Results of a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of Nocturia in adults with multiple sclerosis (MeNiMS).
Study Goal
The researchers aimed to evaluate the effect of melatonin on the mean number of nocturia episodes per night in patients with multiple sclerosis.
Results Summary
The study found no significant difference in nocturia episodes, lower urinary tract symptoms, quality of life, or sleep quality between melatonin and placebo. No significant safety concerns were reported.
Population
26 patients with nocturia secondary to multiple sclerosis who completed the study.
Effective Dosage
2 mg per night (taken at bedtime) of sustained-release melatonin (Circadin®).
Duration
6 weeks per treatment arm, with a 1-month washout period between crossover.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
2 mg per night capsulated sustained-release melatonin (Circadin®) | no change | signs or symptoms of nocturia | patients with nocturia secondary to multiple sclerosis | no significant difference | no significant difference observed | #1 |
2 mg per night capsulated sustained-release melatonin (Circadin®) | decrease | mean number of nocturia episodes on bladder diaries | patients with nocturia secondary to multiple sclerosis | 1.4/night | was | #2 |
placebo | decrease | mean number of nocturia episodes on bladder diaries | patients with nocturia secondary to multiple sclerosis | 1.6/night | was | #3 |
2 mg per night capsulated sustained-release melatonin (Circadin®) | no change | LUTS | patients with nocturia secondary to multiple sclerosis | no significant difference | no significant difference seen | #4 |
2 mg per night capsulated sustained-release melatonin (Circadin®) | no change | QoL | patients with nocturia secondary to multiple sclerosis | no significant difference | no significant difference seen | #5 |
2 mg per night capsulated sustained-release melatonin (Circadin®) | no change | sleep quality | patients with nocturia secondary to multiple sclerosis | no significant difference | no significant difference seen | #6 |
BACKGROUND: Nocturia is a common urinary symptom of multiple sclerosis (MS) which can affect quality of life (QoL) adversely. Melatonin is a hormone known to regulate circadian rhythm and reduce smooth muscle activity such as in the bladder. There is limited evidence supporting use of melatonin to alleviate urinary frequency at night in the treatment of nocturia. The aim of this study was to evaluate the effect of melatonin on the mean number of nocturia episodes per night in patients with MS. METHODS: A randomized, double blind, placebo controlled crossover trial was conducted. 34 patients with nocturia secondary to multiple sclerosis underwent a 4-day pre-treatment monitoring phase. The patients were randomized to receive either 2 mg per night (taken at bedtime) of capsulated sustained-release melatonin (Circadin®) or 1 placebo capsule for 6 weeks followed by a crossover to the other regimen for an additional 6 weeks after a 1-month washout period. RESULTS: From the 26 patients who completed the study, there was no significant difference observed in the signs or symptoms of nocturia when taking 2 mg melatonin compared to placebo. The primary outcome measure, mean number of nocturia episodes on bladder diaries, was 1.8/night at baseline, and 1.4/night on melatonin, compared with 1.6 for placebo (Medians 1.70, 1.50, and 1.30 respectively, p = 0.85). There was also no significant difference seen in LUTS, QoL and sleep quality when taking melatonin. No significant safety concerns arose. CONCLUSIONS: This small study suggests that a low dose of melatonin taken at bedtime may be ineffective therapy for nocturia in MS. TRIAL REGISTRATION: (EudraCT reference) 2012-00418321 registered: 25/01/13. ISRCTN Registry: ISRCTN38687869 .