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

  • Gideon Koren
    Correspondence
    Reprints: Gideon Koren, MD, The Hospital for Sick Children, Division of Clinical Pharmacology/Toxicology, 555 University Ave., Toronto, Ontario, M5G 1X8 Canada
    Affiliations
    Motherisk Program, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada
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  • Shannon Clark
    Affiliations
    Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver National Institute of Child and Human Development, Bethesda, MD

    Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX
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  • Gary D.V. Hankins
    Affiliations
    Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver National Institute of Child and Human Development, Bethesda, MD

    Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX
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  • Steve N. Caritis
    Affiliations
    Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver National Institute of Child and Human Development, Bethesda, MD

    Department of Obstetrics and Gynecology, University of Pittsburgh Medical Center, Pittsburgh, PA
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  • Menachem Miodovnik
    Affiliations
    Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver National Institute of Child and Human Development, Bethesda, MD

    Departments of Obstetrics and Gynecology, Washington Hospital Center and Georgetown University Medical Center, Washington, DC
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  • Jason G. Umans
    Affiliations
    Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver National Institute of Child and Human Development, Bethesda, MD

    Departments of Obstetrics and Gynecology, Washington Hospital Center and Georgetown University Medical Center, Washington, DC
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  • Donald R. Mattison
    Affiliations
    Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver National Institute of Child and Human Development, Bethesda, MD
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Published:September 15, 2010DOI:https://doi.org/10.1016/j.ajog.2010.07.030

      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 improvement in symptoms of nausea and vomiting of pregnancy compared with placebo based on both the pregnancy unique quantification of emesis score (−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 in treating nausea and vomiting of pregnancy.

      Key words

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      Linked Article

      • Effectiveness of doxylamine-pyridoxine for morning sickness
        American Journal of Obstetrics & GynecologyVol. 214Issue 5
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          In 2010 we published in the Journal a primary paper examining the effectiveness of the pyridoxine-doxylamine delayed-release combination in treating symptoms of morning sickness.1 We were asked by readers to report on other endpoints that were listed online in the study plan ( clinicaltrials.gov – NCT00614445 ) but were not reported in the primary paper. The objective of this letter is to report these additional data.
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