclusion: This clinical study proves that the herbal tablets used functioned as a hepatoprotective
drug. They offered better hepatoprotection compared to silymarin. These tablets can be indicated for the management of liver
dysfunction, which occurs due to alcoholic liver damage. It may also be used in similar manner in cases of viral hepatitis,
drug-induced liver damage, as well as acute and chronic hepatitis.