Fibromyalgia is a poorly understood syndrome, characterized by chronic widespread pain, fatigue, and sleep disturbance. It appears to involve an alteration of central pain pathways, in which mast cells, which mediate activation of microglia through cytokines like interleukin 1 beta (IL-1B), interleukin 6 (IL-6), and tumor necrosis factor (TNF) alpha, play a central role. It may as well overlap with other conditions. Existing treatments, none of them completely satisfactory, include memantine, naltrexone, tapentadol, duloxetine, and palmitoylethanolamide.
Cannabinoids may be of promise. This is because they generally show anti-inflammatory and immunomodulatory activity, and often possess a demonstrated analgesic capability, acting on cannabinoid receptors and inhibiting presynaptic gamma-aminobutyric acid (GABA) and glutamatergic transmission. For reasons not completely known, activation of receptors CB1 and CB2 in general seems to have anti-pain-perception effects overall. The exact nature of fibromyalgia pain is elusive, however, since it appears not to be a function of any apparent tissue damage.
On available research evidence, the likeliest cannabinoids to be of help are tetrahydrocannabinol (THC) and cannabidiol (CBD). Both act on CB1 and CB2 receptors. The former influences pain, appetite, orientation, and mood; the latter has anti-inflammatory, anti-anxiety, and analgesic effects. THC is a partial agonist; CBD is primarily a negative allosteric modulator of CB1. This, and the likely existence of an entourage effect, suggests that in combined therapy the proportion of THC to CBD would be of central importance in the development of cannabinoid-based therapy.
Studies confirm that this balance matters, and have shown that there is indeed some symptomatic relief to be had with nabilone and dronabinol (a synthetic form of THC) in neuropathic pain at least, though adverse effects are not unknown. Studies on the direct use of cannabinoids in fibromyalgia, which does not appear classically neuropathic, do exist as well. They center on nabilone, dronabinol, Bedrocan (22.4 mg THC, <1 mg CBD), Bediol (13.4 mg THC, 17.8 mg CBD), and Bedrolite (18.4 mg CBD, <1 mg THC).
In one experimental study, patients who were treated for three months with standard analgesic therapy and showed minor improvement in the symptoms, were then treated with medical cannabis in addition for six months, and did report higher improvement. Another study, with varying cannabis compounds, showed small analgesic responses after a single dose. None of these treatments had an effect greater than placebo, though subjects uniformly reported greater decrease in pain scores in the Bediol cohort. This study also revealed an antagonistic pharmacodynamic interaction between THC and CBD, a feature of the two that has been described elsewhere. Bedrolite, a cannabis variety with a high CBD content, showed no analgesic activity at all. A head-to-head study of Bedrocan and Bediol showed a moderate improvement in anxiety and depression in 50% of treated patients, with no significant difference in pain outcomes between the two treatments. A large safety study conducted between 2015 and 2017 showed that medical cannabis intervention is generally well tolerated. The most common adverse effects in that study were mild, and included dizziness, dry mouth, and gastrointestinal discomfort. Three other studies, of THC-rich medical cannabis, have confirmed that in general subjects tend to report some improved pain scores, and that adverse events are mild.
It therefore appears that cannabinoid compounds may be useful in ameliorating some common and debilitating symptoms associated with fibromyalgia, and could be appropriate when other treatment lines have been exhausted. The exact reasons for this remain to be understood, however, and further long-term study is necessary to assess with precision any long-term efficacy, adverse effects, and potential problems of dependence. The suitable ratio of TCH to CBD also needs to be ascertained for optimal outcome.
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The foregoing is a report on trends and developments in the cannabinoid industry. No product described herein is intended to diagnose, treat, cure or prevent any disease or syndrome.
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