Pregabalin for Neuropathic Pain and Itch in Recessive Dystrophic Epidermolysis Bullosa: A Randomized Crossover Trial

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dc.catalogadorjlo
dc.contributor.authorCalvo Bascuñán, Margarita
dc.contributor.authorTejos Bravo, Macarena Verónica Montserrat
dc.contributor.authorPassi Solar, Álvaro Rodrigo
dc.contributor.authorEspinoza Mihovilovic, Fernanda Mileva
dc.contributor.authorFuentes Bustos, María Ignacia
dc.contributor.authorLara-Corrales, Irene
dc.contributor.authorPope, Elena
dc.date.accessioned2025-07-09T13:59:34Z
dc.date.available2025-07-09T13:59:34Z
dc.date.issued2024
dc.description.abstractImportance: Patients with recessive dystrophic epidermolysis bullosa (RDEB) experience neuropathic pain and itch. There is a lack of evidence on any treatment for these symptoms in patients with RDEB. Objectives: To test the efficacy of pregabalin in the treatment of neuropathic pain and itch in patients with RDEB. Design, Setting, and Participants: A randomized, double-blinded, crossover trial of oral pregabalin (50-300 mg/d) vs placebo was conducted at 2 sites, Toronto (Canada) and Santiago (Chile) from January 1, 2019, to December 31, 2020. Patients eligible to participate were diagnosed with RDEB, aged 8 to 40 years, not pregnant or lactating (if female), and had evidence of probable neuropathic pain and itching defined as distal thermal sensory loss (confirmed by thermal roller), score of 4 or greater on the Douleur Neuropathique 4 questionnaire (DN4), and score greater than 4 on the 10-point visual analog scale [VAS]). Patients with a clinically important or poorly controlled medical or psychiatric condition or pregabalin intolerance or allergy were excluded. Of 41 patients screened, 3 were not eligible and 28 declined enrollment. Data analyses were performed in 2021 through 2023. Intervention: Participants received both pregabalin and matched placebo (titrated to a maximum-tolerated dose of 300 mg/day) in a randomized sequence so that comparisons could be made within participants and between groups. Main Outcomes and Measures: Difference in the mean pain and itch scores between pregabalin and placebo treatment (measured using VAS) before and after intervention. Results: In all, 10 participants were randomized to 2 groups, 6 patients (mean [SD] age, 26.7 [8.1] years; 3 females [50%]) in group 1, and 4 patients (mean [SD] age, 26.5 [7.8] years, 2 females [50%]) in group 2. Group 1 received a sequence of pregabalin-placebo while group 2 received placebo-pregabalin. Pregabalin significantly reduced mean (SD) pain scores by 1.9 (1.5) points when controlling for sequence and treatment period vs baseline, while placebo had 0.1 (2.0) points of reduction. The effect of pregabalin was a mild but significant reduction in itch compared to baseline (mean [SD] points, 0.9 [2.2]), whereas the placebo produced no reduction (0.1 [2.5]). The mean pregabalin dose was generally well tolerated. Conclusions and Relevance: The results of this randomized crossover trial indicate that pregabalin significantly reduced pain and itch scores from baseline compared to placebo in patients with RDEB. This feasibility study provided preliminary data on the efficacy of pregabalin in managing pain and itch in RDEB and gathered essential data to inform the design of a larger cohort trial.
dc.format.extent6 páginas
dc.fuente.origenSCOPUS
dc.identifier.doi10.1001/jamadermatol.2024.3767
dc.identifier.issn2168-6084
dc.identifier.scopusidSCOPUS_ID:85213491815
dc.identifier.urihttps://doi.org/10.1001/jamadermatol.2024.3767
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/104882
dc.information.autorucEscuela de Medicina; Calvo Bascuñán, Margarita; 0000-0003-3349-9189; 3457
dc.information.autorucEscuela de Medicina; Tejos Bravo, Macarena Verónica Montserrat; S/I; 1086270
dc.information.autorucEscuela de Medicina; Passi Solar, Álvaro Rodrigo; 0000-0002-1744-1705; 155739
dc.information.autorucFacultad de Ciencias Biológicas; Espinoza Mihovilovic, Fernanda Mileva; S/I; 1015221
dc.information.autorucFacultad de Ciencias Biológicas; Fuentes Bustos, María Ignacia; S/I; 127312
dc.language.isoen
dc.nota.accesocontenido parcial
dc.pagina.final1319
dc.pagina.inicio1314
dc.revistaJAMA Dermatology
dc.rightsacceso restringido
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.titlePregabalin for Neuropathic Pain and Itch in Recessive Dystrophic Epidermolysis Bullosa: A Randomized Crossover Trial
dc.typeartículo
dc.volumen160
sipa.codpersvinculados3457
sipa.codpersvinculados1086270
sipa.codpersvinculados155739
sipa.codpersvinculados1015221
sipa.codpersvinculados127312
sipa.trazabilidadSCOPUS;2025-01-05
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