TY - JOUR
T1 - Proton pump inhibitor versus prokinetic therapy in patients with functional dyspepsia
T2 - Is therapeutic response predicted by Rome III subgroups?
AU - Hsu, Yao Chun
AU - Liou, Jyh Ming
AU - Yang, Tzeng Huey
AU - Hsu, Wei Lun
AU - Lin, Hwai Jeng
AU - Wu, Huei Tang
AU - Lin, Jaw Town
AU - Wang, Hsiu Po
AU - Wu, Ming Shiang
PY - 2011/2
Y1 - 2011/2
N2 - 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.
AB - 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.
KW - Epigastric pain syndrome
KW - Functional dyspepsia
KW - Lansoprazole
KW - Mosapride
KW - Postprandial distress syndrome
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U2 - 10.1007/s00535-010-0334-1
DO - 10.1007/s00535-010-0334-1
M3 - Article
C2 - 20957498
AN - SCOPUS:79954442464
SN - 0944-1174
VL - 46
SP - 183
EP - 190
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
IS - 2
ER -