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“Chronic pain patients feel let down” – UK’s first digital pain clinic joins Project Twenty21

The UK’s first fully digital pain clinic is giving millions of patients another option

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Leva is the UK's first fully digital pain clinic

The UK’s first fully digital pain clinic is offering another option for the millions of patients who live with chronic pain and have lost hope in conventional healthcare.

Since it launched this year, the doctors at Leva Clinic have seen dozens of patients living with debilitating chronic pain, who are desperate to find a way to control their condition.

Having reached the end of the line in terms of what treatment is available on the NHS, many feel let down by conventional medicine and have lost all hope in ever successfully managing their pain. 

“Patients with chronic pain are often left to cope on their own, they often don’t benefit from the kind of support that they need,” says Dr Benjamin Viaris de Lesegno, chief medical officer and co-founder of Leva.

“Due to the complexity of their conditions and the underfunding of the NHS, a lot of patients with chronic pain feel that they’ve been let down. 

“Once you’ve reached the end of what the NHS defines as the chronic pain pathway, there’s nothing left for those patients. 

“These are patients who have lost all hope.”

In the UK, chronic or persistent pain – defined as pain that lasts for more than three months – is thought to affect between one third and half of the population.

Guidelines from the National Institute for Health and Care Excellence (NICE) now advise doctors against the prescribing of common painkillers, including paracetamol and opioids, for patients with chronic primary pain conditions.

Instead regulators recommend interventions such as exercise programmes and psychological therapies such as CBT and acceptance and commitment therapy (ACT). 

This has left many patients either looking for alternative options – or living in fear of being left without any pain medication at all. 

Leva aims to “hold the hands” of these patients as its team of specialists work with them to find the right treatment.

“Patients are constantly on the lookout for new ways to control their pain, whether that’s diet and exercise or other ways to manage the symptoms that are making their life so difficult,” says Viaris de Lesegno.

Dr Benjamin Viaris de Lesegno, chief medical officer and co-founder of Leva.

“We’re really driven to try to support patients with chronic pain in every way possible.”

An increasingly popular alternative therapy among chronic pain patients is medical cannabis.

But due to what bodies such as NICE and the International Association for the Study of Pain (IASP) have described as a “lack of high quality evidence” for its efficacy in the treatment of chronic pain, access remains limited to private clinics in the UK.

Aware that private healthcare remains out of reach for many chronic pain patients, Leva has recently joined Drug Science’s Project Twenty21 in order to make its unique approach to care accessible to more people.

With around 50 percent of the patients currently enrolled on the project being treated for chronic pain, Viaris de Lesegno believes there is a need for a clinic which is specifically focused on pain management.

Unlike other cannabis clinics, Leva sees this as just one of the treatment options, offering a holistic approach to care through psychology, physiotherapy, digital tools and where suitable, novel therapeutics such as cannabis medicines.

“Pain is the biggest indication for medical cannabis around the world, not only in the UK,” he says.

“Medical cannabis is one of the options available for the doctor, but it shouldn’t be the only treatment option.

“A pain clinic that has the capacity to support patients in every way – and that includes psychology, physiotherapy and other pharmacological management – as well as medical cannabis, is the best way to help patients with chronic pain, even if for now, it is only available through the private market.”

Patients on Project Twenty21 will have free access to Leva’s digital pain management program, an app which can be used any time to offer advice and education on the self-management of their pain.

As well as an initial consultation and pharmacological management review, patients have the option to progress their treatment further with the multidisciplinary team, including a nurse, physiotherapist and a psychologist. 

And the fact that the clinic is fully digital means patients no longer face geographical barriers, giving them access to some of the UK’s most highly regarded specialists in the field.

“We definitely think of ourselves not as a medical cannabis clinic but as a pain clinic,” said Leva’s CEO, Eric Bystrom.

Leva CEO, Eric Bystrom

“We build a very long term relationship with our patients and be there at every point of their pain journey.

“You get your pain team from day one and together you create your bespoke care plan.”

As part of Project Twenty21 Bystrom and Viaris de Lesegno are keen to contribute to the creation of the UK’s largest body of evidence for the efficacy of medical cannabis.

They believe that this holistic approach to treatment is the way forward in opening up wider access to cannabis medicines. 

“A lot of doctors are suspicious of medical cannabis,” Viaris de Lesegno explains.

“If you go to a doctor with a ‘miracle drug’ that will treat everyone perfectly, no one will believe you. 

