PRIMARY STUDY
An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis
Key Findings: Urinary urgency, the number and volume of incontinence episodes, frequency, and nocturia all decreased significantly following treatment. Patient self-assessment of pain, spasticity, and quality of sleep improved significantly (PB/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.
Type of Study: Clinical Trial
Study Sample Size: 15
Study Result: Positive
Research Location(s): United Kingdom, United States
Year of Pub: 2004
Cannabinoids Studied: Cannabidiol (CBD), Tetrahydrocannabinol (THC)
Chemotype: Chemotype I, Chemotype II
Sub-Ratio: 1:1 (THC:CBD) and 1:0 (THC:CBD)
DOSING DETAILS 
Study Dosing Objective: Effective Dose, Safety Profile
Established Protocol: Effective dose
Route of Administration: Sublingual/Oromucosal
Cannabinoid Ratio: (THC : CBD : Pharma THC:CBD) 0 : 0 : -2
Dosage Form: whole-plant extracts of Cannabis sativa: THC and CBD (2.5 mg of each per spray) then THC only (2.5 mg per spray)
Dosing Regimen: 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.
Treatment Duration: 16 weeks
Clinical Relevance: Following treatment with delta-9-tetrahydrocannabinol (THC) and cannabidiol urinary urgency, the number and volume of incontinence episodes, frequency and nocturia all decreased significantly as did self-assessment of pain, spasticity and quality of sleep.
Adverse Events: There were few troublesome side effects.
Citation: Brady CM, et al. An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis. Mult Scler. 2004; 10:425-33. doi: 10.1191/1352458504ms1063oa
Authors: Brady CM, DasGupta R, Dalton C, Wiseman OJ, Berkley KJ, Fowler CJ
