LUMC start klinische studie: fibromyalgie en cannabis

Admin   juli 13, 2017   Reageren uitgeschakeld

fibrolumcHet Leids Universitair Medisch Centrum start de eerste klinische studie met betrekking tot fibromyalgie en cannabis.

Persbericht:

16 februari 2017

Veendam, Nederland – Kan cannabis gebruikt worden om de symptomen van fibromyalgie te verlichten die niet goed met standaard therapie behandeld kan worden?

In 2017 start een wereldwijd double-blind, placebo gecontroleerd klinisch onderzoek met gestandariseerde phamaceutische medicinale cannabis. Het eerste onderzoek zal in Leiden beginnen, waar professor dr. Albert Dahan die werkzaam is op de afdeling anesthesie van het Leidens Universitair Medisch Centrum, de studie zal leiden op de effecten van geïnhaleerde medicinale cannabis bij de symptomen van fibromyalgie.

Fibromyalgie is een aandoening die pijn veroorzaakt in bindweefsel en spieren het  wordt ook wel weke delen reuma genoemd.  Deze symptomen gaan vaak gepaard met chronische vermoeidheid, slaapstoornissen en emotionele veranderingen. Geschat wordt dat ongeveer 3 tot 5 procent van de bevolking wordt beïnvloed door deze ziekte. Interessant en om onbekende redenen, de meerderheid (80-90%) van de patiënten met deze aandoening zijn vrouwen.
Veel gebruikte farmacologische behandelingen voor fibromyalgie omvatten het centrale zenuwstelsel pregabaline (Lyrica®) en selectieve serotonine en noradrenaline reuptake inhibitor duloxetine (Cymbalta®), die beide in meerdere landen goedkeuring heeft gekregen voor de behandeling van deze aandoening. Hoewel deze geneesmiddelen in klinische onderzoeken effectief en relatief veilig bleken, reageerden niet alle patiënten op de behandeling. Bovendien, bij sommige patiënten is gebleken dat verschillende bijwerkingen, zoals duizeligheid, slaperigheid, of emotionele veranderingen die kunnen leiden tot depressie of zelfs, in ernstige gevallen, suïcidale gedachten produceren.


Cannabis als een alternatieve behandeling


Onderzoek toont aan dat cannabinoïden – de actieve verbindingen aanwezig in de cannabisplant – een gunstig effect op fibromyalgiesymptomen door het verminderen van pijn en verbetering van de slaapkwaliteit kan hebben. Hoewel cannabis is niet vastgesteld als een goedgekeurd medicijn voor deze medische aandoening, enquêtes blijkt dat fibromyalgie patiënten die reeds zelfmedicatie met behulp van cannabis. Bovendien hebben sommige patiënten cannabisdetoxificatie minder bijwerkingen veroorzaken dan de beschikbare conventionele behandelingen en, belangrijker nog, effectief.


Klinische studie


Bedrocan International – licentiegever voor de productie van gestandaardiseerde, farmaceutische kwaliteit medicinale cannabis – veronderstelt dat cannabis gebruikt kan worden om fibromyalgie symptomen die niet goed worden beheerd met standaard therapie te behandelen. Daarom is het LUMC een studie die evalueert hoe de symptomen van fibromyalgie worden beïnvloed door de twee belangrijkste cannabinoïden (de werkzame farmaceutische bestanddelen) van de cannabisplant: delta-9-tetrahydrocannabinol (THC) en cannabidiol (CBD). Specifiek wordt een groep patiënten toegediend deze twee verbindingen in de vorm van verdampte cannabisbladeren.

De drie verschillende onderzochte geneesmiddelen zijn Bedrocan®, Bediol® en Bedrolite®, die gestandaardiseerde medicinale cannabis rassen die legaal in Nederland verkrijgbaar zijn, zijn. Tijdens de studie worden patiënten onderworpen aan verschillende gevestigde metingen en tests die informatie over de werkzaamheid van het geneesmiddel bij het verminderen van zowel de fysieke als cognitieve en affectieve symptomen van fibromyalgie zal verschaffen. Gehoopt wordt dat de verkregen informatie gestandaardiseerde medicinale cannabis naar voren zal schuiven als een mogelijke alternatieve behandeling voor fibromyalgie, met name voor patiënten die niet reageren, of niet voldoende reageren op de bestaande behandelingen.


 

volcanoPRESS RELEASE
16th of February 2017
LUMC starts clinical study on fibromyalgia and cannabis
Veendam, Netherlands – can herbal cannabis be used to treat fibromyalgia symptoms that are not properly managed with standard therapy?
2017 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 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 International – licensor for production of standardized, pharmaceutical-grade medicinal cannabis – hypothesizes 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 standardized 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 standardized 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.
Note for editors
For more information please contact our press office at:
e: press@bedrocan.com
t: +31 598 623 731

i: www.bedrocan.com

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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 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 International – licensor for production 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.

 

Bron

Het onderzoek is reeds gaande en zal eind 2017 worden afgerond.