Evidence map›Paper›PMID 30670513›Full record

SynthesisBMJ open2019

Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials.

Igho J Onakpoya, Elizabeth T Thomas, Joseph J Lee, Ben Goldacre, Carl J Heneghan

Registry-linked trialOpen access · goldAbstract readMeta-AnalysisReview
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05324059 (Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.), which is not on this map. Cited by 67 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 12 pooled it
6.7field-weighted citation impact, top 3% 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.

NCT05324059 phase3completednot on this mapstarted 2022, after this paper: background citation

Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.

TypeinterventionalSponsorLaboratorios Silanes S.A. de C.V.Ran2022 to 2023Enrolled110ConditionsNeuropathic PainArmsPregabalin 75mg/ Tramadol 50 mg, Pregabalin 75mg
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 12 syntheses or guidelines pooled it, 125 citations in OpenAlex.

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  6. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
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  15. Healthcare expenditure and its predictors in a cohort of Australians living with sciatica.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2021
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7 more citing papers are in PubMed but not listed here.

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

5 authors at 2 institutions in 2 countries.

Igho J OnakpoyaNuffield Department of Primary Care Health Sciences, Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-2420-0811
Elizabeth T ThomasFaculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.ORCID 0000-0001-7008-8763
Joseph J LeeNuffield Department of Primary Care Health Sciences, Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
Ben GoldacreNuffield Department of Primary Care Health Sciences, Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
Carl J HeneghanNuffield Department of Primary Care Health Sciences, Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-1009-1992
University of Oxford · GBBond University · AU

Funding

Wellcome Trust
6 · The paper itself

Abstract

objectiveTo assess the benefits and harms of pregabalin in the management of neuropathic pain.

designRapid review and meta-analysis of phase III, randomised, placebo-controlled trials.

participantsAdults aged 18 years and above with neuropathic pain defined according to the International Association for the Study of Pain criteria.

interventionsPregabalin or placebo. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcomes were pain (as measured using validated scales) and adverse events. Our secondary outcomes were sleep disturbance, quality of life, Patient Global Impression of Change, Clinician Global Impression scale, anxiety and depression scores, overall discontinuations and discontinuations because of adverse events.

resultsWe included 28 trials comprising 6087 participants. The neuropathic pain conditions studied were diabetic peripheral neuropathy, postherpetic neuralgia, herpes zoster, sciatica (radicular pain), poststroke pain and spinal cord injury-related pain. Patients who took pregabalin reported significant reductions in pain (numerical rating scale (NRS)) compared with placebo (standardised mean difference (SMD) -0.49 (95% CI -0.66 to -0.32, p<0.00001), very low quality evidence). Pregabalin significantly reduced sleep interference scores (NRS) compared with placebo (SMD -0.38 (95% CI -0.50 to -0.26, p<0.00001), moderate quality evidence. Pregabalin significantly increased the risk of adverse events compared with placebo (RR 1.33 (95% CI 1.23 to 1.44, p<0.00001, low quality evidence)). The risks of experiencing weight gain, somnolence, dizziness, peripheral oedema, fatigue, visual disturbances, ataxia, non-peripheral oedema, vertigo and euphoria were significantly increased with pregabalin. Pregabalin was significantly more likely than placebo to lead to discontinuation of the drug because of adverse events (RR 1.91 (95% CI 1.54 to 2.37, p<0.00001), low quality evidence).

conclusionPregabalin has beneficial effects on some symptoms of neuropathic pain. However, its use significantly increases the risk of a number of adverse events and discontinuation due to adverse events. The quality of the evidence from journal publications is low.

Indexed as

AdultAnalgesicsClinical Trials, Phase III as TopicDouble-Blind MethodHumansNeuralgiaPregabalinRandomized Controlled Trials as TopicTreatment OutcomeAnalgesicsPregabalinbenefitsharmsmeta-analysisPregabalinsystematic review

Identifiers

PMID30670513
PMCPMC6347863
OpenAlexW2912056231

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.