TY - JOUR
T1 - Assessment of clinical outcomes in patients with post-traumatic stress disorder
T2 - analysis from the UK Medical Cannabis Registry
AU - Pillai, Manaswini
AU - Erridge, Simon
AU - Bapir, Lara
AU - Nicholas, Martha
AU - Dalavaye, Nishaanth
AU - Holvey, Carl
AU - Coomber, Ross
AU - Barros, Daniela
AU - Bhoskar, Urmila
AU - Mwimba, Gracia
AU - Praveen, Kavita
AU - Symeon, Chris
AU - Sachdeva-Mohan, Simmi
AU - Rucker, James J.
AU - Sodergren, Mikael H.
N1 - Funding Information:
S Erridge, C Holvey, R Coomber, JJ Rucker, and MH Sodergren are the founding clinicians of Sapphire Medical Clinics, which is the first clinic registered with the CQC to evaluate patients for medical cannabis in England. R Coomber and MH Sodergren are directors at Sapphire Medical Clinics. S Erridge undertakes paid consultancy work at Sapphire Medical Clinics. C Holvey, D Barros, U Bhoskar, G Mwimba, K Praveen, C Symeon, S Sachdeva-Mohan, and JJ Rucker are employees of Sapphire Medical Clinics. MH Sodergren is also Chief Medical Officer at Curaleaf International. JJ Rucker is funded by a fellowship (CS-2017-17-007) from the National Institute for Health Research (NIHR). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Publisher Copyright:
© 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2022/12/12
Y1 - 2022/12/12
N2 - Background: The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD. Methods: A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050. Results: Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00–70.00) mg of cannabidiol and 145.00 (IQR: 100.00–200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%). Conclusions: Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.
AB - Background: The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD. Methods: A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050. Results: Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00–70.00) mg of cannabidiol and 145.00 (IQR: 100.00–200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%). Conclusions: Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.
KW - Cannabidiol
KW - medical cannabis
KW - post-traumatic stress disorder
KW - PTSD
KW - tetrahydrocannabinol
UR - https://www.scopus.com/pages/publications/85144135849
U2 - 10.1080/14737175.2022.2155139
DO - 10.1080/14737175.2022.2155139
M3 - Article
C2 - 36503404
AN - SCOPUS:85144135849
SN - 1473-7175
VL - 22
SP - 1009
EP - 1018
JO - Expert Review of Neurotherapeutics
JF - Expert Review of Neurotherapeutics
IS - 11-12
ER -