Proton pump inhibitor versus prokinetic therapy in patients with functional dyspepsia: is therapeutic response predicted by Rome III subgroups?
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 (ClinicalTrials.gov number, NCT00663897).
Hsu
Yao-Chun
YC
Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan.
Liou
Jyh-Ming
JM
Yang
Tzeng-Huey
TH
Hsu
Wei-Lun
WL
Lin
Hwai-Jeng
HJ
Wu
Huei-Tang
HT
Lin
Jaw-Town
JT
Wang
Hsiu-Po
HP
Wu
Ming-Shiang
MS
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D015746:Abdominal Pain; D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001549:Benzamides / Q000627:therapeutic use*; D004415:Dyspepsia / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D015999:Multivariate Analysis; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D012044:Regression Analysis; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001549:Benzamides; D009025:Morpholines; D054328:Proton Pump Inhibitors; D017366:Serotonin Receptor Agonists; D064747:Lansoprazole; C062720:mosapride