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.
Study Goal
The researchers aimed to determine the effect of modified-release melatonin (Circadin™) on sleep disturbance in patients with severe noncancer chronic pain.
Results Summary
Melatonin did not significantly improve sleep disturbance at 6 weeks but showed short-term improvements in sleep quality, latency, and pain-related sleep effects at 3 weeks. Pain intensity improved during both treatment periods, with no differences in adverse events between melatonin and placebo.
Population
60 male and female subjects with chronic severe pain.
Effective Dosage
2 mg of Circadin™ before sleep.
Duration
6 weeks per treatment period, with a >4-week washout between crossover.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
modified-release melatonin as Circadin™ | no change | sleep disturbance | patients with severe noncancer chronic pain | not significantly altered | did not improve | #1 |
modified-release melatonin as Circadin™ | decrease | sleep disturbance | patients with severe noncancer chronic pain | P=0.014 | differences between melatonin and placebo treatment periods after 3 weeks were seen | #2 |
modified-release melatonin as Circadin™ | decrease | sleep latency | patients with severe noncancer chronic pain | P=0.04 | differences between melatonin and placebo treatment periods after 3 weeks were seen | #3 |
modified-release melatonin as Circadin™ | increase | overall sleep quality | patients with severe noncancer chronic pain | P=0.004 | differences between melatonin and placebo treatment periods after 3 weeks were seen | #4 |
modified-release melatonin as Circadin™ | decrease | effect of pain on sleep | patients with severe noncancer chronic pain | P=0.032 | differences between melatonin and placebo treatment periods after 3 weeks were seen | #5 |
modified-release melatonin as Circadin™ | decrease | pain intensity scores | patients with severe noncancer chronic pain | P<0.001 | improved | #6 |
placebo | decrease | pain intensity scores | patients with severe noncancer chronic pain | P<0.001 | improved | #7 |
modified-release melatonin as Circadin™ | no change | adverse events | patients with severe noncancer chronic pain | - | no differences | #8 |
BACKGROUND: Sleep disturbance is a major issue for patients with chronic pain. Melatonin has been shown to improve symptoms of fibromyalgia, but its efficacy in other chronic non-malignant pain conditions is not fully known. Hence, we determined the effect of melatonin in patients with severe noncancer chronic pain. METHODS: This was a randomised double-blinded crossover trial of modified-release melatonin as Circadin™ compared with placebo. Sixty male and female subjects with chronic severe pain were randomised to receive either 2 mg of Circadin™ or placebo before sleep for 6 weeks, followed by a >4 week washout, then crossing over to the other treatment. Sleep disturbance, quality, and latency were measured using three different validated sleep assessment tools. The primary outcome measure was self-reported sleep disturbance after 6 weeks of treatment. Adverse events were also recorded. RESULTS: Sleep disturbance after 6 weeks was not significantly altered by melatonin treatment, but differences between melatonin and placebo treatment periods after 3 weeks were seen: sleep disturbance (P=0.014), latency (P=0.04), overall sleep quality (P=0.004), and effect of pain on sleep (P=0.032). Pain intensity scores improved during both treatment periods (both P<0.001). There were no differences in adverse events between treatment periods. CONCLUSIONS: 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. Given its favourable safety profile, it could be beneficial for some patients with chronic pain. CLINICAL TRIAL REGISTRATION: ISRCTN12861060.