Background Since medical access to medicinal cannabis (MC) was legalised in Australia in 2016, numbers of people prescribed MC have increased exponentially. There is a need for safety and effectiveness data on the longer-term use of MC in real-world settings. This paper describes the methodology of Project Twenty21 Australia, an observational study that commenced early in 2022 and its preliminary findings. Method This study tests whether medicinal cannabis is effective in four primary conditions: chronic pain, anxiety, posttraumatic stress disorder and multiple sclerosis (MS). Participants are prescribed MC from within a Project Formulary, completing questionnaires at baseline then 3 monthly for up to 12 months. Results Between the start of the study in February and 30 August 2022, 278 participants had been recruited into the study: 50.7% female, 48.2% male and 1.1% non-binary with average age 39.2 years (18–77). Patients reported a low quality of life and high levels of co-morbidity. Three-month data, available for 71 participants, indicate that MC was associated with substantial improvements in self-reported quality of life, general health, mood/depression and sleep with standardised effect size estimates ranging from 0.57 to 0.93. Three adverse reactions were reported. Conclusions This paper describes the protocol used for an observational study conducted in Australia assessing the effectiveness of MC in four main conditions. We have established the feasibility of collecting real-world data on symptoms and quality of life in people receiving treatment with MC. Preliminary evidence suggests that MC may be effective in improving quality of life, general health, mood and sleep.
Background Internationally, one of the most common conditions for which people seek medicinal cannabis (MC) is chronic pain. However, relatively little is known about the effectiveness of cannabis for reducing pain in Australia. Medicinal cannabis was made legally available in Australia in 2016. Project Twenty21 Australia is an observational study that follows patients prescribed MC for chronic pain, anxiety, PTSD and multiple sclerosis for up to 12 months. It commenced recruitment in February 2022. This paper describes some preliminary findings for a cohort of patients with chronic pain. Method Participants seeking treatment for chronic pain are prescribed MC from within a Project Formulary, and complete questionnaires at baseline then three monthly for up to 12 months. Pain severity and interference are assessed using the Brief Pain Index while standardised measures of quality of life, mood and sleep quality are also applied. Results By 30 November 2022, 55 participants with chronic pain had completed the first three-month follow-up. Patients reported a low quality of life and high levels of co-morbidity. Three-month data indicate that MC use was associated with significant reductions in self-reported pain intensity and pain interference (Effect sizes = 0.66 [95% CI = 0.34–0.98] and 0.56 [0.24–0.88], respectively). Additionally, there were significant improvements in quality of life, general health, mood/depression and sleep (Effect sizes = 0.53–0.63). One adverse reaction was reported which was mild in nature. Conclusions Preliminary evidence suggests that MC may be effective in reducing both pain severity and pain interference while also improving quality of life, general health, mood and sleep in patients with chronic pain. Increasing uptake of MC coupled with growing evidence of both the effectiveness and safety of these medications indicate a need both to make MC more widely available and to reduce financial costs associated with its use.
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