Can Pinaverium Bromide Plus Simethicone Improve Bloating and Objective Abdominal Distention During a 12-Week Randomized-Clinical Trial in IBS? A Report From the Mexican IBS-Working Group

Background: Bloating and objective abdominal distention are considered gas-related symptoms and while they are related, they may represent expressions of different underlying pathophysiological process and have different response to treatment.1-2 Therefore, the efficacy of 100 mg pinaverium bromide + 300 mg simethicone (PB+S) over these symptoms, was studied in a 12-week randomized placebo-controlled trial. Methods: We studied 285 IBS-Rome III patients. They all filled-out a 12-week questionnaire that included 10-cm visual analog scales (VAS) for evaluating the intensity abdominal pain and bloating, and registered their girth circumference (objective distension) early in the morning and before bedtime during weeks 1, 6 and 12 of treatment. Data was analyzed with ANOVA for repeated measurements, using as covariate the linear combination of the girth measurements during all the weeks (explained 78% to 80% of the total variance). Finally, the abdominal volume was calculated with a mathematical model: (circumference cm)3/[6π2]. Results: Patients were 37±9 years old, F: 83%, BMI: 27±5, and were classified as IBS-C: 44%, IBS-D: 23%, IBS: 31%, and IBS-U: 2%. They reported a significant decrease in abdominal pain and bloating favoring PB+S vs. placebo (Size effect: 23% and 21% respectively, p