We publish a newsletter which is sent to all members, doctors surgeries, libraries, national and local politicians. The newsletter includes details of our events together with news about advances in the treatment of epilepsy and changes in benefits available to members. To see the latest edition view here
In all matters related to this as in other clinical matters we rely on the information from Epilepsy Research UKwho have issued the following statement
The ERUK view of the current debate around cannabis-based products as a treatment for epilepsy can be found below.
To summarise the statement, whilst there is evidence that medical-grade preparations of an active ingredient of cannabis, cannabidiol, can be beneficial in some types of epilepsy, cannabis oil itself cannot be considered a safe or effective treatment. This is due to the variety of compounds found in over-the-counter cannabis oils, some of which may have harmful effects. People with epilepsy and their families should consult with their epilepsy specialist doctor for advice as to treatment options.
With very many thanks to Professor Hannah Cock
Why the interest in cannabis?
The idea that cannabis might be helpful for some people with epilepsy has been around for thousands of years. However, it is only in the last few decades that we have started to understand why this might be. The brain makes chemicals (endocannabinoids) which are very similar in structure to some components of cannabis. These are involved in the regulation of how “excitable” the brain is, and so can also influence the liability to seizures. Cannabis contains hundreds of different chemicals, the two most important of which are Tetrahydrocannabidiol (THC) and Cannabidiol (CBD). Both THC and CBD seem to be effective against seizures . THC is the part that makes people feel “high”, but it can also cause negative effects such as anxiety and paranoia . THC has also been shown in some models of epilepsy to promote seizures. There is also a small risk of the brain getting used to THC, needing more over time (tolerance) and potentially leading to addiction. Taken regularly there is also significant evidence that THC, particularly in the developing brain (up to young adulthood), can sometimes cause permanent damage to IQ, mental health and brain structure. For these reasons doctors and scientists have focussed on CBD, which doesn’t seem to carry these risks.
The first good quality evidence appeared in 2016 , following which several well-controlled clinical trials of a near pure formulation of CBD (Epidiolex™, made by the UK Company GWPharma) were published [4-6]. EpidiolexTM contains less than 0.1% THC.The best trials of new drugs include a period of time when patients and their doctors don’t know if the additional drug they are taking as part of the trial contains the drug being studied or not. There are strict entry criteria so that after allocating people randomly into taking the drug or the placebo, the two groups are otherwise well matched and the effect of the drug (as opposed to other factors) can be more clearly identified. These are called randomised blinded studies, and the pill or solution without the active drug is called the placebo. At the end of the blinded-placebo phase, everyone is then switched to the active drug. This is to measure the “placebo effect”: this refers to the known fact that some people will get better when they start a new pill or solution, even if it doesn’t’ actually contain the new drug under study.The blinded placebo controlled studies of CBD have all been done in people with two particularly severe paediatric onset, drug resistant and often life limiting epilepsies: Dravet’s syndrome and Lennox Gastaut Syndrome. Most of the participants were children, all taking other antiepileptic drugs at the same time, and having at least 8 disabling motor seizures each month. The blinded phase of the studies lasts only a few months, so has to include people with very frequent seizures to measure change
There have also been studies in over 3000 people with a range of different epilepsies taking CBD, with or without some THC, over periods of months to years, but without a blinded placebo arm (known as “Open studies”) . Open studies are often much less well designed, with a higher risk of more positive reports oeffectiveness than might reflect the true situation. That doesn’t mean people in these studies are lying, just that epilepsy is inherently variable and will sometimes improve over time without a change in drugs, so by chance alone this might sometimes be misinterpreted as a response to a new drug. There is also a lot of evidence for epilepsy that factors such as mood and stress can influence seizure frequency. Epilepsy trials, like trials in other conditions, show evidence of a placebo effect, and the placebo effect is known to be bigger where those taking what they think is a new drug have a strong belief that it will work. There has been intense social and media attention around cannabis in recent years. Together with a belief held by many that a natural product is inherently safer and more effective than a synthetic compound, this may mean a placebo effect is more likely with cannabis-derived drugs than some other new agents. Ultimately what this means is that observational data is useful in terms of detecting safety and side effects, but much less reliable as a measure of effectiveness.Effectiveness, side effects and short term safetyBased on the blinded trials, and the better controlled open label studies, the best current estimates are that of every 8 people with drug resistant epilepsy treated with CBD, 1 will have a greater than 50% reduction in the frequency of disabling motor seizures, but only around 1 in 171 will achieve long term seizure freedom. Around 1 in 3 will have side effects, most commonly diarrhoea, drowsiness, reduced appetite, vomiting and fatigue. These are often mild, and improve over time or with a reduction in dose. Around 1 in 23 people will have serious side effects, usually meaning the drug has to be stopped. Interactions with other antiepileptic drugs, so far in particular with valproate and clobazam have also been identified, with dose adjustments sometimes needed .Given the very severe nature of the epilepsies that have been studied in the trials, even a 50% reduction in disabling seizures can make a significant difference to the individual, and for the small number who have a dramatic response without side effects this can be life changing. It is this evidence that has resulted in the American licensing authorities approving Epidiolex™ for use in two severe drug-resistant paediatric onset epilepsies (Dravet and Lennox Gastaut Syndromes). European and UK authorities are expected to follow suit in 2019.Comparison to other licensed antiepileptic drugsThere have been no studies comparing CBD, or other cannabis-based drugs to other licensed drugs. In broad terms, based on the number of people whose seizures improve and the risk of side effects, CBD looks similar to other newer drugs. However, we have much more data about safety and effectiveness of other drugs, especially taken in the long term, than we do about CBD. The possible benefits and risks of trying CBD in patients with drug-resistant epilepsies will vary considerably between individuals. Doctors specializing in epilepsy treatment will discuss this, and other treatment options, with patients and their families to help make the best decision for the individual.
