| 25 |
To evaluate the impact of CBPMs (oil) on symptoms and quality of life of individuals with FMS |
30-mL green glass dropper bottle containing cannabis oil with 24.44-mg/mL concentration of THC and 0.51 mg/mL of CBD (Sublingual) |
The initial dose in both groups was one drop (1.2 mg of THC and 0.02 mg of CBD) a day |
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FIQ: pre-intervention score was 75.5 SD = 12.93 and pos intervention score was 30.5 SD = 16.18, p < 0.001. In the placebo group, the pre-intervention score was 70.22 SD = 11.18 and pos post-intervention score was 61.22 SD = 17.30 p = 0.07 NS*
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| 26 |
To evaluate the analgesic effects of inhaled CBPMs using the cannabis plant with all its natural components |
Bedrocan with 22 % THC and less than 1 % CBD (Vaporized)
Bedrolite with 9 % CBD and less than 1 % THC
Bediol with 6.3 % THC and 8 % CBD (Vaporized)
Placebo variety without any THC or CBD content (Vaporized) |
Not specified |
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Pain in Visual Analogue Scale (VAS)
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Electrical pain response test
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Tolerance to pressure in kilogram-force per square centimeter (kgf/cm2)
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Spontaneous pain scores: No effect greater than placebo
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Pain score: significantly more patients responded to Bediol with a decrease in spontaneous pain by 30 % p = 0.01, compared to placebo
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Spontaneous pain scores were strongly correlated with the magnitude of drug for Bedrocan (p < 0.001) and Bediol (p < 0.001)
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Electrical pain responses: no effect greater than placebo
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Tolerance to pressure: With Bediol: increase in tolerated pressure of 9 to 11 kgf from t = 20 to 90 min (p < 0.001 vs placebo; t = 0 min is the start of cannabis inhalation)
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Bedrocan increased the tolerated pressure by 7 to 9 kgf (p = 0.006 vs placebo)
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| 29 |
To determine whether nabilone is equivalent to amitriptyline in improving the quality of sleep in patients with FMS, and the improvement in other outcomes |
Nabilone (Oral) |
Doses of nabilone 0.5 mg, with a possible dose increase to 1 mg |
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Insomnia Severity Index (ISI)
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Leeds Sleep Evaluation Questionnaire (LSEQ)
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McGill Pain Questionnaire
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Short-form Profile of Mood States (SF-Profile of Mood States)
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Fibromyalgia Impact Questionnaire (FIQ)
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Patient global satisfaction was assessed using the question “Would you wish to continue with this medication?” (Y/N): preference between amitriptyline or Nabilone
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ISI: nabilone was found to have a greater effect on sleep than amitriptyline adjusted difference = −3.25; CI95 %, −5.26 to −1.24
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LSEQ: neither nabilone or amitriptyline was superior
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McGill Pain Questionnaire: Adjusted difference = −0.1; CI95 % = −0.3 to 0.2
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SF-Profile of Mood States difference − 1.4; CI95% = −4.3 to 7.2
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FIQ: difference = −0.7; CI95% = −7.3 to 5.8
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Preference: preference for nabilone was reported by 41 % and for amitriptyline by 32 % of patients (difference - 9 %; 95 % CI95 % = −16 % to 32 %).
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| 47 |
To evaluate if nabilone will significantly reduce the pain and improve quality of life in FMS patients compared with placebo |
Nabilone (Oral) |
0.5 mg nabilone at bedtime for 1 week. Increase to 0.5 mg/12 h after 7 days. Finally increasing to 1 mg/12 h |
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Pain in Visual Analogue Scale (VAS)
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Fibromyalgia Impact Questionnaire (FIQ)
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Fibromyalgia Impact Questionnaire- anxiety (FIQ-anxiety
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Number of positive tender points
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Tender point pain threshold
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VAS: decreased from baseline at 4 weeks (−2.04, p < 0.02) in the treatment group. The difference between the treatment group and the placebo was −1.43, p < 0 0.05
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FIQ: decreased from baseline at 4 weeks (−12.07, p < 0.02) Difference between treatment group and placebo was −10.76, p < 0.01
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After 4 weeks of treatment with nabilone, statistically significant improvements were achieved in the VAS, FIQ, and FIQ-anxiety scale
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Number of tender points and tender points pain threshold NS*
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