Efficacy of Atorvastatin Plus Aspirin in Comparison with Atorvastatin Alone on Liver Function and Degree of Fibrosis in Patients with Cryptogenic Cirrhosis: A Randomized Double-Blind Clinical Trial

Objectives: This study was conducted to evaluate the efficacy of a combination therapy using aspirin (also known as acetylsalicylic acid (ASA)) and atorvastatin in comparison with atorvastatin alone to improve liver fibrosis and function in patients with cryptogenic cirrhosis. Methods: In this randomized double-blinded clinical trail, 40 patients with cryptogenic cirrhosis were randomly allocated to the intervention group (atorvastatin + ASA) and the control group (atorvastatin) treated for six months. Then liver function and stiffness (based on transient electrography) were compared. A checklist was used for data collection and the results were analyzed by SPSS 24 using chi-square test and paired t-test at the 0.05 significance level. Results: A total of 33 cases, including16 patients in group A (atorvastatin + ASA) and 17 in group B (atorvastatin + placebo) with a mean age of 50.3 ± 11.2 and 47.9 ± 10.6 years and BMI of 30.7 ± 4.2 and 30.8± 3.1 in groups A and B, were studied, respectively. Twelve patients (75%) in group A and 14 cases (82%) in group B were male. Both groups were homogenized in terms of demographic information at baseline. A significant improvement in Child score (P = 0.001 and P = 0.002 for groups A and B, respectively) and liver stiffness (P < 0.0001 and P = 0.007 for groups A and B, respectively) were observed in both groups after the intervention, however there was no significant improvement in child score (P = 0.982) and liver stiffness (P = 0.611) in comparing both groups. Conclusions: Although atorvastatin is effective in improvement of liver fibrosis and function in cryptogenic cirrhosis, adding ASA cannot improve its effects.