Melatonin treatment has consistent but transient beneficial effects on sleep measures and pain in patients with severe chronic pain: the DREAM–CP randomised controlled trial
Authors' conclusion
Circadin™ treatment did not improve sleep disturbance in patients with severe chronic pain compared with placebo at 6 weeks, but there were consistent improvements in aspects of sleep in the shorter term.
Study context
- Population
- Male and female subjects with chronic severe noncancer paincrossover, >4 week washout
- Participants
- 60 participants
- Comparison
- Modified-release melatonin vs placebo
- Primary endpoint
- Self-reported sleep disturbance
- Follow-up
- 6 weeks
Methodological detailsdouble-blinded, crossover
- Double-blinded
- Crossover
Primary result
As reported in the abstract
Sleep disturbance
- Sleep disturbance not significantly altered by melatonin vs placebo
Further findings
| Outcome | P value |
|---|---|
| Sleep measures, melatonin vs placebo periods · 3 weeksCircadin™ vs Placebo · sleep disturbance | P = 0.014 |
| Sleep measures, melatonin vs placebo periods · 3 weeksCircadin™ vs Placebo · latency | P = 0.04 |
| Sleep measures, melatonin vs placebo periods · 3 weeksCircadin™ vs Placebo · overall sleep quality | P = 0.004 |
| Sleep measures, melatonin vs placebo periods · 3 weeksCircadin™ vs Placebo · effect of pain on sleep | P = 0.032 |
Pain intensity scores
- Improved during both treatment periods
- both P<0.001
Safety
Adverse events
- No differences between treatment periods
Original publication
Melatonin treatment has consistent but transient beneficial effects on sleep measures and pain in patients with severe chronic pain: the DREAM–CP randomised controlled trial. Br J Anaesth. Published 14 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →