Pharmacological Treatment of Bipolar Depression: Qualitative Systematic Review of Double-Blind Randomized Clinical Trials

Pharmacological Treatment of Bipolar Depression: Qualitative Systematic Review of Double-Blind... Randomized clinical trial (RCT) is the best study design for treatment-related issues, yet these studies may present a number of biases and limitations. The objective of this study is to carry out a qualitative analysis of RCT methodology in the treatment of bipolar depression (BD). A systematic review covering the last 20 years was performed on PubMed selecting double-blind RCTs for BD. The identification items of the articles, their design, methodology, outcome and grant-related issues were all analyzed. Thirty articles were included, all of which had been published in journals with an impact factor >3. While almost half studies (46.7%) used less than 50 patients as a sample, 70% did not describe or did not perform sample size calculation. The Last Observation Carried Forward (LOCF) method was used in 2/3 of the articles and 53.4% of the studies had high sample losses (>20%). Almost half the items were sponsored by the pharmaceutical industry and 33.3% were sponsored by institutions or research foundations. Articles on the pharmacological treatment of BD have several limitations which hinder the extrapolation of the data to clinical practice. Methodological errors and biases are common and statistical simplifications compromise the consistency of the findings. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Psychiatric Quarterly Springer Journals

Pharmacological Treatment of Bipolar Depression: Qualitative Systematic Review of Double-Blind Randomized Clinical Trials

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Publisher
Springer US
Copyright
Copyright © 2011 by Springer Science+Business Media, LLC
Subject
Medicine & Public Health; Psychiatry; Public Health; Sociology, general
ISSN
0033-2720
eISSN
1573-6709
D.O.I.
10.1007/s11126-011-9191-1
Publisher site
See Article on Publisher Site

Abstract

Randomized clinical trial (RCT) is the best study design for treatment-related issues, yet these studies may present a number of biases and limitations. The objective of this study is to carry out a qualitative analysis of RCT methodology in the treatment of bipolar depression (BD). A systematic review covering the last 20 years was performed on PubMed selecting double-blind RCTs for BD. The identification items of the articles, their design, methodology, outcome and grant-related issues were all analyzed. Thirty articles were included, all of which had been published in journals with an impact factor >3. While almost half studies (46.7%) used less than 50 patients as a sample, 70% did not describe or did not perform sample size calculation. The Last Observation Carried Forward (LOCF) method was used in 2/3 of the articles and 53.4% of the studies had high sample losses (>20%). Almost half the items were sponsored by the pharmaceutical industry and 33.3% were sponsored by institutions or research foundations. Articles on the pharmacological treatment of BD have several limitations which hinder the extrapolation of the data to clinical practice. Methodological errors and biases are common and statistical simplifications compromise the consistency of the findings.

Journal

Psychiatric QuarterlySpringer Journals

Published: Sep 17, 2011

References

  • Three times more days depressed than manic or hypomanic in both bipolar I and bipolar II disorder
    Kupka, RW
  • Inositol augmentation of lithium or valproate for bipolar depression
    Eden Evins, A
  • Inositol as an add-on treatment for bipolar depression
    Chengappa, KN
  • Initial lithium augmentation improves the antidepressant effects of standard TCA treatment in non-resistant depressed patients
    Ebert, D
  • Common statistical and research design problems in manuscripts submitted to high-impact psychiatry journals: what editors and reviewers want authors to know
    Harris, AH; Reeder, R; Hyun, JK

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