Aïda Bafeta1, Mitsuki Koh2, Carolina Riveros1, Philippe Ravaud3. 1. INSERM U1153 and Université Paris Descartes-Sorbonne Paris Cité, Paris, France (A.B., C.R.). 2. Columbia University, New York, New York (M.K.). 3. INSERM U1153, Université Paris Descartes-Sorbonne Paris Cité, and French Cochrane Centre, Paris, France, and Columbia University, New York, New York (P.R.).
Abstract
Background: Probiotics, prebiotics, and synbiotics are used increasingly, although the safety and potential harms of these interventions are poorly understood. Purpose: To examine how harms-related information is reported in publications of randomized controlled trials (RCTs) of probiotics, prebiotics, and synbiotics. Data Sources: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science (without language restrictions) from 1 January 2015 to 20 March 2018. Study Selection: RCTs assessing the safety or efficacy of at least 1 intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition. Data Extraction: 4 reviewers independently assessed study characteristics, the reporting of harms, and the presentation of safety results. Data Synthesis: Of 384 trials conducted in healthy volunteers (n = 136) or patients with any of several medical conditions (n = 248), 339 (88%) were published in specialty journals. Trials most often evaluated probiotics (n = 265 [69%]). Studies in persons with medical conditions enrolled outpatients (n = 195) and high-risk patients (n = 53). No harms-related data were reported for 106 trials (28%), safety results were not reported for 142 (37%), and the number of serious adverse events (SAEs) per study group was not given for 309 (80%). Of 242 studies mentioning harms-related results, 37% (n = 89) used only generic statements to describe AEs and 16% (n = 38) used inadequate metrics. Overall, 375 trials (98%) did not give a definition for AEs or SAEs, the number of participant withdrawals due to harms, or the number of AEs and SAEs per study group with denominators. Limitation: Journal publication processes may have affected the completeness of reporting; only English-language publications were examined. Conclusion: Harms reporting in published reports of RCTs assessing probiotics, prebiotics, and synbiotics often is lacking or inadequate. We cannot broadly conclude that these interventions are safe without reporting safety data. Primary Funding Source: No specific funding.
Background: Probiotics, prebiotics, and synbiotics are used increasingly, although the safety and potential harms of these interventions are poorly understood. Purpose: To examine how harms-related information is reported in publications of randomized controlled trials (RCTs) of probiotics, prebiotics, and synbiotics. Data Sources: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science (without language restrictions) from 1 January 2015 to 20 March 2018. Study Selection: RCTs assessing the safety or efficacy of at least 1 intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition. Data Extraction: 4 reviewers independently assessed study characteristics, the reporting of harms, and the presentation of safety results. Data Synthesis: Of 384 trials conducted in healthy volunteers (n = 136) or patients with any of several medical conditions (n = 248), 339 (88%) were published in specialty journals. Trials most often evaluated probiotics (n = 265 [69%]). Studies in persons with medical conditions enrolled outpatients (n = 195) and high-risk patients (n = 53). No harms-related data were reported for 106 trials (28%), safety results were not reported for 142 (37%), and the number of serious adverse events (SAEs) per study group was not given for 309 (80%). Of 242 studies mentioning harms-related results, 37% (n = 89) used only generic statements to describe AEs and 16% (n = 38) used inadequate metrics. Overall, 375 trials (98%) did not give a definition for AEs or SAEs, the number of participant withdrawals due to harms, or the number of AEs and SAEs per study group with denominators. Limitation: Journal publication processes may have affected the completeness of reporting; only English-language publications were examined. Conclusion: Harms reporting in published reports of RCTs assessing probiotics, prebiotics, and synbiotics often is lacking or inadequate. We cannot broadly conclude that these interventions are safe without reporting safety data. Primary Funding Source: No specific funding.
Authors: Rebecca L Morgan; Geoffrey A Preidis; Purna C Kashyap; Adam V Weizman; Behnam Sadeghirad Journal: Gastroenterology Date: 2020-06-24 Impact factor: 22.682
Authors: Jennie Johnstone; Maureen Meade; François Lauzier; John Marshall; Erick Duan; Joanna Dionne; Yaseen M Arabi; Diane Heels-Ansdell; Lehana Thabane; Daphnee Lamarche; Michael Surette; Nicole Zytaruk; Sangeeta Mehta; Peter Dodek; Lauralyn McIntyre; Shane English; Bram Rochwerg; Tim Karachi; William Henderson; Gordon Wood; Daniel Ovakim; Margaret Herridge; John Granton; M Elizabeth Wilcox; Alberto Goffi; Henry T Stelfox; Daniel Niven; John Muscedere; François Lamontagne; Frédérick D'Aragon; Charles St-Arnaud; Ian Ball; Dave Nagpal; Martin Girard; Pierre Aslanian; Emmanuel Charbonney; David Williamson; Wendy Sligl; Jan Friedrich; Neill K Adhikari; François Marquis; Patrick Archambault; Kosar Khwaja; Arnold Kristof; James Kutsogiannis; Ryan Zarychanski; Bojan Paunovic; Brenda Reeve; François Lellouche; Paul Hosek; Jennifer Tsang; Alexandra Binnie; Sébastien Trop; Osama Loubani; Richard Hall; Robert Cirone; Steve Reynolds; Paul Lysecki; Eyal Golan; Rodrigo Cartin-Ceba; Robert Taylor; Deborah Cook Journal: JAMA Date: 2021-09-21 Impact factor: 56.272