A new UK trial will explore the effects of medical cannabis in patients with fibromyalgia and chronic pain.
Primary research sites will be located in the US and the UK, with the hopes of fast-tracking traditional FDA and NHS timelines by running phase trials in parallel.
A human pilot study will be launched in coordination with an internationally recognised clinical research group based at the University of Manchester.
In addition, parallel molecular and pharmacokinetic studies will be conducted in the US with key scientists and colleagues of Dr Annabelle Manalo-Morgan, Flora’s lead scientific advisor.
“A paradigm shift is upon us where healthcare practitioners, researchers, patients, and adult-use consumers are starting to understand, accept, and embrace the therapeutic potential offered by phytocannabinoid-based medicine,” said Dr Manalo-Morgan.
“As such, there is an urgent need for more research to better understand the molecular and biochemical effects of cannabis at the cellular level, to begin to apply its implications as a pharmaceutical drug.”
According to an announcement earlier this month, Flora intends to work with government regulators, as well as academic institutions to initiate academic studies in order to reduce costs and develop new cannabis-based drugs.
It plans to “honour the traditional FDA and NHS route in scientific processes” to deliver cannabinoids for specific disease conditions, backed by data, with an initial focus on fibromyalgia, brain health, pain, and related research.
The firm’s immediate next steps are to submit data for ethics committee review, with further details expected upon approval.
Dr Manalo-Morgan added: “I’m extremely pleased that our team recognises the importance and necessity of this research, not only to create and bring to market novel pharmaceutical cannabis products for patients around the world that are more efficacious and have a superior safety profile compared to traditional and incumbent pharmaceutical treatment options, but to also enhance long-term shareholder value.”
How CBD helps me combat arthritis pain
A patient shares how they combine CBD with lifestyles changes to manage their chronic pain.
Caomihe Ni Drisceoil shares how she uses CBD, alongside other natural remedies, to help combat the pain from arthritis and migraines.
Caoimhe Ni Drisceoil was diagnosed with arthritis when she was in her 50s. The pain began in her knees before moving to her hands and other joints. She also suffered from painful migraines.
“It was a gradual development over the years, to a point where it was becoming uncomfortable to do the things I loved such as gardening or walking,” she said.
Arthritis is a common condition that causes pain and inflammation in the joints. It can affect people of all ages but particularly, older people. Symptoms can include joint pain, tenderness and stiffness, inflammation and restricted movement. It is thought that over 900,000 people in Ireland live with arthritis pain.
Patients will often have to make lifestyle adjustments to help ease the pain they experience. Caoimhe learned to avoid causing extra pressure on her joints if the pain was particularly bad, but she also struggled to fall asleep.
“If I was having a bad day then I wouldn’t stress the area that was inflamed. I would break up what I was doing during the day to relieve the pressure on that area and go back to it again if the pain eased off or I would take medication in the evening,” she said.
“Sometimes it would stop me from sleeping which is difficult for your physical and mental health, as well as not being able to do things you love. It’s also stopped me from learning a musical instrument which was on my bucket list. I haven’t been able to do this because of the joints in my hands being too painful.”
Natural arthritis pain relief
Caoimhe has always been a big believer in natural remedies or homoeopathic alternatives. She often took echinacea for colds or flu. When she began researching pain relief, she looked for the natural options first.
She explained: “I started off with glucosamine and chlondroitin first, they are herbal remedies that you can get over the counter to ease the joints. Glucosamine and vitamins help the cartilage around the joints. The chlondroitin helps the glucose absorb into your body quicker. I was on that for several years while adding paracetamol if I knew I wasn’t going to be able to sleep from it.”
Caomihe had been experiencing migraine pain at the same time, and was struggling to find a pain relief option that helped her with both. As her doctor prescribed pain relief, she began to explore if CBD could offer an alternative.
“I was on half beta-blockers for over a year and they weren’t stopping me from getting the migraines,” she said.
“My doctors wanted to increase the pain relief and I wasn’t happy with that which is why I started taking CBD,” she said. “They were daily headaches that were very uncomfortable. It would make me miserable and stop me from going out.”
