Evidence map›Paper›PMID 39440379›Full record

SynthesisEpidemiology and psychiatric sciences2024

The risks of adverse events with venlafaxine for adults with major depressive disorder: a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis.

C B Kamp, J J Petersen, P Faltermeier, S Juul, F Siddiqui, J Moncrieff, M A Horowitz, M P Hengartner, I Kirsch, C Gluud and 1 more

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Epidemiology and psychiatric sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Double counting, double standards.Psychological medicine · 2025
    Article
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

C B KampCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark.ORCID https://orcid.org/0000-0002-7756-4694
J J PetersenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark.
P FaltermeierCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark.
S JuulCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark.
F SiddiquiCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark.
J MoncrieffDivision of Psychiatry, University College London, London, UK.ORCID https://orcid.org/0000-0003-1214-6974
M A HorowitzDivision of Psychiatry, University College London, London, UK.
M P HengartnerDepartment of Applied Psychology, Zurich University of Applied SciencesZurich, Switzerland.ORCID https://orcid.org/0000-0002-2956-2969
I KirschProgram in Placebo Studies, Harvard Medical School, Boston, MA, USA.ORCID https://orcid.org/0000-0002-1215-4061
C GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark.
J C JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsVenlafaxine is used to treat depression worldwide. Previous reviews have demonstrated that venlafaxine lowers scores on depression rating scales, producing statistically significant results but the relevance to patients remains uncertain. Knowledge of the incidence of the adverse effects associated with venlafaxine has previously been based on the results of non-randomised studies. Our primary objective was to assess the risks of adverse events with venlafaxine in the treatment of adults with major depressive disorder in randomised trials.

methodsWe searched relevant databases and other sources from inception to 7 March 2024 for randomised clinical trials comparing venlafaxine versus placebo or no intervention in adults with major depressive disorder. Data were synthesised using meta-analysis and Trial Sequential Analysis. The primary outcomes were suicides or suicide attempts, serious adverse events and non-serious adverse events.

resultsWe included 28 trials randomising 6,253 participants to venlafaxine versus placebo. All results were at high risk of bias, and the certainty of the evidence was very low. All trials assessed outcomes at a maximum of 12 weeks after randomisation. Meta-analysis and Trial Sequential Analysis showed insufficient information to assess the effects of venlafaxine on the risks of suicides or suicide attempts. Meta-analysis showed evidence of harm of venlafaxine versus placebo on serious adverse events (risk ratio: 2.66; 95% confidence interval: 1.67-4.25;

conclusionsShort-term results show that venlafaxine has uncertain effects on the risks of suicides but increases the risks of serious adverse events (especially sexual dysfunction and anorexia) and many non-serious adverse events. The long-term effects of venlafaxine for major depressive disorder are unknown. It is a particular cause for concern that there are no data on the long-term adverse effects of venlafaxine given that so many people use these drugs for several years.

Indexed as

Major Depressive DisorderVenlafaxine HydrochlorideAdultAntidepressive Agents, Second-GenerationHumansRandomized Controlled Trials as TopicSuicideSuicide, AttemptedAntidepressive Agents, Second-GenerationVenlafaxine Hydrochlorideadverse effectsantidepressantsdepressionsystematic reviews

Identifiers

PMID39440379
PMCPMC11561525

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.