Cited by 202Meta-analysis and systematic reviewsPharmaceutical industry and healthcareStatistical Methods in Clinical Trials

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Differences in Adverse Effect Reporting in Placebo Groups in SSRI and Tricyclic Antidepressant Trials: A Systematic Review and Meta-Analysis

Rief, Winfried, Nestoriuc, Yvonne, von Lilienfeld-Toal, Anna, Dogan, Imis, Schreiber, Franziska, Hofmann, Stefan G., Barsky, Arthur J., Avorn, Jerry·2009·Drug Safety

DOI 10.2165/11316580-000000000-00000

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Abstract

Background Biases in adverse effect reporting in randomized controlled trials (RCTs) [e.g. due to investigator expectations or assessment quality] can be quantified by studying the rates of adverse events reported in the placebo arms of such trials.Objective We compared the rates of adverse effects reported in the placebo arms of tricyclic antidepressant (TCA) trials and placebo arms of selective serotonin reuptake inhibitor (SSRI) trials.Methods We conducted a literature search for RCTs across PUBMED, Scopus and the Cochrane Central Register of Controlled Trials (CENTRAL). Only studies allowing adverse effect analysis were included. Publication year ranged from 1981 to 2007.Results Our systematic review and meta-analysis included 143 placebocontrolled RCTs and data from 12,742 patients. Only 21% of studies used structured and systematic adverse effect ascertainment strategies. The way in which trials recorded adverse events influenced the rate of adverse effects substantially. Systematic assessment led to higher rates than less systematic assessment. Far more adverse effects were reported in TCA-placebo groups compared with SSRI-placebo groups, e.g. dry mouth (odds ratio [OR] = 3.5; 95% CI 2.9, 4.2); drowsiness (OR = 2.7; 95%CI 2.2, 3.4); constipation (OR= 2.7; 95%CI 2.1, 3.6); sexual problems (OR =2.3; 95%CI 1.5, 3.5). Regression analyses controlling for various influencing factors confirmed the results.Conclusion Adverse effect profiles reported in clinical trials are strongly influenced by expectations from investigators and patients. This difference cannot be attributed to ascertainment methods. Adverse effect patterns of the drug group are closely related to adverse effects of the placebo group. These results question the validity of the assumption that adverse effects in placebo groups reflect the 'drug-unspecific effects'.

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Authors: Rief, W., Nestoriuc, Y., von Lilienfeld-Toal, A., Dogan, I., Schreiber, F., Hofmann, S. G., Barsky, A. J., & Avorn, J.
Affiliations: Philipps University of Marburg (DE)
Boston University (US)
Brigham and Women's Hospital (US)
Corresponding author: Rief, Winfried
ORCID: Rief, Winfried
Nestoriuc, Yvonne
Dogan, Imis
Schreiber, Franziska
Hofmann, Stefan G.
Avorn, Jerry
Venue: Drug Safety
Publisher: Springer Science and Business Media LLC
Published: 2009-11
Volume: 32
Issue: 11
Pages: 1041-1056
ISSN: 0114-5916 (ISSN-L)
DOI: 10.2165/11316580-000000000-00000
OpenAlex: W59643826
Semantic Scholar: 50b250c59bddc89685a35b4cffa7ab9cf1b7a1e4
Cited by: 202
References: 192
Citations by year: 2026: 3 · 2025: 6 · 2024: 11 · 2023: 6 · 2022: 15 · 2021: 14 · 2020: 12 · 2019: 18 · 2018: 16 · 2017: 11 · 2016: 17 · 2015: 15 · 2014: 16 · 2013: 11 · 2012: 16
FWCI: 12.82
Type: journal article
Language: en
Open access: closed
Locations: Drug Safety (publishedVersion)
PubMed (publishedVersion)
Radboud Repository (Radboud University) (submittedVersion)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: placebo group, selective serotonin reuptake inhibitors, tricyclic antidepressants, investigator bias, xerostomia, sleepiness, constipation, sexual dysfunction, antidepressant trials
MeSH terms: Antidepressive Agents, Tricyclic, Humans, Regression Analysis, Research Personnel, Bias, Randomized Controlled Trials as Topic, Selective Serotonin Reuptake Inhibitors, Antidepressive Agents, Second-Generation, Research Subjects

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Differences in Adverse Effect Reporting in Placebo Groups in SSRI and Tricyclic Antidepressant Trials: A Systematic Review and Meta-Analysis

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