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Therapeutics |
Design
Randomised (allocation concealed*), blinded (unclear),* controlled trial with a mean follow up of 10 years.
Setting
8 Veterans Affairs medical centres in the US.
Patients
247 patients (mean age 58 y) with complicated GORD. 129 of 160 surviving patients (mean age 67 y, 98% men) were included in the follow up analysis.
Intervention
Patients were allocated to receive surgical treatment (n=82), continuous medical treatment (n=77), or symptomatic medical treatment (n=88). The method of surgical treatment was open Nissen fundoplication. Continuous medical treatment consisted of 2 antacid tablets, 1 and 3 hours after meals; ranitidine 150 mg twice daily; and metoclopramide 10 mg 4 times daily, and sucralfate 1 g in 10 ml of warm water after meals, when necessary for persistent symptoms. Symptomatic medical treatment consisted of the above medications given only when necessary to control symptoms. Treatments were given for 12 to 28 months. Patients were then managed by their physicians.
Main outcome measures
Joel E Richter, MD
Cleveland Clinic Foundation, Cleveland, Ohio, USA
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