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APPG Medicinal Cannabis Initiative

“ Short Inquiry into the case for changing the categorisation of cannabis for medicinal purposes from Schedule 1 to a more appropriate ...

Monday, 5 October 2015

AA - Medicinal Benefits Patents Trials

Medicinal Benefits



Organisations

GW Pharmaceuticals Patents

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Mental Health:

Summary

Organisations

Patents

http://www.faqs.org/patents/app/20140039043

http://www.faqs.org/patents/app/20110038958

Trials

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Addiction

Opioid

Penn Study Shows 25 Percent Fewer Opioid-Related Deaths in States Allowing Medical Marijuana http://www.uphs.upenn.edu/news/News_Releases/2014/08/bachhuber/


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Cancer

Summary

The anti cancer properties of THC, CBD, CBG and other cannabinoids are well established. Scientists have been investigating them since the early 1970s and more than 1100 papers on cannabinoids and cancer have been published. (42) 

It is also well established that cannabis helps with the side effects of cancer treatments, particularly nausea and lack of appetite. (43, 44, 45, 46) 

Cannabis may also help alleviate anxiety, depression, insomnia and mood disorders in cancer patients. However, some patients may find exactly the opposite results. (47) 

A very large quantity of anecdotal reports detail remarkable results with cannabis oil on many different forms of cancer. (48) One of the most important properties of cannabis as a cancer therapy is that it is non-toxic and even if little therapeutic effect is achieved, it causes little harm. 

On balance, while there is good evidence of anti cancer properties in vitro (human cell lines) and in vivo (animal) studies, there is little evidence of actual results in humans except in the treatment of basal cell carcinoma (49). However, few would disagree that the palliative value of cannabis is of great benefit to many cancer patients. (50) 


Organisations


National Cancer Institute: http://www.cancer.gov/about-cancer/treatment/cam/hp/cannabis-pdq

Patents

Anti-TumouralEffects Of Cannabinoid Combinations
http://www.faqs.org/patents/app/20140287067


Phytocannabinoids For Use In The Treatment OfCancer
http://www.faqs.org/patents/app/20140221469


Phytocannabinoids In The Treatment Of Cancer
http://www.faqs.org/patents/app/20130059018



http://www.faqs.org/patents/app/20150086653

http://www.faqs.org/patents/app/20120225136

http://www.faqs.org/patents/app/20100249223

http://www.faqs.org/patents/app/20080262099

http://www.faqs.org/patents/app/20120059062

http://www.faqs.org/patents/app/20100292345

Trials

Clinical trials are underway on cancer pain and the treatment of glioma brain cancer. (51, 52) 

These selected studies indicate the evidence currently available. 

Cannabinoids and cancer: potential for colorectal cancer therapy. Biochem Soc Trans. 2005. http://www.ncbi.nlm.nih.gov/pubmed/16042581 (53) 

A pilot clinical study of Δ9-tetrahydrocannabinol in patients with recurrent glioblastoma multiforme, British Journal of Cancer, 2006 http://www.nature.com/bjc/journal/v95/n2/full/6603236a.html (54) 

Cannabinoids for Cancer Treatment: Progress and Promise. Cancer Res. 2008. http://cancerres.aacrjournals.org/content/68/2/339 (55) 

Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells by Coordinating the Cross-talk between Apoptosis and Autophagy. Mol Cancer Ther., 2011. http://mct.aacrjournals.org/content/10/7/1161.long (56) 

The intersection between cannabis and cancer in the United States. CROH, 2011. http://www.croh-online.com/article/S1040-8428(11)00231-9/fulltext (57) 

Cannabinoids: a new hope for breast cancer therapy? Cancer Treat Rev. 2012 http://www.ncbi.nlm.nih.gov/pubmed/22776349 (58) 

Towards the use of cannabinoids as antitumour agents. Nat Rev Cancer. 2012 http://www.ncbi.nlm.nih.gov/pubmed/22555283 (59) 

Cannabis Extract Treatment for Terminal Acute Lymphoblastic Leukemia with a Philadelphia Chromosome Mutation. Case Rep Oncol. 2013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3901602/ (60) 

Non-hallucinogenic cannabinoids are effective anti-cancer drugs. Anticancer Research, 2013. http://www.sgul.ac.uk/news/news/study-shows-non-hallucinogenic-cannabinoids-areeffective-anti-cancer-drugs (61) 

Cannabidiol as potential anticancer drug. Br J Clin Pharmacol. 2013. http://www.ncbi.nlm.nih.gov/pubmed/22506672%20 (62) 

