Efficacy of Cisapride in Functional Dyspepsia Resistant to Domperidone or Metoclopramide: A Double-Blind, Placebo-Controlled Study: General Discussion

Outryve, M. Van; Nutte, N. De; Eeghem, P Van; Gooris, J P

doi:10.3109/00365529309098328

Cited by 44 publications

(29 citation statements)

References 10 publications

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“…That the cisapride 10 mg group did not quantitatively or qualitatively demonstrate symptom improvement could simply be dose-related and indicate that, based on results from the present study, the preferred dose of cisapride to treat NUD is 20 mg tid. This, however, is difficult to reconcile with results from previously published papers that have shown positive results with cisapride doses administered at 4 mg tid to 10 mg tid (32)(33)(34)(35). Most important, the considerable variation in the design and execution of drug trials in NUD calls for a high degree of critical review when interpreting and comparing their results.…”

Section: Discussionmentioning

confidence: 93%

“…Clinical studies performed with the prokinetic agents metoclopramide (26)(27)(28) and domperidone (29,30) have shown symptomatic improvement over placebo in all but one report (31). Clinical trials with cisapride (19,20,(32)(33)(34)(35) in doses ranging from 4 mg tid to 10 mg tid have consistently demonstrated improvements that usually achieved statistical significance over placebo (32)(33)(34)(35). In contrast, negative results have also been reported in some studies of cisapride (19,20), perhaps due to the small number of subjects studied.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A Double‐Blind Randomized Study of Cisapride in the Treatment of Nonulcer Dyspepsia

MacCANNELL

Thomson

et al. 1997

Canadian Journal of Gastroenterology and Hepatology

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MC CHAMPION, KL MACCANNELL, ABR THOMSON, ET AL, FOR THE CANADIAN CISAPRIDE NUD STUDY GROUP.A double-blind randomized study of cisapride in the treatment of nonulcer dyspepsia. Can J Gastroenterol 1997;11(2):127-134. Cisapride is a substituted benzamide with gastrointestinal prokinetic effects presumed to be due to the enhancement of the physiological release of acetylcholine at the myenteric plexus. In a multicentre study, 189 patients with nonulcer dyspepsia (NUD) received single-blind placebo treatment for two weeks. A total of 123 patients with no or minimal response to placebo and epigastric pain of at least moderate severity and frequency were randomly assigned to one of three parallel double-blind treatments for six weeks: cisapride 10 mg tid, cisapride 20 mg tid or placebo. The severity and frequency of individual symptoms (epigastric pain, heartburn, nausea, vomiting, anorexia, postprandial discomfort, regurgitation, lower abdominal pain, bloating and constipation) were assessed on a four-and five-point categorical scale, respectively, by the investigator at three on-treatment visits and by patients in a daily diary. Analysis of investigator and patient assessments for differences in symptom severity x frequency composite scores among the three treatment groups showed no statistically significant differences for individual symptoms or symptom clusters. As assessed by the investigator, and compared with baseline, cisapride 20 mg tid significantly (P<0.05) improved epigastric pain, bloating and early satiety as well as improved the total symptom cluster. Investigator evaluation of the five most severe and frequent symptoms for each patient showed statistically significant improvement in each treatment group. For patient diary assessments, statistically significant within-treatment improvement of the total symptom cluster, the five most severe symptoms cluster, bloating and early satiety was observed for both cisapride 20 mg and placebo, whereas epigastric pain significantly (P<0.05) improved in all three treatment groups. Investigator evaluation of global response (good + excellent) rate at the end of the six-week treatment period was 38% for cisapride 20 mg, 47% for cisapride 10 mg and 33% for placebo. No statistically significant difference in this parameter among treatments was noted. Cisapride was well tolerated at both doses with a side effect profile comparable with that of placebo. It is concluded that, in this double-blind multicentre study with a single-blind two-week placebo run-in phase, cisapride 10 mg tid and 20 mg tid were not effective compared with placebo in improving symptoms in NUD patients. This study re-emphasizes the good prognosis of patients with NUD, with 14% of patients improving in the two-week placebo run-in phase and a further 33% improving in the next six weeks while on placebo. Within-treatment analysis of investigator assessments showed improvement for cisapride 20 mg tid suggesting a trend for efficacy at this dose. (Pour le résumé, voir page 128) Key Words: Cisapride, N...

