Document Type : Original Research Articles
Authors
1
Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, Iran.
2
School of Global Studies, Oklahoma State University, Stillwater, Oklahoma, USA.
3
Department of Biostatistics and Epidemiology, Nutritional Health, Lorestan University of Medical Sciences, Khorramabad, Iran.
4
Department of Internal Medicine, School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.
Abstract
Background: Ursodeoxycholic acid (UDCA) dissolves selected cholesterol gallstones, but treatment response varies. Whether adding cholesterol-lowering agents improves dissolution remains uncertain. This trial compared UDCA alone with UDCA plus atorvastatin or ezetimibe in patients with asymptomatic gallbladder stones.
Methods: In this three-arm randomized clinical trial, 60 participants were assigned to UDCA (600 mg/day) alone, UDCA plus atorvastatin (20 mg/day), or UDCA plus ezetimibe (10 mg/day) for six months. Following one withdrawal, 59 participants were analyzed. Ultrasonographic outcomes included total gallstone length, stone number, and treatment response. Complete response was defined as no visible stones; partial response required a reduction of at least 50% in stone size without complete disappearance.
Results: Mean total gallstone length decreased from 21.42 to 12.10 with UDCA alone and from 18.02 to 10.65 with UDCA plus atorvastatin, compared with a reduction from 25.55 to 24.95 with UDCA plus ezetimibe. The reported baseline-adjusted analysis indicated an overall between-group difference (P = 0.015). Complete response rates were 47.4%, 60.0%, and 15.0%, respectively. Treatment-response distributions differed among groups (P = 0.005), whereas changes in stone number did not (P = 0.136). Pairwise comparisons did not establish a significant difference between UDCA alone and UDCA plus atorvastatin.
Conclusion: UDCA alone and UDCA plus atorvastatin showed reductions in mean stone length, whereas the ezetimibe combination had a less favorable descriptive response. Neither combination was established as superior to UDCA alone.
Mechanistic and Translational Relevance: UDCA modifies biliary cholesterol saturation, whereas atorvastatin inhibits cholesterol synthesis and ezetimibe reduces intestinal cholesterol absorption. These distinct mechanisms do not necessarily translate into equivalent improvements in gallstone dissolution.
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