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Papers about antidepressant effectiveness


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Free full text at http://content.karger.com/produktedb/produkte.asp?doi=318293

 

or here http://www.mediafire.com/?xpvwzxhtu4n8mv3

 

Abstract at http://www.ncbi.nlm.nih.gov/pubmed/20616621

 

Psychother Psychosom. 2010;79(5):267-79. Epub 2010 Jul 9.

 

Efficacy and effectiveness of antidepressants: current status of research.

 

Pigott HE, Leventhal AM, Alter GS, Boren JJ.

Source NeuroAdvantage, LLC, Clarksville, Md., USA. pathware@erols.com

 

Abstract

 

BACKGROUND:

 

This paper examines the current status of research on the efficacy and effectiveness of antidepressants.

 

METHODS:

 

This paper reviews four meta-analyses of efficacy trials submitted to America's Food and Drug Administration (FDA) and analyzes STAR*D (Sequenced Treatment Alternatives to Relieve Depression), the largest antidepressant effectiveness trial ever conducted.

RESULTS:

 

Meta-analyses of FDA trials suggest that antidepressants are only marginally efficacious compared to placebos and document profound publication bias that inflates their apparent efficacy. These meta-analyses also document a second form of bias in which researchers fail to report the negative results for the pre-specified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure as though it was their primary measure of interest. The STAR*D analysis found that the effectiveness of antidepressant therapies was probably even lower than the modest one reported by the study authors with an apparent progressively increasing dropout rate across each study phase.

 

CONCLUSIONS:

 

The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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Philos Ethics Humanit Med. 2008 May 27;3:14.

 

Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?

 

Ioannidis JP.

 

Source Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine and the Biomedical Research Institute, Foundation for Research and Technology-Hellas, Ioannina, Greece. jioannid@cc.uoi.gr

 

Free full text at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2412901/?tool=pubmed

 

and at http://www.mediafire.com/?qpxp8dc5d434fxj

 

Abstract at http://www.ncbi.nlm.nih.gov/pubmed/18505564

 

Abstract

 

Antidepressants, in particular newer agents, are among the most widely prescribed medications worldwide with annual sales of billions of dollars. The introduction of these agents in the market has passed through seemingly strict regulatory control. Over a thousand randomized trials have been conducted with antidepressants. Statistically significant benefits have been repeatedly demonstrated and the medical literature is flooded with several hundreds of "positive" trials (both pre-approval and post-approval). However, two recent meta-analyses question this picture. The first meta-analysis used data that were submitted to FDA for the approval of 12 antidepressant drugs. While only half of these trials had formally significant effectiveness, published reports almost ubiquitously claimed significant results. "Negative" trials were either left unpublished or were distorted to present "positive" results. The average benefit of these drugs based on the FDA data was of small magnitude, while the published literature suggested larger benefits. A second meta-analysis using also FDA-submitted data examined the relationship between treatment effect and baseline severity of depression. Drug-placebo differences increased with increasing baseline severity and the difference became large enough to be clinically important only in the very small minority of patient populations with severe major depression. In severe major depression, antidepressants did not become more effective, simply placebo lost effectiveness. These data suggest that antidepressants may be less effective than their wide marketing suggests. Short-term benefits are small and long-term balance of benefits and harms is understudied. I discuss how the use of many small randomized trials with clinically non-relevant outcomes, improper interpretation of statistical significance, manipulated study design, biased selection of study populations, short follow-up, and selective and distorted reporting of results has built and nourished a seemingly evidence-based myth on antidepressant effectiveness and how higher evidence standards, with very large long-term trials and careful prospective meta-analyses of individual-level data may reach closer to the truth and clinically useful evidence.

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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Free full text at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2253608/?tool=pubmed

 

and at http://www.mediafire.com/?ucp8whdnguxcma9

 

Abstract at http://www.ncbi.nlm.nih.gov/pubmed/18303940

 

PLoS Med. 2008 Feb;5(2):e45.

 

Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.

 

Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT.

 

Source Department of Psychology, University of Hull, Hull, United Kingdom. i.kirsch@hull.ac.uk

 

Abstract

 

BACKGROUND:

 

Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.

 

METHODS AND FINDINGS:

 

We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug-placebo difference scores. Drug-placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups.

 

CONCLUSIONS:

 

Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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Dr. Ioannidis was the subject of a piece in The Atlantic regarding the reliability and validity of medical research. I posted the link to the article in another thread. I recommend the piece if anyone has not read it yet.

 

http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/

 

 

Alex.i

"Well my ship's been split to splinters and it's sinking fast
I'm drowning in the poison, got no future, got no past
But my heart is not weary, it's light and it's free
I've got nothing but affection for all those who sailed with me.

Everybody's moving, if they ain't already there
Everybody's got to move somewhere
Stick with me baby, stick with me anyhow
Things should start to get interesting right about now."

- Zimmerman

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