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

Abstract

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.

Efficacy of low‐dose versus high‐dose simethicone with polyethylene glycol for bowel preparation: A prospective randomized controlled trial

“…Simethicone, also known as activated dimethicone, is an antifoaming agent. It prevents bubble formation and gas retention, which alleviates abdominal pain and bloating; therefore, it is widely prescribed to patients with irritable bowel syndrome . Several recent randomized controlled trials have demonstrated that addition of SIM to bowel preparation regimens can help improve the quality of bowel preparation, ADR and patient tolerance .…”

Antispasmodics for Chronic Abdominal Pain: Analysis of North American Treatment Options

“…The most common AEs reported were nausea, dizziness, abdominal discomfort, and hypertension ( 15 ). Schmulson reported that the combination of pinaverium 100 mg plus simethicone 300 mg twice daily compared with placebo significantly improved the intensity of abdominal pain ( P = 0.04) and bloating ( P = 0.02); the individual contribution of each agent cannot be determined ( 59 ). The safety profile of pinaverium/simethicone was generally comparable with that of placebo.…”

“…The high placebo response observed in 1 study was potentially because of patient selection and/or the patient-provider relationship ( 54 ). Pinaverium was examined in 5 randomized, placebo-controlled studies that differed in treatment duration, dosing, and outcomes; furthermore, 1 study included only patients with IBS-D ( 15 , 56 – 59 ). Studies generally had an unclear risk of bias ( 15 , 56 – 59 ).…”

Management of Chronic Abdominal Distension and Bloating

“…81 A prospective, randomized, placebo controlled trial in patients with IBS (Rome III criteria; n ¼ 285) found that the combination of pinaverium bromide and simethicone was more effective at relieving symptoms of abdominal pain and bloating than placebo. 82…”