The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC) (CHRONIC) This study seeks to exploit bladder In this post I talk about cannabis, the mode of action of CBD, and the clinical applications of CBD when prescribed by licensed medical professionals. We also consider whether CBD might be helpful in interstitial cystitis.
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC) (CHRONIC)
This study seeks to exploit bladder cannabidiol receptors as a therapeutic drug target by conducting a double-masked, placebo-controlled randomized trial evaluating the effects of vaginal hemp cannabidiol (CBD) suppositories on lower urinary tract symptoms (LUTS), pain severity, and sexual function.
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Bladder Pain Syndrome||Drug: Cannabidiol vaginal suppository Drug: Placebo vaginal suppository||Phase 1|
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic inflammatory disease with an insidious course and is detrimental weight to women’s quality of life, sexual function, and general health. IC/BPS affects nearly 1.2 million women in the United States and although there are currently six lines of treatment, they lack high level evidence and sufficient efficacy. New therapies are in high demand. As the cannabis industry gains popularity in medicine, research has revealed prevalent expression of cannabinoid receptors in bladder detrusor muscle and urothelium suggesting a novel drug target for IC/BPS. This study seeks to exploit this target by conducting a double-masked, placebo-controlled randomized trial evaluating the effects of vaginal hemp cannabidiol (CBD) suppositories on lower urinary tract symptoms (LUTS), pain severity, and sexual function. Women with diagnosed IC/BPS will be randomized to treatment with a placebo vaginal suppository or a hemp CBD vaginal suppository. We will monitor changes in their LUTS, pain, and sexual function using validated questionnaires. Our goal is to evaluate whether CBD is an effective, low-risk and less invasive treatment option for IC/BPS. Attainment of this goal would demonstrate a potential novel use for CBD in our Urogynecology patient population.
Does CBD Help With Interstitial Cystitis?
Unless you’ve been living entirely off-grid for the last five years, you’ve almost certainly heard of CBD and will be aware of its rising popularity within the complementary health sector. Just in case all the hype has passed you by, allow me to provide a brief explanation!
CBD stands for cannabidiol and it is one of 113 identified cannabinoids found in cannabis plants. There are lots of other constituents in cannabis plants besides cannabinoids (similar to how there is lots of other stuff in wine besides alcohol) but it is cannabinoids that are considered the important ingredients. Cannabinoids can be subdivided into several other categories, two of which are the aforementioned cannabidiol (CBD) and tetrahydrocannabinol (THC). To avoid inevitable typing mistakes, I am definitely going to be using those three letter abbreviations for this post!
Cannabis is an umbrella term used for around 170 plant species that belong to the Cannabaceae family. Think of it as like the Rosaceae family – aside from actual garden roses, the Rosaceae family also contains cherries, hawthorn and strawberries. Different types of cannabis contain different proportions of cannabinoids, including CBD and THC. Marijuana is the name used for strains of cannabis that have more than 0.3% of THC; hemp is generally defined as being from the Cannabis sativa strain and having a THC content of less than 0.3%. THC is the constituent of cannabis responsible for the feeling of being ‘high’ and strains of cannabis high in THC (i.e. those classed as marijuana) are illegal in many countries. Hemp, while low in THC, is comparatively high in CBD. This makes it possible for hemp to be processed in order to extract CBD. CBD products are legal within the UK and several other countries, provided their THC content does not exceed certain limits. Within the UK, this legal limit is generally accepted to be 0.2%.
CBD does not have the same psychoactive effects as THC, so it does not induce the same feelings of ‘highness’ that people experience when they use marijuana. CBD may be made into oils, vaping fluids, capsules, and even sold as chocolate products! Within the UK, CBD products can be freely purchased without prescription and it is legal to sell them as long as no medicinal claims are made about them. They must be sold as food supplements only.
Although no medicinal claims can be made about over the counter CBD products, anecdotally people have suggested that CBD may have helped them with their own:
- Pain (including arthritis, multiple sclerosis, ulcerative colitis)
- Cancer-related symptoms and side effects of chemotherapy
- Parkinson’s disease
There are, however, plenty of clinical studies regarding the use of CBD when issued by licensed medical professionals to patients for medicinal use.
- In this double-blind study, 57 healthy males were given either 150mg CBD, 300mg CBD, 600mg CBD or a placebo prior to a simulated public speaking test. The 300mg dose of CBD significantly reduced subjective and measured anxiety during the speech compared to the other doses and the placebo.
