Placebo and nocebo reactions in randomized trials of pharmacological treatments for persistent depressive disorder. A meta-regression analysis
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Placebo and nocebo reactions in randomized trials of pharmacological treatments for persistent depressive disorder. A meta-regression analysis. / Meister, Ramona; Jansen, Alessa; Härter, Martin; Nestoriuc, Yvonne; Kriston, Levente.
in: J AFFECT DISORDERS, Jahrgang 215, 06.2017, S. 288-298.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Placebo and nocebo reactions in randomized trials of pharmacological treatments for persistent depressive disorder. A meta-regression analysis
AU - Meister, Ramona
AU - Jansen, Alessa
AU - Härter, Martin
AU - Nestoriuc, Yvonne
AU - Kriston, Levente
N1 - Copyright © 2017 Elsevier B.V. All rights reserved.
PY - 2017/6
Y1 - 2017/6
N2 - BACKGROUND: We aimed to investigate placebo and nocebo reactions in randomized controlled trials (RCT) of pharmacological treatments for persistent depressive disorder (PDD).METHODS: We conducted a systematic electronic search and included RCTs investigating antidepressants for the treatment of PDD. Outcomes were the number of patients experiencing response and remission in placebo arms (=placebo reaction). Additional outcomes were the incidence of patients experiencing adverse events and related discontinuations in placebo arms (=nocebo reaction). A priori defined effect modifiers were analyzed using a series of meta-regression analyses.RESULTS: Twenty-three trials were included in the analyses. We found a pooled placebo response rate of 31% and a placebo remission rate of 22%. The pooled adverse event rate and related discontinuations were 57% and 4%, respectively. All placebo arm outcomes were positively associated with the corresponding medication arm outcomes. Placebo response rate was associated with a greater proportion of patients with early onset depression, a smaller chance to receive placebo and a larger sample size. The adverse event rate in placebo arms was associated with a greater proportion of patients with early onset depression, a smaller proportion of females and a more recent publication.CONCLUSIONS: Pooled placebo and nocebo reaction rates in PDD were comparable to those in episodic depression. The identified effect modifiers should be considered to assess unbiased effects in RCTs, to influence placebo and nocebo reactions in practice.LIMITATIONS: Limitations result from the methodology applied, the fact that we conducted only univariate analyses, and the number and quality of included trials.
AB - BACKGROUND: We aimed to investigate placebo and nocebo reactions in randomized controlled trials (RCT) of pharmacological treatments for persistent depressive disorder (PDD).METHODS: We conducted a systematic electronic search and included RCTs investigating antidepressants for the treatment of PDD. Outcomes were the number of patients experiencing response and remission in placebo arms (=placebo reaction). Additional outcomes were the incidence of patients experiencing adverse events and related discontinuations in placebo arms (=nocebo reaction). A priori defined effect modifiers were analyzed using a series of meta-regression analyses.RESULTS: Twenty-three trials were included in the analyses. We found a pooled placebo response rate of 31% and a placebo remission rate of 22%. The pooled adverse event rate and related discontinuations were 57% and 4%, respectively. All placebo arm outcomes were positively associated with the corresponding medication arm outcomes. Placebo response rate was associated with a greater proportion of patients with early onset depression, a smaller chance to receive placebo and a larger sample size. The adverse event rate in placebo arms was associated with a greater proportion of patients with early onset depression, a smaller proportion of females and a more recent publication.CONCLUSIONS: Pooled placebo and nocebo reaction rates in PDD were comparable to those in episodic depression. The identified effect modifiers should be considered to assess unbiased effects in RCTs, to influence placebo and nocebo reactions in practice.LIMITATIONS: Limitations result from the methodology applied, the fact that we conducted only univariate analyses, and the number and quality of included trials.
KW - Antidepressive Agents
KW - Depression
KW - Depressive Disorder
KW - Humans
KW - Nocebo Effect
KW - Placebo Effect
KW - Randomized Controlled Trials as Topic
KW - Research Design
KW - Journal Article
KW - Meta-Analysis
KW - Review
U2 - http://doi.org/10.1016/j.jad.2017.03.024
DO - http://doi.org/10.1016/j.jad.2017.03.024
M3 - SCORING: Journal article
C2 - 28363152
VL - 215
SP - 288
EP - 298
JO - J AFFECT DISORDERS
JF - J AFFECT DISORDERS
SN - 0165-0327
ER -