Publications
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Murphy M, Erridge S, Holvey C, et al., 2024, A cohort study comparing the effects of medical cannabis for anxiety patients with and without comorbid sleep disturbance, Neuropsychopharmacology Reports, Vol: 44, Pages: 129-142, ISSN: 2574-173X
BACKGROUND: Research on cannabis-based medicinal products (CBMPs) in anxiety remains inconclusive due to a paucity of high-quality evidence. Studies indicate a bidirectional relationship between generalized anxiety disorder (GAD) and sleep disruption, but it is unclear how this affects CBMP treatment outcomes. This study aims to compare the patient-reported outcome measures (PROMs) of patients prescribed CBMPs for GAD, with and without impaired sleep. METHODS: Changes in PROMs were recorded from baseline to 1, 3, 6, and 12 months between those with impaired or unimpaired sleep. Multivariate logistic regression was applied to compare factors associated with a clinically significant improvement in GAD-7 at 12 months. Secondary outcomes included adverse event incidence and frequency. RESULTS: Of the 302 patients that fit the inclusion criteria, mean GAD-7, single-item sleep quality, and EQ-5D-5L index values improved at all time points (p < 0.001). A relationship between sleep impairment and clinically significant changes in GAD-7 at 1 and 3 months was identified (p ≤ 0.01). On multivariate regression, only baseline GAD severity was associated with an increased likelihood of observing a clinically significant improvement in anxiety (p < 0.001). Seven hundred and seven (234%) adverse events were reported by 55 (18.21%) participants. CONCLUSIONS: This study observed an association between CBMP treatment and improvements in anxiety in patients with GAD. While patients with comorbid sleep disruption had greater improvements in anxiety, the differences were not maintained in a multivariate analysis. Baseline anxiety severity may be a predictor for CBMP treatment outcomes.
Li A, Erridge S, Holvey C, et al., 2024, UK Medical Cannabis Registry: a case series analyzing clinical outcomes of medical cannabis therapy for generalized anxiety disorder patients., Int Clin Psychopharmacol
This study aims to analyze changes in health-related quality of life (HRQoL) and safety in patients with generalized anxiety disorder (GAD) prescribed a homogenous selection of cannabis-based medicinal products (CBMPs). Patients prescribed Adven CBMPs (Curaleaf International, UK) for GAD were identified from the UK Medical Cannabis Registry. Primary outcomes were changes in patient-reported outcome measures (PROMs) from baseline up to 12 months, including GAD-7, Single-Item Sleep Quality Scale (SQS), and EQ-5D-5L. Adverse events were recorded using CTCAE version 4.0. A total of 120 patients were identified for inclusion, of which 38 (31.67%), 52 (43.33%), and 30 (25.00%) were prescribed oils, dried flower, and both formulations of CBMP. Associated improvements in GAD-7, SQS, and EQ-5D-5L at 1, 3, 6, and 12 months were observed compared to baseline (P < 0.010). There were 24 (20.00%) patients who reported 442 (368.33%) adverse events, most of which were mild (n = 184, 41.63%) and moderate (n = 197, 44.57%). This study reports an association between initiation of a homogeneous CBMP therapy and improvements in anxiety severity and HRQoL in individuals with GAD. Moreover, therapy was well-tolerated at 12 months follow-up. Further investigation through randomized controlled trials will ultimately be required to determine causation.
Vivek K, Karagozlu Z, Erridge S, et al., 2024, UK Medical Cannabis Registry: assessment of clinical outcomes in patients with insomnia, Brain and Behavior, Vol: 14, ISSN: 2162-3279
INTRODUCTION: The primary aim of this study was to assess changes in sleep-specific health-related quality of life (HRQoL) for those prescribed cannabis-based medicinal products (CBMPs) for insomnia. METHODS: A case series of UK patients with insomnia was analyzed. Primary outcomes were changes in the Single-Item Sleep-Quality Scale (SQS), Generalized Anxiety Disorder-7 (GAD-7), and EQ-5D-5L at up to 6 months from baseline. Statistical significance was identified as a p value < .050. RESULTS: 61 patients were included in the analysis. There was an improvement in the SQS from baseline at 1, 3, and 6 months (p < .001). There were also improvements in the EQ-5D-5L Index value and GAD-7 at 1, 3, and 6 months (p < .050). There were 28 (45.9%) adverse events recorded by 8 patients (13.1%). There were no life-threatening/disabling adverse events. CONCLUSION: Patients with insomnia experienced an improvement in sleep quality following the initiation of CBMPs in this medium-term analysis. Fewer than 15% of participants reported one or more adverse events. However, due to the limitations of the study design, further investigation is required before definitive conclusions can be drawn on the efficacy of CBMPs in treating insomnia.
