Starch Solutions in the Critically Ill: Research Fraud?

Bret Stetka, MD; Tom Woodcock


June 07, 2013

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Hello. I'm Bret Stetka, Editorial Director at Medscape. Welcome to the F1000 Practice-Changing Minute, where we report commentaries from the Faculty of 1000 on highly rated studies that may change clinical practice.

Our commentary today covers the study "Association of Hydroxyethyl Starch Administration With Mortality and Acute Kidney Injury in Critically Ill Patients Requiring Volume Resuscitation," from Drs. Zarychanski and colleagues, published in the Journal of the American Medical Association.[1] The F1000 commentator has given this study a ranking of "Changes Clinical Practice," with the conclusion that given absent safety data and no evidence of benefit, hydroxyethyl starches should not be administered in general clinical practice and should only be given to patients in ethically approved and patient-consented research trials.

The following F1000 commentary on this study was written by Tom Woodcock of the Critical Care Directorate, Southampton General Hospital, Hants, United Kingdom:

"This is the first meta-analysis relevant to the fiercely argued debate about the safety of intravenous hydroxyethyl starch solutions to show that the contributions of the research fraudster Joachim Boldt concealed risks of harm to patients. A total of 38 trials involving 10,868 patients were considered, of which Boldt contributed seven studies (including a claimed 590 patients). We can be confident that hydroxyethyl starch solutions 1) confer no benefit over alternatives; 2) are nephrotoxic; and 3) increase the risk of death at 90 days following administration. A meta-analysis focusing on just six trials of hydroxyethyl starch in patients with severe sepsis found, in addition, an increased risk of exposure to allogeneic transfusion.[2] Proponents of hydroxyethyl starch therapy are reduced to claiming that so-called 'modern starches' cause no harm to non-critically ill patients undergoing surgery, based on 59 studies of 2139 patients receiving a tetrastarch.[3] The retailers of starch solutions are generous financial supporters of selected researchers and professional societies and are working hard to minimise the negative impact reviews like this will have on multi-million dollar sales worldwide."

This concludes today's commentary from Tom Woodcock for the F1000 Practice-Changing Minute. I am Bret Stetka. Thank you for listening.