Proton pump inhibitor versus prokinetic therapy in patients with functional dyspepsia: Is therapeutic response predicted by Rome III subgroups?
Journal
Journal of Gastroenterology
Journal Volume
46
Journal Issue
2
Pages
183-190
Date Issued
2011
Author(s)
Abstract
Background: The comparative effectiveness of proton pump inhibitor versus prokinetic therapy in relieving the symptoms of patients with functional dyspepsia remains unknown. Whether the Rome III subgroups predict therapeutic response has not been investigated. Methods: This was an open-label, parallel randomized controlled trial. A total of 329 adult outpatients fulfilling the Rome III criteria for functional dyspepsia were randomly allocated to receive either lansoprazole 30 mg once daily (n = 166) or mosapride 5 mg thrice daily (n = 163) for 2 weeks. Enrolled patients were evaluated with the validated Hong Kong Index questionnaire for symptom severity at baseline and at the end of the trial. The primary outcome was symptom relief as defined by the Hong Kong Index, and the secondary outcome was decrease of symptom scores. Post-hoc multivariate logistic regression analysis was conducted to identify independent predictors for therapeutic response. Results: After 2-week therapy, 50.6% (84/166) and 47.85% (78/163) of the patients treated with lansoprazole and mosapride, respectively, achieved significant symptom relief (odds ratio 1.12, 95% confidence interval 0.72-1.72, p = 0.62). Differences in decreases of symptom scores between lansoprazole and mosapride receivers were also insignificant (-0.08, 95% confidence interval -1.25 to 1.09, p = 0.89). Therapeutic responses to either pharmacotherapy did not differ in the subgroup of patients fulfilling the criteria for epigastric pain syndrome (n = 256) or in those fulfilling the criteria for postprandial distress syndrome (n = 161). Multivariate logistic regression confirmed that the treatment allocation and Rome III subgroup were unrelated to treatment outcome. Conclusions: The effectiveness of proton pump inhibitor therapy and that of prokinetic therapy in functional dyspepsia are not different, and cannot be predicted by Rome III subgroups. ? 2010 Springer.
SDGs
Other Subjects
lansoprazole; mosapride; prokinetic agent; unclassified drug; adult; article; comparative effectiveness; controlled study; disease classification; disease severity; drug efficacy; drug response; dyspepsia; epigastric pain; female; functional dyspepsia; gastrointestinal symptom; Hong Kong Index; human; major clinical study; male; morning dosage; open study; outcome assessment; outpatient; parallel design; postprandial distress syndrome; priority journal; questionnaire; randomized controlled trial; symptom; treatment duration; treatment outcome; unspecified side effect; 2-Pyridinylmethylsulfinylbenzimidazoles; Abdominal Pain; Adult; Anti-Ulcer Agents; Benzamides; Dyspepsia; Female; Humans; Male; Middle Aged; Morpholines; Multivariate Analysis; Proton Pump Inhibitors; Regression Analysis; Serotonin Receptor Agonists; Severity of Illness Index; Treatment Outcome
Type
journal article