Management of heartburn in a large, randomized, community-based study: comparison of four therapeutic strategies

Am J Gastroenterol. 2001 Jun;96(6):1704-10. doi: 10.1111/j.1572-0241.2001.03861.x.


Objective: Our objective was to compare four management strategies for heartburn: therapy with an H2-receptor antagonist (ranitidine), therapy with a proton pump inhibitor (lansoprazole), crossover from ranitidine to lansoprazole ("step-up" therapy), and crossover from lansoprazole to ranitidine ("step-down" therapy).

Methods: This was a controlled, double-blind, multicenter trial comprising 593 adults with heartburn, randomized to one of four groups for 20 wk. Subjects received either ranitidine 150 mg b.i.d. for 20 wk, or lansoprazole 30 mg once daily for 20 wk, or ranitidine 150 mg b.i.d. for 8 wk [corrected] followed by lansoprazole 30 mg once daily for 12 wk ("step-up"), or lansoprazole 30 mg once daily for 8 wk followed by ranitidine 150 mg b.i.d. for 12 wk ("step-down"). Outcome measures were based on self-reports in daily diaries of 24-h heartburn severity, measured by maximum daytime and nighttime severity, and percentage of 24-h heartburn-free days measured by absence of both daytime and nighttime heartburn.

Results: Median heartburn severity was significantly lower (p < 0.05) for lansoprazole (0.25) than the other groups (0.46 ranitidine, 0.44 "step-up," 0.35 "step-down"). The lansoprazole group had a significantly higher percentage of 24-h heartburn-free days (median 81.4%, p < 0.01) than other groups (66.6, 66.9, and 73.6%, respectively). In the "step-up" and "step-down" groups, heartburn was less severe, and percentages of 24-h heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence.

Conclusion: Proton pump inhibitor treatment provides more consistent heartburn relief than an H2-receptor antagonist, or "step-up" or "step-down" therapy.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Adolescent
  • Adult
  • Aged
  • Cross-Over Studies
  • Double-Blind Method
  • Enzyme Inhibitors / therapeutic use*
  • Family Practice
  • Gastroesophageal Reflux / drug therapy
  • Heartburn / drug therapy*
  • Histamine H2 Antagonists / therapeutic use*
  • Humans
  • Lansoprazole
  • Middle Aged
  • Omeprazole / analogs & derivatives
  • Omeprazole / therapeutic use*
  • Proton Pump Inhibitors
  • Ranitidine / therapeutic use*
  • Time Factors


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Enzyme Inhibitors
  • Histamine H2 Antagonists
  • Proton Pump Inhibitors
  • Lansoprazole
  • Ranitidine
  • Omeprazole