 |
 |
In a message dated 19/09/2007 07:01:16 GMT Standard Time, [log in to unmask] writes: Amanda wrote: <<Has anyone got better as a result of the sham surgery ? That'd muck up the figures?>> Double-blind, placebo-controlled trials are considered to be the gold standard in clinical research. Many investigators cite the Freed fetal cell tissue transplant study (in the late 1990's) for advanced Parkinson’s disease and subsequent follow- up studies as evidence that the placebo effect may be especially strong and long lasting—as much as a year or more—in surgical treatments for Parkinson’s patients. And it is also currently being cited as evidence that sham surgery as a placebo control is necessary in testing new surgical treatments for PD - such as gene therapies. In the Freed study half of the participants received fetal tissue transplant - the other half had sham surgery - holes were drilled into the skull, but no treatment was received. Both groups were given anesthesia and intravenous antibiotics. Researchers argued that the risks associated with the surgery were reasonable in relation to the possible benefits from the outcome of the study. During the 12 month follow up, those who thought they received the fetal tissue implant scored higher on Quality of Life scales - whether they actually did receive treatment or not. One theory is that the expectation of getting better itself causes more dopamine to be released in the brain, and thus one feels better. However there was no improvement in actual motor scores in the sham surgery group . Definitely the placebo effect in PD needs to be studied further. Current insistence on the need for sham surgery as a placebo seems to be largely based on this one study. And it's use is supported mostly among North American scientists. Researchers in other parts of the world seem to be able to conduct valuable Parkinson's research without having to resort to doing sham brain surgery. Linda Herman ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn recovery (eveen temporarily) due to the placebo effect - suggests dead brain cells being revived by a change in emotional balance ? Am I missing something ? ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn