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 | |
| State | Published - Aug 2013 |
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Keywords
- Diclectin®
- Epidemiology
- Nausea and vomiting of pregnancy
- Placebo
- Wellbeing
ASJC Scopus subject areas
- Obstetrics and Gynecology
Cite this
Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial. / Matok, I.; Umans, J.; Feghali, M. N.; Clark, Shannon; Caritis, S.; Miodovnik, M.; Hankins, Gary; Mattison, D. R.; Nordeng, H.; Koren, G.
In: Journal of Obstetrics and Gynaecology, Vol. 33, No. 6, 08.2013, p. 557-560.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial
AU - Matok, I.
AU - Umans, J.
AU - Feghali, M. N.
AU - Clark, Shannon
AU - Caritis, S.
AU - Miodovnik, M.
AU - Hankins, Gary
AU - Mattison, D. R.
AU - Nordeng, H.
AU - Koren, G.
PY - 2013/8
Y1 - 2013/8
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.
AB - 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.
KW - Diclectin®
KW - Epidemiology
KW - Nausea and vomiting of pregnancy
KW - Placebo
KW - Wellbeing
UR - http://www.scopus.com/inward/record.url?scp=84881279655&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84881279655&partnerID=8YFLogxK
U2 - 10.3109/01443615.2013.774327
DO - 10.3109/01443615.2013.774327
M3 - Article
C2 - 23919849
AN - SCOPUS:84881279655
VL - 33
SP - 557
EP - 560
JO - Journal of Obstetrics and Gynaecology
JF - Journal of Obstetrics and Gynaecology
SN - 0144-3615
IS - 6
ER -