Introduction: Treatment is generally not available for drug-induced liver injury (DILI)
patients except in some specific circumstances. The management of DILI is based on
the withdrawal of the responsible drug and monitoring the patients and only a few patients
need to be referred to a transplant center. Some studies on the role of ursodeoxycholic
acid (UDCA) in DILI have been published. The aim of this study was to perform a systematic
review of the role of UDCA in the treatment and prevention of DILI.
Methods: A search was undertaken in PubMed, with the key words ursodeoxycholic acid,
drug-induced liver injury and hepatotoxicity following the PRISMA guidelines.
Results: A total of 33 publications were identified: 25 case reports and 8 case series. In 18
of the 25 cases reports (22 patients), authors reported improvement of liver injury
associated with UDCA therapy whereas 7 case reports did not show clinical or
biochemical improvement after UDCA treatment. There were 4 studies evaluating the
role of UDCA in the treatment of DILI, three prospective (one being a clinical trial) and one
retrospective studies. Three studies observed liver profile improvements associated with
UDCA. In addition, four studies evaluated UDCA in the prevention of DILI: one pilot study,
two randomized clinical trials (RCT) and one retrospective study. Three of these studies
observed a lower percentage of patients with an increase in transaminases in the groups
that used UDCA for DILI prevention.
Conclusion: According to available data UDCA seems to have some benefits in the
treatment and prevention of DILI. However, the design of the published studies does not
alow a firm conclusion to be drawn on the efficacy of UDCA in DILI. A well designed RCT to
evaluate the role of UDCA in DILI is needed.