Journal article
The impact of missing data on clinical trials: A re-analysis of a placebo controlled trial of Hypericum perforatum (St Johns wort) and sertraline in major depressive disorder
AC Grobler, G Matthews, G Molenberghs
Psychopharmacology | SPRINGER | Published : 2014
Abstract
Rationale and objective: Hypericum perforatum (St John's wort) is used to treat depression, but the effectiveness has not been established. Recent guidelines described the analysis of clinical trials with missing data, inspiring the reanalysis of this trial using proper missing data methods. The objective was to determine whether hypericum was superior to placebo in treating major depression. Methods: A placebo-controlled, randomized clinical trial was conducted for 8 weeks to determine the effectiveness of hypericum or sertraline in reducing depression, measured using the Hamilton depression scale. We performed sensitivity analyses under different assumptions about the missing data process...
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Awarded by National Institute of Mental Health
Funding Acknowledgements
[ "Data used in the preparation of this article were obtained from the limited access datasets (version 4.1) distributed from the NIH-supported \"A Placebo-Controlled Clinical Trial of a Standardized Extract of H. perforatum in Major Depressive Disorder\" (Hypericum). This is a multisite, clinical trial of persons with depression comparing the effectiveness of randomly assigned medication treatment. The purpose of this trial is to study the acute efficacy and safety of a standardized extract of the herb H. perforatum (St. John's wort) in the treatment of patients with major depression. The study was supported by NIMH contract # N01MH70007 to the Duke University Medical Center. The ClinicalTrials.gov identifier is NCT00005013. This manuscript reflects the views of the authors and may not reflect the opinions or views of the Hypericum Study Investigators or the NIH. Anneke Grobler had full access to the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.", "Geert Molenberghs gratefully acknowledges financial support from the IAP research Network P7/06 of the Belgian Government (Belgian Science Policy)." ]