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...
A survey was mailed to all institutions in Canada licensed to use radiopharmaceuticals. Questions addressed meal type; mode of preparation; and means, ranges and SD of emptying times. Seventy-eight per cent of 222 facilities responded, including all 55 teaching centres. Eighty-five per cent of teaching and 56% of nonteaching centres perform solid phase gastric emptying studies (GES). The majority use 99mTc sulphur colloid (Tc-SC) added to eggs before cooking as the standard meal. Twenty-five per cent of teaching and 21% of nonteaching centres perform liquid phase GES. Most use a watery solution of 111Indiethylenetriamine pentaacetic acid. Gastric emptying for solid phase GES, expressed as time for 50% emptying (mean t1/2), varied from 42 to 105 mins for centres using the Tc-SC egg meal. Twenty-eight per cent of teaching centres used +/- 2 SD to define their normal range, 26% used +/- 1 SD, 6% used +/- 1.5 SD, and 40% did not know the number of SD used. Twenty per cent of nonteaching centres used +/- 2 SD, 12% used +/- 1 SD and 68% did not know how many SD were used. For liquid phase GES, mean t1/2 varied from 20 to 60 mins. Eighteen per cent of centres used healthy volunteers to establish or validate normal ranges. There is substantial variability among the normal ranges for radionuclide solid and liquid phase GES in both teaching and nonteaching centres across Canada. A minority of facilities have established or validated their own normal ranges in healthy volunteers. There is a need for a more standardized protocol and range of normal, with internal validation by each institution.
In a randomised cross-over study of treatment for 7 days with cimetidine 600 mg twice daily and placebo, cimetidine had no effect on the pharmacokinetics of a single intravenous dose of dexamethasone sodium phosphate. Likewise the elimination characteristics of endogenous cortisol in the dexamethasone suppressed state were not affected by cimetidine.
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