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dc.creatorGrobler, Anna Christina.
dc.creatorMatthews, Glenda.
dc.creatorMolenberghs, Geert.
dc.date.accessioned2016-10-24T10:00:05Z
dc.date.available2016-10-24T10:00:05Z
dc.date.created2014
dc.date.issued2014
dc.identifier.citationGrobler, A.C., Matthews, G. and Molenberghs, G. 2014. 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. Psychopharmacology 231(9), 1987-1999.en_US
dc.identifier.urihttp://dx.doi.org/10.1007/s00213-013-3344-xen_US
dc.identifier.urihttp://hdl.handle.net/10413/13538
dc.descriptionCAPRISA, 2013.en_US
dc.description.abstractRationale 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. Results Three hundred forty participants were randomized, with 28 % lost to follow-up. The missing data mechanism was not missing completely at random. Under missing at random assumptions, some sensitivity analyses found no difference between either treatment arm and placebo, while some sensitivity analyses found a significant difference from baseline to week 8 between sertraline and placebo (−1.28, 95 % credible interval [−2.48; −0.08]), but not between hypericum and placebo (0.56, [−0.64;1.76]). The results were similar when the missing data process was assumed to be missing not at random. Conclusions There is no difference between hypericum and placebo, regardless of the assumption about the missing data process. There is a significant difference between sertraline and placebo with some statistical methods used. It is important to conduct an analysis that takes account of missing data using valid statistically principled methods. The assumptions about the missing data process could influence the results.en_US
dc.language.isoenen_US
dc.publisherSpringer.en_US
dc.subjectSt John's wort.en_US
dc.subjectHypericum perforatum.en_US
dc.subjectHerbal medicine.en_US
dc.subjectAntidepressant.en_US
dc.subjectSertraline.en_US
dc.subjectHamilton depression scale.en_US
dc.subjectBayesian.en_US
dc.subjectMultiple imputation.en_US
dc.subjectMissing at random.en_US
dc.subjectMissing not at random.en_US
dc.titleThe 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.en_US
dc.typePeer reviewed journal articleen_US


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