ArticlePain reports
Low-dose naltrexone for treatment of pain in patients with fibromyalgia: a randomized, double-blind, placebo-controlled, crossover study.
Article in Pain reports. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Low Dose Naltrexone In The Management Of Chronic Pain Syndrome: A Meta-Analysis Of Randomized Controlled Clinical Trials.Current pain and headache reports · 2025Pooled it
- The use of naltrexone in the treatment of chronic pain: a systematic review.Pain management · 2024Pooled it
- Efficacy of Low-Dose Naltrexone in Women With Fibromyalgia Syndrome: A 12-Month Randomised, Double-Blind, Placebo-Controlled Single-Centre Clinical Trial (INNOVA Study).European journal of pain (London, England) · 2026Trial
- Trial
- Low-Dose Naltrexone: What is the Evidence? A Narrative Review.Advances in therapy · 2026Review
- The expanding potential of low-dose naltrexone in clinical practice with a focus on long COVID.The mental health clinician · 2026Article
- Authors' reply to the letter to the editor regarding "Low-dose naltrexone for fibromyalgia: a re-analysis suggests lower efficacy than previously reported".The Korean journal of pain · 2026Article
- Low-dose naltrexone for fibromyalgia: a re-analysis suggests lower efficacy than previously reported.The Korean journal of pain · 2026Article
- Low dose naltrexone for fibromyalgia: case series demonstrating pain relief and other health benefits.Frontiers in pain research (Lausanne, Switzerland) · 2026Article
- Reserpine-induced fibromyalgia model in female rats is a long-lasting painful condition masked by antinociceptive endogenous opioids.Frontiers in pharmacology · 2026Article
- Authors' response to comments on "Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis".The Korean journal of pain · 2025Article
- Review
- Therapeutic approach to fibromyalgia: a consensus statement on pharmacological and non-pharmacological treatment from the neuropathic pain special interest group of the Italian neurological society.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Article
- Efficacy and safety of low-dose naltrexone (LDN) in fibromyalgia: a systematic review and meta-analysis.Annals of medicine and surgery (2012) · 2025Article
- Review
- Real-World Effectiveness and Tolerability of Low Dose Naltrexone to Treat Chronic Pain: A Retrospective Cohort Study of One Pain Physician's Practice.Journal of pain research · 2025Article
- Pharmacologic treatment of fibromyalgia: an update.Frontiers in pharmacology · 2025Review
- Drug Repurposing as an Effective Drug Discovery Strategy: A Critical Review.Drug design, development and therapy · 2025Review
- Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis.The Korean journal of pain · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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: 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; Conclusion: Outcome data did not indicate any clinically relevant analgesic efficacy of the LDN treatment in patients with FM.
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Registered trials
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.