Cisapride 20 mg b.i.d. Provides Symptomatic Relief of Heartburn and Related Symptoms of Chronic Mild to Moderate Gastroesophageal Reflux Disease

Objective: We evaluated the efficacy and safety of a twice-daily dosage regimen of cisapride 20 mg in relieving the symptoms of mild-moderate gastroesophageal reflux disease (GERD) in patients with moderate intensity heartburn and no history of erosive esophagitis.
Methods: After a 2-wk, single-blind, placebo run-in period, 398 patients who continued to experience moderate intensity heartburn were randomized to either placebo (  n = 196  ) or cisapride 20 mg (  n = 202  ) twice daily for 4 wk.
Results: Compared with placebo, cisapride significantly reduced scores for daytime and nighttime heartburn (   p < 0.001  ), total regurgitation (   p < 0.001  ), eructation (   p = 0.04  ), and early satiety (   p = 0.04  ). Cisapride 20 mg b.i.d. was also superior to placebo in reducing total use of rescue antacid medication (   p < 0.001  ); reducing, in concordance analyses, daytime and nighttime heartburn with antacid usage (   p < 0.001  ); increasing the percentage of heartburn-free days and antacid-free nights (   p < 0.5  ); and increasing the percentage of patients self-rated as having minimal or better symptomatic improvement (   p = 0.01  ). Cisapride 20 mg b.i.d. was well tolerated. The most common adverse event in the cisapride group was diarrhea, reported by 10% of patients, compared with an incidence of 4% in the placebo group.
Conclusion: Cisapride 20 mg b.i.d. was shown to be effective and safe for the short-term treatment of daytime and nighttime heartburn and for other symptoms associated with mild-moderate GERD.     

Cisapride versus placebo in reflux esophagitis. A multicenter double-blind trial

In a 6 to 12-week double-blind trial, the effect of cisapride (10 mg q.i.d.) was compared with that of placebo in 63 patients with esophagitis confirmed by endoscopy and/or biopsy. In only one patient (3%) in the cisapride group but in 43% of the placebo patients (p = 0.001), symptoms had not improved after 6 weeks. Forty patients continued treatment until week 12. At that time, control endoscopy showed a significantly (p = 0.005) higher rate of healing (no erosions, ulcers, or bleeding mucosa) in the cisapride patients (63%) than in the placebo patients (12%). At week 12, only three of the 21 cisapride patients still had moderate reflux symptoms, whereas eight of the 19 placebo patients had moderate or severe symptoms (p less than 0.05). Cisapride patients also took significantly (p less than 0.001) less antacids during the trial. These results show that cisapride, 10 mg q.i.d., heals esophagitis lesions and greatly reduces associated symptoms. The treatment was well tolerated.     

Sucralfate used as adjunctive therapy in patients with severe erosive peptic esophagitis resulting from gastroesophageal reflux

A total of 36 patients with grade 2 or greater erosive esophagitis and an abnormal 24-h pH monitor study, were treated in a randomized, double-blind fashion to assess the efficacy of sucralfate suspension as adjunctive therapy to cimetidine for severe esophagitis secondary to gastroesophageal reflux. Treatment consisted of cimetidine, 300 mg qid and either sucralfate suspension (1 g/10 ml) or an identical placebo suspension, 10 ml after meals and 20 ml hs. Patients were treated for 12 wk unless endoscopic healing occurred earlier. Initial evaluation and monthly follow-up consisted of symptom monitoring, endoscopic evaluation and pre- and post-therapy esophageal manometry, Bernstein test, and 24-h pH monitoring. The combination of cimetidine and sucralfate suspension was superior to cimetidine alone in improving daytime heartburn symptoms (p less than 0.05) but not nighttime heartburn, dysphagia, or regurgitation. Sucralfate plus cimetidine improved the overall endoscopic outcome of esophagitis more than cimetidine alone (p less than 0.05). More patients exhibited endoscopic healing in the adjunctive sucralfate group than in the cimetidine-only group. Endoscopic healing, however, was not statistically different between groups. We conclude that sucralfate used as adjunctive therapy to cimetidine resulted in improvement of some of the symptoms of reflux, and probably increases the likelihood of complete healing of esophagitis, compared with cimetidine alone.     

