BMJ  2003;326:1118 (24 May), doi:10.1136/bmj.326.7399.1118

Paper

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

¹ Department of Gastroenterology, Cardarelli Hospital, Via Solimena 101, 80129 Naples, Italy

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.

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• Delaney, B. C, Qume, M., Moayyedi, P., Logan, R. F A, Ford, A. C, Elliott, C., McNulty, C., Wilson, S., Hobbs, F D R. (2008). Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial). BMJ 336: 651-654 [Abstract] [Full text]  
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Rapid Responses:

Read all Rapid Responses

Comparing H pylori eradication and simple anti-ulcer treatment lacks equipoise.

Christopher J Martin
bmj.com, 27 May 2003 [Full text]

Study of H.pylori test and treat v. PPI cannot be applied to the Primary Care setting.

Brendan C Delaney, et al.
bmj.com, 30 May 2003 [Full text]

The efficacy of the Test and treat treatment for dyspepsia is improved by super-selection of patient

Cesare Tosetti
bmj.com, 6 Jun 2003 [Full text]

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