At present, the Rome V criteria are being developed, with an emphasis on the key aspects for revision of a number of provisions, including elimination of diagnostic problems in the overlap syndrome (Address Diagnostic Overlap). On the other hand, the presence of the “overlap syndrome” worsens the course of and treatment outcomes in such conditions. And the most common symptoms overlap is the combination of functional dyspepsia (FD) and irritable bowel syndrome (IBS).

Methods

The group for inclusion in the study was selected by questionnaire survey, subject to the basic Rome IV criteria and modified Leeds Dyspepsia Questionnaire validated using more than 18,000 cases. Treatment efficacy assessment was based on patient-reported outcomes (PROs) obtained during the final treatment visit (Visit 3). Effects were detailed according to a special self-assessment questionnaire (medication and treatment satisfactory questionnaires TSQ) validated using 18,724 cases in an earlier study. Additionally, taking into account peculiarities of alverin action, the participants of the study undergone a grip test. To assess safety a number of parameters available in routine clinical practice were determined during all visits: blood chemistry values, hematological blood values, urinalysis values. During the randomization visit, hsCRP was determined in all patients; values were below 5 mg/L. Fecal calprotectin was determined by rapid test kit for semi-quantitative, with the cut-off value 50 µg/L to exclude bowel inflammatory, and only these patients included in the study. Group A with Meteospasmyl: 21 pts age: 46.5 (95% CI 39.7–53.4), median 45 (Q-25–Q-75 = 31–60), 23.8% (95% CI (Fisher’s) 11.3–52.2%) of males. 5 volunteers were smokers (23.8% (95% CI (Fisher’s) 8.2-47.2%). Group B with comparator: Height: age- 45.4 (95% CI 35.0–55.9), median 49 (Q-25–Q-75 = 37–53), 11.1% (95% CI (Fisher’s) 0.3–48.2%) of males. Comparison of the analysis results in groups A and B showed that there was no statistically significant difference in height, weight and age. There is a difference in the number of smokers: group A had a larger number of smokers

Results

The study results showed the high efficiency of the combination alverine with simethicone (Meteospasmyl) according to self-assessment by patients with overlapping symptoms of UD and IBS-N: positive effect – 86.7 % (95% CI Fisher’s = 78.6 – 92.5) cases and a high Odds ratio (22.7, at 95% CI = 8.9-58.4) compared with the control group (treatment without the use of Meteospasmyl). Treatment adherence higher in12 times (Odds ratio) (95% CI = 1.42 – 112.06) with Meteospasmil (85.7% (95% CI = 63.7 – 97.0), versus the control group (33.3% ( 95% CI = 7.5 – 70.1). A high safety degree of this drug has been demonstrated, both in terms of clinical and laboratory parameters. Results were obtained confirming the effect of Metespasmyl on skeletal muscles with a significant increase in the grip strength of the right hand both at the 2nd week of treatment with Meteospasmyl (increase by 0.4 kg) and by the 4th week of treatment (by 0.6 kg), in contrast with comparison group (F test ANOVA(2;60)=7.2; p=0.0015; Kruskal Wallis test-H(2;63)=27.6161; p=0.00001). The applied method of multivariate analysis of variance with a hypothesis decomposition model confirmed the effect of Meteospasmyl on the increase in the values of hand dynamometry on the 28th day of admission (p trend less than 0.001).

Conclusion

1. New data were obtained on the option of overlapping UD and IBS-N,
2. Patients’ self-assessment of effectiveness in this variant of disoders was not previously studied,
3. Meteospasmyl demonstrated greater efficiency and high safety profile.,
4. Meteospasmyl increased the functional state of skeletal muscles.