Cisapride and cimetidine in the treatment of erosive esophagitis

The efficacy of cisapride, as compared with cimetidine, in the treatment of erosive esophagitis was studied in a double-blind trial. One hundred and twenty-nine patients were assigned to one of four dosage schedules: cisapride 10 mg b.i.d. (20 mg group) or q.i.d. (40 mg group), or cimetidine 400 mg b.i.d. (800 mg group) or q.i.d. (1600 mg group). Treatment lasted 8 to 12 weeks. The degree of esophagitis and the severity of diurnal and nocturnal heartburn and regurgitation were significantly (p less than 0.01) reduced in the four treatment groups. Endoscopy did not show any significant differences among the four groups, although cisapride tended to be more effective in moderate to severe esophagitis, in which cases mucosal healing (i.e. absence of erosions and ulcers) was observed in 69%, 64%, 55% and 55% of the patients treated with cisapride 40 mg, cisapride 20 mg, cimetidine 1600 mg and cimetidine 800 mg. Improvement in reflux symptoms in the two cisapride groups was not significantly different from that in the cimetidine 1600 mg group, but was better (p less than 0.05) than that in the cimetidine 800 mg patients. The severity score for all reflux symptoms had decreased by 79%, 74% (cisapride 40 mg and 20 mg), 69% and 57% (cimetidine 1600 mg and 800 mg) by the end of treatment. These results show that cisapride is at least as effective as acid-suppressing therapy in patients with reflux esophagitis, and is therefore a valuable alternative to it.     

Two doses of omeprazole versus placebo in symptomatic erosive esophagitis: the U.S. Multicenter Study.

Two hundred thirty patients with reflux symptoms and endoscopically proven erosive esophagitis were enrolled from 15 U.S. centers into a randomized, double-blind, dose-ranging study comparing placebo with omeprazole, 20 or 40 mg given once daily in the morning. Esophagitis grade 2 was present in 44% of patients, grade 3 in 37% of patients, and grade 4 in 19% of patients. Endpoints, defined as complete relief of heartburn and complete esophageal mucosal healing, were assessed after 4 and 8 weeks of treatment. Both omeprazole doses were significantly superior to placebo in complete endoscopic healing. After 8 weeks of treatment, 73.5% of patients in the 20-mg omeprazole group and 74.7% in the 40-mg omeprazole group, compared with 14.0% in the placebo group, had complete healing of the esophageal mucosa. At the end of the study, complete relief of daytime heartburn was obtained in 79.5% of patients in the 20-mg omeprazole group, 81.6% in the 40-mg omeprazole group, and 37.2% in the placebo group (P less than or equal to 0.05). Complete relief of nighttime heartburn was noted by 79.5% of patients in the 20-mg omeprazole group, 85.1% in the 40-mg omeprazole group, and 34.9% in the placebo group (P less than or equal to 0.05). The median time to complete relief of daytime and nighttime heartburn occurred earlier in the 40-mg group than in the 20-mg group (9 vs. 17 days and 9 vs. 20 days, respectively); however, these differences were not statistically significant. Relief of acid regurgitation and dysphagia also occurred earlier in the 40-mg group. Omeprazole was well tolerated in this group of patients. No unexpected adverse experiences occurred. The results of this study confirm those of six multicenter, international trials in which omeprazole in doses of 20-60 mg provided a degree of esophageal mucosal healing and complete relief of reflux symptoms superior to any other medical treatment.     

