The effectiveness of Regasthym Gastro in restoring acid production in the stomach according to daily pH-metry in patients with chronic atrophic gastritis

Objective: to evaluate the effectiveness of alpha-glutamyl-tryptophan (Regasthym Gastro) in restoring acid-forming function of the stomach according to daily pH-metry in patients with chronic H. pylori-associated atrophic gastritis (CAG). Materials and methods: we conduct the double-blind placebo-controlled randomized study was conducted in parallel groups in three treatment centres. 116 patients aged 40-76 years (average age 58.1±0.8) with a diagnosis of CAG, confirmed by endoscopic, histological examination, pH-metry data on the presence of a hypoacidic condition (pH more than 5.0) were examined. All patients underwent daily pH-metry before and after the therapy (Gastroscan-24 device) with an assessment of the minimum pH value, average pH value, aggressiveness index (AgI) and acidity index (AcI). Patients received standard eradication therapy and were then randomized into 2 groups in a 1:1 ratio (58 patients each) depending on the subsequent therapy. The main group of patients took alpha-glutamyl-tryptophan powder for gel preparation (Regasthym Gastro) orally for 28 days; the comparison group - placebo. Data were compared before and after treatment between groups of patients receiving the study drug and placebo. Statistical analysis was made in “Statistica 12.0 for Windows”. The study was approved by the Ministry of Health of the Russian Federation, the Ethics Committee at the Ministry of Health of the Russian Federation and local ethics committees. Results: when comparing the results before and after treatment while taking alpha-glutamyl-tryptophan (Regasthym Gastro) compared with placebo, we saw the statistically significant improvement in pH metrics: a shift in the acidic side of the average pH value (from 4.3 to 2.7 in the main group, from 4.35 to 3.6 in the placebo group), an improvement in AgI (from 4.8 to 3.25 in the main group, from 4.9 to 4.15 in the placebo group), an increase in AcI (from 8.95 to 48.7 in the main group, from 22.8 up to 16.55 in the placebo group) (p<0.05). Conclusions: this study shown the presence of the studied drug activity in the restoration of the acid-forming function of the stomach in CAG patients.

chronic atrophic gastritis, Helicobacter pylori, Regasthym Gastro, pH-metry, acidity, acid production, stomach

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