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Thread: Sativex? Abstract about MS spasticity remedies

  1. #1
    Distinguished Community Member agate's Avatar
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    Default Sativex? Abstract about MS spasticity remedies

    Nabiximols (=Sativex, a cannabis extract) is mentioned here as a drug that will help MS spasticity. Has anyone had any experience with it? It may be available only in the UK.



    From the Multiple Sclerosis Journal, May 19, 2016:

    Pharmacological management of spasticity in multiple sclerosis: Systematic review and consensus paper

    Susana Otero-Romero
    Multiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology-Neuroimmunology, Vall d’Hebron University Hospital, Barcelona, Spain/Preventive Medicine and Epidemiology Department, Vall d’Hebron University Hospital, Barcelona, Spain

    Jaume Sastre-Garriga
    Multiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology-Neuroimmunology, Vall d’Hebron University Hospital, Barcelona, Spain

    Giancarlo Comi
    Neurological Department, Institute of Experimental Neurology (INSPE), Scientific Institute Hospital San Raffaele, University Vita-Salute San Raffaele, Milan, Italy

    Hans-Peter Hartung
    Department of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany

    Per Soelberg Sørensen
    Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

    Alan J Thompson
    Department of Brain Repair & Rehabilitation, Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK

    Patrick Vermersch
    Université Lille, INSERM, CHU Lille, Lille Inflammation Research International Center (LIRIC) UMR 995, Lille, France

    Ralf Gold
    Department of Neurology, Ruhr University, St. Josef-Hospital, Bochum, Germany

    Xavier Montalban
    Multiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology-Neuroimmunology, Vall d’Hebron University Hospital, Barcelona, Spain
    Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d’Hebron, Pg. Vall d’Hebron, 119-129, 08035 Barcelona, Spain. sotero@cem-cat.org

    Background and objectives:


    Treatment of spasticity poses a major challenge given the complex clinical presentation and variable efficacy and safety profiles of available drugs. We present a systematic review of the pharmacological treatment of spasticity in multiple sclerosis (MS) patients.

    Methods:

    Controlled trials and observational studies were identified. Scientific evidence was evaluated according to pre-specified levels of certainty.

    Results:

    The evidence supports the use of baclofen, tizanidine and gabapentin as first-line options. Diazepam or dantrolene could be considered if no clinical improvement is seen with the previous drugs. Nabiximols has a positive effect when used as add-on therapy in patients with poor response and/or tolerance to first-line oral treatments.

    Despite limited evidence, intrathecal baclofen and intrathecal phenol show a positive effect in severe spasticity and suboptimal response to oral drugs.

    Conclusion:

    The available studies on spasticity treatment offer some insight to guide clinical practice but are of variable methodological quality. Large, well-designed trials are needed to confirm the effectiveness of antispasticity agents and to produce evidence-based treatment algorithms.
    Link to this abstract:

    http://msj.sagepub.com/content/early...43600.abstract
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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  3. #2
    Distinguished Community Member jendie's Avatar
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    Default

    I only have experience with cannabis itself in the edible form. It works so much better than baclofen, tizanidine, or diazepam for relief from MS spasticity.

    The US govt has a patent on Cannabis and they lie about it's medical usefulness.

    Jendie
    I've been a member of this forum during its different incarnations since I was dx in 9/98


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    Distinguished Community Member SalpalSally's Avatar
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    Passed the Senent waiting on the Gov's okie dokie in Ohio.
    About time !
    Love, Sally


    "The best way out is always through". Robert Frost







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    Sally, if it goes through in Ohio do you think it will be given to you. It might make the world you are in appear a little brighter.
    Virginia

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  9. #5
    Distinguished Community Member Frog42's Avatar
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    The trouble with this could be something like mine. It's legal here but the dispensary is in a remote location. There is no way I could go there once a month.

    You need to do some checking into the requirements before you get too excited. Would you be allowed to have it at the NH?


    Whatever happens around you, don't take it personally. Nothing other people do is because of you. It is because of themselves. -- Miguel Ruiz

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    Distinguished Community Member SalpalSally's Avatar
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    I've never had MJ, so don't know. We will probably have to smuggle it into the NH....LOL!
    Love, Sally


    "The best way out is always through". Robert Frost







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  13. #7
    Distinguished Community Member Sherman Peabody's Avatar
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    SATIVEX: Cannabinoid treatment for MS

    As a blog concerned with new developments in cannabinoid science, we tend to do a lot of writing about future treatments, or new scientific developments that may eventually lead to treatments. Part of the issue is that large-scale, clinical testing of new cannabinoid based medicine is still years away in a lot of areas, particularly in cancer-related fields. That’s why reading a good, new large-scale study is always exhilarating. In this case, a recent study from the University of Bari in Italy took a look at a large scale, real-world application of a THC/CBD oral spray in treating adults with treatment-resistant Multiple Sclerosis (MS). In the past, we’ve written about treating MS models via lab mice with THC and CBD, and also the theory behind that treatment. So being able to finally see how things play out in real life with real patients is particularly rewarding for us and is yet another confirmation of the efficacy of cannabis based treatments.