Erridge S, Sodergren MH, 2024, Cannabis use: a marker of clinical severity in inflammatory bowel disease?, Inflammatory Bowel Diseases, Vol: 30, Pages: 322-323, ISSN: 1078-0998
Ciesluk B, Erridge S, Sodergren MH, et al., 2024, Corrigendum: Cannabis use in the UK: a quantitative comparison of individual differences in medical and recreational cannabis users., Front Psychol, Vol: 15, ISSN: 1664-1078
[This corrects the article DOI: 10.3389/fpsyg.2023.1279123.].
Erridge S, Leung O, Holvey C, et al., 2023, An observational study of clinical outcome measures in patients treated with cannabis-based medicinal products on the UK Medical Cannabis Registry, Neuropsychopharmacology Reports, Vol: 43, Pages: 616-632, ISSN: 2574-173X
INTRODUCTION: While there is increasing evidence of the effects of cannabis-based medicinal products (CBMPs) on health-related quality of life (HRQoL), a major limitation of the current literature is the heterogeneity of studied CBMPs. This study aims to analyze changes in HRQoL in patients prescribed a homogenous selection of CBMPs. METHODS: Primary outcomes were changes in patient-reported outcomes (PROMs) at 1, 3, 6, and 12 months from baseline. The secondary outcome was an adverse events analysis. Statistical significance was defined as p < 0.050. RESULTS: 1378 patients prescribed Adven® CBMPs (Curaleaf International, Guernsey, UK) were included in the final analysis. 581 (42.16%) participants were current users of cannabis at baseline. 641 (46.51%), 235 (17.05%), and 502 (36.43%) patients were treated with oils, dried flowers, or a combination of the two, respectively. Improvements were found in all PROMs in each route of administration at 1, 3, 6, and 12 months from baseline (p < 0.010). Those prescribed dried flower only or both oils and dried flower experienced greater improvements in GAD-7, SQS, and EQ-5D-5L index values at 12 months (p < 0.050). There was no difference in outcomes between those prescribed dried flower only or dried flower with oils (p > 0.050). 3663 (265.82%) adverse events were reported by 297 (21.55%) patients. CONCLUSION: There was an associated improvement in self-reported anxiety, sleep quality, and HRQoL in patients treated with the CBMPs. Those prescribed treatment formulations including dried flower were most likely to show a clinical improvement. However, these results must be interpreted with caution given the limitations of study design.
Ittiphakorn P, Erridge S, Holvey C, et al., 2023, UK Medical Cannabis Registry: an analysis of clinical outcomes of medicinal cannabis therapy for attention-deficit/hyperactivity disorder, Neuropsychopharmacology Reports, Vol: 43, Pages: 596-606, ISSN: 2574-173X
AIM: This study aims to analyze the health-related quality of life (HRQoL) and safety outcomes in attention-deficit/hyperactivity disorder (ADHD) patients treated with cannabis-based medicinal products (CBMPs). METHODS: Patients were identified from the UK Medical Cannabis Registry. Primary outcomes were changes in the following patient-reported outcome measures (PROMs) at 1, 3, 6, and 12 months from baseline: EQ-5D-5L index value, generalized anxiety disorder-7 (GAD-7) questionnaire, and the single-item sleep quality score (SQS). Secondary outcomes assessed the incidence of adverse events. Statistical significance was defined as p < 0.050. RESULTS: Sixty-eight patients met the inclusion criteria. Significant improvements were identified in general HRQoL assessed by EQ-5D-5L index value at 1, 3, and 6 months (p < 0.050). Improvements were also identified in GAD-7 and SQS scores at 1, 3, 6, and 12 months (p < 0.010). 61 (89.71%) adverse events were recorded by 11 (16.18%) participants, of which most were moderate (n = 26, 38.24%). CONCLUSION: An association between CBMP treatment and improvements in anxiety, sleep quality, and general HRQoL was observed in patients with ADHD. Treatment was well tolerated at 12 months. Results must be interpreted with caution as a causative effect cannot be proven. These results, however, do provide additional support for future evaluation within randomized controlled trials.
