Project Twenty21 Publishes First Observations on Chronic Pain
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In the latest publication to come out of Drug Science’s Project Twenty21 observational patient registry, researchers have described the characteristics of the more than 900 chronic pain patients seeking prescribed medical cannabis treatment through the project.
Chronic pain is the most common primary diagnosis among the patients affiliated with Project Twenty21, the researchers revealed, and these chronic pain patients often reporting high numbers of comorbid conditions. High THC flower was the most common cannabis product prescribed; the majority of patients also reported using at least one other non-cannabis prescribed medicine.
Following the publication of this new paper in Frontiers in Pain Research, a second paper is scheduled to be published later in 2022 which will examine the effect of medical cannabis treatment on these patients at the three- and six-month follow-up appointments.
Who suffers from chronic pain?
Of the 1,782 patients enrolled in Project Twenty21 by November 2021, 53.5% (or 949 individuals) reported chronic pain as their primary health condition. For contrast, the next most commonly reported primary condition was anxiety, coming in at just 33.4%.
The average age of the chronic pain patients was 42, with just under 55% identifying as male. Interestingly, only around 15% reported having never used cannabis previously, while nearly two-thirds said that they were currently using cannabis to manage their pain. Of those pain patients using cannabis, 52.7% reported using the drug daily.
The mean pain scores reported by the patients was 5.9 on a 10-point scale, with just over 45% of the patients meeting the classification for “severe pain”.
Through Project Twenty21, around 54% of the pain patients received a prescription for a single cannabis-based medicinal product (CBMP), 35.6% received two products, 10.7% being prescribed three or more CBMPs. Nearly half of all the prescribed CBMPs were high THC flower, with another quarter being balanced THC:CBD oils. Around one-tenth of prescribed products were high CBD oils, while high THC oils and high CBD flower were both relatively uncommon.
The majority of patients also reported using at least one other prescribed medication, most commonly anti-neuropathic agents, weak opioids, and other analgesics.
Chronic pain patients have very high rate of comorbidities
Pain isn’t the only cause for concern with chronic pain patients. Just under 92% of chronic pain patients also reported at least one comorbid secondary condition, most commonly anxiety, depression, stress, or insomnia. Astoundingly, some 34.4% of the chronic pain patients reported having six or more comorbid secondary conditions.
Unsurprisingly then, the chronic pain group also reported quite low scores on the questionnaire intended to assess quality of life. Around 31% reported severe mobility problems, 12% said they struggled severely with self-care, 41.5% said they were unable to complete normal activities, and around 18% reported problems with severe or extreme anxiety and depression.
The mean quality of life score reported by the chronic pain patient group was just 45.6 points on a 100-point scale, marginally worse than the 46.8 score averaged in a wider group of Project Twenty21 patients who were surveyed in an earlier analysis.
“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, previously 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].”
This comorbidity data is important, as patients with significant comorbidities are often excluded from formal clinical trials, and so there is an even greater lack of data describing the effectiveness of medical cannabis for these kinds of patients. This is one of the key strengths of compiling observational databases built on real world data, the Drug Science researchers say.
Such a large variation in comorbidities, prescribed adjunct meditations, and severity of chronic pain again highlights the need for real world evidence to be considered alongside results from clinical trials, the Project Twenty21 organizers say. Especially given the legal status of cannabis and the relative inaccessibility of medical cannabis prescriptions in the UK, there are valuable insights that can be gained from recognizing patterns in such data.
“Our [total] 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,” Schlag told Analytical Cannabis.
“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.
Early findings from Project Twenty21 found that medical cannabis could improve the average patient quality of life across a broad range of conditions, including chronic pain, multiple sclerosis, Tourette’s syndrome, epilepsy, and post-traumatic stress disorder.
“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,” Schlag said.
“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.”