Ranitidine effectively relieves symptoms in a subset of patients with functional dyspepsia.

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.

Ranitidine for non-ulcer dyspepsia. A clinical study of the symptomatic effect of ranitidine and a classification and characterization of the responders to treatment.

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.

Postpartum bacteriuria. A multicenter evaluation of different screening procedures and a controlled short-course treatment trial with amoxycillin.

A total of 10,909 puerperal women from 6 different hospitals were screened for bacteriuria by culture of voided midstream urine (MSU), and a significant growth was found in 881 patients (8.1%). In 731 cases the urine was reexamined by using suprapubic aspiration (SPA), and in only 354 (48%) of the samples the diagnosis of bacteriuria was confirmed. The contamination rate of the MSU samples varied from 46 to 69% between the different hospitals, indicating that in the postpartum period positive MSU findings would necessitate more thorough examination in order to confirm the diagnosis of urinary tract infection. In our study, suprapubic aspiration was found to be a simple and acceptable method without any side effects. Confirmed bacteriuria occurred in 3.2% of the women. Operative delivery (Cesarean section, forceps and vacuum extractor delivery), epidural anesthesia and bladder catheterization increased the risk of bacteriuria in the postpartum period. Only 27% of the women with positive bladder urine complained of dysuria and this symptom was significantly more common in women who had been catheterized. 230 patients with confirmed bacteriuria with amoxycillin-sensitive bacterias participated in a randomized short-course treatment trial: 114 women received 3 days treatment with amoxycillin (1.5 g/day), 116 received the traditional 10 days therapy (750 mg amoxycillin/day). Both antibiotic regimens were observed to be effective with a cure rate of 96 and 98%, respectively. Short-course antibiotic treatment should thus be recommended to puerperal women with urinary tract infections since this avoids prolonged drug exposure to the lactating mother.