Anand U, Anand P, Sodergren MH, 2023, Terpenes in Cannabis sativa inhibit capsaicin responses in rat DRG neurons via Na+/K+ ATPase activation, International Journal of Molecular Sciences, Vol: 24, ISSN: 1422-0067
Terpenes in Cannabis sativa exert analgesic effects, but the mechanisms are uncertain. We exam-ined the effects of 10 terpenes on capsaicin responses in an established model of neuronal hyper-sensitivity. Adult rat DRG neurons cultured with neurotrophic factors NGF and GDNF, were loaded with Fura2AM for calcium imaging, and treated with individual terpenes or vehicle for 5 minutes, followed by 1 µMol capsaicin. In vehicle treated control experiments, capsaicin elicited immediate and sustained calcium influx. Most neurons treated with terpenes responded to capsaicin after 6-8 minutes. Few neurons showed immediate capsaicin responses that were transient or normal. The delayed responses were found to be due to calcium released from the endoplasmic reticulum, as they were maintained in calcium/magnesium free media, but not after thapsigargin pre-treatment. Terpene inhibition of calcium influx was reversed after washout of medium, in the absence of terpenes, and in the presence of the Na+/K+ ATPase inhibitor ouabain, but not CB1 or CB2 receptor antagonists. Thus terpenes inhibit capsaicin evoked calcium influx by Na+/K+ ATPase activation. Immunofluorescence showed TRPV1 co-expression with α1β1 Na+/K+ ATPase in most neurons while others were either TRPV1 or α1β1 Na+/K+ ATPase positive.
Mcclements J, Valle JW, Blackburn L, et al., 2023, Variation in treatment of intrahepatic cholangiocarcinoma: a nationwide multicentre study, BRITISH JOURNAL OF SURGERY, ISSN: 0007-1323
Rifkin-Zybutz R, Erridge S, Holvey C, et al., 2023, Clinical outcome data of anxiety patients treated with cannabis-based medicinal products in the United Kingdom: a cohort study from the UK Medical Cannabis Registry, Psychopharmacology, Vol: 240, Pages: 1735-1745, ISSN: 0033-3158
RationaleCannabis-based medicinal products (CBMPs) have been identified as novel therapeutics for generalised anxiety disorder (GAD) based on pre-clinical models; however, there is a paucity of high-quality evidence on their effectiveness and safety.ObjectivesThis study aimed to evaluate the clinical outcomes of patients with GAD treated with dried flower, oil-based preparations, or a combination of both CBMPs.MethodsA prospective cohort study of patients with GAD (n = 302) enrolled in the UK Medical Cannabis Registry prescribed oil or flower-based CBMPs was performed. Primary outcomes were changes in generalised anxiety disorder-7 (GAD-7) questionnaires at 1, 3, and 6 months compared to baseline. Secondary outcomes were single-item sleep quality scale (SQS) and health-related quality of life index (EQ-5D-5L) questionnaires at the same time points. These changes were assessed by paired t-tests. Adverse events were assessed in line with CTCAE (Common Terminology Criteria for Adverse Events) v4.0.ResultsImprovements in anxiety, sleep quality and quality of life were observed at each time point (p < 0.001). Patients receiving CBMPs had improvements in GAD-7 at all time points (1 month: difference −5.3 (95% CI −4.6 to −6.1), 3 months: difference −5.5 (95% CI −4.7 to −6.4), 6 months: difference −4.5 (95% CI −3.2 to −5.7)). Thirty-nine participants (12.9%) reported 269 adverse events in the follow-up period.ConclusionsPrescription of CBMPs in those with GAD is associated with clinically significant improvements in anxiety with an acceptable safety profile in a real-world setting. Randomised trials are required as a next step to investigate the efficacy of CBMPs.
