Randomized Trialhigh evidence

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)·July 1, 2026·PMID 42385209

Why it matters

LDN is widely used off-label for fibromyalgia despite limited long-term evidence. This first long-term RCT provides robust data that LDN lacks efficacy for pain and other symptoms, helping clinicians counsel patients and avoid ineffective treatments.

Infographic summary of Efficacy of Low-Dose Naltrexone in Women With Fibromyalgia Syndrome: A 12-Month Randomised, Double-Blind, Placebo-Controlled Single-Centre Clinical Trial (INNOVA Study).
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