Abstract
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.
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.
| Original language | English |
|---|---|
| Journal | Therapeutic Advances in Psychopharmacology |
| Volume | 12 |
| DOIs | |
| Publication status | Published - 20 Sept 2022 |