Management of heartburn in a large, randomized, community-based study: comparison of four therapeutic strategies

OBJECTIVE: Our objective was to compare four management strategies for heartburn: therapy with an H2-receptor antagonist (ranitidine), therapy with a proton pump inhibitor (lansoprazole), crossover from ranitidine to lansoprazole ("step-up" therapy), and crossover from lansoprazole to ranitidine ("step-down" therapy). METHODS: This was a controlled, double-blind, multicenter trial comprising 593 adults with heartburn, randomized to one of four groups for 20 wk. Subjects received either ranitidine 150 mg b.i.d. for 20 wk, or lansoprazole 30 mg once daily for 20 wk, or ranitidine 150 mg b.i.d. for 8 wk [corrected] followed by lansoprazole 30 mg once daily for 12 wk ("step-up"), or lansoprazole 30 mg once daily for 8 wk followed by ranitidine 150 mg b.i.d. for 12 wk ("step-down"). Outcome measures were based on self-reports in daily diaries of 24-h heartburn severity, measured by maximum daytime and nighttime severity, and percentage of 24-h heartburn-free days measured by absence of both daytime and nighttime heartburn. RESULTS: Median heartburn severity was significantly lower (p < 0.05) for lansoprazole (0.25) than the other groups (0.46 ranitidine, 0.44 "step-up," 0.35 "step-down"). The lansoprazole group had a significantly higher percentage of 24-h heartburn-free days (median 81.4%, p < 0.01) than other groups (66.6, 66.9, and 73.6%, respectively). In the "step-up" and "step-down" groups, heartburn was less severe, and percentages of 24-h heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence. CONCLUSION: Proton pump inhibitor treatment provides more consistent heartburn relief than an H2-receptor antagonist, or "step-up" or "step-down" therapy.     

Metoclopramide in Gastroesophageal Reflux Disease: Rationale for its Use and Results of a Double-Blind Trial

We investigated the acute effect of metoclopramide on lower esophageal sphincter pressure, esophageal contraction amplitude, and gastric emptying and compared metoclopramide, 10 mg four times a day, to placebo in improving the symptoms and objective parameters of reflux esophagitis in 19 patients in a randomized, double-blind 4-wk outpatient trial. Orally administered metoclopramide, 10 mg, significantly accelerated gastric emptying of a semisolid meal in patients in whom it was delayed; lower esophageal sphincter pressure was significantly increased for up to 90 min, but there were no changes in esophageal contraction amplitude. During the treatment trial, metoclopramide resulted in an overall improvement in heartburn and regurgitation of 60%, significantly better than 32% improvement after placebo (p less than 0.05). Compared to baseline symptoms scores, metoclopramide significantly improved both daytime and nighttime heartburn and regurgitation. Compared to placebo-treated patients, the metoclopramide group had significantly fewer episodes of daytime heartburn and regurgitation (p less than 0.05), while nighttime symptoms significantly improved with both treatments. Mean antacid consumption was significantly reduced by metoclopramide, 61%, compared to placebo-treated patients, 21% (p less than 0.05), who were ingesting a mean of 1.9 oz of antacid daily. Endoscopic and histological improvement were similar in both groups, although histological healing occurred in three patients after metoclopramide compared with none in the placebo group. Our data suggest that: 1) gastric emptying and lower esophageal sphincter pressure were significantly improved by acute administration of oral metoclopramide; 2) metoclopramide therapy for 4 wk is significantly more effective than placebo (medium dose antacid therapy) in relieving the symptoms of gastroesophageal reflux without significantly altering objective parameters of esophagitis; 3) metoclopramide effectively addresses the diffuse upper gastrointestinal motor disturbances present in reflux esophagitis patients.     

