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


METHODS
Randomised controlled trial.


METHODS
Hospital gastroenterology unit.


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


METHODS
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.


METHODS
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.
Manes
Gianpiero
G
Department of Gastroenterology, Cardarelli Hospital, Via Solimena 101, 80129 Naples, Italy. gimanes@tin.it
Menchise
Antonella
A
de Nucci
Claudio
C
Balzano
Antonio
A
D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D016099:Endoscopy, Gastrointestinal; D005260:Female; D016481:Helicobacter Infections / Q000150:complications*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D010349:Patient Compliance; D012008:Recurrence
D000897:Anti-Ulcer Agents; D009853:Omeprazole