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21st December 2022
Cannabidiol (CBD) oil given to patients with advanced cancer receiving palliative care provided no additional benefit to that care according to the findings of a randomised trial by Australian researchers.
Although there have been several advances in medical care, a proportion of patients with advanced cancer still experience substantial symptom distress. The use of palliative care seeks to improve both symptom control and quality of life but despite this, some symptoms can be difficult to control, necessitating more effective medications. Both cannabis and cannabinoid drugs containing cannabidiol, are widely used to treat disease or alleviate symptoms. However, a 2015 meta-analysis concluded that whilst there was moderate-quality evidence to support the use of cannabinoids for the treatment of chronic pain and spasticity, there was low-quality evidence suggesting that cannabinoids were associated with improvements in nausea and vomiting due to chemotherapy. In a feasibility study, Australian researchers examined the use of global symptom burden measures to assess the response to medicinal cannabis with both cannabidiol and tetrahydrocannabinol. They concluded that doses of both cannabidiol and tetrahydrocannabinol were generally well tolerated and that the outcome measure of total symptom distress was promising as a measure of overall symptom benefit.
Based on the these early and promising findings, the same group undertook a randomised trial to determine whether cannabidiol oil could improve symptom distress in patients with advanced cancer receiving palliative care. They included adult participants with advanced cancer and symptom distress which was measured using the Edmonton Symptom Assessment Scale [ESAS]. Participants received titrated CBD oil 100 mg/mL, 0.5 mL once daily to 2 mL three times a day, or matched placebo for 28 days. The ESAS scale is designed to rate the intensity of nine common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. For the trial participants, the inclusion criterion was an ESAS score greater than or equal to 10/90. The primary outcome was set as the total ESAS symptom distress score (TSDS) at day 14, with a response defined as a decrease greater than or equal to, 6 at day 14.
Cannabidiol oil and symptom distress
A total of 58 patients receiving CBD and 63 placebo, reached the primary analysis point (i.e., day 14) and the median dose of participant-selected CBD was 400 mg per day.
The unadjusted change in TSDS from baseline -6.2 for the placebo group and -3.0 for those receiving CBD and this difference was non-significant (p = 0.24). Equally, there was no significant difference in proportion of responders (placebo = 58.7% and CBD = 44.8% p = 0.13).
In fact, during the study, all components of the ESAS improved (that is, reduced) over time with no difference between the placebo and CBD arms. In addition, there was no detectable effect of CBD on quality of life, depression, or anxiety. Overall, most participants reported feeling better (53% CBD vs 65% placebo) or much better (70% CBD and 64% placebo) by day 14.
The authors concluded that CBD oil did not add value to the reduction in symptom distress provided by specialist palliative care alone.
Hardy J et al. Phase IIb Randomized, Placebo-Controlled, Dose-Escalating, Double-Blind Study of Cannabidiol Oil for the Relief of Symptoms in Advanced Cancer (MedCan1-CBD). J Clin Oncol 2022
10th November 2022
Cannabidiol (CBD) given as a full-spectrum (i.e., containing all the components in the plant) solution, significantly reduced anxiety levels but also appeared to improve scores on several cognitive-related tests according to the results of a small, open-label study by US researchers.
A 2013 systematic review estimated that globally, anxiety disorders affect 7.3% of the population but can be as high as 10.4% in Euro/Anglo cultures. Whilst there are several effective anxiolytic therapies available, only about 60% of patients respond to those treatments to any significant degree and many have residual symptoms or remain treatment refractory. Cannabidiol is the most abundant non-psychoactive component of cannabis and has received growing attention due to its anxiolytic and antidepressant properties, representing a promising new agent in the treatment of anxiety and mood disorders. For example, CBD has been found to be effective in patients with generalised social anxiety disorder although to date, only one randomised trial has been undertaken. In this trial, teenagers with social anxiety disorder, received either cannabis oil containing 300 mg of CBD or placebo every day for 4 weeks and saw significant reductions in anxiety. Although cognitive functioning has rarely been examined in CBD studies, some evidence from studies of those using medical marijuana have found improvements in the multi-source interference test (MSIT), which is a measure of executive function and cognitive control. This finding is at variance to other evidence that suggests chronic, heavy recreational of marijuana use is related to cognitive decrements. While previous research has examined the anxiolytic action of CBD, this is usually with a highly purified version. In the present study, the US researchers wondered about the anxiolytic effect of a full-spectrum product. The researchers speculated that CBD in its natural form would not only improve anxiety but might also help other related outcomes such as mood, sleep and quality of life. Moreover, given the suggestion that use of medical marijuana appeared to improve cognition, this too was examined as a secondary outcome. Anxiety was assessing using the Beck Anxiety Inventory (BAI) and for which values > 16 represent at least moderate anxiety. However, several other anxiety related measures were also included. Participants were required to be either cannabis naive or abstinent from regular use. The cannabidiol extract was homogenised into a solution and given as a 1 ml dose (containing 9.97 mg/ml of CBD) sublingually three times a day. Cognitive assessments included a battery of tests to assess executive function and memory.
cannabidiol and improvement in anxiety
A total of 14 participants with a mean age of 41.36 years (21.4% male) were enrolled. The mean BAI score was 20.29 and this reduced by 79.9% to a mean of 16.21 (p < 0.001) at week 4. In addition, there were significant reductions in all of the other anxiety measures after 4 weeks of treatment. Moreover, self-reported measures of mood, sleep and quality of life were also all significantly improved compared to baseline. Furthermore, the product was well tolerated with no serious adverse events noted.
In terms of cognition, there were also significant improvements in several of the measures assessed, in particular the MSIT which was significantly reduced compared to baseline (p < 0.006).
The authors concluded that the data supported both the efficacy and tolerability of a high cannabidiol product for anxiety and suggested that future clinical studies would focus on the cognitive impact of the formulation.
Dahlgren MK et al. Clinical and cognitive improvement following full-spectrum, high-cannabidiol treatment for anxiety: open-label data from a two-stage, phase 2 clinical trial. Commun Med 2 2022