CBD for arthritis
Caomihe began to take CBD drops in the morning. She describes experiencing the effects “almost immediately” on her migraines. However, when it came to arthritis pain, it took further lifestyle changes.
“I noticed that once I was on it, I didn’t get full-blown migraines. I would get headaches, but they never developed into migraine symptoms. I wouldn’t get the tingling in the arms or the tongue, the brain fog or lose the ability to think clearly. It would just be a normal headache,” she said.
Caoimhe found that CBD was just part of the many different things she could do to fight the pain rather than a cure for everything. She combined her CBD intake with dietary changes. One of her daughters is a personal trainer who was able to design a diet plan with pain relief in mind.
She said: “There are things that flare up inflammation in the body such as bell peppers, aubergines. Those [can be] bad if you are prone to inflammation so I avoided those, added more protein for energy and stopped eating gluten as a personal preference. I also gave up red wine, chocolate and cheese as they were triggers for my headaches.”
She also started to combine the CBD with ginger and turmeric which are also known for their anti-inflammatory properties.
“It’s part of a whole collection of things that you do to alleviate the problem,” she said.
But she does hope that the CBD industry will eventually regulate the way that dosage is worked out to make it easier for consumers.
“Figuring out the right dosage is the worst thing, especially if you are new to it,” she added.
“You do tend to find one bottle and stick to it because you get used to the system. I know they need to declare what is in the bottle but it’s not put out clearly. It doesn’t make it any easier to compare one week to another what strength you are taking.”
The difference in her pain levels has been incredible, Caoimhe says, noticing it most when she took her first holiday since the beginning of the pandemic.
“Two years ago, going on holiday would have been difficult because I would have to carry my own luggage, and would struggle going up and down the steps of the plane. This time I was able to put the case up by myself over the seats. I suddenly realised I had been able to do that and walk up all the steps without any pain,” she added.
“That was something that really shocked me because we hadn’t done anything like that since Covid. I had been in my normal routine and not really noticed it.”
Caoimhe lives in a rural part of Ireland, but thankfully access to CBD has not been an issue. The town she is closest to has many health food stores that stock Irish CBD products. She says she would consider trying medical cannabis for the pain if it increases over time, but with the restrictions concerning chronic pain through Ireland’s MCAP program, this is not currently an option.
“I was taking medication from the doctor for years that was doing my liver absolutely no good, THC is a natural, herbal thing,” she said.
“I would have taken CBD for either condition, but I was lucky that it worked for both. I was able to come off the medication from my doctor as a result.
“I haven’t taken beta-blockers or anti-inflammatories in a couple of years, not since I’ve been taking the CBD.”
“I felt like myself again” – How medical cannabis can help with post-surgery recovery
Sara shares how medical cannabis helped her recover after major surgery.
Integro Clinics explores how medical cannabis can help with post-surgery pain, inflammation, sleep and recovery.
Naturally, it is every patient and doctor’s desire to avoid surgery and the potential risks that accompany it, whenever possible. But sometimes, it is necessary to fully address injuries and illnesses that are keeping you from the things you love, or it becomes vital for your overall physical wellbeing.
In the initial recovery process after an invasive surgical procedure, prescription painkillers and opioids may well need to be prescribed. Since these can have negative side effects and even be habit-forming, the sooner the patient can manage day to day without them in the recovery process the better.
Medical cannabis can prove very useful in transitioning off traditional post-operative pain medicines and is filled with phytochemicals that engage your body’s regulatory, or endocannabinoid system. This regulatory system controls your pain and inflammation responses, hunger signals, mood, and more.
These cannabis compounds interact mainly with CB1 and CB2 receptors in your body to help naturally relieve pain and inflammation that may be inhibiting your progress in post-surgery recovery.
Medical cannabis has been used successfully to help improve appetite, reduce pain, relieve anxiety, and help sleep allowing the patient to cease taking stronger traditional post-surgery pain medications.
“I was in a considerable amount of chronic pain for a couple of years after an accident that had damaged the C4, C5 and C6 disks in my spine and neck. It was clear from looking at the MRI Scans with my neurosurgeon that the original steroid injections and simply giving my body time to potentially stop feeling the pain was just not working.