Cannabis, cannabinoids and cancer – the evidence so far. Cancer Research UK, 2014. http://scienceblog.cancerresearchuk.org/2012/07/25/cannabis-cannabinoids-andcancer-the-evidence-so-far/ (63) 

The Combination of Cannabidiol and 9-Tetrahydrocannabinol Enhances the Anticancer Effects of Radiation in an Orthotopic Murine Glioma Model. Mol.Cancer.Ther. 2014. http://mct.aacrjournals.org/content/13/12/2955 (64)

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Multiple Sclerosis

Summary

MS is the condition which has most commonly been associated with the therapeutic use of cannabis. It was the increasing illicit use of cannabis to treat MS that led to the House of Lords Science and Technology Committee inquiry in 1998. (76) The approval of Sativex (nabiximols) for the treatment of spasticity in MS is the first licensed cannabis medicine in modern times. (77) 

Most MS patients also suffer from chronic pain, for which evidence in respect of medicinal cannabis is set out above. 

A great deal of research has been carried out on cannabinoids in MS but much of it is fundamentally flawed by focusing on individual and/or synthetic cannabinoids, in particular the large scale CUPID trial used oral, synthetic THC (dronabinol). It is difficult to understand why this reductionist approach has been taken in view of evidence on the ‘entourage effect’ and that these studies were inspired by anecdotal reports of using whole plant cannabis. (10, 11, 12) 

There is a clear consensus amongst scientists and doctors that cannabis is safe and effective as a palliative treatment for MS. (78, 79, 80) Further promising research is underway into whether cannabinoids may have a curative effect by promoting repair of the myelin sheath. (81, 82, 83)


Organisations

National Multiple Sclerosis Society
Multiple Sclerosis Trust
Multiple Sclerosis Society UK

Patents

Trials

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Epilepsy

Summary

Organisations

Epilepsy Foundation
Epilepsy Action UK

Patents

A Pharmaceutical Composition Comprising The Phytocannabinoids Cannabidivarin (CBDV) And Cannabidiol (CBD)
http://www.faqs.org/patents/app/20140243405

Use Of The Phytocannabinoid Cannabidivarin (CBDV) In The Treatment Of Epilepsy
http://www.faqs.org/patents/app/20120004251

Use Of The Phytocannabinoid Cannabidiol (CBD) In Combination With A Standard Anti-Epileptic Drug (SAED) In The Treatment Of Epilepsy
http://www.faqs.org/patents/app/20140155456

Use Of One Or A Combination Of Phyto-Cannabinoids In The Treatment Of Epilepsy
http://www.faqs.org/patents/app/20120165402

Trials

Cannabinoids and Epilepsyhttp://www.ncbi.nlm.nih.gov/pubmed/26282273
http://www.ncbi.nlm.nih.gov/pubmed/25845492

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Anxiety and Depression

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Fybromyalgia

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Diabetes

Patents

New Use For Cannabinoids
http://www.faqs.org/patents/app/20110082195

Trials

2013 The Impact of Marijuana Use on Glucose, Insulin, and Insulin Resistance among US Adults: http://www.amjmed.com/article/S0002-9343(13)00200-3/abstract#/article/S0002-9343(13)00200-3/abstract

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Chronic and Neuropathic Pain

Summary

Chronic pain is the condition for which cannabis is most widely used. It seems to be particularly effective in neuropathic pain for which opioids, NSAIDs and other pharmaceutical medicines are not effective. It also appears to reduce the required dose when used in conjunction with opioids. (65) 

THC, CBD and other cannabinoids each have different effects both as analgesics and in the perception of pain. Patients commonly report that even if pain is not eliminated, cannabis helps them to deal with it by altering their perception and allowing them to focus elsewhere.

There is a large quantity of good quality evidence, including clinical trials with placebo controls, that demonstrate the efficacy and safety of cannabis in treating chronic pain. 

Organisations

Patents

Cannabinoids For Use In The Treatment Of Neuropathic Pain
http://www.faqs.org/patents/app/20140107192

Cannabinoid-Containing Plant Extracts As Neuroprotective Agents
http://www.faqs.org/patents/app/20140377382

Pharmaceutical Compositions For The Treatment Of Pain
http://www.faqs.org/patents/app/20110230549

Cannabinoids For Use In The Treatment Of Neuropathic Pain
http://www.faqs.org/patents/app/20120245224

Cannabinoid-Containing Plant Extracts As Neuroprotective Agents
http://www.faqs.org/patents/app/20100239693

Combination Of Cannabinoids For The Treatment Of Peripheral Neuropathic Pain
http://www.faqs.org/patents/app/20100035978

Cannabinoids for use in the treatment of Neuropathic pain
http://www.faqs.org/patents/app/20100016418

Cannabinoids For Use In The Treatment Of Neuropathic Pain

http://www.faqs.org/patents/app/20140378539

Trials

2007, Neurology “…52% of patients who smoked marijuana had a greater than 30% reduction in pain compared to 24% in the placebo group. In this study, smoked marijuana was well tolerated and effectively relieved chronic neuropathic pain…” (66) 

2007. Journal of Pain. “This study adds to a growing body of evidence that cannabis may be effective at ameliorating neuropathic pain, and may be an alternative for patients who do not respond to, or cannot tolerate, other drugs.” (67) 

2008. Neuropsychopharmacology “Smoked cannabis was generally well-tolerated and effective when added to concomitant analgesic therapy…” (68) 

2010. Canadian Medical Association Journal “Our results support the claim that smoked cannabis reduces pain, improves mood and helps sleep.” (69) 

2013. Neuropsychopharmacolgy “This study is the first to demonstrate the dose- and route-dependent analgesic effectiveness of cannabinoids for acute experimentally-induced pain in a pain-free population, evidence that supports the role of cannabinoids for the management of pain.” (70)

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IBD/Crohn's

Summary

Crohn’s disease, ulcerative colitis and other forms of inflammatory bowel disease (IBD) are widely and successfully treated with cannabis. (71) 

A clinical trial using cannabis extract to treat ulcerative colitis was concluded by GW Pharmaceuticals in 2014. (72) 

Anecdotally, there are many reports of dramatic improvements in symptoms shortly after cannabis use, e.g. cessation of rectal bleeding, increased appetite. 

Recent clinical trials have produced dramatic results with 50% of Crohn’s patients achieving complete remission and over 90% achieving substantial improvement. The evidence for the use of cannabis in Crohn’s and other forms of IBD is conclusive. 


Patents

Use Of Tetrahydrocannabinol And/Or Cannabidiol For The Treatment Of Inflammatory Bowel Disease
http://www.faqs.org/patents/app/20100286098

Therapeutic Uses Of Cannabigerol

http://www.faqs.org/patents/app/20100292345


Trials

2012. Digestion “Three months’ treatment with inhaled cannabis improves quality of life measurements, disease activity index, and causes weight gain and rise in BMI in long-standing IBD patients.” (73) 

2013. Clinical Gastroenterology and Hepatology “In this trial, cannabis induced clinical remission in 50% of patients. Taking into account that our participants had longstanding Crohn’s disease, with 80% nonresponse or intolerance to anti–TNF-a, this result is impressive.” (74) 

2014. Pharmacology “Cannabis sativa has lived up to expectations and proved to be highly efficient in cases of inflammatory bowel diseases… cannabis produces significant clinical benefits in patients with Crohn’s disease.” (75)

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Arthritis

Summary

Patents

Trials

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Alzheimer's Disease

Summary

Cannabis has proven anti-inflammatory and neuroprotective properties. Inflammation plays a major role in not only Alzheimer’s, but motor neurone disease, Parkinson’s, AIDS, dementia, multiple sclerosis, autism, schizophrenia, etc. 

The evidence is strong that regular, moderate use of cannabis helps to delay the onset and progression of Alzheimer’s disease and other neurodegenerative conditions. 

Organisations

alzheimers.net

Patents

Trials

2003. The US government holds patent US6630507, ‘Cannabinoids as antioxidants and neuroprotectants’: “…for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia.” (34) 

2006. THC has been shown to inhibit the progression of Alzheimer’s more effectively than any currently prescribed pharmaceutical product. (35) 

2007. British Journal of Pharmacology: “Cannabinoids offer a multi-faceted approach for the treatment of Alzheimer’s disease by providing neuroprotection and reducing neuroinflammation, whilst simultaneously supporting the brain’s intrinsic repair mechanisms...” (36) 

2012. Andras Bilkei-Gorzo of the University of Bonn: “…elevation of cannabinoid receptor activity either by pharmacological blockade of the degradation of cannabinoids or by receptor agonists could be a promising strategy for slowing down the progression of brain ageing and for alleviating the symptoms of neurodegenerative disorders.” (37) 

2012. Journal of Neuroinflammation: “The chronic administration of non-selective cannabinoids may delay the onset of cognitive deficits in AD patients; this will dramatically reduce the socio-economic burden of AD and improve the quality of life of the patients and their families.” (38) 

