Efficacy and Safety of Oral Betaine Glucuronate in Non-alcoholic steatohepatitis - A double-blind, randomized, parallel-group, placebo-controlled prospective clinical study

In a prospective, randomized, double-blind therapeutic trial, 191 patients with non-alcoholic steatohepatitis were treated for 8 weeks daily b.i.d. or ally either with betaine glucuronate combined with diethanolamine glucurona te and nicotinamide ascorbate (Ietegar(R)) (96 patients) or with undistingu ishable placebo capsules (95 patients). The verum treatment effectively reduced by 25 % hepatic steatosis (p < 0.01 ) and by 6 % hepatomegaly (p < 0.05), while placebo did not significantly r educe the disorders. Verum was also more effective than placebo on discomfo rt in abdominal upper right quadrant. The global efficacy of treatment was rated by the doctor "very good" or "good" in 48 % of verum treated patients and only in 17 % after placebo (P of difference 9 x 10(-6)). 52 % of patie nts self-rated efficacy as "very good" or "good" after verum and only 34 % after placebo (P of difference = 0.017). The verum treatment provoked a sig nificant reduction of the increased liver transaminases (ALT, AST and gamma -GT) while placebo was ineffective. Adverse events were recorded in 10 % of verum-treated patients and in 7 % under placebo (no significant difference ). In both groups the adverse events were mild and transient, did not requi re treatment discontinuation and were undistinguishable from common symptom s of liver disorders. In conclusion, the 8-week treatment with betaine glucuronate combined with diethanolamine glucuronate and nicotinamide ascorbate was found effective i n non-alcoholic steatohepatitis, a disorder for which the hitherto pharmaco logical interventions were poorly and inconsistently effective.