Randomised trial of eradication of Helicobacter pylori before non-steroidal anti-inflammatory drug therapy to prevent peptic ulcers
CommentIn this trial, patients starting NSAID therapy who were H pylori positive and who were pre-treated with one week of anti-H pylori therapy had a significantly lower rate of peptic ulcer disease than those who were not treated. The cumulative rate of gastric and duodenal ulcers after 8 weeks of NSAID therapy was 26% without treatment, vs. 7% with treatment.
The trial appears to have been well-designed, although it was not fully blinded. Patients obviously knew whether they had undergone antibiotic therapy or not. It is stated that the endoscopist was blinded to the patient's treatment status.
One limitation to the results presented here lies in the patient population: these patients all were "NSAID naive". None of them had had prolonged NSAID therapy in the past. Since many ulcer complications of NSAID therapy occur early, these results probably do not apply to patients who have taken NSAIDS without problem in the past, and who are thus at a lower risk of complications.
Although the authors state that endoscopy should not be necessary to
apply their findings, they did not report H pylori serologies in their
series, so the utility of the serologic approach cannot be directly extrapolated.
October 19, 1997
ReferencesReferences related to this article from the NLM's PubMed database.
Reader CommentsDate: Tue, 21 Oct 97
From: Masatoshi Matsumoto <email@example.com>
This paper is a well designed article, and supplies good information about the association between NSAIDs-induced peptic ulcer disease and H.pylori.
But following points seem to be necessary for the author's conclusion:
1. Direct trial of H. pylori serology to these patients.
As for the cost comparison, the following costs to the pharmacist are from the Medical Letter, January 3, 1997:
Bismuth subsalicylate 525 mg qid for one week -- approx. $5
These prices will be higher for the consumer, and this is a particularly cheap regimen (which does not incorporate a PPI or clarithromycin). However, if this regimen is as effective as it was in this study, it is extremely cheap compared with the cost of misoprostol, famotidine or the Proton Pump Inhibitors for any length of time. In fact, even the most expensive regimen for H Pylori eradication plus the cost of determining serology will be cheaper than taking these other drugs for several months. This would not apply if the duration of NSAID use were short; a cost-effectiveness analysis would indeed be necessary for this case. -- mj
From the corresponding author of this study:
Date: Tue, 04 Nov 1997
Dear Dr. Jacobson and Dr. Matsumoto,
Thank you for your interest in this study and your valuable comments are highly appreciated.
1.Since ulcer complications tend to occur during the first few weeks of NSAID treatment especially in those without previous drug exposure, it would be more relevant to eradicate H. pylori in this group of patients than those who are at a lower risk of ulcer disease.
2.We are now testing the H. pylori serology of these patients and will report the results in due course.
3.Based on the price list from our local pharmacy, we have estimated that serology test plus one-week of bismuth triple therapy cost US$25, whereas 8 weeks of prophylactic treatment using misoprostol (200 ug q.i.d.) costs US$58. Eradication of H. pylori with a short course of antimicrobial therapy is cheaper than prophylaxis with antiulcer drugs.
December 1, 1997
One letter to the editor about this article appeared in the Lancet, November 22, 1997.
January 5, 1998
to the editor about this article, with authors response, in the Lancet,
January 3, 1998.
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