2014. Professor Gary Wenk, of Ohio State University: “…using low doses of marijuana for prolonged periods of time at some point in your life, possibly when you’re middle-aged to late middle-aged, is probably going to slow the onset or development of dementia, to the point where you’ll most likely die of old age before you get Alzheimer’s.” (39) 

2014. Steven Fagan of the University of Dublin: “Pharmacological modulation of the endocannabinoid system has been shown to reduce chronic activation of the neuroinflammatory response, aid in Ca2+homeostasis, reduce oxidative stress, mitochondrial dysfunction and the resulting proapoptotic cascade, while promoting neurotrophic support.” (40) 

2014. Chuanhai Cao of the University of South Florida: “These sets of data strongly suggest that THC could be a potential therapeutic treatment option for Alzheimer’s disease through multiple functions and pathways.” (41)
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Other Medical Indications

The International Association for Cannabinoid Medicines (IACM) maintains a database of clinical studies and case reports from 1970 to 2013. http://www.cannabis-med.org/studies/study.php (84) 

105 Peer-Reviewed Studies on Medical Marijuana. Medical Studies Involving Cannabis and Cannabis Extracts (1990 - 2012) http://medicalmarijuana.procon.org/view.resource.php?resourceID=000884 (85) 

The Medicalization of Cannabis. Wellcome Trust Witness Seminar, 2010 http://www.histmodbiomed.org/sites/default/files/44870.pdf (86) 

Emerging Clinical Applications For Cannabis & Cannabinoids. A Review of the Recent Scientific Literature. NORML, 2014. http://norml.org/pdf_files/NORML_Clinical_Applications_for_Cannabis_and_ Cannabinoids.pdf (87) 

What does marijuana do? It rebalances everything. Vipperman, 2014 https://michaelvipperman.wordpress.com/2014/04/20/what-does-marijuana-do-itrebalances-everything/ (88)
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References:

