Effect of essentiale in diabetic subjects with non-alcoholic fatty liver

Abstract

Nonalcoholic fatty liver (NAFL) has been reported to be common among subjects with diabetes. However, there are not much therapeutic options for NAFL. In this open labeled clinical trial we studied the effect of Essentiale in diabetic subjects with NAFL. Twenty-eight type 2 diabetic patients attending the out-patient division of M.V. Diabetes Specialities Centre, Chennai and satisfying the inclusion criteria were recruited for the study. High resolution B mode ultrasonography was carried out for diagnosis of NAFL. Liver function markers [Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma Glutamyl transferase (GGT)] were measured. 22 out of the 28 patients (78.5%) were available for follow up. The mean age of the study subjects was 41±8 years and 50% were males. A significant reduction in all the liver enzymes were observed after Essentiale treatment (baseline vs. six months after treatment: ALT: 54.5± 29.6 IU/L vs. 37.1±18.7 IU/L, p< 0.05, AST: 38.0±18.0 IU/L vs. 27.6±12.4 IU/L, p< 0.05, GGT: 38.7±27.5 IU/L vs. 29.6±13.8 IU/L, p< 0.05). Ultrasound studies revealed that the hepatic echotexture improved after Essentiale treatment in 12/22 (54.5%) of the study subjects, while there was no change in 9/22 (40.9%), and it worsened in only one patient (4.5%). The study results suggest that Essentiale protects and improves liver function in diabetic subjects with NAFL. Prospective, blinded clinical trials are required to confirm these findings.