Evidence map›Paper›PMID 24574047›Full record

ReviewPaediatric drugs2014

The delayed-release combination of doxylamine and pyridoxine (Diclegis®/Diclectin ®) for the treatment of nausea and vomiting of pregnancy.

Svetlana Madjunkova, Caroline Maltepe, Gideon Koren

Registry-linked trialOpen access · hybridAbstract readReview
In one paragraph

Review in Paediatric drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06055192 (Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 9% 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.

NCT06055192 unknown statusnot on this mapstarted 2023, after this paper: background citation

Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022

TypeobservationalSponsorEffik SARan2023 to 2024Enrolled200ConditionsNausea, Vomiting of PregnancyArmsSurvey
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Diagnosis and treatment of hyperemesis gravidarum.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2024
    Review
  6. Article
  7. Bioavailability of CaribanDrugs in R&D · 2023
    Article
  8. Article
  9. Nausea and vomiting of pregnancy - What's new?Autonomic neuroscience : basic & clinical · 2017
    Review
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

3 authors at 1 institution in 2 countries.

Svetlana MadjunkovaThe Motherisk Program, Division of Clinical Pharmacology/Toxicology, Department of Pediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Canada, svetlana.madjunkova@sickkids.ca.
Caroline Maltepe
Gideon Koren
University of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nausea and vomiting of pregnancy (NVP) affects up to 85 % of all pregnancies. Effective treatment can greatly improve a woman's quality of life, reduce the risk for maternal and fetal complications, and reduce healthcare costs. Unfortunately, many women receive either no pharmacological treatment or are recommended therapies for which fetal safety and efficacy have not been established. First-line treatment of NVP, as recommended by several leading healthcare and professional organizations, is the combination of doxylamine and pyridoxine. This combination, formulated as a 10 mg/10 mg delayed-release tablet, was approved by the US Food and Drug Administration (FDA) for the treatment of NVP in April 2013 under the brand name Diclegis(®), and has been on the Canadian market since 1979, currently under the brand name Diclectin(®). The efficacy of Diclegis(®)/Diclectin(®) has been demonstrated in several clinical trials, and, more importantly, studies on more than 200,000 women exposed to doxylamine and pyridoxine in the first trimester of pregnancy have demonstrated no increased fetal risk for congenital malformations and other adverse pregnancy outcomes. The present review aims to present the scientific evidence on the effectiveness and fetal safety of Diclegis(®)/Diclectin(®) for the treatment of NVP to justify its use as first-line treatment for NVP.

Indexed as

AntiemeticsDelayed-Action PreparationsDicyclomineDoxylamineDrug CombinationsFemaleHumansNauseaPregnancyPregnancy ComplicationsPyridoxineTreatment OutcomeVomitingAntiemeticsDelayed-Action PreparationsDicyclominedicyclomine, doxylamine, pyridoxine drug combinationDoxylamineDrug CombinationsPyridoxine

Identifiers

PMID24574047
PMCPMC4030125
OpenAlexW2012731801

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.