Question:

Here is a link to the 7 May 2002 article in The Washington Post regarding placebos versus antidepressants. http://www.washingtonpost.com/wp-dyn/articles/A42930-2002May6.html Cut and paste it into the address spot in your Internet browser.

Response:

As if you didn’t know?

Response:

> But hasn’t EACH ONE of these anti depressants undergone trials for > effectiveness before approval and use by the general public? Part of that is > to be better than placebo. What am I missing?

Evidently the FDA requires that the drug manufacturer furnish data from at least 2 studies (so usually only data from 2 studies are provided) showing the drug to be better than placebos.  Sometimes manufacturers must conduct 5 studies (maybe even more!) to obtain 2 that show their drug has qualities that exceed those of the placebo. The studies not sent to the FDA to gain approval for the drug may show that the placebo performed better than the drug, or that the drug was not found to be better than the placebo with suitable statistical significance (based on the number of patients involved in the study, etc.). Evidently patients who learn they improved using the placebo are prone to sudden reversal of the gains of the non-drug placebo!  So how much of "getting better" is in the mind of the patient, that "thinking one has gotten better" is a major part of "getting better"?  We must all wonder…

Response:

But hasn’t EACH ONE of these anti depressants undergone trials for effectiveness before approval and use by the general public? Part of that is to be better than placebo. What am I missing?

– Hide quoted text — Show quoted text -> Placebos & Antidepressants Work the same Way > Antidepressants also cause additional brain changes > http://mentalhealth.about.com/library/weekly/aa050502a.htm > We have known for some time that patients given placebos (pills with no > active ingredient) often respond the same way that patients given > antidepressants. Their depression often lifts as a result of either > treatment. A new study (5/02) shows us that these two treatments both > cause similar changes in the brain. > Helen Mayberg, M.D., and her colleagues at the University of Texas > Health Science Center, San Antonio, used functional brain imaging to > study glucose metabolism in different parts of the brain following > treatment with either fluoxetine or placebo. The study was a > randomized, double-blind trial of 17 middle-aged men who were > hospitalized for unipolar depression. The researchers found that their > depressed male subjects who got better (four in each condition) > responded with increased cortical activity and decreased limbic > activity after six weeks of either treatment. Patients receiving > fluoxetine also showed changes in lower parts of the brain – in the > brainstem, striatum and hippocampus. These changes were not seen in > patients who received placebo. > A graphic illustration of the changes shows the similarities and > differences between the two conditions. > Composite PET (positron emission tomography) scan data, superimposed on > MRI (magnetic resonance imaging) scans, show brain areas that increased > (red) or decreased (yellow) in activity in men who responded to placebo > (top row) and fluoxetine (bottom row). Both groups shared a pattern of > increased activity in the cortex (e.g., prefrontal, posterior > cingulate) and decreased activity in limbic regions (e.g., subgenual > cingulate), which the researchers suggest is necessary for therapeutic > response. Men who responded to the active medication, in addition, > experienced decreased activity in certain lower brain areas (e.g., > hippocampus, anterior insula) thought to sustain the cortical/limbic > changes and prevent relapse. (Graphic and key courtesy of NIMH, 2002) > What does this all mean? There are several ways to think about this > study. One conclusion that we can draw is that the placebo effect is > real – and that the act of taking an inert substance (along with other > aspects of a hospital treatment program) can trigger certain changes in > the brain. In an interview with NIMH Dr. Mayberg cautioned against > equating antidepressants and placebos. "Our findings do not support > the notion that antidepressants work merely via a placebo effect. > Patients on active medication who failed to improve did not sustain the > brainstem, striatal and hippocampus changes unique to antidepressant > responders." Rather, the authors speculate that "clinical improvement > in the group receiving placebo as part of an inpatient study is > consistent with the well-recognized effect that altering the > therapeutic environment may significantly contribute to reducing > clinical symptoms. The additional subcortical and limbic metabolism > decreases seen uniquely in fluoxetine responders may convey additional > advantage in maintaining long-term clinical response and in relapse > prevention" (Mayberg, et.al., 2002). > This study is important because it helps us begin to understand how > antidepressants and other treatment techniques change the brain. We > are just beginning to understand the brain at this level, and further > research will undoubtedly build upon this foundation. We already know > that both psychiatric medications and psychotherapy result in changes > in the brain. This study begins to tell us how the brain changes. > Reference: > Helen S. Mayberg, J. Arturo Silva, Steven K. Brannan, Janet L. Tekell, > Roderick K. Mahurin, Scott McGinnis, and Paul A. Jerabek, The > Functional Neuroanatomy of the Placebo Effect, Am J Psychiatry 2002 > 159: 728-737. [Abstract available Online]

