Patients with functional dyspepsia responding to omeprazole have a characteristic gastro-oesophageal reflux pattern.

BACKGROUND: The effect of acid secretion inhibitors in patients with functional dyspepsia (FD) is equivocal. One previous trial showed an effect in patients with a characteristic gastro-oesophageal reflux pattern. This double-blind trial compares the number of reflux episodes in responders and non-responders to omeprazole. METHODS: Twenty-four patients (men/women, 11:13; mean age, 49 years) with FD were included; those with reflux as the main symptom were excluded. An upper endoscopy and a 24-h oesophageal pH measurement were performed before randomization to treatment with 10-20 mg omeprazole or placebo for 4 weeks. Patients who at questioning considered themselves to have achieved sufficient relief of dyspeptic symptoms after 4 weeks were characterized as responders. RESULTS: The number of responders in the omeprazole and placebo groups was 8 of 14 (57%) and 2 of 10 (20%), respectively (P = 0.07). The mean number of reflux episodes at the 24-h oesophageal pH measurement in responders and non-responders to omeprazole was 57 and 25, respectively (P < 0.003). In the omeprazole group the number of responders was 0 of 5 (0%) in those with < 32 reflux episodes and 8 of 9 (89%) in those with > 32 reflux episodes (P < 0.003). CONCLUSION: Patients with FD responding to omeprazole were characterized by many reflux episodes.

The symptomatic effect of cisapride in patients with irritable bowel syndrome and constipation.

BACKGROUND: Cisapride improves symptoms in patients with idiopathic constipation. This trial compares the effect of cisapride with that of placebo in patients with irritable bowel syndrome (IBS) and constipation. METHODS: Seventy patients were randomized to 12 weeks' treatment with 5 mg cisapride three times daily or placebo in a double-blind trial. The dose could be doubled after 4 weeks in patients without satisfactory improvement. The patients scored their symptoms on a 100-mm visual analogue scale (VAS) (0 = best, 100 = worst), and the investigators evaluated the symptomatic effect. RESULTS: The dose was doubled in 17 and 23 patients in the cisapride and placebo groups, respectively, after 4 weeks. The patients' mean VAS score for global evaluation of IBS symptoms in the cisapride and placebo groups was 73 and 71 mm, respectively, at the start of treatment and 47 and 41 mm at the end. The difference between cisapride and placebo at the end was 6 mm in favour of placebo (95% confidence interval (CI), -6, 18) (NS). The investigators evaluated the effect as good or excellent in 39.2% and 58.8% in the cisapride and placebo groups, respectively. The difference in favour of placebo was 19.5% (95% CI, -5, 44) (NS). Nor were any statistically significant differences seen between cisapride and placebo in the other effect factors. CONCLUSIONS: The trial seems to exclude a clinically significant effect of 15-30 mg cisapride daily in patients with IBS and constipation during a 12-week treatment period.

The effect of cisapride in maintaining symptomatic remission in patients with gastro-oesophageal reflux disease.

BACKGROUND: Successful treatment of gastro-oesophageal reflux disease (GORD) has traditionally been assessed as healing of reflux oesophagitis, which may not be relevant in patients with moderate disease. In these patients symptom relief and patient satisfaction with therapy are of fundamental importance. Cisapride has well-documented prokinetic effects and may be well suited for long-term therapy of GORD, but its effectiveness in purely symptomatic treatment is unknown. We therefore compared two dosage regimens of cisapride with placebo over a period of 6 months in patients with evidence of gastrooesophageal reflux, initially treated with antisecretory medication, with regard to maintaining symptom relief and satisfaction with treatment. METHODS: Five hundred and thirty-five patients with reflux oesophagitis grade 1 (n = 293) or 2 (n = 124) or with no reflux oesophagitis but pathologic 24-h pH-metry (n = 118) achieved satisfactory symptom relief with an H2-receptor antagonist or proton pump inhibitor within 4-8 weeks. In a double-blind randomized, parallel-group study, they were then treated with cisapride, 20 mg at night or 20 mg twice daily, or placebo and followed up for a maximum period of 6 months. Relapse was defined as dissatisfaction with therapy or an average consumption of more than two antacid tablets a day. RESULTS: Median time to relapse was 63 days for cisapride, 20 mg twice daily; 59 days for cisapride, 20 mg at night; and 49 days for placebo. Time to relapse was not significantly different (P = 0.09). Presence and grade of oesophagitis at base line, type of therapy before randomization, and pattern of non-reflux symptoms at base line did not influence these findings significantly. CONCLUSION: The study indicates that cisapride is of limited value in maintenance therapy of GORD in patients in whom symptom relief has been accomplished with potent antisecretory medication. This 'step-down' approach to therapy seems disadvantageous in the long-term therapy of GORD.

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.

