Myths in the Field of Medical Cannabis /
Dr. Joshua (Shuki) Aviram

1. Medical cannabis must be smoked for the treatment to be effective:

To date, no scientific clinical article has been published showing that a particular route of administration of cannabis has better efficacy than another.

Today, two routes of administration of medical cannabis are allowed in Israel¹ – the first is medical cannabis extract mixed with olive/coconut oil. This route of administration was reported in a study conducted among patients suffering from chronic pain in Israel to be associated with higher side effects than vaping/smoking infloresence². The second is medical cannabis inflorescences sold either as ready-made cigarettes (“pre-rolled”) or as whole flowers, from which patients can roll cigarettes for themselves for smoking by mixing tobacco with the medical cannabis, smoke them using a bong, or vaporize them using one of the hundreds of types of vaporizers available on the market (only two of which are approved for use by the Ministry of Health) – at variable temperatures according to the patient’s discretion. Due to the multitude of “strains” available on the market and the consumption of several “strains” at the same time each month and in varying amounts, it is extremely difficult to discern the effect of a specific cannabis “strain”³.

Also included in the category of medical cannabis inflorescence is Syqe® Medical’s SyqeAir Inhaler for precise and metered-dose administration of medical cannabis by inhalation. This inhaler contains a single strain (Bedrocan®) which is imported from the only medical cannabis company in the Netherlands (Bedrocan) and enables precise control of the amount of tetrahydrocannabinol (THC) that is evaporated into the patient’s oral cavity in low doses (micro-dosing) up to about 79 times lower than the inhaled daily dose of THC in patients who consume medical cannabis inflorescence by smoking/vaping³. The SyqeAir Inhaler was studied in four different clinical trials as well as real-world data and was found to be easy to use, effective, and safe^4,6.

2. Treatment with medical cannabis is only suitable for chronic pain:

There are several indications for which a patient can obtain a license for the treatment of medical cannabis in Israel, according to Protocol 106 of the Medical Cannabis Unit (YAKAR) of the Ministry of Health¹. Patients who can obtain a license for medical cannabis treatment:

• In the oncology field (cancer), patients with “an active oncological disease, or going through active antineoplastic (anti-cancer) treatment to alleviate the symptoms of the active disease or the side effects of the active treatment.”
• In the gastroenterology field (diseases of the digestive system), “patients suffering from an active and proven inflammatory disease (Crohn’s Disease or Ulcerative Colitis).”
• In the field of pain, “patients suffering from neuropathic pain of definable organic origin.”
• In the infectious diseases field, “patients diagnosed with acquired immunodeficiency syndrome (AIDS)… suffering from extreme weight loss.”
• In the neurology field (nervous system diseases), “patients diagnosed with Multiple Sclerosis in spastic conditions (muscle stiffness)”, “patients diagnosed with Parkinson’s Disease, suffering from chronic pain or pain caused by rigidity (muscle stiffness)”, “elderly patients diagnosed with Tourette Syndrome, suffering from a significant functional disorder in their daily life”, “adult patients suffering from epilepsy”, and “young patients suffering from severe and uncontrollable epilepsy”.
• In the palliative care field (supportive care for relieving symptoms), “terminal patients with an estimated life expectancy of up to six months.”
• In the psychiatry field, “adult patients diagnosed with post-traumatic stress disorder (PTSD),” and according to the most recent addition to the Protocol from January 2017, in the field of behavioral disorders related to autism spectrum disorder, “patients over the age of 5 diagnosed with an autism spectrum disorder.”

For all these indications except for the oncology and palliative fields, many conditions and stipulations have to be met before applying for a medical cannabis license that require the exhaustion of acceptable drug treatment in the relevant field and that take into consideration the duration of the illness and treatment.

3. There are two types of medical cannabis – Indica and Sativa, and each of them has a different clinical/physical effect:

There are claims that have not yet been backed up by clinical studies but are supported by the guidelines of Protocol 106 of the YAKAR (The Green Book)¹ that don’t include references, that “strains” from a genetic origin of Sativa are stimulants – stimulate appetite, creativity, reduce depression, and are recommended for use during the day. This is in contrast to the claims that “strains” of a genetic origin of Indica are relaxing – reduce anxiety, sedating, relieve pain, and are recommended for use at night.

Only one study conducted in the Netherlands on Coffee Shop’s strains and medical cannabis strains showed a slight difference in the terpene content between strains of the genetic origin of Sativa and strains of the genetic origin of Indica⁸; however, the researchers reported that the strains compared were not pure but actually hybrid, therefore, to test this properly, it is necessary to conduct a study on strains with pure genetic origin.

Also, the various growers in Israel name hybrid strains as Sativa or Indica according to their assessment of which genetic origin is more dominant in the specific “strain”. Furthermore, no clinical research has yet been conducted on the question of the different clinical effects of the genetic origin of the cannabis “strains”.

