Effects of domperidone in patients with chronic unexplained upper gastrointestinal symptoms: A double-blind, placebo-controlled study

Davis, Richard H.; Clench, Mary H.; Mathias, John R.

doi:10.1007/bf01535938

Cited by 109 publications

(63 citation statements)

References 15 publications

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“…Results reported in the literature on clinical trials with H 2 -receptor antagonists in NUD are contradictory, with only approximately half the studies showing significant improvement over placebo (8,24). 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).…”

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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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: 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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“…For a long time, it was felt that treatment of gastroparesis using prokinetic medication improved motility, thereby reducing symptoms. Most of the available studies [21, 22, 23, 24, 25, 26, 27, 28]report a partial reduction of symptoms; however, this improvement is poorly correlated with improvement in gastric emptying [19, 20, 29], although some studies reported a normalization of electrogastrographic activity [18]. In a meta-analysis of the existing studies examining the efficacy of prokinetics in gastroparesis, Strum et al [30]found that most studies had methodological limitations and showed no or little correlation between gastrokinetic and symptomatic effects.…”

Section: Discussionmentioning

confidence: 99%

Gastric Electrical Stimulation in Intractable Symptomatic Gastroparesis

et al. 2002

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Background: The treatment of gastroparesis remains unsatisfactory despite prokinetic and anti-emetic drugs. Gastric electrical stimulation has been proposed as a therapeutic option. We have assessed the effect of gastric electrical stimulation on symptoms, medical treatment, body weight and gastric emptying in patients with intractable symptomatic gastroparesis in a non-placebo-controlled study. Methods: In this multicenter study, 38 highly symptomatic patients with drug-refractory gastroparesis were enrolled. Patients first received temporary electrical stimulation using percutaneous electrodes. The 33 responders to temporary stimulation then underwent surgical implantation of a permanent stimulator. Severity of vomiting and nausea was assessed before and after stimulation. Patients were reassessed 3, 6, and 12 months after permanent implantation. Results: With stimulation, 35/38 patients (97%) experienced >80% reduction in vomiting and nausea. This effect persisted throughout the observation period (2.9–15.6 months, 341 patient-months). Gastric emptying did not initially change, but improved in most patients at 12 months. At 1 year, the average weight gain was 5.5% and 9/14 patients initially receiving enteral or parenteral nutrition were able to discontinue it. Conclusion: Electrical stimulation of the stomach has an immediate and potent anti-emetic effect. It offers a safe and effective alternative for patients with intractable symptomatic gastroparesis.

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“…The prokinetic action of domperidone may be transitory in nature. Although its effect on solid gastric emptying was lost at 6 weeks [7,9] , persistent reduction in symptom severity has been reported [9] . Domperidone is the drug of choice for patients with Parkinson's disease with gastrointestinal symptoms secondary to gastroparesis or to dopaminergic drugs used to treat the disease [10] .…”

Section: Domperidonementioning

confidence: 99%

“…In controlled clinical trials, domperidone is more effective than placebo in patients with diabetic gastroparesis and in symptomatic diabetic patients with normal gastric emptying [8,9] . The prokinetic action of domperidone may be transitory in nature.…”

Section: Domperidonementioning

confidence: 99%

Promotility Medications – Now and in the Future

Karamanolis

Tack²

2006

Dig Dis

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Gastrointestinal promotility drugs stimulate smooth muscle contractions to enhance gastric emptying and small and large bowel transit. Currently available drug classes with prokinetic properties include antidopaminergic agents, serotonergic agents, and motilin-receptor agonists. Due to moderate prokinetic effects, poor symptomatic responses and the presence of adverse effects, there is a clear need for new classes of prokinetics. Several newer prokinetic drugs and drug classes are currently under evaluation. Selecting candidate agents and designing the appropriate therapeutic trials is hampered by the lack of insight in the pathophysiology of motility-related symptoms. As gastrointestinal motor disorders are chronic, relapsing, and remitting disorders, it seems desirable that studies with candidate prokinetic drugs establish a long-term efficacy and not only short-term effects on gastrointestinal functions.

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Effects of domperidone in patients with chronic unexplained upper gastrointestinal symptoms: A double-blind, placebo-controlled study

Cited by 109 publications

References 15 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

Gastric Electrical Stimulation in Intractable Symptomatic Gastroparesis

Promotility Medications – Now and in the Future

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