CISAPRIDE IN FUNCTIONAL DYSPEPSIA - A DOUBLE-BLIND, PLACEBO-CONTROLLED RANDOMIZED TRIAL IN GENERAL-PRACTICE PATIENTS

This trial included patients from general practice with endoscopy-nega tive chronic dyspepsia and epigastric pain or discomfort. Eleven eligi ble patients with sufficiently severe dyspeptic symptoms after a 2-wee k placebo run-in period were entered into a 4-week, parallel group, do uble-blind randomized comparison of 10 mg cisapride three times daily and matched placebo, and were subsequently evaluable. Symptoms were co mparable in the two treatment groups at the start of double-blind trea tment. The cisapride group had a significantly greater reduction in th e frequency of daytime epigastric pain/discomfort and the frequency an d severity of nocturnal pain/discomfort after 2 weeks. After 2 weeks, all six cisapride recipients were free of nocturnal pain, compared wit h only one of five placebo recipients. After 4 weeks of double-blind t herapy, improvements in the placebo group had reduced between-treatmen t differences, with five of six cisapride recipients and three of five placebo recipients being free of nocturnal pain. Cisapride was well t olerated.