Efficacy of the Combination of Pinaverium Bromide 100 mg Plus Simethicone 300 mg in Abdominal Pain and Bloating in Irritable Bowel Syndrome: A Randomized, Placebo-controlled Trial.

Autor:	Schmulson MJ; Laboratory of Liver, Pancreas and Motility (HIPAM)-Unit of Research in Experimental Medicine, Faculty of Medicine, National Autonomous University of Mexico (UNAM). General Hospital of Mexico 'Dr. Eduardo Liceada'.; Gastroenterology and Endoscopy in MGP, ABC Medical Center.; Lomas Altas SC Clinic, Mexico City., Chiu-Ugalde J; Medical Information, Takeda Mexico., Sáez-Ríos A; Central Military Hospital.; Faculty of Medicine, and Mano Amiga Foundation-Anahuac University, Mexico City.; Medical Department Takeda Ecuador and Peru., López-Colombo A; Department of Health Education and Research, Specialty Hospital-Manuel Avila Camacho National Medical Center, National Institute of Social Security (IMSS), Puebla., Mateos-Pérez GJ; Department of Gastroenterology, Endoscopy and Surgery, Angeles del Pedregal Hospital. Mexico City., Remes-Troche JM; Laboratory of Digestive Physiology and Gastrointestinal Motility, Institute of Medical-Biologic Research, University of Veracruz, Veracruz, Ver.-México., Sobrino-Cossio S; Pedregal Angeles Hospital.; Service of Gastroenterology and Digestive Endoscopy, High Specialty South Central Hospital of Petroleos Mexicanos (PEMEX), Mexico City., Soto-Pérez JC; Digestive Physiology Clinic, Metropolitan Angeles Hospital.; Center for Research and Education in Health Sciences, Autonomous University of Sinaloa, Civil Hospital of Culiacan., Tamayo de la Cuesta JL; Center for Research and Education in Health Sciences, Autonomous University of Sinaloa, Civil Hospital of Culiacan., Teramoto-Matsubara OT; Gastroenterology and Endoscopy in MGP, ABC Medical Center., López-Alvarenga JC; Department of Human Genetics, School of Medicine, University of Texas Rio Grande Valley, TX.; Research Division Mexican-American University of the North (UMAN), Reynosa, Tamaulipas, Mexico.
Jazyk:	angličtina
Zdroj:	Journal of clinical gastroenterology [J Clin Gastroenterol] 2020 Apr; Vol. 54 (4), pp. e30-e39.
DOI:	10.1097/MCG.0000000000001242
Abstrakt:	Goals: We aimed to evaluate the efficacy and safety of PB+S (pinaverium bromide 100 mg plus simethicone 300 mg) in patients with irritable bowel syndrome (IBS). Background: IBS is a multifactorial disorder; thus, combination therapy with different mechanisms of action is expected to be useful. PB+S has shown effectiveness in an open-label clinical study in IBS. However, there are no placebo-controlled trials. Materials and Methods: IBS-Rome III patients with abdominal pain/discomfort for at least 2 days within the week prior to baseline assessment were included in this 12-week, randomized, double-blind, placebo-controlled study of PB+S versus placebo, bid. The primary endpoint was overall symptom improvement, evaluated weekly by the patient (Likert Scale). Secondary endpoints included the weekly improvement in the severity of abdominal pain and bloating assessed both by patients (10-cm Visual Analogue Scale) and investigators (Likert Scale); frequency of Bristol Scale stool types (consistency) evaluated by patients and the IBS Quality of Life scores. Results: A total of 285 patients (female: 83%; 36.5±8.9 y old) received at least 1 dose of PB+S (n=140) or placebo (n=145). No difference was observed in overall symptom improvement between the groups (P=0.13). However, PB+S was superior in abdominal pain (effect size: 31%, P=0.038) and bloating (33%, P=0.019). Patients with IBS-C and IBS-M showed the best improvement in the frequency of stool types with PB+S. No differences were observed in IBS Quality of Life scores and adverse events. Conclusions: PB+S was superior to placebo in improving abdominal pain and bloating in patients with active IBS. The effect on the frequency of stool consistency was particularly significant in IBS-C and IBS-M.
Databáze:	MEDLINE
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