LUMC starts clinical study on fibromyalgia and cannabis

Can herbal cannabis be used to treat fibromyalgia symptoms that are not properly managed with standard therapy?

This year marks the start of a worldwide series of double-blind, placebo controlled clinical trials with standardised, pharmaceutical grade medicinal cannabis. The first trial is being conducted in Leiden, The Netherlands, where prof. dr. Albert Dahan of the department of Anesthesiology of the Leiden University Medical Center (LUMC) is leading a study on the effects of inhaled medicinal cannabis on fibromyalgia symptoms.

Fibromyalgia

Fibromyalgia is a disorder characterised by widespread musculoskeletal pain and sensitivity to touch. These symptoms are frequently accompanied by chronic fatigue, sleep disturbance, and emotional changes. It is estimated that around 3 to 5 percent of the general population is affected by this disease. Interestingly and for unknown reasons, the majority (80 to 90 %) of patients diagnosed with this condition are women.

Commonly used pharmacologic treatments for fibromyalgia include the central nervous system depressant pregabalin (Lyrica®) and the selective serotonin and norepinephrine reuptake inhibitor duloxetine (Cymbalta®), both of which have received regulatory approval in multiple countries for the treatment of this disorder. However, while these medicines have been shown in clinical trials to be effective and relatively safe, not all patients have responded to treatment. In addition, in some patients they have been found to produce a variety of side-effects, including dizziness, drowsiness, or emotional changes which may lead to depression or even, in severe cases, suicidal thoughts.

Cannabis as an alternative treatment

Research shows that cannabinoids – the active compounds present in the cannabis plant – can have a beneficial effect on fibromyalgia symptoms by reducing pain and improving sleep quality. Although cannabis has not been established as an approved medicine for this medical condition, surveys indicate that fibromyalgia patients already self-medicate using cannabis. Moreover, some patients have reported cannabis to produce fewer side-effects than the available conventional treatments and, most importantly, to be effective.

Clinical study

Bedrocan, producer of standardised, pharmaceutical-grade medicinal cannabis, hypothesises that herbal cannabis can be used to treat fibromyalgia symptoms that are not properly managed with standard therapy. For that reason, the LUMC is conducting a study that evaluates how the symptoms of fibromyalgia are affected by the two major cannabinoids (the active pharmaceutical ingredients) of the cannabis plant: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Specifically, a group of patients is being administered these two compounds in the form of vaporized herbal cannabis. The three different investigated drug products are Bedrocan®, Bediol® and Bedrolite®, which are standardised medicinal cannabis varieties that are legally available in the Netherlands. During the study, patients are being subjected to different established measurements and tests that will provide information about the efficacy of the medication in reducing both the physical, as well as cognitive and affective, symptoms of fibromyalgia. It is hoped that the obtained information will push standardised medicinal cannabis forward as a possible alternative treatment for fibromyalgia, particularly for patients who do not respond, or do not respond sufficiently, to existing treatments.