August 19, 2013
ZURICHNew research in Lancet questioned probiotics' ability to prevent diarrhea in older patients, and now, industry associations are responding to the study's results and media portrayal. The International Probiotics Association (IPA) addressed several industry concerns about the study's design, while noting the importance of conducting such a large-scale trial of antibiotic associated diarrhea (AAD) and Clostridium difficile diarrhea (CDD).
The study, conducted by Swansea University College of Medicine researchers, found no statistically significant positive effect of a multi-strain preparation of lactobacilli and bifidobacteria on AAD and CDD. However, IPA said the low illness incidence could be to blame. The expected incidence of AAD and CDD is 20 percent and 4 percent respectively; the study's incidence was 10.6 percent and 1 percent.
"Therefore, any positive effect of the probiotics would be lost upon statistical analysis," IPA said in a statement. "So despite this being the largest study of its kind, ironically there were actually not enough subjects in the study or enough events to make a meaningful analysis of the potential benefits of the therapy."
The association also noted some subjects were already on antibiotic therapy prior to starting the trial.
Above all, IPA noted the study authors should clarify their findings, which read, "this large study did not to reproduce, the same, statistically significant, positive effect seen previously for the same microbial preparation for the prevention of AAD and CDD." By adding the phrase "in the elderly" at the end of the statement, the researchers would have properly represented the study's scope.
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