Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota
Authors: Aïda Bafeta, Mitsuki Koh, Carolina Riveros, Philippe Ravaud
Journal: Annals of Internal Medicine (2019)

Letters15 January 2019Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying MicrobiotaAïda Bafeta, PhD, Mitsuki Koh, MPH, Carolina Riveros, MSc, and Philippe Ravaud, MD, PhDAïda Bafeta, PhDINSERM U1153 and Université Paris Descartes-Sorbonne Paris Cité, Paris, France (A.B., C.R.)Search for more papers by this author, Mitsuki Koh, MPHColumbia University, New York, New York (M.K.)Search for more papers by this author, Carolina Riveros, MScINSERM U1153 and Université Paris Descartes-Sorbonne Paris Cité, Paris, France (A.B., C.R.)Search for more papers by this author, and Philippe Ravaud, MD, PhDINSERM U1153, Université Paris Descartes-Sorbonne Paris Cité, and French Cochrane Centre, Paris, France (P.R.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L18-0562 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We agree with Dr. Baldassarre that the regulatory model for approval of probiotics, prebiotics, and synbiotics could alter the evaluation of adverse events in randomized controlled trials, which may cause study publications to omit some safety data. This regulatory model has remained ambiguous and complex and varies by region (1, 2). Probiotics that have a long historical use or are used as additives or processing aids have been subject to few or no regulations. In contrast, those intended for new therapeutic purposes must follow a strict process for approval (3).We recognize that the safety and efficacy findings ...References1. von Wright A. Regulating the safety of probiotics—the European approach. Curr Pharm Des. 2005;11:17-23. [PMID: 15638749] CrossrefMedlineGoogle Scholar2. Sanders ME, Akkermans LM, Haller D, Hammerman C, Heimbach J, Hörmannsperger G, et al. Safety assessment of probiotics for human use. Gut Microbes. 2010;1:164-85. [PMID: 21327023] doi:10.4161/gmic.1.3.12127 CrossrefMedlineGoogle Scholar3. Doron S, Snydman DR. Risk and safety of probiotics. Clin Infect Dis. 2015;60 Suppl 2:S129-34. [PMID: 25922398] doi:10.1093/cid/civ085 CrossrefMedlineGoogle Scholar4. Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced [Editorial]. Arch Intern Med. 2009;169:1737-9. [PMID: 19858427] doi:10.1001/archinternmed.2009.313 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: INSERM U1153 and Université Paris Descartes-Sorbonne Paris Cité, Paris, France (A.B., C.R.)Columbia University, New York, New York (M.K.)INSERM U1153, Université Paris Descartes-Sorbonne Paris Cité, and French Cochrane Centre, Paris, France (P.R.)Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-0343. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoHarms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota Aïda Bafeta , Mitsuki Koh , Carolina Riveros , and Philippe Ravaud Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota Maria Elisabetta Baldassarre Metrics Cited byGut microbiota - nutrition and healthUse of Probiotics for the Management of Acute Gastroenteritis in Children: An UpdateIntestinal Barrier Function–Non-alcoholic Fatty Liver Disease Interactions and Possible Role of Gut Microbiota 15 January 2019Volume 170, Issue 2Page: 143-144KeywordsAdverse eventsDecision makingDisclosurePrevention, policy, and public healthProbioticsPulsed-field gel electrophoresisResearch designSafetySafety studiesToxicology ePublished: 15 January 2019 Issue Published: 15 January 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...