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Randomized Controlled Trial
. 2018 Aug 6;18(1):107.
doi: 10.1186/s12883-018-1114-4.

Results of a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of Nocturia in adults with multiple sclerosis (MeNiMS)

Marcus J Drake  1   2 , Luke Canham  3 , Nikki Cotterill  4 , Debbie Delgado  4 , Jenny Homewood  3 , Kirsty Inglis  3 , Lyndsey Johnson  4 , Mary C Kisanga  4 , Denise Owen  3 , Paul White  5 , David Cottrell  3
Affiliations
Randomized Controlled Trial

Results of a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of Nocturia in adults with multiple sclerosis (MeNiMS)

Marcus J Drake et al. BMC Neurol. .

Abstract

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 .

Keywords: Antidiuretic; Antimuscarinic; LUTS; Melatonin; Multiple sclerosis; Nocturia.

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Conflict of interest statement

The U.K. National Research Ethics Service Committee South West – Exeter approved the study protocol (REC reference number: 12/SW/0322).

Not applicable.

MJD; Research grants, Speaker bureau, advisory boards for Allergan, Astellas, Ferring. Speaker bureau for Hikma and Pfizer. Other authors; not applicable.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow chart
See this image and copyright information in PMC

References

    1. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the international continence society. Neurourol Urodyn. 2002;21(2):167–178. doi: 10.1002/nau.10052. - DOI - PubMed
    1. Bing MH, Moller LA, Jennum P, Mortensen S, Skovgaard LT, Lose G. Prevalence and bother of nocturia, and causes of sleep interruption in a Danish population of men and women aged 60-80 years. BJU Int. 2006;98(3):599–604. doi: 10.1111/j.1464-410X.2006.06390.x. - DOI - PubMed
    1. Stanley N. The underestimated impact of nocturia on quality of life. Eur Urol Suppl. 2005;4:17–19. doi: 10.1016/j.eursup.2005.07.002. - DOI
    1. Gulur DM, Mevcha AM, Drake MJ. Nocturia as a manifestation of systemic disease. BJU Int. 2011;107(5):702–713. doi: 10.1111/j.1464-410X.2010.09763.x. - DOI - PubMed
    1. Lightner DJ, Krambeck AE, Jacobson DJ, McGree ME, Jacobsen SJ, Lieber MM, Roger VL, Girman CJ, St Sauver JL. Nocturia is associated with an increased risk of coronary heart disease and death. BJU Int. 2012;110(6):848–853. doi: 10.1111/j.1464-410X.2011.10806.x. - DOI - PMC - PubMed

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