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Medical guidelines designed to avoid damage to the heart during non-cardiac surgery in Europe recommend the use of beta-blockers. But the guidance was partially written by and largely based on work by the recently disgraced dutch researcher Don Poldermans.

Forbes sums up the story:

Current European Society of Cardiology guidelines recommend that beta-blockers be given to many patients having surgery for noncardiac reasons to protect the heart during surgery. (US guidelines are somewhat less aggressive in their endorsement of perioperative beta-blockade.) The guidelines, which were published in 2009, were based on analyses of the available trials. The strongest evidence came from the DECREASE family of trials, which appeared to strongly support perioperative beta-blockade, and one other large trial, POISE, which raised concerns that beta-blockers might lead to an increase in deaths. When the ESC committee combined all the data they found a neutral effect on mortality but a strong benefit due to significant reductions in non-fatal MI and stroke with beta blocker use. This was the basis for the strong recommendation in the ESC guidelines.

In 2011, however, faith in the reliability of the DECREASE trials was shattered as a result of a scientific misconduct scandal centering on the principal investigator of the studies, the now disgraced Dutch researcher Don Poldermans. The issue was further complicated because, in addition to his key role in the trials, Poldermans was the chairman of the committee that drafted the guidelines.

A reanalysis of the known results when Poldermans' work is excluded showed that the standard recommended practice of using beta-blockers would significantly increase deaths. Forbes summarises their initial results:

Each year in the UK, according to the Heart authors, 2.5 million procedures are performed each year for which this treatment is recommended in the current guidelines. Based on a 27% increase in the risk of death associated with perioperative beta-blockade, they calculated that as many as 10,000 deaths might be caused by physicians faithfully following the guidelines.

But their work is not entirely uncontroversial and an extension of their estimate to Europe as a whole has been withdrawn by a journal (see the follow up story in Forbes).

Have clinical guidelines based on this faulty research killed tens of thousands of people undergoing surgery?

  • @GlenTheUdderboat The situation is in flux so I'm not sure. Originally I had it in the past tense, but there was conflicting evidence about whether the guidelines had ben changed. – matt_black Jan 18 '14 at 16:45
  • @GlenTheUdderboat Because the estimate was extended beyond the UK to the rest of europe suggesting far more deaths (in fact hundreds of thousands) so tens of thousands seemed a good compromise. – matt_black Jan 18 '14 at 19:02
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The only peer reviewed article is a meta-analysis they published so far makes the following claim:

The well-conducted trials indicate a statistically significant 27% increase in mortality from the initiation of perioperative β-blockade that guidelines currently recommend.

--Meta-analysis of secure randomised controlled trials of β-blockade to prevent perioperative death in non-cardiac surgery

But, as one reviewer put it:

The recent meta-analysis by Bouri et al. has concluded that, according to these 9 trials, beta-blockade significantly increases mortality (risk ratio=1.27; 95% confidence interval: 1.01 to 1.60; p=0.04), but this result was at the limits of statistical significance.

--Beta-blocakde to prevent perioperative death in non-cardiac surgery: a trial-sequential analysis

In short, there's a controversy. The authors of the original meta-analysis claim to have found more significant results, but their second work was temporarily retracted because it hasn't been peer reviewed yet.

  • A good summary of the situation now, but I wonder whether there has been any discussion on the authors' extrapolation to give the large numbers of potential deaths? – matt_black Jan 18 '14 at 16:47
  • See the second part of my answer. Their published results are at the limit of statistical significance - this is out of a discussion on their result. – Sklivvz Jan 18 '14 at 16:50
  • @GlenTheUdderboat I thought that reference was to the problematic trial which originally provided the evidence that is now being questioned. – matt_black Jan 19 '14 at 1:19

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