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Timothy L. Vollmer, MD
Department of Neurology
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Co-Director of the RMMSC at Anschutz Medical Center

Medical Director-Rocky Mountain MS Center
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Multiple Sclerosis Institute
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Weill Medical College of Cornell University

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Timothy L. Vollmer M.D.
Department of Neurology
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Cannabis Extracts May Ease MS Spasticity

Multiple sclerosis patients with spasticity may feel better after taking whole plant extracts of cannabis, researchers said, but a review of six studies showed that the drug had no significant effect on objective measurements of patients' condition.

The extracts did appear to be well tolerated, despite some adverse events, according to an online report in BMC Neurology by Shaheen Lakhan, MD, PhD, and Marie Rowland, both of the Global Neuroscience Initiative Foundation, a nonprofit organization in Los Angeles.

Earlier research had indicated that cannabis might be an effective treatment for the spasticity associated with MS, Lakhan and Rowland wrote in the journal.

But most such studies focused on one component of the plant: Δ9-tetrahydrocannabinol (THC), which also has psychotropic properties.

Recently, researchers have combined THC and another extract, cannabidiol (CBD), hoping to obtain an antispastic effect without intoxication, the researchers wrote. The CBD appears to block the entry of THC to the brain, reducing psychotropic effects.

So Lakhan and Rowland conducted a systematic review of studies published between 1999 and April 2009, looking for randomized, placebo-controlled trials in which a combination THC and CBD extract was tested.

All told, they found six, published between 2002 and 2007, involving a total of 481 patients with MS. Three used a crossover design and three a parallel design in which a total of 339 patients were administered a placebo only.

All six trials reported changes on the Ashworth scale, which measures spasticity. Other measures in some or all studies included a visual analog scale, walk time, the Rivermead Mobility Index which measures disability related to mobility, and self-reported ratings of spasm frequency or severity.

Overall, five studies concluded that the extracts may decrease spasticity and improve mobility in patients with MS and one reported no reduction in spasticity, the researchers reported in the journal.

But only one study, of 50 patients assessed with the Ashworth scale, showed significant improvement, while the other five reported little to no improvement in their versions of the Ashworth scale.

Lakhan and Rowland noted in the journal that "the Ashworth scale is subject to individual assessor evaluation, and there may have been variation between studies in the modification of scale measures."

Three studies reported visual analog scales, two of which found a significant improvement, they reported.

Two studies reported improved walk time results, but the changes were not significant in one, and significance was not reported in the other.

Three studies, including a total of 275 patients, reported improvements in the Rivermead Mobility Index, but only one reached significance.

Finally, Lakhan and Rowland reported, five studies reported significant improvements in spasticity as subjectively rated by patients with MS, while one reported deterioration.

The National Multiple Sclerosis Society has said it is "clear that cannabinoids have potential both for the management of MS symptoms such as pain and spasticity, as well as for neuroprotection."

But the society doesn't recommend medical marijuana because there's no clearly demonstrated benefit, compared with existing treatments. As well, the society said on its Web site, "issues of side effects, systemic effects, and long-term effects are not yet clear."

The authors noted several limitations including the fact that this review did not include unpublished data and "the possibility that other clinical reports using whole plant cannabis extracts may have been appropriate for review, but were not included without report of specific methodology." Story in MedPage Today


Biogen Idec's Oral Compound BG-12 Achieves Development Milestones In MS And RA

Biogen Idec (NASDAQ: BIIB) today announced that its oral compound BG-12 (dimethyl fumarate) achieved key milestones in clinical trials for multiple sclerosis (MS) and rheumatoid arthritis (RA). In recent months, the last patient was enrolled in the CONFIRM trial, the second of two Phase III trials designed to evaluate the efficacy and safety of BG-12 as a monotherapy in patients with relapsing-remitting multiple sclerosis (RRMS). Both the DEFINE and CONFIRM Phase III trials are now fully enrolled and will evaluate the effect of BG-12 on clinical relapse, disability progression, various MRI measures of disease activity, and safety.

The last patient was also enrolled in a Phase II study to evaluate the safety, tolerability and efficacy of BG-12 in combination with methotrexate in subjects with active RA who had an inadequate response to conventional disease-modifying antirheumatic drug (DMARD) therapy.

"There is significant unmet need in both the MS and RA communities for additional treatment options," said Kate Dawson, M.D., senior director, Medical Research, Biogen Idec. "The Phase IIb study of oral BG-12 in patients with MS showed promising MRI results regarding the compound's ability to reduce inflammation and its potential for neuroprotection. We look forward to results from the DEFINE and CONFIRM Phase III MS studies, as well as the proof-of-concept trial in RA."

BG-12 has been shown to activate the Nrf2 transcriptional pathway, which pre-clinical studies have shown defends against oxidative-stress induced neuronal death, protects the blood-brain barrier and supports maintenance of myelin integrity in the central nervous system. Central nervous system inflammation and damage may trigger the symptoms common in RRMS such as fatigue cognitive deterioration and physical disability. Because of BG-12's unique effect on the Nrf2 pathway and its oral delivery, BG-12 is also being considered for future MS combination therapy studies. Additionally, as an oral compound, BG-12 holds promise for patients with RA. Its combination of anti-inflammatory and potential cytoprotective properties support the compound's evaluation in RA.

BG-12 is an oral formulation of dimethyl fumarate. Fumaderm®, a therapeutic for the treatment of psoriasis in Germany, includes dimethyl fumarate as one of the active ingredients. Fumaderm has more than 14 years of post-marketing experience and approximately 100,000 patient years of use. ....full report in Medical News Today


Physical Activity Reduces Disease-Related Fatigue And Depression By Increasing Self-Efficacy Or Mastery

Researchers in the US studying people with chronic diseases found that physical activity may reduce depression and fatigue by increasing self-efficacy, or the belief that one can master physical goals and attain a sense of accomplishment from applying oneself.

These were the findings of a study by lead author Dr Edward McAuley, a professor of kinesiology and community health at the University of Illinois in Champaign, and colleagues, and appears in the journal Psychosomatic Medicine...full report in Medical News Today


Brain Science: MS is a disease from a dark place

Part one of a four-part series: What's inside the black box of multiple sclerosis baffles patients and scientists alike

Multiple sclerosis is a frustrating black box. Something is going on in that box that leads to lesions in the brain and damage to the myelin insulating layer on nerve cells. What that means to patients such as Gabrielle Veto is muscle pain, loss of strength, constant fatigue, occasional paralysis and the spectre of life in a wheelchair always lurking beyond the next attack.

"One of the biggest frustrations with MS is that so much is unknown," said Veto, who was diagnosed at the age of 27 when she started to experience abdominal pain in 1996. She had been married to husband Alan Pearce for one year.

Veto's case is like all cases of MS: it is completely unique and unpredictable......full story in The Vancouver Sun


What's new for 'Multiple Sclerosis' in PubMed

Multiple sclerosis: Distribution of inflammatory cells in newly forming lesions. - Early loss of oligodendrocytes is a prominent feature in tissue bordering rapidly expanding MS lesions. Macrophage activity is largely an innate scavenging response to the presence of degenerate and dead myelin. Adaptive immune activity involving T and B cells is conspicuous chiefly in recently demyelinated tissue, which may show signs of oligodendrocyte regeneration. The findings suggest that plaque formation has some basis other than destructive cell-mediated immunity directed against a myelin or oligodendrocyte antigen. - Ann Neurol 2009;66:739-753. in PubMed

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