By Hempel, S etal
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Extra resources for Safety of Probiotics to Reduce Risk and Prevent or Treat Disease
Sample text
Fungemia or presence of Saccharomyces cerevisiae/boulardii in blood cultures was reported for 33 cases in 21 publications (Bassetti, 1998; Cesaro, 2000; Cherifi, 2004; Force, 1995; Fredenucci, 1998; Hennequin, 2000; Henry, 2004; Lherm, 2002; Lolis, 2008; Lungarotti, 2003; Munoz, 2005; Niault, 1999; Perapoch, 2000; Piarroux, 1999; Piechno, 2007; Pletinex, 1995; Rijnders, 2000; Riquelme, 2003; Trautmann, 2008; Viggiano, 1995; Zunic, 1991). In addition, one publication reported the spread of fungemia to another infant who had not consumed probiotic organisms (Perapoch, 2000).
Whereas participants completing the intervention may report no adverse events, adverse events can lead to withdrawal (and might or might not be accounted for). In 290/387 studies, the numbers of withdrawals and dropouts were reported and the reasons for dropping out were described, or it was clearly reported that there were no dropouts and all participants were followed up. Of all parallel RCTs, 75 percent were judged by two independent 27 reviewers to report adequately on withdrawals. As a general quality measure, we also assessed whether studies reported an intention-to-treat analysis.
All specific adverse events that were recorded are presented in Evidence Table C4, Results in Appendix C. These adverse events were reported in the publication, even though the study might not have stated upfront that safety was assessed or defined what would be considered an adverse event. The table covers the presence as well as the absence of adverse events (zero events). In other words, the publications that reported identified no instances of a particular harm. ” In total, 59 studies reported the absence or presence of diarrhea incidences in the treatment arms.