Tag: CBD (page 1 of 7)

CBD Shown to be Effective for Treating Schizophrenia in Randomized Controlled Trial

Cannabidiol has been shown to have beneficial effects for the treatment of schizophrenia in a study conducted by a wide variety of organizations. This is promising for sufferers of the condition and good news for cannabis, which has received a lot of negative press and coverage regarding THC and its possible effects on schizophrenia.

The study is: “Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial.”

The various organizations involved with the findings are:

The study, an “8-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial was conducted at 15 hospital sites in the U.K., Romania, and Poland” where patients were either given 1,000 mg/day of CBD orally in two doses, or a placebo.

The results were clear that CBD was effective in the “Positive and Negative Syndrome Scale” or PANSS score:

CBD Showing Positive PANSS Results

CBD Shows Positive PANSS Results

The changes over the course of the treatment also clearly showed improvements for those taking CBD over a placebo in their Clinical Global Impressions severity scores:

CBD Better than Placebo in Clinical Global Impressions Severity Scores at End of Treatment

CBD Better than Placebo in Clinical Global Impressions Severity Scores at End of Treatment

There have been a number of studies on cannabis and schizophrenia over the years, with much attention paid to the possibly exacerbating effects of THC on the condition. This study doesn’t provide guidance to start using cannabis as treatment for schizophrenia, but it does show promise for CBD as a treatment.

“This is, to our knowledge, the first placebo-controlled trial of CBD in schizophrenia. The data indicate that 6 weeks of treatment adjunctive to antipsychotic medication was associated with significant effects both on positive psychotic symptoms and on the treating clinicians’ impressions of improvement and illness severity. There were also improvements in cognitive performance and in the level of overall functioning, although these fell short of statistical significance.”

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FDA Sends Warning Letters to CBD Product Brands with GW Pharmaceuticals Links

Warning letters have been sent to four cannabidiol (CBD) product brands as the FDA makes good on their promises from a month ago.

The brands that received these warning letters are:

The letters take issue with a number of different violations and give each company 15 days to respond. Happy Halloween.

In each letter, the FDA spells out how they take issue with stating treatment for any type of illness or condition. Whether it is bipolar disorder, cancer, autism, or anything in between.

“Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”

Additionally, the FDA took issue in many complains regarding the fact that there were no “adequate directions for use.”

“A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.”

Three of the four letters contain reference to GW Pharmaceuticals and their clinical trials for Sativex and Epidolex with the letter to the Stanley Brothers going into the most detail:

“The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex[1] Under FDA’s regulations [21 CFR § 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue. . FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.”

The links to the GW Pharmaceuticals references are:

The letters came from three different parties with two from Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV, one from Maridalia Torres-Irizarry Director San Juan District Program Division Director OHAFO IV East, and one from Darla R. Bracy, District Director Office of Human and Animal Food Division 5 West.

These are some of the clearest indications of desire for control of labeling from the federal government as CBD products begin to hit shelves and get quickly pulled from them as well.

These letters also come just one day after GW Pharmaceuticals made a significant announcement. From GW Pharmaceuticals and Its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome:

“The submission of the Epidiolex NDA is an important milestone for patients with LGS and Dravet syndrome in that a potential new treatment option is within sight for these very difficult to treat and devastating conditions,” stated Justin Gover, CEO of GW Pharmaceuticals. “On behalf of all those patients, clinicians and GW employees who have supported the Epidiolex program, we are pleased to submit this promising therapy for FDA review and we look forward to working with the FDA throughout the review process. This regulatory submission is a demonstration of GW’s commitment to developing innovative cannabinoid-based treatments that have the potential to address significant unmet medical needs.”

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Recipe: Anti-Inflammatory Turmeric CBD Tonic

This article was originally published by the editorial team at GetSava.com.

Based on the Ayurvedic recipe for “Golden Milk”, this tea combines turmeric, ginger, coconut oil, honey, and CBD to provide relief from inflammation, arthritis, sore muscles, hangover, and a range of other maladies.

turmeric-300x300

Turmeric has long been used in South Asia for its anti-inflammatory and antioxidant properties.

On the Japanese island of Okinawa – where the population has one of the longest average lifespans – turmeric tea is a staple of daily life. In India, turmeric was first used in food and was then discovered to have a range of medicinal benefits – antiseptic, anti-inflammatory detoxifying.

It has also been shown to prevent and reverse the effects of Alzheimer’s,[1] and is currently being studied for its anti-cancer effects.

curcumin

Curcumin, the ingredient in turmeric that makes it yellow and gives it spice, is what science attributes many of its healing properties. In order for your body to absorb the curcumin, it is paired with both a fat and with black pepper.

black-pepper

Piperine, a compound found in black pepper, has been shown to increase the bioavailability of otherwise hard to absorb curcumin by 2000%.[2] Without the piperine, curcumin is metabolized in the liver and intestinal wall. When I make this tonic, I either add in or leave out black pepper based on how I feel.

