1. Dr. Nikki Cotterill Study funded by the MS Society x
† All financial ties (over the last year) that you may have with any business organisation with respect to the subjects mentioned during your presentation x

2. QUALITATIVE FINDINGS FROM A DOUBLE BLIND RCT
PARTICIPANT’S EXPERIENCES OF TAKING MELATONIN FOR THE TREATMENT OF NOCTURIA IN MS:
QUALITATIVE FINDINGS FROM A DOUBLE BLIND RCT
Khan R, Uren A, Homewood J, Inglis K, Johnson L, Owen D, Cottrell D, Drake M, Cotterill N

3. Background
Nocturia:
Prominent symptom associated with MS
Significant impact on quality of life
Compounds fatigue experienced with MS
An MS Society funded randomised, double blind, placebo controlled, crossover trial of melatonin for the treatment of nocturia.
Delgado et al, BMC Neurology (1): 63.
Qualitative study to explore the participants’ experience and patient-centred perspective.

4. Qualitative interview
Study overview
4 week washout
Participants in qualitative study
10 females, 7 males
Age range years
Aims of qualitative study
Experience of nocturia
Experience of the intervention and impact on quality of life
Analysis
Transcribed verbatim
NVivo10
Thematic analysis
6 weeks
Placebo/2mg Melatonin
6 weeks
Alternate treatment
Final study visit
Qualitative interview

5. Perceived improvements
Results
“It's having more energy the following day and having a better life really… I think that's what it is really just giving me a better standard of life.”
“To go from getting up twice every night to only getting up once in the last week is significant progress.”
Perceived improvements
“My sleep was a lot better… so it's the quality of sleep is a lot better and because the quality of sleep's a lot better I feel a lot better. I've got more energy I just felt great.”

6. Results continued Adverse effects
“You were getting up with a very thick head and quite grumpy and it would take you a long time to come round”.
“I could have been on the placebo both times really yeah I didn't notice enough to go wow that's made a difference.”
Adverse effects
“An hour or so after I’d fallen asleep I would have a dream. They weren’t unpleasant, they weren’t nightmares they were just a bit whacky”.

7. Interpretation Some participants reported perceived improvements in:
Episodes of nocturia, sleep quality and energy levels
With positive impact on quality of life and engagement with daily life.
Others reported a range of negative experiences including:
Vivid dreams, headaches and fatigue and tiredness
With lack of change to nocturia.
Trial data suggests a low dose of melatonin taken at bedtime may be ineffective therapy.

8. Thank you