Impact of betaine on hepatic fibrosis and homocysteine in nonalcoholic steatohepatitis - A prospective, cohort study

Introduction: Nonalcoholic steatohepatitis (NASH) is an important cause of cirrhosis and over the past decade has accounted for an increasing proportion of liver transplants in the United States. Unfortunately there is no treatment for NASH except for risk factor modification. The aims of our study were to assess the impact of betaine on liver function tests, homocysteine levels and hepatic fibrosis in a prospective cohort of NASH patients Materials and Methodology: Between July 2003 and June 2006, consecutive patients with NASH were screened to determine treatment eligibility. Eligibility criteria included elevated aminotransferases and a liver biopsy within twelve months of study entry satisfying the Brunt criteria for NASH. Patients were treated with betaine anhydrous 10 grams twice a day for one year. Liver function tests, homocysteine levels and liver biopsy were performed prior to and at the end of treatment. Outcomes were calculated using intention to treat analysis. Results: 35 patients were eligible. 23 patients completed treatment, seven were intolerant and five dropped out and were lost to follow up. Improvement or normalization in aminotransferases occurred in 62.9% of patients (p<0.05) and in homocysteine in 45.7% (p> 0.05). Resolution or improvement in steatosis occurred in 57.1% (p<0.05), improvement or stabilization of inflammation in 60% (p<0.05) and fibrosis in 62.9% (p<0.05). Conclusion: Betaine appears to improve hepatic function tests, homocysteine levels and histology in this cohort of NASH patients. Large randomized studies with long-term follow up are required to assess the effect of betaine for this growing epidemic.