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

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 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.

• Authors: Gideon Koren, Shannon Clark, Gary D V Hankins, Steve N Caritis, Menachem Miodovnik, Jason G Umans, Donald R Mattison
• Journal: American journal of obstetrics and gynecology (Am J Obstet Gynecol) Vol. 203 Issue 6 Pg. 571.e1-7 (Dec 2010) ISSN: 1097-6868 [Electronic] United States
• PMID: 20843504 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Mosby, Inc. All rights reserved.

Chemical References

• Delayed-Action Preparations
• Drug Combinations
• dicyclomine, doxylamine, pyridoxine drug combination
• Dicyclomine
• Doxylamine
• Pyridoxine

Topics

• Adult
• Delayed-Action Preparations (administration & dosage)
• Dicyclomine
• Dose-Response Relationship, Drug
• Double-Blind Method
• Doxylamine (administration & dosage)
• Drug Administration Schedule
• Drug Combinations
• Female
• Follow-Up Studies
• Gestational Age
• Humans
• Morning Sickness (drug therapy)
• Nausea (diagnosis, drug therapy)
• Pregnancy
• Pregnancy Complications (diagnosis, drug therapy)
• Pyridoxine (administration & dosage)
• Quality of Life
• Reference Values
• Severity of Illness Index
• Treatment Outcome
• Vomiting (diagnosis, drug therapy)
• Young Adult