Evidence map›Paper›PMID 41157180›Full record

ArticleLife (Basel, Switzerland)2025

Non-Inferiority Study of Two Capsaicin Formulations for Painful Diabetic Neuropathy.

Tamara Rodríguez Araya, Francisco Abad-Santos, José Miguel Sempere Ortells, Juan Nieto Navarro, Pablo González-López, Javier Abarca-Olivas, Elena Baño Ruiz, Carlos Iglesias-García, José Fernando Villalba García

Abstract read
In one paragraph

Article in Life (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Tamara Rodríguez ArayaPrimary Chronic Pain and Fibromyalgia Unit, Hospital Clínic in Barcelona, 170 Villarroel Street, 08036 Barcelona, Spain.
Francisco Abad-SantosClinical Pharmacology Department, Hospital Universitario de La Princesa, Faculty of Medicine, Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autonóma de Madrid (UAM), 28006 Madrid, Spain.ORCID 0000-0002-6519-8885
José Miguel Sempere OrtellsDepartment of Biotechnology, University of Alicante, San Vicente del Raspeig Road, San Vicente del Raspeig, 03690 Alicante, Spain.
Juan Nieto NavarroDepartment of Neurosurgery, Miguel Hernández University of Elche, University Avenue, 03202 Elche, Spain.
Pablo González-LópezDepartment of Neurosurgery, University General Hospital of Alicante, 03010 Alicante, Spain.
Javier Abarca-OlivasDepartment of Neurosurgery, University General Hospital of Alicante, 03010 Alicante, Spain.ORCID 0000-0001-9808-2291
Elena Baño RuizDepartment of Neurosurgery, University General Hospital of Alicante, 03010 Alicante, Spain.
Carlos Iglesias-GarcíaClinical Partner & Innovation, S.L. 49 Princesa Street, 28008 Madrid, Spain.ORCID 0000-0002-3100-7833
José Fernando Villalba GarcíaDepartment of Biotechnology, University of Alicante, San Vicente del Raspeig Road, San Vicente del Raspeig, 03690 Alicante, Spain.

Funding

Arafarma Group (Spain) n/a
6 · The paper itself

Abstract

While capsaicin topical formulations are established treatments, conventional creams using this substance have limited application due to handling-related adverse events. This study aimed to demonstrate that the efficacy of a novel 0.75 mg/g capsaicin roll-on solution is non-inferior to the approved 0.75 mg/g cream in patients with painful diabetic neuropathy (PDN). In total, 160 patients were randomized to receive either the roll-on or the cream, applied four times daily for 8 weeks, followed by a 4-week washout period and crossover to the alternate treatment. The primary endpoint was pain intensity (numerical rating scale), with secondary endpoints including quality of life (EQ-5D) and safety. Both groups showed significant reductions in pain, with no statistically significant differences in absolute (

Indexed as

capsaicincrossover studynon-inferiority clinical trialpainful diabetic peripheral neuropathysafety

Identifiers

PMID41157180
PMCPMC12565387

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Registered trials

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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.