Variability with omeprazole-amoxicillin combinations for treatment of Helicobacter pylori infection

K. S. Graham, H. Malaty, H. M T El-Zimaity, R. M. Genta, R. A. Cole, M. T. Al-Assi, M. M. Yousfi, G. A. Neil, D. Y. Graham

Research output: Contribution to journalArticle

54 Citations (Scopus)

Abstract

Objective: Although omeprazole co-therapy enhances the effectiveness of some antimicrobials for the treatment of Helicobacter pylori infection, results have not been uniform. A meta-analysis suggested that 20 mg of omeprazole b.i.d. and 2 g or more of amoxicillin would yield a >80% success rate (Gastroenterology 1994;106: 142A). Our objective in this study was to test that hypothesis. Methods: Volunteers with H. pylori infection were studied. Anti-H. pylori therapy was administered with meals for 14 days (omeprazole 20 mg b.i.d. plus amoxicillin 1 g t.i.d., or omeprazole 20 mg b.i.d. plus amoxicillin 0.5 g t.i.d.). Endoscopy was performed 4-6 wk after antimicrobial therapy ended, and the presence or absence of H. pylori was determined with biopsy specimens by Genta stain. Results: Fifty-nine volunteers completed the study; 30 were studied twice. The overall success for initial treatment with either combination of amoxicillin and omeprazole was 18 of 59 [30.5%; 95% confidence interval (CI) = 19-44%]. The success rate with 500 mg amoxicillin t.i.d. was 7 of 29 (24%; 95% CI = 10-43%). With 1 g t.i.d. amoxicillin, the cure rate was higher (36.6%) (11 of 30; 95% CI = 20- 56%), or intention-to-treat result was 11 of 31 (35.4%), which includes the early dropout. Compliance was >95% for both therapies. Side effects were experienced by eight patients, two receiving 1.5 g amoxicillin and six receiving 3 g amoxicillin (p > 0.2). German trials suggest that better results might be achieved when amoxicillin is given as suspension while fasting. Thirty treatment failures were re-treated with 1 g amoxicillin suspension t.i.d., given fasting, and omeprazole 20 mg b.i.d. The cure rate was 16.6% (95% CI = 6-35%). Conclusion: Amoxicillin/omeprazole combinations for treatment of H. pylori infection do not yield consistent results. The reason is unknown, but the reported high rate of success with 40 mg of omeprazole and 750 mg t.i.d. suggests that almost complete inhibition of acid secretion is necessary to obtain consistent results with this combination.

Original languageEnglish (US)
Pages (from-to)1415-1418
Number of pages4
JournalAmerican Journal of Gastroenterology
Volume90
Issue number9
StatePublished - 1995

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Omeprazole
Amoxicillin
Helicobacter Infections
Helicobacter pylori
Therapeutics
Confidence Intervals
Volunteers
Fasting
Suspensions
Gastroenterology
Treatment Failure
Endoscopy
Compliance
Meals
Meta-Analysis
Coloring Agents
Biopsy

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Graham, K. S., Malaty, H., El-Zimaity, H. M. T., Genta, R. M., Cole, R. A., Al-Assi, M. T., ... Graham, D. Y. (1995). Variability with omeprazole-amoxicillin combinations for treatment of Helicobacter pylori infection. American Journal of Gastroenterology, 90(9), 1415-1418.

Variability with omeprazole-amoxicillin combinations for treatment of Helicobacter pylori infection. / Graham, K. S.; Malaty, H.; El-Zimaity, H. M T; Genta, R. M.; Cole, R. A.; Al-Assi, M. T.; Yousfi, M. M.; Neil, G. A.; Graham, D. Y.

In: American Journal of Gastroenterology, Vol. 90, No. 9, 1995, p. 1415-1418.

