Alverin with Simethicone Combination: Efficacy and Safety Clarification in Overlap Syndrome (Dyspepsia with Nonspecific/ Unspecified Irritable Bowel Syndrome) by Patients’ Self-assessment

Abstract

The study results showed the high efficiency of the combination in one form of two active substances- alverine (alverine) and simeticone (simeticone)-in the drug Meteospasmyl according to the results of self-assessment by patients with overlapping symptoms of uninvestigated dyspepsia(UD) and nonspecific irritable bowel syndrome(IBS-N), with a positive effect of 86.7% (95% CI Fisher’s 78.6–92.5) cases and a high Odds ratio (chance) (22.7, at 95% CI 8.9–58.4) of the effect compared with the comparator group (treatment without the use of Meteospasmyl). Treatment adherence higher in 12 times (Odds ratio) (95% CI 1.42– 112.06) with Meteospasmyl (85.7% (95% CI 63.7–97.0)), versus the comparator group (33.3% (95% CI 7.5–70.1)). Thus, Meteospasmyl can be used as a first-line drug in overlapping dyspepsia with an nonspecific variant of irritable bowel syndrome, especially during the period of performing and waiting for the results of the patient’s clarifying examination. 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 Meteospasmyl 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). The advantages of the presented study are the following characteristics: • New data were obtained on the option of overlapping uninvestigated dyspepsia with nonspecific irritable bowel syndrome. • Patients’ self-assessment of effectiveness in this variant of disorders was not previously studied. • Meteospasmyl demonstrated greater efficiency in comparison with mebeverine and drotaverine. • Meteospasmyl increased the functional state of skeletal muscles. • Meteospasmyl showed a high safety profile.