Medicinal cannabis may be safe and effective: study

A new study of medicinal cannabis being taken in a real-world setting has found that the drug is safe, well tolerated and helpful for people experiencing issues with pain, sleep and wellbeing.

The study, led by the Australian Emyria Clinical e-Registry (AECeR), looked at around 4000 Australians with a wide range of ages, and conditions who were taking medicinal cannabis (MC) over two years. There were over 40 different primary clinical indications for prescription of oral MC: pain (71.9%), psychiatric (15.4%) and neurological (2.1%).

All patients in the cohort were prescribed oral oil-based MC with careful titration of dose and ratio to safely achieve clinical goals with minimal adverse effects (AEs). AEs importantly include all cognitive effects ascribed to Tetrahydrocannabinol (THC) such as sedation, feeling high and lack of concentration. These were recognised treatment related AEs and subsequently required alteration of the MC ratio and often reduction in THC dose.

Generally, the oral medicinal cannabis (MC) was well tolerated, with less than 2% experiencing severe treatment-related AEs and only two serious AEs — hallucination and mania. This safety is particularly salient in contrast to the safety and tolerability of prescribed long-term opioids.

The Australian Emyria Clinical e-Registry (AECeR) collected clinical, demographic, dosing and safety data, as well as over 200,000 individual standardised validated questionnaires over this period.

In Australia, oral MC is not subsidised, costing the patient an additional AU$2000–4000 per year. Despite this, the retention rate in the AECeR was over 90% at six months and nearly 70% at 12 months.

The average number of concomitant medications over time initially significantly decreased but by 2 years was not significantly lower. No addictive or dependence behaviours were detected and there was no increase in concomitant medications.

The health survey, RAND SF36, was the assessment tool used to determine the effect of the MC.

Scores were significantly improved for over two years across all of the measured parameters. The developers of the SF-36 advise that a five-point difference is considered “clinically and socially relevant”. Across all parameters the average improvement was greater than 10, two times the reported minimum clinically important difference. This was particularly pronounced in mental health (65 points) and less in physical function (5 points).

The study found significant improvements for pain severity, mental health, insomnia, physical function and emotional wellbeing, and the improvements were sustained for over two years.

Read the full study here.

Image credit: iStock.com/Magnifical Productions