Systematic review: maintenance treatment of gastro-oesophageal reflux disease with proton pump inhibitors taken 'on-demand'.

BACKGROUND: Proton pump inhibitors (PPI) therapy 'on-demand' is often used as an alternative to continuous maintenance therapy in gastro-oesophageal reflux disease (GERD). AIM: We conducted a systematic review with the specific objectives to ascertain whether on-demand PPI therapy was effective in preventing symptomatic relapse and to assess the relative efficacy of on-demand vs. continuous PPI maintenance strategy. METHODS: Randomized-controlled clinical trials comparing on-demand PPI vs. placebo or on-demand vs. continuous PPI therapy in GERD patients were identified by searching the Medline database and the Cochrane Controlled Trials Register. RESULTS: Seventeen studies were found which met inclusion criteria. Out of the 17 studies: five investigated exclusively patients with non-erosive reflux disease (NERD), four patients with NERD and mild oesophagitis, two patients with erosive oesophagitis only, and two patients with uninvestigated GERD symptoms, respectively. Four further studies were not investigating the effectiveness of the therapies but primarily pharmacoeconomic or quality of life parameters. CONCLUSIONS: On the basis of the analysis of 17 studies, we can conclude that on-demand therapy with currently available PPI appears to be effective in the long-term management of patients with NERD or mild and uninvestigated forms of GERD, but not in patients with (severe) erosive oesophagitis.

Cost effectiveness of omeprazole and ranitidine in intermittent treatment of symptomatic gastro-oesophageal reflux disease.

OBJECTIVE: This 1-year study compared the cost effectiveness of omeprazole and ranitidine when used as initial therapy in an intermittent treatment strategy for the management of patients with symptomatic gastro-oesophageal reflux disease with or without erosive oesophagitis. DESIGN AND SETTING: A prospective health economic analysis was conducted alongside an international multicentre randomised, double-blind clinical study. The economic analysis was performed from a societal perspective. PATIENTS: A total of 704 patients in the UK, the Republic of Ireland, Germany, France, Italy and Spain were randomised to 1 of the 3 treatment groups. INTERVENTIONS: Patients were randomised to receive either omeprazole 20 mg once daily, omeprazole 10 mg once daily or ranitidine 150 mg twice daily. Initial treatment failure resulted in dose titration and drug switching from ranitidine to omeprazole, and subsequently open maintenance treatment. MAIN OUTCOME MEASURES AND RESULTS: The estimated mean direct medical costs (medication and number of visits and endoscopies) were found to be lower for both dosages of omeprazole than for ranitidine in all countries except Germany. However, none of the differences were statistically significant. The differences between omeprazole 10 mg and omeprazole 20 mg were small and nonsignificant. With regard to numbers of symptom-free days, both omeprazole 20 mg and omeprazole 10 mg were found to be more effective than ranitidine. However, none of the differences were statistically significant. CONCLUSIONS: Following a pragmatic interpretation, incorporating intermediate short term results, the results in this study give no support to the notion that a step-up approach, either as dose titration from omeprazole 10 mg to omeprazole 20 mg or as drug switching from ranitidine to omeprazole, will result in cost savings and thereby be cost effective.

Short and long-term outcome of medically treated reflux esophagitis.

The purpose of this retrospective study was to characterize the clinical course of medically-treated reflux esophagitis and to identify factors related to acute healing and relapse of the disease. We investigated 77 patients (56 males, 21 females, mean age 46.9 years) suffering from esophagitis (grade I-IV according to Savary and Miller), who were referred to our Unit during the period between January 1984 and December 1988. Typical GER symptoms were present in 63 patients, 51 of whom had esophageal 24-hour pH-monitoring suggestive of pathological GER, defined as total time with pH < 4 equal to or greater than 7%. All patients received 3 to 6 months of treatment (H2-antagonists = 68, antacids = 6, prokinetic drugs = 1, omeprazole = 2). After 3 months of therapy 39/88 patients (50.7%) had healed, and this figure increased to 56/77 patients (72.7%) after 6 months. The majority of these patients (N = 49) subsequently underwent a 24-week course of treatment, mostly with low-dose H2-antagonists (N = 44). At the end of treatment, 34/49 patients (69.3%) remained healed, while 15/49 (30.7%) relapsed, 40% asymptomatically. 14/21 patients (66.7%) who were not healed after 6 months' therapy, healed when the same treatment was prolonged up to 18 months (median: 11 months). The only factor found to influence acute healing significantly was the type of therapy, while none of the variables analyzed were seen to correlate with disease relapse.

Treatment of active duodenal ulcer with oral cimetidine: a multicenter controlled endoscopic trial.

A double-blind 4-week trial of cimetidine (1 g daily) versus placebo was conducted in 68 adult outpatients with active duodenal ulceration endoscopically confirmed. 3 of the patient admitted to the study (1 on cimetidine and 2 on placebo) did not complete the trial. After 4 weeks of treatment, 25 of 33 patients (76%) receiving cimetidine had healed their ulcers compared with 15 (47%) of 32 patients receiving placebo (p less than 0.02). Antacid consumption was also significantly decreased by cimetidine when compared with placebo. Tolerability of the drug was good.

Gastro-intestinal blood loss during administration of indoprofen, aspirin and ibuprofen.

The acute effect of three non-steroidal anti-inflammatory drugs, ibuprofen, acetylsalicylic acid (ASA) and indoprofen, on faecal blood loss was investigated in 15 subjects by means of 51Cr-labelled erythrocytes. Ibuprofen (900 mg/day for 5 days) and indoprofen capsules and tablets (300 mg and 600 mg/day for 5 days, respectively) slightly increased the amount of blood eliminated in faeces. The increase was of the same order of magnitude for both doses of indoprofen. ASA (1,500 mg/day for 5 days) caused about a 6-fold increase in blood loss. Four days after withdrawal of ASA, faecal blood was still about twice as high as in faeces of subjects given ibuprofen and indoprofen. The method appears sensitive and reliable for comparison of the immediate effect of anti-inflammatory drugs on gastro-intestinal mucosa.