Real-world data collected by Khiron Life Sciences in Columbia shows the effectiveness of medical cannabis on managing chronic pain.
Khiron Life Sciences, a medical cannabis company operating throughout Latin America and Europe, has published the results of its first clinical study on the use of medical cannabis in treating chronic pain.
The data, which appears in the international peer-reviewed journal Frontiers in Pain Research, captures patient-reported outcome measures and adverse effects in a cohort of 2,112 adult patients in Columbia.
This is the largest study of its kind in Latin America, and the first published clinical evidence on the effectiveness and safety of Khiron’s THC and CBD oil-based cannabis formulations – two of the most prescribed products at Khiron’s Zerenia Clinics.
According to the results, nine out of 10 patients (92 per cent) reported some degree of improvement of their chronic pain, with seven out of 10 reporting an improvement larger than 50 per cent after four weeks of treatment.
Seven out of 10 patients did not experience any adverse effects related to the treatment, while those reported adverse side effects were mild and transient, fading after 12 weeks.
The majority of patients were female, with an average age of 58-years-old. One third of participants were aged 65 and over.
The authors concluded that the cannabis-based oral formulations represent a “safe and efficacious adjuvant therapeutic option in the management of chronic pain” and “may represent a valuable option for physicians”.
Khiron operates 14 clinics across Latin America and has treated over 14,000 patients with medical cannabis.
It launched its first Zerenia Clinic in the UK at the end of last year.
Alvaro Torres, Khiron CEO and Director, commented: “This study, based on Khiron’s medical products, is critical to reassure physicians and health insurance providers of the efficacy of medicinal cannabis to treat chronic pain. The global impact and economic burden of chronic pain in our society, mounting medical evidence will increase access to cannabinoid-based medicines worldwide.
“The recent vote in the US House of Representatives promoting medical research on cannabis clearly shows the pressing need to develop effective and safe cannabis-based medication for suffering patients worldwide. With this and upcoming studies, Khiron will continue to stand above in the field of medical research and to expand the access for patients in those jurisdictions in which we are present.”
Additional studies are expected as Khiron continues to expand globally, with the aim of creating a 360-solution for healthcare providers, insurance companies, and patients to benefit from the prescription of medical cannabis.
Guillermo Moreno-Sanz, the first author of the study and Global Scientific Director of Khiron Life Sciences added: “We believe these findings to be generalisable across patient populations, considering that our results are extremely well-aligned with those reported by researchers working with similar clinical populations in nations with long-standing medicinal cannabis access programs, such as Israel and Canada.”
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.
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.”
Project Twenty21 publishes first findings on chronic pain
Data from over 900 medical cannabis patients, living with chronic pain, has been published this week.
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”.
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.”
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.
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.
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.”
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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