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Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study
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Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity.
Methods and analysis
A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan.
Ethics and dissemination
The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.
Keywords: rheumatoid arthritis, ankylosing spondylitis, chronic pain, treatment with medical cannabis
Strengths and limitations of this study
The randomised, double-blind and placebo-controlled design aims to determine outcome data (on the defined endpoints) and, thus, reduces the risk of bias, especially selection bias.
Recruitment in routine care is expected to appropriately reflect the patients and conditions in the two diagnostic groups.
The performance of a controlled study demands the use of medical cannabidiol, and tetrahydrocannabinol instead of plant extracts, that is, tea or herbal preparations.
There is no clinical evidence for the optimal dosage and application ranges. Thus, the treatment regimens for the drugs used are an extrapolation of expert knowledge.
Both primary and secondary endpoints are based on patient-reported outcome measurements and may be influenced by bias.
The treatment of rheumatoid arthritis (RA) and ankylosing spondylitis (AS) has improved significantly over the last three decades. 1–3 Chronic pain and fatigue are symptoms typical of these major inflammatory rheumatic disorders. 4–6 Cognitive dysfunctions, such as concentration and memory problems, are also often reported in patients with chronic pain. These cognitive dysfunctions can be related to pain itself, sleep problems or reflect a side effect of the pharmacological treatment. 4 6 RA affects the small joints of the hands and feet, but can also involve the larger joints. 7 AS mainly affects the spinal and sacroiliac joints and is characterised by back pain and stiffness. 8 Pain may involve nociceptive and non-nociceptive components and is based on the interaction between peripheral inflammation and central sensitisation. 9 10 The immediate pain is triggered by the inflammation of the synovial tissue and/or consecutive oedema of the subchondral bone, and leads to a sensitisation of the peripheral nociceptors. 11
Thus, chronic pain is likely to be due to peripheral joint and central neuropathic pain mechanisms at various stages. 11–16
Treatment of moderate to severe chronic pain is difficult to overcome, for several reasons: heterogeneity of the patients in a given diagnostic group, the progressive nature of the disease, involvement of multiple pain mechanisms and the presence of comorbidities, particularly in elderly patients. 17 The rheumatologist is likely to pay full attention to the anti-inflammatory treatment. This approach implies the fact that chronic pain associated with increased mortality can be overlooked. 18 19
There is a lack of knowledge about the effect of cannabinoids in rheumatic diseases. Based on a Cochrane meta-analysis, the authors concluded that the existing clinical studies of c annabidiol (CBD) applied in monotherapy are of such poor quality that there is insufficient data to draw any conclusions about the effectiveness and/or long-term security of the compound. 20
Currently, only very few studies have investigated how medical cannabis affects cognitive functions, such as concentration and attention. 21 A few studies have investigated the impact of illegally obtained cannabis in RA. 20 Furthermore, studies that have assessed medical cannabis did so mostly in the context of multiple sclerosis. 20 22 23 In contrast to studies of recreational cannabis, the studies in persons with multiple sclerosis indicate that medical cannabis does not negatively affect cognition and could improve sleep quality. Given the limited data and the lack of a proper control condition, no definite conclusions of the potential cognitive impact of medical cannabis could be drawn. 20 24
Hence, concerns about potential negative side effects of medical cannabis on cognition have led the Danish health authorities’ attention on a patient’s ability to drive safely. 20 23 Furthermore, in the treatment of rheumatic diseases, there is no established routine nor rheumatological competence to prescribe medical cannabis. Consequently, there is considerable uncertainty and caution towards the use of medical cannabis, even in the North American countries, where it is already legal to prescribe these compounds for rheumatological conditions. 23 24 This can lead to patients resorting to self-medication with cannabinoids. 20 24 25 Thus, there is a strong need for high-quality studies of the efficacy and side effects of cannabinoids.
