LONDON, September 4. Clinical trials that use a heart patient's 'quality of life' as the only measure of the success of their treatment may skew results because of a significant placebo effect, according to researchers at the European Society of Cardiology meeting in Amsterdam last week.
James Jollis of the Duke Clinical Research Institute, North Carolina, and his colleagues have studied the endpoint of clinical trials of novel cardiac therapies to determine whether a patient's own assessment of their health, a common 'endpoint' used by clinical researchers, is appropriate in assessing a new therapy.
In a study of 1189 patients with severe coronary artery disease, Jollis and his team found that a patient's sense of well-being was unaffected by the treatment they received. Yet their treatment dramatically affected the actual clinical outcome: mortality rates for patients given drug therapy were twice as high as those for patients undergoing heart bypass ...