Research output: Contribution to journalArticle

Graham, KS, Malaty, H, El-Zimaity, HMT, Genta, RM, Cole, RA, Al-Assi, MT, Yousfi, MM, Neil, GA & Graham, DY 1995, 'Variability with omeprazole-amoxicillin combinations for treatment of Helicobacter pylori infection', American Journal of Gastroenterology, vol. 90, no. 9, pp. 1415-1418.
Graham, K. S. ; Malaty, H. ; El-Zimaity, H. M T ; Genta, R. M. ; Cole, R. A. ; Al-Assi, M. T. ; Yousfi, M. M. ; Neil, G. A. ; Graham, D. Y. / Variability with omeprazole-amoxicillin combinations for treatment of Helicobacter pylori infection. In: American Journal of Gastroenterology. 1995 ; Vol. 90, No. 9. pp. 1415-1418.
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abstract = "Objective: Although omeprazole co-therapy enhances the effectiveness of some antimicrobials for the treatment of Helicobacter pylori infection, results have not been uniform. A meta-analysis suggested that 20 mg of omeprazole b.i.d. and 2 g or more of amoxicillin would yield a >80{\%} success rate (Gastroenterology 1994;106: 142A). Our objective in this study was to test that hypothesis. Methods: Volunteers with H. pylori infection were studied. Anti-H. pylori therapy was administered with meals for 14 days (omeprazole 20 mg b.i.d. plus amoxicillin 1 g t.i.d., or omeprazole 20 mg b.i.d. plus amoxicillin 0.5 g t.i.d.). Endoscopy was performed 4-6 wk after antimicrobial therapy ended, and the presence or absence of H. pylori was determined with biopsy specimens by Genta stain. Results: Fifty-nine volunteers completed the study; 30 were studied twice. The overall success for initial treatment with either combination of amoxicillin and omeprazole was 18 of 59 [30.5{\%}; 95{\%} confidence interval (CI) = 19-44{\%}]. The success rate with 500 mg amoxicillin t.i.d. was 7 of 29 (24{\%}; 95{\%} CI = 10-43{\%}). With 1 g t.i.d. amoxicillin, the cure rate was higher (36.6{\%}) (11 of 30; 95{\%} CI = 20- 56{\%}), or intention-to-treat result was 11 of 31 (35.4{\%}), which includes the early dropout. Compliance was >95{\%} for both therapies. Side effects were experienced by eight patients, two receiving 1.5 g amoxicillin and six receiving 3 g amoxicillin (p > 0.2). German trials suggest that better results might be achieved when amoxicillin is given as suspension while fasting. Thirty treatment failures were re-treated with 1 g amoxicillin suspension t.i.d., given fasting, and omeprazole 20 mg b.i.d. The cure rate was 16.6{\%} (95{\%} CI = 6-35{\%}). Conclusion: Amoxicillin/omeprazole combinations for treatment of H. pylori infection do not yield consistent results. The reason is unknown, but the reported high rate of success with 40 mg of omeprazole and 750 mg t.i.d. suggests that almost complete inhibition of acid secretion is necessary to obtain consistent results with this combination.",
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AU - Malaty, H.

AU - El-Zimaity, H. M T

AU - Genta, R. M.

AU - Cole, R. A.

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N2 - Objective: Although omeprazole co-therapy enhances the effectiveness of some antimicrobials for the treatment of Helicobacter pylori infection, results have not been uniform. A meta-analysis suggested that 20 mg of omeprazole b.i.d. and 2 g or more of amoxicillin would yield a >80% success rate (Gastroenterology 1994;106: 142A). Our objective in this study was to test that hypothesis. Methods: Volunteers with H. pylori infection were studied. Anti-H. pylori therapy was administered with meals for 14 days (omeprazole 20 mg b.i.d. plus amoxicillin 1 g t.i.d., or omeprazole 20 mg b.i.d. plus amoxicillin 0.5 g t.i.d.). Endoscopy was performed 4-6 wk after antimicrobial therapy ended, and the presence or absence of H. pylori was determined with biopsy specimens by Genta stain. Results: Fifty-nine volunteers completed the study; 30 were studied twice. The overall success for initial treatment with either combination of amoxicillin and omeprazole was 18 of 59 [30.5%; 95% confidence interval (CI) = 19-44%]. The success rate with 500 mg amoxicillin t.i.d. was 7 of 29 (24%; 95% CI = 10-43%). With 1 g t.i.d. amoxicillin, the cure rate was higher (36.6%) (11 of 30; 95% CI = 20- 56%), or intention-to-treat result was 11 of 31 (35.4%), which includes the early dropout. Compliance was >95% for both therapies. Side effects were experienced by eight patients, two receiving 1.5 g amoxicillin and six receiving 3 g amoxicillin (p > 0.2). German trials suggest that better results might be achieved when amoxicillin is given as suspension while fasting. Thirty treatment failures were re-treated with 1 g amoxicillin suspension t.i.d., given fasting, and omeprazole 20 mg b.i.d. The cure rate was 16.6% (95% CI = 6-35%). Conclusion: Amoxicillin/omeprazole combinations for treatment of H. pylori infection do not yield consistent results. The reason is unknown, but the reported high rate of success with 40 mg of omeprazole and 750 mg t.i.d. suggests that almost complete inhibition of acid secretion is necessary to obtain consistent results with this combination.

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