donderdag 17 december 2009

Inspectorate publishes evaluation of controversial probiotics trial

The Netherlands Health Care Inspectorate (IGZ) has released its evaluation report on the probiotics trial conducted at the University Medical Centre (UMC) in Utrecht. This trial was characterised by an unexpectedly high mortality rate among patients with acute pancreatitis in the experimental group. The report conclude that several organisational mistakes have been made. However, it does not conclude that the deaths can be attributed to these shortcomings.

The UMC Utrecht trial aimed to test whether patients with acute pancreatitis may benefit from probiotics. This was expected to be the case, given the positive effect of probiotics on the immune system. However, 24 of the 152 patients in the probiotics group died, versus 9 out of the 144 control patients. This difference was statistically significant.The IGZ-report does not address a potential underlying cause of this extra mortality. It only addresses the procedures that were followed.
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