The overall aim of the study is to investigate the effect of medical cannabis on pain in patients with RA and AS, to elaborate on the potential dosage of CBD and tetrahydrocannabinol (THC) and to explore if and how the test compounds affect patients’ cognitive functions and sleep.
Materials and methods
Setting and study design
The study is an investigator-initiated, double-blinded, randomised, placebo-controlled intervention study of CBD, followed by an open label add-on of THC. It is designed to evaluate the efficacy and safety of medical cannabis, either as CBD or in the form of the combination treatment of CBD and THC as ‘add-on’ treatment for chronic pain in RA and AS. The patient-reported outcome measurement (PROM), 26 a pain visual analogue scale (VAS) score 27 at a value of at least 50 are the key inclusion criterion. The score range is from 0 to 100; a higher score indicates greater pain intensity. Thus, the null hypothesis, H 0 , is that receiving the active treatment with cannabis derivatives does not improve the pain situation in clinical assessment after 12, 24 and 36 weeks.
Clinical data and outcomes are registered in an electronic Case Report Form (eCRF), based on the Reuma-eCRF system available within the Danish nationwide registry DANBIO. 15 28 DANBIO contains actualised data on ongoing treatment regiments, which therefore easily can be monitored.
Biological samples are collected via the Danish Rheumatologic Biobank. 29 Patients are recruited from four Danish university hospital departments. Patient inclusion is planned to start in November 2018 and is expected to continue for 14 months.
The study population consists of the following:
Patients with seropositive RA 1 currently treated with either conventional disease modifying antirheumatic drugs (cDMARDs) or biological disease modifying antirheumatic drugs (bDMARDs), and without clinical signs of arthritis, as assessed by a 40-swollen joint count.
Patients with AS, according to the modified New York criteria, 2 currently receiving either non-steroidal anti-inflammatory drugs (NSAIDs) and/or bDMARD, who show an absence of clinical signs of axial and peripheral arthritis and enthesitis, and who have an Ankylosing Spondylitis Disease Activity Score (ASDAS)
Ongoing treatment or earlier attempt to treat with paracetamol or NSAIDs without clinical signs of arthritis or spondyloarthritis.
Comorbidities, more specific competitive rheumatological disorders, such as systemic lupus erythematosus, scleroderma, polymyositis or chronic pain condition based on a further clinical detectable aetiology (eg, fibromyalgia).
Evidence of serious uncontrolled concomitant cardiovascular, pneumological, neurological, endocrinological, gastroenterological, urogenital, nephrological or hepatic impairment.
Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
Evidence of active malignant disease, malignancies diagnosed or treated within the previous 2 years, including haematological malignancies and solid tumours.
Actual or previous harmful use of alcohol or drug abuse, in accordance with the WHO definition, 30 within the previous 2 years.
Ongoing treatment with opioids and/or cannabis products and/or neuroleptics, or treatment terminated
Suspected for, or evidence of, active schizophrenia, other psychotic illness in the family history (first degree relatives), other significant psychiatric disorder or treated depression associated with underlying condition.
The treatment starts with oral CBD 10 mg or placebo before bedtime, and increases after 2 weeks to 10 mg two times per day. Finally, and in case of lack of effect (VAS-pain reduction <20) from the beginning of the fifth week, the treatment increases to 10 mg three times per day.
The clinical assessment after 12 weeks defines how to proceed during the following 12 weeks: in case of a sufficient response, that is, a VAS-pain reduction of ≥20, the established treatment continues randomised and without any further adjustment.
Figure 1 presents the consort flowchart and figure 2 the treatment flowchart.
Presents the consort flowchart. TMT, Trail Making Test; VAS, visual analogue scale.
Presents the treatment flowchart. CBD, cannabidiol; THC, tetrahydrocannabinol.