Ranitidine therapy for gastroesophageal reflux disease. Results of a large double-blind trial

In a multicenter, double-blind trial, 284 patients with gastroesophageal reflux disease were evaluated before, during, and after six weeks of treatment with either placebo or ranitidine (150 mg twice daily). Randomization resulted in two comparable patient groups. Ranitidine treatment was significantly more effective than placebo treatment in decreasing the frequency and the severity of heartburn during both daytime and nighttime assessment periods. There was a significant correlation between improvement in heartburn symptoms and decrease in antacid consumption; hence, patients receiving ranitidine consumed significantly fewer antacid tablets. Among patients with endoscopic esophagitis at baseline, the overall change in endoscopic classification after six weeks of therapy was significantly better for the ranitidine-treated patients. The ranitidine-treated group had less evidence of erosions and ulcerations as well as greater healing. There were no differences between the groups with respect to changes in esophageal mucosal sensitivity to acid perfusion or changes in histologic grading of esophageal mucosal biopsy specimens. The ranitidine safety profile was similar to that of previous studies. We conclude that, in patients with gastroesophageal reflux disease, ranitidine therapy, 150 mg twice daily, markedly reduced the heartburn symptoms of reflux disease and significantly improved the endoscopic appearance of the esophageal mucosa.     

Effect of cisapride on gastroesophageal reflux in children with chronic bronchopulmonary disease: a double-blind cross-over pH-monitoring study

Fourteen patients with chronic bronchopulmonary disease and suspected of having gastroesophageal reflux were studied for 16 hr by intraesophageal pH monitoring to investigate the effect of the prokinetic drug cisapride. Cisapride was administered orally in a double-blind cross-over study. The initial dose was 0.3 mg/kg, followed by 0.15 mg/kg every 4 hr for 12 hr. Cisapride was shown to be superior to placebo in reducing gastroesophageal reflux. Both during the total recording period and during the sleep period, cisapride significantly decreased the percentage of time during which the pH was 4 or less (vs placebo; total period, -60%; sleep, -80%) and reduced the number of reflux spells of at least 5 min (-64%; -92%). No adverse effects of cisapride were observed.     

Cisapride versus ranitidine in the treatment of reflux esophagitis

The healing effect of the prokinetic drug cisapride (10 mg q.i.d.) on esophageal lesions, and its therapeutic control of gastroesophageal reflux symptoms were compared with the effects of the H2-antagonist ranitidine (150 mg b.i.d. + placebo b.i.d.) in a double-blind trial. In each group, 28 patients with Savary-Miller Grade I or II esophagitis were treated for 6 or 12 weeks. At the end of treatment, follow-up endoscopy showed that mucosal lesions were absent in 89% of the cisapride patients and in 79% of the ranitidine patients. In addition, 86% and 82% of the patients in the cisapride and the ranitidine group, respectively, had no, or only mild, reflux symptoms. Minor side effects were experienced in both groups. From these data, cisapride appears to be as effective as ranitidine in controlling reflux symptoms and in promoting the healing of mucosal lesions in milder forms of reflux esophagitis.     

Effect of cisapride on secondary peristalsis in patients with gastroesophageal reflux disease

OBJECTIVE: Improvement of esophageal acid clearance appears to be an important effect of cisapride in the treatment of reflux disease. The mechanism underlying this effect is not clear. Esophageal peristalsis is a major component of the acid clearance process. In normal subjects secondary peristalsis is an important mechanism of esophageal acid clearance during sleep, and this response appears to be impaired in patients with reflux esophagitis. The effects of cisapride on secondary peristalsis are not known. The aim of this study was to investigate the effects of cisapride on the triggering and characteristics of secondary peristalsis in patients with reflux esophagitis. METHODS: In 17 patients with reflux esophagitis and impaired secondary peristalsis cisapride, 10 mg q.i.d., or placebo were administered in a randomized double blind, crossover design for 4 days separated by a 4-7 day washout period. On the fourth day of treatment, primary peristalsis and secondary peristalsis in response to 10- and 20-ml air boluses were assessed. RESULTS: Secondary peristaltic success and amplitude were greater with the 20-ml bolus than with the 10-ml bolus. However, cisapride had no effect on either secondary peristaltic success or amplitude. Cisapride also had no effect on primary peristalsis or basal LES pressure. CONCLUSIONS: The improvement in esophageal acid clearance by cisapride is not explainable by improvement in secondary peristalsis.     

