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Therapeutics |
Design
Randomised {allocation concealed*}
, blinded {patients, clinicians, data collectors, outcome assessors, and data safety and monitoring committee}
,* controlled trial with 8 week follow up.
Setting
162 clinical centres in the USA.
Patients
3510 patients who were
18 years of age (mean age 47y, 57% men), had endoscopically confirmed erosive oesophagitis
grade 2, and had had
1 episode of moderate to very severe heartburn during the previous 3 days or nights, or both. Exclusion criteria included duodenal or gastric ulcers
3 mm in diameter; systemic disease affecting the oesophagus; history of gastrointestinal bleeding or gastric, duodenal, or oesophageal surgery; and long term use of ulcerogenic drugs. 96% of patients completed the study.
Intervention
Patients were allocated to lansoprazole, 30 mg (n=1754), or omeprazole, 20 mg (n=1756), once daily before breakfast for 8 weeks.
Main outcome measures
Presence and severity (none [score 0] to very severe [score 4]) of daytime and night time heartburn, which were
W A Hoogerwerf, MD, P Jay Pasricha, MD
University of Texas Medical Branch
Galveston
Texas
USA
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