Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy

A randomized placebo controlled trial

Gideon Koren, Shannon Clark, Gary Hankins, Steve N. Caritis, Menachem Miodovnik, Jason G. Umans, Donald R. Mattison

Research output: Contribution to journalArticle

59 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate the effectiveness of Diclectin (doxylamine succinate 10 mg-pyridoxine hydrochloride 10 mg, delayed-release preparation) as compared with placebo for nausea and vomiting of pregnancy. STUDY DESIGN: A randomized, double-blind, multicenter placebo controlled trial studying pregnant women suffering from nausea and vomiting of pregnancy, analyzed by intention to treat. Women received Diclectin (n = 131) or placebo (n = 125) for 14 days. Nausea and vomiting of pregnancy symptoms were evaluated daily using the pregnancy unique quantification of emesis scale. RESULTS: Diclectin use resulted in a significantly larger improvementin symptoms of nausea and vomiting of pregnancy compared with placebo based on both the pregnancy unique quantification of emesisscore (-4.8±2.7 vs-3.9±2.6; P =.006) and quality of life. After the trial, 64 (48.9%) women receiving Diclectin asked to continue compassionate use of their medication, as compared with 41 (32.8%) of placebo-treated women (P=.009). CONCLUSION: Diclectin delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated intreating nausea and vomiting of pregnancy.

Original languageEnglish (US)
JournalAmerican Journal of Obstetrics and Gynecology
Volume203
Issue number6
DOIs
StatePublished - Dec 2010

Fingerprint

Doxylamine
Pyridoxine
Nausea
Vomiting
Randomized Controlled Trials
Placebos
Pregnancy
Compassionate Use Trials
dicyclomine, doxylamine, pyridoxine drug combination
Pregnant Women
Quality of Life

Keywords

  • Doxylamine
  • Effectivenss
  • Nausea and vomiting of pregnancy
  • Pyridoxine
  • Safety

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy : A randomized placebo controlled trial. / Koren, Gideon; Clark, Shannon; Hankins, Gary; Caritis, Steve N.; Miodovnik, Menachem; Umans, Jason G.; Mattison, Donald R.

In: American Journal of Obstetrics and Gynecology, Vol. 203, No. 6, 12.2010.

Research output: Contribution to journalArticle

Koren, Gideon ; Clark, Shannon ; Hankins, Gary ; Caritis, Steve N. ; Miodovnik, Menachem ; Umans, Jason G. ; Mattison, Donald R. / Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy : A randomized placebo controlled trial. In: American Journal of Obstetrics and Gynecology. 2010 ; Vol. 203, No. 6.
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