Patients are stratified by diagnosis and by recruiting centre. Patients are randomly allocated to one of the two treatment arms—CBD or Placebo—by random permuted blocks. Randomisation is blinded to the treatment allocation. Allocation is not known to anyone other than Glostrup Pharmacy, who produces and dispatches drug packages on request to each site. Sites receive a sealed, opaque envelope for each patient with the treatment allocation ready to be revealed, should this be required. Treatment is initiated within 2 weeks after randomisation. Measurements of effect are carried out at baseline before randomisation, and postintervention at 12, 24 and 36 weeks postrandomisation. Data analysis and statistical programming are blinded. The randomisation procedure and data analysis are performed by an independent statistician at the Department of Regional Health Research (IRS), University of Southern Denmark, Gråsten, Denmark.
Designated outcomes and clinical data
Primary outcome is the number of patients achieving an improvement of pain-VAS (Δ VAS-pain ≥20) after 12 weeks of treatment.
The fraction (%) of RA and AS patients that achieve an improvement in VAS-pain, as assessed by the reduction of Δ VAS ≥20 and outcome of the PainDETECT Questionnaire, 10 31 after 24 and 36 weeks.
The fraction (%) of RA and AS patients that achieve an improved quality of life (QoL) situation, as assessed by Global-VAS with Δ VAS reduction ≥20 and by the Short Form (36) Health Survey (SF-36), 32 after 24 and 36 weeks.
The fraction (%) of AS patients that achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
A characterisation of AS and RA patients’ cognition and sleep quality, as assessed by the Trail Making Test (TMT), 34 the Digit Symbol Substitution Test (DSST) 35 36 and the Pittsburgh Sleep Quality Index, 37 performed at baseline and after 12, 24 and 36 weeks.
A characterisation of the patients’ expectation for the treatment effect, as assessed by the Credibility/Expectancy Questionnaire (CEQ) and by performing semistructured interviews 38–42 at baseline and after 12 weeks.
The outcome measures include parameters recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) paper. 43
At baseline, and after 12, 24 and 36 weeks, respectively, data are collected in the DANBIO Reuma-eCRF system. Furthermore, two additional nurse consultations are performed after 4 and 16 weeks, to obtain safety information and VAS-pain and to possibly perform a treatment increase from the beginning of the 5th and/or 17th week, respectively, as presented in the Experimental treatment section. The following data are collected at the time points as presented in figure 3 .
Clinical measurements, that is, in RA the Disease Activity Score 28-joints (DAS28-CRP), 44 45 Health Assessment Questionnaire and, in AS, the ASDAS and Bath Ankylosing Spondylitis scores for disease activity (BASDAI), function and measures are registered. 46 47 In both patient groups, additional PROMs are obtained: VASs for pain, fatigue, patient’s global QoL score SF-36 and pain-score PainDETECT. 10 31 Furthermore, the effect of intervention on attention and concentration is investigated using the TMT and DSST. 34–36 Additionally, sleep quality is evaluated with the Pittsburgh Sleep Quality Index. 37 The expected effect of treatment is measured with the CEQ and semistructured interviews.
Exposures, that is, all concomitant treatment, especially current treatments with cDMARDs, bDMARDs and/or analgesics, including dosing schedule and treatment onset.
Patient demographics, for example, diagnosis, age, gender, height, weight, body mass index, disease duration, smoking status, educational level, marital status, sick leave, occupation and ethnicity are obtained at baseline.
The schedule of assessments and procedures. AE, adverse event; ASDAS, Ankylosing Spondylitis Disease Activity Score; BAS, Bath Ankylosing Spondylitis; BP, bloodpressure; CEQ, Credibility/Expectancy Questionnaire; DAS, Disease Activity Score; DSST, Digit Symbol Substitution Test; SAE, serious adverse event; TMT, Trail Making Test; VAS, visual analogue scale.
