Levosulpiride and cisapride in the treatment of dysmotility-like functional dyspepsia: a randomized, double-masked trial.

BACKGROUND & AIMS: Levosulpiride is a benzamide derivate D(2) dopamine antagonist with prokinetic activity that can accelerate gastric emptying and reduce discomfort in response to gastric distention. The aim of the study is to compare the clinical efficacy of levosulpiride and cisapride in patients with dysmotility-like functional dyspepsia. METHODS: In a exploratory pilot study performed as a multicenter, randomized, double-masked trial, the effects of 8 weeks of treatment with either levosulpiride, 25 mg, 3 times daily (n = 69) or cisapride, 10 mg, 3 times daily (n = 71) were compared. Individual symptoms (pain/discomfort, fullness, bloating, early satiety, and nausea/vomiting), global symptom score, effect on health-related quality of life (HRQoL), and anxiety-state and anxiety-trait were evaluated. Adverse events also were recorded. RESULTS: Both levosulpiride and cisapride improved dyspeptic symptoms and decreased total symptom score (79.9% and 71.3%, respectively); no significant statistical difference between treatments was found (P = 0.07 for total symptom score). HRQoL improved similarly after both treatments, whereas no change was observed in anxiety. Medication-related adverse effects were present in 13 of 69 patients (18.8%) in the levosulpiride group and 8 of 71 patients (11.3%) in the cisapride group. Significantly more (P = 0.03) patients treated with cisapride had to abandon the trial because of side effects. CONCLUSIONS: Levosulpiride is at least as effective as cisapride in the treatment of dysmotility-like functional dyspepsia.     

Symptomatic,radionuclide and therapeutic assessment of chronic idiopathic dyspepsia

Twenty-eight patients with chronic idiopathic dyspepsia defined by the presence of chronic unexplained symptoms suggestive of gastric stasis and directly related to food ingestion were included in this prospective study. Gastric emptying of the liquid and solid phases of a meal was quantified by a dual-isotope method, and symptoms were evaluated by a diary and a visual analog scale. Delay in gastric emptying was evidenced in 59% of the dyspeptic patients; it occurred with liquids in more cases than solids. Quantitative and qualitative evaluation of symptoms was of no practical value in predicting the presence of objective stasis. The dyspeptic patients were included in a double-blind randomized controlled trial of cisapride, a new gastrokinetic drug devoid of central antiemetic effects. After six weeks of cisapride treatment, all patients with initially abnormal gastric emptying rates for liquids, and all but one for solids returned to normal ranges, and significant differences between cisapride and placebo groups were observed for half emptying times of both solids (136 +/- 16 min vs 227 +/- 32 min; P less than 0.02) and liquids (61 +/- 4 min vs 132 +/- 37 min; P less than 0.01). Cisapride also significantly improved dyspeptic symptom scores at weeks 3 and 6 of treatment as compared to those measured before treatment. Nevertheless, the decrease in global diary score was significantly higher than that seen with placebo at week 3 (-16 +/- 6 vs -1 +/- 9; P less than 0.05), but not at week 6 (-18 +/- 5 vs -10 +/- 8).(ABSTRACT TRUNCATED AT 250 WORDS)     

Effect of chronic administration of cisapride on gastric emptying of a solid meal and on dyspeptic symptoms in patients with idiopathic gastroparesis.

In a double blind crossover comparison with placebo, the effects of cisapride (10 mg tid for two weeks), a non-antidopaminergic gastrointestinal prokinetic drug, on gastric emptying times and on symptoms were evaluated in 12 patients with chronic idiopathic dyspepsia and gastroparesis. Gastric emptying was studied by a radioisotopic gamma camera technique. The test meal was labelled in the solid component (99mTc-sulphur colloid infiltrated chicken liver). Nine symptoms (nausea, belching, regurgitations, vomiting, postprandial drowsiness, early satiety, epigastric pain or burning, heartburn) were graded weekly on a questionnaire. Cisapride was significantly more effective than placebo in shortening the t1/2 of gastric emptying (p2 = 0.04), but no significant difference was observed between the two treatments with regard to the improvement of total symptom score (p2 = 0.09). No side effects were reported during the study.     

