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Psychiatric Association


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Antidepressants play the major role in treating depressive patients not only due to the factthat they have to undergo the most rigorous proof of efficacy but also because they areeasy to apply in the everyday clinical practice. Nearly all psychiatrists and general practitionerstreating depressive patients agree about the relevance of antidepressants in thetreatment of depressive patients. However, a number of meta-analytic studies recently challengedthis belief and it has been put up for discussion to psychiatry/clinical psychopharmacology whetherthe efficacy of antidepressants is clinically relevant. Despite that all medication were judged to havesufficient data to receive approval from the FDA and the EMA and other agencies worldwide, someauthors went further and questioned the effectiveness of antidepressants. They even proposedthat "alternative" therapies of unproven efficacy or of proven negative efficacy should be preferredto medication. These authors do not take into consideration that for methodological reasons it isnot acceptable to deduce too extensive conclusions. Some assumptions they rely on, like the suggestionof NICE, which regards a mean placebo-verum difference of 3 HAM-D points as clinicallyrelevant, is downright arbitrary on statistical grounds, and not supported by empirical findings orby expert opinion. It seems that the difference in change in HAM-D score between the active drugand placebo is somewhere between 2 and 3, with maybe some agents performing a little betterthan others. It is uncertain whether initial severity determines response; different interpretationsexist. However, much more important for the evaluation of the clinical relevance is the result of theresponder/remitter analysis, which compares the relative frequency of these categories betweenthe placebo and verum groups. This approach results in a number needed to treat (NNT) of 5–7. InEvidence Based Medicine such a NNT is traditionally regarded as a sign of moderate to strong efficacyand corresponds to the referring values of many therapies, which e.g. are standard therapiesin internal medicine. However, from many meta-analyses it is clear that when concepts of evidencebasedmedicine and health economy are applied, which are far away from clinical thinking, problemsoccur and results are very difficult to interpret in clinical terms.

Key words: depression, antidepressants, efficacy, effectiveness, tolerability

H.J. Möller, K.N. Fountoulakis (page 298) - Full article