Blood samples are obtained at baseline, and at 12, 24 and 36 weeks. In addition to routine blood tests, blood samples are collected in one EDTA tube (9 mL), two serum tubes (2×9 mL) and one PAXgene blood RNA tube (2.5 mL, Becton & Dickinson, Lyngby, Denmark), as described previously. 48 These are collected for definition of drug concentration of CBD and THC, that is, monitoring of compliance, possible adverse events (AEs) and for further future analyses.
Statistical analysis plan
The power calculation is based on the following assumptions for the primary outcome.
An expected proportion with a response of 50% or more in the CBD group and expected 20% in the placebo group (OR=4). Response is defined as a reduction in VAS-pain of at least 20 (range 0–100) after 12 weeks of treatment.
This setup gives a statistical power of 0.98 for the primary outcome. The power is reduced if the true difference between the groups is less than the expected 30 percentage points, and if more than an expected 10% of the patients drop out of the experiment. Balanced groups of 45 patients will yield a power of 83% for two-group comparisons on binary outcomes, such as the primary outcome. Slight deviations in sample sizes might occur because of block randomisation.
The primary outcome is tested by a z-test in a logistic regression model. The main parameter estimates the ratio of the odds of response for the intervention group relative to the control group. All tests are two-sided. Secondary outcomes are analysed using logistic and linear regression, depending on the data type. In the case of deviations from the normality assumption, a non-parametric proportional odds model will be used. The secondary outcomes measured at baseline and postintervention, 12, 24 and 36 weeks (follow-up) will be analysed using mixed-effects models, controlling for time of measurement. The random-effects parameter is estimated for the clustering of repeated observations within patients. Analysis for the direct effects of CBD, THC and the interaction between those will be carried out separately, with placebo as the reference group for CBD.
Patient and public involvement
King Christian X’s Hospital for rheumatic diseases involves patients with inflammatory rheumatic diseases actively in both quality assurance projects, research projects and in the development of educational programmes. Furthermore, a user council was established in 2013 in the research department. The project is a consequence of rheumatic patient’s pain reality and the idea of the project was originally presented to the user council back in autumn 2017. Since then, two patients have been involved in the processing of the project. So far, the patient information brochures have been developed based on the integration of the patient’s perspectives. PROMs, especially the patient’s pain VAS, are the main focus of the outcome measurements. Thus, both the burden and consequence of the intervention and the results of the given intervention are transparent.
Meetings with the projects patient representatives will be arranged two times per year and the progress of the project is presented continuously for the user council.
Ethics and dissemination
All patients receive verbal and written information and give their written consent before enrolment, in accordance with Danish Ethics Committee guidelines. Online supplementary appendix 1 presents the projects consent statement in English. All patients are informed that they can withdraw from the study at any time. Although this would lead to the termination of project medication, patient withdrawal will have no consequences for regular course of treatment. In case of withdrawal, no subsequent patient-related registrations will be obtained.
Supplementary file 1
The two cannabis derivatives used in this study are comparable to the authorised compounds in the drug Sativex, which is a registered drug in DenmarK. 49 The patients will receive the information that efficacy of the applied test compound, as well as potential side effect may be comparable to Sativex. The patient’s rheumatologist will provide relevant project information in an outpatient setting. Chronicity of the chosen diseases and the inclusion criteria implies the typical project patient to be well known with a serious burden of disease. Investigators and study nurses are specialists in the rheumatic field.
The treatment consists of CBD tablets and THC herbal capsule preparation, which are produced based on natural raw materials by Glostrup Pharmacy’s laboratory. The drugs are manufactured according to quality-ensured standardised procedures specifying the exact ingredients in milligrams. This makes dosage and monitoring of the therapy safe according to Danish national Good Clinical Practice (GCP) guidelines. The side effects, are well known and well described. 50 The study subjects are patients who are already associated to one of the four participating outpatient clinics. The blood samples at baseline, after 12 and 24 weeks, respectively, will be realised in connection with routine blood tests, in accordance with an a priori arranged outpatient visit and thus will not pose increased risks. At all visits, participants will asked about events and/or reactions. Based on this information, the investigator will assess whether there is an AE, an adverse reaction, a SAE or a suspected unexpected serious adverse reaction. The GCP unit of the University of Southern Denmark monitors the study independently.
