Source: Neuron  |  Posted 9 years ago

Otilonium bromide is more effective than placebo in relieving pain and discomfort in patients with irritable bowel syndrome (IBS), Italian research confirms.

Investigators from the University of Bologna, SS Giovanni e Paolo Hospital in Venezia and Menarini Ricerche spa in Firenze did an efficacy assessment of a large clinical trial of otilonium bromide therapy in 378 patients.

Trial participants were treated with either 40 milligrams of otilonium bromide or placebo three times a day for 15 weeks. Data on 12 single efficacy endpoints were assessed.

The new efficacy evaluation of the double-blind, parallel-group study was based on information reported by patients. Investigators used an assessment that integrated key IBS symptoms. These included pain frequency and intensity as well as the presence of meteorism and distension.

The primary efficacy outcome measure was the rate of response within two to four months of therapy.

Results indicate response within two to four months was significantly higher in patients in the otilonium bromide group (36.9 percent) than in the placebo group (22.5 percent).

"In each month of treatment, the rate of monthly response was higher in the otilonium bromide group as compared with the placebo group," the researchers report.

Differences in total monthly and weekly responses to individual endpoints were also significantly more frequent in the otilonium bromide group. These endpoints were: intensity/frequency of pain/discomfort, meteorism/abdominal distension, diarrhoea/constipation severity and mucus in the stool.

Patients with diarrhoea had an additional benefit, the investigators add.