Evidence map›Paper›PMID 26581442›Full record

Trial reportEuropean journal of pain (London, England)2016

Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain.

M Haanpää, G Cruccu, T J Nurmikko, W T McBride, A Docu Axelarad, A Bosilkov, C Chambers, E Ernault, A K Abdulahad

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of pain (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 4 pooled it
6.4field-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.

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

49 citing papers in PubMed, 4 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Guideline
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  3. Drug therapy for chronic idiopathic axonal polyneuropathy.The Cochrane database of systematic reviews · 2017
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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

9 authors at 8 institutions in 5 countries.

M HaanpääHelsinki University Central Hospital, Finland.
G CruccuDepartment of Neurology and Psychiatry, Sapienza University, Rome, Italy.
T J NurmikkoThe Walton Centre NHS Foundation Trust, Liverpool, UK.
W T McBrideBelfast Health and Social Care Trust, Belfast, Northern Ireland.
A Docu AxelaradOvidius University, General Medicine, Constanta, Romania.
A BosilkovCentre for Mental Health, Russe, Bulgaria.
C ChambersAstellas Pharma Europe Ltd., Chertsey, UK.
E ErnaultAstellas Pharma Europe B.V., Leiden, The Netherlands.
A K AbdulahadAstellas Pharma Europe Ltd., Chertsey, UK.
Astellas Pharma (United Kingdom) · GBAstellas Pharma (Netherlands) · NLBelfast Health and Social Care Trust · GBCentre for Mental Health · GBHelsinki University Hospital · FIOvidius University · ROSapienza University of Rome · ITWalton Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trials have not yet compared the efficacy of capsaicin 8% patch with current standard therapy in peripheral neuropathic pain (PNP).

objectivesHead-to-head efficacy and safety trial comparing the capsaicin patch with pregabalin in PNP.

methodsOpen-label, randomized, multicentre, non-inferiority trial. Patients with PNP, aged 18-80 years, were randomly assigned to either the capsaicin 8% patch (n = 282) or an optimised dose of oral pregabalin (n = 277), and assessed for a ≥30% mean decrease in Numeric Pain Rating Scale (NPRS) score from baseline to Week 8. Secondary endpoints included optimal therapeutic effect (OTE), time-to-onset of pain relief and treatment satisfaction.

resultsThe capsaicin 8% patch was non-inferior to pregabalin in achievement of a ≥30% mean decrease in NPRS score from baseline to Week 8 (55.7% vs. 54.5%, respectively; Odds ratio: 1.03 [95% CI: 0.72, 1.50]). The proportion of patients achieving OTE at Week 8 was 52.1% for the capsaicin 8% patch versus 44.8% for pregabalin (difference: 7.3%; 95% CI: -0.9%, 15.6%). The median time-to-onset of pain relief was significantly shorter for capsaicin 8% patch versus pregabalin (7.5 vs. 36.0 days; Hazard ratio: 1.68 [95% CI: 1.35, 2.08]; p < 0.0001). Treatment satisfaction was also significantly greater with the capsaicin 8% patch versus pregabalin. TEAEs were mild-to-moderate in severity, and resulted in treatment discontinuation only with pregabalin (n = 24). Systemic adverse drug reactions ranged from 0 to 1.1% with capsaicin 8% patch and 2.5 to 18.4% with pregabalin.

conclusionsThe capsaicin 8% patch provided non-inferior pain relief to an optimized dose of pregabalin in PNP, with a faster onset of action, fewer systemic side effects and greater treatment satisfaction.

Indexed as

Administration, OralAdolescentAdultAgedAged, 80 and overCapsaicinFemaleHumansMaleMiddle AgedNeuralgiaPain ManagementPain MeasurementPregabalinTransdermal PatchTreatment OutcomeCapsaicinPregabalin

Identifiers

PMID26581442
PMCPMC4738436
OpenAlexW2178247063

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.