Study on CBM (cannabis based medicine) and Multiple Sclerosis

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Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis

David J. Rog, BMBS, Turo J. Nurmikko, PhD, Tim Friede, PhD and Carolyn A. Young, MD

From the Walton Centre for Neurology and Neurosurgery (Drs. Rog and Young), Liverpool, University of Liverpool (Drs. Rog, Nurmikko, and Young); Pain Research Institute (Dr. Nurmikko), Liverpool; Medical Statistics Unit (Dr. Friede), Lancaster University, Lancaster, United Kingdom.
Background: Central pain in multiple sclerosis (MS) is common and often refractory to treatment.
Methods: We conducted a single-center, 5-week (1-week run-in, 4-week treatment), randomized, double-blind, placebo-controlled, parallel-group trial in 66 patients with MS and central pain states (59 dysesthetic, seven painful spasms) of a whole-plant cannabis-based medicine (CBM), containing delta-9-tetrahydrocannabinol:cannabidiol (THC:CBD) delivered via an oromucosal spray, as adjunctive analgesic treatment. Each spray delivered 2.7 mg of THC and 2.5 of CBD, and patients could gradually self-titrate to a maximum of 48 sprays in 24 hours.
Results: Sixty-four patients (97%) completed the trial, 34 received CBM. In week 4, the mean number of daily sprays taken of CBM (n = 32) was 9.6 (range 2 to 25, SD = 6.0) and of placebo (n = 31) was 19.1 (range 1 to 47, SD = 12.9). Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale. CBM was superior to placebo in reducing the mean intensity of pain (CBM mean change –2.7, 95% CI: –3.4 to –2.0, placebo –1.4 95% CI: –2.0 to –0.8, comparison between groups, p = 0.005) and sleep disturbance (CBM mean change –2.5, 95% CI: –3.4 to –1.7, placebo –0.8, 95% CI: –1.5 to –0.1, comparison between groups, p = 0.003). CBM was generally well tolerated, although more patients on CBM than placebo reported dizziness, dry mouth, and somnolence. Cognitive side effects were limited to long-term memory storage. Conclusions: Cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with multiple sclerosis related central neuropathic pain and is mostly well tolerated.

click here for the entire article...
http://www.neurology.org/cgi/content/abstract/65/6/812

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Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis.

Wade DT (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Wade%20DT%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus), Makela PM (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Makela%20PM%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus), House H (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22House%20H%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus), Bateman C (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Bateman%20C%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus), Robson P (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Robson%20P%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus).
Oxford Centre for Enablement, Windmill Road, Oxford OX3 7LD, UK. derick.wade@noc.anglox.nhs.uk
The object of this study was to monitor the safety and efficacy of long-term use of an oromucosal cannabis-based medicine (CBM) in patients with multiple sclerosis (MS). A total of 137 MS patients with symptoms not controlled satisfactorily using standard drugs entered this open-label trial following a 10-week, placebo-controlled study. Patients were assessed every eight weeks using visual analogue scales and diary scores of main symptoms, and were followed for an average of 434 days (range: 21 -814). A total of 58 patients (42.3%) withdrew due to lack of efficacy (24); adverse events (17); withdrew consent (6); lost to follow-up (3); and other (8). Patients reported 292 unwanted effects, of which 251 (86%) were mild to moderate, including

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http://www.ncbi.nlm.nih.gov/pubmed/17086911?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_RVDocSum

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Cannabis Use as Described by People with Multiple Sclerosis

S.A. Page A1, M.J. Verhoef A1, R.A. Stebbins A1, L.M. Metz A1, J.C. Levy A1
A1 Office of Medical Bioethics (SAP), Department of Community Health, Sciences (MJV), Department of Sociology (RAS), Department of Clinical, Neurosciences (LMM), Faculty of Law (JCL), University of Calgary, Calgary, AB, Canada.

Abstract:
Background: Multiple sclerosis (MS) is one of the most common neurological diseases affecting young adults. The prevalence of MS in Alberta has been described as among the highest reported in the world, estimated at 217 per 100,000. Numerous anecdotal reports, and a few small empirical investigations have suggested that cannabis use may relieve the symptom experience of those with MS. The present study was undertaken to describe cannabis use by this patient group. Information on peoples'beliefs, practices and experiences related to use were investigated. Methods: Aquestionnaire was mailed to a sample of 780 adults with MS in southern Alberta, Canada. Results: Completed questionnaires were returned by 420/673 eligible subjects (response rate 62%). Mean sample age was 48 years and 75% were women. Respondents ranged from mildly to severely impaired. The majority of respondents (96%) was aware cannabis was potentially therapeutically useful for MS and most (72%) supported legalization for medicinal purposes. Forty-three percent had tried cannabis at some point in their lives, 16% for medicinal purposes. Symptoms reported to be ameliorated included anxiety/depression, spasticity and chronic pain.



