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Predictors of failure of Helicobacter pylori eradication and predictors of ulcer recurrence: a randomized controlled trial.
Clin Invest Med. 1999 Oct; 22(5):185-94.CI

Abstract

OBJECTIVE

In light of evidence that Helicobacter pylori treatment fails 5% to 20% of the time, the objective of this study was to determine predictors of unsuccessful H. pylori eradication and of duodenal ulcer recurrence.

DESIGN

Randomized, double-blind, placebo-controlled trial.

SETTING

Gastroenterology services of 2 general hospitals in Montreal, Que.

PATIENTS

All patients (aged 16 to 90) with an endoscopically proven duodenal ulcer within the previous year and H. pylori infection detected on antral biopsy were asked to participate; 85 were included.

INTERVENTIONS

Patients were randomized in double-blind fashion to 1 of 2 eradication therapies, consisting of metronidazole, bismuth subcitrate and either amoxicillin or placebo. Endoscopy was performed at follow-up every 3 months for 12 months.

OUTCOME MEASURES

Demographic data, characteristics of patients and disease, previous history and family history of ulcer disease, compliance at day 10 and day 28 of therapy; in vitro metronidazole resistance of H. pylori; eradication of H. pylori (determined by endoscopic biopsy 3 months after therapy); and ulcer recurrence within 12 months after therapy.

RESULTS

Metronidazole resistance (odds ratio [OR] 0.11, 95% confidence interval [CI] 0.017 to 0.69) was the only independent predictor of eradication. Compliance (as defined in the study), density of organisms on culture, as well as several other factors examined, were not significant predictors. Treatment group, although a significant factor on univariate analysis, was not an independent predictor on multivariate analysis, as there were relatively good eradication rates (82% and 97% among compliant patients) in both groups. With regard to ulcer recurrence, 3 independent predictors were identified: failed H. pylori eradication (OR 86.5, 95% CI 4.2 to 1769), unemployment (OR 13.2, 95% CI 1.8 to 95) and a family history of ulcer disease (OR 12.2, 95% CI 1.2 to 128).

CONCLUSIONS

The best predictor of ulcer recurrence is failure of H. pylori eradication, which, in turn, depends on metronidazole resistance. Hence, treatments containing metronidazole should be avoided in populations with high rates of metronidazole resistance. A family history of ulcer disease and unemployment were also predictors of ulcer recurrence, which suggests a potential role for treatment of contacts.

Authors+Show Affiliations

Division of Gastroenterology, McGill University Health Centre, Montreal, Que. cfallone@lan1.molonc.mcgill.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10579057

Citation

Fallone, C A., et al. "Predictors of Failure of Helicobacter Pylori Eradication and Predictors of Ulcer Recurrence: a Randomized Controlled Trial." Clinical and Investigative Medicine. Medecine Clinique Et Experimentale, vol. 22, no. 5, 1999, pp. 185-94.
Fallone CA, Loo V, Joseph L, et al. Predictors of failure of Helicobacter pylori eradication and predictors of ulcer recurrence: a randomized controlled trial. Clin Invest Med. 1999;22(5):185-94.
Fallone, C. A., Loo, V., Joseph, L., Barkun, J., Kostyk, R., & Barkun, A. N. (1999). Predictors of failure of Helicobacter pylori eradication and predictors of ulcer recurrence: a randomized controlled trial. Clinical and Investigative Medicine. Medecine Clinique Et Experimentale, 22(5), 185-94.
Fallone CA, et al. Predictors of Failure of Helicobacter Pylori Eradication and Predictors of Ulcer Recurrence: a Randomized Controlled Trial. Clin Invest Med. 1999;22(5):185-94. PubMed PMID: 10579057.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Predictors of failure of Helicobacter pylori eradication and predictors of ulcer recurrence: a randomized controlled trial. AU - Fallone,C A, AU - Loo,V, AU - Joseph,L, AU - Barkun,J, AU - Kostyk,R, AU - Barkun,A N, PY - 1999/12/1/pubmed PY - 1999/12/1/medline PY - 1999/12/1/entrez SP - 185 EP - 94 JF - Clinical and investigative medicine. Medecine clinique et experimentale JO - Clin Invest Med VL - 22 IS - 5 N2 - OBJECTIVE: In light of evidence that Helicobacter pylori treatment fails 5% to 20% of the time, the objective of this study was to determine predictors of unsuccessful H. pylori eradication and of duodenal ulcer recurrence. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Gastroenterology services of 2 general hospitals in Montreal, Que. PATIENTS: All patients (aged 16 to 90) with an endoscopically proven duodenal ulcer within the previous year and H. pylori infection detected on antral biopsy were asked to participate; 85 were included. INTERVENTIONS: Patients were randomized in double-blind fashion to 1 of 2 eradication therapies, consisting of metronidazole, bismuth subcitrate and either amoxicillin or placebo. Endoscopy was performed at follow-up every 3 months for 12 months. OUTCOME MEASURES: Demographic data, characteristics of patients and disease, previous history and family history of ulcer disease, compliance at day 10 and day 28 of therapy; in vitro metronidazole resistance of H. pylori; eradication of H. pylori (determined by endoscopic biopsy 3 months after therapy); and ulcer recurrence within 12 months after therapy. RESULTS: Metronidazole resistance (odds ratio [OR] 0.11, 95% confidence interval [CI] 0.017 to 0.69) was the only independent predictor of eradication. Compliance (as defined in the study), density of organisms on culture, as well as several other factors examined, were not significant predictors. Treatment group, although a significant factor on univariate analysis, was not an independent predictor on multivariate analysis, as there were relatively good eradication rates (82% and 97% among compliant patients) in both groups. With regard to ulcer recurrence, 3 independent predictors were identified: failed H. pylori eradication (OR 86.5, 95% CI 4.2 to 1769), unemployment (OR 13.2, 95% CI 1.8 to 95) and a family history of ulcer disease (OR 12.2, 95% CI 1.2 to 128). CONCLUSIONS: The best predictor of ulcer recurrence is failure of H. pylori eradication, which, in turn, depends on metronidazole resistance. Hence, treatments containing metronidazole should be avoided in populations with high rates of metronidazole resistance. A family history of ulcer disease and unemployment were also predictors of ulcer recurrence, which suggests a potential role for treatment of contacts. SN - 0147-958X UR - https://www.unboundmedicine.com/medline/citation/10579057/Predictors_of_failure_of_Helicobacter_pylori_eradication_and_predictors_of_ulcer_recurrence:_a_randomized_controlled_trial_ L2 - https://medlineplus.gov/antibiotics.html DB - PRIME DP - Unbound Medicine ER -