PMID- 38226027
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240117
IS  - 2471-2531 (Electronic)
IS  - 2471-2531 (Linking)
VI  - 8
IP  - 4
DP  - 2023 Jul-Aug
TI  - Low-dose naltrexone for treatment of pain in patients with fibromyalgia: a 
      randomized, double-blind, placebo-controlled, crossover study.
PG  - e1080
LID - 10.1097/PR9.0000000000001080 [doi]
LID - e1080
AB  - INTRODUCTION: Fibromyalgia (FM) is a chronic fluctuating, nociplastic pain 
      condition. Naltrexone is a micro-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.
CI  - Copyright (c) 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of The International Association for the Study of Pain.
FAU - Bested, Kirsten
AU  - Bested K
AUID- ORCID: 0000-0002-2087-3349
AD  - Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
FAU - Jensen, Lotte M
AU  - Jensen LM
AD  - Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
FAU - Andresen, Trine
AU  - Andresen T
AD  - Molecular Diagnostics and Clinical Research Unit, Hospital Sonderjylland, 
      Aabendraa, Denmark.
FAU - Tarp, Grete
AU  - Tarp G
AD  - Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
FAU - Skovbjerg, Louise
AU  - Skovbjerg L
AD  - Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen 
      University Hospitals, Copenhagen, Denmark.
FAU - Johansen, Torben S D
AU  - Johansen TSD
AD  - Department of Economics, University of Southern Denmark, Odense, Denmark.
FAU - Schmedes, Anne V
AU  - Schmedes AV
AD  - Department of Clinical Biochemistry and Immunology, Lillebaelt Hospital, 
      University Hospital of Southern Denmark, Vejle, Denmark.
FAU - Storgaard, Ida K
AU  - Storgaard IK
AD  - Department of Drug Design and Pharmacology, Copenhagen University Hospitals, 
      Copenhagen, Denmark.
FAU - Madsen, Jonna S
AU  - Madsen JS
AD  - Department of Clinical Biochemistry and Immunology, Lillebaelt Hospital, 
      University Hospital of Southern Denmark, Vejle, Denmark.
AD  - Department of Regional Health Research, University of Southern Denmark, Odense, 
      Denmark.
FAU - Werner, Mads U
AU  - Werner MU
AD  - Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen 
      University Hospitals, Copenhagen, Denmark.
FAU - Bendiksen, Anette
AU  - Bendiksen A
AD  - Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
LA  - eng
PT  - Journal Article
DEP - 20230615
PL  - United States
TA  - Pain Rep
JT  - Pain reports
JID - 101683899
PMC - PMC10789452
OTO - NOTNLM
OT  - Chronic pain
OT  - Fibromyalgia patients
OT  - Low-dose naltrexone
OT  - RCT
COIS- The authors declare that the article is a transparent and accurate report of the 
      research undertaken and that there are no conflicts of interest to 
      disclose.Sponsorships or competing interests that may be relevant to content are 
      disclosed at the end of this article.
EDAT- 2024/01/16 06:42
MHDA- 2024/01/16 06:43
PMCR- 2023/06/15
CRDT- 2024/01/16 03:39
PHST- 2022/10/19 00:00 [received]
PHST- 2023/01/26 00:00 [revised]
PHST- 2023/04/15 00:00 [accepted]
PHST- 2024/01/16 06:43 [medline]
PHST- 2024/01/16 06:42 [pubmed]
PHST- 2024/01/16 03:39 [entrez]
PHST- 2023/06/15 00:00 [pmc-release]
AID - PAINREPORTS-D-22-0128 [pii]
AID - 10.1097/PR9.0000000000001080 [doi]
PST - epublish
SO  - Pain Rep. 2023 Jun 15;8(4):e1080. doi: 10.1097/PR9.0000000000001080. eCollection 
      2023 Jul-Aug.