This article is more than 5 years old. Information may no longer be current.
Patients with IBS-D see no benefit from Mesalazine
Click Here to Manage Email Alerts
Mesalazine was not superior to placebo in relieving symptoms of diarrhea-predominant irritable bowel syndrome, according to recent study data.
The purpose of this multicenter, double-blind placebo-controlled trial was to determine the efficacy of mesalazine (Pentasa, Ferring Pharmaceuticals) for treating irritable bowel syndrome with diarrhea (IBS-D), and also its effect on mast cell numbers and mediator release for predicting response to treatment. Researchers recruited patients with IBS-D from several centers in the UK from April 2011 through May 2013, and randomly assigned 136 (82 women; 54 men) to receive either 4 g per day mesalazine or placebo for 12 weeks (2 g per day the first week).
Patients kept a stool diary and completed four follow-up visits and three telephone calls throughout the study period to ensure tolerance and compliance. Stool and sigmoid biopsy samples were collected before and at the end of the trial for patients at one center. In total, 115 patients completed the trial with primary outcome data (57 mesalazine; 58 placebo).
Intention-to-treat analysis showed no significant difference in the daily average stool frequency for the last 2 weeks of follow-up, with 2.8 ± 1.2 for the mesalazine group compared with 2.7 ± 1.9 for the placebo group (0.1; 95% CI, – 0.33 to 0.53). Mesalazine also did not improve abdominal pain, stool consistency or the proportion of patients who reported satisfactory relief compared with placebo during the last 2 weeks of follow-up.
Analysis of biopsy samples showed no significant change in mast cell percentage area stained between patients with IBS-D and controls before and after treatment, and analysis of stool samples showed no significant change in calprotectin before and after treatment. The most common side effect was exacerbation of IBS symptoms including worsening abdominal pain or diarrhea.
A subgroup of patients with postinfectious IBS (n = 13) appeared to have significant improvement in average abdominal pain severity, average urgency score and average daily stool consistency after mesalazine therapy.
“Although mesalazine has been available to use for many decades with good safety profile, our adequately powered study has showed it does not help the majority of patients with IBS-D,” the researchers wrote. “The fact that certain subgroups might benefit emphasizes that there is still a need for better phenotyping of this heterogeneous group of patients when evaluating new treatments.” – by Adam Leitenberger
Disclosure: Spiller reports receiving research funding from Lesaffre and Ironwood and free drugs for the clinical trial from Norgin and Ferring Pharmaceuticals Limited. Please see the study for a list of all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts