The Mucosal Protection in the Treatment of Erosive Reflux Esophagitis: Mechanisms for Restoring Epithelial Permeability. A Randomized Clinical Trial
Abstract
BACKGROUND AND AIMS
Gastroesophageal reflux disease (GERD) is widespread in the population and is characterized by the risk of developing Barrett's esophagus and associated adenocarcinoma. Key factors in the progression of the disease are not only the frequency and duration of reflux episodes, but also the resistance of the esophageal mucosa to aggressive reflux molecules. Assessment of the state of tight junction proteins, the rate of their recovery under the influence of various treatment regimens is an urgent task for choosing optimal approaches to curing patients with GERD. The purpose of the study was to evaluate the efficacy and safety of the combination therapy with a proton pump inhibitor (PPI) and a topical mucosal protective agent (MPA) to relieve GERD symptoms and achieve a complete remission of reflux esophagitis faster.
METHODS
60 patients (38 men and 22 women with an average age 41.5 years) with GERD duration of 5 years, took part in an open randomized prospective clinical study. Participants were randomized in a 1:1 ratio to be divided into the main group taking MPA and PPI and a comparison group taking a PPI only. The duration of therapy was 4 weeks. Before the treatment onset and after the end of treatment, the occurrence and severity of GERD symptoms were assessed, an endoscopic examination was performed and biopsy specimens were taken from the edge of the erosive area and the area of unchanged esophageal mucosa. The severity of histological signs of…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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