    To review, MS is an auto-immune disease in which the body’s immune system is confused into turning against the body and attacking cells. In particular, MS is caused by the immune system stripping neurons of their outer protective linings, which normally prevent “signals” from being crossed or lost in the brain, both for conscious and unconscious tasks. This stripping eventually results in loss of physical mobility and function and can prevent patients from fulfilling active, healthy lives. Spasticity, which affects about 2/3rds of patients, is particularly problematic. Unfortunately, at this time not many treatments are available that are effective. Aside from instructing patients to try to avoid seizure triggers, doctors often prescribe anti-spastic pharmaceuticals and muscle relaxers as a method of decreasing seizure rate. However, these medications, specifically benzodiazepines, are sedative and hypnotic, and come with risk of physical dependence and withdrawal. Additionally, many patients’ conditions are treatment resistant, meaning these medications make no difference in the first place.

    As a result, the medical community has been searching for more effective treatments. Enter cannabis. Cannabis is a well-established anti-inflammatory agent and has been shown to help dampen immune system over-stimulation in a multitude of conditions. Initial lab tests also confirmed that THC and CBD were helpful in animal models of MS. As a result, the authors of this study decided to conduct a large-scale human trial. At the time being, Sativex, produced by GW Pharmaceuticals, is one of the most respected and convenient cannabinoid based treatments for conducting such a trial. Currently available in 15 countries, Sativex is a 1:1 preparation of THC:CBD which can be sprayed orally multiple times daily. Realistically, Sativex faces a much easier time acquiring approval than cannabis in many countries, both because cannabis is more difficult to standardize, and also because cannabis itself carries a lot of cultural baggage as a recreational drug.

    The MOVE 2 EU study is a multi-institution, non-interventional study of patients in Europe with MS spasticity receiving THC:CBD oral spray in an outpatient setting. Non-interventional means that patients’ current treatment plans are not altered, rather Sativex is added to their treatment to see what changes. The MOVE 2 EU study specifically aims to “determine the effectiveness of THC:CBD, collect data on tolerability/safety, determine patient satisfaction with THC:CBD, and determine resource use by patients over a 3-month period after adjustment” to the spray. The set up, of course, is straight-forward. Patients are prescribed Sativex and data is collected three times: once at the beginning of the study, once one month later, and finally three months later at the conclusion of the study. Data collection consists of not only patient surveys, which answer questions about patient satisfaction and usage, but also two tests known as the Modified Ashworth Scale (MAS) and the Numerical Rating Scale (NRS), which rank spasticity severity and spasticity numerically in a more objective manner. Other scales are used in addition to establish mobility and pain and fatigue symptoms.

    While the study will eventually expand to multiple countries, Italy was the first to reach the initial target of 300 enrolled patients, with a total of 322 patients responding and 203 patients following the study through to completion. In this case, the trial population was mostly female with an average age of around 50.

    The results are that spasticity dropped significantly in both cases after three months of treatment, proving that in a large population, Sativex appears to be capable of making a significant difference! Of course, you’ll also notice that the “n” number under each bar, which stands for the number of patients data was available for, decreases with each successive data point. This occurs as patients drop out of the study for various reasons, mostly due to lack of impact or inability to tolerate the side effects of Sativex (although in some cases due to pregnancy). Assuming those patients were to be factored in, the drop in spasticity would be lower. What that means is that Sativex is helpful to a little under 70% of patients, with another 30% either seeing no real change or being unable to tolerate treatment. For the rest, a roughly 20% improvement is observed on average, indicating that the treatment “works” in a clinical sense. In fact, after three months’ treatment, over half of the original population “were deriving sufficient benefit in the opinion of their treating physicians to warrant continued use”. However, beyond asking if Sativex simply works, researchers sought to understand how practical the treatment is for MS patients and how likely they are to adhere to using it. In this particular study, patients averaged between only 6-7 sprays a day, which combined with the portable, quick method of administration, makes it a very reasonable treatment.

    As the study spreads to other countries, we’ll keep you posted on new developments. However, we already expect to see more real-life studies based on the outcomes here, particularly in America. In the meantime, patients with treatment-resistant MS may benefit from discussing cannabinoid preparations with their physicians.

    https://cornerstonecollective.com/re...ple-sclerosis/

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