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...

To evaluate earlier observations, including our own, showing usefulness of vitamin C for managing the common cold, we performed a double-blind trial of vitamin C versus placebo in 868 children. There was no difference in number becoming ill (133 versus 129), number of episodes (166 versus 159) or mean illness duration (5.5 versus 5.8 days) between the groups. Children receiving vitamin C had fewer throat cultures yielding beta-hemolytic streptococcus (six versus 13, P less than 0.10), but no difference in overall complicated illness rate (24 versus 25). Plasma ascorbic acid levels were higher in the vitamin group 24 to 26 hours after supplementation (1.28 versus 1.04 mg per 100 ml, P less than 0.01). Children with high plasma ascorbic acid concentrations had longer mean illness (6.8 versus 4.0 days, P less than 0.05) than those with low levels. Vitamin C does not seem to be an effective prophylactic or therapeutic agent for upper respiratory illness.

In a large double-blind study among Navaho school children, we evaluated the effects of vitamin C in 1-and 2-gram daily doses on acute respiratory illness during a 14-week period. 1 We found no evidence of significant prophylaxis, but our findings did suggest a modest therapeutic benefit in that children taking vitamin C had from 28% to 34% fewer days of morbidity caused by respiratory episodes than those taking placebo. Likewise, in classroom surveillance, younger children on vitamin C had 26% fewer symptom-days of cough and nasal discharge recorded. These observations were consistent with other recent trials using 1 gram daily (4 grams during illness) in Canadian adults 2 and 250-500 milligrams daily in Irish schoolchildren. 3The clinical significance of this modest therapeutic result in minor, selflimited illness was, in itself, questionable. However, further study was indicated to determine: (a) if use of vitamin C could prevent complications of the common cold in children, such as superinfections or otitis media; (b) if certain symptoms or symptom complexes responded specifically to vitamin C therapy; and (c) if indeed, as our data had suggested, 1 higher blood ascorbic acid levels were correlated with fewer days of illness. A second investigation was designed to confirm, if possible, and expand our previous findings. The second trial was conducted in two Navaho boarding schools during January through May 1974, using doses of 1 gram vitamin C daily versus placebo tablets. This report presents preliminary routine surveillance findings from the second study.

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