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Background: IBS is a functional gastrointestinal disorder with a high placebo response; however, Pinaveriumbromide 100mg + Symeticone 300mg bid (PB+S) has shown to improve the severity of abdominal pain and bloating.1-2 Recently, increased IL-8 concentrations have been found in intestinal segments of IBD compared with non-inflamed IBS mucosa,3 and according to our findings, lower IL-8 concentrations are present in unstimulated-cultured PBMCs in IBS vs. controls.4 Additionally, IBS has been associated with the IL-8 intronic variant GG at +396 (rs2227307).5 These results suggest that this cytokine may be related with an inflammatory variant of IBS. Aim: To analyze the association between improvement of abdominal pain in IBS patients treated with PB+S and IL-8 variant rs2227307. Methods: Two-hundred and seventy nine patients with active IBS were randomly allocated to PB+S (n=104) or placebo (n=109), in a 3-month double-blind clinical trial. A 10-cm VAS was used to evaluate the severity of abdominal pain. The rs2227307 was analyzed by QPCR. MANOVA analysis for repeated measurements adjusted by gender, age, BMI and IBS subtype, was performed. A priori multiplicative interaction was considered significant if p,0.20 and for main effects if p,0.05. Results: Mean (+/-SD) age of the population was 36 (+/-9) years and mean BMI 26.5 (+/-5.3). Allele frequencies were T=0.63, G=0.37 and genotypes TT= 38.7%, TG= 48.4% and GG=12.9%. The sample was in HW equilibrium (X2= 0.38, p= 0.54). Abdominal pain improved in patients with the three genotypes with a size effect of 34% (favoring PB+S p=0.004). The larger size effect was in those with GG (70.5%, interaction with treatment p=0.18). Conclusions: This study shows that patients with the rs2227307 do not have the same magnitude of response to placebo compared to those with the other genotypes. We hypothesized that an underlying inflammatory-variant of IBS may be more responsive to PB+S. An effect on mucosal immunological mediators and/or epithelial permeability needs to be elucidated. This study was supported by Takeda-Mexico. References: 1.Schmulson M, et al. Gastroenterology 2011;140(Suppl.1):M1327. 2.Remes-Troche JM. Gastroenterology 2011;140(Suppl.1):M1332. 3.Nielsen OH, et al. Gastroenterol. 1997;32:1028-34. 4.Rodriguez-Fandino O et al. Submitted to DDW 2013. 5. RomeroValdovinos M et al. Mol Biol Rep. 2012 Sep;39(9):8837-43.

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