Non-alcoholic steatohepatitis (NASH) is marked by histological features that resemble alcoholic liver disease and occurs in individuals who consume little or no alcohol. NASH forms a part of the spectrum of non-alcoholic fatty liver disease (NAFLD). The condition is characterized by the presence of ballooning (zone 3) hepatocellular injury and inflammation, besides steatosis.

A study by Ghosh and colleagues was conducted to assess the safety and efficacy of a polyherbal formulation containing Capparis spinosa, Cichorium intybus, Mandura bhasma, Solanum nigrum, Terminalia arjuna, Cassia occidentalis, Achillea millefolium and Tamarix gallica, in the management of NASH. Fifty eligible patients with NASH were included in the study.  Patients were administered polyherbal tablets twice daily for 3 months. The predefined primary endpoints included improvement in steatohepatitis following the administration of polyherbal tablets. The efficacy parameters included improvements in clinical as well as liver function tests, ultrasonographic examination and a non-invasive NAFLD score that determines the severity of fatty liver fibrosis.  The predefined secondary endpoints included incidences of adverse events and overall compliance to the drug therapy.

The study reported no clinically significant adverse reactions. The overall compliance to the treatment was good and there were no treatment discontinuations. Abdominal discomfort due to hepatomegaly, fatigue, weakness, weight loss improved at 1^st as well as 3^rd months. Blood parameters, including hemoglobin, and total WBC count improved with study drug. Lymphocyte count and ESR also improved. TSH levels were shown to reduce at the end of treatment period. Random sugar and total protein levels also reduced with the treatment. Total bilirubin levels also reduced at the end of the treatment. Alkaline phosphatase, SGOT, SGPT, total cholesterol and serum triglycerides also reduced at the end of treatment period. NAFLD score was -0.98±0.39 at entry and improved to 1.22±0.41 following treatment, thus signifying that the liver fibrosis became less severe. About 58% of the participants showed varying response to therapy.

The polyherbal formulation was thus shown to be effective and safe in the management of NASH. The formulation was beneficial in improving clinical and liver function parameters as well as in ultrasonographic and NAFLD scores of NASH.

Source: Ghosh S, Singh DP, Mandal KD, Kumar S. Evaluation of safety and efficacy of a Polyherbal formulation Liv.52 DS in the Management of Non-Alcoholic Steatohepatitis (NASH): An open clinical study. Int J Curr Res Aca Rev. 2014;2(9):305-16.