Farup and colleagues conducted a double-blind multi-crossover (MCO) study to determine the effect of ranitidine in selected subsets of patients with functional dyspepsia and compared it with a placebo.

A total of 226 patients with functional dyspepsia were included in the study. Part I of the study (MCO period) was a 6-week double-blind alternating treatment with 150 mg ranitidine twice a day and placebo, with 1 week of each alternative. After 6 weeks, investigators calculated an effect score (Xs) with a range of 0-5. In Part II, a double-blind trial with a traditional parallel-group design, the patients were segregated into two groups - responders and nonresponders – based on the outcome of part I. They were randomly assigned to treatment with 150mg ranitidine twice daily or placebo for 4 weeks. Symptoms were scored on a 100-mm visual analogue scale, and the change in score (measured in mm) was the primary measure. In all, 206 patients completed the study.

The effect of ranitidine and placebo among the responders (76 patients with Xs 4–5) was 28 mm and 5 mm, respectively (P < 0.001). In all patients, it was 19 mm and 12 mm, respectively (P < 0.03).

There was no effect in nonresponders (130 patients with Xs of 0–3 after MCO period).

Clinical improvement, judged by patients receiving ranitidine over the last 4-week period, was statistically significantly different, in favor of responders.

To conclude, ranitidine appears to have a clinically significant effect in a subgroup of patients with functional dyspepsia.

Source: Farup PG, Wetterhus S, Osnes M, Ulshagen K. Ranitidine Effectively Relieves Symptoms in a Subset of Patients with Functional Dyspepsia. Scandinavian Journal of Gastroenterology 1997;32(8):755-759.