A randomized controlled trial of test-and-treat strategy for Helicobacter pylori: clinical outcomes and health care costs in a managed care population receiving long-term acid suppression therapy for physician-diagnosed peptic ulcer disease

Arch Intern Med. 2003 May 26;163(10):1165-71. doi: 10.1001/archinte.163.10.1165.


Background: Guidelines recommend Helicobacter pylori (HP) testing and treatment for patients with a history of peptic ulcer disease (PUD), assuming that PUD has been documented and that successful HP eradication would eliminate the need for further therapy and medical utilization.

Methods: An open-label, randomized controlled trial in a managed care setting evaluated the clinical outcome and costs of an HP test-and-treat (T & T) strategy in 650 patients receiving long-term acid suppression therapy for physician-diagnosed PUD. Patients were randomized to T & T for HP (n = 321) or to usual care (n = 329). Outcome measures included presence and severity of PUD symptoms, use of acid-reducing medication, and acid-peptic-related health care costs during 12-month follow-up.

Results: Only 17% of study participants had PUD confirmed by radiography or endoscopy; only 38% of the T & T group tested positive for HP. At 12 months, patients in the T & T group were less likely to report ulcerlike dyspepsia or use of acid-reducing medication; however, 75% of the T & T group used acid-reducing medication during the second half of the 12-month follow-up. In the 12 months after randomization, the T & T group had higher total acid-peptic-related costs than the usual care group.

Conclusions: Most patients receiving long-term acid suppression therapy for physician-diagnosed PUD in community practice settings are likely to have HP-negative, uninvestigated dyspepsia. Routine testing and treating for HP will not reduce acid-peptic-related costs and have only a modest (though statistically significant) effect in reducing clinical symptoms and use of acid-reducing medications.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Ulcer Agents / therapeutic use*
  • Chi-Square Distribution
  • Drug Therapy, Combination
  • Female
  • Health Care Costs
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / economics
  • Helicobacter pylori*
  • Histamine H2 Antagonists / therapeutic use*
  • Humans
  • Male
  • Managed Care Programs / economics
  • Middle Aged
  • Peptic Ulcer / diagnosis*
  • Peptic Ulcer / drug therapy*
  • Peptic Ulcer / economics
  • Peptic Ulcer / microbiology
  • Statistics, Nonparametric
  • Treatment Outcome


  • Anti-Ulcer Agents
  • Histamine H2 Antagonists