Multiple Sclerosis
Study register · detail Open-Label Pilotstudie · Multiple Sclerosis · 2004

An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis.

Clear benefit GRADE Moderate 238 citations
Samplen = 15 Pat.
Duration8 weeks THC+CBD, followed by 8…
EndpointMicturition frequency/urgency
Blindingoffen
DesignOpen-Label Pilotstudie
Cannabinoidvollspektrum
THC:CBD1:1
Max. dose5.0 mg
Routeoromukosal
Key finding

Both cannabis extracts significantly reduced urinary incontinence, urgency and frequency as well as pain and spasticity.

Summary

n=15 evaluable MS patients (of 21 recruited) with refractory urinary tract symptoms; cannabis extracts THC+CBD (2,5 mg/spray) over 8 weeks; urgency, incontinence episodes, frequency and nocturia significantly reduced (P<0,05, Wilcoxon); patient-rated pain, spasticity and sleep significantly improved (P<0,05). Improvement in pain persisted up to a median of 35 weeks.

P
PopulationAdults with advanced Multiple Sclerosis and refractory lower urinary tract symptoms (LUTS), n=15 evaluated (21 recruited)
I
InterventionTwo whole-plant extracts of Cannabis sativa: first THC+CBD (2,5 mg/spray each) for 8 weeks, then THC-only (2,5 mg/spray) for a further 8 weeks, followed by a long-term extension
O
OutcomeSignificant reduction in urgency, incontinence episodes (number and volume), frequency and nocturia (p<0,05, Wilcoxon); likewise significant improvement in pain, spasticity and sleep quality
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding Open-label
Effect size Clear benefit
Citations / year
Authors
Brady CM, DasGupta R, Dalton C, Wiseman OJ, Berkley KJ, Fowler CJ.
DOI 10.1191/1352458504ms1063oa
Design: Open-Label Pilotstudie
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Abstract
The majority of patients with multiple sclerosis (MS) develop troublesome lower urinary tract symptoms (LUTS). Anecdotal reports suggest that cannabis may alleviate LUTS, and cannabinoid receptors in the bladder and nervous system are potential pharmacological targets. In an open trial we evaluated the safety, tolerability, dose range, and efficacy of two whole-plant extracts of Cannabis sativa in patients with advanced MS and refractory LUTS. Patients took extracts containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD; 2.5 mg of each per spray) for eight weeks followed by THC-only (2.5 mg THC per spray) for a further eight weeks, and then into a long-term extension. Assessments included urinary frequency and volume charts, incontinence pad weights, cystometry and visual analogue scales for secondary troublesome symptoms. Twenty-one patients were recruited and data from 15 were evaluated. Urinary urgency, the number and volume of incontinence episodes, frequency and nocturia all decreased significantly following treatment (P <0.05, Wilcoxon's signed rank test). However, daily total voided, catheterized and urinary incontinence pad weights also decreased significantly on both extracts. Patient self-assessment of pain, spasticity and quality of sleep improved significantly (P <0.05, Wilcoxon's signed rank test) with pain improvement continuing up to median of 35 weeks. There were few troublesome side effects, suggesting that cannabis-based medicinal extracts are a safe and effective treatment for urinary and other problems in patients with advanced MS.

The impediment to action advances action. — Marcus Aurelius