The patients will be contacted and informed regarding the overall study results if they indicate interest in this, and in accordance with the patient study consent form and as directed by the Danish Ethics Committee guidelines. The physician in charge of the project at each participating outpatient clinic is responsible for conducting the study in accordance with the fifth edition of the Helsinki declaration. Study participation does not affect the established anti-inflammatory treatment course of individual patients.
Results will be presented at international conferences and published in international and peer-reviewed medical journals. Negative, positive as well as inconclusive results will be published.
Discussion and potential limitations
The project’s focus is on chronic pain, which cannot be attributed to inflammatory activity.
Conventional and bDMARDs possess the potential to treat inflammation sufficiently. Thus, a treatment situation characterised by inflammatory disease activity should be treated according to the existing guidelines, that is, by adjusting the treatment to an adequate DMARD regiment. 1 2 Consequently, the absence of inflammation is a major inclusion criteria. Potential participants are well known as the study demands that their course of treatment has taken place for at least 2 years. Thus, we assume that alcohol or drug abuse, as well as information about ongoing opioid and/or cannabis treatment are accessible information for the involved investigators. Furthermore, the demand of a disease duration of at least 2 years is supposed to ensure the presence of chronical pain.
CBD and THC are two of >80 active compounds in the marijuana plant. 51
In contrast to THC, CBD does not exhibit a narcotic effect and/or intoxication. 52 53 The biochemical effect of the cannabinoids is explained by the compounds’ interaction with specific receptors; the Cannabinoid receptor 1 (CB-1) receptor is located on neurons and glial cells in different parts of the central nervous system, whereas the Cannabinoid receptor 2 (CB-2) receptor is found in structures of the immune system. The stimulating and narcotic effects of THC are considered to be caused by activation of CB-1 receptors. CBD has a very low affinity for these receptors. 51 Thus, CBD binding to the CB-1 receptors causes little to no narcotic effect. New studies show evidence that CBD affects autoimmune signalling pathways and that these mechanisms may be relevant to CBD’s therapeutic profile. 52 53
The effect of CBD is studied in a placebo-controlled design, whereas the effect of a combination of CBD and THC is an open label continuation of the study. The scientifically ideal solution would have been a randomised study comparing both CBD, THC and placebo, for instance, in a cross-over design. Such a design would be characterised by the implicit risks of THC for all patients during the entire study period and it would require a significantly larger study. The actual design represents the balance between a wish to assess the effect of both CBD and THC correctly, while recognising risks, including traffic safety issues, especially due to the THC treatment. Also, the possible negative effect on cognitive functioning can have a large impact on job functioning. Therefore, a more definite answer as to whether medical cannabis negatively affects cognition is important in relation to job functioning and autonomy. We feel our design will provide important information on THC, despite the design, and it has the advantage that we know when THC is applied, and thereby can take the necessary precautions.
The trial population is monitored regularly at the participating outpatient clinics and the individual longitudinal treatment is registered. DANBIO is the nationwide clinical quality database for rheumatology. 16 29 All adult patients treated with biological drugs are registered. Furthermore, patients with AS and RA are registered, regardless of treatment. Thus, the DANBIO based Reuma-eCRF system provides particularly good conditions for the collection and monitoring of validated data.
CBD Oil for Ankylosing Spondylitis [How Does It Work?]
Among the top reasons why people use CBD are chronic pain, aching joints, and arthritis. These are all symptoms that affect people with ankylosing spondylitis. So, how can the cannabinoid benefit this debilitating disorder?
Here’s our complete guide to CBD oil for ankylosing spondylitis. We’ll discuss how it works and how to use it for maximum effect. But first, here’s a brief overview of the condition.
