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Research

Research on safety and efficacy of Cannabidiol - CBD

Various in-vivo and in-vitro studies have shown the broad application potential of CBD (cannabidiol). Known are, among other things, the anti-inflammatory and immune-modulating properties of the anti-epileptic effects.
An interesting Danish study1 provides a nice overview of various clinical studies that have shown that CBD can be used simultaneously in the treatment of physical and psychological complaints. In addition to the effectiveness of CBD, the researchers have also mapped the safety of CBD use.
Currently there are more than 30 registered studies (www.clinicaltrials.gov) that discuss the effects of CBD in the treatment of addiction, psychosis, anxiety and cognitive complaints.

Below is an overview of white papers and studies related to cannabidiol.

White Papers

White paper on the science of CBD

Dating back more than 1800 years ago, different applications of cannabis have been documented (Clarke & Watson, 2002). All parts of the cannabis plant have been recorded in historical Chinese medical texts, ranging from using the seeds as moistening laxatives, to the more commonly known applications like in western Europe, where cannabis was used as a treatment for conditions resulting in pain and restricted movement (Brand & Zhao, 2017). Other applications involved processing the leaves and flower tops for treating severe spasm, headaches, insomnia and coughing. This tells us that even hundreds of years ago, people were aware of the medicinal power cannabis possesses, which parts of the plant to harvest and how they should process these plant parts for consumer use (Zuardi, 2006). Even though the exact substance causing these effects was not chemically understood then, it clearly shows both basic and applied research has been done on cannabis for some time. Nowadays, research has taught us that the chemicals causing these effects are known as CBD and THC.
Download the white paper: Science of CBD

White paper on the therapeutic potential of CBD

As all cannabinoids have affinity with the endocannabinoid system, either through endocannabinoid receptors, endocannabinoids, neurotransmitters and certain GPCRs, they influence the homeostatic role that the endocannabinoid system plays (Piscitelli et al., 2021). This role includes regulating appetite, energy and metabolism, stress levels, nervous systems, analgesia, thermoregulation and sleep (Di marzo, 2009). While most of these mechanisms remain unclear, some target cells and their therapeutic results are better understood.
Download the white paper: Therapeutic potential of CBD

White paper on the therapeutic potential of FreshFlower-CBD SanaCan

The goal of this research was to investigate the possible therapeutic applications of the FreshFlower-CBD oil comparing (where possible) the results found in the literature study, with the final data that was found during the empirical research.

Studies

An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies

Published online 2017 Jun 1. Kerstin Iffland and Franjo Grotenhermen
In conclusion, CBD safety profile is already established in a plethora of ways. However, some knowledge gaps detailed above should be closed by additional clinical trials to have a completely well-tested pharmaceutical compound.
This study shows, a great deal of research has found that it’s a relatively safe treatment. The studies analyzed in that review didn’t show that there’s one universal dosage of CBD that everyone should take. Instead, it underscored the fact that different people (and, in the animal studies, different animals) respond to different dosages of CBD.

Cannabidiol as a Potential Treatment for Anxiety and Mood Disorders: Molecular Targets and Epigenetic Insights from Preclinical Research

2019 Sep;85(9):1888-1900. doi: 10.1111/bcp.14038. Epub 2019 Jul 19. S A Millar, N L Stone, Z D Bellman, A S Yates, T J England, S E O’Sullivan
Conclusion: CBD’s therapeutic potential has been investigated in a number of neuropsychiatric diseases and pathological conditions. In the present preclinical review, we provided an overview of behavioral and neuropharmacological studies that evaluated CBD as an anxiolytic- and antidepressant-like compound. Moreover, we outlined evidence suggesting that CBD’s therapeutic-like properties may involve epigenetic mechanisms that include DNA methylation, histone modifications, and the regulation of miRNA expression. Collectively, and given CBD’s safety profile, these studies support the continued evaluation of CBD as a promising new agent in the treatment of anxiety and mood disorders.

Cannabidiol may hold benefit for anxiety-related disorders. Cannabidiol in Anxiety and Sleep.

Published online 2019 Jan 7. doi: 10.7812/TPP/18-041. Scott Shannon, Nicole Lewis, Heather Lee, Shannon Hughes
The final sample consisted of 72 adults presenting with primary concerns of anxiety (n = 47) or poor sleep (n = 25). Anxiety scores decreased within the first month in 57 patients (79.2%) and remained decreased during the study duration. Sleep scores improved within the first month in 48 patients (66.7%) but fluctuated over time. In this chart review, CBD was well tolerated in all but 3 patients.
Conclusion: Cannabidiol may hold benefit for anxiety-related disorders.

Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series

2019 Apr;25(4):392-397. doi: 10.1089/acm.2018.0437. Epub 2018 Dec 13. Lucas Elms, Scott Shannon, Shannon Hughes, Nicole Lewis
Results: From the total sample of 11 patients, 91% (n = 10) experienced a decrease in PTSD symptom severity, as evidenced by a lower PCL-5 score at 8 weeks than at their initial baseline. The mean total PCL-5 score decreased 28%, from a mean baseline score of 51.82 down to 37.14, after eight consecutive weeks of treatment with CBD. CBD was generally well tolerated, and no patients discontinued treatment due to side effects.
Conclusions: Administration of oral CBD in addition to routine psychiatric care was associated with PTSD symptom reduction in adults with PTSD. CBD also appeared to offer relief in a subset of patients who reported frequent nightmares as a symptom of their PTSD. Additional clinical investigation, including double-blind, placebo-controlled trials, would be necessary to further substantiate the response to CBD that was observed in this study.

Effectiveness of Cannabidiol Oil for Pediatric Anxiety and Insomnia as Part of Posttraumatic Stress Disorder: A Case Report

2016 Fall;20(4):16-005. doi: 10.7812/TPP/16-005. Epub 2016 Oct 12. Scott Shannon, Janet Opila-Lehman
Introduction: Anxiety and sleep disorders are often the result of posttraumatic stress disorder and can contribute to an impaired ability to focus and to demonstration of oppositional behaviors.
Case presentation: These symptoms were present in our patient, a ten-year-old girl who was sexually abused and had minimal parental supervision as a young child under the age of five. Pharmaceutical medications provided partial relief, but results were not long-lasting, and there were major side effects. A trial of cannabidiol oil resulted in a maintained decrease in anxiety and a steady improvement in the quality and quantity of the patient’s sleep.
Discussion: Cannabidiol oil, an increasingly popular treatment of anxiety and sleep issues, has been documented as being an effective alternative to pharmaceutical medications. This case study provides clinical data that support the use of cannabidiol oil as a safe treatment for reducing anxiety and improving sleep in a young girl with posttraumatic stress disorder.

Cannabidiol (CBD) in Rheumatic Diseases (Musculoskeletal Pain)

2022 Jul;24(7):238-246. doi: 10.1007/s11926-022-01077-3. Epub 2022 May 3. Kevin F Boehnke, Winfried Häuser, Mary-Ann Fitzcharles
Purpose of review: This review will address the many uncertainties surrounding the medical use of cannabidiol (CBD). We will begin with an overview of the legal and commercial environment, examine recent preclinical and clinical evidence on CBD, explore questions concerning CBD raised by healthcare professionals and patients, investigate dosing regimens and methods of administration, and address current challenges in the accumulation of sound evidence.
Recent findings: CBD has potential for relief of symptoms of pain, sleep, and mood disturbance in rheumatology patients, but sound clinical evidence is lacking. CBD is safe when accessed from a regulated source, whereas wellness products are less reliable regarding content and contaminants. Dosing for symptom relief has not yet been established. As many rheumatology patients are trying CBD as a self-management strategy, the healthcare community must urgently accrue sound evidence for effect.

Clinicians' Guide to Cannabidiol and Hemp Oils

2019 Sep;94(9):1840-1851. doi: 10.1016/j.mayocp.2019.01.003. Epub 2019 Aug 22. Harrison J VanDolah, Brent A Bauer, Karen F Mauck
Cannabidiol (CBD) oils are low tetrahydrocannabinol products derived from Cannabis sativa that have become very popular over the past few years. Patients report relief for a variety of conditions, particularly pain, without the intoxicating adverse effects of medical marijuana. In June 2018, the first CBD-based drug, Epidiolex, was approved by the US Food and Drug Administration for treatment of rare, severe epilepsy, further putting the spotlight on CBD and hemp oils. There is a growing body of preclinical and clinical evidence to support use of CBD oils for many conditions, suggesting its potential role as another option for treating challenging chronic pain or opioid addiction. Care must be taken when directing patients toward CBD products because there is little regulation, and studies have found inaccurate labeling of CBD and tetrahydrocannabinol quantities. This article provides an overview of the scientific work on cannabinoids, CBD, and hemp oil and the distinction between marijuana, hemp, and the different components of CBD and hemp oil products. We summarize the current legal status of CBD and hemp oils in the United States and provide a guide to identifying higher-quality products so that clinicians can advise their patients on the safest and most evidence-based formulations. This review is based on a PubMed search using the terms CBD, cannabidiol, hemp oil, and medical marijuana. Articles were screened for relevance, and those with the most up-to-date information were selected for inclusion.

Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients: a prospective cohort study

2020 Jan;132(1):56-61. doi: 10.1080/00325481.2019.1685298. Epub 2019 Nov 12. Alex Capano, Richard Weaver, Elisa Burkman
Context: Chronic pain is highly prevalent in most of the industrialized nations around the world. Despite the documented adverse effects, opioids are widely used for pain management. Cannabinoids, and specifically Cannabidiol, is proposed as an opioid alternative, having comparable efficacy with better safety profile.
Objectives: We aim to investigate the impact of full hemp extract cannabidiol (CBD) on opioid use and quality of life indicators among chronic pain patients.
Methods: An initial sample of 131 patients was recruited from a private pain management center’s investigative population. Ninety-seven patients completed the 8-week study. The primary inclusion criteria included patients between 30 and 65 years old with chronic pain who have been on opioids for at least 1 year. Data were collected at three different time points: baseline, 4, and 8 weeks. Opioid and other medication use were evaluated via the medication and psychiatric treatment receipt. Improvement was evaluated using four indices: Pain Disability Index (PDI-4); Pittsburgh Sleep Quality Index (PSQI), Pain Intensity and Interference (PEG); and Patient Health Questionnaire (PHQ-4).
Results: Over half of chronic pain patients (53%) reduced or eliminated their opioids within 8 weeks after adding CBD-rich hemp extract to their regimens. Almost all CBD users (94%) reported quality of life improvements. The results indicated a significant relationship between CBD and PSQI (p = 0.003), and PEG (p = 0.006). There was a trend toward improvement but no significant relationship between CBD use and PHQ and PDI.
Conclusion: CBD could significantly reduce opioid use and improve chronic pain and sleep quality among patients who are currently using opioids for pain management.
Key Message: This is a prospective, single-arm cohort study for the potential role of cannabinoids as an alternative for opioids. The results indicate that using the CBD-rich extract enabled our patients to reduce or eliminate opioids with significant improvement in their quality of life indices.

Cannabinoid therapies in the management of sleep disorders: A systematic review of preclinical and clinical studies

2020 Oct;53:101339. doi: 10.1016/j.smrv.2020.101339. Epub 2020 May 16. Anastasia S Suraev, Nathaniel S Marshall, Ryan Vandrey, Danielle McCartney, Melissa J Benson, Iain S McGregor, Ronald R Grunstein, Camilla M Hoyos
Cannabinoids, including the two main phytocannabinoids Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), are being increasingly utilised as pharmacological interventions for sleep disorders. THC and CBD are known to interact with the endocannabinoid and other neurochemical systems to influence anxiety, mood, autonomic function, and circadian sleep/wake cycle. However, their therapeutic efficacy and safety as treatments for sleep disorders are unclear. The current systematic review assessed the available evidence base using PubMed, Scopus, Web of Science, Embase, CINAHL and PsycInfo databases. A total of 14 preclinical studies and 12 clinical studies met inclusion criteria. Results indicated that there is insufficient evidence to support routine clinical use of cannabinoid therapies for the treatment of any sleep disorder given the lack of published research and the moderate-to-high risk of bias identified within the majority of preclinical and clinical studies completed to-date. Promising preliminary evidence provides the rationale for future randomised controlled trials of cannabinoid therapies in individuals with sleep apnea, insomnia, post-traumatic stress disorder-related nightmares, restless legs syndrome, rapid eye movement sleep behaviour disorder, and narcolepsy. There is a clear need for further investigations on the safety and efficacy of cannabinoid therapies for treating sleep disorders using larger, rigorously controlled, longer-term trials.

Biological properties and therapeutic applications of cannabidiol

Elanne Costa Glória, Adriana Idalina Torcato de Oliveira, Juliana Fonseca Moreira da Silva, Raphael Sanzio Pimenta
Cannabidiol (CBD) is considered the non-psychoactive component of the plant and has a multitude of pharmacological activities. There is scientific evidence that CBD can be used as a useful treatment for different therapeutic conditions such as schizophrenia, anxiety, epilepsy and motor disorders such as Parkinson’s disease, among others CBD and phytocannabinoids have potential health benefits for human health.

Cannabidiol: from an inactive cannabinoid to a drug with wide spectrum of action

2008 Sep;30(3):271-80. doi: 10.1590/s1516-44462008000300015. Antonio Waldo Zuardi
In the last 45 years it has been possible to demonstrate that CBD has a wide range of pharmacological effects, many of which being of great therapeutic interest, but still waiting to be confirmed by clinical trials.