A multicenter, double-blind trial was designed to ascertain if ranitidine therapy could reduce the symptoms of gastroesophageal reflux disease (GERD). The study compared the effect of treatment with ranitidine 150 mg twice daily and placebo for a duration of six weeks.

A total 284 patients with GERD were assessed before, during, and after six weeks of treatment with either placebo or ranitidine.

Findings of the study:

• Ranitidine was significantly more effective in decreasing the frequency and severity of heartburn during both daytime and nighttime assessment periods, compared to placebo.
• At weekly intervals, significantly more patients receiving ranitidine achieved clinical improvement, in comparison with those who received placebo.
• A significant correlation was evident between improvement in heartburn symptoms and a reduction in antacid consumption. Patients who received ranitidine consumed significantly fewer antacids.
• Among patients with endoscopic esophagitis at study entry, the overall change in endoscopic classification six weeks following treatment was significantly better with ranitidine. Patients treated with ranitidine had less evidence of erosions and ulcerations and had greater healing.
• Complete healing was noted in 56% of patients on ranitidine therapy and 41% of patients on placebo.
• No differences were evident between the two groups in terms of changes in esophageal mucosal sensitivity to acid perfusion or changes in histologic grading of esophageal mucosal biopsy specimens.
• The safety profile of ranitidine was similar to that of previous studies.

It was concluded that in GERD patients, ranitidine 150 mg twice daily led to considerable reduction in heartburn symptoms and significant improvement in the endoscopic appearance of esophageal mucosa.

Source: Sontag S, Robinson M, McCallum RW, et al. Ranitidine Therapy for Gastroesophageal Reflux Disease. Results of a Large Double-blind Trial. Arch Intern Med. 1987;147(8):1485-1491.