Nizatidine versus placebo in gastroesophageal reflux disease

In a randomized, multicenter trial, nizatidine 150 mg or 300 mg, or placebo, was administered twice daily for six weeks to 515 patients with gastroesophageal reflux disease (GERD). Gelusil antacid tablets were taken as needed for pain. Significantly superior rates of endoscopically proven complete healing (normal-appearing mucosa) versus placebo occurred after three weeks with nizatidine 150 mg, and after six weeks with nizatidine 300 mg. Six-week healing rates were 38.5% for nizatidine 300 mg, 41.1% for nizatidine 150 mg, and 25.8% for placebo. The nizatidine 150 mg treatment group had significantly greater improvement in daytime and nighttime heartburn severity after one day of therapy versus placebo. Twice-daily administration of nizatidine 150 mg or 300 mg provides prompt relief from the major symptom of GERD, heartburn, and complete healing of esophagitis is seen in many patients.     

A Placebo-Controlled Dose-Ranging Study of Lansoprazole in the Management of Reflux Esophagitis

Objective : We compared the efficacy of three different doses of the proton pump inhibitor lansoprazole in the management of reflux esophagitis. Methods : Two hundred ninety-two patients with endoscopically confirmed reflux esophagitis were enrolled in a double-blind, multicenter study and were randomized to lansoprazole 15, 30, or 60 mg or placebo administered once daily for 8 wk. Results : Healing rates after 4 wk of lansoprazole 15, 30, and 60 mg/d were 67.6%, 81.3%, and 80.6%, respectively. These were all significantly superior (   p < 0.001  ) to placebo, which produced endoscopic healing in only 32.8% of the patients after 4 wk. The 4-wk healing rates with lansoprazole 30 or 60 mg were significantly higher than that with lansoprazole 15 mg (   p < 0.05  ), confirming a dose-response effect. Cumulative healing rates after 8 wk of treatment were 52.5% with placebo and 90.0%, 95.4%, and 94.4% with lansoprazole 15, 30, and 60 mg, respectively (   p < 0.001  for all doses of lansoprazole vs placebo). Lansoprazole was also significantly superior to placebo in relieving symptoms in patients with reflux esophagitis. Lansoprazole was well tolerated, and no serious treatment-related adverse events were encountered. Up to 3 months after discontinuation of treatment, all lansoprazole-treated groups had more patients free of endoscopic evidence of esophagitis than the group treated with placebo. Conclusions : Lansoprazole was safe and effective for the treatment of reflux esophagitis in this trial. This study indicates that the optimum daily dose of lansoprazole for reflux esophagitis is 30 mg.     

Chronic Oral Treatment with Cisapride Decreases High Bile Salt Reflux Rates

The effect of cisapride, a new gastrokinetic drug, on gastric emptying and duodenogastric reflux of bile salts was tested in healthy volunteers in a placebo-controlled double-blind randomized cross-over trial. Twenty subjects were treated with either 10 mg of cisapride, tid orally or with matching placebo tablets for 1 wk. On test days, the subjects were studied using a marker technique with gastric intubation in the fasting state and after feeding a mixed liquid meal. Cisapride did not affect gastric secretion and gastric emptying. There was a tendency to lower reflux rates after cisapride treatment both fasting (0.63 +/- 0.14 versus 0.38 mumol/min +/- 0.05 SEM) and after feeding (2.60 +/- 0.61 versus 1.88 mumol/min +/- 0.33 SEM). This was due to a decrease of high placebo reflux rates: the reduction of reflux rate achieved by cisapride was significantly correlated to the height of the placebo reflux rate (p less than 0.001). A similar relationship was found for gastric bile salt concentration (p less than 0.001). It is concluded that cisapride reduces high bile salt reflux. Therapeutic trials with this drug in diseases where high bile reflux is believed to play a pathogenic role are of interest.     

The effect of cisapride on oesophageal motility and lower sphincter function in patients with gastro-oesophageal reflux disease

OBJECTIVES : To evaluate the efficiency by which the 5-HT4 agonist cisapride affects important motor functions involved in the control of gastro-oesophageal reflux. METHOD : Thirty patients with proven gastro-oesophageal reflux disease (endoscopy and 24 h pH-metry) were included in a randomized, double-blind, placebo controlled study with a cross-over design. Cisapride, 20 mg b.i.d., during 4 weeks was compared with placebo. At baseline, as well as after 4 and 8 weeks all patients underwent symptom assessments, sleeve manometry with concomitant oesophageal pH-monitoring and an acid clearance test. RESULTS : Despite adequate plasma levels cisapride had no significant effect on swallow induced peristaltic amplitude, duration, propagation speed, the elicitation of secondary peristalsis nor on acid clearance. Neither the basal tone of the lower oesophageal sphincter nor the number of transient lower oesophageal sphincter relaxations induced by gas distension of the stomach was affected by the administered dose of cisapride. CONCLUSION : Although cisapride has been alleged to improve symptoms as well as the oesophagitis in patients with gastro-oesophageal reflux disease, we found the compound (20 mg b.i.d.) devoid of effects on important motor mechanisms involved in the pathogenesis of the disease.     

阻塞性睡眠呼吸暂停与胃食管反流的关系及对抗反流治疗的效果

目的 研究阻塞性睡眠呼吸暂停（ＯＳＡ）与胃食管反流（ＧＥＲ）的关系及西沙必利和奥美拉唑对两者的治疗效果。方法 １８例有睡眠打鼾和反流症状的患者接受了昼夜食管ｐＨ和压力监测,并在夜间睡眠时与多导睡眠图（ＰＳＧ）同步监测;对同时有ＧＥＲ和ＯＳＡ患者予以西沙必利（１０ｍｇ,４次／日）和奥美拉唑（２０ｍｇ,２次／日）治疗１周后重复以上检查。结果 ７例（３８．９％）同时合并有ＯＳＡ及重度ＧＥＲ,除１例外不仅     

Rabeprazole is superior to ranitidine in the management of active duodenal ulcer disease: results of a double-blind, randomized North American study

OBJECTIVE: The primary purpose of this study was to compare the efficacy and tolerability of rabeprazole versus ranitidine in the treatment of patients with active duodenal ulcer disease. METHODS: This multicenter, double-blind, randomized, parallel-group study enrolled 376 patients. Patients were randomly assigned to receive rabeprazole 20 mg administered once daily in the morning (q.a.m.) with matching ranitidine placebo twice daily (b.i.d.) (n = 188), or ranitidine 150 mg b.i.d. with matching rabeprazole placebo q.a.m. (n = 188). Three visits were scheduled: wk 0 (baseline; days -3 to -1), wk 2 (day 15+/-3 days), and wk 4 (day 29+/-3 days). The primary efficacy response variable was defined as complete regeneration of the mucosa at the site of all ulcers identified during the study. Secondary efficacy variables included patients' ratings of frequency and severity of ulcer pain, frequency of antacid use, and improvement of overall physical well-being. Tolerability was evaluated with analyses of adverse events, laboratory evaluations, fasting serum gastrin levels, vital signs, body weight, and electrocardiograms. RESULTS: Up to 4 wk of treatment with rabeprazole 20 mg q.a.m. produced significantly greater healing rates, compared to treatment with ranitidine 150 mg b.i.d. (83% vs 73%; p = 0.017). Significant differences between treatment groups were also observed for secondary efficacy indices. At wk 2, rabeprazole was more likely than ranitidine to produce complete resolution of duodenal ulcer pain (39% vs 25%; p = 0.006), improvement in duodenal ulcer nighttime pain severity (76% vs 65%; p = 0.044), and improvement in overall well-being (55% vs 41%; p = 0.009). At wk 4, the proportion of patients with normalization of overall well-being was significantly higher in the rabeprazole group than in the ranitidine group (45% vs 29%; p = 0.003). Rabeprazole was safe and well tolerated in this study. CONCLUSIONS: In patients with active duodenal ulcer disease, rabeprazole 20 mg q.a.m. is superior to ranitidine 150 mg b.i.d. in healing, resolving ulcer pain frequency, improving nighttime pain severity, and improving overall well-being. Rabeprazole is an effective and well-tolerated alternative treatment for patients with active duodenal ulcer disease.     

