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Low-dose naltrexone for treatment of pain in patients with fibromyalgia: a randomized, double-blind, placebo-controlled, crossover study.
Bested, Kirsten; Jensen, Lotte M; Andresen, Trine; Tarp, Grete; Skovbjerg, Louise; Johansen, Torben S D; Schmedes, Anne V; Storgaard, Ida K; Madsen, Jonna S; Werner, Mads U; Bendiksen, Anette.
Afiliación
  • Bested K; Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
  • Jensen LM; Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
  • Andresen T; Molecular Diagnostics and Clinical Research Unit, Hospital Sonderjylland, Aabendraa, Denmark.
  • Tarp G; Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
  • Skovbjerg L; Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospitals, Copenhagen, Denmark.
  • Johansen TSD; Department of Economics, University of Southern Denmark, Odense, Denmark.
  • Schmedes AV; Department of Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
  • Storgaard IK; Department of Drug Design and Pharmacology, Copenhagen University Hospitals, Copenhagen, Denmark.
  • Madsen JS; Department of Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
  • Werner MU; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
  • Bendiksen A; Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospitals, Copenhagen, Denmark.
Pain Rep ; 8(4): e1080, 2023.
Article en En | MEDLINE | ID: mdl-38226027
ABSTRACT

Introduction:

Fibromyalgia (FM) is a chronic fluctuating, nociplastic pain condition. Naltrexone is a µ-opioid-receptor antagonist; preliminary studies have indicated a pain-relieving effect of low-dose naltrexone (LDN) in patients with FM. The impetus for studying LDN is the assumption of analgesic efficacy and thus reduction of adverse effects seen from conventional pharmacotherapy.

Objectives:

First, to examine if LDN is associated with analgesic efficacy compared with control in the treatment of patients with FM. Second, to ascertain the analgesic efficacy of LDN in an experimental pain model in patients with FM evaluating the competence of the descending inhibitory pathways compared with controls. Third, to examine the pharmacokinetics of LDN.

Methods:

The study used a randomized, double-blind, placebo-controlled, crossover design and had a 3-phase setup. The first phase included baseline assessment and a treatment period (days -3 to 21), the second phase a washout period (days 22-32), and the third phase a baseline assessment followed by a treatment period (days 33-56). Treatment was with either LDN 4.5 mg or an inactive placebo given orally once daily. The primary outcomes were Fibromyalgia Impact Questionnaire revised (FIQR) scores and summed pain intensity ratings (SPIR).

Results:

Fifty-eight patients with FM were randomized. The median difference (IQR) for FIQR scores between LDN and placebo treatment was -1.65 (18.55; effect size = 0.15; P = 0.3). The median difference for SPIR scores was -0.33 (6.33; effect size = 0.13; P = 0.4).

Conclusion:

Outcome data did not indicate any clinically relevant analgesic efficacy of the LDN treatment in patients with FM.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: Pain Rep Año: 2023 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: Pain Rep Año: 2023 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Estados Unidos