Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Amoxicillin and omeprazole for duodenal ulcer disease

ACP J Club. 1994 May-June;120:64. doi:10.7326/ACPJC-1994-120-3-064


Source Citation

Labenz J, Gyenes E, Rühl GH, Börsch G. Amoxicillin plus omeprazole versus triple therapy for eradication of Helicobacter pylori in duodenal ulcer disease: a prospective, randomized, and controlled study. Gut. 1993 Sep;34:1167-70.


Abstract

Objective

To evaluate the effectiveness of amoxicillin and omeprazole in eradicating Helicobacter pylori in patients with duodenal ulcer disease.

Design

Randomized, controlled trial lasting 6 weeks.

Setting

A teaching hospital in Germany.

Patients

40 patients (28 men) between 18 and 80 years of age with active duodenal ulcer disease and who tested positive for H. pylori qualified for enrollment. Exclusion criteria were additional gastric ulcer; treatment with omeprazole, bismuth compounds, or antibiotics during the 4 weeks before endoscopy; history of ulcer surgery, pregnancy or lactation; renal insufficiency; severe liver disease; disorder of clotting; allergy to penicillin; and lack of compliance. 38 patients completed the study.

Intervention

Patients assigned to the experimental treatment group (group 1) received omeprazole, 20 mg twice daily, and amoxicillin, 500 mg 4 times daily for 2 weeks. Control group patients (group 2) received bismuth subsalicylate, 600 mg 3 times daily; metronidazole, 400 mg 3 times daily; tetracycline, 500 mg 3 times daily; and ranitidine, 300 mg at night for 2 weeks. After the study treatment, all patients received ranitidine, 300 mg once daily, for 4 weeks after the experimental period. Compliance was assessed by checking patient diaries, counting the number of returned tablets, and calculating the amount of amoxicillin suspension used.

Main Outcome Measures

Pain relief was measured by a 4-grade symptom score; extent of ulcer healing was investigated endoscopically; and eradication of H. pylori was assessed by urease test, microscopy, culture, histologic examination, and urea breath test.

Main Results

Complete pain relief was achieved after a median time of 1 day for group 1 compared with 6 days for group 2 (P = 0.03). H. pylori was eradicated 79% of group 1 and in 84% of (P > 0.2). The ulcer healing rate was 100% in group 1 and 79% in group 2 after 6 weeks of therapy (P = 0.11). Minor side effects occurred in 16% of group 1 patients and in 63% of patinets in group 2 (P < 0.01).

Conclusion

Amoxicillin combined with omeprazole was as effective as the conventional triple therapy combined with ranitidine in eradicating Helicobacter pylori, was superior in pain relief, and had fewer side effects in patients with duodenal ulcer disease.

Source of funding: Not stated.

For article reprint: Dr. J. Labenz, Department of Medicine, Elisabeth Hospital, Moltkestr 61, 45138 Essen, Germany. FAX 49-201-8970-2249.


Commentary

Metronidazole and tetracycline frequently produce side effects, including dyspepsia. One or both of these medications have been components of standard triple-agent therapies used to eradicate H. pylori. Side effects and use of multiple agents have made these standard therapies clinically unattractive. The study by Labenz and colleagues addresses these issues by investigating the efficacy of omeprazole-amoxicillin for the treatment of H. pylori-associated duodenal ulcer. Although the omeprazole-amoxicillin regimen is a well tolerated and viable treatment alternative, some caution is warranted in recommending it for routine clinical use.

The efficacy of the omeprazole-amoxicillin regimen may be markedly diminished if patients are pretreated with omeprazole. A previous study by Labenz and colleagues (1) revealed that treatment with omeprazole for 1 week before amoxicillin therapy resulted in H. pylori eradication of only 29%. It remains unclear whether this decreased efficacy is unique to omeprazole or is a general phenomenon related to acid suppression. Information on the effect of pretreatment acid suppression with agents other than omeprazole is not available.

In the United States, it is unusual to find a patient with an H. pylori duodenal ulcer who is not already receiving some form of empiric acid suppression therapy (usually histamine-2 receptor antagonists). The omeprazole-amoxicillin regimen represents a well-tolerated effective treatment approach for the patient with an H. pylori duodenal ulcer who has not received pretreatment with omeprazole. The effect of pretreatment acid suppressive therapy needs further study.

James S. Barthel, MD
University of Missouri Columbia, Missouri, USA