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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 "Negative" trials were either left unpublished or were distorted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. 相似文献
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Mamta?Swaroop Sagar?C?Galwankar Stanislaw?PA?Stawicki Jayaraj?M?Balakrishnan Tamara?Worlton Ravi?S?Tripathi David?P?Bahner Sanjeev?Bhoi Colin?Kaide Thomas?J?PapadimosEmail author 《Philosophy, ethics, and humanities in medicine : PEHM》2014,9(1):8
INDUS-EM is India’s only level one conference imparting and exchanging quality knowledge in acute care. Specifically, in general and specialized emergency care and training in trauma, burns, cardiac, stroke, environmental and disaster medicine. It provides a series of exchanges regarding academic development and implementation of training tools related to developing future academic faculty and residents in Emergency Medicine in India. The INDUS-EM leadership and board of directors invited scholars from multiple institutions to participate in this advanced educational symposium that was held in Thrissur, Kerala in October 2013. 相似文献
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