Cannabidiol use and effectiveness: real-world evidence from a Canadian medical cannabis clinic

Abstract

Background Cannabidiol (CBD) is a primary component in the cannabis plant; however, in recent years, interest in CBD treatments has outpaced scientific research and regulatory advancement resulting in a confusing landscape of misinformation and unsubstantiated health claims. Within the limited results from randomized controlled trials, and lack of trust in product quality and known clinical guidelines and dosages, real-world evidence (RWE) from countries with robust regulatory frameworks may fill a critical need for patients and healthcare professionals. Despite growing evidence and interest, no real-world data (RWD) studies have yet investigated patients’ reports of CBD impact on symptom control in the common expression of pain, anxiety, depression, and poor wellbeing. The objective of this study is to assess the impact of CBD-rich treatment on symptom burden, as measured with a specific symptom assessment scale (ESAS-r). Methods This retrospective observational study examined pain, anxiety, depression symptoms, and wellbeing in 279 participants over 18 years old, prescribed with CBD-rich treatment at a network of clinics dedicated to medical cannabis in Quebec, Canada. Data were collected at baseline, 3 (FUP1), and 6 (FUP2) month after treatment initiation. Groups were formed based on symptom severity (mild vs moderate/severe) and based on changes to treatment plan at FUP1 (CBD vs THC:CBD). Two-way mixed ANOVAs were used to assess ESAS-r scores differences between groups and between visits. Results All average ESAS-r scores decreased between baseline and FUP1 (all ps < 0.003). The addition of delta-9-tetrahydrocannabinol (THC) during the first follow-up had no effect on symptom changes. Patients with moderate/severe symptoms experienced important improvement at FUP1 (all ps < 0.001), whereas scores on pain, anxiety, and wellbeing of those with mild symptoms actually increased. Differences in ESAS-r scores between FUP1 and FUP2 were not statistically different. Conclusion This retrospective observational study suggests CBD-rich treatment has a beneficial impact on pain, anxiety, and depression symptoms as well as overall wellbeing only for patients with moderate to severe symptoms; however, no observed effect on mild symptoms. The results of this study contribute to address the myths and misinformation about CBD treatment and demand further investigation.

Real World Evidence in Medical Cannabis Research

“…The study highlighted perceived benefits in conditions where medical cannabis had not yet been licensed Gulbransen et al [ 39 ] An audit of all patients who presented to a Cannabis Care clinic in New Zealand. This study highlighted the anxiolytic effects of cannabidiol Rapin et al [ 40 ] A retrospective observational study looking at patients who had been prescribed CBD treatment from data collated from a network of clinics Analysis of registries Habib et al [ 27 ] Looked at the efficacy of medical cannabis for treatment of fibromyalgia. It used data from two hospital registries.…”

A large Australian longitudinal cohort registry demonstrates sustained safety and efficacy of oral medicinal cannabis for at least two years

“…For instance, in our cohort for anxiety, 54% of 3,350 responses at baseline were normal (<8), mild/moderate 14%, severe 16%, extremely severe 16%. Similarly other observational studies have shown effect on moderate to severe symptoms of anxiety, but not mild symptoms of anxiety [39]. Further sub analysis of the AECeR registry will be conducted to determine outcome differences in different severity categories.…”

“…The ISI uses a 5-point Likert scale of 0-4 to rate each item (0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8)(9)(10)(11)(12)(13)(14); moderate insomnia (15)(16)(17)(18)(19)(20)(21); and severe insomnia (22)(23)(24)(25)(26)(27)(28).…”

“…A recent study by Schneider et al 2022 of registry data of 10,000 patients from Israel's largest clinic, observed high safety, decrease in pain levels and improvements in QOL on 4166 patients that reported at 6-month follow-up, however this study included a range of MC formulations -smoking, vaporised or sublingual oil [10]. MC registries in other jurisdictions where RC and inhaled products are included, have been required to estimate dose and exposure to these major cannabinoids based on patient reported usage [8,11,12] and makes it difficult to determine optimal dose. The Australian Emyria Clinical e-Registry (AECeR) describes the longitudinal monitoring of cannabis naïve patients who commence a defined dose of oral MCs utilising the available range of TGA regulated MC products in Australia.…”

Considerations for Cannabinoids in Perioperative Care by Anesthesiologists

“…There are also a significant number of claims in the media that are difficult to validate but influence patients' consumption of cannabinoid products [17,19,25,[35][36][37][38]. Patients often consume cannabinoids regardless of their efficacy [39,40]. Other confounding variables affecting the assessment of cannabinoid properties are the lack of compound standardization and the increasing variability in their strength and composition [17,19,35,36].…”