World-first NZ study shows CBD can ease anxiety, chronic pain

A new study of the first 400 patients in New Zealand assessed for medical cannabis suggests potential benefits for thousands of people beyond currently recognised uses.



The study, a collaboration between the University of Auckland and GP Dr Graham Gulbransen, who opened the first medical cannabis clinic in New Zealand, examined the records of 400 patients assessed for treatment at Dr Gulbransen’s west Auckland clinic Cannabis Care.


Summary

  • Throughout 2018, 400 patients were assessed at Cannabis Care Clinic in Auckland for medicinal cannabis.

  • 397 were prescribed 100mg per ml strength CBD oil taken by mouth.

  • Patients were categorised as having chronic pain (46%), emotional distress (16%), neurological symptoms (15%) or cancer symptoms (23%).

  • The results section of the paper details some of the conditions treated.

  • The mean age was 51 years old.

  • 63% of patients were reviewed after about a month of CBD, leaving 37% who did not attend follow-up.

  • Validated 'Quality of Life' questionnaires were completed at first and follow-up consultations.

  • Follow-up patients showed a 13.6% mean improvement in quality of life. This was statistically significant (many reported CBD was ‘life-changing’). This applied to all 4 categories of illness, see above.

  • Also statistically significant were improvements in chronic (long term, or more than 3 months) pain and emotional distress, such as depression and anxiety. In detail, chronic pain patients reported improvement in mobility, ability to complete usual tasks, pain, anxiety and depression. Emotionally distressed patients reported improvement in their ability to complete their usual activities, as well as pain, anxiety and depression. Patients with cancer symptoms reported improvement in pain.

  • 44% of 397 reported that CBD provided good to excellent relief. This equated to 70% of those who attended follow up.

  • There were no major adverse effects. About 10% reported one of these unwanted side effects: sedation, vivid dreams, worsening of pre-existing condition, emotional disturbance, insomnia, nausea, diarrhoea, headaches, oral irritation, hallucinations.

  • CBD is safe and often beneficial for patients with intractable conditions not improved with standard medical treatments, such chronic (long-term) pain, emotional distress, cancer and neurological symptoms.

  • This audit was self-funded with support from University of Auckland statisticians and student summer scholarship. Resources did not allow for longer term follow up.


Products containing cannabidiol (CBD) oil, an active compound derived from the cannabis plant which does not give people a ‘high’, were legalised for prescription by doctors in New Zealand in 2017.


CBD is FDA-approved for the treatment of two childhood seizure disorders, but early evidence suggests it could also help treat anxiety and chronic pain, and may reduce psychotic symptoms of schizophrenia. Due to a lack of large-scale, controlled studies in humans, there are no prescribing guidelines.


Dr Graham Gulbransen

The new study found that CBD oil taken for four weeks significantly improved the self-reported quality of life most for patients living with non-cancer chronic pain and anxiety-related mental health conditions. Patients with cancer or neurological symptoms also experienced improved quality of life, but to a lesser degree. Because symptom assessments were subjective, it is not possible to determine how much of this was due to placebo effect.


“Our findings show that CBD is well-tolerated in most patients and can markedly ease symptoms in a range of hard-to-treat conditions, and that there are people keen to access this and self-fund the medication (about $300 per month),” says Professor Bruce Arroll, senior author in the study and head of the Department of General Practice and Primary Healthcare at the University of Auckland.

“The study has limitations due to drop-out and other factors, but the findings are consistent with other evidence and underline the need for more research to allow us to fully realise the therapeutic potential of medical cannabis.”


Professor Bruce Arroll

Of the first 400 patients, 397 received a prescription for CBD. Slightly more patients were female (214 or 54%) than male (183 or 46%). Patients were asked to rate their own pain, anxiety, debility, and depression across different areas of their lives before taking CBD, and then four weeks after starting the treatment. They were also asked to also rate satisfaction with CBD after four weeks. Just over a quarter, or 110, patients completed all assessments; although a greater number – 250 – gave feedback on their satisfaction with CBD.


After taking CBD oil, patients with non-cancer pain symptoms reported on average improved mobility and ability to complete their usual activities and less pain, anxiety and depression. Patients with mental health-related symptoms reported improved ability to complete activities and reduced pain, anxiety and depression. Overall, patients with cancer-related pain reported less pain, but no other improvements.


Of the 250 patients who rated their satisfaction with CBD use, 70% (175) reported it was good, very good or excellent; while 30% (75) reported no benefit from CBD use. Adverse side-effects, which included sedation and vivid dreams, were reported by 25 out of 253 patients (10%) reached at follow-up, while two (0.8%) reported a worsening of a pre-existing condition. The CBD seemed to be very well tolerated.


