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BMJ. 2003 May 24;326(7399):1118.

Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment.

Author information

  • 1Department of Gastroenterology, Cardarelli Hospital, Via Solimena 101, 80129 Naples, Italy. gimanes@tin.it

Abstract

OBJECTIVE:

To compare the efficacy of a "Helicobacter pylori test and treat" strategy with that of an empirical trial of omeprazole in the non-endoscopic management by empirical prescribing of young patients with dyspepsia.

DESIGN:

Randomised controlled trial.

SETTING:

Hospital gastroenterology unit.

PARTICIPANTS:

219 patients under 45 years old presenting with dyspepsia without alarm symptoms.

INTERVENTION:

Patients received treatment with omeprazole 20 mg (group A) or with a urea breath test followed by an eradication treatment in case of H pylori infection or omeprazole alone in non-infected patients (group B). Lack of improvement or recurrence of symptoms prompted endoscopy.

MAIN OUTCOME MEASURES:

Improvement in symptoms assessed by a dyspepsia severity score every two months; use of medical resources (endoscopic workload and medical consultation); clinical outcome.

RESULTS:

96/109 (88%) patients in group A and 61/110 (55%) in group B (P < 0.0001) had endoscopy: in 19 patients in group A and 32 in group B (20/67 infected and 12/43 non-infected) because of no improvement; in 77 further patients in group A and 29 in group B (7 infected and 22 non-infected) because of recurrence of symptoms during follow up. Endoscopy showed peptic ulcers only in group A; oesophagitis occurred significantly more often in group B than in group A. About 80% of examinations were normal in both groups, but nine duodenal scars occurred in group A.

CONCLUSIONS:

Eradication treatment allows resolution of symptoms in a large number of patients with dyspepsia and reduces the endoscopic workload. After a trial of omeprazole, symptoms recur in nearly every patient. Such treatment is also likely to mask an appreciable number of peptic ulcers and cases of oesophagitis.

PMID:
12763982
[PubMed - indexed for MEDLINE]
PMCID:
PMC156019
Free PMC Article
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