Evidence map›Paper›PMID 30864085›Full record

ReviewInternational journal of clinical pharmacy2019

Critical review of European Medicines Agency (EMA) assessment report and related literature on domperidone.

Kıvanç Yüksel, Işık Tuğlular

Abstract readReview
PubMed Publisher
In one paragraph

Review in International journal of clinical pharmacy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 29% 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, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. 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

2 authors at 1 institution in 1 country.

Kıvanç YükselCenter for Drug Research and Development and Pharmacokinetic Applications (ARGEFAR), Ege University, Izmir, Turkey. kivancyuksel@yahoo.com.ORCID http://orcid.org/0000-0003-3491-0099
Işık TuğlularCenter for Drug Research and Development and Pharmacokinetic Applications (ARGEFAR), Ege University, Izmir, Turkey.ORCID http://orcid.org/0000-0002-9731-2929
Ege University · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

European Medicines Agency (EMA) issued a final decision on September 01, 2014 that restricts the maximum daily dose of domperidone to 30 mg and treatment duration to 7 days. This paper presents a critical review of the scientific basis of the literatures having a role in the decision of EMA on domperidone with an approach based on statistical and epidemiological perspective. Although observational studies used by EMA were published, the EMA didn't use an algorithm including "randomized clinical trials" according to evidence-based medicine when presenting their results. In conclusion, the results obtained from published studies are controversial, especially for the bias. From these publications, it cannot be concluded that domperidone exposure definitely increases the risk of "sudden cardiac death", "death associated with ventricular arrhythmia" or "ventricular arrhythmia" The most concrete result of these studies is that the risk is higher with metoclopramide exposure compared to domperidone exposure.

Indexed as

Death, Sudden, CardiacAntiemeticsArrhythmias, CardiacDomperidoneHumansMetoclopramideRisk AssessmentAntiemeticsDomperidoneMetoclopramideCritical reviewDomperidoneEMA decisionRestrictionSafety

Identifiers

PMID30864085
OpenAlexW2921045378

What OpenQuestion holds

Textmetadata
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.