A new study, led by Southern Cross University in Australia, will research the efficacy of medicinal cannabis in the treatment of patients with fibromyalgia.
The project, which is expected to commence in early 2022, will assess the safety, tolerability and efficacy of medicinal cannabis in relieving pain and other symptoms in adult patients diagnosed with fibromyalgia syndrome (FMS)
FMS affects approximately 2.7 percent of the global population and is characterised by chronic widespread pain, sleep disturbances, morning stiffness, severe fatigue and cognitive dysfunction.
It is often accompanied by other somatic and psychological impairments including mood changes, depression, anxiety, irritable bowel syndrome, vulvodynia, interstitial cystitis, chronic prostatitis, temporomandibular joint dysfunction and headaches.
Treatment options are limited for people suffering FMS with previous studies demonstrating medicinal cannabis may be beneficial for some people suffering FMS.
Intended to run over a three-year period, the Southern Cross study will be conducted in three stages starting with a literature review and survey.
The final stage, a Phase 2 randomised controlled, double blinded, placebo-controlled clinical trial, is planned to begin recruitment in 2022 and uses medicinal cannabis in a 1 THC: 1 CBD ratio versus a placebo for a three-month period with follow-ups for a further six months post-trial.
The Principal Investigator for this research undertaken by Southern Cross University is Dr Janet Schloss, part of the National Centre for Naturopathic Medicine as the Clinical Research Fellow conducting clinical trials and has also been in private practice as a Naturopath and Nutritionist for over 20 years.
Australian medical cannabis company Little Green Pharma (LGP) will provide funding for the three-year PhD Scholarship and research supervision, as well as medicinal cannabis products in connection with the research project.
Commenting on the research program, LGP Head of Research and Innovation Dr Leon Warne said: “LGP is proud to be associated with Southern Cross University in this important research study. FMS is a debilitating disease and knowing that LGP is doing its part to assist in a clinical trial into the effectiveness of medicinal cannabis in treating FMS sufferers goes to the heart of our goal of providing a cost-effective therapy to enhance the quality of life of patients.”
Under the Scholarship grant agreement, LGP will provide scholarship funding to support PhD candidate Inna Kurlyandchik.
Kurlyandchik commented: “Fibromyalgia is a complex condition with limited treatment options available. Last year we undertook a systematic review and found that medicinal cannabis has potential to reduce pain and improve the quality of life in fibromyalgia patients. I would like to express my gratitude for the PhD scholarship provided to me by Little Green Pharma LTD and Southern Cross University, which will allow me to build upon previous research in this area and further understand safety and efficacy of medicinal cannabis in treatment of this complex disorder.”
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