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Background: Acid secretion inhibitors are of dubious value to most patients with functional dyspepsia but might be effective in a subset. The aims of the trial were to compare the effect of ranitidine with that of placebo in selected subsets of patients., Methods: Two hundred and twenty-six patients with functional dyspepsia were included in a double-blind multi-crossover (MCO) trial. After 6 weeks an effect score (Xs) with a range of 0-5 was calculated. They were then stratified in accordance with their score and randomized to 4 weeks' double-blind treatment with ranitidine or placebo. Overall symptoms were scored on a 100-mm visual analogue scale, and the change in score (measured in millimetres) was the primary effect measure., Results: Two hundred and six patients completed the study. The effect of ranitidine and placebo in the 'responders' (76 patients with Xs of 4-5 after the MCO period) was 28 mm and 5 mm, respectively (P < 0.001), and in all patients 19 mm and 12 mm, respectively (P < 0.03). No effect was seen in 'nonresponders' (130 patients with Xs of 0-3 after the MCO period). The clinical improvement, as judged by the patients given ranitidine during the last 4-week period was statistically significantly different in favour of responders compared with nonresponders. We were unable to characterize the responders on the basis of demographics, symptoms, and signs., Conclusions: Ranitidine has a good and clinically significant effect in a subset of patients with functional dyspepsia.

Seven Norwegian centres recruited 61 female and 54 male patients with non-ulcer dyspepsia (NUD). Their mean age was 40 years. After 6 weeks' double-blind alternating treatment with 150 mg ranitidine twice daily and placebo, 1 week of each alternative (part I), an effect score (Xs) and an efficacy index (Ei) were calculated. Ranitidine was significantly superior to placebo for symptomatic relief (p less than 0.01). Twenty-eight, 49, and 38 patients were Xs-classified as 'responders', 'unclassified', and 'nonresponders' to ranitidine, respectively. The symptomatic effect was impressive in the responder group and moderate but significant also in the unclassified group. The nonresponders had a significantly unfavourable effect of ranitidine compared with placebo. The Xs-classified responders and unclassified continued single-blind treatment with ranitidine for 4 weeks (part II) and were reclassified as 'new responders/nonresponders'. The new responders received single-blind treatment with placebo until relapse or maximum 8 weeks (part III). Parts II and III verified the good Xs classification of responders to ranitidine treatment. The overall effect of ranitidine in patients with NUD was due to good symptomatic effect in a subpopulation characterized by meal-related heartburn and/or regurgitation, large body mass index, first-degree relatives with gastrointestinal diseases, a relatively low frequency of gastrointestinal symptoms per week, and absence of soft stools.