Systematic evaluation of the 'efficacy-effectiveness gap' in the treatment of depression with venlafaxine and duloxetine.

Publisher: Wiley-Blackwell Country of Publication: United States NLM ID: 0370364 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1600-0447 (Electronic) Linking ISSN: 0001690X NLM ISO Abbreviation: Acta Psychiatr Scand Subsets: MEDLINE

Publication: Malden, MA : Wiley-Blackwell
Original Publication: Copenhagen : Munksgaard International Publishers

Antidepressive Agents* ; Depression*; Duloxetine Hydrochloride ; Humans ; Prospective Studies ; Venlafaxine Hydrochloride/pharmacology

Objective: Evidence of larger drug effects in highly standardized studies (efficacy) compared to clinical routine (effectiveness) is discussed as efficacy-effectiveness gap. This study aimed to quantify effect size differences of RCTs and non-RCTs in the treatment of depression with venlafaxine and duloxetine and to identify effect modifying predictors.
Methods: A comprehensive systematic review and meta-analysis was conducted, including all prospective trials, which evaluated the treatment effects of duloxetine or venlafaxine in patients with depression. The primary outcome was the pre-post effect size after acute therapy, which were compared between RCTs and non-RCTs. Moreover, an exploratory analysis of predictors in a mixed meta-regression model within an information-theoretic approach was performed.
Results: 171 RCTs and 74 non-RCTs were included. The pre-post effect size differed significantly between RCTs and non-RCTs (-3.04 vs. -2.62, Δ = 0.41, p = 0.012, high heterogeneity). Study characteristics were very similar between RCTs and non-RCTs. Most important variables to predict effect sizes were 'depression severity', 'dose' and 'number of participants'.
Conclusion: Despite differences in effect sizes between RCTs and non-RCTs, study design is not clearly an important predictor for the effect sizes. Our results question the common assumption that non-RCTs are generally better suited to describe a drug's effectiveness in clinical practice than RCTs. Future studies and their reporting should put more emphasis on the description of external validity, in order to allow better assessments of clinical relevance.
(© 2021 The Authors. Acta Psychiatrica Scandinavica published by John Wiley & Sons Ltd.)

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Keywords: antidepressives; depression; meta-analysis; psychopharmacology

0 (Antidepressive Agents)
7D7RX5A8MO (Venlafaxine Hydrochloride)
9044SC542W (Duloxetine Hydrochloride)

Date Created: 20210304 Date Completed: 20210910 Latest Revision: 20220531

20231215

10.1111/acps.13293

33661520