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http://cjns.metapress.com/app/home/contribution.asp?referrer=parent&backto=issue,5,22;journal,30,58;linkingpublication results,1:300307,1

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MS

Sativex in patients with symptoms of spasticity due to multiple sclerosis
http://www.cannabis-med.org/studies/...w.php?s_id=169 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=169)

Marijuana Helps MS Patients Alleviate Pain, Spasms
http://www.mult-sclerosis.org/news/S...msAndPain.html (http://www.mult-sclerosis.org/news/Sep2002/MedMJForMSSpasmsAndPain.html)

Cannabis-based medicine in central pain in multiple sclerosis
http://www.neurology.org/cgi/content.../65/6/812?etoc (http://www.neurology.org/cgi/content/abstract/65/6/812?etoc)

Cannabis-based medicine in spasticity caused by multiple sclerosis
http://www.cannabis-med.org/studies/...w.php?s_id=192 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=192)

Sativex in patients suffering from multiple sclerosis associated detrusor overactivity
http://www.cannabis-med.org/studies/...w.php?s_id=168 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=168)

The effect of cannabis on urge incontinence in patients with multiple sclerosis
http://www.cannabis-med.org/studies/...w.php?s_id=185 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=185)

Nabilone significantly reduces spasticity-related pain
http://www.cannabis-med.org/studies/...w.php?s_id=200 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=200)

Cannabinoids in multiple sclerosis (CAMS) study
http://www.cannabis-med.org/studies/...w.php?s_id=160 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=160)

Sativex produced significant improvements in a subjective measure of spasticity
http://www.cannabis-med.org/studies/...w.php?s_id=170 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=170)

Cannabis-based medicine in central pain in multiple sclerosis.
http://www.cannabis-med.org/studies/...w.php?s_id=175 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=175)

Do cannabis-based medicinal extracts have general or specific effects
http://www.cannabis-med.org/studies/...ow.php?s_id=56 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=56)

cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis.

http://www.cannabis-med.org/studies/...ow.php?s_id=81 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=81)

Cannabis based medicinal extracts (CBME) in central neuropathic pain due to multiple sclerosis.


http://www.cannabis-med.org/studies/...ow.php?s_id=82 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=82)

Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis
http://www.cannabis-med.org/studies/...w.php?s_id=108 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=108)

The perceived effects of smoked cannabis on patients with multiple sclerosis.


http://www.cannabis-med.org/studies/...ow.php?s_id=13 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=13)

Nabilone in the treatment of multiple sclerosis

http://www.cannabis-med.org/studies/...ow.php?s_id=11 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=11)

Effect of cannabinoids on spasticity and ataxia in multiple sclerosis.
http://www.cannabis-med.org/studies/...how.php?s_id=2 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=2)

Delta-9-THC in the treatment of spasticity associated with multiple sclerosis.
http://www.cannabis-med.org/studies/...how.php?s_id=1 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=1)

Tetrahydrocannabino l for tremor in multiple sclerosis.
http://www.cannabis-med.org/studies/...how.php?s_id=9 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=9)

Marihuana as a therapeutic agent for muscle spasm or spasticity
http://www.cannabis-med.org/studies/...ow.php?s_id=53 (http://www.cannabis-med.org/studies/ww_en_db_study_show.php?s_id=53)

Cannabis-based medicine in spasticity caused by multiple sclerosis.
http://www.unboundmedicine.com/medli...iple_sclerosis (http://www.unboundmedicine.com/medline/ebm/record/17355549/abstract/Randomized_controlled_trial_of_cannabis_based_medi cine_in_spasticity_caused_by_multiple_sclerosis)

Cannabis based treatments for neuropathic and multiple sclerosis-related pain.
http://www.unboundmedicine.com/medli...s_related_pain (http://www.unboundmedicine.com/medline/ebm/record/17257464/abstract/Meta_analysis_of_cannabis_based_treatments_for_neu ropathic_and_multiple_sclerosis_related_pain)

The effect of cannabis on urge incontinence in patients with multiple sclerosis
http://www.unboundmedicine.com/medli...al__CAMS_LUTS_ (http://www.unboundmedicine.com/medline/ebm/record/16552618/abstract/The_effect_of_cannabis_on_urge_incontinence_in_pat ients_with_multiple_sclerosis:_a_multicentre_rando mised_placebo_controlled_trial__CAMS_LUTS_)

Can Cannabis Help Multiple Sclerosis? An International Debate Rages
http://www.pacifier.com/~alive/cmu/c...is_help_ms.htm (http://www.pacifier.com/~alive/cmu/can_cannabis_help_ms.htm)