Effects of cisapride on gastric and esophageal emptying in progressive systemic sclerosis

The effects of cisapride on gastric emptying, esophageal emptying, and gastrointestinal symptoms were evaluated in 8 patients with progressive systemic sclerosis who had delayed gastric emptying of the solid or liquid component of a meal, or both. A double-isotope technique was used to measure gastric emptying, and esophageal emptying was measured as the time for a bolus of the solid meal to enter the stomach. Gastrointestinal symptoms were assessed by a questionnaire. On 2 days each patient received cisapride (10 mg) or placebo intravenously, 5 min before an esophageal and gastric emptying test. After these 2 days each subject took cisapride (10 mg q.i.d., p.o.) for 1 mo. Cisapride improved solid and liquid gastric emptying (p less than 0.001), but had no significant effect on esophageal emptying (p less than 0.1). Upper gastrointestinal symptoms were reduced after cisapride (p less than 0.001), and no side effects were reported. These results indicate that gastroparesis is a treatable cause of morbidity in progressive systemic sclerosis.     

Effect of cisapride on gastric emptying of indigestible solids in patients with gastroparesis diabeticorum. A comparison with metoclopramide and placebo

Cisapride is a prokinetic agent believed to facilitate acetylcholine release from the myenteric plexus of the gut. The effect of cisapride on gastric emptying of solids was studied in 9 diabetic patients, all of whom had delayed gastric emptying of indigestible solids (gastroparesis). Six patients had chronic nausea and vomiting, and 3 had no symptoms. Cisapride (5 mg) was given intravenously 15 min before ingestion of a 400-kcal test meal and 10 indigestible solid radiopaque markers. On separate days and in random order each patient also received intravenous metoclopramide (10 mg) or placebo 15 min before ingestion of the meal and markers. Mean gastric emptying of radiopaque markers, assessed by serial radiographs of the gastric region, was accelerated by metoclopramide and cisapride, but the difference reached significance only with cisapride (p less than 0.05). There was considerable intersubject variability in gastric emptying responses to cisapride and metoclopramide. No side effects occurred with either drug. This study indicates that acute, intravenous administration of cisapride accelerates gastric emptying of indigestible solids in patients with diabetic gastroparesis.     

Treatment of uninvestigated dyspepsia with cisapride for patients with negative Helicobacter pylori serologies

OBJECTIVE: The aim of this study was to compare symptoms for patients with uninvestigated dyspepsia and a negative Helicobacter pylori serology who were treated with cisapride or placebo. METHODS: Helicobacter pylori-seronegative patients with chronic dyspepsia were randomized to receive cisapride 10 mg t.i.d. or placebo t.i.d. for 30 days. Symptom scores were performed 1 month and 3 months after randomization. Outcomes measured were dyspepsia symptom scores and a treatment "success" variable defined as absence of symptoms or decrease in the most severe individual symptom by two grades. RESULTS: A total of 60 patients were randomized; 56 completed the 1-month follow-up and 40 completed the 3-month follow-up interview. The mean score for all patients at the time of entry was 11.0 and declined to 8.3 and 8.2 at 1 and 3 months, respectively, after randomization. At 1 month and 3 months after randomization, there was no significant difference in the number of patients meeting the "success" variable for patients receiving cisapride as compared to placebo. The mean decline in symptom severity scores was not significantly different for patients receiving placebo or cisapride at 1 month (mean, -2.8 vs -3.1; difference = 0.3, p = 0.74) or 3 months (-3.1 vs -2.6, difference = -0.5, p = 0.58) after randomization. CONCLUSIONS: No significant difference in the severity of dyspeptic symptoms was found for patients receiving cisapride as compared to placebo in the setting of uninvestigated dyspepsia and a negative Helicobacter pylori serology.     

Longterm oral cisapride improves interdigestive antroduodenal motility in dyspeptic patients.

