Efficacy and safety of ursodeoxycholic acid composite on fatigued patients with elevated liver function and/or fatty liver: a multi‐centre, randomised, double‐blinded, placebo‐controlled trial

AIM: The aim of this study was to assess the effects of ursodeoxycholic acid composite (URSA‐S) on fatigue in patients with elevated liver function tests and/or fatty liver disease. METHODS: In this multi‐centre randomised double‐blinded placebo‐controlled trial, 168 adults who were diagnosed with fatigue based on our criteria and had elevated liver function tests (but not > 5 times the normal level) and/or fatty liver on ultrasonography, were randomised to either the placebo or URSA‐S administration group. The rate of improvement of checklist individual strength (CIS) using a cut‐off of 76 points at the end of the study (8 weeks), the change in fatigue scale [CIS score and visual analogue scale (VAS)] were evaluated. The adverse effects of URSA‐S were also recorded. RESULTS: The rate of CIS improvement at the end‐point was 79.76% and 45.68% in the therapy and placebo groups, respectively (p < 0.05). The fatigue recovery rate of the CIS score and VAS were higher in the therapy (−25.44 ± 18.57, −27.84 ± 2.70) than in the placebo group (−16.59 ± 17.29, −19.46 ± 2.81) (p < 0.05). The difference in fatigue recovery rate between the therapy and placebo groups was significant after 8 weeks. When analysed separately in patients with abnormal liver function tests and fatty liver disease, the fatigue recovery rate of the CIS score and VAS at 8 weeks was higher in the therapy than in the placebo group (p < 0.05). The frequency of adverse events in the therapy group was not significantly higher than that in the placebo group. CONCLUSION: URSA‐S is effective for alleviating fatigue in patients with liver dysfunction and/or fatty liver. The adverse effects of URSA‐S are not significant. This study is registered at https://clinicaltrials.gov/ct2/show/ NCT02415777.