Over the counter preparations
There are a range of cannabis oils available in health food shops, over the internet, and in countries where “medicinal cannabis” is available. These products contain both CBD and THC in varying proportions. Products with <0.2% THC are legal in the UK, but are not manufactured under the same controlled conditions as pharmaceutical drugs are. They can contain other chemicals, including pesticides and impurities, including some components of the cannabis plant linked to cancers and other long term health problems . The quantities of CBD and THC may not match what they say on the label and can vary from batch to batch. Doctors and scientists do not recommend use of these products. People with severe drug-resistant epilepsies should consult with their epilepsy specialist to explore treatment options, including whether there may be clinical trials they can take part in. With the impending change in licensing for cannabis-based products, and early promising evidence, it is very likely that there will be new trials recruiting in a broader range of epilepsy types in the coming months and years.
If you usually take Carbagen SR, speak to your GP, epilepsy nurse or epilepsy specialist for advice. You may need to temporarily switch to a different version of carbamazepine until Carbagen SR is back in stock.
The charity Contact a Family which give valuable adto families of disabled children has shortemed its name to Contact. Their website and contact details remiain the same
The next meeting of Epilepsy HERE will be at Headway House, Kent and Canterbury Hospital, Ethelbert Road, Canterbury on Monday1st October2018at 6.30 pm.Future meetings wil be held at Headway Houe, Kent and Canterbury Hospital on the first MONDAY of each month except January and August or if it is a Bank Holiday from 6.30 pmto 8.00 p.m.
The next Coffee Break meeting at Whitstable United Reformed Church, Middle Wall, Whitstable on Tuesday 18th September 2018 from 10.00-11.30 a.m. Why not come along to meet us and chat about whatever interests you.
The Kent & Medway Care Record
Recent changes in the law means that all NHS organisations must now legally share information about your care with other professionals to enable this joined up care to happen.
The complex picture in Kent & Medway means there are 4 x hospital trusts, 3 x provider of core community services, 2 x providers of community based mental health services Also there are 249 GP practicesaround 466 social care providers. 394 dentists
157 opticians more than 335 pharmacies in primary care 2 x Out-of-hours primary care services and 303 privately run residential and nursing care homes In addition a number of people travel from outside Kent and Medway to use services in Kent and Medway hospitals.
So what’s the vision?
Vision for the KMCR “Regardless of who employs them, health and care professionals are able to quickly and easily view their patient’s digital records (or relevant components of them) from wherever they are, and without the need to navigate multiple systems, regardless of the local health or care provider who holds them.”
How will this happen?
The way in which this is going to be done is via the Kent & Medway Care Record which is a computer system that NHS organisations can view and read on a range of devices to help them plan and deliver the health care that you need. Only registered health and social care professionals can read your records and they can only see the elements that are relevant to their role and the care that they are providing you.
For example, a Care worker visiting someone at home might be able to see that they have recently been discharged from A&E without having full access to that person’s entire medical history. But they would be able to see who to contact to find out more if needed.
What are the planned benefits?
- Improved outcomes because care professionals have better data about their condition, needs and wishes.
- Reduced delays in receiving the right care in the right place at the right time, and where applicable quicker discharge because care professionals do not have to wait for information to be received from another care setting
- Improved transitions of care that should avoid having to give their details and history each time.
- Assurance that all care professionals involved are aware of their needs and care plans.
- Access to own care record allowing better self-management supported by information and advice about how they can help themselves.
- Increased control over their personal health information through a consent model that enables them to determine which organisations and care professionals should have access to their records.
- Personal health analytics enabling them to understand their usage of the care system.
- Personalisation of communication preferences e.g. email, letter or SMS.
For health and social care professionals and providers:
- Better integrated care by sharing data for handovers and MDTs; and enabling new models for delivering integrated care.
- Improved safeguarding: ensuring that children and vulnerable adults that are at risk are immediately known as being so and reducing the level of risk
- Improved quality of clinical and professional decision making: taking into account all relevant information, especially in complex cases.
- Reduced care costs through: avoiding repeated tests and unnecessary treatment; more effective use of out-of-hospital care packages, reducing pressure on emergency care; shorter hospital stays through multi-agency discharge planning; more effective medication reconciliation.
- Quicker and more efficient communication between care organisations
- More efficient workflows: enabling visibility of workflows between care professionals.
- Assurance that care is provided consistently, safely and in accordance with the needs and wishes of the individual.
What is the Governance for the Care Record?
The basis for sharing information for direct care is General Data Protection Regulation Article 9(2)(h) and Article 9(3). The Kent and Medway Care Record will enable health and social care organisations to meet the statutory ‘duty to share’ set out in the Health and Social Care Act 2012 /2015. Care providers do not need the consent of the patient to access relevant information about the patient or to share it with those who provide (or support the provision of) direct care to the patient if all of the following are met.
Next steps (anything else to add?)
Your feedback on the proposed KMCR will be taken back to the reference Group.
The development of the KMCR requirements will be led by a Citizen User Group and the Clinical Reference Group.
For more information about the Kent & Medway Care Record and other plans to improve health and social care services please visit: