Abstract

Objective: to evaluate the effectiveness of an esophagoprotector in reducing the risk of recurrent symptoms of gastroesophageal reflux disease (GERD) in patients who requiring temporary cancellation of therapy with proton pump inhibitors (PPIs). Material and methods. For the prospective comparative study there were selectively chose patients who had been taking PPIs for a long time (at least one month) for the underlying disease and who required temporary discontinuation of antisecretory therapy due to objective medical reasons. The study included patients with endoscopically and/or pH-metrically verified GERD, as well as histologically verified Barrett's esophagus. In the process of randomization of patients, two equal groups were formed, depending on the therapy received at the time of PPI withdrawal: group 1 received antacids on demand, group 2 received antacids on demand, as well as the esophagoprotector Alfasoxx at a dose of 10 ml four times a day (after each meal and at night). The follow-up period was two weeks. The patients recorded episodes of heartburn in their personal diaries. Results. The study included 60 patients (28 men and 32 women). The average age of the examined patients was 43.1 ± 5.3 years. By the end of the two-week follow-up period, the frequency of recurrent symptoms in group 1 was 36.7%, while in group 2 it was 13.3%. The use of the esophagoprotector Alfasoxx contributed to the significant regression of the risk of heartburn recurrence (odds ratio 0.2657; 95% confidence interval (CI) 0.07328-0.9637; p = 0.0438) in comparison with the group of patients who received only antacids in the on-demand mode. When analyzing the population of patients who had relapsed symptoms, it was demonstrated that the average number of heartburn episodes in group 1 was 6.18 (95% CI 4,1930-8,1706), and in group 2 – 4.50 (95% CI 0,7121-8,2879). Conclusion. This prospective comparative study demonstrated that the use of the esophagoprotector Alfasoxx helps to reduce the risk of relapse of GERD symptoms in patients requiring temporary cancellation of PPI therapy.

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