Interpretation of clinical trial data

In April 2007, the The Daily Telegraph ran a story linking non-steroidal anti-inflammatory drug use with an increased risk of heart attack. The article was headlined “High doses of ibuprofen raises heart attack risk” and stated that that for some individuals the risk of heart attack or stroke is nine times higher when taking ibuprofen. According to this report, these results will bring more anxiety to the millions of arthritis sufferers in Britain (published 6th April 2007).

You can read The Daily Telegraph article here

Here, Dr Shaun Treweek, specialist in the methodology of randomised controlled trials, responds:

The original research should not bring more anxiety to the millions of arthritis sufferers in Britain as the “nine times greater risk” is not based on thousands of patients but nine. Eight of 373 patients (2.14%) taking ibuprofen and aspirin had an adverse outcome compared to one of 394 patients (0.25%) taking an alternative drug and aspirin. The authors of the research themselves say that the risk could be as low as 1.13 or as high as 72.76. This huge range is exactly what you’d expect with so few patients and makes the estimate of risk largely meaningless. The study’s authors do point out that their research has many limitations and say it should be used for future research ideas rather than as a statement on the risks of ibuprofen.

    Last updated: May 24 2007