We have evaluated the effect of cisapride on interdigestive antroduodenal motility during a prolonged oral therapy in 20 consecutive dyspeptic subjects. Individuals with less than two migrating motor complexes (MMCs) starting from the antral region in 240 minutes and without evidence of upper gastrointestinal tract diseases were randomly treated with either cisapride (10 cases), or placebo (10 cases) for 15 days. Computerised manometry of antroduodenal region was performed for 240 minutes, in basal conditions and on the 15th day of therapy. Symptomatic evaluation of patients was also performed before and after treatment. After cisapride administration, a significant increase in the incidence of antral migrating motor complexes was noticed (p = 0.022); likewise, the motility index, calculated for phase-2 periods, appeared to be significantly higher both in the antrum and in the duodenum (p less than 0.001). Symptomatic improvement was observed in both groups, with a hardly significant (p = 0.049) reduction of dyspeptic symptoms severity only but not of frequency in cisapride treated patients v controls. We conclude that longterm oral therapy with cisapride improves interdigestive antroduodenal motor activity.     

The effects of cisapride on gastric and oesophageal emptying in dystrophia myotonica

The effects of cisapride on gastric emptying, oesophageal emptying, and gastrointestinal symptoms were evaluated in 10 patients with dystrophia myotonica who had delayed gastric emptying of the solid and/or liquid component of a meal. A double isotope technique was used to measure gastric emptying and oesophageal emptying was measured as the time taken for a bolus of the solid meal to enter the stomach. Gastrointestinal symptoms were assessed by a questionnaire. Gastric and oesophageal emptying and gastrointestinal symptoms were measured before and when each subject had taken cisapride (10 mg, q.i.d., p.o.) for 4 weeks. Cisapride improved solid gastric emptying, and there was a non-significant trend for improved liquid emptying. Cisapride had no effect on oesophageal emptying. Upper gastrointestinal symptoms were less after cisapride and there was an increased frequency of bowel actions. No side effects were reported. These results indicate that gastroparesis is a treatable cause of morbidity in dystrophia myotonica.     

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.     

Effects of oral cisapride on interdigestive jejunal motor activity,psychomotor function,and side-effect profile in healthy man

Intravenous cisapride was shown to induce a phase-2-like pattern of human interdigestive jejunal motor activity containing an increased number of propagated contractions. This study investigated the effects of oral cisapride in 12 fasting healthy males. Jejunal pressures were recorded by a pneumohydraulic system and five catheter orifices positioned 10–30 cm aborad the ligament of Treitz. Single oral doses of 5 and 10mg cisapride, administered 5 min after an activity front under random double-blind conditions, induced a phase-2-like jejunal motor pattern with a significantly higher number and amplitude of contractions and significantly more aborally propagated waves than placebo (P<0.001), while the number of subjects with activity fronts decreased with increasing dose. Five and 10mg cisapride administered tid for three days affected psychomotor function, subjective feelings, and side-effect frequency, apart from increases in systolic blood pressure and heart rate, no more than placebo. It is concluded that in fasting man, oral cisapride induces a highly propagative phase-2-like jejunal motor pattern causing only minor side effects.     

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.     

Effect of cisapride on gastric emptying in dyspeptic patients

The effect of the new gastrokinetic agent cisapride on gastric emptying was evaluated in 17 dyspeptic patients using the dual radionuclide technique. Eight patients with idiopathic dyspepsia and nine postsurgical dyspeptic patients were studied and compared to a control group. Gastric emptying of solids and liquids was determined after ingestion of a standardized meal using^99mTc-sulfur colloid scrambled eggs as the solid phase and [¹¹¹In]DTPA-labeled water as the liquid phase. Following a basal study and on a separate occasion, each patient received an intravenous bolus of 10 mg of cisapride after ingestion of the test meal; 10 of the patients were restudied after a two-week period of chronic oral administration of the drug (10 mg four times a day). Baseline gastric emptying of solids was significantly delayed in idiopathic and postsurgical patients; liquid emptying was only delayed in the postsurgical group. Intravenous and oral administration of cisapride significantly shortened gastric emptying in both groups. In all but one patient, the clinical improvement was confirmed by the test. Cisapride appears to be a good alternative to metoclopramide and domperiodone in the treatment of dyspeptic patients. The dual radionuclide technique appears to be a useful physiologic tool for evaluating and predicting the efficacy of a gastric prokinetic therapy in man.     

