Ingestion of Cannabis oil in Fibromyalgic people

INTERVENTION: A randomized, double‐blind, placebo‐controlled clinical trial was conducted for eight weeks to determine the benefits of a THC‐rich Cannabis oil on symptoms and quality of life of people with Fibromyalgia. Twenty people were recruited, with 17 meeting the inclusion criteria for the study. The selected participants, with the help of a collaborator and the researcher's lack of knowledge, were randomized into two groups (intervention and placebo). According to the randomization, each participant received a a bottle of Cannabis oil ‐ integral extract of the plant rich in THC ‐ or a bottle of olive oil, drawing the intervention (Cannabis oil) and placebo (olive oil) groups. Intervention group was composed of 8 participants and Placebo group was composed of 9 participants. Participants were informed about the existence and importance of the placebo group. The bottles containing each substance had identical physical characteristics (translucent dark green dropper glass) and were supplied in partnership by the AMA + ME Association. The initial dose of therapy was one drop at night, used sublingually, which could be increased after individual assessments that occurred every ten days during the eight‐week trial period. There was no contact between the participants during the intervention. The therapeutic measures already used by each person for the treatment of Fibromyalgia were maintained. Drug Phytotherapy CONDITION: Fibromyalgia M00‐M99 PRIMARY OUTCOME: Significant improvement in symptoms and quality of life of patients in the Intervention Group, comparing the pre‐intervention and post‐intervention moments, assessed with the Fibromyalgia Impact Questionnaire SECONDARY OUTCOME: Não são esperados desfechos secundários INCLUSION CRITERIA: Fibromyalgia diagnosis (ACR 2010 criteria); age over 18 years; ability to sign the informed consent form; presence of moderate to severe symptoms despite therapies in use; at least one medical or nursing consultation at Health Center on the last year.