Highlights
- •Analyzed quality of life with CBD treatment in adults with refractory epilepsy
- •Quality of life (QOL) significantly improved after 1 year of CBD treatment.
- •Improvement in QOL somewhat dependent on improvements in mood
- •QOL changes not dependent on improvement in seizure control
- •CBD may have independent positive effects on QOL beyond improved seizure control.
Abstract
Treatment-resistant epilepsy (TRE) is associated with low quality of life (QOL). Cannabidiol
(CBD) may improve QOL, but it is unclear if such improvements are independent of improvements
in seizure control. Our aim was to compare QOL at baseline and after 1 year of treatment
with CBD. We hypothesized that QOL would improve independent of changes in seizure
frequency (SF) or severity, mood, or adverse events. We assessed QOL using Quality
of Life in Epilepsy-89 (QOLIE-89) in an open-label study of purified CBD (Epidiolex®)
for the treatment of TRE. All participants received CBD, starting at 5 mg/kg/day and
titrated to 50 mg/kg/day in increments of 5 mg/kg/day. We collected QOLIE-89 in adult
participants at enrollment and after 1 year of treatment, or at study exit if earlier.
We analyzed if the change in QOLIE-89 total score could be explained by the change
in SF, seizure severity (Chalfont Seizure Severity Scale, CSSS), mood (Profile of
Moods States, POMS), or adverse events (Adverse Event Profile, AEP). Associations
among the variables were assessed using bivariate tests and multiple regression. Fifty-three
participants completed enrollment and follow-up testing, seven at study termination.
Mean QOLIE-89 total score improved from enrollment (49.4 ± 19) to follow-up (57 ± 21.3;
p = .004). We also saw improvements in SF, POMS, AEP, and CSSS (all p ≤ .01). Multivariable
regression results showed QOLIE-89 at follow-up associated with improvements in POMS
at follow-up (p = .020), but not with AEP, CSSS, or SF (p ≥ .135). Improvement in
QOL after treatment with CBD is associated with better mood but not with changes in
SF, seizure severity, or AEP. Cannabidiol may have beneficial effects on QOL and mood
that are independent of treatment response.
Abbreviations:
QOL (quality of life), TRE (treatment-resistant epilepsy), ASD (antiseizure drug), CBD (cannabidiol), UAB (University of Alabama at Birmingham), VNS (vagus nerve stimulator)Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Epilepsy & BehaviorAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Measuring health-related quality of life in drug clinical trials: is it given due importance?.Pharm World Sci. 2008; 30: 154-160
- Assessment of quality-of-life outcomes.N Engl J Med. 1996; 334: 835-840
- Quality of life of people with epilepsy: a European study.Epilepsia. 1997; 38: 353-362
- Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality.Epilepsia. 1997; 38: S1-S8
- Seizure frequency and the health-related quality of life of adults with epilepsy.Neurology. 1999; 2001: S69-S73
- Seizure frequency, patient-perceived seizure severity and the psychosocial consequences of intractable epilepsy.Epilepsy Res. 1991; 9: 231-241
- Depression but not seizure frequency predicts quality of life in treatment-resistant epilepsy.Neurology. 2004; 62: 258-261
- The effect of seizure severity on quality of life in epilepsy.Epilepsy Behav. 2007; 11: 208-211
- Seizure disorders, depression, and health-related quality of life.Epilepsy Behav. 2004; 5: 50-57
- Quality of life in medication-resistant epilepsy: the effects of patient's age, age at seizure onset, and disease duration.Epilepsy Behav. 2006; 8: 547-551
- Associated and predictive factors of quality of life in patients with temporal lobe epilepsy.Epilepsy Behav. 2018; 86: 85-90
- Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial.Neurology. 2004; 62: 23-27
- Measuring outcomes of treatment with antiepileptic drugs in clinical trials.Epilepsy Behav. 2010; 18: 24-30
- Development of the quality of life in epilepsy inventory.Epilepsia. 1995; 36: 1089-1104
- Evaluating health-related quality of life outcomes in clinical trials of antiepileptic drug therapy.Epilepsia. 1998; 39: 965-977
- Principles of health-related quality of life: assessment in clinical trials.Epilepsia. 2002; 43: 1084-1095
- Telephone validation of the Quality of Life in Epilepsy Inventory-89 (QOLIE-89).Epilepsia. 1999; 40: 97-106
- Effect of cannabidiol on drop seizures in the Lennox–Gastaut syndrome.N Engl J Med. 2018; 378: 1888-1897
- Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome.Neurology. 2018; 90: e1204-e1211
- Cannabidiol in patients with seizures associated with Lennox–Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial.Lancet. 2018; 391: 1085-1096
- Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial.Lancet Neurol. 2016; 15: 270-278
- Cannabidiol as a new treatment for drug-resistant epilepsy in tuberous sclerosis complex.Epilepsia. 2016; 57: 1617-1624
- Long-term safety and treatment effects of cannabidiol in children and adults with treatment-resistant epilepsies: expanded access program results.Epilepsia. 2018; 59: 1540-1548
- Cannabidiol improves frequency and severity of seizures and reduces adverse events in an open-label add-on prospective study.Epilepsy Behav. 2018; 87: 131-136
- Quality of life in childhood epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.Epilepsia. 2017; 58: 96-100
- Report of a parent survey of cannabidiol-enriched cannabis use in pediatric treatment-resistant epilepsy.Epilepsy Behav. 2013; 29: 574-577
- A prospective open-label trial of a CBD/THC cannabis oil in Dravet syndrome.Ann Clin Transl Neurol. 2018; 5: 1077-1088
- Profile of Mood States.Education and Industrial Testing Service, San Diego, CA1971
- The Chalfont Seizure Severity Scale.J Neurol Neurosurg Psychiatry. 1991; 54: 873-876
- Development of a patient-based symptom check list to quantify adverse events in persons receiving antiepileptic drugs.Epilepsia. 1993; 34: 18
- Clinically important change in quality of life in epilepsy.J Neurol Neurosurg Psychiatry. 2002; 73: 116-120
- Psychopathology and quality of life: psychogenic non-epileptic seizures versus epilepsy.Med Sci Monit. 2003; 9 (Cr113–8)
- Measuring depressive symptoms among treatment-resistant seizure disorder patients: POMS depression scale as an alternative to the BDI-II.Epilepsy Behav. 2005; 7: 266-272
- Seizure diaries for clinical research and practice: limitations and future prospects.Epilepsy Behav. 2012; 24: 304-310
- Outlier impact and accommodation methods: multiple comparisons of type 1 error rates.J Mod Appl Stat Methods. 2016; 15: 452-471
- Neuroimaging studies towards understanding the central effects of pharmacological cannabis products on patients with epilepsy.Epilepsy Behav. 2017; 70: 349-354
- The impact of comorbid depression on health resource utilization in a community sample of people with epilepsy.Epilepsy Behav. 2004; 5: 337-342
- The influence of comorbid depression on quality of life for people with epilepsy.Epilepsy Behav. 2003; 4: 515-521
- Placebo effect of medication cost in Parkinson disease: a randomized double-blind study.Neurology. 2015; 84: 794-802
- Interactions between cannabidiol and commonly used antiepileptic drugs.Epilepsia. 2017; 58: 1586-1592
- Drug–drug interaction between clobazam and cannabidiol in children with refractory epilepsy.Epilepsia. 2015; 56: 1246-1251
Article info
Publication history
Published online: April 16, 2019
Accepted:
March 18,
2019
Received in revised form:
March 18,
2019
Received:
February 1,
2019
Identification
Copyright
© 2019 Elsevier Inc. All rights reserved.
