King's College London

TY - JOUR

T1 - Clinical outcome analysis of patients with autism spectrum disorder

T2 - analysis from the UK Medical Cannabis Registry

AU - Erridge, Simon

AU - Kerr-Gaffney, Jess

AU - Holvey, Carl

AU - Coomber, Ross

AU - Barros, Daniela A Riano

AU - Bhoskar, Urmila

AU - Mwimba, Gracia

AU - Praveen, Kavita

AU - Symeon, Chris

AU - Sachdeva-Mohan, Simmi

AU - Sodergren, Mikael H

AU - Rucker, James J

N1 - © The Author(s), 2022.

PY - 2022/9/20

Y1 - 2022/9/20

N2 - Introduction: Cannabis-based medicinal products (CBMPs) have been identified as a promising novel therapeutic for symptoms and comorbidities related to autism spectrum disorder (ASD). However, there is a paucity of clinical evidence of their efficacy and safety. This case series aims to assess changes to health-related quality of life and the incidence of adverse events in patients treated with CBMPs for associated symptoms of ASD enrolled on the UK Medical Cannabis Registry (UKMCR). Methods: Patients treated with CBMPs for ASD-related symptoms for a minimum of one month were identified from the UKMCR. Primary outcomes were changes in validated patient reported outcome measures [Generalised Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), EQ-5D-5L index values] at 1, 3, and 6 months compared to baseline. Adverse events were recorded and analysed. Statistical significance was determined by p<0.050.Results: 74 patients with ASD were included in the analysis. The mean age of participants was 32.7 (±11.6) years. There were significant improvements in general health-related quality of life and sleep as assessed by the EQ-5D-5L, SQS and GAD-7 at 1 and 3 months, with sustained changes in EQ-5D-5L and SQS at 6 months (p<0.010). There were 180 (243.2%) adverse events reported by 14 (18.9%) participants. If present, adverse events were commonly mild (n=58; 78.4%) or moderate (n=81; 109.5%), rather than severe (n=41; 55.4%).Conclusions: This study demonstrated in patients with ASD an associated improvement in general health-related quality of life, and anxiety- and sleep-specific symptoms following initiation of treatment with CBMPs. These findings, whilst promising, are limited by the confines of the study which lacks a control arm and is subject to attrition bias. Therefore, further evaluation is required with randomised controlled trials.

AB - Introduction: Cannabis-based medicinal products (CBMPs) have been identified as a promising novel therapeutic for symptoms and comorbidities related to autism spectrum disorder (ASD). However, there is a paucity of clinical evidence of their efficacy and safety. This case series aims to assess changes to health-related quality of life and the incidence of adverse events in patients treated with CBMPs for associated symptoms of ASD enrolled on the UK Medical Cannabis Registry (UKMCR). Methods: Patients treated with CBMPs for ASD-related symptoms for a minimum of one month were identified from the UKMCR. Primary outcomes were changes in validated patient reported outcome measures [Generalised Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), EQ-5D-5L index values] at 1, 3, and 6 months compared to baseline. Adverse events were recorded and analysed. Statistical significance was determined by p<0.050.Results: 74 patients with ASD were included in the analysis. The mean age of participants was 32.7 (±11.6) years. There were significant improvements in general health-related quality of life and sleep as assessed by the EQ-5D-5L, SQS and GAD-7 at 1 and 3 months, with sustained changes in EQ-5D-5L and SQS at 6 months (p<0.010). There were 180 (243.2%) adverse events reported by 14 (18.9%) participants. If present, adverse events were commonly mild (n=58; 78.4%) or moderate (n=81; 109.5%), rather than severe (n=41; 55.4%).Conclusions: This study demonstrated in patients with ASD an associated improvement in general health-related quality of life, and anxiety- and sleep-specific symptoms following initiation of treatment with CBMPs. These findings, whilst promising, are limited by the confines of the study which lacks a control arm and is subject to attrition bias. Therefore, further evaluation is required with randomised controlled trials.

U2 - 10.1177/20451253221116240

DO - 10.1177/20451253221116240

M3 - Article

C2 - 36159065

VL - 12

JO - Therapeutic Advances in Psychopharmacology

JF - Therapeutic Advances in Psychopharmacology

SN - 2045-1253

ER -