Putting trials on trial--the costs and consequences of small trials in depression: a systematic review of methodology - PubMed (original) (raw)
Review
Putting trials on trial--the costs and consequences of small trials in depression: a systematic review of methodology
M Hotopf et al. J Epidemiol Community Health. 1997 Aug.
Abstract
Study objective: To determine why, despite 122 randomised controlled trials, there is no consensus about whether the selective serotonin reuptake inhibitors or tricyclic and related antidepressants should be used as first line treatment of depression.
Design: Systematic review of all RCTs comparing selective serotonin reuptake inhibitors and tricyclic or heterocyclic antidepressants.
Main results: The shortcomings identified in the 122 trials were as follows: (1) there was inadequate description of randomisation, (2) the outcomes used were mainly observer rated measurements of depression, and studies failed to use quality of life measures or perform economic evaluations, (3) doses of tricyclic antidepressants were inadequate, (4) generalisability of studies was poor (including a reliance on secondary care settings and inadequate follow up), and (5) there were statistical shortcomings such as low statistical power, failure to use intention to treat analyses, and the tendency to make multiple comparisons.
Conclusions: Future RCTs should be designed to inform policy makers and address these methodological shortcomings.
Similar articles
- Efficacy and tolerability of selective serotonin reuptake inhibitors compared with tricyclic antidepressants in depression treated in primary care: systematic review and meta-analysis.
MacGillivray S, Arroll B, Hatcher S, Ogston S, Reid I, Sullivan F, Williams B, Crombie I. MacGillivray S, et al. BMJ. 2003 May 10;326(7397):1014. doi: 10.1136/bmj.326.7397.1014. BMJ. 2003. PMID: 12742924 Free PMC article. Review. - Fluoxetine versus other types of pharmacotherapy for depression.
Magni LR, Purgato M, Gastaldon C, Papola D, Furukawa TA, Cipriani A, Barbui C. Magni LR, et al. Cochrane Database Syst Rev. 2013 Jul 17;(7):CD004185. doi: 10.1002/14651858.CD004185.pub3. Cochrane Database Syst Rev. 2013. PMID: 24353997 Review. - Selective serotonin reuptake inhibitors: meta-analysis of efficacy and acceptability.
Song F, Freemantle N, Sheldon TA, House A, Watson P, Long A, Mason J. Song F, et al. BMJ. 1993 Mar 13;306(6879):683-7. doi: 10.1136/bmj.306.6879.683. BMJ. 1993. PMID: 8471919 Free PMC article. - Treatment discontinuation with selective serotonin reuptake inhibitors compared with tricyclic antidepressants: a meta-analysis.
Anderson IM, Tomenson BM. Anderson IM, et al. BMJ. 1995 Jun 3;310(6992):1433-8. doi: 10.1136/bmj.310.6992.1433. BMJ. 1995. PMID: 7613276 Free PMC article.
Cited by
- The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomised trial.
Lewis G, Duffy L, Ades A, Amos R, Araya R, Brabyn S, Button KS, Churchill R, Derrick C, Dowrick C, Gilbody S, Fawsitt C, Hollingworth W, Jones V, Kendrick T, Kessler D, Kounali D, Khan N, Lanham P, Pervin J, Peters TJ, Riozzie D, Salaminios G, Thomas L, Welton NJ, Wiles N, Woodhouse R, Lewis G. Lewis G, et al. Lancet Psychiatry. 2019 Nov;6(11):903-914. doi: 10.1016/S2215-0366(19)30366-9. Epub 2019 Sep 19. Lancet Psychiatry. 2019. PMID: 31543474 Free PMC article. Clinical Trial. - Constraint-induced movement therapy for upper extremities in people with stroke.
Corbetta D, Sirtori V, Castellini G, Moja L, Gatti R. Corbetta D, et al. Cochrane Database Syst Rev. 2015 Oct 8;2015(10):CD004433. doi: 10.1002/14651858.CD004433.pub3. Cochrane Database Syst Rev. 2015. PMID: 26446577 Free PMC article. Review. - Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the prevention of tension-type headache in adults.
Banzi R, Cusi C, Randazzo C, Sterzi R, Tedesco D, Moja L. Banzi R, et al. Cochrane Database Syst Rev. 2015 May 1;2015(5):CD011681. doi: 10.1002/14651858.CD011681. Cochrane Database Syst Rev. 2015. PMID: 25931277 Free PMC article. Review. - Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the prevention of migraine in adults.
Banzi R, Cusi C, Randazzo C, Sterzi R, Tedesco D, Moja L. Banzi R, et al. Cochrane Database Syst Rev. 2015 Apr 1;4(4):CD002919. doi: 10.1002/14651858.CD002919.pub3. Cochrane Database Syst Rev. 2015. PMID: 25829028 Free PMC article. Review. - SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. Chan AW, et al. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. BMJ. 2013. PMID: 23303884 Free PMC article.
References
- Br J Soc Clin Psychol. 1967 Dec;6(4):278-96 - PubMed
- J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62 - PubMed
- Arch Gen Psychiatry. 1981 Apr;38(4):381-9 - PubMed
- Acta Psychiatr Scand Suppl. 1981;290:447-53 - PubMed
- Med Care. 1981 Aug;19(8):787-805 - PubMed
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources