The SMILES trial: do undisclosed recruitment practices explain the remarkably large effect?
- PMID: 30591065
- PMCID: PMC6309075
- DOI: 10.1186/s12916-018-1221-5
The SMILES trial: do undisclosed recruitment practices explain the remarkably large effect?
Abstract
The SMILES trial showed substantial improvement of depressive symptoms following seven consultations on healthy dieting. The very large effect size on depression reduction seems remarkable and we suggest that selectively induced expectancy and a loss of blinding have contributed to the observed effect.
Conflict of interest statement
Competing interests
The authors declare that they have no competing interests.
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Comment in
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The SMILES trial: an important first step.BMC Med. 2018 Dec 28;16(1):237. doi: 10.1186/s12916-018-1228-y. BMC Med. 2018. PMID: 30591059 Free PMC article.
Comment on
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A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial).BMC Med. 2017 Jan 30;15(1):23. doi: 10.1186/s12916-017-0791-y. BMC Med. 2017. PMID: 28137247 Free PMC article. Clinical Trial.
References
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- Furukawa TA, Weitz ES, Tanaka S, Hollon SD, Hofmann SG, Andersson G, et al. Initial severity of depression and efficacy of cognitive–behavioural therapy: individual-participant data meta-analysis of pill-placebo-controlled trials. Br J Psychiatry. 2017;210(3):190–196. doi: 10.1192/bjp.bp.116.187773. - DOI - PMC - PubMed
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