New possibilities for treatment of gastroesophageal reflux disease

Abstract

Objective — to evaluate the clinical efficacy of the addition of Gyalera emulsion (Alpiflor SRL, Italy) to the standard therapy of patients with gastroesophageal reflux disease (GERD) and to study the effects of such treatment on the state of the esophagus epithelium.Materials and methods. A multicenter, randomized, open, comparative study with the parallel control has been carried out. It involved 60 patients with GERD aged 18 to 65 years, from them 25 women (42 %), and 35 men (58 %). The inclusion criteria included the presence of GERD symptoms (primarily heartburn), confirmed endoscopically and morphologically. The participants were divided into two groups of 30 subjects in each. Omeprazole in a dose of 20 mg 2 times a day and domperidone at a dose of 10 mg 3 times a day were used as basic therapy in both groups. In the first group, an additional «Gyalera» emulsion of 15 ml sticks was administered in a dose of 1 stick after a meal 3 times a day.Results. After the treatment, heartburn frequency in the first group was almost three times lower than in the comparison group (p = 0.035). This group did not suffer from nighttime heartburn and dysphagia, whereas in the second group it was observed in almost 7 % of patients. The incidence of belching after the treatment was 17 % and 20 % respectively. Esophagitis was detected endoscopically in 4.5 times more often in the second group than in the first, in one patient it was erosive. In the patients of the first group, morphologically significant positive dynamics was defined.Conclusions. In patients with GERD, the addition of Gyalera emulsion to the standard therapy with proton pump inhibitor and prokinetics promoted significant (in comparison with the control group) reduction of the heartburn frequency and severity, the degree of esophagus damage as per the esophagoscopy data, and elimination of dysphagia and nocturnal heartburn. Morphological analysis of esophageal mucosa demonstrated a decrease in the degree of epithelial inflammation and degeneration, and increase in the synthesis of protective mucus and epithelial integration on account of claudine 1 in tight junctions.