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Journal of Gastroenterology

, Volume 46, Issue 2, pp 183–190 | Cite as

Proton pump inhibitor versus prokinetic therapy in patients with functional dyspepsia: is therapeutic response predicted by Rome III subgroups?

  • Yao-Chun Hsu
  • Jyh-Ming Liou
  • Tzeng-Huey Yang
  • Wei-Lun Hsu
  • Hwai-Jeng Lin
  • Huei-Tang Wu
  • Jaw-Town Lin
  • Hsiu-Po Wang
  • Ming-Shiang WuEmail author
Original Article—Alimentary Tract

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 (ClinicalTrials.gov number, NCT00663897).

Keywords

Functional dyspepsia Lansoprazole Mosapride Epigastric pain syndrome Postprandial distress syndrome 

Notes

Acknowledgments

The authors are indebted to Fang-Yu Liu and Wan-Jen Sung for their skillful assistance in patient recruitment and data analysis.

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Copyright information

© Springer 2010

Authors and Affiliations

  • Yao-Chun Hsu
    • 1
  • Jyh-Ming Liou
    • 2
    • 5
  • Tzeng-Huey Yang
    • 3
  • Wei-Lun Hsu
    • 3
  • Hwai-Jeng Lin
    • 4
  • Huei-Tang Wu
    • 3
  • Jaw-Town Lin
    • 1
    • 2
    • 5
  • Hsiu-Po Wang
    • 2
    • 5
  • Ming-Shiang Wu
    • 2
    • 5
    Email author
  1. 1.Department of Internal MedicineE-Da Hospital, I-Shou UniversityKaohsiungTaiwan
  2. 2.Department of Internal MedicineNational Taiwan University HospitalTaipeiTaiwan
  3. 3.Division of Gastroenterology, Department of MedicineLotung Poh-Ai HospitalIlanTaiwan
  4. 4.Division of Gastroenterology, Department of MedicineChanghua Christian HospitalChanghuaTaiwan
  5. 5.National Taiwan University College of MedicineTaipeiTaiwan

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