Dear Amy,
There are, it seems to me, two very different issues. 1. Denying a patient an agreed effective remedy and 2. Giving a patient a placebo.
In fact, placebos are really only used to blind trials and they are nearly always employed in active controlled studies to achieve that aim. So the fact that an active control is used does not mean that placebos are not used as anyone familar with drug trials (which have to use the double dummey technique) will tell you.
Furthermore, many so-called placebo controlled trials are 'add on' trials since, where an effective remedy exists for a serious condition, it is unethical to withhold it (see 1 above) and hence all patients receive the therapy: some receive an additional active treatment and some receive a placebo.
However, I don't think that any of this can be relevant to the situation you describe since it is hard to see what a placebo to cognitive rehabilitation could consist of. That being so, your trial cannot be double blind. 9But perhaps I have misunderstood.)
You will find these points discussed in Senn, S. J. (2001). "The Misunderstood Placebo." Applied Clinical Trials 10(5): 40-46.
Regards
Stephen
Stephen Senn
Professor of Statistics
School of Mathematics and Statistics
Direct line: +44 (0)141 330 5141
Fax: +44 (0)141 330 4814
Private Webpage: http://www.senns.demon.co.uk/home.html
University of Glasgow
15 University Gardens
Glasgow G12 8QW
The University of Glasgow, charity number SC004401
________________________________________
From: Evidence based health (EBH) [[log in to unmask]] On Behalf Of Dr. Amy Price [[log in to unmask]]
Sent: 28 February 2011 05:04
To: [log in to unmask]
Subject: Placebo ethics
Dear All,
I am working on a five site in-house addiction study that offers cognitive rehabilitation treatment. For the sake of validity etc it is suggested that we do this as placebo, randomised, double blind study . My concern is that even though I can arrange for controls to have access to the experimental treatment following the study, in reality this is not likely to be happen as they are institutionalized for only 30 days. The downside is the controls who are in need will go untreated and the ineffectiveness of the placebo may discourage them from further treatment and in addition they will not receive the benefits of early intervention for this condition. Even wait listing 50% of them after initial baselines would provide similar ethical concerns. I am certain the double blind with placebo will pass IRB protocols etc. What I am wondering is would the greater strength of the controlled study outweigh the disadvantages for the few who are excluded from early intervention and what would others do given these circumstances?
I appreciate the depth and breadth of the wisdom and experience represented on this listserve. Ethics and best practice are important to me and I will consider carefully the information you have time to share.
Thank you for your help with this,
Amy
|