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Randomized Controlled Trial
. 2016 Apr;70(4):302-11.
doi: 10.1111/ijcp.12790. Epub 2016 Mar 20.

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

B Oh  1 , W S Choi  2 , S B Park  3 , B Cho  4 , Y J Yang  5 , E S Lee  5 , J H Lee  5
Affiliations
Randomized Controlled Trial

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

B Oh et al. Int J Clin Pract. 2016 Apr.

Erratum in

  • Corrigendum.
    [No authors listed] [No authors listed] Int J Clin Pract. 2017 Feb;71(2):e12930. doi: 10.1111/ijcp.12930. Int J Clin Pract. 2017. PMID: 28238230 Free PMC article. No abstract available.

Abstract

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.

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Figures

Figure 1
Figure 1
Study participation flow chart. FAS, full analysis set; PPS, per‐protocol set
Figure 2
Figure 2
Proportion of subjects with improved CIS scores (≤ 76 points) at 4 and 8 weeks (full analysis set). CIS, checklist individual strength. *Statistically significant difference
See this image and copyright information in PMC

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