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Cisapride for gastroesophageal reflux disease: a placebo-controlled, double-blind study.
Am J Gastroenterol 1995; 90(3):423-30AJ

Abstract

OBJECTIVES

To evaluate the safety and efficacy of cisapride in patients with gastroesophageal reflux disease.

METHODS

Patients (N = 177) were randomized to double-blind treatment with cisapride (10 or 20 mg q.i.d.) or placebo for 12 wk. Efficacy was determined by pre- and poststudy endoscopies, symptom assessments by patient and physician, and Maalox consumption. Safety evaluations included vital signs, electrocardiograms, clinical laboratory tests, and reports of adverse events.

RESULTS

Cisapride 10 mg significantly reduced daytime and nighttime heartburn at 4 wk compared with placebo. Cisapride 20 mg reduced both daytime and nighttime heartburn at 4, 8, and 12 wk, compared with placebo, and was also significantly superior to the 10-mg dose at 12 wk. The percent of patients with endoscopic healing was significantly higher with cisapride 20 mg than with placebo [healing: 51 vs 36% (p < or = 0.044)]. Maalox usage declined significantly with cisapride 20 mg compared with placebo. No clinically significant changes in safety variables occurred with cisapride. The most frequently reported adverse events in the cisapride group were diarrhea, headache, and sinusitis.

CONCLUSIONS

Cisapride 10 and 20 mg q.i.d. were safe and well tolerated in a population of patients with mild-to-moderate gastroesophageal reflux disease. Both symptoms and endoscopic grade improved after 12 wk of treatment with cisapride 20 mg q.i.d.

Authors+Show Affiliations

Department of Gastroenterology, Cleveland Clinic Foundation, Ohio.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

7872282

Citation

Richter, J E., and J F. Long. "Cisapride for Gastroesophageal Reflux Disease: a Placebo-controlled, Double-blind Study." The American Journal of Gastroenterology, vol. 90, no. 3, 1995, pp. 423-30.
Richter JE, Long JF. Cisapride for gastroesophageal reflux disease: a placebo-controlled, double-blind study. Am J Gastroenterol. 1995;90(3):423-30.
Richter, J. E., & Long, J. F. (1995). Cisapride for gastroesophageal reflux disease: a placebo-controlled, double-blind study. The American Journal of Gastroenterology, 90(3), pp. 423-30.
Richter JE, Long JF. Cisapride for Gastroesophageal Reflux Disease: a Placebo-controlled, Double-blind Study. Am J Gastroenterol. 1995;90(3):423-30. PubMed PMID: 7872282.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cisapride for gastroesophageal reflux disease: a placebo-controlled, double-blind study. AU - Richter,J E, AU - Long,J F, PY - 1995/3/1/pubmed PY - 1995/3/1/medline PY - 1995/3/1/entrez SP - 423 EP - 30 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 90 IS - 3 N2 - OBJECTIVES: To evaluate the safety and efficacy of cisapride in patients with gastroesophageal reflux disease. METHODS: Patients (N = 177) were randomized to double-blind treatment with cisapride (10 or 20 mg q.i.d.) or placebo for 12 wk. Efficacy was determined by pre- and poststudy endoscopies, symptom assessments by patient and physician, and Maalox consumption. Safety evaluations included vital signs, electrocardiograms, clinical laboratory tests, and reports of adverse events. RESULTS: Cisapride 10 mg significantly reduced daytime and nighttime heartburn at 4 wk compared with placebo. Cisapride 20 mg reduced both daytime and nighttime heartburn at 4, 8, and 12 wk, compared with placebo, and was also significantly superior to the 10-mg dose at 12 wk. The percent of patients with endoscopic healing was significantly higher with cisapride 20 mg than with placebo [healing: 51 vs 36% (p < or = 0.044)]. Maalox usage declined significantly with cisapride 20 mg compared with placebo. No clinically significant changes in safety variables occurred with cisapride. The most frequently reported adverse events in the cisapride group were diarrhea, headache, and sinusitis. CONCLUSIONS: Cisapride 10 and 20 mg q.i.d. were safe and well tolerated in a population of patients with mild-to-moderate gastroesophageal reflux disease. Both symptoms and endoscopic grade improved after 12 wk of treatment with cisapride 20 mg q.i.d. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/7872282/Cisapride_for_gastroesophageal_reflux_disease:_a_placebo_controlled_double_blind_study_ L2 - http://www.diseaseinfosearch.org/result/2996 DB - PRIME DP - Unbound Medicine ER -