Pilot study: a randomised, double blind, placebo controlled trial of pancrealipase for the treatment of postprandial irritable bowel syndrome-diarrhoea

Abstract

ObjectiveTo evaluate the efficacy of pancrealipase (PEZ) compared with placebo in the reduction of postprandial irritable bowel syndrome-diarrhoea (IBS-D).DesignAn intention to treat, double blind, randomised, crossover trial comparing PEZ to placebo for reduction of postprandial IBS-D. Patients had to recognise at least two different triggering foods, be willing to consume six baseline ‘trigger meals’ and again blinded with PEZ and placebo. Patients then chose which drug they preferred for another 25 meals.SettingOutpatient internal medicine practice clinic.Patients255 patients were screened; 83 met the criteria, including 5 years of symptoms, recognised ‘food triggers’, no other identifiable cause for the symptoms, either a normal colonoscopy or barium enema while symptomatic and able to discontinue all anticholinergic medications. 69 patients were enrolled, 20 withdrew before randomisation, leaving 49 patients: 14 men, 35 women, mean age 52 years (SD 15.3). Over 60% had experienced symptoms for 11–30 years and 16% for more than 40 years.InterventionsAfter completing six baseline meals, patients were randomised in blocks of four to receive either identical PEZ or a placebo for another six meals, and after a washout period of time received the alternative drug.Main outcome measuresThe primary analysis was number of patients who chose PEZ over placebo for the extended use.ResultsOverall, 30/49 (61%) would have chosen PEZ (p=0.078), with first drug preference for PEZ at 0.002. Among the PEZ subgroup, PEZ use compared with placebo, demonstrated improvement in all symptoms (p≤0.001) for cramping, bloating, borborygami, urge to defecate, global pain and decrease stooling with increase in stool firmness.ConclusionsPEZ was found in a small group of patients to reduce postprandial IBS-D symptoms and deserves further evaluation.

Does Irritable Bowel Syndrome Exist? Identifiable and Treatable Causes of Associated Symptoms Suggest It May Not

“…A similar prevalence of exocrine pancreatic insufficiency of 4.1% (FE-1 <100 µg/g) was found in another study across IBS subtypes [19]. A good response to enzyme supplementation in diarrhea-predominant, and galacto-oligosaccharide intolerant IBS has been reported by other investigators [123,124].…”

Functional variants in the sucrase–isomaltase gene associate with increased risk of irritable bowel syndrome

“… 7 Avoidance of carbohydrates due to perceived maldigestion is common, and a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs, which are poorly absorbed in the small intestine) has been proposed as effective in reducing IBS symptoms. 8 9 At least in some patients, the food–symptom relation may involve malabsorption of carbohydrates due to inefficient enzymatic breakdown of polysaccharides, which may find indirect support in the observed symptom improvement in patients with postprandial IBS-D treated with pancrealipase, 10 and the detection of disaccharidase deficiency in children with FGID. 11 …”

Microencapsulated sodium butyrate reduces the frequency of abdominal pain in patients with irritable bowel syndrome

“…Unfortunately the wide array of therapeutic approaches results in only 7–15% advantage over placebo [7]. Ongoing research is focusing on new treatments such as pancrealipase [8], linaclotide [9], Lactobacillus LB [5] or butyrate [10].…”