Wang C, Erridge S, Holvey C, et al., 2023, Assessment of clinical outcomes in patients with fibromyalgia: analysis from the UK Medical Cannabis Registry, Brain and Behavior, Vol: 13, ISSN: 2162-3279
Introduction: There are limited therapeutic options for individuals with fibromyalgia. The aim of this study is to analyze changes in health-related quality of life and incidence of adverse events of those prescribed cannabis-based medicinal products (CBMPs) for fibromyalgia.Methods: Patients treated with CBMPs for a minimum of 1 month were identified from the UK Medical Cannabis Registry. Primary outcomes were changes in validated patient-reported outcome measures (PROMs). A p-value of <.050 was deemed statistically significant.Results: In total, 306 patients with fibromyalgia were included for analysis. There were improvements in global health-related quality of life at 1, 3, 6, and 12 months (p < .0001). The most frequent adverse events were fatigue (n = 75; 24.51%), dry mouth (n = 69; 22.55%), concentration impairment (n = 66; 21.57%), and lethargy (n = 65; 21.24%).Conclusion: CBMP treatment was associated with improvements in fibromyalgia-specific symptoms, in addition to sleep, anxiety, and health-related quality of life. Those who reported prior cannabis use appeared to have a greater response. CBMPs were generally well-tolerated. These results must be interpreted within the limitations of study design.
Greco R, Francavilla M, Demartini C, et al., 2023, Characterization of the biochemical and behavioral effects of cannabidiol: implications for migraine (vol 24, 48, 2023), JOURNAL OF HEADACHE AND PAIN, Vol: 24, ISSN: 1129-2369
D'Alessio A, Pai M, Spalding D, et al., 2023, Neoadjuvant immunotherapy with ipilimumab plus nivolumab and radiologically and pathologically quantifiable responses through modulation of the tumour microenvironment in resectable hepatocellular carcinoma, Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0732-183X
Ergisi M, Erridge S, Harris M, et al., 2023, An updated analysis of clinical outcome measures across patients from the UK medical cannabis registry, Cannabis and Cannabinoid Research, Vol: 8, Pages: 557-566, ISSN: 2378-8763
Introduction: There is a growing body of literature supporting the efficacy of cannabis-based medicinal products (CBMPs). Despite an increase in prescribing globally, there is a paucity of high-quality clinical data on the efficacy of CBMPs for many conditions. This study aims to detail the changes in health-related quality of life (HRQoL) and associated clinical safety in patients prescribed CBMPs for any clinical indication from the UK Medical Cannabis Registry (UKMCR). Methods: An uncontrolled prospective case series of the UKMCR was analyzed. Primary outcomes included change from baseline in patient-reported outcome measures collected across all patients (the Generalized Anxiety Disorder Scale [GAD-7], EQ-5D-5L, and Sleep Quality Scale [SQS]) at 1, 3, and 6 months. Secondary outcomes included the self-reported incidence and severity of adverse events. Statistical significance was defined as p<0.050. Results: Three hundred twelve patients were included in the final analysis, with a mean age of 44.8. The most common primary diagnoses were chronic pain of undefined etiology (n=102, 32.7%), neuropathic pain (n=43, 13.8%), and fibromyalgia (n=31, 9.9%). Before enrolment, 112 (35.9%) patients consumed cannabis daily. The median cannabidiol and (-)-trans-Δ9-tetrahydrocannabinol doses prescribed at baseline were 20.0 mg (0.0-510.0 mg) and 3.0 mg (0.0-660.0 mg), respectively. Statistically significant improvements were observed in GAD-7, EQ-5D-5L Index, EQ-5D Visual Analog Scale and SQS scores at 1, 3, and 6 months (p<0.050). There were 94 (30.1%) reported adverse events, of which nausea (n=12, 3.8%), dry mouth (n=10, 3.2%), dizziness (n=7, 2.2%), and somnolence (n=7, 2.2%) were the most common. Conclusion: This study demonstrated CBMP treatment to be associated with a relatively low incidence of severe adverse events in the medium-term. Positive changes following treatment were observed in general, as well as anxiety and sleep-spe
Greco R, Francavilla M, Demartini C, et al., 2023, Characterization of the biochemical and behavioral effects of cannabidiol: implications for migraine, JOURNAL OF HEADACHE AND PAIN, Vol: 24, ISSN: 1129-2369
