Navigation Links
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).

  • Placebos were often described in negative terms, such as 'dummy' or 'fake'.

  • The leaflets emphasised both the benefits and adverse effects that might be triggered by the target treatment, but largely ignored any potential effects of the placebo.

Crucially, the study showed the target treatments were prioritised over the placebo, from the words in the leaflet titles, to the description of the trial process, through to explaining what would happen at the end of the trial.

Professor of Health Research at the University of Southampton, George Lewith, comments, "The leaflets largely ignored the overwhelming evidence that placebos can actually have significant and sustained effects on people. This could affect the treatment beliefs and expectations of those volunteering for studies and in turn the results.

"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. The placebo effect works by releasing our bodies' own natural painkillers into our nervous system."

The researchers argue that volunteers for clinical trials should be more fully informed about the health changes they might experience from a placebo, otherwise their informed consent, crucial to taking part, is in jeopardy. They believe different ways of describing placebos need to be developed and tested, both for participant information leaflets and for personal contact with those conducting research.


'/>"/>

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

Related medicine news :

1. Study Suggests Vaccine May Help Kids With Brain Cancer
2. Study reveals how cancer drug causes diabetic-like state
3. Coffee Drinking in Pregnancy Wont Lead to Sleepless Baby: Study
4. Lower GI problems plague many with rheumatoid arthritis, Mayo Clinic study finds
5. Veggies Like Broccoli, Cabbage May Help Fight Breast Cancer: Study
6. No Added Cancer Risk From Hip Replacement Materials: Study
7. Reported Decline in U.S. Pneumonia Deaths May Be False: Study
8. Early Study Finds Some Promise for Lung Cancer Vaccine
9. Narcissists Often Ace Job Interviews, Study Finds
10. Sexual objectification of female artists in music videos exists regardless of race, MU study finds
11. Soy may alleviate hot flashes in menopause, large-scale study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 2017 , ... The International Association of Eating Disorders Professionals ... the field of eating disorders, announces the opening of early registration for the ... at the Omni Resort at ChampionsGate. , The annual iaedp™ Symposium ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes ... of the facility as part of a disaster drill on October 3rd. , Apple ... Shelton City Emergency Manager, as well as the Connecticut Long Term Care Mutual ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th ... Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, ... The fun run is geared towards children of all ages; it is a non-competitive, ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest ... its plans to open a flagship location in Covington, LA at 401 N. U.S. ... Go store next to Office Depot in the Holiday Square shopping center. Its location ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
(Date:9/22/2017)... AVACEN Medical (AVACEN) announced that its CE-Marked ... those with the widespread pain associated with fibromyalgia in ... Essex, England commented, "I had ... no sleep at all, tremendous pain, with every movement ... [the AVACEN 100] enough, how this has and is ...
(Date:9/18/2017)... , Sept. 18, 2017 EpiVax, ... of bioinformatics and immune engineering, today announced ... influenza A (H7N9) vaccine. ... to seasonal influenza and presents a challenge ... prior exposure to be effective. Using state-of-the-art ...
Breaking Medicine Technology: