The aim of our study was to evaluate the clinical efficacy of esophageal mucus barrier correction by complex treatment with sodium hyaluronate and sodium alginate (Hyalera/Gastropiù Bustine) application in patients with gastroesophagic reflux disease (GERD). We conducted a multicenter, randomized, open, comparative study with parallel monitoring to evaluate the effectiveness and safety of combination therapy for patients with GERD using the sodium hyaluronate and sodium alginate (Hyalera/Gastropiù Bustine). Under our supervision, there were 72 patients with GERD aged 18 to 65years. Women were 30 (41.7%), men 42 (58.3%). The criterion for inclusion in the study was the presence of GERD symptoms (primarily heartburn) with endoscopic and morphological confirmation. Omeprazole at a dose of 20mg 2 times a day and domperidone at a dose of 10mg 3 times a day were used as basic therapy in both groups. In the first group, an additional sodium hyaluronate and sodium alginate (Hyalera/Gastropiù Bustine) emulsion of 15ml sticks (Alpiflor, Italy) was prescribed. The emulsion was administered 1 stick after a meal 3 times a day.
The frequency of heartburn in the first group after treatment was almost three times lower than in the comparison group (p =0.035) and they did not have nightly heartburn. Also, dysphagia was absent in the first group (almost 7% of patients remained in the second), at the same time, the incidence of belching after treatment was identical in both groups (20 and 17%). Endoscopically, in the second group, 4.5 times more often than in the first, esophagitis was detected, and in 1 patient it was erosive. Morphologically, in patients of the first group, significant positive dynamics was noted.