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Erridge S, Mangoo S, Sodergren M, 2023, Letter to the editor: reflections on the future of medical cannabis research for depression, Expert Review of Neurotherapeutics: a key contribution to decision making in the treatment of neurologic and neuropsychiatric disorders, Vol: 23, Pages: 481-482, ISSN: 1473-7175
Plummer R, Sodergren M, Ryan B, et al., 2023, MTL-CEBPA in combination with pembrolizumab converts an immune desert to an inflamed TME in solid tumors resistant to checkpoint blockade, 114th Annual Meeting of the American Association for Cancer Research (AACR), Publisher: AMER ASSOC CANCER RESEARCH, ISSN: 0008-5472
Tait J, Erridge S, Holvey C, et al., 2023, Clinical outcome data of chronic pain patients treated with cannabis-based oils and dried flower from the UK Medical Cannabis Registry, Expert Review of Neurotherapeutics: a key contribution to decision making in the treatment of neurologic and neuropsychiatric disorders, Vol: 23, Pages: 413-423, ISSN: 1473-7175
BackgroundThe following study evaluated the clinical outcomes of patients enrolled in the UK Medical Cannabis Registry, who were treated with inhaled dried flower (Adven® EMT2, Curaleaf International, Guernsey), and sublingual/oral medium-chain triglyceride-based oils (Adven, Curaleaf International, Guernsey) for chronic pain.MethodsIn this cohort study, the primary outcomes were changes in validated patient reported outcome measures (PROMs) at 1, 3, and 6 months compared to baseline, and adverse event analysis. Statistical significance was defined as p < 0.050.ResultsThree hundred and forty-eight (45.7%), 36 (4.7%), and 377 (49.5%) patients were treated with oils, dried flower, or both, respectively. Patients treated with oils or combination therapy recorded improvements within health-related quality of life, pain, and sleep-specific PROMs at 1, 3, and 6 months (p < 0.050). Patients treated with combination therapy recorded improvements in anxiety-specific PROMs at 1, 3, and 6 months (p < 0.050). 1,273 (167.3%) adverse events were recorded, with previously cannabis naïve users, ex-cannabis users, and females more likely to experience adverse events (p < 0.050).ConclusionsThis study observed an association between initiation of CBMP treatment and improved outcomes for chronic pain patients. Prior cannabis use and gender were associated with adverse event incidence. Placebo-controlled trials are still necessary to establish the efficacy and safety of CBMPs for chronic pain.
Erridge S, Shetye A, Mangal N, et al., 2023, Patient Perceptions on Evaluating Pancreatic Cancer Treatments Prior to Clinical Translation, GBIHPBA
Yeung KTD, Sodergren MH, 2023, Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS)-a fine balance, HEPATOBILIARY SURGERY AND NUTRITION, ISSN: 2304-3881
Olsson F, Erridge S, Tait J, et al., 2023, An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry., Expert Review of Clinical Pharmacology, Vol: 16, Pages: 257-266, ISSN: 1751-2433
BACKGROUND: There is a paucity of high-quality data on patient outcomes and safety after initiating treatment with cannabis-based medicinal products (CBMPs). The aim of this study was to assess the clinical outcomes and safety of CBMPs by analyzing patient-reported outcome measures and adverse events across a broad spectrum of chronic conditions. RESEARCH DESIGN AND METHODS: This study analyzed patients enrolled in the UK Medical Cannabis Registry. Participants completed the EQ-5D-5L to assess health-related quality of life, Generalized Anxiety Disorder-7 (GAD-7) questionnaire to measure anxiety severity, and the Single-item Sleep Quality Scale (SQS) to rate sleep quality at baseline and follow-up after 1, 3, 6, and 12 months. RESULTS: A total of 2833 participants met inclusion criteria. The EQ-5D-5L index value, GAD-7, and SQS all improved at each follow-up (p < 0.001). There was no difference in EQ-5D-5L index values between former or current illicit cannabis consumers and naïve patients (p > 0.050). Adverse events were reported by 474 (16.73%) participants. CONCLUSIONS: This study suggests that CBMPs are associated with an improvement in health-related quality of life in UK patients with chronic diseases. Treatment was tolerated well by most participants, but adverse events were more common in female and cannabis-naïve patients.
