Is a Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia? A Pilot Study and Systematic Review
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design, Setting, and Outcomes
2.2. Treatment Regimen
2.3. Statistical Analysis
2.4. Systematic Review
Methodological Quality Assessment
3. Results
3.1. Patients Characteristics
3.2. Numerical Pain Rating Scale (NRS)
3.3. Short-Form Health Survey (SF-12)
3.4. Collateral Effects
3.5. Systematic Review
Risk of Bias Assessment
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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No Problem | Mild | Moderate | Severe | |
---|---|---|---|---|
Difficulty thinking or remembering | 0 | 1 | 2 | 3 |
Awakening tired (not rested) | 0 | 1 | 2 | 3 |
Fatigue | 0 | 1 | 2 | 3 |
Class | |
---|---|
FDA approved drug | |
Duloxetine | Serotonin–Norepinephrine Reuptake Inhibitor (SNRI) |
Milnacipram | Serotonin–Norepinephrine Reuptake Inhibitor (SNRI) |
Pregabalin | Anticonvulsant/Neuropathic Pain Agent |
Commonly used drug | |
Amitriptyline | Tricyclic Antidepressant (TCA) |
Cyclobenzaprine | Muscle Relaxant |
Gabapentin | Anticonvulsant/Neuropathic Pain Agent |
Naltrexone | Opioid Antagonist |
Acetaminophen | Analgesic |
Parameters | n = 30 | |||
---|---|---|---|---|
Gender | Male | 20% | ||
Female | 80% | |||
Mediana | IQR | Mean ± SD | 95% CI | |
Age | 50.50 | 45.75 | 53.17 ± 13.07 | 48.49–57.84 |
Weight | 70.00 | 67.75 | 73.40 ± 10.28 | 69.72–77.08 |
BMI (kg/m2) | 26.14 | 24.77 | 26.80 ± 3.89 | 25.41–28.19 |
WPI | 8.00 | 6.00 | 7.53 ± 2.16 | 6.76–8.31 |
SS | 7.00 | 5.00 | 7.10 ± 1.88 | 6.43–7.77 |
Comorbidities | Pain Syndrome Associated with FM | ||||
---|---|---|---|---|---|
Patients | % | Patients | % | ||
Hypertension | 6 | 20 | Polydistrict pain | 12 | 40 |
Hypothyroidism | 3 | 10 | Migraine | 2 | 6.67 |
Hereditary thrombophilia | 1 | 3.33 | Arthrosis | 1 | 3.33 |
Convers syndrome | 1 | 3.33 | Rhizarthrosis | 1 | 3.33 |
Hypercholesterol | 1 | 3.33 | Insomnia | 1 | 3.33 |
Migraine | 1 | 3.33 | Trigeminal pain | 1 | 3.33 |
Dyspeptic syndrome | 1 | 3.33 | Headache | 1 | 3.33 |
Obesity | 1 | 3.33 | FBSS | 1 | 3.33 |
Heart disease | 1 | 3.33 | |||
Scleroderma | 1 | 3.33 | |||
Raynaud’s disease | 1 | 3.33 |
NRS | SF-12 | ||||||||
---|---|---|---|---|---|---|---|---|---|
PCS-12 | MCS-12 | ||||||||
Prior MC | After MC | p-Value | Prior MC | After MC | p-Value | Prior MC | After MC | p-Value | |
Median | 8.00 | 4.00 | <0.001 | 27.40 | 51.46 | <0.001 | 36.22 | 58.46 | <0.001 |
IQR | 7.00 | 2.00 | 21.49 | 39.80 | 27.29 | 51.65 | |||
Mean | 8.10 | 4.03 | 28.21 | 47.62 | 38.56 | 56.09 | |||
±SD | 1.24 | 2.11 | 8.72 | 9.81 | 12.41 | 7.28 | |||
95% CI | 7.66–8.54 | 3.28–4.79 | 25.09–31.33 | 44.11–51.13 | 34.12–43.00 | 53.48–58.69 |
Author and Reference | Type of Study | Duration of the Study | Number of Investigated Subjects | Type of Cannabis Administered | Route of Administration | Evaluation Modality | Outcomes |
---|---|---|---|---|---|---|---|
Fiz et al., 2011 [29] | Observational (cross-sectional survey) | 1 day Data were taken at baseline and after 2 h of cannabis administration | 28 93% women | Not tirtrated cannabis | Smoked (54%), oral (46%) combined (43%). | VAS FIQ PSQI SF-36 | VAS score pain and stiffness relaxation feeling well being SF-36 mental component ~SF-36 phisical component ~FIQ ~PSQI |
Habib and Artul, 2018 [30] | Observational (Retrospective) | 2 months | 26 73% women | Not tirtrated cannabis 26 ± 8.2 g/month | Smoked (58%) Vaporized (23%) Vaporized + Smoked (14%) Oral oil drop + Smoked (8%) | Revised FIQ | Improvement of all parameters evaluated with the revised FIQ |
Habib and Avisar, 2018 [31] | Observational (Retrospective) | Not specified | 383 85% women | Not titrated cannabis 31.4 ± 16.3 g/month | Smoked with tobacco 63% Smoked pure cannabis 17% Sublingual oil drop 5% Vaporized 15% | Evaluation of daily activity, pain relief, slip quality, anxiety, and depression | Improvement of all evaluated parameters |
