Tag Archives: safe

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

Posted on by
Reply

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

Posted on by
Reply

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

Posted on by
Reply

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.

Posted on by
Reply

“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.

Posted on by
Reply

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.

Posted on by
Reply

 “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

Cannabidiol Administered During Peri-Adolescence Prevents Behavioral Abnormalities in an Animal Model of Schizophrenia.

Posted on by
Reply

Image result for frontiers in pharmacology

“Schizophrenia is considered a debilitating neurodevelopmental psychiatric disorder and its pharmacotherapy remains problematic without recent major advances. The development of interventions able to prevent the emergence of schizophrenia would therefore represent an enormous progress.

Here, we investigated whether treatment with cannabidiol (CBD – a compound of Cannabis sativa that presents an antipsychotic profile in animals and humans) during peri-adolescence would prevent schizophrenia-like behavioral abnormalities in an animal model of schizophrenia: the spontaneously hypertensive rat (SHR) strain.

Treatment with CBD prevented the emergence of SHRs’ hyperlocomotor activity (a model for the positive symptoms of schizophrenia) and deficits in prepulse inhibition of startle and contextual fear conditioning (cognitive impairments). CBD did not induce any of the potential motor or metabolic side effects evaluated. Treatment with CBD increased the prefrontal cortex 5-HIAA/serotonin ratio and the levels of 5-HIAA on post-natal days 61 and 90, respectively.

Our data provide pre-clinical evidence for a safe and beneficial effect of peripubertal and treatment with CBD on preventing positive and cognitive symptoms of schizophrenia, and suggest the involvement of the serotoninergic system on this effect.”

https://www.ncbi.nlm.nih.gov/pubmed/30186164

https://www.frontiersin.org/articles/10.3389/fphar.2018.00901/full

Medical Marijuana Use in Older Adults.

Posted on by
Reply

Journal of the American Geriatrics Society banner“Symptom management in older adults, including pain and distressing non-pain symptoms, can be challenging. Medications can cause side effects that worsen quality of life or create other symptoms, and polypharmacy itself can be detrimental in older adults. 

Cannabinoids may offer a way of managing selected symptoms with fewer side effects.

Medical marijuana is an important area of study for older adults because of the side effects of other medications. It is also important for Baby Boomers, who are likely to have more experience with marijuana than older adults of previous generations. Therefore, geriatricians should understand medical marijuana’s clinical indications, adverse effects, and legal context.

This article reviews the evidence regarding indications for and risks of medical marijuana use in older adults.”

https://www.ncbi.nlm.nih.gov/pubmed/29668039

https://onlinelibrary.wiley.com/doi/abs/10.1111/jgs.15346

“Our study finds that the therapeutic use of cannabis is safe and efficacious in the elderly population.” https://www.ncbi.nlm.nih.gov/pubmed/29398248

“Medical cannabis significantly safer for elderly with chronic pain than Opioids”  https://www.sciencedaily.com/releases/2018/02/180213111508.htm

The effect of nabilone on appetite, nutritional status, and quality of life in lung cancer patients: a randomized, double-blind clinical trial.

Posted on by
Reply

Supportive Care in Cancer

“Over one half of the patients diagnosed with advanced lung cancer experience anorexia. In addition to its high incidence, cancer-induced anorexia promotes the development of the anorexia-cachexia syndrome, which is related to poor clinical outcomes.

Recently, drugs derived from cannabinoids, such as Nabilone, have been recognized for their appetite improvement properties.

METHODS:

This is a randomized, double-blind, placebo-controlled clinical trial to assess the effect of Nabilone vs. placebo on the appetite, nutritional status, and quality of life in patients diagnosed with advanced Non-small cell lung cancer (NSCLC) (NCT02802540).

CONCLUSION:

Nabilone is an adequate and safe therapeutic option to aid in the treatment of patients diagnosed with anorexia. Larger trials are necessary in order to draw robust conclusions in regard to its efficacy in lung cancer patients.”

https://www.ncbi.nlm.nih.gov/pubmed/29550881

https://link.springer.com/article/10.1007%2Fs00520-018-4154-9
“Nabilone is a synthetic cannabinoid with therapeutic use as an antiemetic and as an adjunct analgesic for neuropathic pain. It mimics tetrahydrocannabinol (THC), the primary psychoactive compound found naturally occurring in Cannabis.”  https://en.wikipedia.org/wiki/Nabilone

Prospective analysis of safety and efficacy of medical cannabis in large unselected population of patients with cancer

Posted on by
Reply

Cover image volume 49, Issue

“Cancer is a major public health problem as the leading cause of death. Palliative treatment aimed to alleviate pain and nausea in patients with advanced disease is a cornerstone of oncology.

In 2007, the Israeli Ministry of Health began providing approvals for medical cannabis for the palliation of cancer symptoms. The aim of this study is to characterize the epidemiology of cancer patients receiving medical cannabis treatment and describe the safety and efficacy of this therapy.

Methods

We analyzed the data routinely collected as part of the treatment program of 2970 cancer patients treated with medical cannabis between 2015 and 2017.

Results

The average age was 59.5 ± 16.3 years, 54.6% women and 26.7% of the patients reported previous experience with cannabis. The most frequent types of cancer were: breast (20.7%), lung (13.6%), pancreatic (8.1%) and colorectal (7.9%) with 51.2% being at stage 4. The main symptoms requiring therapy were: sleep problems (78.4%), pain (77.7%, median intensity 8/10), weakness (72.7%), nausea (64.6%) and lack of appetite (48.9%). After six months of follow up, 902 patients (24.9%) died and 682 (18.8%) stopped the treatment. Of the remaining, 1211 (60.6%) responded; 95.9% reported an improvement in their condition, 45 patients (3.7%) reported no change and four patients (0.3%) reported deterioration in their medical condition.

Conclusions

Cannabis as a palliative treatment for cancer patients seems to be well tolerated, effective and safe option to help patients cope with the malignancy related symptoms.”

https://www.ncbi.nlm.nih.gov/pubmed/29482741

http://www.ejinme.com/article/S0953-6205(18)30023-2/pdf

“Cannabis to be a “Safe,” “Effective” Medical Treatment in First-of-its-Kind, Peer-Reviewed Study of Thousands of Cancer Patients Using Tikun Olam™ Strains”  http://markets.businessinsider.com/news/stocks/cannabis-to-be-a-safe-effective-medical-treatment-in-first-of-its-kind-peer-reviewed-study-of-thousands-of-cancer-patients-using-tikun-olam-strains-1017297749

“For the first time, a major scientific study has confirmed what cannabis advocates have known for decades: that cannabis can be a safe and effective palliative treatment in patients suffering from the debilitating effects of cancer.”  https://www.prnewswire.com/news-releases/cannabis-to-be-a-safe-effective-medical-treatment-in-first-of-its-kind-peer-reviewed-study-of-thousands-of-cancer-patients-using-tikun-olam-strains-300604361.html