Evaluation of Effect of mast cell stabilizer on elastographic findings of patients with nonalcoholic fatty liver disease: A pilot interventional study

Abstract

Non-alcoholic fatty liver includes a range of liver diseases ranging from steatosis to hepatic steatohepatitis. Elastography is a method based on ultrasound waves, which is used with sufficient efficiency to investigate liver fibrosis and liver steatosis, which are two important characteristics of NAFLD. Among the elastography parameters, LSM is used to check the severity of liver fibrosis and CAP is used to check liver steatosis. Studies on mast cells and liver disease progression have clearly identified these immune cells as important regulators of pathogenic processes. Mast cells are involved in liver fibrosis, cholangiopathies, liver cancer, alcoholic liver damage, fatty liver disease and allograft liver transplant rejection. Considering the widespread prevalence of obesity and its complications, including non-alcoholic fatty liver disease, which can progress to liver failure and hepatocellular carcinoma, and considering the lack of specific treatment for NAFLD and considering the recent hypotheses regarding the role of mast cells in the pathophysiology of diseases liver including NAFLD and the lack of human studies in the form of clinical trials in this field, we decided to investigate the effect of ketotifen as a mast cell stabilizer on patients with non-alcoholic fatty liver disease and evaluate its effect based on elastography findings. Materials and Methods : This study was conducted as an interventional clinical trial in 1402 at Imam Reza Hospital in Tabriz and on 50 patients with non-alcoholic fatty liver disease. To remove confounding factors, patients were divided into two groups correspondingly one by one. One group received ketotifen 1 mg every twelve hours and the other group received placebo in the same way. Demographic findings and elastography results were recorded in the form of LSM and CAP parameters in both groups before the intervention and six months after the intervention, and the effects of mast cell stabilizing drugs on the elastography findings of the patients were investigated. Results: Ketotifen, as a mast cell stabilizer, improved the CAP parameter in elastography of patients with non-alcoholic fatty liver disease, but had no effect on the LSM parameter. No life-threatening side effects were observed .