OBJECTIVES: Cholelithiasis is a disease that occurs in 80% of cases asymptomatic with incidental diagnosis made by other exams and may never evolve to the symptomatic form. However, has the risk of pancreatitis or cholangitis as complications. In Brazil, an oral treatment for gallstone dissolution has been a recurrent issue of judicialization. This study assessed evidence of the efficacy and safety of ursodeoxycholic acid (UDCA) to gallstone dissolution therapy in asymptomatic cholelithiasis patients.

METHODS: Systematic searches for articles were conducted on electronic databases of MEDLINE, EMBASE and Cochrane Library. Searches strategies were constructed for each database using terms of interest and no filters. The Clinicaltrials.gov have also been searched for any published or unpublished study. Some of inclusion criteria were used and only Randomized Clinical Trials (RCT) and Systematic Reviews written in English, Portuguese or Spanish were selected. Data extraction was performed by two reviewers and verified by consensus. Quality assessment of evidence was based on GRADE system.

RESULTS: Three RCT were elected from 25 full-text articles selected from 434 retrieved articles in electronic databases. These studies showed results favoring the UDCA when compared to placebo. However, the evidence quality of these 3 RCT was graduated as very low by GRADE criteria. This drug has been used for more than four decades and highlights the reduced amount of new studies about its effectiveness for biliary lithiasis.

CONCLUSIONS: A very low evidence of these three studies, with small samples and drug doses heterogeneity, generates uncertainties about defined outcomes. Adverse events and long-term treatment with 50% of gallstone recurrence shows the need to careful recommendation for asymptomatic patients. Nevertheless, it would be an option for against indication to surgery or patients who need a solid organ transplant. Choledocholithiasis has no indication for oral gallstone dissolution and the treatment should be surgical for the risk of pancreatitis.