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Randomised Controlled Trial Of Cannabis Based Medicinal Extracts (CBME)

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Background: Central neuropathic pain can be an intractable problem for some multiple sclerosis (MS) patients.

Aim: To evaluate the efficacy and safety of THC:CBD CBME in the relief of central neuropathic pain due to MS, using the Neuropathic Pain Scale (NPS) and single Box Scale-11 (BS-11) pain severity score.

Methods: A 5-week (1 week run-in, 4 week treatment), randomised, double-blinded, placebo-controlled, parallel group trial in 66 MS patients was conducted.
The study medication was an oro-mucosal preparation of a whole plant extract which delivered 2.7mg of THC and 2.5mg CBD per spray. Patients were allowed to self-titrate up to a maximum of 48 sprays per day.
Results: Sixty-four patients (96.9%) completed the trial (n=32 CBME, n=32 placebo).

Efficacy: Significant mean reductions in pain were observed at Week 4 for CBME compared to placebo, using both BS-11 score (p=0.005) and Neuropathic Pain Scale (NPS) scores (p=0.039).
A statistically significant reduction in sleep disturbance using a 0-10 scale (p=0.003), and a greater overall impression of change (p=0.005) in favour of CBME was observed.

Safety: Thirty patients (88.2%) on CBME and 22 (68.8%) on placebo had at least one adverse event; however only 1 patient (CBME) withdrew from the study.
There was a small, but statistically significant mean difference between treatments in the long term storage component of the Selective Reminding Test, in favour of placebo (p = 0.009).

Conclusion: CBME showed significant reductions in both neuropathic pain and pain-related sleep disturbance in patients with MS. CBMEs appear well tolerated by most patients.

Source: Clinical Studies and Case Reports
 
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