Nocebo in clinical trials for depression: a meta-analysis
Dimos D Mitsikostas1, Leonidas Mantonakis2, Nikolaos Chalarakis2
1Neurology Department, Athens Naval Hospital, 77A Vas. Sofias Avenue, 11521 Athens, Greece.
Psychiatry Research
|November 12, 2013
Summary
The nocebo effect, where negative expectations cause adverse events (AEs), significantly impacts depression trials. Nearly 5% of patients discontinue placebo treatment due to these nocebo-related AEs.
Area of Science:
- Psychiatry
- Clinical Psychology
- Medical Research Methodology
Background:
- The nocebo effect involves adverse events (AEs) stemming from negative treatment expectations.
- Assessing the nocebo effect is crucial in placebo-controlled randomized clinical trials (RCTs).
Purpose of the Study:
- To examine adverse events (AEs) following placebo administration in depression (D) RCTs.
- To determine the extent of the nocebo effect and influencing factors in depression treatment trials.
Main Methods:
- Systematic Medline search for depression RCTs published in the last decade.
- Assessment of placebo-treated patients reporting AEs or discontinuing due to intolerance.
- Analysis of factors influencing the nocebo effect's extent.
Main Results:
- 44.7% of 3255 placebo-treated patients reported at least one AE.
- 4.5% of placebo-treated patients discontinued treatment due to intolerance.
- AE rates correlated between placebo and active drug groups, but dropout rates did not.
Conclusions:
- A significant nocebo effect exists in depression treatment trials, with nearly 1 in 20 patients discontinuing due to AEs.
- The nocebo effect adversely affects adherence and efficacy of depression treatments.
- Findings have implications for designing clinical trials and understanding treatment outcomes.
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