Predictors of the placebo response in functional dyspepsia

N. J. Talley, G. R. Locke, B. D. Lahr, A. R. Zinsmeister, M. Cohard-Radice, T. V. D'Elia, J. Tack, D. L. Earnest

Research output: Contribution to journalArticlepeer-review

84 Scopus citations

Abstract

Background: Trials in functional dyspepsia report placebo response rates of 30% to 40%. Aim: We aimed to identify predictors of the placebo response. Methods: Patients from primary, secondary and tertiary practices with functional dyspepsia defined by Rome II criteria were enrolled into one of four clinical trials; 220 patients were randomized to receive placebo. Scintigraphic assessment of gastric emptying at baseline was repeated at the end of the treatment in those with delayed emptying. After a 2 week run-in period, patients were followed for 8 weeks on placebo. Response was assessed on a weekly basis and a responder was defined as satisfactory relief of meal-related symptoms on at least 50% of weeks. Results: The mean age was 44 years (range 18-82) and 74% were female; 76 (35%) were placebo responders. The predominant symptom was an unstable measure over the trial. Independent predictors of a lower placebo response were lower body mass index and a more consistent predominant symptom pattern (both P < 0.05). No association was seen with age, gender, centre type, baseline symptom score, baseline or change in gastric emptying, or baseline quality of life. Conclusion: In functional dyspepsia, a consistent predominant symptom pattern and lower body mass index may be associated with a lower placebo response rate.

Original languageEnglish (US)
Pages (from-to)923-936
Number of pages14
JournalAlimentary Pharmacology and Therapeutics
Volume23
Issue number7
DOIs
StatePublished - Apr 2006

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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