FIBROMYALGIA: YEAR IN REVIEW
Presentation by Valeria Giorgi; Report written by Janice Sumpton
This report summarizes drug management in fibromyalgia discussed at the 2021 International Congress on Controversies in Fibromyalgia.
Adding Cannabis to Analgesics:
- 6-month Italian study observed 102 FM patients with pain scores ≥ 4
- 2 oil-diluted extracts (22% THC/<1% CBD and 6.3% THC/8% CBD)
- 64% of patients remained at the end of study
- Significant improvement in:
- FM severity (FIQR) in 33% of patients
- Sleep (PSQI) in 44% of patients
- Moderate improvement in anxiety and depression in 50% of patients
- Inverse correlation between BMI and FM improvement (eg. Lower the BMI the greater the improvement)
- A decrease or holding of usual analgesics seen in 47% of patients
- 1/3 patients mild side effects that did not change their management
- Cannabis offers a possible advantage especially in those with sleep difficulties.
- Number of patients that remained in the study and the changes in their analgesic use reflects improved quality of life with cannabis.
- Further studies needed to confirm these results.
Reference: Clin Exp Rheumatol 2020;38(Suppl. 123): S53-9.
Safety and Efficacy of Cannabis in Fibromyalgia:
- 6-month study observed 367 FM patients (of which 283 patients taking specifically for FM)
- 81.1% (194 patients) had at least a moderate or significant improvement at follow-up six months after study ended
- Age > 60 yrs and patients with concerns about cannabis use were both associated with treatment failure
- Spasticity at start of cannabis and previous use of cannabis were both associated with treatment success
- Side effects reported 6 months after end of study most commonly were dizziness in 7.9% (19 pts), dry mouth in 6.7% (16 pts), nausea/vomiting in 5.4% (13 pts) and hyperactivity in 5% (12 pts)
- 14 different strains of cannabis used
- Cannabis may be an effective and safe treatment for fibromyalgia
- Consider cannabis in those not responding to standard care
- Further study needed to see effect of cannabis on cognitive impairment, fatigue and other chronic pain syndromes associated with FM
Reference: J Clin Med 2019;8:807.
Cannabis Use and Its Association with Psychological Disorders:
- Caution using cannabis in patients with underlying psychological conditions since cannabis use is linked to a higher incidence of:
- Psychosis and schizophrenia
- Memory impairment
- Developmental and cognitive disorders
Reference: Psychopharmacol Bull 2020;50(2):56e67.
LOW DOSE NALTREXONE
Low-dose Naltrexone for the treatment of Fibromyalgia: Investigation of Dose-Response Relationships:
- 27 women (18-60 yrs old) with FM, 2 withdrew, 25 women evaluated
- Test doses naltrexone were 0.75mg – 6mg and the adjustments to doses were in 0.75mg increments
- 11 out of 25 patients responded
- The dose for improvement in 50% of patients was 3.88mg
- The dose for improvement in 95% of patients was 5.4mg
- Looking at ten common FM symptoms there was much variation between patients at start of study and variation in symptoms that were improved by naltrexone
- First look at dose adjustments and their effects
- Future study needed with randomized comparison of placebo and naltrexone
- 4.5mg dose, previously used seems to be relevant test dose
- Need to see effect of naltrexone on non-pain FM symptoms
Reference: Pain Med 2020;21(10):2253-61.
Repeated Intravenous Lidocaine Infusions in Fibromyalgia patients:
- Higher Doses have a stronger and longer-lasting effect on Pain Reduction.
- Chart review of 74 FM patients had intravenous lidocaine infusion once every 2 months (Wilderman Medical Clinic, Thornhill, Ontario, Canada)
- Initial dose was 5mg/kg body weight, if patient had >25% pain relief for < 2 weeks then dose increased to 7.5mg/kg lidocaine alone and third dose change was addition of 2.5g magnesium sulfate to the 7.5mg/kg lidocaine.
- Evaluated pain (0-10 VAS) just before and after infusion at every visit.
- 5mg/kg, 7.5mg/kg and 7.5mg/kg lidocaine + 2.5g magnesium produced an average decrease in pain by 2.41 on number scale (statistically significant)
- No statistical difference at the 7.5mg doses if magnesium was added or not
- Short-term responders (at least 25% decrease in pain score immediately after infusion):
- Dose was 5mg/kg in 55.4% of patients
- Dose was 7.5mg/kg in 83.8% of patients
- Dose was 7.5mg/kg lidocaine + 2.5g magnesium sulfate in 75.7% of patients
- Long-term responders (at least 25% decrease in pain relief lasting at least 14 days):
- Dose was 5mg/kg in 25.8% of patients
- Dose was 7.5mg/kg in 45.5% of patients
- Dose was 7.5mg/kg lidocaine + 2.5g magnesium sulfate in 57.6% of patients
- Maximum Duration of Pain Relief:
- Up to 49 days after 5mg/kg
- Up to 90 days after 7.5mg/kg
- 75 days after 7.5mg/kg lidocaine + magnesium 2.5g
- Side Effects:
- Mild to moderate, no major cardiovascular events and resolved shortly after infusion
- Seen in 10.3% of patients on 5mg/kg dose
- Seen in 10.8% of patients on 7.5mg/kg dose
- 90 minute lidocaine infusions safely and effectively decrease pain in a significant number of fibromyalgia patients not responding to usual FM treatment
- Higher doses provided a greater relief in pain
- The addition of magnesium sulfate showed a trend of greater response but did not show a statistically significant benefit
- A randomized placebo-controlled trial to look at the different lidocaine doses in fibromyalgia patients is needed
Reference: Pain Med 2020;21:1230-39.
Review of Tramadol for Management of Fibromyalgia Pain and Symptoms:
- Included 4 studies (459 patients total).
- Tramadol with acetaminophen improved quality of life compared to placebo BUT tramadol by itself did not show the same benefit.
- Tramadol + amitriptyline compared to celecoxib + amitriptyline did not show a significant effect on sleep or depressive symptoms.
- A single dose of intravenous 100mg did not show a significant effect on pain compared to placebo.
- Did not find enough evidence to use tramadol in fibromyalgia patients
Reference: Int J Clin Pract 2020;74:e13455.