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.
The autours have provided a randomized, double blind, placebo controlled, crossover study of melatonin for treatment of Nocturia in patients with multiple sclerosis (MS). The study is of importance as nocturia is common in patients with MS and affects their quality of life adversely.
The relatively small study group of 34 patients with nocturia secondary to MS underwent a 4-day pre-treatment monitoring phase and were randomized to receive either 2 mg melatonin (Circadin®) per night or 1 placebo followed by a crossover to the other regimen after 6 weeks for an additional 6 weeks after a 1-month washout period. Only 26 patients who completed the study who showed no significant difference observed in the signs or symptoms of nocturia when taking 2 mg melatonin vs placebo. Therefore this small study concluded that a low dose of melatonin taken at bedtime is not effective for nocturia in MS patients.
Nocturia in MS patients is mostly part of their overactive bladder syndrome and has a neurogenic aetiology and therefore, a neurogenic targeted therapy of nocturia would probably be a more interesting modality to study in this patient group.