Treatment with CBD

Cannabidiol as a prescription medicine

This article describes a clinical audit study of 400 patients who received cannabidiol as a prescription medicine from their physicians in New Zealand. What are the indications, patient quality of life, patient satisfaction, and dosage levels in this patient population? We discuss the following:

Cannabidiol as a prescription medicine in New Zealand

In 2017, cannabidiol became a legal prescription medicine in New Zealand.  As such, doctors in New Zealand now have the legal right to prescribe CBD products that contain less than 2% THC.

This attitude and practice of New Zealand lawmakers and health care providers recognize the potential of CBD as a medicine outside the indications that the FDA in the USA has approved. Indeed, CBD has tremendous potential as a medicine to treat a number of health conditions, including a range of inflammation- and psychiatry-related conditions.

In addition, many studies show that CBD is very safe: patients tolerated CBD well even in doses of 6000 mg/day. Despite all this promising evidence, there are only very few clinical trials assessing both the effect and the safety of CBD.

Participating patients for CBD prescription

The study assessed 400 patients to whom their doctors prescribed CBD during a year between December of 2017 and December of 2018. The CBD oil had a concentration of 100 mg/mL in a 25 mL bottle, which had an oral dropper. The bottles cost about USD 300 each. While the law in New Zealand makes CBD prescribing possible, health insurance does not cover the cost of CBD.

The gender distribution of patients was about equal (54% women and 46% men), and the average age was 51.5 years. About 15% would have fit more than one symptom category, and therefore was assigned to the one with the most serious symptom (primary condition).

Symptoms treated with CBD

The doctors assessed patients based on the following categories:

  • non-cancer chronic pain symptoms (46%),
    • fibromyalgia,
    • osteoarthritis,
    • rheumatoid arthritis,
    • neuropathic pain,
    • chronic non-specific pain,
    • pain due to ulcerative colitis, and
    • migraines
  • neurological symptoms (15%),
    • Parkinson’s disease,
    • multiple sclerosis,
    • epilepsy,
    • autism spectrum disorder with challenging behavior,
    • amyotrophic lateral sclerosis,
    • multiple system atrophy,
    • various neuropathies, and
    • tremors
  • mental health-related symptoms (16%),
    • anxiety disorders,
    • depressive disorders,
    • post-traumatic stress disorder, and
    • insomnia
  • cancer symptoms (23%)
    • pain,
    • nausea,
    • poor appetite,
    • emotional distress, and
    • adverse effects of radiotherapy and/or chemotherapy treatment

If a patient fit into several categories, the doctor assigned them into the category in which they had the most severe symptoms.

Patient symptoms in a clinical audit study of 400 patients who received cannabidiol as a prescription medicine from their physicians in New Zealand.

Follow-up assessment of CBD as a prescription medicine

Of the 400 patients, 253 (64%) either came back for follow-up appointments or talked to the clinic over the phone. Of these, 250 (almost all of those who were followed up) reported that they were satisfied with taking CBD. Overall, 110 patients completed a before-and-after follow-up assessment.

Altogether 62 patients (16% of the total and 25% of those who were available for follow-up) reported that they stopped taking CBD. These were their reasons:

  • death
  • CBD oil was too expensive
  • severe illness
  • they started participating in a clinical trial, which did not allow them to take anything else
  • they started taking other (albeit illicit) cannabis products for their condition instead of CBD

Outcomes of CBD treatment as prescription medicine

The following table summarizes the outcome results for those 110 patients that had filled out their before-and-after follow-up questionnaires. 

Please note that in life sciences statistical tests show a probability, and not a certainty. In statistics, something is considered significant if the calculated probability of that event happening by chance is less than 5%.

Meaningful means that there is a considerable difference between the before and the after scores.

Notations:

  • N/N: Neither significant nor meaningful means that there was no effect.
  • S: Statistically significant but not meaningful means that statistical tests showed that the results were not due to chance, but the difference is too small to mean anything.
  • M/S: Both meaningful and significant means that there was a big enough difference and it was not due to chance, but most probably due to the effect of CBD.
The following table summarizes the outcome results for those 110 patients that had filled out their before-and-after follow-up questionnaires.
Effects and benefits of CBD among patients

Please note that this was a very small sample. The larger a sample, the more likely it is that an observer will detect a difference in before-and-after scores. We do not know if, for example, the group of the neurological patients had contained more patients, we would have detected an effect of CBD.

Side effects and dosage

Only few patients experienced side effects, which were:

  • Positive:
    • improved sleep (31 patients)
    • improved appetite (7 patients)
  • Negative
    • sedation (5 patients)
    • vivid dreams (5 patients)
    • emotional disturbances (being irritable, depressed, anxious – 5 patients)
    • disorientation (3 patients)
    • sleeplessness (1 patient)
    • nausea (1 patient)
    • constipation (1 patient)
    • diarrhea (1 patient)
    • headaches (1 patient)
    • mouth irritation (1 patient)
    • hallucinations (1 patient)

While the physician recommended a dose of at least 100 mg/day, the actual dose that patients took varied between 40-300 mg/day. However, there was no association between dosage and benefits. This suggests that in this patient population the beneficial effect of cannabidiol as a prescription medicine was dose independent.

Conclusions

Even though this study assessed the effect of cannabidiol as a prescription medicine in New Zealand among a small group of patients, it showed that CBD has promising effects and a potential as a medicine. While future studies are obviously needed to confirm and augment these findings, this study is a very important piece of evidence testifying for the medicinal benefits of CBD. Unfortunately, however, price may be a barrier to patients who want to take CBD. The fact that doctors in New Zealand can now prescribe CBD to their patients may be the first step towards insurance coverage – and an example for other countries as well.

Reference

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