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3. All Trials campaign http://www.alltrials.net/find-out-more/
4. Extent of Non-Publication in Cohorts of Studies Approved by Research Ethics
Committees or Included in Trial Registries. PLOS 2014
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5. Archaeological Evidence for the Tradition of Psychoactive Plant Use in the Old World.
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21. Cannabinoid Science. Mechanism of Action. GW Pharma.
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22. Multiple Sclerosis Guidelines, 1.5.23, NICE, 2014
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23. Bedrocan BV website http://www.bedrocan.nl/english/home.html
24. Bedrocan Canada website https://bedrocan.ca/
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lung-cancer
32. Association Between Marijuana Exposure and Pulmonary Function Over 20 Years. JAMA,
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33. If cannabis caused schizophrenia--how many cannabis users may need to be
prevented in order to prevent one case of schizophrenia? Addiction, 2009.
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34. Patent: Cannabinoids as antioxidants and neuroprotectants, US 6630507 B1, 2003.
http://www.google.co.uk/patents/US6630507
35. A molecular link between the active component of marijuana and Alzheimer’s disease
pathology. Mol Pharm. 2006 http://www.ncbi.nlm.nih.gov/pubmed/17140265
36. Alzheimer’s disease; taking the edge off with cannabinoids? BJP, 2007.
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37. The endocannabinoid system in normal and pathological brain ageing, Phil.
Trans.R.Soc.B, 2012. http://www.medicinalgenomics.com/wp-content/uploads/2011/12/
Cannabinoids-and-Brain-Ageing.pdf
38. Can the benefits of cannabinoid receptor stimulation on neuroinflammation,
neurogenesis and memory during normal aging be useful in AD prevention? J
Neuroinflammation. 2012. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3284401/
39. How Smoking Marijuana Might Be The Best Way To Prevent Alzheimer’s Disease, Leaf
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preventalzheimers-disease/
40. The influence of cannabinoids on generic traits of neurodegeneration. British Journal of
Pharmacology, 2014. http://onlinelibrary.wiley.com/doi/10.1111/bph.12492/full
41. The potential therapeutic effects of THC on Alzheimer’s disease. J Alzheimers Dis. 2014.
http://www.ncbi.nlm.nih.gov/pubmed/25024327#
42. PubMed search term ‘cannabinoid cancer’
http://www.ncbi.nlm.nih.gov/pubmed?term=cannabinoid%20cancer
43. Cannabis and Cannabinoids. National Cancer Institute, 2014
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18 Medicinal Cannabis The Evidence
49. Physician’s documentation confirms successful treatment of basal cell carcinoma
resulted from the application of a topical cannabis extract. Cannabis Science,
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confirms-successful-skin-cancer-11517.html
50. Cannabis in Palliative Medicine: Improving Care and Reducing Opioid-Related
Morbidity. AM J HOSP PALLIAT CARE, 2011. http://ajh.sagepub.com/content/28/5/297
51. Third phase III Sativex cancer pain trial commences http://www.gwpharm.com/
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Pharmaceuticals%20Commences%20Phase%201b2a%20Clinical%20Trial%20%20
for%20the%20Treatment%20of%20Glioblastoma%20Multiforme%20GBM.aspx
53. Cannabinoids and cancer: potential for colorectal cancer therapy. Biochem Soc Trans.
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54. A pilot clinical study of Δ9-tetrahydrocannabinol in patients with recurrent glioblastoma
multiforme, British Journal of Cancer, 2006
http://www.nature.com/bjc/journal/v95/n2/full/6603236a.html
55. Cannabinoids for Cancer Treatment: Progress and Promise. Cancer Res. 2008.
http://cancerres.aacrjournals.org/content/68/2/339
56. Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells by Coordinating
the Cross-talk between Apoptosis and Autophagy. Mol Cancer Ther., 2011.
http://mct.aacrjournals.org/content/10/7/1161.long
57. The intersection between cannabis and cancer in the United States. CROH, 2011.
http://www.crohonline.com/article/S1040-8428(11)00231-9/fulltext
58. Cannabinoids: a new hope for breast cancer therapy? Cancer Treat Rev. 2012
http://www.ncbi.nlm.nih.gov/pubmed/22776349
59. Towards the use of cannabinoids as antitumour agents. Nat Rev Cancer. 2012
http://www.ncbi.nlm.nih.gov/pubmed/22555283
60. Cannabis Extract Treatment for Terminal Acute Lymphoblastic Leukemia with a
Philadelphia Chromosome Mutation. Case Rep Oncol. 2013.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3901602/
61. Non-hallucinogenic cannabinoids are effective anti-cancer drugs. Anticancer Research,
2013. http://www.sgul.ac.uk/news/news-archive/study-shows-non-hallucinogeniccannabinoids-
are-effective-anti-cancer-drugs
62. Cannabidiol as potential anticancer drug. Br J Clin Pharmacol. 2013.
http://www.ncbi.nlm.nih.gov/pubmed/22506672%20
63. Cannabis, cannabinoids and cancer – the evidence so far. Cancer Research UK, 2014.
http://scienceblog.cancerresearchuk.org/2012/07/25/cannabis-cannabinoids-andcancer-
the-evidence-sofar/
64. The Combination of Cannabidiol and 9-Tetrahydrocannabinol Enhances the Anticancer
Effects of Radiation in an Orthotopic Murine Glioma Model. Mol.Cancer.Ther. 2014.
http://mct.aacrjournals.org/content/13/12/2955
65. Medical Marijuana: Clearing Away the Smoke. Open Neurol J. 2012.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3358713/
66. Cannabis in painful HIV-associated sensory neuropathy: A randomized placebocontrolled
trial. Neurology, 2007. http://www.cmcr.ucsd.edu/images/pdfs/Abrams_2007.pdf
67. A Randomized, Placebo Controlled Cross-Over Trial of Cannabis Cigarettes in
Neuropathic Pain. J.Pain, 2007. http://www.cmcr.ucsd.edu/images/pdfs/Wilsey_2008.pdf
68. Smoked Medicinal Cannabis for Neuropathic Pain in HIV: A randomized, cross-over
clinical trial. Neuropsychopharmacology, 2008.
http://www.cmcr.ucsd.edu/images/pdfs/Ellis_2008.pdf
69. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ,
2010. http://www.cmaj.ca/content/182/14/E694.full.pdf+html
Medicinal Cannabis The Evidence 19
70. Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily
Marijuana Smokers. Neuropsychopharmacology, 2013.
http://www.nature.com/npp/journal/v38/n10/full/npp201397a.html
71. Cannabis use amongst patients with inflammatory bowel disease. Eur J Gastroenterol
Hepatol. 2011. http://www.ncbi.nlm.nih.gov/pubmed/21795981
72. A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis. GW
Pharma, 2014. https://clinicaltrials.gov/ct2/show/NCT01562314
73. Impact of Cannabis Treatment on the Quality of Life, Weight and Clinical Disease
Activity in Inflammatory Bowel Disease Patients: A Pilot Prospective Study. Digestion,
2012. http://www.karger.com/Article/Abstract/332079
74. Cannabis Induces a Clinical Response in Patients With Crohn’s Disease: A Prospective
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