What Is Ankylosing Spondylitis?
Ankylosing spondylitis is a condition involving inflammation of the spine. It can also cause inflammation of the joints (arthritis) and the points where ligaments and tendons connect to bone (enthesitis).
Unlike many inflammatory conditions, ankylosing spondylitis tends to affect young people. It usually becomes evident during the teenage years or early adulthood. It is more common in men than in women.
Ankylosing Spondylitis Symptoms
The symptoms of ankylosing spondylitis can range from mild to disabling. Some patients experience back pain that comes and goes and may even improve over time. However, for others, the disease follows a more progressive course.
In severe cases, ankylosing spondylitis can cause permanent spinal damage.
As the body tries to compensate, it generates new bone, causing the vertebrae to fuse. This leads to a loss of flexibility and mobility, known as ankylosis. It can also affect the ribs and cause breathing problems.
Other ankylosing spondylitis symptoms include:
- Painful, swollen joints
- Pain in the buttock area
- Eye inflammation (iritis)
- Increased risk of osteoporosis
- Increased risk of cardiovascular disease
People with ankylosing spondylitis also frequently suffer from sleep disturbances. This is primarily due to pain and difficulty getting comfortable at night.
What Causes Ankylosing Spondylitis?
Ankylosing spondylitis is associated with changes in a gene known as HLA-B. It is responsible for regulating the production of proteins in the immune system.
The genetic variation HLA-B27 exists in around 90% of ankylosing spondylitis patients. However, not everyone with this variation develops the disease. Some scientists believe that environmental factors can trigger the condition’s onset in susceptible people.
Understand the difference!…
Ankylosing Spondylitis Treatment (Not CBD)
Physical activity tends to relieve ankylosing spondylitis pain. Therefore, physical therapy and exercise are among the most effective treatments. Massage and daily stretching can also help.
Patients who need additional pain-relief may find the following medications beneficial:
- Traditional painkillers, including opioids
- Non-steroidal anti-inflammatory drugs
- Tumor necrosis factor (TNF) inhibitors
- Disease-modifying drugs
- Corticosteroid injections
The problem with most of these medicines is that they can cause unpleasant side effects, especially with long-term use. Therefore, many patients are wondering whether natural remedies like CBD can help ankylosing spondylitis.
Does CBD Help Ankylosing Spondylitis?
There is currently no research on CBD for ankylosing spondylitis, specifically. However, a study is in the pipeline. It aims to test the efficacy of cannabinoids for ankylosing spondylitis and rheumatoid arthritis.
As the prospective researchers explain, these are two systemic inflammatory conditions. And one of the most significant ways that cannabinoids work is by reducing inflammation. They do this by interacting with the body’s endocannabinoid system (ECS). The ECS has a regulatory function over many of our physiological processes, including the inflammatory response.
Inflammation is the immune system’s way of dealing with injuries or infections, and, in acute situations, it is highly beneficial.
However, sometimes the immune system can become overactive and generate inflammation for no apparent reason. This leads to a variety of painful conditions, including ankylosing spondylitis. It appears that this is where cannabinoids like THC and CBD can help. They dampen immune system activity and reduce inflammation and pain.
THC exerts its effects by binding directly with cannabinoid receptors in the ECS. However, CBD works slightly differently. It seems to enhance the activity of the body’s natural cannabinoid compounds to produce healing without intoxication. CBD also affects several receptors outside the ECS, adding to its overall effectiveness.
So, while CBD will not cure ankylosing spondylitis, it could provide symptomatic relief.
Research on CBD Oil for Inflammation and Pain
Although there are no existing studies on ankylosing spondylitis and CBD, plenty of research has been conducted on inflammation and pain.
One such study appeared in the European Journal of Pain in 2016. Its authors investigated the effects of transdermal CBD on rats with inflammation due to arthritis. They massaged CBD gel into the rats’ skin for four days. At the end of this timeframe, the rats showed reductions in joint swelling and pain.
