Evidence map›Paper›PMID 34193496›Full record

ArticleBMJ open2021

Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation.

Evan Mayo-Wilson, Xiwei Chen, Riaz Qureshi, Stephanie Dickinson, Lilian Golzarri-Arroyo, Hwanhee Hong, Carsten Görg, Tianjing Li

Abstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Problems associated with the ATC system of drug classification.Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Article
  3. 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.

Evan Mayo-WilsonDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA emayowil@iu.edu.ORCID 0000-0001-6126-2459
Xiwei ChenDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA.
Riaz QureshiDepartment of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Stephanie DickinsonDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA.
Lilian Golzarri-ArroyoDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA.
Hwanhee HongDepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.
Carsten GörgDepartment of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, Colorado, USA.
Tianjing LiDepartment of Ophthalmology, University of Colorado, Denver, Colorado, USA.

Funding

Maximizing Use of High-Quality Evidence in Eye Care: Cochrane Eyes and Vision US ProjectUG1EY020522 · NEI · UNIVERSITY OF COLORADO DENVER · PI Tianjing Li · 2017 to 2026
$10.1M
NEI NIH HHS UG1 EY020522
6 · The paper itself

Abstract

introductionGabapentin (Neurontin) is prescribed widely for conditions for which it has not been approved by regulators, including certain neuropathic pain conditions. There is limited evidence that gabapentin is safe and effective for the treatment of neuropathic pain. Published trial reports, and systematic reviews based on published trial reports, mislead patients and providers because information about gabapentin's harms has been published only partly. We confirmed that trials conducted by the drug developer have been abandoned, and we plan to conduct a restoration with support from the Restoring Invisible and Abandoned Trials Support Centre (https://restoringtrials.org/). METHODS AND ANALYSIS: In this study, we will analyse and report the harms that were observed in six trials of gabapentin, which have not been reported publicly (eg, in journal articles). We will use clinical study reports and individual participant data to identify and report the harms observed in each individual trial and to summarise the harms observed across all six trials. We will report all adverse events observed in the included trials by sharing deidentified data and summary tables on the Open Science Framework (https://osf.io/w8puv/). Additionally, we will produce a summary report that describes differences between the randomised groups in each trial and across trials for prespecified harms outcomes. ETHICS AND DISSEMINATION: We will use secondary data. This study was determined to be exempt from Institutional Review Board (IRB) review (protocol #1910607198).

Indexed as

Cyclohexanecarboxylic AcidsNeuralgiaAminesGabapentingamma-Aminobutyric AcidHumansAminesCyclohexanecarboxylic AcidsGabapentingamma-Aminobutyric Acidadverse eventsclinical trialsdiabetic neuropathystatistics & research methods

Identifiers

PMID34193496
PMCPMC8246349

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.