MeSH Major

  • Gastric Acid
  • Gastroesophageal Reflux
  • Proton Pump Inhibitors


  • Objective: To determine whether patients with reflux oesophagitis who fail to heal after 4 wk of omeprazole 20 mg q.d. have improved healing if increased to 40 mg/day for the next 4 wk compared to 4 more weeks of treatment with 20 mg?Study Design: 8‐wk trial. Single blind—first 4 wk; double‐blind second 4 wk. Setting: United Kingdom, Ireland. Methods: Patients with symptomatic endoscopically verified esophagitis (grade II‐IV) were treated with 20 mg omeprazole a day for 4 wk and reendoscoped. Those not healed and not symptom free were randomized to continue treatment for 4 more weeks with 20 mg/day or 40 mg/day, and were reendoscoped at the end of the trial. Symptom evaluation included hearthurn, dysphagia, and regurgitation. Gaviscon was allowed, for symptom relief, throughout the trial. Exclusions: Age < 18 > 80 yr, varices, stricture not passahle with diagnostic endoscope, bleed, peptic ulcer, or other symptomatic illness, usual medication known to treat GERD and phenytoin, warfarin, steroids. Patients: 313 randomized, both groups equal. Esophagitis hy grade: II‐199, III‐98, IV‐14, Barretts 34. Stricture 31. M:F‐2:1. Duration of GERD approx 3.7 yr + 6.8 months (calculated from two groups). Endpoints: Healing defined as grade zero esophagitis and asymptomatic (no symptoms, no Gaviscon). Symptom improvement and healing also were assessed separately. Effect of sex, alcohol, smoking, age not reported. Resutts: 154/313 (49%) completely healed at 4 wk, 183/313 (58%) asymptomatic. Overall 127/313 (41%) were healed and symptom free. 12 were lost to follow‐up; 174 were randomized to 20 mg or 40 mg for 4 more wk. At 8 wk, 65% of 20/20 mg group were healed compared with 74% in 20/40 mg group (p = NS); an additional 17 patients (divided hetween groups) had grade 1 esophagitis after 8 wk of treatment (p= NS between groups). Complete heartburn relief was 78% in 20/20 group versus 89% in 20/40 group (p < 02). When all symptoms were evaluated, no difference was noted (75%vs. 78% asymptomatic). Total numher of patients healed and symptom‐free after 8 wk was 59% (20/20) versus 68% (20/40) p = NS. Conclusion: Increasing omeprazole from 20 to 40 mg/day after 4 wk affords no significant advantage over continuation of 20 mg/day for an additional 4 wk, in most clinical situations. A minority of symptomatic patients may benefit from an increased dose in the second 4 wk. Treatment with either dose beyond 8 wk was not assessed, but appears to he indicated in a fair numher of patients. Copyright © 1994, Wiley Blackwell. All rights reserved

publication date

  • January 1994



  • Report


Digital Object Identifier (DOI)

  • 10.1111/j.1572-0241.1994.tb09193.x

Additional Document Info

start page

  • 1592

end page

  • 1593


  • 89


  • 9