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Moncrieff J, Wessely S, Hardy R

Summary
Tricyclic antidepressants are only slightly better than active placebos.

This review examined trials which compared antidepressants with 'active' placebos, that is placebos containing active substances which mimic side effects of antidepressants. Small differences were found in favour of antidepressants in terms of improvements in mood. This suggests that the effects of antidepressants may generally be overestimated and their placebo effects may be underestimated.

Main results
Nine studies involving 751 partcipants were included. Two of them produced effect sizes which showed a consistent and statistically significant difference in favour of the active drug. Combining all studies produced a pooled estimate of effect of 0.39 standard deviations (confidence interval, 0.24 to 0.54) in favour of the antidepressant measured by improvement in mood. There was high heterogeneity due to one strongly positive trial. Sensitivity analysis omitting this trial reduced the pooled effect to 0.17 (0.00 to 0.34). The pooled effect for inpatient and outpatient trials was highly sensitive to decisions about which combination of data was included but inpatient trials produced the lowest effects.
A
uthors' conclusions
The more conservative estimates from the present analysis found that differences between antidepressants and active placebos were small. This suggests that unblinding effects may inflate the efficacy of antidepressants in trials using inert placebos. Further research into unblinding is warranted.

This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 2, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Moncrieff J, Wessely S, Hardy R. Active placebos versus antidepressants for depression. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD003012. DOI: 10.1002/14651858.CD003012.pub2




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The Scientific Review of Mental Health Practice
Spring ~ Summer 2003 Volume 2 Number 1

Although Vedantam (2002) provides considerable evidence from recent research showing the substantial placebo effect in antidepressant clinical trials, he neglects to cover adequately alternative explanations for these findings. Therefore, the article may leave some readers with the erroneous impression that the antidepressants that they are being prescribed are no more worthwhile than sugar pills. Even critics of antidepressants acknowledge that a genuine difference exists between antidepressants and placebos, with the debate focusing on how large this difference is and the mechanisms responsible for it. It is true that some speculate that the remaining difference is attributable to such factors as the unblinding of raters resulting from the side effects of active drugs. They argue that active placebos, or pills that mimic common side effects but contain no clinical benefit, should be used more often in these trials. However, Quitkin et al. (2000) assert that, in their analyses, the placebo response rate in studies using active placebos is similar to that using inert sugar pills (viz., about 30%). In contrast, Moncrieff and colleagues (2002) conducted a meta-analysis of available antidepressant trials using active placebos and found that the difference between antidepressants and active placebo was negligible, and was much smaller than in trials using inert placebos. Furthermore, unblinding still could not be ruled out entirely in the active placebo trials because of methodological limitations. Only more research will be able to provide definitive answers to these questions. (с)


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