OBJECTIVE

To evaluate the effectiveness of alpha-glutamyl-tryptophan in the form of gel (Regasthym Gastro) in reducing mucosal inflammation of patients with H.pylori-associated atrophic gastritis (AG).

MATERIAL AND METHODS

We conducted a multicenter, double-blind, placebo-controlled randomized trial. 116 patients aged 40—76 years (58.1±0.8) with AG were examined in two parallel groups. The diagnosis was confirmed by endoscopy, histology, and pH-monitoring (pH>5.0). In the first stage, patients received standard eradication therapy. Then the main group (58 patients) took Regasthym Gastro; the control group (58 patients) — a placebo according to the scheme: orally twice daily for 28 days. All patients underwent: endoscopy with biopsies from the atrophy zones; biopsies histology with inflammatory cells count (neutrophils, eosinophils, macrophages, lymphocytes, plasmocytes) per 1 mm² of the gastric mucosa; blood test — «GastroPanel» (including anti-H.pylori antibody (IgG) titer). Data were compared before and after treatment in each group and between groups.

RESULTS

Regasthym Gastro compared with placebo significantly decreases in the number of inflammatory cells per 1 mm² of gastric mucosa: eosinophils by 3 times (z=3.036351; p=0.002395), neutrophils by 4 times (z=3.841236; p=0.000122), macrophages by 1.5 times (z=3.085251; p=0.002034), lymphocytes by 28.2% (z=2.815422; p=0.004872), plasmocytes by 29.6% (z=2.423776; p=0.015361); anti-H.pylori antibody titer by 65.4% (z=2.264637; p=0.023536) . The compared groups did not differ in the number of adverse events (p>0.05).

CONCLUSIONS

Regasthym Gastro has an anti-inflammatory effect that provides regression of chronic inflammatory reaction (including allergic and autoimmune components) and a good level of safety in patients with AG.