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.     

Effect of cisapride on gastric and esophageal emptying in insulin-dependent diabetes mellitus

The effects of cisapride on gastric emptying, esophageal emptying, gastrointestinal symptoms, and glycemic control were evaluated in 20 insulin-dependent diabetics who had delayed gastric emptying of the solid or liquid component of a meal, or both. A double-isotope technique was used to measure gastric emptying, and esophageal emptying was measured as the time for a bolus of the solid meal to enter the stomach. On 2 days each patient received cisapride (20 mg) or placebo orally, 60 min before an esophageal and gastric emptying test. A third gastric and esophageal emptying test was performed after each patient had orally taken 10 mg of cisapride or placebo q.i.d. for 4 wk. Single-dose cisapride increased esophageal emptying (p less than 0.01) and both solid and liquid gastric emptying (p less than 0.001). The response to cisapride was most marked in patients with the greatest delay in esophageal and gastric emptying (p less than 0.05). After administration of cisapride for 4 wk, gastric emptying of solid and liquid were faster (p less than 0.001), but esophageal emptying was not significantly different from the placebo test. Upper gastrointestinal symptoms were less after cisapride (p less than 0.05), whereas there was no change on placebo (p greater than 0.2). Plasma glucose and glycosylated hemoglobin concentrations were not different after cisapride compared with placebo. These results indicate that single-dose cisapride increases esophageal emptying in insulin-dependent diabetics and that chronic administration of cisapride is effective in the treatment of diabetic gastroparesis.     

米曲菌胰酶片治疗消化不良症状的多中心、随机、安慰剂交叉对照临床研究

背景：米曲菌胰酶片是含有米曲菌酶和胰酶的口服双层包膜复合消化酶制剂，在国外用于治疗消化不良已有数十年．然而目前国内尚无米曲菌胰酶片治疗消化不良症状疗效和安全性的资料。目的：评价米曲菌胰酶片对中国人群消化不良症状的疗效和安全性。方法：采用多中心、随机、安慰剂交叉对照试验设计，在上海地区7个临床中心，对有消化不良症状的门诊患者先予安慰剂治疗1周，症状积分改善〈50％者中共有151例[男76例，女75例，年龄22～67岁，平均（44．67±6．46）岁]完成疗效观察研究，79例随机进入流程A（予米曲菌胰酶片2片tid，餐后立即服用，治疗2周；1周药物清洗期；再予安慰剂2片tid，餐后立即服用，治疗2周），72例进人流程B（予安慰剂2片tid，餐后立即服用，治疗2周；1周药物清洗期；再予米曲菌胰酶片2片tid，餐后立即服用，治疗2周）。分别于研究流程的第1、8、22、29和43d评估消化不良症状积分。结果：经米曲菌胰酶片治疗2周，患者消化不良症状总积分下降幅度与安慰剂相比差异有统计学意义（从27．64±1．77降至9．72±1．33对从23．99±1．28降至22．03±1．40，P〈0．01）。根据症状积分改善幅度．米曲菌胰酶片改善消化不良症状的效果依次为腹胀、腹泻、嗳气、腹痛、食欲不振和上腹部烧灼感。米曲菌胰酶片治疗消化不良症状的总有效率显著优于安慰剂（89．6％对21．7％，P〈0．01）。研究过程中无与研究药物相关的不良反应发生。结论：米曲菌胰酶片用于治疗中国人群的消化不良症状安全、有效。     

Healing and prevention of relapse of reflux oesophagitis by cisapride.

Altogether, 138 patients were included in a study aimed at evaluating the effect of cisapride on healing and relapse of oesophagitis shown endoscopically. In the first phase of the study cisapride was given in an open fashion at 10 mg four times a day for 8 to 16 weeks, and healing was obtained in 69% of patients. Healing occurred later in patients with grades II to IV oesophagitis. The total score for reflux symptoms decreased by 67%. Eighty of the healed patients were included in the second phase. They were randomly assigned to double blind treatment with either cisapride 10 mg (n = 37) or placebo (n = 43) twice a day. Control endoscopy was performed when symptoms recurred or at the end of the six month trial. The cumulative percentage of patients in remission was higher (p = 0.06, survival analysis) in the cisapride group than in the placebo group, the relapse rates being 20% and 39%. The duration of remission tended to be longer in patients with a lower initial degree of oesophagitis. Adverse effects were no more frequent with cisapride than with placebo. In conclusion, cisapride is efficacious in healing oesophagitis, and, unlike other gastrointestinal prokinetic drugs or low dose cimetidine (400-800 mg daily) or ranitidine (150 mg daily), it may prevent relapse of oesophagitis.     