- In this case study, a ten year old girl presenting with PTSD manifesting as anxiety and insomnia experienced improved sleep and reduced anxiety when taking 25mg of supplemental CBD nightly along with an extra 6-12mg of CBD liquid spray on some nights. demonstrated that cannabis based medicine containing CBD and THC provided better protection against chemotherapy induced nausea and vomiting than antiemetic treatment alone. Acute and delayed chemotherapy induced nausea and vomiting have been found to significantly reduce patients’ quality of life. found that CBD might reduce the frequency of seizures in young people with treatment-resistant epilepsy, with a mean reduction of 36.5%. found that CBD may improve quality of life in Parkinson’s Disease patients while this very small study showed “prompt and substantial reduction” in the frequency of REM sleep behaviour disorder episodes in patients with Parkinson’s Disease.
Fascinating though all that is, I know what you really want to know: can CBD help with interstitial cystitis or other bladder pain conditions? Given the strict rules around making medicinal claims about CBD products, I won’t answer that directly, but I WILL tell you a little about the endocannabinoid system and direct you to some bladder-specific studies.
Endocannabinoids are molecules made by the human body to maintain bodily homeostasis. They are made by the body regardless of whether or not we use cannabis and are important in regulating processes like:
- Appetite and digestion
- Reproduction and fertility
Within our body are cannabinoid receptors that endocannabinoids can bind to. Initially these were thought to exist only in the brain and nerves, but they are now known to also exist in immune cells, the gastrointestinal tract, the heart, the kidneys – oh, and the bladder! It is known that THC binds to cannabinoid receptors, but CBD doesn’t. This leaves scientists somewhat mystified as to how exactly CBD exerts its effects, but it is suggested that it might either prevent your own body’s endocannabinoids from being broken down, or improve the receptors’ ability to actually bind to them. It is also possible that CBD binds to another type of receptor that hasn’t been discovered yet.
There are two types of cannabinoid receptors: CB1 and CB2. CB1 receptors are found extensively in the brain and can moderate mood, memory, motor function and perception of pain. They may also have roles in hormone production and digestion. CB2 receptors are found on immune cells and play a role in inflammation and immune response. They may have an impact on conditions like asthma, allergies, autoimmune disorders and inflammatory bowel disease. (Is anyone else thinking what I’m thinking? I’m remembering my post about quercetin and interstitial cystitis and my post about food intolerances and I can’t help but draw parallels.)
- In this study, human bladders were dissected at the detrusor and urothelial levels. (You may be interested in a previous post I wrote entitled Layers of the Bladder and What Can Go Wrong to find out what exactly the detrusor and urothelium do.) The study confirmed the presence of CB1 and CB2 receptors in both layers of the human bladder and suggested them as “a target for drugs acting on the symptoms of interstitial cystitis/painful bladder syndrome”.
- Another study investigated the expression of CB1 receptors in human urinary bladder and hypersensitivity disorders. It found increased CB1 receptors in the bladders of those with painful bladder syndrome or idiopathic detrusor over-activity as compared with controls and concluded that these may be related to pain and urgency, recommending clinical trials of CB1 agonists in bladder disorders.
- There have been studies into CBD for patients with bladder issues as part of multiple sclerosis. This one suggests cannabis to have a clinical effect on incontinence episodes in patients with MS. I found another detailed article on the topic, but it explicitly forbids the copying or emailing without written permission. I don’t think I had better link to it in case the author would mind, but if you search for ‘Open label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis’, that should get you to it. You are allowed to print or download it for personal use.
- Relating specifically to CBD being used in interstitial cystitis, click this link to read a personal anecdote from a sufferer. And click this link to read another.
I have used CBD myself, but never in relation to bladder pain, PGAD or pain of any kind. I tried it to help with chronic insomnia and I have to be honest it didn’t do much there. I did also try it a couple of times for anxiety – the kind that feels like it’s in your tummy. It was quite effective for that, but happily I don’t get no-reason anxiety too often these days so it wasn’t something I needed to do very often. I now realise that it didn’t stand a chance of helping my insomnia, which I believe was to a large extent being caused by undetected food intolerances. To use one of my favourite healing analogies, you can’t complain that a blister cream doesn’t work if you keep doing five mile hikes in the stilettos that caused the blister in the first place. The issue there is the shoes! I was unwittingly eating foods that were triggering IgG immune responses on a daily basis, so a CBD capsule could hardly be expected to offset that.
My own personal thoughts, for what they are worth, are that CBD may be a highly effective tool in the interstitial cystitis kit. I am struck by the similarities between CB1 and CB2 receptors in the bladder and the things I wrote in my Might You Have an Allergic Bladder post. To me, it seems eminently plausible that if CBD can increase circulating endocannabinoids by impeding their breakdown, or can improve their ability to stick to receptors, that the effects of this would be felt as readily in the bladder as anywhere else around the body. I am really interested to see what emerges in the way of clinical research into this over the next few years and if any of you have personal anecdotes to share, I would love to hear them!
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