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


METHODS
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).


CONCLUSIONS
Diclectin delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated in treating nausea and vomiting of pregnancy.
Koren
Gideon
G
Motherisk Program, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada. gkoren@sickkids.ca
Clark
Shannon
S
Hankins
Gary D V
GD
Caritis
Steve N
SN
Miodovnik
Menachem
M
Umans
Jason G
JG
Mattison
Donald R
DR
D000328:Adult; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004025:Dicyclomine; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004319:Doxylamine / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D048968:Morning Sickness / Q000188:drug therapy; D009325:Nausea / Q000175:diagnosis / Q000188:drug therapy*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000188:drug therapy; D011736:Pyridoxine / Q000008:administration & dosage*; D011788:Quality of Life; D012016:Reference Values; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014839:Vomiting / Q000175:diagnosis / Q000188:drug therapy*; D055815:Young Adult
D003692:Delayed-Action Preparations; D004338:Drug Combinations; C004454:dicyclomine, doxylamine, pyridoxine drug combination; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine