Long-term treatment for unspecified anxiety disorders with cannabidiol (CBD): A retrospective case series from real-world evidence (RWE) in Colombia

Abstract

Introduction: Preclinical and clinical evidence has elucidated that cannabis based medical formulations (CBMFs) may display anxiolytic, anti-depressive, and neuro-protective properties. CBMFs are often considered as novel therapeutic anxiolytic agents that can be prescribed as pharmacotherapy for symptomatic domains in anxiety disorders. Our aim was to explore effectiveness and tolerability of enriched cannabidiol (CBD) oil extract formulations in adults with anxiety symptoms in an outpatient mental health program in Colombia during the COIVD – 19 pandemic. Methods: We conducted an observational, retrospective, real world evidence (RWE) case-series at Zerenia Clinic in Bogotá, Colombia between June 2021 and December 2022. Our convenience sample consisted of people searching for CBMFs for the treatment of anxiety symptoms. A cohort of 24 adults was prescribed with enriched CBD in the form of non-sterile oral liquids suspended in sesame seed oil extracts unspecified anxiety disorder (UAD) and followed throughout the first year of treatment. Primary outcome measures established were the anxiety subscale in the hospital anxiety and depression scale (HADS – A), and the clinical global impression scale with regards to severity (CGI – S) at baseline, 6-month, and 12-month during follow-up. Secondary outcome measures established were HADS depression subscale (HADS – D) and the Epworth Sleepiness Scale (ESS) respectively. Results: After 6 months of treatment with sublingually administered enriched CBD oil extracts in a median dosage of 100mg, more than half (54.17%) of the sample continued to report significant anxiety symptoms. After 12 months, only 37.50% persisted with significant anxiety symptoms with a median dose of 120mgs of enriched CBD oil extracts. Similar subjective improvements were reported with regards to sleep disturbances (SDs) as a secondary outcome. At baseline, less than half (46,83%) of the sample reported significant daytime sleepiness. After 6-months of enriched CBD oil extract treatment, less than one third(29,17%) continued to report SDs. At end point, a high proportion of the sample (87.50%) were considered to have normal daytime sleepiness. No significant adverse–drug reactions or deaths were reported during the 12-month follow-up. Conclusions: Further research should determine the long-term efficacy, safety and appropriate dosages of enriched CBD oil extracts in treating specific anxiety disorders rather than broad and unspecified anxiety symptoms. The state of the art of MCBFs for anxiety disorders should be warranted and solidified through randomized controlled trials. The next stage for cannabis research should be focused in performing head-to-head trials comparing enriched CBD extracts or capsules versus first-line treatments proven to be effective in anxiety disorders.