4. Medical cannabis oil administered sublingually is absorbed directly into the bloodstream from the mucosa of the oral cavity and is safer than the administration of inflorescences via vaping/smoking:

Since cannabinoids are lipophilic substances (having an affinity for lipids such as fats) and are being dissolved in olive/coconut oil for medical treatment purposes, their sublingual absorption directly into the blood circulation, which is supposed to be fast in an area with as many blood vessels as under the tongue is limited, and it is estimated that in practice, most of the oil is swallowed and enters the digestive system. This can be seen, for example, in a study in which two types of medical cannabis oils were administrated (one THC-rich and the other with an equal ratio of THC and CBD)⁹.

This study showed that the blood level of THC and CBD in blood tests reached the maximum after three hours or more. Also, the researchers reported a significant rate of side effects: about 67% of the subjects who were administrated THC-rich cannabis oil reported experiencing side effects, and about 75% of the subjects who were administrated cannabis oil with an equal ratio of THC and CBD reported experiencing side effects. These side effects were mainly related to the digestive system – a finding indicating that a large amount of cannabis oil probably goes directly into the digestive system.

In comparison, the clinical study conducted on patients who inhaled the highest dose of 1,000 mcg using the SyqeAir Inhaler reported a lower rate of side effects of 66%⁶, with minimum side effects related to the digestive system.

5. Tetrahydrocannabinol (THC) is the primary psychoactive cannabinoid, while cannabidiol (CBD) is not psychoactive at all and even moderates the psychoactive effects of THC:

This concept has become deeply rooted in the understanding of physicians and patients based on very preliminary findings, some of which have shown that high-dose CBD can inhibit the effects of THC, while other studies have shown that CBD actually increases the effects of THC¹⁰. In addition, in a recent study from 2021 on Israeli patients who consumed medical cannabis via vaping/smoking, it was actually found that among the patients who consumed, among other things, high doses of CBD and relatively low doses of THC reported more psychoactive side effects, while among patients who consumed the highest doses of THC (relatively) and very low doses of CBD, have not reported any psychoactive side effects after a year-long treatment³. All of this does not even take into account that the cannabis plant contains over a hundred cannabinoids¹¹ and over 90 terpenes¹², which have been biologically proven, and they may have caused some of the clinical effects observed.

6. Different THC/CBD ratios in medical cannabis strains have been proven to be optimally effective in different diagnoses:

According to the YAKAR guidelines in Protocol 106 (The Green Book)¹, there are guidelines (for which there are no references to support) for prescribing medical cannabis products with varying THC:CBD ratios according to the different types of diagnoses mentioned in Section 2. This only has two exceptions:

One is a study that tested one specific type of cannabis (CBD-rich cannabis oil) and showed subjective efficacy (using questionnaires), yet not objective effectiveness (in endoscopic tests), for the treatment of Crohn’s inflammatory bowel disease¹³ – but it did not compare it to THC-rich cannabis oil, for example.

The second is a feasibility study of the treatment of behavioral disorders related to autistic spectrum disorder with CBD-rich cannabis oil and cannabis oil distilled to an equal CBD:THC ratio without the other ingredients of the plant, which had not observed an improvement in the main indices but had observed an improvement in some of the secondary indices. The researchers concluded that although there were no significant side effects to the treatment (mainly drowsiness and decreased appetite), the evidence for the effectiveness of the treatment is insufficient¹⁴.

The rest of the studies conducted in Israel on chronic pain^2,15, fibromyalgia¹⁶, Parkinson’s disease¹⁷, and oncological diseases^18,19 studied patients who independently selected the combination of medical cannabis “strains” they consumed. Therefore it was impossible to decipher which specific medical cannabis “strain” was effective for each indication.

To illustrate this, a study on oncology patients showed that after one month from the beginning of their treatment¹⁹, a comparison was made between three groups: 1) patients who consumed only THC-rich medical cannabis “strains”, 2) patients who consumed only CBD-rich medical cannabis “strains”, and 3) patients who consumed equal THC:CBD ratio medical cannabis “strains” or combined THC-rich and CBD-rich medical cannabis “strains” in the course of the same month. No difference has been demonstrated between the groups in the rate of side effects nor in the improvement of most indices. However, a relatively high increase in sleep duration was found among the patients who only consumed THC-rich medical cannabis “strains”, and also a better improvement in the physiological symptoms of cancer among patients who only consumed CBD-rich medical cannabis “strains”. In conclusion, because not all existing THC:CBD ratios have been tested, it is impossible to definitively determine which ratio is likely to have more effectiveness or a lower rate of side effects.

*Dr. Joshua (Shuki) Aviram is the Clinical Research Director at Syqe®.

The article was published on e-Med website on July 6th, 2021. Link to the article in Hebrew>>

References:

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