Sagy et al., 2019 [32] | Observational | 6 month | 211 | THC- or CBD-rich strains 670 mg/day of cannabis at the beginning and 700 to 1000 mg at six months Median THC at six months 140 mg/day Madian CBD at six months 39 mg/day | Oil drops Inflorescence Capsules Cigarettes (the specific percentage of patients that used one or the other mode of administration was not specified) | NRS 5 and 8 point Linkert scale | Sleep problems Depression Quality life |
Van de Donk Kowal, 2019 [33] | Randomised Placebo-Controlled 4-Way Crossover Trial | Not specified (patients received 1 of the 4 available type of cannabis with a minimum 2-week interval between visits) | 25 female patients | Bedrocan®: 22.4 mg THC, <1 mg CBD Bediol®: 13.4 mg THC, 17.8 mg CBD. Bedrolite® (Bedrocan International): <1 mg THC, 18.4 mg CBD. Placebo One inhalation. | Vaporization | Pressure pain test Electrical pain test Bowdle questionnaire Bond and Lader questionnaire | pressure pain threshold for cannabis variety containing THC pain score of 30% for Bediol compared to placebo |
Giorgi et al., 2020 [34] | Observational (Perspective) | 6 month | 102 91% women | Bedrocan®: 22% THC, <1% CBD Bediol®: 6.3% THC, 8% CBD. | Oil oral drops | FAS Revised FIQ PSQI SAPS ZSR-D ZSR-A FACIT | PSQI in 44% of subjects FIQ score in 33% of patients Moderate improvement in ZSR-D and ZRS-A in 50% of subjects |
Chaves et al., 2020 [35] | Randomised Double Bling Placebo-Controlled Clinical trial | 8 weeks | 17 female patients | White Widow variety - 48:1 THC:CBD Placebo 1 drop/day | Sublingual oil drop | FIQ | FIQ score in cannabis group compared to placebo |
Mazza et al., 2021 [36] | Observational (Retrospective) | 12 months | 38 95% women | FM2 5–8% THC, 7.5–12% CBD Bediol 6% THC, 8% CBD FM1 13–20% THC, <1% CBD Bedrocan 22% THC, < 1% CBD Pedanios 17–26% THC, <1% CBD THC-dominant variety minimum 50 mg/day; maximum 600 mg/day Hybrid cannabis variety minimum 100 mg/day, maximum 600 mg/day | Oral decoction Sublingual oil drop Vaporized | ODI HADS SyS | 1 month follow up NRS, ODI, WPI and severity score 3 months follow up NRS, ODI, WPI 12 months follow up NRS, ODI, and severity score |
Fitzcharles et al., 2021 [37] | Observational | 2 months | 117 91.5% women | Prescribed and not prescribed cannabis For inhaled cannabis 0.5 to 2 g per day, mostly | Smoked Vaporized Oil | VAS PtGA PGA | Pain syndrome relief |
Nunnari et al., 2022 [38] | Observational (Retrospective) | The median duration of cannabis consumption is 12 months | 56 73.2% women | Bedrocan 78.5% of patients Bediol 17.9% of patients FM2 3.6% of patients | Cannabis oil | Effect of cannabis administration on pain medication discontinuation | Reduction in opioid users |
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Giardina, A.; Palmieri, R.; Ponticelli, M.; Antonelli, C.; Carlucci, V.; Colangelo, M.; Benedetto, N.; Di Fazio, A.; Milella, L. Is a Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia? A Pilot Study and Systematic Review. J. Clin. Med. 2024, 13, 4088. https://doi.org/10.3390/jcm13144088
Giardina A, Palmieri R, Ponticelli M, Antonelli C, Carlucci V, Colangelo M, Benedetto N, Di Fazio A, Milella L. Is a Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia? A Pilot Study and Systematic Review. Journal of Clinical Medicine. 2024; 13(14):4088. https://doi.org/10.3390/jcm13144088
Chicago/Turabian StyleGiardina, Antonio, Rocco Palmieri, Maria Ponticelli, Carlo Antonelli, Vittorio Carlucci, Monica Colangelo, Nadia Benedetto, Aldo Di Fazio, and Luigi Milella. 2024. "Is a Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia? A Pilot Study and Systematic Review" Journal of Clinical Medicine 13, no. 14: 4088. https://doi.org/10.3390/jcm13144088
APA StyleGiardina, A., Palmieri, R., Ponticelli, M., Antonelli, C., Carlucci, V., Colangelo, M., Benedetto, N., Di Fazio, A., & Milella, L. (2024). Is a Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia? A Pilot Study and Systematic Review. Journal of Clinical Medicine, 13(14), 4088. https://doi.org/10.3390/jcm13144088