%0 Journal Article
%T Reactions to treatment debriefing among the participants of a placebo controlled trial
%A Zelda Di Blasi
%A Fay Crawford
%A Colin Bradley
%A Jos Kleijnen
%J BMC Health Services Research
%D 2005
%I BioMed Central
%R 10.1186/1472-6963-5-30
%X Survey of trial participants using a semi-structured questionnaire including close and open-ended questions administered as telephone interviews and postal questionnaires. Trial participants were enrolled in a double-blind placebo-controlled RCT evaluating the effectiveness of corticosteroid for heel pain (ISRCTN36539116). The trial had closed and participants remained blind to treatment allocation. We assessed treatment expectations, the percentage of participants who wanted to be informed about their treatment allocation, their ability to guess and reactions to debriefing.Forty-six (73%) contactable participants responded to our survey. Forty-two were eligible (four participants with bilateral disease were excluded as they had received both treatments). Most (79%) participants did not have any expectations prior to receiving treatment, but many 'hoped' that something would help. Reasons for not having high expectations included the experimental nature of their care and possibility that they may get a placebo. Participants were hopeful because their pain was so severe and because they trusted the staff and services. Most (83%) wanted to be informed about their treatment allocation and study results. Over half (55%) said they could not guess which treatment they had been randomized to, and many of those who attempted a guess were incorrect. Reactions to treatment debriefing were generally positive, including in placebo responders.Our study suggests that most trial participants want to be informed about their treatment allocation and trial results. Further research is required to develop measure of hope and expectancy and to rigorously evaluate the effects of debriefing prospectively.One of the most famous examples of the placebo effect is an account given by Dr. Klopfer of a trial patient with advanced cancer randomized to a new drug called 'Kebriozen'. Klopfer describes how within ten days: 'all signs of his disease [had] vanished'. The patient relapsed within two
%U http://www.biomedcentral.com/1472-6963/5/30