Ranitidine for Non-Ulcer Dyspepsia: A Clinical Study of the Symptomatic Effect of Ranitidine and a Classification and Characterization of the Responders to Treatment

Abstract

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.

H2 receptor antagonists and prokinetics in dyspepsia: a critical review

“…As a consequence, parallel group studies may mask individual responders to treatment. This problem has been addressed by special study designs, such as the single subject trial designs, multiple crossover designs, [49][50][51][52][53][54] and by post hoc analysis of patient characteristics in groups of responders.…”

“…55 The other six studies were single subject trials using a multiple crossover design to identify individual responders to treatment. [49][50][51][52][53][54] All of these studies claimed that a small proportion of patients, typically 10-20%, obtained significantly better symptom relief during the periods on the H 2 receptor antagonists compared with periods on placebo. A therapeutic gain cannot be estimated from these study designs.…”

A Systematic Overview of the Use of Diary Cards, Quality-of-Life Questionnaires, and Psychometric Tests in Treatment Trials ofHelicobacter pylori-Positive and -Negative Non-Ulcer Dyspepsia

“…Five of these 11 studies (45%) used VAS to assess daily symptoms (41,47,49,50,68), whereas 6 (55%) studies used VAS for global assessment at the end of a specified time period (every week, every 2 weeks, or at the end of treatment) (38,51,52,55,60,61). Five of these 11 studies (45%) used VAS to assess daily symptoms (41,47,49,50,68), whereas 6 (55%) studies used VAS for global assessment at the end of a specified time period (every week, every 2 weeks, or at the end of treatment) (38,51,52,55,60,61).…”

Nizatidine and Gastric Emptying in Functional Dyspepsia

“…Ranitidine seems to reduce symptoms in patients with FD [13][14][15], while nizatidine was ineffective for treating FD patients when the therapeutic period was short, only 2 weeks [16]. The primary aim of this study was to test the hypothesis that nizatidine accelerates gastric emptying in patients with FD; the secondary aim was to evaluate the effect of nizatidine on dyspeptic symptoms and quality of life of patients with FD.…”