If I want my liver and intestinal wall to receive the benefits – maybe after a large rich meal or one too many glasses of wine – I leave the pepper out.

If I want relief from joint or muscle pain or want my entire body to reap the effects, I add pepper in. Fat also assist with absorption,[3] hence coconut oil which has its own host of benefits.

Ginger-Root-Benefits

Ginger, another powerful root with a big reputation, has been shown time and time again to have strong anti-inflammatory properties without the side effects of pharmaceuticals[4] as well as anti-oxidative and anti-cancer effects.[5], It has also long been used to soothe the digestive system.

cbd

Cannabidiol, also known as CBD, is an important medicinal cannabinoid that produces no “high.” CBD relieves pain and anxiety, and research has shown it to have antibacterial, anti-convulsive, anti-carcinogenic, anxiolytic, antidepressant, analgesic, antiemetic, anti-inflammatory, anti-ischemic, antispasmodic, antipsychotic, anti-insomnia and neuroprotection properties.

Screen Shot 2016-06-08 at 2.15.06 PM

Mix all of this together with a spoonful of honey and you have a delicious health tonic that can be used for specific ailments or as an everyday preventative medicine.

Ingredients

  • ½ to 1 inch of turmeric root (or a tsp of turmeric powder)
  • ½ to 1 inch of ginger root
  • 1 tsp coconut oil
  • 1 cup of your favorite milk (almond or hemp is delicious!)
  • 1 cup of warm water
  • 2 tsp honey
  • Sprinkle of black pepper
  • Drops of high CBD tincture

How-To

Warm the milk. Add all other ingredients to a blender. Combine in your favorite mug and enjoy!

Alternately, all ingredients can be blended together cool and served over ice.

This can be made in a larger batch and store in your refrigerator for several days or you can combine all ingredients, aside from milk and water, into a paste that you keep for up to a week adding to hot water and milk when you want a cup. Adjust the honey, pepper, ginger, and turmeric depending on your flavor preferences – whether you like things spicy or sweet – and drink to good health.

High CBD Tinctures

All of these high CBD tinctures are currently available from GetSava.com.

  • 20:1 High CBD Tincture by Treatwell

    350_42c9729346d04e3c63b4bce64869bd4f4e7e5ed9_fitThis extremely high quality tincture is made from top shelf flowers only to provide the widest spectrum of useful cannabinoids and terpenes possible. This tincture is non-psychoactive and targets neurological issues. Patients have found this tincture useful for anxiety, migraines, cerebral palsy, depression, menstrual cramps, muscle soreness, epilepsy, mild arthritis, parkinson’s and restless leg syndrome.

  • 3:1 Recover Tincture by Moxie Meds

    350_8c8efec2b45adff638a11a5d6458505ac93632d9_fitRecover 4:1 Tincture minimizes stress and tension, levels out emotional swings, and reduces inflammation all with little to no psychoactivity. Formulated for women by women, Moxie Med tinctures combine MCT oil and full cannabis plant extract to provide the best possible medications for menstrual cramps, hormone-related stress, menopausal symptoms, and other reproductive concerns.

  • 3:1 CBD Tincture by TreatWell

    450_fbe2bda6df8cbe6086b0633de88ee2c4b285bf61_fitThis extremely high quality tincture is made from top shelf flowers only to provide the widest spectrum of useful cannabinoids and terpenes possible. This tincture is low to non-psychoactive and targets auto-immune conditions. Patients have found this tincture useful for IBS, crohn’s disease/colitis, mild inflammation and pain relief, arthritis, multiple sclerosis and breast cancer.

References

[1] Mishra S, and Palanivelu K. The effect of curcumin (turmeric) on Alzheimer’s disease: An overview. Ann Indian Acad Neurol. 2008 Jan-Mar; 11(1): 13–19. DOI: 10.4103/0972-2327.40220

[2] Shoba G, Joy D, Joseph T, Majeed M, Rajendran R, Srinivas PS. Influence of piperine on the pharmacokinetics of curcumin in animals and human volunteers. Planta Med. 1998 May;64(4):353-6.

[3] Sahdeo P, Tyagi AK, Aggarwal BB. Recent Developments in Delivery, Bioavailability, Absorption and Metabolism of Curcumin: the Golden Pigment from Golden Spice. Cancer Res Treat. 2014 Jan; 46(1): 2–18. DOI: 10.4143/crt.2014.46.1.2

[4] Grzanna R, Lindmark L, Frondoza CG. Ginger–an herbal medicinal product with broad anti-inflammatory actions. J Med Food. 2005 Summer;8(2):125-32.

[5] Mashhadi NS, Ghiasvand, R, Gholamreza A, Hariri M, Darvishi, and Mofid MR. Anti-Oxidative and Anti-Inflammatory Effects of Ginger in Health and Physical Activity: Review of Current Evidence. Int J Prev Med. 2013 Apr; 4(Suppl 1): S36–S42.

This article was originally published on GetSava.com. For the most up to date info on Cannabis Reports, follow us on Twitter, and like us on our Facebook page.

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