Response:

This surprises me. Worries me for some reason also. On one hand I think that my anti depressant probably works for me. (Indeed, speculation is that too much antidressants can set off a manic cycle.) On the other hand I KNOW that my other medications do control my mania.

– Hide quoted text — Show quoted text -> Placebos & Antidepressants Work the same Way > Antidepressants also cause additional brain changes > http://mentalhealth.about.com/library/weekly/aa050502a.htm > We have known for some time that patients given placebos (pills with no > active ingredient) often respond the same way that patients given > antidepressants. Their depression often lifts as a result of either > treatment. A new study (5/02) shows us that these two treatments both > cause similar changes in the brain. > Helen Mayberg, M.D., and her colleagues at the University of Texas > Health Science Center, San Antonio, used functional brain imaging to > study glucose metabolism in different parts of the brain following > treatment with either fluoxetine or placebo. The study was a > randomized, double-blind trial of 17 middle-aged men who were > hospitalized for unipolar depression. The researchers found that their > depressed male subjects who got better (four in each condition) > responded with increased cortical activity and decreased limbic > activity after six weeks of either treatment. Patients receiving > fluoxetine also showed changes in lower parts of the brain – in the > brainstem, striatum and hippocampus. These changes were not seen in > patients who received placebo. > A graphic illustration of the changes shows the similarities and > differences between the two conditions. > Composite PET (positron emission tomography) scan data, superimposed on > MRI (magnetic resonance imaging) scans, show brain areas that increased > (red) or decreased (yellow) in activity in men who responded to placebo > (top row) and fluoxetine (bottom row). Both groups shared a pattern of > increased activity in the cortex (e.g., prefrontal, posterior > cingulate) and decreased activity in limbic regions (e.g., subgenual > cingulate), which the researchers suggest is necessary for therapeutic > response. Men who responded to the active medication, in addition, > experienced decreased activity in certain lower brain areas (e.g., > hippocampus, anterior insula) thought to sustain the cortical/limbic > changes and prevent relapse. (Graphic and key courtesy of NIMH, 2002) > What does this all mean? There are several ways to think about this > study. One conclusion that we can draw is that the placebo effect is > real – and that the act of taking an inert substance (along with other > aspects of a hospital treatment program) can trigger certain changes in > the brain. In an interview with NIMH Dr. Mayberg cautioned against > equating antidepressants and placebos. "Our findings do not support > the notion that antidepressants work merely via a placebo effect. > Patients on active medication who failed to improve did not sustain the > brainstem, striatal and hippocampus changes unique to antidepressant > responders." Rather, the authors speculate that "clinical improvement > in the group receiving placebo as part of an inpatient study is > consistent with the well-recognized effect that altering the > therapeutic environment may significantly contribute to reducing > clinical symptoms. The additional subcortical and limbic metabolism > decreases seen uniquely in fluoxetine responders may convey additional > advantage in maintaining long-term clinical response and in relapse > prevention" (Mayberg, et.al., 2002). > This study is important because it helps us begin to understand how > antidepressants and other treatment techniques change the brain. We > are just beginning to understand the brain at this level, and further > research will undoubtedly build upon this foundation. We already know > that both psychiatric medications and psychotherapy result in changes > in the brain. This study begins to tell us how the brain changes. > Reference: > Helen S. Mayberg, J. Arturo Silva, Steven K. Brannan, Janet L. Tekell, > Roderick K. Mahurin, Scott McGinnis, and Paul A. Jerabek, The > Functional Neuroanatomy of the Placebo Effect, Am J Psychiatry 2002 > 159: 728-737. [Abstract available Online]

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