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Study calls for drug trial patients to receive more information about effects of placebos
Date:6/28/2012

Research carried out at the University of Southampton has concluded that participants in drug trials should be better informed about the potential significant benefits and possible side-effects of placebos.

Placebos are traditionally thought of as 'inert' pills, given in trials to act as a yardstick or constant by which to measure the effects of new 'active' drugs, known in clinical trials as the 'target treatment'. However, placebos themselves have been shown to create substantial health changes in patients.

"We believe the health changes associated with placebos should be better represented in the literature given to patients before they take part in a clinical trial. At the moment these effects are largely being ignored in the patient information leaflets," says lead researcher at Southampton and lecturer in psychology, Dr Felicity Bishop.

She continues, "There is an important issue of consent here patients should be fully aware of possible health changes from all treatments in a trial before agreeing to take part."

The research team, led by the University of Southampton in collaboration with Harvard Medical School and Northern Arizona University, examined the wording of 45 participant information leaflets from clinical trials which used placebos and are listed on the UK Clinical Research Network Database.

Analysis of the participant leaflets led to these key observations:

  • Emphasis was given to the target treatment being more desirable to receive than the placebo.

  • Target treatments were widely described as 'real', 'genuine' and the focus of the study. Placebos were rarely described in their own right, rather they were mostly referred to in comparison to target treatments.

  • Target treatments were often described in relation to a class of drug, thus implying a particular effect, for example, antibiotics (infection fighting) or statins (cholesterol lowering).

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Contact: Peter Franklin
44-238-059-5457
University of Southampton
Source:Eurekalert

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