“The flare ups were becoming increasingly agonising and frequent over the years, and after another MRI scan and discussion with my surgeon at the end of September 2021, I decided to take the plunge and go ahead with the surgery.
“This would involve the removal of the cervical discs, insertion of the artificial ones and then stabilisation with a titanium cage. All of this is done by slicing open the front of your neck and moving your vocal cords and larynx to the side before replacing the damaged discs.
“It goes without saying that I was pretty scared, but I trusted my surgeon and knew that he has a fantastic track record. I thought that I would make a rapid and very straightforward recovery since I was relatively young and very fit – how wrong I was.
“Prior to my surgery, I researched the stories of other people who had the same procedure and surprisingly, they all seemed very positive in their on-line recovery diaries, so I hoped I would quickly join their ranks. Nothing prepared me for how much pain I found myself in and how totally mentally and physically wiped out I was by the whole experience.
“Even though I was assured the operation itself went smoothly and was apparently ‘textbook’, I had excruciating muscle spasm in my shoulders, as a result of the recalibration of all my muscles and ligaments. My body went into high alert and defence mode. I was in terrible pain and found sleeping at night or being able to rest in a comfortable position impossible.
“On being discharged, I had been given a two week supply of opioids and paracetamol to take four times a day as well as diazepam to relax my muscle spasms at night. I went through the drugs swiftly and had to have them supplemented with another two weeks’ worth, of the same medications. During this time, I began to feel very disorientated, drowsy, depressed, entirely lost my appetite, and began to actually feel anxious that the operation had made my situation worse, which in turn made me more tense.
“I knew that I needed to stop taking the opioids and diazepam as long term they bring more problems than they solve. Prior to my operation, I had received THC and CBD oils and flower to vape prescribed by Dr Ordman, which had improved my sleep and helped with the day-to-day chronic pain. Dr Ordman advised that I start the Cannabis-based medicines (CBM’s) again, and after two weeks, I stopped taking the traditional medications and was only using CBM’s and finally felt like myself.
“The brain fog had gone, and I was sleeping much better. The six-week review and scan with my surgeon was positive and the bone fusion looked to be progressing fairly well. I still have twinges and bad days, but now, I’m no longer using any medicines on a daily basis and have begun physio and clinical Pilates to open up and relax by shoulders.
“What really interested me, was that both Dr Ordman and my surgeon said that if you have been suffering a chronic pain pathway for years, even once the mechanical issue is resolved, it can take a while for the nerve pathways to stop feeling pain.
“I feel that I am now on track and that the cannabis medicines were, and still are, very helpful when I need them and are a much better option than the opioids because they have no negative side effects on me.”
Pain management and medical cannabis
Integro Clinics nurse, Sophie Hayes commented: “Here at Integro Clinics we manage many patients living with chronic back pain. Physiotherapy is usually the long-term solution to managing this kind of pain, however, often patients find that their pain is so severe that they really struggle to engage with this. Cannabis medicines can be a very effective form of pain management that allows patients to re-engage with these important therapies. The cannabinoid THC is an effective muscle relaxant and neuropathic pain killer, whilst CBD can be an effective anxiolytic, combatting the anxiety surrounding the anticipation of pain following physical activity.”
If you would like to book an appointment to see Dr Ordman and discuss your, or a family member’s back pain, please contact Integro Clinics or speak to our nurse who can take all your details. Consultations are remote so you can have an appointment from the comfort of your own home.
Integro Clinics Ltd always recommends remaining under the care and treatment of your GP and specialist for your condition, while using cannabis-based medicines, and the Integro Clinical team would always prefer to work in collaboration with them.
For further information, or to make an appointment for a medical consultation, contact:
“It was the biggest shock to be diagnosed with arthritis at 30”
Denise Lynch shares how she has found pain relief for arthritis with CBD
Former hairdresser, Denise Lynch, was only 30 when she was diagnosed with psoriatic arthritis. She reveals us how CBD has helped her recovery.