“Whereas if you say you have implemented medical cannabis within a dedicated care plan that includes psychology, physiotherapy and other pharmacological treatments, that sounds much more plausible to any clinician.”

It is also hoped that this approach will allow for more patients, who haven’t ever considered cannabis as an option to benefit from it. 

Head of communications, Project Twenty21, Mags Houston

Eric added: “To our knowledge, the medical cannabis market in the UK has so far been made up of patients who are highly knowledgeable and understand cannabis very well.

“With this approach we’re also aiming to treat those patients who have never even thought that medical cannabis could be something that helps them, to open up an avenue that they hadn’t even considered was available to them.”

This is something that those behind Project Twenty21 are also keen to see more of.

“A more holistic clinical model is something Drug Science is very much behind, as it opens up the pathways for patients who are ‘cannabis-naive’, in other words they have never tried cannabis before,” says the project’s head of communications, Mags Houston.

“We really hope that this approach will get the attention of those who haven’t previously considered medical cannabis.”

Houston continues: “Leva is giving the doctor the freedom to prescribe from a range of treatment options, not only medical cannabis. This way the doctor can do their job properly, by finding and recommending the best treatment option to suit that patient’s individual needs, and the patient can decide if it’s right for them.”

She adds: “We really want to see medical cannabis normalised as an option when choosing the best form of treatment, and this should hopefully encourage other doctors to come forward and to want to learn more about prescribing medical cannabis.”

Find out more about Project Twenty21

 

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Largest ever cannabinoid trial on pain finds significant improvement

All formulations in the trial led to “clinically meaningful” improvements in pain after just 4 weeks.

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cannabinoid trial

Results have been released from what is claimed to be the largest ever randomised blinded clinical trial on cannabinoids and pain.

Results from a large-sale cannabinoid trial demonstrated “clinically meaningful” improvements in pain across the different formulations of CBD and rare cannabinoids studied.

Claimed to be history’s largest clinical trial on cannabinoids and pain, Radicle Science – an AI-driven healthtech firm – worked in partnership with cannabinoid manufacturer and distributor Open Book Extracts (OBX) to complete the study.

Involving more than 1600 participants from across the US, the companies said the study is the first of its kind to examine the synergistic impact of rare cannabinoids like Cannabichromene (CBC) and Cannabigerol (CBG) on pain.

All of the enhanced product formulations included in this clinical trial led to statistically significant improvements in pain, anxiety, sleep quality and overall quality of life. On average, nearly half (44.8 per cent) of participants who received any of the enhanced products experienced a clinically meaningful improvement in their pain, meaning they realised a distinct and palpable improvement in their quality of life through improved pain symptoms.

The trial was specifically designed to examine if adding other ingredients to a formulation in conjunction with CBD could lead to better outcomes than with CBD alone. The trial included 6 product arms, which all contained CBD at 40 mg per serving. Most arms also contained varying levels of rare cannabinoids, including CBG and CBC.

Overall, the formulations performed roughly the same for the improvement of pain, anxiety, sleep quality and quality of life. However, for people with moderate pain, there was evidence that the addition of 20mg CBC to a formulation containing 40mg of CBD could significantly improve its pain-relieving effects—particularly when this enhanced product was taken for two or more weeks.

“It’s a privilege to make history with OBX,” said Dr Jeff Chen, Radicle Science’s CEO and UCLA Cannabis Research Initiative’s founder. “Rare cannabinoids are present in a variety of health and wellness products containing cannabis and hemp, but there has been virtually no clinical data on their effectiveness for any medical condition, including pain.

“Radicle Science assessed for the first time in history the potential synergistic effects of certain rare cannabinoids on pain and demonstrated that these natural products can make a measurable positive impact.”

A diverse sample of 1629 pain sufferers from across the US were randomised to take one of the six product formulations for a month while reporting their pain relative to specific benchmarks that included severity, general activity, sleep quality, anxiety symptoms and overall quality of life.

All products tested were deemed safe to consume and only about 1 in 10 participants reported side effects, none of which were deemed severe.

“While existing studies suggest that cannabidiol and rare cannabinoids, including CBG and CBC, have considerable potential to support wellness, there has been a glaring gap in scientifically valid research dedicated to guiding effective product development,” said OBX CEO Dave Neundorfer.

“That’s why we collaborated with the renowned medical experts and data scientists at Radicle Science to better understand the potential of rare cannabinoids as an ingredient and, in particular, their ability to support better quality of life outcomes relating to pain.”

