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Randomised Controlled Study Of Cannabis-Based Medicine (Sativex®) In Patients

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Bladder problems are a common feature of Multiple Sclerosis (MS), with up to 80% of MS subjects experiencing voiding dysfunction..
Methods: A 10 week double blind, randomized, placebo controlled parallel group trial was conducted. After a 2 week baseline period, 135 subjects with MS and detrusor overactivity were randomized to receive either Sativex (a standardised whole plant cannabis medicine), or placebo. The primary end point was a reduction in the daily number of episodes of urgency incontinence. Other end points included incidence of nocturia and urgency, overall bladder condition (measured on an 11-point numerical rating scale), daytime frequency, quality of life, patient's global impression of change (PGIC) and volume voided.
Results: For the primary endpoint, the decrease from baseline in incontinence episode frequency per day was in favour of the Sativex treated group but was not statistically significant (-1.08, p=0.57). Of the secondary/tertiary end points, 10 of the 11 were in favour of Sativex. In 4 out of 7 secondary end points there was statistical significance in favour of Sativex. These were reduction in nocturia episodes (-0.28, p=0.010); highly statistically significant improvement in patient's opinion of bladder symptom severity (-1.16 points, p=0.001); reduction in the number of voids per day (-0.85, p=0.007) and PGIC where 83.6% of subjects receiving Sativex compared with 58.2% receiving placebo considered the status of their bladder condition had improved (odds ratio 2.56, p=0.005). The decrease in number of urgency episodes in Sativex treated subjects just failed to reach statistical significance (-0.76, p=0.071). Of the tertiary end points, the number of daytime voids was statistically significantly in favour of Sativex (-0.57, p=0.044). There was a trend in favour of improvement in Quality of Life but which did not reach statistical significance.
Conclusions: Sativex treatment had a positive impact on the symptoms of overactive bladder in multiple sclerosis patients. It provides qualitative and quantitative symptomatic improvement and a normalisation of the symptoms of urinary frequency for many subjects with MS and further research is warranted.

Source: Clinical Studies and Case Reports
 
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