Fibromyalgia & musculoskeletal pain
Naltrexone 6 mg once daily versus placebo in women with fibromyalgia: a randomised, double-blind, placebo-controlled trial
Primary result · Mean change in pain intensity (11-point NRS)Result — go to the resultBetween-group difference −0.34 95% CI −0.95 to 0.27Authors' conclusion
This study did not show that treatment with low-dose naltrexone was superior to placebo in relieving pain.
Study context
- Population
- Women aged 18–64 years diagnosed with FM, Denmarkno participants lost to follow-up
- Participants
- 99 women
- Comparison
- Low-dose naltrexone 6 mg once daily for 12 weeks vs placebo
- Low-dose naltrexonen = 49
- Placebon = 50reference
- Primary endpoint
- Change in pain intensity on an 11-point NRS from baseline to week 12, ITT population
- Follow-up
- Week 12
Methodological detailssingle-centre, double-blind, placebo-controlled
- Single-centre
- Double-blind
- Placebo-controlled
Primary result
Mean change in pain intensity (11-point NRS)
Between-group difference
−0.34
95% CI −0.95 to 0.27
P = 0.27
Change by group
Low-dose naltrexone
−1.3
mean · 95% CI −1.7–-0.8 · points
Placebo
−0.9
mean · 95% CI −1.4–-0.5
Low-dose naltrexonevs Placebo
between-group difference −0.34 (95% CI −0.95 to 0.27); P = 0.27
As reported in the abstract
Safety
Discontinuations due to adverse events
Any adverse event
Events
| Outcome | Low-dose naltrexone | Placebo |
|---|---|---|
| Serious adverse events and deaths | 0 | 1 |
Serious adverse events and deaths
- No deaths occurred
Original publication
Naltrexone 6 mg once daily versus placebo in women with fibromyalgia: a randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. Published 5 December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →