Polar vectors as a method for evaluating the effectiveness of irritable bowel syndrome treatments: An analysis with pinaverium bromide 100 mg plus simethicone 300 mg po bid

• Published in: Revista de gastroenterología de México 2013-01, Vol.78 (1), p.21-27
• Main Authors: López-Alvarenga, J.C, Sobrino-Cossío, S, Remes-Troche, J.M, Chiu-Ugalde, J, Vargas-Romero, J.A, Schmulson, M
• Format: Article
• Language: eng ; spa
• Subjects: Bristol Stool Scale; Clinical studies; Gastroenterology and Hepatology; Irritable Bowel Syndrome; Outcome measures; Pinaverium bromide plus Simethicone; Polar vectors
• ISSN: 0375-0906
• DOI: 10.1016/j.rgmx.2012.10.003

Abstract Background Irritable Bowel Syndrome (IBS) is a disorder characterized by abdominal pain or discomfort associated with changes in bowel habit. Currently there are no objective outcome measures for evaluating the effectiveness of treatments for this disorder. Aims To determine the usefulness of a method of analysis that employs polar vectors to evaluate the effectiveness of IBS treatments. Methods Data from a Phase IV clinical study with 1677 active IBS-Rome III patients who received 100 mg of pinaverium bromide + 300 mg of simethicone (PB + S) po bid for a period of four weeks were used for the analysis. Using the Bristol Stool Scale as a reference, the consistency and frequency of each type of bowel movement were recorded weekly in a Bristol Matrix (BM) and the data were expressed as polar vectors. Results The analysis showed a differential response to the PB + S treatment among the IBS subtypes: in reference to the IBS with constipation subtype, the magnitude of the vector increased from 10.2 to 12.5, reaching maximum improvement at two weeks of treatment ( p < 0.05, Scheffé). In the IBS with diarrhea and mixed IBS subtypes, the magnitude of the vector decreased from 19 to 14 ( p