Pinaverium bromide–simethicone combo useful for treating IBS
Treatment with the combination of pinaverium bromide plus simethicone effectively relieves abdominal pain and bloating in patients with active irritable bowel syndrome (IBS), in addition to improving stool consistency in those with constipation-predominant IBS (IBS-C) or a mixed bowel movement pattern (IBS-M), according to the results of a trial.
The trial involved 285 IBS-Rome III patients (mean age, 36.5 years; 83 percent female; mean body mass index, 26.7 kg/m2) with abdominal pain/discomfort for ≥2 days within the week prior to baseline assessment. Most of the patients had IBS-C (43.5 percent) or IBS-M (31.2 percent), while 23 percent had diarrhoea-predominant (IBS-D) and 2.1 percent had unknown subtype (IBS-U).
In the cohort, 140 patients were randomized to receive pinaverium bromide 100 mg plus simethicone 300 mg (PB+S; n=140) or placebo (n=145) twice a day, 10 to 15 minutes before breakfast and dinner, for 12 weeks. There was no significant between-group difference seen in the primary endpoint of overall symptom improvement at treatment conclusion (p=0.13). [J Clin Gastroenterol 2019;doi:10.1097/MCG.0000000000001242
However, PB+S yielded superior weekly improvements in the severity of abdominal pain (total effect size, 30 percent; p=0.04) and bloating (total effect size, 33 percent; p=0.02), as assessed by patients using a 10-cm visual analogue scale.
In terms of stool consistency, “PB+S produced a shift toward Bristol stool types 3 to 5, mainly in the IBS-C and IBS-M patients,” the investigators noted.
Quality of life was similar in the two treatment groups, and PB+S was safe and well-tolerated. There were two serious adverse events reported: a case of acute pancreatitis not related to treatment in the PS+S group and a brain aneurism in the placebo group.
Taken together, the present data show that combination therapy is advantageous in the management of IBS. The observed relief of bloating regardless of the bowel habit subtype is especially important given that only few treatments have proven to be effective on such a common symptom, according to the investigators. “The improvement … may have been exerted by the additional effect of the antifoaming simethicone with the smooth muscle relaxant properties of pinaverium bromide.” [Aliment Pharmacol Ther 2011;33:1071-1086]
Another noteworthy finding is the increased frequency of Bristol stool types 3 to 5, mainly in the IBS-C and IBS-M patients, the investigators continued. “One may speculate that the high dose of simethicone used in the current trial helps patients to increase the frequency of bowel movements by dissolving the gas bubbles, thus facilitating bowel movements.”
Nevertheless, further investigation is needed to establish the mechanism of improvement according to the IBS subtypes, they added.