No clinical benefit of adding cisapride to pantoprazole for treatment of gastro-oesophageal reflux disease

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dc.contributor.authorVan Rensburg C.J.
dc.contributor.authorBardhan K.D.
dc.date.accessioned2011-05-15T16:16:19Z
dc.date.available2011-05-15T16:16:19Z
dc.date.issued2001
dc.description.abstractObjective Although a proton pump inhibitor (PPI) and a prokinetic drug are often combined for the medical treatment of gastro-oesophageal reflux disease (GORD), there are few well-conducted clinical studies on the efficacy and tolerability of this therapy. This study investigates whether pantoprazole plus cisapride leads to an additional benefit in comparison to pantoprazole alone. Design and setting Randomized double-blind prospective multicentre study conducted in patients of 33 hospitals in Ireland, South Africa and the UK. Participants A total of 350 intention-to-treat (ITT) patients aged 18 years or older with GORD of grade II and III were included in the study. The per-protocol (PP) population comprised 152 patients in the pantoprazole group and 136 in the pantoprazole plus cisapride group. Interventions Patients received either pantoprazole 40 mg once daily or pantoprazole 40 mg once daily plus cisapride 20 mg twice daily. Treatment outcome was assessed after 4 and 8 weeks. The primary criterion was endoscopically confirmed healing after 4 weeks. Additionally, relief of leading symptoms was studied. Main outcome measures The prior null hypothesis was no difference in healing rates between both treatment groups. Results After 4 weeks of treatment 81% and 82%, and after 8 weeks 89% and 90%, of PP patients treated with pantoprazole or pantoprazole plus cisapride were healed, respectively. Thus, equivalence of the two treatment strategies could be proven. Additionally, improvement of symptom relief showed no significant difference between the two regimens. In contrast to disease grade at baseline, Helicobacter pylori status did not influence the healing rates in our study. Both study medications were tolerated well. Conclusion Addition of cisapride to pantoprazole provides no further benefit in the treatment of GORD. © 2001 Lippincott Williams & Wilkins.
dc.description.versionArticle
dc.identifier.citationEuropean Journal of Gastroenterology and Hepatology
dc.identifier.citation13
dc.identifier.citation8
dc.identifier.issn0954691X
dc.identifier.other10.1097/00042737-200108000-00006
dc.identifier.urihttp://hdl.handle.net/10019.1/13732
dc.subjectcisapride
dc.subjectpantoprazole
dc.subjectprokinetic agent
dc.subjectproton pump inhibitor
dc.subjectadult
dc.subjectarticle
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdisease severity
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug induced disease
dc.subjectdrug tolerability
dc.subjectendoscopy
dc.subjectfemale
dc.subjectgastroesophageal reflux
dc.subjecthealing
dc.subjectHelicobacter pylori
dc.subjecthuman
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjecttreatment outcome
dc.subject2-Pyridinylmethylsulfinylbenzimidazoles
dc.subjectBenzimidazoles
dc.subjectCisapride
dc.subjectDouble-Blind Method
dc.subjectDrug Therapy, Combination
dc.subjectEnzyme Inhibitors
dc.subjectEsophagoscopy
dc.subjectFemale
dc.subjectGastroesophageal Reflux
dc.subjectGastrointestinal Agents
dc.subjectH(+)-K(+)-Exchanging ATPase
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectOmeprazole
dc.subjectProton Pumps
dc.subjectSulfoxides
dc.subjectTreatment Outcome
dc.titleNo clinical benefit of adding cisapride to pantoprazole for treatment of gastro-oesophageal reflux disease
dc.typeArticle
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