Medical Cannabis for the Management of Pain and Quality of Life in Chronic Pain Patients: A Prospective Observational Study

Pain Medicine (Journal) by Oxford University Press

“Objective: To evaluate the short-term and long-term effects of plant-based medical cannabis in a chronic pain population over the course of one year.

Results: Medical cannabis treatment was associated with improvements in pain severity and interference (P < 0.001) observed at one month and maintained over the 12-month observation period. Significant improvements were also observed in the SF-12 physical and mental health domains (P < 0.002) starting at three months. Significant decreases in headaches, fatigue, anxiety, and nausea were observed after initiation of treatment (P ≤ 0.002). In patients who reported opioid medication use at baseline, there were significant reductions in oral morphine equivalent doses (P < 0.0001), while correlates of pain were significantly improved by the end of the study observation period.

Conclusions: Taken together, the findings of this study add to the cumulative evidence in support of plant-based medical cannabis as a safe and effective treatment option and potential opioid medication substitute or augmentation therapy for the management of symptoms and quality of life in chronic pain patients.”

https://pubmed.ncbi.nlm.nih.gov/32556203/

https://academic.oup.com/painmedicine/article-abstract/doi/10.1093/pm/pnaa163/5859722?redirectedFrom=fulltext

Medicinal Cannabis Effective for Chronic Insomnia in Clinical Trial

April 2020 cover“A randomized double-blind clinical trial evaluating the efficacy of a medicinal cannabis formulation (ZTL-101; Zelira Therapeutics Ltd, Perth, Australia) for treating chronic insomnia showed that the therapy is effective and safe.

Participants treated with medicinal cannabis went to sleep faster, slept significantly longer, and went back to sleep sooner after waking. Those participants reported significant improvements in quality of life, including feeling rested after sleep, feeling less stressed and less fatigued, and overall improved functioning.

For the trial, 23 participants were treated with the therapy for 14 nights, and after a 1-week washout period, received a placebo for 14 nights. Each participant took a single dose (.5 ml of 11.5 mg total cannabinoids) or a double dose (1 ml of 23 mg total cannabinoids) of the therapy, delivered sublingually, according to their symptoms.

“The fact that ZTL-101 treatment achieved statistically significant, dose-responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short 2-week dosing window,” said Peter Eastwood, director, Centre for Sleep Science, University of Western Australia.”

https://practicalneurology.com/news/medicinal-cannabis-effective-for-chronic-insomnia-in-clinical-trial

Safety and Efficacy of Medical Cannabis in Fibromyalgia

jcm-logo“Chronic pain may be treated by medical cannabis. Yet, there is scarce evidence to support the role of medical cannabis in the treatment of fibromyalgia. The aim of the study was to investigate the characteristics, safety, and effectiveness of medical cannabis therapy for fibromyalgia.

Results: Among the 367 fibromyalgia patients, the mean age was 52.9 ± 15.1, of whom 301 (82.0%) were women. Twenty eight patients (7.6%) stopped the treatment prior to the six months follow-up. The six months response rate was 70.8%. Pain intensity (scale 0–10) reduced from a median of 9.0 at baseline to 5.0 (p < 0.001), and 194 patients (81.1%) achieved treatment response. In a multivariate analysis, age above 60 years (odds ratio [OR] 0.34, 95% C.I 0.16–0.72), concerns about cannabis treatment (OR 0.36, 95% C.I 0.16–0.80), spasticity (OR 2.26, 95% C.I 1.08–4.72), and previous use of cannabis (OR 2.46 95% C.I 1.06–5.74) were associated with treatment outcome. The most common adverse effects were mild and included dizziness (7.9%), dry mouth (6.7%), and gastrointestinal symptoms (5.4%).

Conclusion: Medical cannabis appears to be a safe and effective alternative for the treatment of fibromyalgia symptoms. Standardization of treatment compounds and regimens are required.”

https://www.mdpi.com/2077-0383/8/6/807

“Medical cannabis appears to be a safe and effective alternative for the treatment of fibromyalgia symptoms.”  https://www.ncbi.nlm.nih.gov/pubmed/31195754

Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy.

“Prior studies have evaluated the use of various constituents of cannabis for their anti-seizure effects. Specifically, cannabidiol, a non-psychoactive component of cannabis, has been investigated for treatment-resistant epilepsy, but more information is needed particularly on its use in a pediatric population.

OBJECTIVE:

The objective of this study was to evaluate the pharmacokinetics and safety of a synthetic pharmaceutical-grade cannabidiol oral solution in pediatric patients with treatment-resistant epilepsy.