Denise started taking CBD around five years ago when she was diagnosed with Ankylosing spondylitis, psoriatic arthritis. She was working as a hairdresser which meant she was on her feet all day and bending over to reach clients at the basins.
Ankylosing spondylitis (AS) is a long term condition where the spine and other parts of the body are inflamed. It can develop at a young age. Symptoms can include back pain, stiffness and extreme fatigue. Psoriatic arthritis results in more swelling, pain and stiffness in the joints, especially the fingers and toes.
Denise was diagnosed with Ankylosing spondylitis in the spine, hips and buttocks first. This was before a further diagnosis of psoriatic arthritis due to the stiffness, swelling and pain in her hands and the presence of psoriasis on her knees and elbows.
“I started hairdressing when I was 19 after college but I started to suffer from a lot of back pain. I put this down to the job for a long time but it seemed to get worse and had migrated to my hips,” Denise explained.
“It wasn’t until I was 30 that my doctor diagnosed me with Ankylosing Spondylitis sciatic arthritis.”
Back pain can be common among hairdressers or makeup artists as they spend long periods of time on their feet or bending over to reach clients. But arthritis is normally associated with older people who have developed the condition over time. Denise was shocked at her diagnosis at such a young age.
She said: “It was the biggest shock to be diagnosed with arthritis. at 30. I thought it was for older people but the type I have can actually develop in your late teens or early 20s.”
Arthritis pain management
For pain management, Denise’s rheumatologist suggested anti-inflammatory medication, but over time, she noticed the impact it was having on her stomach, including developing ulcers, and had to introduce treatments to cope with this. Desperate for an alternative, she visited a local hemp farm.
“I visited the Canna hemp farm where they grew their own hemp and used to make their own products there,” she said.
“I decided to try the hemp juice powder which you add to water and then drink. I used to take a spoonful of it before bed because the pain would be worse at night. When you are moving all day then the pain isn’t so bad, but I would wake up at night crying. My husband would have to turn me over because I couldn’t move.”
Denise began to notice a difference from the hemp powder within a few weeks.
“CBD doesn’t work overnight as it has to build up in your system, I was taking the hemp juice for about a week and a half before I started to feel a bit better. My sons said I had more energy and my husband noticed my mood had improved,” Denise explained.
“When you are in pain all the time, it does affect your mood. I could be tired, snappy, irritable and very down. I found I was more optimistic and that was a big thing for me. It was another two weeks before I realised that at nighttime, I could turn over in bed. I was getting a full nights sleep rather than waking up three or four times a night.”
Denise also noticed an improvement in her anxiety. She struggled being so young with a condition normally associated with older people, and worried about what the future would bring.
When all the hair salons were forced to close during lockdown, Denise decided to be proactive and take the opportunity to open her own CBD store in her local town.
“The industry changed completely, andI realised that with arthritis in my spine that it can fuse your bones together and I won’t have the flexibility in years to come and may not be able to do hairdressing,” she said.
The store, D’Hemp shop, opened in May 2021 in Cavan, Ireland. It attracted a huge amount of attention from curious locals, canna-enthusiasts and unfortunately, the gardai. Denise has been subject to raids and products seizures as a result of ongoing confusion over the THC levels in CBD products.
While Ireland, which is part of the EU, must adhere to European regulations, there is a lack of education over the difference between THC and CBD products. Store owners throughout Ireland have been experiencing raids as a result.
Denise has taken the brave step of launching a legal challenge with the high court. She hopes this will force change in Ireland and introduce clarity around regulations. However, the stress has been a difficult time for her mental health.
“It is very stressful, so many people have been closing down shops and unable to recover,” she said.
“I know a lot of hemp farmers who just gave up because of the red tape and obstacles that were in their way. It’s so disheartening and it’s tragic what is going on in this industry at the moment.”
Denise added: I honestly think that if I wasn’t taking my CBD, I wouldn’t be as calm about the whole thing. It’s keeping me level-headed and keeping the fight in me as well.
“We are not against the pharmaceutical companies, there is room for both of us. It feels like we are being pushed out all the time. If I end up in the hospital and need to take medication then I have no issue with that, but I want the choice to take something alternative too. People aren’t getting that choice [at the moment].”
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