Science Digest – Clinical CBD Study: Adding medical cannabis to standard analgesic treatment for fibromyalgia

    In addition to their current drug regimen, many fibromyalgia (FM) patients seek alternative ways to manage their pain, such as the use of medical cannabis. Can cannabis help? Is it safe? What does science say?

    Can medical cannabis help fibromyalgia patients?

    Just this year, a team of doctors and scientists from Italy published a study that may shed some light on questions like these. They followed 102 FM patients visiting their outpatient clinic at the Luigi Sacco University Hospital in Milan that did not respond to standard painkiller treatment. The selected patients had received stable analgesic therapy for a minimum of three months. Still, they had a pain visual analogue scale (VAS) score of ≥4. This study did not include any FM patients with other conditions or who had recently used cannabis.

    Patients were told to start medical cannabis treatment slowly, beginning with a low night-time dose of Bedrocan (22% THC, 1% CBD) followed by Bediol (6.3% THC, 8% CBD) in the morning. Previously most studies tended to use nabilone, a single synthetic cannabinoid often sold as Cesamet. However, if you are familiar with the Entourage Effect, then you are aware that the best therapeutic potential comes from using the whole cannabis flower, as Bedrocan and Bediol do, which contains multiple cannabinoids.

    Because different cannabis plants can vary in their chemical composition (known as chemovars), it is important to try various cannabis preparations to treat the same disease. 

    As the authors of this study explain: 

    This rationale lies behind the use of two different formulations in the present study: A higher THC/CBD ratio has more potent analgesic properties, but cannot be used in the morning for legislative concerns. On the other hand, a lower THC/CBD formulation can be taken in the morning since it is associated with less drowsiness.

    It is clear that in general, since an ideal [medical cannabis treatment] formulation and dose is still under investigation for FM, the treatment strategy is empirical and based on clinical experience.”

    The full cannabis plant extract used in this study was prepared from standardised cannabis plant material and diluted in oil (1 g of cannabis in 10 g of olive oil). The initial dose prescribed ranged from 10 to 30 drops of the extract. However, patients were allowed to increase the quantity as required without exceeding a total of 120 drops per day.

    How were patients evaluated?

    The first follow-up visit was after 4-8 weeks of treatment with medical cannabis and from then on, every 2-3 months for a total of 6 months. During each visit, the patients answered several questionnaires:

    1. The Revised Fibromyalgia Impact Questionnaire (FIQR) is divided into three domains:
      • Physical function
      • The overall impact of FM on functioning and overall symptom severity
      • Symptoms (memory, tenderness, balance, and environmental sensitivity to loud noises, bright lights, odours and cold temperatures)

    The total FIQR score is the sum of the three adjusted scores. 

    1. The Fibromyalgia Assessment Status (FAS), combines scores relating to fatigue with quality of sleep and Self-Administered Pain Scale (SAPS) scores to provide a single measure of disease activity (range 0–10). 
    1. The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale used to assess fatigue. The total score is the sum of 13 individual parts and ranges from 0 (maximum fatigue) to 52 (no fatigue). 
    1. The Pittsburgh Sleep Quality Index (PSQI) retrospectively measures sleep quality and disturbances with higher scores indicating poorer sleep.
    1. The Zung Self-Rating Depression Scale (ZSR-D) that quantifies depression with higher scores indicating more significant depression. 
    1. The Zung Self-Rating Anxiety Scale (ZSR-A) that quantifies anxiety with higher scores indicating more significant anxiety.

    Before we go through the study’s main findings, it is crucial to keep in mind that of the 102 initially recruited FM patients, 66 completed the study. Therefore, the results are from a group of 66 patients. This is a good size group for this type of research, but too small to truly represent the FM patient population. If you are wondering why they even bother to write that 102 patients were initially recruited, it’s simple. Studies such as these have to report their dropout rate and what drove the patient to discontinue treatment. Later we will look at their reasons for dropping out.

    What were the study’s findings?

    Let’s take a look at the results from the questionnaires: 

    • 45.5% of the patients remained in a stable clinical condition according to the FAS scores
    • 54.5% of the patients experienced more fatigue according to the FACIT-Fatigue scores
    • 44% of the patients experienced better sleep quality and fewer disturbances according to the PSQI scores
    • 33% of the patients experienced a significant clinical improvement according to the FIQR scores
    • 42.4% of the patients experienced less anxiety according to the ZRS-A scores
    • 50% of the patients felt less depressed according to the ZRDS-D scores 

    It’s important to mention that the only variable associated with an improvement in FIQR scores was the patient’s body mass index (BMI): Patients with a higher BMI required higher doses of cannabis. 

    By the end of the 6-month treatment period, almost half of the patients had reduced or discontinued their analgesic treatment.

    Source: Adding medical cannabis to standard analgesic treatment
    for fibromyalgia: a prospective observational study

    One-third of the FM patients that completed the study reported experiencing mild to severe side effects. These included the usual side effects of medical cannabis: dizziness, sleepiness, palpitation, nausea and dry mouth.

    Source: Adding medical cannabis to standard analgesic treatment
    for fibromyalgia: a prospective observational study

    If a significant number of FM patients benefited from medical cannabis treatment (MCT) and the side effects were mild-moderate, then what drove others to drop out?

    Of the 102 initially recruited FM patients, 36 did not complete the study: 

    • Twenty-five patients did not return to the clinic, but ten of these continued treatment with cannabinoids at another centre
    • Six patients stopped treatment because of side effects
    • Three patients discontinued treatment because they didn’t feel any improvement
    • Two stopped treatment because of the high cost

    The authors of this study argue that based on their results, medical cannabis should be considered for symptom management of FM, especially for those patients who suffer significantly from sleep disturbances and mild anxio-depressive symptoms. They also stress that it is vital to determine which subgroups of FM patients are most responsive to treatment.

    [This study] showed that MCT offers a clinical advantage in terms of efficacy, especially for its effects on sleep and quality of life. However, further studies are required to establish the best therapeutic strategy in terms of posology, the THC/CBD ratio, and treatment duration.

    So, what does this mean for fibromyalgia patients?

    This study suggests that for those with fibromyalgia, CBD alongside other cannabinoids could improve sleep and general mental health. Furthermore, it may also be possible to reduce or terminate other pain medications sufferers currently take.

    Even though, according to this study, taking THC/CBD can help manage FM symptoms, sadly it looks unlikely to actually heal the condition. If you are considering adding broad spectrum CBD oil to your diet, please consult with your doctor as it may interact with your medication.



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