Evidence map›Paper›PMID 27881103›Full record

Trial reportBMC pregnancy and childbirth2016

Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy.

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

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pregnancy and childbirth, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.3field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 3 countries.

Gideon KorenUniversity of Toronto, Toronto, Canada. gidiup_2000@yahoo.com.
Shannon ClarkDepartment of Obstetrics and Gynecology, University of Texas, Medical Branch Galveston, Galveston, TX, USA.
Gary D V HankinsDepartment of Obstetrics and Gynecology, University of Texas, Medical Branch Galveston, Galveston, TX, USA.
Steve N CaritisDepartment of Obstetrics and Gynecology, University of Pittsburgh, Medical Center, Pittsburgh, PA, USA.
Jason G UmansMedstar Health Research Institute, Hyattsville, MD, USA.
Menachem MiodovnikMedstar Health Research Institute, Hyattsville, MD, USA.
Donald R MattisonThe Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver, National Institute of Child and Human Development, Bethesda, MD, USA.
Ilan MatokUniversity of Toronto, Toronto, Canada.
Eunice Kennedy Shriver National Institute of Child Health and Human Development · USGeorgetown-Howard Universities Center for Clinical and Translational Science · USThe University of Texas Medical Branch at Galveston · USUniversity of Pittsburgh Medical Center · USUniversity of Toronto · CAWestern University · CA

Funding

Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
NCATS NIH HHS UL1 TR001409
6 · The paper itself

Abstract

backgroundNausea and vomiting of pregnancy (NVP) affects up to 80% of expecting mothers. In April 2013 the FDA approved the delayed-release combination of doxylamine succinate and pyridoxine hydrochloride (Diclegis®) for NVP, based in part, on the results of a phase III randomized trial demonstrating the efficacy of this drug combination [study drug marketed under the trade name Diclectin® in Canada and Diclegis® in the United States] compared to placebo in pregnant women. Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies. The objective of this study was to evaluate, through secondary analysis, whether the primary measure of efficacy can be demonstrated after five days of treatment.

methodsWomen suffering from NVP were randomized to receive Diclegis® (n = 131) or placebo (n = 125) for 14 days at doses ranging from two to four tablets a day, based on a pre-specified titration protocol. The primary efficacy endpoint was the change in the validated Pregnancy-Unique Quantification of Emesis (PUQE) score at baseline versus Day 15 between Diclegis®-treated and placebo-treated women. For the present study, the change in PUQE score between baseline and Day 15 (end of the study) was compared to the changes observed for Days 3, 4, and 5.

resultsThe use of delayed-release doxylamine succinate and pyridoxine hydrochloride tablets show improved NVP symptom control as compared to placebo on Days 3,4 and 5, with sustained efficacy until the end of the trial.

conclusionA four day study drug dosing trial with Diclegis® is sufficient to document efficacy, as the results are similar to those achieved after 14 study drug dosing days. The benefit seen at the earlier time validates drug efficacy and minimizes the natural course of improvement.

trial registrationCTR No. NCT006 14445 2007.

Indexed as

AntiemeticsDelayed-Action PreparationsDicyclomineDoxylamineDrug CombinationsFemaleHumansMorning SicknessPregnancyPyridoxineTime FactorsAntiemeticsDelayed-Action PreparationsDicyclominedicyclomine, doxylamine, pyridoxine drug combinationDoxylamineDrug CombinationsPyridoxine

Identifiers

PMID27881103
PMCPMC5122025
OpenAlexW2551831190

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.