----- Original Message -----
From: "rayilynlee" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Tuesday, July 17, 2007 11:09 AM
Subject: Re: Survey of the use of sham surgery in clinical trials
> Having had brain surgery twice (DBS) I don't favor it as a "sham" for
> trials
> or in the future as any kind of routine treatment for PD or anything else.
> It is too much to ask of anyone. Even though PD is "'in your head" it
> isn't subject to a placebo effect anyway, in my opinion.
> Ray
> Rayilyn Brown
Ray; This may be of interest to you.
Research into placebo effect among Parkinsons patients
Disease/Infection News Published: Friday, 14-May-2004
Parkinson's disease patients who thought they had received a
transplant of human neurons into their brains-but who actually
hadn't-reported an improved quality of life one year later.
Research reported by education Prof. Cynthia McRae provides strong
evidence for significant mind-body connections among patients who
participated in a double-blind Parkinson's surgical trial. The findings were
published in the April Archives of General Psychiatry.
Forty patients from the United States and Canada participated to
determine the effectiveness of transplantation of human embryonic dopamine
neurons into the brains of those with advanced Parkinson's disease. Twenty
patients received the transplant, while 20 more were randomly assigned to
undergo a sham surgery.
McRae, a counseling psychologist, reports that the "placebo effect"
was very strong among the 30 patients who participated in the
quality-of-life portion of the study.
"Those who thought they received the transplant reported better
quality of life at 12 months than those who thought they received the sham
surgery, regardless of which surgery they actually received," McRae says.
Measures of improved quality of life included physical functioning, social
support and a global rating of change since surgery.
One of study's the most impressive results was that objective ratings
of neurological functioning by medical personnel showed a similar effect. In
the Archives article, McRae writes: "Medical staff, who did not know which
treatment each patient received, also reported more differences and changes
at 12 months based on patients' perceived treatment than on actual
treatment."
One patient, for example, reported that she had not been physically
active for several years before surgery, but in the year following surgery
she resumed hiking and ice-skating. She was surprised to learn after the
double-blind was lifted that she had received the sham surgery.
The findings have both scientific and practical implications, says the
study's co-author, Dan Russell of the Institute for Social and Behavioral
Research at Iowa State University.
"This study is extremely important in regard to the placebo effect
because we know of no placebo studies that have effectively maintained the
double-blind for at least 12 months. The average length of placebo studies
is eight weeks," Russell says.
McRae notes that similar results related to the placebo effect have
been found in other studies of patients with Parkinson's disease. She says
that there is a need for placebo controls in studies evaluating treatment
for Parkinson's, as the placebo effect seems to be particularly strong in
this disease.
McRae has had a strong interest in Parkinson's disease ever since her
father was diagnosed with the disease. When she heard the surgeries were
taking place in Denver, she expressed interest in conducting a follow-up
quality-of-life study and later received a grant from the National Institute
of Neurological Disorders and Stroke. http://www.du.edu
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