Low-dose naltrexone was not superior to placebo in relieving pain for female patients with fibromyalgia, according to a study published by Bruun et al in The Lancet Rheumatology. In the FINAL trial (ClinicalTrials.gov identifier: NCT04270877), researchers randomly assigned 99 female patients aged 18 to 64 years with fibromyalgia to receive either 6 mg of naltrexone once daily (n = 49) or placebo (n = 50). The primary outcome of the trial was change in pain intensity using an 11-point numeric rating scale after a follow-up of 12 weeks. The researchers discovered that the patients in the naltrexone group experienced a mean change in pain intensity of –1.3 points (95% confidence interval [CI] = –1.7 to –0.8) compared with –0.9 (95% CI = –1.4 to –0.5) in the placebo group. The researchers concluded that low-dose naltrexone was not superior to placebo in reducing pain in this patient population; however, the agent did show the potential to improve memory issues associated with fibromyalgia. They emphasized that further studies may be needed to better understand the benefits of low-dose naltrexone.


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