The study also showed that CBD reduced the activity of pro-inflammatory chemicals, including TNF-alpha. The authors concluded:
“…transdermal administration of CBD has long-lasting therapeutic effects without psychoactive side-effects. Thus, [the] use of topical CBD has potential as [an] effective treatment of arthritic symptomatology.”
A more recent 2019 study for Postgraduate Medicine found that CBD also benefits humans living with chronic pain. It included 97 participants with painful conditions who had been using opioids for at least one year.
After taking full-spectrum CBD hemp extract for eight weeks, 53% of the participants either reduced or stopped their opioid use. Moreover, an impressive 94% of the participants said that their quality of life had improved. One significant aspect of this was better sleep.
How to Use CBD for Ankylosing Spondylitis
There are many different CBD products, and choosing the best one for ankylosing spondylitis can be challenging. The primary consideration is whether to use CBD orally, by inhalation, or as a topical cream. Each option has pros and cons.
Oral CBD products include oils, capsules, and edibles. Consumers take them by mouth, and the cannabinoid passes through their digestive system into the bloodstream. The main advantage of this is that CBD can influence the whole body, making it ideal for systemic symptoms.
The downside of oral CBD consumption is that it has a low bioavailability rate. This means that much of the active ingredient is lost in the metabolization process. That can lead to significant waste, especially considering the cost of high-quality CBD.
Inhalation offers a higher bioavailability rate. This consumption method includes vaping or smoking high-CBD hemp flower. Inhalation also provides almost instant effects, making it popular among those living with painful conditions.
The obvious disadvantage is that smoking is bad for the lungs. It is also pro-inflammatory and could exacerbate ankylosing spondylitis symptoms. Most experts consider vaping a safer option, but the long-term effects are still unclear.
Finally, topical creams and balms provide targeted relief in a specific area. They allow CBD to absorb through the skin rather than the digestive tract, making them popular among people with aches and pains. These products may also contain other anti-inflammatory ingredients to provide another level of relief.
The main drawback is that CBD topicals are only effective in a specific area. Therefore, they may not be the best for ankylosing spondylitis patients with pain in multiple joints. Of course, it is possible to apply these products to more than one area, but this can become expensive.
Full-Spectrum vs. CBD Isolate
A further consideration for anyone wishing to try CBD oil for ankylosing spondylitis is whether to choose full-spectrum CBD or an isolate. The former contains a range of cannabinoids and terpenes, while the latter contains almost pure CBD.
Many experts consider full-spectrum CBD products superior.
They believe that the various active compounds in cannabis and hemp work together synergistically. This phenomenon is widely known as the entourage effect.
Furthermore, other cannabinoids such as CBG and CBC have anti-inflammatory and painkilling effects. So do various terpenes. Therefore, full-spectrum CBD allows consumers to benefit from therapeutic properties beyond CBD alone.
However, full-spectrum products do contain trace levels of THC. Although it is not enough to cause intoxication, it may cause some people concern. In this case, CBD isolate may be the solution.
Another compromise is broad-spectrum CBD, which is essentially full-spectrum minus the THC. These products are more difficult to come by, but they are steadily becoming available from an increasing number of manufacturers.
When buying any kind of CBD for ankylosing spondylitis, choose a company that provides third-party lab reports. They tell potential customers precisely how much of each cannabinoid their products contain and indicate a reliable brand.
CBD Oil for Ankylosing Spondylitis: Final Thoughts
There is no research currently available on CBD oil for ankylosing spondylitis. However, there is evidence of its anti-inflammatory and pain-relieving properties. This could be enough to inspire those looking for natural alternatives to prescription painkillers to try it.
While CBD is safe for most people, we advise anyone trying it for the first time to consult a physician first. They will ensure that CBD is a suitable treatment, whether for ankylosing spondylitis or any other condition.