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.
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.
Allison
James E
JE
Division of Research, Kaiser Permanente Medical Care Program, Northern California Region, 2000 Broadway, Oakland, CA 94612, USA. jallison@medsfgh.ucsf.edu
Hurley
Leo B
LB
Hiatt
Robert A
RA
Levin
Theodore R
TR
Ackerson
Lynn M
LM
Lieu
Tracy A
TA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D017048:Health Care Costs; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000188:drug therapy* / Q000191:economics; D016480:Helicobacter pylori; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008329:Managed Care Programs / Q000191:economics; D008875:Middle Aged; D010437:Peptic Ulcer / Q000175:diagnosis* / Q000188:drug therapy* / Q000191:economics / Q000382:microbiology; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists