A multicenter study of the combination of spasmolytic and antiflatulent effectiveness for alleviation of the symptoms in patients with gut-brain interaction disorders

Objective — to determine the clinical efficacy of the combined drug «Enterospasmil® H» (antiflatulent simethicone and antispasmodic floroglucinol dihydrate) by assessing the dynamics of functional gastrointestinal disorders using a patient questionnaire in a multicentre study. Materials and methods. The multicentre study included 30 patients aged 20 to 69 years (mean age: 39.4 years) who completed the programme in full according to the agreed protocol. Recruitment of study participants, their questionnaires, and counselling support were carried out in healthcare facilities in five regions (Kyiv, Poltava, Ternopil, Lviv, and Odesa) of Ukraine. Six patients were selected from each research centre according to the inclusion criteria. The study participants took the combined product «Enterospasmil® H» (simethicone/floroglucinol dihydrate) for 30 days. The dynamics of general manifestations of disorders of the brain‑gastrointestinal tract axis, abdominal pain and bloating were assessed. The questionnaire method was used to determine the effectiveness of the intervention. Results. The results of the comparison of the intensity of the manifestations before the inclusion into the study of the combined agent «Enterospasmil® H», during weekly questionnaire and 30 days after the start of the study demonstrated a pronounced dynamics of symptom relief and a significant difference in the intensity of the disease manifestations when comparing the initial and final scores. Conclusions. Summarizing the results allows us to confirm the high effectiveness of the combination of the antispasmodic phloroglucinol dihydrate and the antiflatulent simethicone and to recommend its use to alleviate the manifestations of functional digestive disorders.