Tuesday, September 27, 2005

Study: Sativex effective in reducing neuropathic central pain (which is what's kicking my ass)

I found a press release pointing to the forthcoming publication in the journal Neurology of a UK study of Sativex involving 66 patients. The manufacturer obviously thinks it's good news, but I'm interested in what the science-types have to say:
This randomised, controlled trial demonstrates that Sativex® was significantly superior to placebo in reducing the mean intensity of pain (p=0.005) and sleep disturbance (p=0.003) amongst people with MS. The study was conducted in 66 patients, 65% of whom required support to walk or were wheelchair bound and were suffering from moderate to severe central neuropathic pain which had not been alleviated by currently available medications. Patients continued to take their existing medication throughout the trial. Sativex® was administered as an oromucosal spray allowing flexible dosing which is ideally suited to the variable nature of MS. Sativex® was generally well tolerated in the study, although more patients on Sativex® than placebo reported dizziness, dry mouth and somnolence. Cognitive side effects were limited to long-term memory storage.

Here's the cite:
D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812

I wonder if they had problems with "unmasking" in this one...
Link to press release.

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1 comment:

Beth said...

I read the paper and was surprised that they found anything statistically different. Even if the pain scores were "statstically" different they were not perceived as being different by the people taking drug- none reported feeling "much improved" or "very much improved". However, they didn't take anyone off of the pain medication they were already on- maybe if they had everyone start "cold turkey" there would be a greater difference from placebo. In contrast to past studies that found no significant effect- this one allowed people to take it repetively for at least 3 weeks (I think), whereas in previous studies they were only allowed to take a much lower dose or single dose.