Efficacy of combination therapy with lifestyle modification and ursodeoxycholic acid in patients with non-alcoholic fatty liver disease: Results of a prospective study

Introduction. Non-alcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease. The complexity of its pathogenesis determines the urgency of finding effective therapeutic strategies. Aim. To evaluate the efficacy of combination therapy with lifestyle modification (LM) and ursodeoxycholic acid (UDCA) in patients with NAFLD using transient elastography (TE) with the CAP (controlled attenuation parameter) function, steatosis indices (FLI, ST), and liver fibrosis indices (FIB-4, APRI). Materials and methods. A total of 142 patients with NAFLD were included in the prospective study. All patients were assessed with fibrosis and steatosis index scores, and TE with the CAP function. Patients were divided into two groups based on the type of treatment for the following 6 months: group I — LM and group II — LM and UDCA. All patients were prescribed a hypocaloric Mediterranean diet and aerobic exercise as part of LM. Repeat comprehensive examination was done after 6 months to assess the efficacy of treatment. Results. After 6 months of treatment, 111 patients came for a follow-up examination. The LM resulted in improvements in both groups, but the group who received UDCA in addition to LM exhibited statistically more significant improvements. There was a significant decrease in biochemical markers: ALT (median -43.60, p < 0.0001), AST (-17.8, p = 0.0001), GGT (-45.00, p < 0.00013), ALP (-74.91, p < 0.00015), TG (-0.165, p = 0.0085). More significant improvements were also detected in non-invasive scores: APRI (-0.22, p < 0.0001), FIB-4 (-0.17, p = 0.0272), ST (-0.09, p < 0.0001), FLI (-3.90, p = 0.0001). According to CAP (-25.00 dB/m), the TE findings showed a significant reduction in fibrosis (-0.70) and steatosis in the UDCA group. Conclusions. Adding UDCA to the basic non-drug treatment is associated with a statistically significant improvements in biochemical, elastographic, and calculated liver steatosis and fibrosis scores in patients with NAFLD.