Medical Cannabis Significantly Improves Quality of Life, Finds Europe’s Largest Patient Study
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Project Twenty21, Europe’s largest ever medical cannabis patient study, has released its first preliminary results – the first real-world data to be published on medical cannabis patients in the United Kingdom.
The study findings show significant improvements in outcomes measuring patients’ quality of life and in the ability of patients to manage other secondary conditions, such as anxiety, insomnia, and depression, when prescribed with legally licensed medical cannabis.
The Project Twenty21 team hopes that these findings, in conjunction with planned future research on the long-term effects of medical cannabis, will help to provide clinicians and the UK’s National Health Service (NHS) with the data they need to inform decisions on prescribing cannabis-based medicinal products (CBPMs).
Patients report 51 percent increase in health and quality of life
So far over 7000 people have signed up to take part in Project Twenty21, with just under 700 patients having been formally enrolled into the study as of March 2021. The new preliminary findings published by Drug Science – the organization coordinating Project Twenty21 – concern a further subset of 64 patients.
Data from this patient group was taken over the course of three months on from the initiation of medical cannabis treatment. The patient group was representative of a diverse set of health conditions – including chronic pain, multiple sclerosis, Tourette’s syndrome, epilepsy, and post-traumatic stress disorder (PTSD) – and included patients aged between 18 and 80 years old.
The researchers tracked improvements over these three months through self-reports of patient health as assessed by the EQ-5D-5L, a standardized measure of quality of life covering five variables: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The study found a 51 percent increase in patients’ self-reported health and ability to lead a more normal life after three months of treatment.
“On a measurement of 0-to-100, where 100 presents the best imaginable quality of life, the mean score for our T21 patients [when initiating treatment] was 46.8,” Dr Anne Katrin Schlag, head of research at Drug Science, told Analytical Cannabis.
“We compared our findings to normative data from the UK household population. Here, the mean was 85.7 – showing just how low quality of life is for our patients [at initiation of treatment].”
“Yet our 3-month follow up data, albeit with a small sample size of 64 so far, shows that patients' quality of life improved significantly, from 46.8 to 63.3 – a 50 percent increase in self-reported quality of life, which indicates a large effect of CBMPs for improved health.”
The researchers also observed significant improvements in the patients’ ability to manage secondary conditions, such as anxiety or depression, occurring outside of their main diagnosis.
What is Project Twenty21?
Project Twenty21 is not a clinical trial, as the researchers behind the project readily point out.
Studying medical cannabis through the lens of randomized controlled trials (RCTs) is incredibly difficult. The general hype around cannabis-based medicines in the UK runs the risk of there being a particularly strong placebo effect which can interfere with formal study. Prospective patients with comorbid conditions also might not be accepted into such RCTs, which further complicates matters.
Project Twenty21 offers an alternative way of studying the effects of medical cannabis, through creating the largest single body of real-world evidence describing patients’ experience with legally prescribed medical cannabis treatments. The project also aims to improve access to medical cannabis and has partnered with a number of licensed medical cannabis producers in order to reduce the cost barrier for patients.
“Our patient population comprises a huge age range, more or less from 18 to 80 years old. Their consistently high rates of comorbidity and low quality of life demonstrate just how unwell many of them are. As such, we can reject the stereotypes of medical cannabis patients as being 20-something, healthy, recreational users looking for a legal source,” explained Dr Schlag.
“With these high rates of comorbidity, many of our patients would have automatically been excluded from formal randomized controlled trials, highlighting the importance of a large-scale observational registry such as T21,” she continued.
“Our findings to date are promising, especially when looking at improvements in patients' quality of life, and we are hopeful that the longitudinal approach of T21 will substantially add to the scientific evidence base of medical cannabis. Moreover, we hope that the findings of Project Twenty21 will provide evidence for NHS funding where the benefits of treatment with medicinal cannabis are proven to outweigh the potential risks.”
In order for clinicians and health governing bodies to become more comfortable with the idea of prescribing medical cannabis, they wish to see a greater amount of evidence backing up the safety and efficacy of the drug. In lieu of forthcoming RCTs, Project Twenty21 aims to provide this deeper evidence base.
Following on from the publication of these preliminary results, the Project Twenty21 team intends to focus on evaluating the effectiveness of cannabis in reducing symptomatology across different primary conditions, in addition to improving general quality of life over the long-term. There are also plans to examine whether these CBMPs may alter use of other prescribed pharmaceuticals, such as opioids.