Healing of grade-II and III oesophagitis through motility stimulation with cisapride

The clinical relevance of cispride's stimulating effects on lower oesophageal motility was studied in 19 patients with documented (endoscopy, biopsy) grade II or III oesophagitis. Patients were treated for 8 or 16 weeks (depending essentially on whether the result was cure or failure) with 10 mg of cisapride four times a day (n = 11) or placebo (n = 8). Cisapride was superior to placebo with regard to mucosal healing (p less than 0.001) and symptomatic improvement (p less than 0.05): at the end of treatment, healing (grade 0) was observed in 8 cisapride patients, against 1 placebo patient, and reflux symptoms had disappeared in 7 and 1 patients, respectively. In conclusion, cisapride was of significant benefit to oesophagitis patients and was well tolerated.     

Effect of cisapride on postprandial gastro-oesophageal reflux.

We studied the effect of cisapride on oesophageal motor function and postprandial gastro-oesophageal reflux in a randomised, double blind, placebo controlled crossover study. In 16 patients with symptomatic gastro-oesophageal reflux, cisapride 10 mg orally and placebo were studied on separate days according to identical protocols. Cisapride and placebo were given 30 minutes before a standard meal. Each study day was preceded by corresponding three day oral loading of cisapride (10 mg tds) or placebo. Lower oesophageal sphincter pressure, oesophageal body motility and oesophageal pH were monitored for 30 minutes before and three hours after the meal. Plasma cisapride concentrations were measured before and after dosing on both study days. With cisapride treatment, the plasma cisapride levels ranged from 48.1 (5.0) to 75.9 (6.9) ng/ml. Plasma levels were undetectable during placebo treatment. Cisapride enhanced acid clearance but had no significant effect on the duration of acid exposure, the rate of reflux episodes, the pattern of lower oesophageal sphincter pressure associated with the reflux episodes, basal lower oesophageal sphincter pressure or oesophageal peristalsis. These findings do not suggest a major role for cisapride, at the dosage tested, for the control of troublesome postprandial gastro-oesophageal reflux.     

Effects of cisapride on parameters of oesophageal motility and on the prolonged intraoesophageal pH test in infants with gastro-oesophageal reflux disease.

The effect of cisapride, a new gastrointestinal prokinetic drug, on oesophageal motility and acid reflux was studied in 14 children with gastro-oesophageal reflux disease, receiving either placebo or cisapride 0.15 mg/kg intravenously. Cisapride significantly (p less than 0.01) increased the lower oesophageal sphincter pressure (+124%), the amplitude (+84%) and duration (+24%) of oesophageal peristaltic waves, whereas the placebo treatment did not produce any changes. Subsequently, all 14 children underwent 24 hour oesophageal pH-monitoring before and after four weeks of treatment with oral cisapride 0.2 mg/kg tid given in addition to postural therapy and thickened feedings. The 24 hour intraoesophageal pH recordings and symptomatic scores were compared with those of 10 control patients treated only by postural therapy and thickened feedings. When compared with baseline pH data, cisapride significantly reduced the oesophageal acid exposure time, the mean duration of each reflux episode, the duration of the longest reflux episode and the number of long lasting reflux episodes; the number of reflux episodes was not influenced. The effect of cisapride was marked and consistent during fasting and sleep periods. Oesophageal acid exposure was reduced more significantly in patients given cisapride (-61%) than in controls (-24%; p less than 0.001). Symptom improvement was greater after four weeks of cisapride treatment (score reduction: 61%) than after postural and dietary therapy alone (score reduction: 42%; p less than 0.01). No adverse effects occurred. These findings suggest that cisapride is a valuable drug in the management of gastro-oesophageal reflux disease in children.