Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data - PubMed (original) (raw)
Review
Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data
Craig J Whittington et al. Lancet. 2004.
Abstract
Background: Questions concerning the safety of selective serotonin reuptake inhibitors (SSRIs) in the treatment of depression in children led us to compare and contrast published and unpublished data on the risks and benefits of these drugs.
Methods: We did a meta-analysis of data from randomised controlled trials that evaluated an SSRI versus placebo in participants aged 5-18 years and that were published in a peer-reviewed journal or were unpublished and included in a review by the Committee on Safety of Medicines. The following outcomes were included: remission, response to treatment, depressive symptom scores, serious adverse events, suicide-related behaviours, and discontinuation of treatment because of adverse events.
Findings: Data for two published trials suggest that fluoxetine has a favourable risk-benefit profile, and unpublished data lend support to this finding. Published results from one trial of paroxetine and two trials of sertraline suggest equivocal or weak positive risk-benefit profiles. However, in both cases, addition of unpublished data indicates that risks outweigh benefits. Data from unpublished trials of citalopram and venlafaxine show unfavourable risk-benefit profiles.
Interpretation: Published data suggest a favourable risk-benefit profile for some SSRIs; however, addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people. Clinical guideline development and clinical decisions about treatment are largely dependent on an evidence base published in peer-reviewed journals. Non-publication of trials, for whatever reason, or the omission of important data from published trials, can lead to erroneous recommendations for treatment. Greater openness and transparency with respect to all intervention studies is needed.
Comment in
- Depressing research.
[No authors listed] [No authors listed] Lancet. 2004 Apr 24;363(9418):1335. doi: 10.1016/S0140-6736(04)16080-7. Lancet. 2004. PMID: 15110484 No abstract available. - Depressing research.
Green J. Green J. Lancet. 2004 Jun 19;363(9426):2088. doi: 10.1016/S0140-6736(04)16465-9. Lancet. 2004. PMID: 15207966 No abstract available. - Use of selective serotonin reuptake inhibitors in childhood depression.
Wohlfarth T, Lekkerkerker F, van Zwieten B. Wohlfarth T, et al. Lancet. 2004 Aug 21-27;364(9435):659-60; author reply 661. doi: 10.1016/S0140-6736(04)16880-3. Lancet. 2004. PMID: 15325820 No abstract available. - Use of selective serotonin reuptake inhibitors in childhood depression.
Curtin F, Schulz P. Curtin F, et al. Lancet. 2004 Aug 21-27;364(9435):660; author reply 661. doi: 10.1016/S0140-6736(04)16881-5. Lancet. 2004. PMID: 15325821 No abstract available. - Use of selective serotonin reuptake inhibitors in childhood depression.
Salerian AJ. Salerian AJ. Lancet. 2004 Aug 21-27;364(9435):660-1; author reply 661. doi: 10.1016/S0140-6736(04)16882-7. Lancet. 2004. PMID: 15325822 No abstract available. - Review: most selective serotonin reuptake inhibitors lead to adverse events that appear to outweigh the benefits in children.
Pryjmachuk S. Pryjmachuk S. Evid Based Nurs. 2004 Oct;7(4):106. doi: 10.1136/ebn.7.4.106. Evid Based Nurs. 2004. PMID: 15487082 No abstract available. - Review: relying on published data alone overestimates efficacy and safety of SSRIs in children.
Wolraich ML. Wolraich ML. Evid Based Ment Health. 2004 Nov;7(4):115. doi: 10.1136/ebmh.7.4.115. Evid Based Ment Health. 2004. PMID: 15504803 No abstract available. - Academia's failure to support systematic reviews.
Chalmers I. Chalmers I. Lancet. 2005 Feb 5-11;365(9458):469. doi: 10.1016/S0140-6736(05)17854-4. Lancet. 2005. PMID: 15705448 No abstract available.
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