Evaluation of the Efficacy and Safety of the Complex Phytotherapeutic Drug Gastritol® in the Treatment of Patients with Functional Dyspepsia: Results of a Multicenter Study

The objective: to evaluate the clinical efficacy and tolerability of Gastritol® oral drops in patients with functional dyspepsia (FD). Materials and methods. A multicenter, open-label, controlled study was conducted involving 533 patients aged 18–45 years with diagnosed FD. The study group (SG) – 288 patients – received standard therapy (a proton pump inhibitor (PPI) and a prokinetic/antispasmodic) combined with Gastritol® (20–30 drops 3 times daily). The control group (CG) – 245 patients – received the standard regimen only. Evaluation was performed using the Gastrointestinal Symptom Score (GIS), a physician-rated scale, and quality of life parameters on the 1st and 21st days of treatment. Statistical analysis was performed using R environment (version 4.5.1). Results. The addition of Gastritol® provided a statistically significant advantage in symptom relief compared to standard therapy (PPIs + prokinetic/antispasmodic), p < 0.001. The most pronounced dynamics in the SG were observed regarding epigastric pain, feeling of fullness, bloating, and early satiety. The clinical success rate (4–5 points on the physician-rated scale) in the Gastritol® group was 83.7% vs 52.2% in CG (p < 0.0001). The chances of successful treatment increased 4.69-fold (Odds Ratio = 4.69; 95% Confidence Interval [3.14; 7.00]), with a number needed to treat (NNT) of 3.2. Combined therapy was associated with a significantly higher level of compliance (96.5% vs 86.9%) and substantial improvement in patients’ psychoemotional and physical well-being (p < 0.0001). Conclusions. Inclusion of Gastritol® in standard treatment protocols for FD allows for more profound and rapid relief of dyspeptic syndrome. The drug demonstrates a favorable safety profile and high clinical significance, ensuring recovery for every third additional patient. The multi-target action of the herbal extracts contributes to effective restoration of quality of life and increased treatment adherence.