Marco Bobbio

2 Comments

  1. Iole
    28 luglio 2018 @ 15:19

    Vorrei ricevere il testo dell’articolo sui probiotici per intero, grazie

    Reply

    • Marco Bobbio
      28 luglio 2018 @ 16:58

      Grazie per l’interesse per il sito Troppamedicina.
      Attualmente on sono in grado di scaricare l’originale.
      Posso inviare solo l’abstract. Cordialmente Marco Bobbio

      Ann Intern Med. 2018 Jul 17. doi: 10.7326/M18-0343. [Epub ahead of print]
      Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota: A Systematic Review.

      Bafeta A1, Koh M2, Riveros C1, Ravaud P3.
      Author information
      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.
      PMID: 30014150 DOI: 10.7326/M18-0343

      Reply

Lascia un commento