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Longer term use of Sativex - risks and benefits

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Sativex was the first cannabis based medicine to be licensed in the UK. It is prescribed for spasticity (muscle stiffness), usually if someone has not benefitted from first line treatments for spasticity such as baclofen and gabapentin or if they have found their side effects unbearable.

It contains two chemical extracts derived from the cannabis plant. Sativex is sprayed into the mouth either on the inside of the cheek or under the tongue. The number of sprays needed depends on the individual and the severity of their spasticity.

This research project followed people using Sativex in the longer term to see if it was safe, continued to be effective or whether the dose needed to be increased with time.

An initial six week trial of Sativex had already shown that it had an effect on spasticity in people with MS. Participants were able to decide for themselves how many sprays of Sativex were best for relieving their spasticity without making them too weak or bringing on unwanted side effects.

146 participants decided to continue on a longer trial. On average, they took part in the Sativex trial for about 11 months (334 days) but there was a wide time range with some participants being on the trial for either much longer or much shorter than 11 months.

Just over a third (36%) decided to stop the trial in the first year, 14% because of side effects and 9% because Sativex did not help their spasticity.

Most of the side effects were mild or moderate in severity. The most common were dizzyness (one in four people) and fatigue (one in eight people). Five people (3% of the total) experienced serious side effects.

Cannabis is a psychoactive drug and so trials of cannabis derivatives look for any effects on mental health, drug dependency or withdrawal symptoms. In this trial there was no evidence of psychological or psychiatric problems and no evidence of withdrawal symptoms even though treatment was stopped quite suddenly.

The improvement in spasticity continued throughout the trial so there was no evidence that people became tolerant to Sativex or needed to increase the dose. Other MS symptoms remained stable throughout the trial.

Serpell MG, Notcutt W, Collin C.
Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis.
J Neurol. 2012 Aug 10. [Epub ahead of print]
abstract

More about Sativex and spasticity

Sativex is a relatively new treatment for spasticity. This research provides reassuring evidence that using Sativex is safe and that it remains an effective treatment in the longer term.

You can read more about Sativex in the A to Z of MS.

There is more information on spasticity in the A to Z of MS and we've produced a guide to spasticity triggers.  Alternatively you can order or download our Managing spasticity and spasms book.

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Optic neuritis, its differential diagnosis and management.
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Disease modifying treatments

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Drugs in development

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Expert Rev Clin Immunol. 2012 Jul;8(5):423-6.
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Gait Posture. 2012 Aug 9. [Epub ahead of print]
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Reilmann R, Holtbernd F, Bachmann R, et al.
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Carrubba S, Minagar A, Chesson AL Jr, et al.
Increased determinism in brain electrical activity occurs in association with multiple sclerosis.
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Vitamin D

Décard BF, von Ahsen N, Grunwald T, et al.
Low vitamin D and elevated immunoreactivity against Epstein-Barr virus before first clinical manifestation of multiple sclerosis.
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Psychological aspects

Patti F., et al.
Treatment of cognitive impairment in patients with multiple sclerosis.
Expert Opin Investig Drugs. 2012 Aug 9. [Epub ahead of print]
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Physical activity

Corporaal SH, Gensicke H, Kuhle J, et al.
Balance control in multiple sclerosis: Correlations of trunk sway during stance and gait tests with disease severity.
Gait Posture. 2012 Aug 5. [Epub ahead of print]
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Pathophysiology

Oberwahrenbrock T, Schippling S, Ringelstein M, et al.
Retinal damage in multiple sclerosis disease subtypes measured by high-resolution optical coherence tomography.
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Oliveira SR, Kallaur AP, Simão AN, et al.
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Self management

Chaplin H, Hazan J, Wilson P.
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