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Pilot study: a randomised, double blind, placebo controlled trial of pancrealipase for the treatment of postprandial irritable bowel syndrome-diarrhoea
  1. Mary E Money1,2,
  2. Jaroslaw Walkowiak3,
  3. Chris Virgilio1,4,
  4. Nicholas J Talley5,6
  1. 1Washington County Health Systems, Hagerstown, Maryland, USA
  2. 2Department of Internal Medicine, University of Maryland, Baltimore, Maryland, USA
  3. 3Department of Gastroenterology and Metabolism, Poznań University of Medical Sciences, Poznań, Poland
  4. 4Bernard J Dunn School of Pharmacy, Shenandoah University, Winchester, Virginia, USA
  5. 5Department of Medicine, Mayo Clinic, Mayo Clinic College of Medicine, Jacksonville, Florida, USA
  6. 6Faculty of Health, Bowman Building, University of Newcastle, Callaghan, NSW, Australia
  1. Correspondence to Dr M E Money, Washington County Health Systems, 354 Mill Street, Hagerstown, MD 21740, USA; MEWaldman{at}aol.com

Abstract

Objective To evaluate the efficacy of pancrealipase (PEZ) compared with placebo in the reduction of postprandial irritable bowel syndrome-diarrhoea (IBS-D).

Design An 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.

Setting Outpatient internal medicine practice clinic.

Patients 255 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.

Interventions After 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 measures The primary analysis was number of patients who chose PEZ over placebo for the extended use.

Results Overall, 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.

Conclusions PEZ was found in a small group of patients to reduce postprandial IBS-D symptoms and deserves further evaluation.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl

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Footnotes

  • Funding Pancreatic enzymes were supplied at no cost by Axcan Pharma. The company also funded the statistical analysis and initial editing but was not involved in the planning or conduct of the trial. Small unrestricted grants were received from the Medical Staff of the Washington County Hospital, the Washington County Health Systems Community Health Council Fund and the Hagerstown Medical Laboratory. Individual donations were also received from G Manger, MD, M Elliott, J Hershey and J Morgan.

  • Competing interests MEM—Axcan Pharma study support only: Viokase medication; funding for statistical analysis and editing of the paper. NT—Novartis, Takeda, GlaxoSmithKline, Dynogen, Tioga.

  • Ethical approval This randomised controlled trial was approved by the Washington County Hospital Institutional Review Board on 18 January 2002.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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