Project Twenty21 publishes first findings on chronic pain

The first condition-specific findings from the UK observational study, Project Twenty21, have been published on chronic pain. 

Data from over 900 chronic pain patients, enrolled on Drug Science’s Project Twenty21 (T21), has been published in the leading academic journal, Frontiers, this week.

The first of two papers, explores how cannabis-based medicines can be used in the treatment of chronic pain, and gives an overview of the current patient demographic, as well as highlighting the key challenges facing those living with persistent pain.

Project Twenty21 was launched by UK drug reform charity, Drug Science, in 2019 with the aim of building a database for the safety and efficacy of medical cannabis.

There are currently over 2,600 patients enrolled in the study, of which over 50 per cent are prescribed cannabis for chronic pain.

Who are pain patients in the UK?

According to this new paper, of the 949 people reporting chronic pain as a primary condition, just over half were male, with an average age of 42-years-old.

A range of cannabinoid products were prescribed to this group, with just under half being classified as high-THC flower.

In addition, 92 per cent of those with a primary condition of chronic pain reported experiencing at least one co-morbid secondary condition, with over a third reporting up to six. 

These include psychiatric conditions including anxiety and depression, which can also be treated with medical cannabis products. The majority of patients also reported using at least one other prescribed medication (69 per cent).

According to lead author and head of research at Drug Science, Dr Anne Katrin Schlag, one of the key findings of the paper was the low quality of life among pain patients, compared to the general population. 

Over half of the sample reported that they experience “severe or extreme problems due to pain”. 

“The majority of patients have many co-morbid conditions and because of that suffer with a low quality of life,” Dr Schlag told Cannabis Health.

“The pain interference and pain intensity for the majority of these patients is very high. A lot of them are unable to live their life in the way they would like to do, because the pain is so dominant.

“The low quality of life of the patient was quite astounding in terms of the extent of their problems, in relation to mobility and being able to conduct their usual activities, self-care, as well as issues of anxiety and depression.”

This is significant, the paper says, as the low quality of life of patients, their high number of co-morbidities and wide age range shows that the “myth of medical cannabis patients as young, recreational users looking for a legal source of cannabis can be firmly dispelled”.

Influencing regulators 

A further paper, due to be published later this year, will explore the effects of medical cannabis at a three and six month follow up appointment, including whether the treatment has enabled patients to reduce other prescription medicines, including opioids.

The researchers hope that these findings, which are already showing “promise” will go some way to encouraging regulators to consider real-world evidence.

“This is a huge patient group, chronic pain is a very prevalent condition in the population and NICE does not currently recommend the prescription of cannabis-based medicinal products for chronic pain,” said Dr Schlag.

“We wanted to show that there are lots of people using it already and it would most likely be very beneficial for them to get access through the NHS, as a lot of them need this for chronic conditions for longer periods of time.”

She continued: “If we can show in a follow up paper that cannabis medications have improved pain intensity and the amount that pain interferes in their life, as well as that opioid and other medication use declined, we hope this would influence regulators, including NICE, to perhaps reconsider their recommendations.”

Elsewhere in the world 

The initial findings are said to be in line with other real-world data from elsewhere in the world, such as Canada and America. 

Similar databases from countries such as Canada, Germany, and Denmark, also include thousands of patients, presenting “convincing findings” according to Dr Schlag. 

“There’s so much already out there and findings tend to follow a pattern, especially in terms of pain patients and how beneficial medical cannabis can be to treat chronic pain,” she said.

“We’re hoping that this large-scale database will have an impact on regulators. Especially when you consider that there are more patients combined within all these databases than within all the randomised control trials in this area put together.”

Real-world evidence vs RCTs

Bodies such as NICE, which have called for more robust evidence on the use of medical cannabis in chronic pain, consider randomised control trials (RCTs) to be the “gold standard” of science, despite how restrictive they can be.

“RCTs take place in a very restrictive environment, over a short period of time, with a very small subsample of patients, and are usually not able to involve patients with the number of co-morbidities that we have in this study, ” explained Dr Schlag.

“When we are able to analyse the data over three months, six months, one year – hopefully we will be able to see the benefits, as well as any potential risks, which may or may not occur, and which may not be shown in a short-lived RCT.”

She added: “This is going to be extremely helpful for regulators and prescribers, and we’re very keen for T21 as well as other real world evidence, to be able to contribute to the scientific evidence-base on cannabis medicine.”

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