Synbiotic complex improved the efficacy and tolerability of quadruple therapy with amoxicillin, clarithromycin and bismuth in patients from Vinnytsia region, Ukraine

Abstract

Introduction: Both the effectiveness and tolerability of Helicobacter py- lori (H.p.) eradication therapy regimens are important in the management of H.p. infection, since the presence of side effects significantly reduces compliance between the doctor and the patient and sometimes can lead to treatment interruption. Our study aimed to compare the efficacy and tolerability of eradication therapy depending on the addition of Saccharo- myces boulardii or a synbiotic complex. Aims & Methods: The study included 78 patients (54 women and 24 men) with confirmed H.p. infection using validated tests, without previous eradication in the anamnesis. All patients underwent a course of eradica- tion therapy, which included proton pump inhibitor (PPI) + amoxicillin (A) + clarithromycin (C) + bismuth subcitrate (B). Patients were divided into 2 groups: in group A (37 patients, 25 women, 12 men, mean age 44±3.2 years) S. boulardii CNCM I-745 was added to the mentioned regimen. In group B (41 patients, 29 women, 12 men, mean age 47±2.8 years), a synbiotic complex containing strains of probiotic bacteria Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus fermentum, Lactobacillus rhamnosus, Lacto- bacillus casei subsp. casei, Streptococcus thermophilus, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium adolescentis, Propi- onibacterium freudenreichii subsp. Shermanii, prebiotics inulin and lac- tulose were added to the indicated regimen. The duration of eradication therapy was 10 days. The duration of taking the probiotic and synbiotic complex ‒ 15 days. Results: In group A, the effectiveness of the PPI+A+C+B regimen with the addition of S. boulardii was 75.7%. In group B (with the addition of a syn- biotic) - 87.8%. We compared the tolerability of the indicated regimens. In no case (in both groups) was the treatment interrupted due to the pres- ence of serious side effects. In total, 20 (54.1%) patients from group A and 17 patients (41.5%) from group B reported non-serious adverse events, including nausea (group A ‒ 8 patients (21.6%), group B ‒ 6 (14.6%), bitter taste in the mouth (group A ‒ 16 patients (43.2%), group B ‒ 15 (36.6%), and diarrhoea (group A ‒ 6 patients (16.2%), group B ‒ 0 (0%). No other adverse events were documented. Comparing gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS) showed that in group A, mean values of the total score before treatment were 35.9±3.14 points, vs 26.2±1.64 points 20 days after the eradication course (p<0.05). In group B 34.1±2.44 points before treatment, vs 21.7±1.98 points 20 days after the eradication course (p<0.05). Comparing the total score of the GSRS questionnaire after treatment between groups A and B also showed a significant difference: 26.2±1.64 points in group A vs 21.7±1.98 points in group B (p<0.05). Conclusion: Our study revealed better efficacy (87.8%) of the eradication regimen PPI+A+C+B with the addition of a synbiotic compared to the sim- ilar regimen with the addition of Saccharomyces boulardii (75.7%) in pa- tients from Vinnytsia region, Ukraine. In addition, it was found that when the synbiotic complex was added, side effects of eradication therapy were noted in a smaller percentage of patients and significantly (p<0.05) lower values of the total score of the GSRS questionnaire were noted 20 days after treatment, in contrast to the regimen with the addition of Saccharo- myces boulardii. Disclosure: Nothing to disclose.