Cannabis' Potential Exciting Researchers in Treatment of ALS, Parkinson's Disease
http://www.illinoisnorml.org/index2....o_pdf=1&id=104 (http://www.illinoisnorml.org/index2.php?option=com_content&do_pdf=1&id=104)

The endocannabinoid system is dysregulated in multiple sclerosis
http://brain.oxfordjournals.org/cgi/...tract/awm160v1 (http://brain.oxfordjournals.org/cgi/content/abstract/awm160v1)

Cannabinoids inhibit neurodegeneration in models of multiple sclerosis
http://brain.oxfordjournals.org/cgi/...ll/126/10/2191 (http://brain.oxfordjournals.org/cgi/content/full/126/10/2191)

[Sequoiacrone]

Marijuana and Multiple Sclerosis
In the condition known as MS the normal functioning of the nerves in the brain and spinal cord is disrupted. Dibilitating attacks, which last for weeks, come and go unpredictably, with gradual deterioration and eventual disability. Because the central nervous system controls the entire body, the effects may appear anywhere. Common symptoms include tingling, numbness, impaired vision, difficulty in speaking, painful muscle spasms, loss of co-ordination and balance, fatigue, weakness or paralysis, loss of bladder control, urinary tract infections, constipation, skin ulcerations and severe depression.

There is no known effective treatment. The standard drugs used to treat the muscle spasms are addicitve, have severe short-term side effects and worryingly damaging long-term side effects. Many MS sufferers find that they don't even work. Cannabis has a startling and profound effect on the symptoms of MS. It stops muscle spasms, reduces tremors, restores balance, restores bladder control and restores speech and eyesight. Many wheelchair-bound patients report that they can walk unaided when they have smoked cannabis. Patients also report that they find smoked herbal cannabis better at controlling their symptoms that synthetic derivatives. According to Marijuana - The Forbidden Medicine cannabis may even retard the progression of the disease.
Scientific Evidence
In 1995 Mills reviewed all the scientific evidence of MS treatment using cannabis, and discussed all the surrounding issues. He concluded that the evidence is sparse and of poor quality and that a proper clinical trial of smoked cannabis for MS, was needed. Dr Roger Pertwee of the Department of Biomedical Sciences at Aberdeen University wants to carry out such a study. Unfortunately he still needs proper funding and a source of legal cannabis.

In 1997 Dr Pertwee, along with Consroe et al. carried out a survey of MS patients who are using cannabis to see how cannabis helped their condition. The patients reported that cannabis helped the following conditions: spasticity, chronic pain of extremities, acute paroxysmal phenomenon, tremor, emotional dysfunction, anorexia/weight loss, fatigue states, double vision, sexual dysfunction, bowel and bladder dysfunctions, vision dimness, dysfunctions of walking and balance, and memory loss (these results are ranked in order, 97% of the patients said cannabis helped the first condition, spasticity, down to 30% reporting the last condition, memory loss.
Although there has never been a clinical trial of MS patients, that used smoked herbal cannabis, there is some direct evidence of cannabis' effect on tremor. Both Clifford and Meinck et al. reported that cannabis reduced tremors and provided graphic evidence of this, in the form of before and after tremor recordings and handwriting samples.
During the 80's there were three trials of oral synthetic THC in small numbers of MS patients. All were placebo-controlled, and involved various doses of THC from 2.5 to 15 mg daily. Many of the patients claimed to get a beneficial effect from THC, but the doctors, looking on objectively could find no effect in most of them - perhaps cannabis has a psychological benefit rather than a muscular one. Petro & Ellenberg found that THC improved spasticity compared with placebo, and that half their 8 patients had a "substantial" improvement. Clifford found that 7 of his 9 patients claimed a benfefit, but doctors could only confirm that 2 patients had benefited. Ungerleider et al. studied 13 patients with MS that proved untreatable with standard drugs. Although the patients said their spasticity had improved significantly, the doctors couldn't spot an improvement. Large THC doses were poorly tolerated by the patients, with weakness, dry mouth, dizziness and psychoactive effects the common complaints - interestingly none of the patients asked to keep a supply of THC after the trial ended.
A recent letter in the Lancet from Martyn et al. reports synthetic cannabinoid, nabilone being of benefit in a single patient study. Weeks of placebo and nabilone were alternated, and muscle spasm, general well-being and sleep all improved when cannabis was given. There is also evidence from animal experiments. EAE is an artificial disease that has been used as a laboratory model of MS in guinea pigs. Lyman et al. reported that when animals were exposed to the disease and treated with a placebo, they all developed severe EAE and 98% died. The animals that were treated with THC had no or mild symptoms and 95% survived.

for the entire article see here:
http://www.concept420.com/marijuana_medical_med_uses.htm#Glaucoma