Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial.

MedStar author(s):
Citation: Journal of Obstetrics & Gynaecology. 33(6):557-60, 2013 Aug.PMID: 23919849Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov'tSubject headings: *Dicyclomine/tu [Therapeutic Use] | *Doxylamine/tu [Therapeutic Use] | *Histamine H1 Antagonists/tu [Therapeutic Use] | *Morning Sickness/dt [Drug Therapy] | *Placebo Effect | *Pyridoxine/tu [Therapeutic Use] | Adult | Double-Blind Method | Drug Combinations | Female | Humans | Logistic Models | Pregnancy | Randomized Controlled Trials as Topic | Young AdultYear: 2013ISSN:
  • 0144-3615
Name of journal: Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and GynaecologyAbstract: The placebo effect has not been characterised in pregnant women suffering from nausea and vomiting of pregnancy (NVP). Our aim was to characterise determinants of the placebo effect in women treated with placebo for NVP. We analysed data from a multicentre, double blind randomised controlled trial of Diclectin (delayed release doxylamine and pyridoxine) vs placebo for the treatment of NVP. A total of 127 women in the placebo arm and 130 in the active arm provided evaluable data for this analysis. Women who chose to continue placebo on a compassionate basis (n = 41) had significantly better improvement in symptoms of NVP and higher Wellbeing scores than those who did not ask to continue compassionate use. Results were similar in the active drug arm. The request to continue compassionate use of either placebo or active drug could be predicted by greater improvement in symptoms of NVP during the trial period.All authors: Caritis S, Clark S, Feghali MN, Hankins G, Koren G, Matok I, Mattison DR, Miodovnik M, Nordeng H, Umans JFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-08-21
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Journal Article MedStar Authors Catalog Article 23919849 Available 23919849

The placebo effect has not been characterised in pregnant women suffering from nausea and vomiting of pregnancy (NVP). Our aim was to characterise determinants of the placebo effect in women treated with placebo for NVP. We analysed data from a multicentre, double blind randomised controlled trial of Diclectin (delayed release doxylamine and pyridoxine) vs placebo for the treatment of NVP. A total of 127 women in the placebo arm and 130 in the active arm provided evaluable data for this analysis. Women who chose to continue placebo on a compassionate basis (n = 41) had significantly better improvement in symptoms of NVP and higher Wellbeing scores than those who did not ask to continue compassionate use. Results were similar in the active drug arm. The request to continue compassionate use of either placebo or active drug could be predicted by greater improvement in symptoms of NVP during the trial period.

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