Radicle Science and OBX said they will continue their partnership with similar large-scale randomised controlled clinical trials on rare cannabinoids, including THCV, CBN, CBG and CBC. Radicle will be studying their effects on other health and lifestyle benchmarks, such as energy, focus, appetite, sleep disturbance, stress and anxiety, across thousands of study participants.

Pelin Thorogood, Radicle Science Co-founder and Executive Chair added: “It was promising to see that the addition of a rare cannabinoid could augment the effects of CBD.

“We will be further exploring the entourage effect with an upcoming study, Radicle Spectrum, which will be the first head-to-head study comparing full or broad-spectrum CBD to isolate and placebo. It is our hope this study will provide data to help the FDA ascertain whether CBD isolate is a drug.”

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Project Twenty21 publishes first findings on chronic pain

Data from over 900 medical cannabis patients, living with chronic pain, has been published this week.

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Project Twenty21 publishes first findings on chronic pain
Project Twenty21 is building a database for the safety and efficacy of medical cannabis.

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.

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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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Medical cannabis reduces pain and opioid use in cancer patients – study

Findings suggest that medicinal cannabis can be carefully considered as an alternative to the pain relief medicines.

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Pain measures improved significantly with medical cannabis and other cancer-related symptoms also decreased.

Medical cannabis reduces cancer-related pain and the need for opiate-based painkillers, reveals a new study in oncology patients.

A comprehensive assessment of the benefits of medical cannabis for cancer-related pain, has found that for most oncology patients, pain measures improved significantly, other cancer-related symptoms also decreased, the consumption of painkillers was reduced, and the side effects were minimal. 

Published in Frontiers in Pain Research, these findings suggest that medicinal cannabis can be carefully considered as an alternative to the pain relief medicines that are usually prescribed to cancer patients.

Pain, along with depression, anxiety, and insomnia, are some of the most fundamental causes of oncology patient’s disability and suffering while undergoing treatment therapies, and may even lead to worsened prognosis.

Keto: A banner advert for Medical Cannabis Clinics

Author, David Meiri, assistant professor at the Technion Israel Institute of Technology, explained: “Traditionally, cancer-related pain is mainly treated by opioid analgesics, but most oncologists perceive opioid treatment as hazardous, so alternative therapies are required.

“Our study is the first to assess the possible benefits of medical cannabis for cancer-related pain in oncology patients; gathering information from the start of treatment, and with repeated follow-ups for an extended period of time, to get a thorough analysis of its effectiveness.”

Need for alternative treatment

After talking to several cancer patients, who were looking for alternative options for pain and symptom relief, the researchers were keen to thoroughly test the potential benefits of medicinal cannabis.

“We encountered numerous cancer patients who asked us whether medical cannabis treatment can benefit their health,” said co-author Gil Bar-Sela, associate professor at the Ha’Emek Medical Center Afula. 

“Our initial review of existing research revealed that actually not much was known regarding its effectiveness, particularly for the treatment of cancer-related pain, and of what was known, most findings were inconclusive.”

The researchers recruited certified oncologists who were able to issue a medical cannabis license to their cancer patients. These oncologists referred interested patients to the study and reported on their disease characteristics.

Bar-Sela said: “Patients completed anonymous questionnaires before starting treatment, and again at several time points during the following six months. We gathered data on a number of factors, including pain measures, analgesics consumption, cancer symptom burden, sexual problems, and side effects.”

Improved symptoms

An analysis of the data revealed that many of the outcome measures improved, with less pain and cancer symptoms. Importantly, the use of opioid and other pain analgesics decreased. 

In fact, almost half of the patients studied stopped all analgesic medications following six months of medicinal cannabis treatment.

“Medical cannabis has been suggested as a possible remedy for appetite loss, however, most patients in this study still lost weight. As a substantial portion were diagnosed with progressive cancer, a weight decline is expected with disease progression,” reported Meiri.

He continued: “Interestingly, we found that sexual function improved for most men but worsened for most women.”

Meiri would like future studies to dig deeper and look at the effectiveness of medicinal cannabis in different groups of cancer patients.

“Although our study was very comprehensive and presented additional perspectives on medical cannabis, the sex, age, and ethnicity, as well as cancer types and the stage of the cancer meant the variety of patients in our study was wide-ranging. Therefore, future studies should investigate the level of effectiveness of medicinal cannabis in specific subgroups of cancer patients with more shared characteristics.”

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