Study: Better Placebo Info Needed for Drug Trials

Felicity Bishop (University of Southampton)

An analysis of pamphlets used to inform patients in clinical trials about the studies in which they take part indicates the literature short-changes discussion of placebos, in favor of the treatments being tested. The findings of health researchers led by psychology professor Felicity Bishop (pictured right) at University of Southampton in the U.K. appear in the online journal PLoS One.

In clinical trials, a placebo acts as a yardstick or constant by which to measure the effects of new active drugs, known in clinical trials as the target treatment. Some clinical trials use a control group where patients receive a placebo instead of an active drug or experimental treatment.

The team, including researchers from Harvard Medical School and University of Northern Arizona, examined the wording of 45 participant information leaflets from clinical trials using placebos listed on the U.K. Clinical Research Network Database.

The analysis indicated that the literature characterize the target treatments in more positive terms than the placebos. The descriptions of the studies emphasize the target treatments as more desirable to receive than the placebo. Target treatments are widely described as real or genuine and the main focus of the study.

The researchers found placebos, on the other hand, are rarely described in their own right, rather mostly in comparison to target treatments. Placebos, the team found, are described using negative terms like fake or dummy, while the target treatments are described in terms of a type of drug (e.g., anibiotic, statin).

The leaflets likewise emphasize both the benefits and adverse effects that might be triggered by the target treatment, but largely ignore any potential effects of the placebo. The researchers conclude that the current pamphlets for clinical trial participants provide incomplete and at times inaccurate information about placebos.

Co-author George Lewith, a primary care professor at Southampton, says placebos may be designed as inert, but they still have an effect. “Studies at Southampton have clearly shown placebos can help about half of the people we treat with chronic pain and can be effective for a long time afterwards,” says Lewith. “The placebo effect works by releasing our bodies’ own natural painkillers into our nervous system.”

The authors urge that clinical trial participants be better and more fully informed about the role of placebos. “There is an important issue of consent here,” says Bishop. “Patients should be fully aware of possible health changes from all treatments in a trial before agreeing to take part.”

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