There has been much scientific research using CBD. We at Pureis® Academy have summarised some of the scientific studies and what CBD was being assessed for. We have presented this data in the below table; please note this is not an exhaustive list. We at Pureis® Academy need to point out these are scientific studies and not clinical trials. In order to have a proven therapeutic benefit, a medicine licence must be issued by a respective medicine authority.

In June 2018, the US Food and Drug Administration (FDA) approved the first oral solution drug (Epidiolex®-a purified form of CBD oil) comprised of CBD as an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Under orphan approval status Epidiolex® was approved in Europe on the 19th of September 2019 for treating two types of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. There is no other pure CBD approved as a licensed drug at this time.

 

Table 1. Various research topics published in scientific journals using CBD 

Research topic that was investigated 

Scientific paper

Anxiety

Lemos et al., 2010, Almeida et al., 2013, Shannon et al., 2016 Crippa et al., 2011, Blessing et al., 2015

Cancer

Rocha et al., 2014, Ramer et al., 2014

Cardiovascular diseases

Durst et al., 2007, Booz 2011

Depression

El-alfy et al., 2010, Hsiao et al., 2012, Shoval et al., 2016

Diabetic complications

Weiss et al., 2006, Rajesh et al., 2010

Epilepsy

Maa 2014, Cilio et al., 2014, Millar et al., 2019

Huntington’s disease

Iuvone et al., 2009, Sagredo et al., 2011

Hypoxia ischemia injury

Pazos et al., 2012, Hayakawa et al., 2007

Inflammatory bowel and Chron’s diseases

Sacerdote et al., 2005, De Flilippis et al,. 2011

Inflammatory diseases

Ribeiro et al., 2012, Mecha et al., 2012

Insomnia

Shannon et al., 2016, Shannon et al., 2019

Nausea

Parker et al., 2002

Pain

Crippa et al., 2015, Gomes et al., 2015, Notcutt et al., 2004

Parkinson’s disease

Zuardi et al., 2009, Khoury et al., 2016

Rheumatoid arthritis

Malfait et al., 2000

Schizophrenia

McGuire et al., 2017, Mannucci et al., 2017

These scientific studies presented are not an exhaustive list.

 

The variance in CBD strengths are the distinguishing factor between the different therapeutic indications.

CBD produces a biphasic response with different doses of CBD. Dosing is closely related to weight and is reported mg/kg/day. Using the global average body mass of 62kg (adult) the same conversion rate is used to convert mg/day. For example, 1mg/kg/day is equivalent to 62mg/day for an average adult. Various scientific literature shows therapeutic CBD doses ranging from 1mg/kg/day to 50/mg/kg day. A summary of therapeutic benefits linked to defined CBD doses are presented in Table 2.

 

Table 2. Various therapeutic benefits published in scientific journals using CBD 

Therapeutic benefits using CBD

Reported dose*

Scientific paper

Anxiety

1mg/kg/day or less

Daily dose of 25mg-75mg

Shannon et al., 2016, Shannon et al., 2019

Cardiovascular diseases

5mg/kg ip

Durst et al., 2007, Booz 2011

Depression

15, 30 and 45mg/kg

Shoval et al., 2016

Epilepsy

10mg/kg/day up to 50mg/kg/day 

Millar et al., 2019

Hypoxia ischemia injury

1mg/kg CBD

Pazos et al., 2012

Inflammatory bowel and Chron’s diseases

10mg/kg

De Flilippis et al., 2011

Insomnia

Daily dose of 25mg-75mg

Shannon et al., 2016, Shannon et al., 2019

Pain

0.4mg/kg/day up to 22.5mg/day

Notcutt et al., 2004

Parkinson’s disease

1.25mg/kg/day to 7mg/kg/day

Khoury et al., 2016

Rheumatoid arthritis

25mg/kg/day

Malfait et al., 2000

Schizophrenia

1000mg daily dose

McGuire et al., 2017

*Doses may range from other scientific journals available in the public domain.

 

CBD drug interactions 

CBD can interfere with the breakdown of certain prescription medicines; this is due to the way in which CBD is metabolised. CBD is metabolised by the cytochrome P450 enzymes, principally CYP3A4 and CYP2D6, and therefore may interact with other prescription medicines that interact with these liver enzymes. The majority of studies that have been assessed for drug interactions used anti-epileptic drugs; for example, CBD was administered at 5mg/kg/day and increased every two weeks up to a maximum dose of 50mg/kg/day with the co-administration of common anti-epileptic drugs such as topiramate, rufinamide and N-desmethylclobazam, decreases in Clobazam serums levels as CBD doses increased. While CBD is reported to have minimum adverse events, the potential for drug-drug interaction should be considered based on the patient medication history.

 

Natural CBD and synthetic CBD 

To isolate CBD solely from a plant is difficult. Whether the product is naturally grown or derived in a laboratory setting, to claim CBD content it does require laboratory intervention. There are various ways of manufacturing CBD as summarised below. The methodology will vary, so may the composition of the products and extracts. This in turn should be taken into consideration in the risk assessment of plant-based CBD products.

To derive CBD from plant sources the following extraction techniques are available.

  • Using liquid solvents such as alcohols 
  • Supercritical fluid extraction
  • CO2 extraction
  • Oil extraction
  • CBD nano-delivery
  • Decarboxylation

Synthetic cannabinoids are manufactured artificially and are designed to mimic the DNA of CBD in the plant.

There is a growing trend towards synthetically derived CBD for the following reasons:

  1. No reliance on weather or soil conditions which affect yield.
  2. No intra batch variability.
  3. Free from pollutants (insecticides or pesticides).
  4. Scalable, no shortages.
  5. Free from other cannabinoids and terpenes that are practically impossible to remove from the plant, all having their side effects profile.
  6. Ultra-pure CBD (selectivity and guaranteed purity).
  7. More control process in eliminating the presence of THC.
  8. Synthetic CBD is produced under chemical process; it must be synthesised in a pharmaceutical plant which assures the raw material has been produced under the highest quality level possible.
  9. Guaranteed no psychoactive properties. CBD is available in two common forms: (-)-CBD and (+)-CBD. (-)-CBD only stimulates the CB2 receptor (primarily expressed on immune cells). (+)-CBD has affinity for both receptors and has the potential to display effects similar to THC (psychoactive response). With synthetic you can carefully design the correct negative enantiomer (-)-CBD compound therefore being CB2 selective to guarantee no psychoactive effects.
  10. Odourless; there are pungent smells from the plant – this is likely due to the presence of terpenes – and this will affect the taste of the product, therefore impacting patient compliance.
  11. No risk of contamination of plant impurities using synthetic raw material. With plant-based material, other cannabinoids and terpenes can come through; these have been major issues (there are scientific journal summaries which outline these issues).

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