Posted by Larry Hoover on August 10, 2003, at 7:57:42
In reply to Unpublished (suppressed) studies and 41% efficacy, posted by BobS. on August 9, 2003, at 18:50:41
> The most important issues raised in this article are as follows. I know because I work in human clinical trial arena....
I'm not meaning to sound contrary, but it needs to be said that clinical trials are an exceedingly artificial environment. The very act of controlling variables makes that so.
> "Even in adults, S.S.R.I.'s have been found to offer only modest benefits. In about half of all adult tests, the drugs prove no more effective than placebos. On average, they reduce symptoms of depression by about 41 percent on a widely used scale, versus a 31 percent reduction among those taking placebos, according to a survey in 2000 of studies used by the F.D.A. in approving the drugs.For one such in-depth meta-analysis, go to:
http://www.psychiatrictimes.com/p000429.html which was written by Dr. Khan, an expert in the field.
It's important to emphasize that subjects receiving placebo pills in antidepressant trials are *not* untreated.
From the referenced article:
"The less-than-impressive results in these and other studies also calls to mind the fact that patients assigned to placebo treatment in clinical trials are not "getting nothing." The capsule they receive is pharmacologically inert but hardly inert with respect to its symbolic value and its power as a conditioned stimulus. In addition, placebo-treated patients receive all of the commonly employed treatment techniques: a thorough evaluation; an explanation for their distress; an expert healer; a plausible treatment; expectation of improvement; a healer's commitment, enthusiasm and positive regard; and an opportunity to verbalize their distress. "He goes on to include a very important warning about the interpretation of the data arising from antidepressant clinical trials. Note particularly the concluding statement.
"A cautionary note is indicated about the generalization of these data to the clinical management of depressed patients. The less-than-impressive difference between drug and placebo in this and other studies of clinical trials does not speak directly to the effectiveness of antidepressants in clinical practice. Participants in antidepressant clinical trials are a highly select group and are not representative of the general population of depressed patients. They are not actively suicidal, they are almost always outpatients who are moderately rather than severely or mildly depressed, and they are free of comorbid physical or psychiatric illness. They are likely to have a higher placebo response rate than more severely ill depressed patients. "
"Furthermore, the primary aim of these studies is not to assess the optimal effect of antidepressants, but rather to rapidly assess efficacy of new drugs so they can be brought to the market. Therefore, dose, duration and diagnosis in clinical trials are not necessarily ideally suited to identify the optimal effects of antidepressants. Accordingly, clinical trials may identify the lower bound of the effect size compared to placebo. "
Lar
poster:Larry Hoover
thread:248910
URL: http://www.dr-bob.org/babble/20030807/msgs/249749.html