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Probiotics for Antibiotic-Associated Diarrhea—Reply

Probiotics for Antibiotic-Associated Diarrhea—Reply In Reply: The objective of our review was to broadly evaluate the available evidence on probiotic interventions for the prevention or treatment of AAD. We presented sensitivity analyses, including results for studies explicitly aiming to prevent or treat AAD, which excluded wider applications, and results were virtually identical (relative risk, 0.58 [95% CI, 0.50-0.68] vs relative risk, 0.58 [95% CI, 0.49-0.68]). Intention-to-treat analyses provide a conservative estimate of treatment effects. Studies were included in the meta-analysis if the number of participants randomized to each treatment group and the number of participants with diarrhea in each group were reported, independent of the analytic approach applied in individual studies. The specific studies authored by Dr Cremonini and colleagues are not included in Figure 1 of the article because they did not report the analyzed outcome (total number of patients with diarrhea). The individual reasons vary by study. Armuzzi et al1 reported percentages for each treatment and follow-up week, but the denominator and the duration of diarrhea incidences are not reported; it is therefore unclear whether or how many of the participants with diarrhea in the triple therapy week were the same participants with diarrhea in follow-up week 1, week 2, or both. Cremonini et al2 reported explicit numerical data on diarrhea incidences only for the Helicobacter pylori eradication week. The data reported by Nista et al3 included percentages but not the total number of patients with diarrhea or the denominator, nor is information about the overlap of patients with diarrhea between follow-up weeks reported. All 3 studies are included in the review, reported in the evidence table, and contribute data to other analyses such as the AAD incidence after cessation of antibiotic therapy. Because all 3 studies reached conclusions qualitatively similar to that of our pooled result, our principle conclusion is unaffected by their exclusion from that analysis. Back to top Article Information Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. References 1. Armuzzi A, Cremonini F, Bartolozzi F, et al. The effect of oral administration of Lactobacillus GG on antibiotic-associated gastrointestinal side-effects during Helicobacter pylori eradication therapy. Aliment Pharmacol Ther. 2001;15(2):163-16911148433PubMedGoogle ScholarCrossref 2. Cremonini F, Di Caro S, Covino M, et al. Effect of different probiotic preparations on anti- Helicobacter pylori therapy-related side effects: a parallel group, triple blind, placebo-controlled study. Am J Gastroenterol. 2002;97(11):2744-274912425542PubMedGoogle ScholarCrossref 3. Nista EC, Candelli M, Cremonini F, et al. Bacillus clausii therapy to reduce side-effects of anti- Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial. Aliment Pharmacol Ther. 2004;20(10):1181-118815569121PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Probiotics for Antibiotic-Associated Diarrhea—Reply

JAMA , Volume 308 (7) – Aug 15, 2012

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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.8738
Publisher site
See Article on Publisher Site

Abstract

In Reply: The objective of our review was to broadly evaluate the available evidence on probiotic interventions for the prevention or treatment of AAD. We presented sensitivity analyses, including results for studies explicitly aiming to prevent or treat AAD, which excluded wider applications, and results were virtually identical (relative risk, 0.58 [95% CI, 0.50-0.68] vs relative risk, 0.58 [95% CI, 0.49-0.68]). Intention-to-treat analyses provide a conservative estimate of treatment effects. Studies were included in the meta-analysis if the number of participants randomized to each treatment group and the number of participants with diarrhea in each group were reported, independent of the analytic approach applied in individual studies. The specific studies authored by Dr Cremonini and colleagues are not included in Figure 1 of the article because they did not report the analyzed outcome (total number of patients with diarrhea). The individual reasons vary by study. Armuzzi et al1 reported percentages for each treatment and follow-up week, but the denominator and the duration of diarrhea incidences are not reported; it is therefore unclear whether or how many of the participants with diarrhea in the triple therapy week were the same participants with diarrhea in follow-up week 1, week 2, or both. Cremonini et al2 reported explicit numerical data on diarrhea incidences only for the Helicobacter pylori eradication week. The data reported by Nista et al3 included percentages but not the total number of patients with diarrhea or the denominator, nor is information about the overlap of patients with diarrhea between follow-up weeks reported. All 3 studies are included in the review, reported in the evidence table, and contribute data to other analyses such as the AAD incidence after cessation of antibiotic therapy. Because all 3 studies reached conclusions qualitatively similar to that of our pooled result, our principle conclusion is unaffected by their exclusion from that analysis. Back to top Article Information Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. References 1. Armuzzi A, Cremonini F, Bartolozzi F, et al. The effect of oral administration of Lactobacillus GG on antibiotic-associated gastrointestinal side-effects during Helicobacter pylori eradication therapy. Aliment Pharmacol Ther. 2001;15(2):163-16911148433PubMedGoogle ScholarCrossref 2. Cremonini F, Di Caro S, Covino M, et al. Effect of different probiotic preparations on anti- Helicobacter pylori therapy-related side effects: a parallel group, triple blind, placebo-controlled study. Am J Gastroenterol. 2002;97(11):2744-274912425542PubMedGoogle ScholarCrossref 3. Nista EC, Candelli M, Cremonini F, et al. Bacillus clausii therapy to reduce side-effects of anti- Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial. Aliment Pharmacol Ther. 2004;20(10):1181-118815569121PubMedGoogle ScholarCrossref

Journal

JAMAAmerican Medical Association

Published: Aug 15, 2012

References