himalaya update

Liv.52 DS Tablets Evaluation of Efficacy and Safety in Alcoholic Liver Cirrhosis

Dr. Subash Agal Department of Gastroenterology, Jagjivanram Western Railway Hospital, Mumbai Central, Mumbai, India.

Dr. S.R. Prasad*, Medical Advisor, Dr. S.K. Mitra, Executive Director, R&D Center, The Himalaya Drug Company, Bangalore-562 123, India.

*Corresponding author: Dr. S.R. Prasad, M.D, Medical Advisor, R&D Center, The Himalaya Drug Company, Bangalore, India. Phone : 91 080-2371 4444 Fax : 91 080-2371 4471 E-mail : [email protected]

Volume 15

I Number 6 I

2007

I

ABSTRACT The present study was planned to evaluate the clinical efficacy and safety of Liv.52 DS tablet in alcoholic liver cirrhosis. Alcoholic liver disease is a major cause of morbidity and mortality worldwide. Alcohol can cause liver damage in the form of steatosis or fatty liver, hepatitis, fibrosis, and liver cirrhosis. The present study was an open clinical trial, conducted as per the ethical guidelines of Declaration of Helsinki. All patients suffering from early alcoholic cirrhosis were included in the study, while patients having evidence of esophageal varices, hepatic encephalopathy and malignant jaundice, and pregnant women were excluded from the study. A thorough history, symptomatic evaluation and clinical examination was done for all patients before treatment and during followup visits every month till the end of treatment after 6 months along with recording the occurrence of any adverse event/s. Liver function tests, hemogram and other biochemical tests were done at baseline and at the end of the study after 6 months. The predefined primary endpoints were rapid relief from clinical symptoms and physical signs along with improvement of efficacy biochemical parameters. The predefined secondary endpoints were short- and long-term safety, and overall compliance to the drug treatment. A total of 50 patients were enrolled into the trial and all patients

MEDICINE UPDATE

completed the study. The study observed a significant reduction in the clinical symptom scores of asthenia, easy fatigability, tiredness, nausea, anorexia, abdominal discomfort, abdominal pain, stool frequency and muscle cramps; physical sign scores of muscle wasting, jaundice, anemia, edema, ascites, and hepatomegaly; and liver function test parameters of alanine transaminase, aspartate transaminase, total bilirubin, alkaline phosphatase, albumin, and prothrombin time at the end of the 6month therapy with Liv.52 DS tablet. There were no clinically significant adverse events, either reported or observed, during the entire study period. Therefore, it may be concluded that Liv.52 DS tablet is clinically safe and effective in the management of alcoholic liver cirrhosis. INTRODUCTION Alcoholic liver disease is a major cause of morbidity and mortality worldwide.1,2 In Western countries, up to 50% of end-stage liver disease has alcohol as the main etiologic factor.3 The mortality from alcoholic cirrhosis is higher than nonalcoholic cirrhosis, and survival at 5 and 10 years is only 23% and 7% in some studies, with 25% of patients dying within 1 year.3,4 Alcohol can cause liver damage in the form of steatosis or fatty liver, hepatitis, fibrosis, and liver cirrhosis. In general, the amount and duration of alcohol abuse

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himalaya update Figure 1. Efficacy of Liv.52 DS tablet in clinical symptoms of asthenia, easy fatigability, tiredness, nausea, and anorexia in alcoholic liver cirrhosis patients

Easy fatigability

Asthenia *p