Symptomatic gastro-oesophageal reflux disease: double blind controlled study of intermittent treatment with omeprazole or ranitidine
Abstract Objective: To assess intermittent treatment over 12 months in patients with symptomatic gastro-oesophageal reflux disease. Design: Randomised, multicentre, double blind, controlled study. Patients with heartburn and normal endoscopy results or mild erosive changes received omeprazole 10 mg...
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Published in | BMJ Vol. 318; no. 7182; pp. 502 - 507 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
London
British Medical Journal Publishing Group
20.02.1999
British Medical Association BMJ Publishing Group LTD BMJ Publishing Group British Medical Journal |
Edition | International edition |
Subjects | |
Online Access | Get full text |
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Summary: | Abstract Objective: To assess intermittent treatment over 12 months in patients with symptomatic gastro-oesophageal reflux disease. Design: Randomised, multicentre, double blind, controlled study. Patients with heartburn and normal endoscopy results or mild erosive changes received omeprazole 10 mg or 20 mg daily or ranitidine 150 mg twice daily for 2 weeks. Patients remaining symptomatic had omeprazole 10 mg or ranitidine dose doubled for another 2 weeks while omeprazole 20 mg was continued for 2 weeks. Patients who were symptomatic or mildly symptomatic were followed up for 12 months. Recurrences of moderate or severe heartburn during follow up were treated with the dose which was successful for initial symptom control. Setting: Hospitals and primary care practices between 1994 and 1996. Subjects: 677 patients with gastro-oesophageal reflux disease. Main outcome measures: Total time off active treatment, time to failure of intermittent treatment, and outcomes ranked from best to worst. Results: 704 patients were randomised, 677 were eligible for analyses; 318 reached the end of the study with intermittent treatment without recourse to maintenance antisecretory drugs. The median number of days off active treatment during follow up was 142 for the entire study (281 for the 526 patients who reached a treatment related end point). Thus, about half the patients did not require treatment for at least 6 months, and this was similar in all three treatment groups. According to outcome, 378 (72%) patients were in the best outcome ranks (no relapse or one (or more) relapse but in remission until 12 months); 630 (93%) had three or fewer relapses in the intermittent treatment phase. Omeprazole 20 mg provided faster relief of heartburn. The results were similar in patients with erosive and non-erosive disease. Conclusions: Intermittent treatment is effective in managing symptoms of heartburn in half of patients with uncomplicated gastro-oesophageal reflux disease. It is simple and applicable in general practice, where most patients are seen. |
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Bibliography: | PMID:10024259 local:bmj;318/7182/502 Correspondence to: Dr Bardhan istex:3C360B4821A7EAB4282016F25DD4AAC251AE58E8 href:bmj-318-502.pdf ark:/67375/NVC-M66J55M5-P Correspondence to: Dr Bardhan kdbardhan@d-morton.demon.co.uk Contributors: KDB developed the concept of intermittent treatment (based on an earlier similar approach for the treatment of duodenal ulcer). SM-L, MAB, GBP, KRWG, RAP, and KDB designed the study through its various stages to the final protocol. In this they were helped by their team members and colleagues at Astra. JP, JH, MS, and DW also conducted the study with the help of colleagues in various centres. CF (and colleagues) and KRWG conducted the study, a major undertaking, and CF arranged the various investigators’ meetings, large and small, when many different aspects of the study were discussed by several of the above contributors and other colleagues. RAP carried out the statistical analysis and produced the report. The paper went through several drafts and was written by KDB, SM-L, MAB, GBP, KRWG, RAP. KDB stands as guarantor. |
ISSN: | 0959-8138 0959-8146 1468-5833 1756-1833 |
DOI: | 10.1136/bmj.318.7182.502 |