Evidence map›Paper›PMID 30793411›Full record

ArticleEuropean journal of pain (London, England)2019

Reproducibility of a battery of human evoked pain models to detect pharmacological effects of analgesic drugs.

Pieter S Siebenga, Guido van Amerongen, Pieter Okkerse, William S Denney, Pinky Dua, Richard P Butt, Justin L Hay, Geert J Groeneveld

Open access · hybridAbstract read
In one paragraph

Article in European journal of pain (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

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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 4 institutions in 3 countries.

Pieter S SiebengaCentre for Human Drug Research, Leiden, The Netherlands.ORCID 0000-0001-5505-9454
Guido van AmerongenCentre for Human Drug Research, Leiden, The Netherlands.
Pieter OkkerseCentre for Human Drug Research, Leiden, The Netherlands.
William S DenneyPfizer Inc., Cambridge, Massachusetts.
Pinky DuaPfizer Ltd., Cambridge, UK.
Richard P ButtPfizer Ltd., Cambridge, UK.
Justin L HayCentre for Human Drug Research, Leiden, The Netherlands.
Geert J GroeneveldCentre for Human Drug Research, Leiden, The Netherlands.
Centre for Human Drug Research · NLPfizer (United Kingdom) · GBLeiden University Medical Center · NLPfizer (United States) · US

Funding

Pfizer
6 · The paper itself

Abstract

backgroundAlthough reproducibility is considered essential for any method used in scientific research, it is investigated only rarely; thus, strikingly little has been published regarding the reproducibility of evoked pain models involving human subjects. Here, we studied the reproducibility of a battery of evoked pain models for demonstrating the analgesic effects of two analgesic compounds.

methodsA total of 81 healthy subjects participated in four studies involving a battery of evoked pain tests in which mechanical, thermal and electrical stimuli were used to measure pain detection and tolerance thresholds. Pharmacodynamic outcome variables were analysed using a mixed model analysis of variance, and a coefficient of variation was calculated by dividing the standard deviation by the least squares means.

resultsA total of 76 subjects completed the studies. After being administered pregabalin, the subjects' pain tolerance thresholds in the cold pressor and pressure stimulation tests were significantly increased compared to the placebo group. Moreover, the heat pain detection threshold in UVB-irradiated skin was significantly increased in subjects who were administered ibuprofen compared to the placebo group. Variation among all evoked pain tests ranged from 2.2% to 30.6%.

conclusionsFour studies using a similar design showed reproducibility with respect to the included evoked pain models. The relatively high consistency and reproducibility of two analgesics at doses known to be effective in treating clinically relevant pain supports the validity of using this pain test battery to investigate the analgesic activity and determine the active dosage of putative analgesic compounds in early clinical development. SIGNIFICANCE: The consistency and reproducibility of measuring the profile of an analgesic at clinically relevant doses illustrates that this pain test battery is a valid tool for demonstrating the analgesic activity of a test compound and for determining the optimal active dose in early clinical drug development.

Indexed as

AdultAnalgesicsCross-Over StudiesDouble-Blind MethodDrug ToleranceFemaleHealthy VolunteersHumansIbuprofenMaleMiddle AgedPainPain MeasurementPain ThresholdPregabalinReproducibility of ResultsAnalgesicsIbuprofenPregabalin

Identifiers

PMID30793411
PMCPMC6618124
OpenAlexW2916606858

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.