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• W2307126302 abstract "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.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.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.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." @default.
• W2307126302 created "2016-06-24" @default.
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• W2307126302 date "2016-03-20" @default.
• W2307126302 modified "2023-10-17" @default.
• W2307126302 title "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" @default.
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• W2307126302 doi "https://doi.org/10.1111/ijcp.12790" @default.
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