Prevention of peptic ulcer and dyspeptic symptoms with omeprazole in patients receiving continuous non-steroidal anti-inflammatory drug therapy. A Nordic multicentre study.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are known to cause gastroduodenal lesions and dyspeptic symptoms. METHODS: Patients with a history of dyspepsia or uncomplicated peptic ulcer disease and with a need for continuous NSAID treatment were randomized to receive either 20 mg omeprazole once daily or placebo. Gastroduodenal ulcers, erosions, and dyspeptic symptoms were evaluated after 1 and 3 months. RESULTS: During a 3-month study period 4.7% (4 of 85) of omeprazole-treated patients developed peptic ulcer, compared with 16.7% (15 of 90) of patients treated with placebo. This prophylactic effect of omeprazole was sustained independently of previous peptic ulcer history or Helicobacter pylori status. Development of dyspeptic symptoms requiring active treatment, either alone or in combination with ulcer(s) or erosions, occurred in 15.3% (15 of 85) of patients treated with omeprazole and 35.6% of those who received placebo. CONCLUSIONS: Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated peptic ulcers or dyspeptic symptoms.

Low-dose antacids versus 400 mg cimetidine twice daily for reflux oesophagitis. A comparative, placebo-controlled, multicentre study.

Ninety-one patients with reflux oesophagitis were randomly allocated to treatment with one chewable antacid tablet (acid-neutralizing capacity, 30 mmol) four times daily, 400 mg cimetidine twice daily, or placebo. The study was double-blind, with a double-dummy technique. Endoscopy was performed before inclusion and after 8 weeks' treatment. Symptoms were recorded on diary cards and on visual analogue scales. Statistically significant healing of oesophagitis was achieved in all three treatment groups, but none of the active regimens were significantly superior to placebo. Symptoms were significantly reduced with both cimetidine and antacids compared with placebo. Patients taking antacids consumed significantly less extra antacids for pain relief and had significantly better global assessment score than patients taking cimetidine during the first and second half of the study, respectively. In conclusion, neither cimetidine nor antacids were significantly superior to placebo in healing of reflux oesophagitis. Both the active regimens were superior to placebo for symptomatic relief.

[Intestinal spirochetes]. / Intestinal spirochaetose.

We report a case of intestinal spirochaetosis. The bacteria were seen by light microscopy and reacted in an indirect immunofluorescence test on the biopsy material with serum with high levels of IgG antibodies against Borrelia burgdorferi. The patient's own serum had no detectable antibody activity against the bacteria. No inflammatory response was observed. Aspects of these findings are discussed.

Comparative study of cimetidine and trimipramine in the short-term treatment of duodenal and gastric ulcer.

Sixty-nine outpatients with endoscopically confirmed duodenal and prepyloric (DU) or gastric ulcers (GU) completed a 4-week double-blind trial with either cimetidine, 1 g/day, or trimipramine, 50 mg/day. Ulcer healing was assessed by endoscopy at 4 weeks. At the end of the study 14 of 23 patients with DU treated with cimetidine and 13 of 25 treated with trimipramine had healed ulcers. In the patients with GU 7 of 11 ulcers (cimetidine) and 4 of 10 (trimipramine) healed. The differences in healing rates between the two treatment groups were not statistically significant, either in DU and GU groups separately or in the total material. The number of pain attacks per week decreased and the symptoms improved significantly in both treatment groups in DU, GU, and totally. Both drugs were well tolerated, but two patients in each treatment group developed a slight increase in serum transaminases. No serious side effects occurred. The study suggests trimipramine as an alternative drug to the well-established drug cimetidine in the treatment of duodenal and possibly also of gastric ulcer.

Long-term treatment of duodenal ulcer with trimipramine. A double-blind study.

Sixty-two patients with healed duodenal or prepyloric ulcers completed a double-blind long-term trial with either 25 mg/day of trimipramine (32 patients) or placebo (30 patients). Endoscopy was performed when marked dyspeptic complaints occurred or after a 1-year follow-up study. Eleven patients in the trimipramine-treated group and 18 patients in the placebo group had relapses, with endoscopically confirmed ulcers or erosions with duodenitis and severe symptoms, revealing a statistically significant difference between the groups in favour of trimipramine. Twenty-one patients (66%) receiving trimipramine and 12 patients (40%) receiving placebo were in remission at the end of the study. The probability of having a relapse increased with the time from start of placebo but decreased in the group that received trimipramine. No serious side effects occurred. In conclusion, 25 mg of trimipramine daily reduced significantly the recurrence rate of duodenal ulcer disease, when compared with placebo.

Trimipramine in the treatment of duodenal ulcer. A multicenter, open study.

Sixty patients with endoscopically confirmed duodenal ulcers were treated with 50 mg of trimipramine daily. After the end of the treatment 45 patients showed healed ulcers. Ulcer healing was not related to serum concentration of trimipramine, but seemed to be influenced by smoking habits and duration of the total and actual disease history.

Serum levels of penicillin v after oral administration of pediatric preparations to healthy subjects.

The bioavailability of nine commercial pediatric preparations of penicillin V was tested in a double-blind, cross-over fashion on ten healthy student nurses who were given 1 mill I.U. of the various preparations. The serum concentrations were determined using the paper disc method of "AB Biodisc" Sweden. The preparations could be divided into two different groups: (1) the mixtures (2) the effervescent tablets, substance for drops and granulate. This classification is based upon the mean peak serum levels obtained. With one exception the peak serum levels in group 2 were significantly higher than in group 1. 2,4 and 6 hours after ingestion there were no differences in the serum levels, indicating that none of the preparations gave sustained high serum levels. The results presented indicate that the preparations in group 2 should be preferred.