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 gastric sensitivity to distension, gastric compliance and duodeno-gastric reflexes in healthy humans

BACKGROUND AND AIMS: Visceral hypersensitivity and impaired gastric relaxation after the ingestion of a meal are frequent features in patients with functional dyspepsia. Cisapride improves dyspeptic symptoms. The study aims to evaluate whether cisapride influences gastric sensitivity to distension as well as gastric compliance and duodenogastric reflexes. PATIENTS AND METHODS: Eight healthy males were studied on two different days, each after 7 days' treatment either with placebo or cisapride 10 mg qid in randomized order. A spherical bag connected to a barostat was placed in the gastric fundus and an 8-lumen manometric catheter was positioned with 4 side holes in antrum and 4 in duodenum. During a phase II of the migrating motor complex, the intragastric bag was inflated at a constant pressure 1 mm Hg above the intra-abdominal pressure and the gastric volume was measured during intraduodenal infusion of lipids and citric acid at different rates. Once the stomach returned to the basal volume, the bag was distended according to two different protocols until subjects reported discomfort. Antroduodenal motility was measured throughout the study. RESULTS: Intraduodenal infusion of lipids and citric acid caused relaxation of gastric fundus. Relaxation was similar for lipids and acid (203 +/- 30 vs 199 +/- 43 ml), and was not influenced by cisapride and infusion rate. Cisapride did not influence gastric sensitivity to distension (10 +/- 1.5 vs 9.7 +/- 1.3 mm Hg) and gastric compliance (52.7 +/- 1.2 vs 49.8 +/- 1.8 ml/mm Hg). The antral motor index significantly decreased following infusion of acid and lipids with placebo but not with cisapride. CONCLUSIONS: Cisapride inhibits the physiological duodenoantral reflexes but does not influence either the mechanical properties of the gastric fundus nor the gastric sensitivity to distension.     

Objective and subjective results of a randomized,double-blind,placebo-controlled trial using cisapride to treat gastroparesis

Cisapride, a relatively new gastrointestinal prokinetic agent, has been reported to increase gastric emptying and improve symptoms of gastroparesis. We investigated these effects of cisapride in patients with severe idiopathic and diabetic gastroparesis during an eight-week trial. The study design was a two-week single-blind placebo run in period to exclude placebo responders, followed by a six-week randomized, double-blind, placebo-controlled treatment phase. Delayed gastric emptying of solids on radionuclide scan and a minimum symptom intensity score were inclusion criteria. Forty-three patients were entered: four placebo responders and one other patient were excluded, leaving 19 patients randomized to cisapride (20 mg per os three times a day before meals), and 19 patients to placebo. Seven individual symptoms of gastroparesis were scored in a daily diary and reviewed at two-week visits. Sixteen patients in the cisapride group were able to complete the trial compared to 12 on placebo. The gastric emptying study was repeated at the end of treatment or at the time of withdrawal for those who dropped out. Cisapride significantly increased solid gastric emptying relative to baseline (P=0.005) whereas placebo did not (P>0.10). Cisapride did not significantly improve any symptom of gastroparesis relative to baseline or to placebo. We conclude that in a population of severe, refractory gastroparetic patients cisapride significantly accelerates gastric emptying of a solid meal without significantly reducing symptoms during a short-term treatment trial compared to placebo. Further trials of cisapride in less advanced and end-stage gastroparetics than studied here or combining cisapride with other prokinetic agents or antiemetics, are warranted.Financial support was provided by Janssen Pharmaceutica. This study took place in the General Clinical Research Center of the University of Virginia Medical Center and was supported by NIH grant M01-RR 00847.     

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.