J Cannabis Ther 2003(3/4):153-161

Clinical Studies

Cannabis and Cannabis Based Medicine Extracts: Additional Results

Author
E. Russo

Abstract
This study reviews results in recent human clinical trials with cannabis based medicine extract (CBME), THC or cannabis. In a study performed at Queen's Square, London, both High THC and THC:CBD fixed ratio sublingual CBME demonstrated significant benefits on mean maximum cystometric capacity, mean daytime frequency of urination, frequency of nocturia, and mean daily episodes of incontinence in 11 multiple sclerosis patients with intractable lower urinary tract symptoms. A Phase II clinical study in Oxford, England with 24 MS and intractable pain patients was performed as a consecutive series of doubleblind, randomized, placebo-controlled single patient cross-over trials with sublingual CBME. Pain scores on visual analogue scales were significantly improved over placebo with both High THC and High CBD CBME. Subjectively, spasm was significantly improved with High THC and THC:CBD fixed ratio extracts. Spasticity was also subjectively improved with the High THC CBME. All three extracts significantly improved objective measures of spasticity, while the High THC and THC:CBD fixed ratio CBME significantly improved objective measures of spasm. In 34 intractable pain patients in Great Yarmouth, England, seven experienced substantial improvement over best available conventional treatment with CBME, 13 moderate, and eight some benefit. Many extended the range of their activities of daily living with acceptable levels of adverse effects. Preliminary results of four Phase III clinical trials of CBME by GW Pharmaceuticals have revealed highly significant benefits in neuropathic pain in MS, pain and sleep disturbance in MS and other neurological diseases, multiple symptoms in MS, and neuropathic pain in brachial plexus injury, respectively. Most patients attained good symptomatic control with minimal side effects. In Germany, a recent Phase II clinical trial has demonstrated significant benefit of oral THC in treatment of the tics of Tourette syndrome.

Keywords
Medical marijuana, cannabis, alternative delivery systems, THC, cannabidiol, CBD, multiple sclerosis, chronic pain, Tourette syndrome, brachial plexus injury, pharmacotherapy

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