“Of those first 400 patients referred or self-referred to my clinic, 62 chose not to take CBD oil. Reasons included death, the cost barriers, severe illness, participating in a clinical trial, or consuming cheaper illicit cannabis products,” says Dr Gulbransen.


“Our evidence of CBD’s potential benefits in treating pain and anxiety, if corroborated by future clinical trials, suggests we may need to consider subsidising medical cannabis.”

The study is published in the British Journal of General Practice Open (BJGP Open).



Abstract


Background: Cannabidiol (CBD) is the non-euphoriant component of cannabis. In 2017, the New Zealand Misuse of Drugs Act (1977) were amended, allowing doctors to prescribe CBD. Therapeutic benefit and tolerability of CBD remains unclear.


Aim: To review the changes in self-reported quality of life measurements, drug tolerability, and dose-dependent relationships in patients prescribed CBD oil for various conditions at a single institution.


Design & setting: An audit including all patients (n = 400) presenting to Cannabis Care, New Zealand, between 7 December 2017 and 7 December 2018, seeking CBD prescriptions


Method: Indications for CBD use were recorded at baseline. Outcomes included EuroQol quality of life measures at baseline and after 3 weeks of use, patient-reported satisfaction, incidence of side effects, and patient-titrated dosage levels of CBD.


Results: Four hundred patients were assessed for CBD and 397 received a prescription. Follow-up was completed on 253 patients (63.3%). Patients reported a mean increase of 13.6 points (P<0.001) on the EQ-VAS scale describing overall quality of health. Patients with non-cancer pain and mental-health symptoms achieved improvements to patient-reported pain and depression and anxiety symptoms (P<0.05). There were no major adverse effects. Positive side effects included improved sleep and appetite. No associations were found between CBD dose and patient-reported benefit.


Conclusion: There may be analgesic and anxiolytic benefits of CBD in patients with non-cancer chronic pain and mental health conditions such as anxiety. CBD is well tolerated, making it safe to trial for non-cancer chronic pain, mental health, neurological, and cancer symptoms.


Background


  • From 7 September 2017, all New Zealand doctors have been able to prescribe cannabidiol (CBD), because of amendment to Misuse of Drugs Act 1977: https://www.health.govt.nz/system/files/documents/pages/summary-of-approvals-required-to-prescribe-cannabis-based-products.pdf

  • CBD is a non-euphoriant and very therapeutic substance extracted from cannabis plants.

  • CBD is written like most medicines on standard prescriptions that do not require Ministry of Health approval.

  • CBD can be prescribed by any doctor to any patient for any condition as in a normal medical consultation.

  • CBD oil is taken orally and costs most patients about $10 to $15 per day. It is not subsidised and patients usually pay about $250 to $350 for a 25ml bottle at the pharmacy. This lasts about a month.

  • This paper shows that CBD is often effective for chronic pain and for anxiety.

  • About 90% of patients reported no side effects. Some found the side effect of drowsiness improved their sleep.

  • What is unusual about CBD treatment in New Zealand is that it would not normally be the first type of medicinal cannabis to be prescribed for chronic pain. In USA, Canada and Australia chronic pain would be treated with a blend of CBD and low-dose THC. Such blends are very effective without any intoxication or euphoria and are usually much cheaper.

  • New Zealand regulations have improved patient access to CBD – safe and often effective.

  • THC is often more effective and cheaper than CBD. A blend of both being the best option.

  • Patient access to THC has been stymied by the Ministry of Health (MoH). THC prescriptions require an application form to be signed by a Medical Specialist and the MoH. The Medical Council of NZ determines who are Specialists and states that Vocationally Registered GPs are Specialists. However the MoH ignores this and requires patients to have a non-GP specialist sign the application – a huge barrier to many patients.

  • From 1/4/20 patients and GPs are expecting to be able to prescribe medicinal cannabis containing THC. However the MoH is saying they will begin assessing THC products from 1/4/20 and it may be up to 6 months (called ‘transition’) before patients can be prescribed cheaper and more effective products containing THC.

  • By restricting access to THC, the MoH should not be surprised to find patients continuing to use illicit cannabis remedies. These ‘green fairy’ oils may be effective, but the ingredients are usually unknown and both suppliers and their patients risk prosecution. A safer option would be to allow all doctors to prescribe current approved THC medicinal cannabis blends from 1 April 2020, without further delay.


You can hear Dr Graham Gulbransen speak at New Zealand's first medicinal cannabis conference, MedCan 2020, coming up on 18-19 March at SkyCity Convention Centre.



© Helius Therapeutics 2018