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

A Double‐Blind Randomized Study of Cisapride in the Treatment of Nonulcer Dyspepsia

MacCANNELL

Thomson

et al. 1997

Canadian Journal of Gastroenterology and Hepatology

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“…85 There were no significant differences within any of these trials, although cisapride tended to be the most effective. The RR reduction for cisapride compared with domperidone was 48% (95% CI, -72 to 84), while compared to metoclopramide it was 43% (95% CI, -75 to 81).…”

Section: Comparisons Of Different Brands Of the Same Class Of Drugmentioning

confidence: 91%

“…83 One report suggested that cisapride was more effective than metoclopramide in treating NUD 84 but evidence for this is conflicting. 85 …”

Section: Evidence For Gastric Acid Secretion Abnormalitiesmentioning

confidence: 99%

The management of dyspepsia: a systematic review.

Delaney

Moayyedi²,

Deeks³

et al. 2000

Health Technology Assessment

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Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. NHS libraries can subscribe free of charge. Public libraries can subscribe at a very reduced cost of £100 for each volume (normally comprising 30-40 titles). The commercial subscription rate is £300 per volume. Please see our website for details. Subscriptions can only be purchased for the current or forthcoming volume. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email. Paying by official purchase orderYou can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK.We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA Programme and lists the membership of the various committees. Competing interests: R Hobbs is a board member of the European Society of Primary Care Gastroenterology, and has received sponsorship for travel and honoraria from a number of biotechnology and pharmaceutical companies for plenary talks and attendance at major scientific congresses and conferences. HTA Published end of 2000This report should be referenced as follows:Delaney B, Moayyedi P, Deeks J, Innes M, Soo S, Barton P, et al. NHS R&D HTA ProgrammeT he NHS R&D Health Technology Assessment (HTA) Programme was set up in 1993 to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS.Initially, six HTA panels (pharmaceuticals, acute sector, primary and community care, diagnostics and imaging, population screening, methodology) helped to set the research priorities for the HTA Programme. However, during the past few years there have been a number of changes in and around NHS R&D, such as the establishment of the National Institute for Clinical Excellence (NICE) and the creation of three new research programmes: Service Delivery and Organisation (SDO); New and ...

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“…There is evidence that metoclopramide liquid formulation may actually be more effective than the tablet [166] . Domperidone, a dopamine-2 receptor antagonist that does not cross the blood-brain barrier, is shown to improve symptoms in adults with FD [167] though it may be less effective when compared to cisapride [168,169] . Domperidone is currently available for pediatric patients only as an investigational new drug for compassionate use.…”

Section: Targeting Electromechanical Dysfunctionmentioning

confidence: 99%

Visceral hypersensitivity and electromechanical dysfunction as therapeutic targets in pediatric functional dyspepsia

Rosen

Cocjin

Schurman

et al. 2014

WJGPT

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Functional gastrointestinal disorders (FGID) are common clinical syndromes diagnosed in the absence of biochemical, structural, or metabolic abnormalities. They account for significant morbidity and health care expenditures and are identifiable across variable age, geography, and culture. Etiology of abdominal pain associated FGIDs, including functional dyspepsia (FD), remains incompletely understood, but growing evidence implicates the importance of visceral hypersensitivity and electromechanical dysfunction. This manuscript explores data supporting the role of visceral hypersensitivity and electromechanical dysfunction in FD, with focus on pediatric data when available, and provides a summary of potential therapeutic targets. Visceral sensitivity and intestinal electromechanical function both are demonstrated to be altered in some FD patients and are potential targets for treatment. Limited studies in pediatric FD are available, but available evidence supports adult data that targeting visceral hypersensitivity and electromechanical dysfunction is warranted, particularly in the context of the biopsychosocial model. Future studies in pediatrics are needed to determine optimal therapy and appropriate patient application.Rosen JM, Cocjin JT, Schurman JV, Colombo JM, Friesen CA. Visceral hypersensitivity and electromechanical dysfunction as therapeutic targets in pediatric functional dyspepsia. World

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Efficacy of Cisapride in Functional Dyspepsia Resistant to Domperidone or Metoclopramide: A Double-Blind, Placebo-Controlled Study: General Discussion

Cited by 44 publications

References 10 publications

A Double‐Blind Randomized Study of Cisapride in the Treatment of Nonulcer Dyspepsia

A Double‐Blind Randomized Study of Cisapride in the Treatment of Nonulcer Dyspepsia

The management of dyspepsia: a systematic review.

Visceral hypersensitivity and electromechanical dysfunction as therapeutic targets in pediatric functional dyspepsia

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