RESULTS:

Overall, 61 patients across three cohorts received one of three doses of cannabidiol oral solution (mean age, 7.6 years). The age composition was similar in the three cohorts. There was a trend for increased cannabidiol exposure with increased cannabidiol oral solution dosing, but overall exposure varied. Approximately 2-6 days of twice-daily dosing provided steady-state concentrations of cannabidiol. A bi-directional drug interaction occurred with cannabidiol and clobazam. Concomitant administration of clobazam with 40 mg/kg/day of cannabidiol oral solution resulted in a 2.5-fold increase in mean cannabidiol exposure. Mean plasma clobazam concentrations were 1.7- and 2.2-fold greater in patients receiving clobazam concomitantly with 40 mg/kg/day of cannabidiol oral solution compared with 10 mg/kg/day and 20 mg/kg/day. Mean plasma norclobazam values were 1.3- and 1.9-fold higher for patients taking clobazam plus 40 mg/kg/day of cannabidiol oral solution compared with the 10-mg/kg/day and 20-mg/kg/day groups. All doses were generally well tolerated, and common adverse events that occurred at > 10% were somnolence (21.3%), anemia (18.0%), and diarrhea (16.4%).

CONCLUSIONS:

Inter-individual variability in systemic cannabidiol exposure after pediatric patient treatment with cannabidiol oral solution was observed but decreased with multiple doses. Short-term administration was generally safe and well tolerated.”

https://www.ncbi.nlm.nih.gov/pubmed/31049885

https://link.springer.com/article/10.1007%2Fs40263-019-00624-4

Assessment of Efficacy and Tolerability of Medicinal Cannabinoids in Patients With Multiple Sclerosis: A Systematic Review and Meta-analysis.

Image result for jama network open

“Cannabinoids have antispastic and analgesic effects; however, their role in the treatment of multiple sclerosis (MS) symptoms is not well defined.

OBJECTIVE:

To conduct a systematic review and meta-analysis to assess the efficacy and tolerability of medicinal cannabinoids compared with placebo in the symptomatic treatment of patients with MS.

STUDY SELECTION:

Randomized, double-blind, and placebo-controlled trials evaluating the effect of medicinal cannabinoids by oral or oromucosal route of administration on the symptoms of spasticity, pain, or bladder dysfunction in adult patients with MS.

RESULTS:

Seventeen selected trials including 3161 patients were analyzed. Significant findings for the efficacy of cannabinoids vs placebo were SMD = -0.25 SD (95% CI, -0.38 to -0.13 SD) for spasticity (subjective patient assessment data), -0.17 SD (95% CI, -0.31 to -0.03 SD) for pain, and -0.11 SD (95% CI, -0.22 to -0.0008 SD) for bladder dysfunction. Results favored cannabinoids. Findings for tolerability were RR = 1.72 patient-years (95% CI, 1.46-2.02 patient-years) in the total adverse events analysis and 2.95 patient-years (95% CI, 2.14-4.07 patient-years) in withdrawals due to adverse events. Results described a higher risk for cannabinoids. The serious adverse events meta-analysis showed no statistical significance.

CONCLUSIONS AND RELEVANCE:

The results suggest a limited efficacy of cannabinoids for the treatment of spasticity, pain, and bladder dysfunction in patients with MS. Therapy using these drugs can be considered as safe.”

https://www.ncbi.nlm.nih.gov/pubmed/30646241

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706499

Cannabis in palliative care: current challenges and practical recommendations.

 “Pain and symptom control challenges are common in palliative care, and the search for other therapeutic strategies is ongoing. Unfortunately, patients and their caregivers are receiving little information or support from healthcare providers regarding the increasingly popular cannabinoid-based medicines (CBM). Clinicians, meanwhile, feel understandably perplexed by the discrepancy between the available evidence and the rapid interest in which patients and their families have demonstrated for CBM. There is an urgent need to address the many challenges that are delaying the appropriate integration of CBM into clinical practice, notwithstanding the obvious need for a solid general knowledge of pharmacology, mechanism of action and available clinical evidence supporting its use. The authors will address these challenges and provide practical recommendations regarding patient assessment for the use of CBM. The authors will also make suggestions regarding patient expectations in order to define clear objectives, review the necessary precautions prior to initiating treatment, aid in selecting the appropriate strain and route of administration as well as establishing proper titration and monitoring protocols. The authors will also discuss the lesser known but potentially therapeutic psychoactive effects of cannabis. As this class of therapeutic agents are likely to play a major role in palliative medicine in the near future, clinicians would benefit from familiarizing themselves with CBM and we can expect that patients and their caregivers will appreciate receiving support in their search for safe and effective therapeutic alternatives.” https://www.ncbi.nlm.nih.gov/pubmed/30180728 http://apm.amegroups.com/article/view/20097
]]>