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

I. Matok, J. Umans, M. N. Feghali, S. Clark, S. Caritis, M. Miodovnik, G. Hankins, D. R. Mattison, H. Nordeng, G. Koren*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

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.

Original languageAmerican English
Pages (from-to)557-560
Number of pages4
JournalJournal of Obstetrics and Gynaecology
Volume33
Issue number6
DOIs
StatePublished - Aug 2013
Externally publishedYes

Bibliographical note

Funding Information:
Th e study was sponsored by Duchesnay Inc, Blainville Quebec, Canada. G. Koren has been a paid consultant of Duchesnay Inc. Funding was also provided in part by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Health to DRM. This paper was prepared in part by DRM as an employee of the US Government making this a ‘work of the US Government’ and therefore copyright is non-transferable. JGU was supported in part by RR031975.

Keywords

  • Diclectin®
  • Epidemiology
  • Nausea and vomiting of pregnancy
  • Placebo
  • Wellbeing

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