Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: A randomized placebo controlled trial

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

Research output: Contribution to journalArticle

61 Scopus citations

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)
Pages (from-to)571.e1-571.e7
JournalAmerican journal of obstetrics and gynecology
Volume203
Issue number6
DOIs
StatePublished - Dec 2010

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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