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; Gary Hankins; D. R. Mattison; H. Nordeng; G. Koren

doi:10.3109/01443615.2013.774327

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, Gary Hankins, D. R. Mattison, H. Nordeng, G. Koren

Research output: Contribution to journal › Article › peer-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 language	English (US)
Pages (from-to)	557-560
Number of pages	4
Journal	Journal of Obstetrics and Gynaecology
Volume	33
Issue number	6
DOIs	https://doi.org/10.3109/01443615.2013.774327
State	Published - Aug 2013
Externally published	Yes

Keywords

Diclectin®
Epidemiology
Nausea and vomiting of pregnancy
Placebo
Wellbeing

ASJC Scopus subject areas

Obstetrics and Gynecology

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10.3109/01443615.2013.774327

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Matok, I., Umans, J., Feghali, M. N., Clark, S., Caritis, S., Miodovnik, M., Hankins, G., Mattison, D. R., Nordeng, H., & Koren, G. (2013). Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial. Journal of Obstetrics and Gynaecology, 33(6), 557-560. https://doi.org/10.3109/01443615.2013.774327

Matok, I, Umans, J, Feghali, MN, Clark, S, Caritis, S, Miodovnik, M, Hankins, G, Mattison, DR, Nordeng, H & Koren, G 2013, 'Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial', Journal of Obstetrics and Gynaecology, vol. 33, no. 6, pp. 557-560. https://doi.org/10.3109/01443615.2013.774327

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

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{\textregistered} (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.",

keywords = "Diclectin{\textregistered}, Epidemiology, Nausea and vomiting of pregnancy, Placebo, Wellbeing",

author = "I. Matok and J. Umans and Feghali, {M. N.} and S. Clark and S. Caritis and M. Miodovnik and Gary Hankins and Mattison, {D. R.} and H. Nordeng and G. Koren",

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 {\textquoteleft}work of the US Government{\textquoteright} and therefore copyright is non-transferable. JGU was supported in part by RR031975.",

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doi = "10.3109/01443615.2013.774327",

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N2 - 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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Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial

Abstract

Keywords

ASJC Scopus subject areas

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