Bapir L, Erridge S, Nicholas M, et al., 2023, Comparing the effects of medical cannabis for chronic pain patients with and without co-morbid anxiety: A cohort study., Expert Review of Neurotherapeutics: a key contribution to decision making in the treatment of neurologic and neuropsychiatric disorders, Vol: 23, Pages: 281-295, ISSN: 1473-7175
INTRODUCTION: There is growing evidence on the efficacy of cannabis-based medicinal products (CBMPs) for chronic pain (CP). Due to the interaction between CP and anxiety, and the potential impact of CBMPs on both anxiety and CP, this article aimed to compare the outcomes of CP patients with and without co-morbid anxiety following CBMP treatment. METHODS: Participants were prospectively enrolled and categorized by baseline General Anxiety Disorder-7(GAD-7) scores, into 'no anxiety'(GAD-7 < 5) and 'anxiety'(GAD-7 ≥ 5) cohorts. Primary outcomes were changes in Brief Pain Inventory Short-Form, Short-form McGill Pain Questionnaire-2, Pain Visual Analogue Scale, Sleep Quality Scale (SQS), GAD-7 and EQ-5D-5L index values at 1, 3 and 6 months. RESULTS: 1254 patients (anxiety = 711; no anxiety = 543) met inclusion criteria. Significant improvements in all primary outcomes were observed at all timepoints (p < 0.050), except GAD-7 in the no anxiety group(p > 0.050). The anxiety cohort reported greater improvements in EQ-5D-5L index values, SQS and GAD-7(p < 0.050), but there were no consistent differences in pain outcomes. CONCLUSION: A potential association between CBMPs and improvements in pain and health-related quality of life (HRQoL) in CP patients was identified. Those with co-morbid anxiety reported greater improvements in HRQoL.
Tait J, Erridge S, Sodergren MH, 2023, UK medical cannabis registry: a patient evaluation, Journal of Pain and Palliative Care Pharmacotherapy, Vol: 37, Pages: 170-177, ISSN: 0742-969X
The UK Medical Cannabis Registry is the largest real world data platform for medical cannabis outcomes in the UK, providing insight into clinical outcomes and monitoring safety of this novel therapy. This study aims to assess the functionality and accessibility of the online data collection platform and patient priorities for future research. Descriptive statistics were used to analyze quantitative data. For open-ended questions an inductive thematic analysis was performed. 600 responses were recorded. 554 (92.3%) patients had used the platform. 272 (90.4%) patients believed it was easy to input medications. 52 (8.67%) patients recorded an adverse event with 38 (73.1%) finding it easy to record. 535 (96.6%) patients had completed health questionnaires with 490 (91.6%) patients finding this easy to do. 553 (92.2%) patients agreed that contributing to the registry would impact the medical care of future patients. 'Assessing the impact of medical cannabis on quality of life generally' was the top research priority for 357 (59.3%) patients. This study demonstrates that most enrolled patients found the platform easy to use and believed they were positively impacting future medical cannabis patient care. Future patient research priorities included assessment of quality of life and condition-specific outcomes.
Nicholas M, Erridge S, Bapir L, et al., 2023, UK medical cannabis registry: assessment of clinical outcomes in patients with headache disorders, Expert Review of Neurotherapeutics: a key contribution to decision making in the treatment of neurologic and neuropsychiatric disorders, Vol: 23, Pages: 1-12, ISSN: 1473-7175
ObjectivesHeadache disorders are a common cause of disability and reduced health-related quality of life globally. Growing evidence supports the use of cannabis-based medicinal products (CBMPs) for chronic pain; however, a paucity of research specifically focuses on CBMPs’ efficacy and safety in headache disorders. This study aims to assess changes in validated patient-reported outcome measures (PROMs) in patients with headaches prescribed CBMPs and investigate the clinical safety in this population.MethodsA case series of the UK Medical Cannabis Registry was conducted. Primary outcomes were changes from baseline in PROMs (Headache Impact Test-6 (HIT-6), Migraine Disability Assessment (MIDAS), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7) questionnaire and Single-Item Sleep Quality Scale (SQS)) at 1-, 3-, and 6-months follow-up. P-values <0.050 were deemed statistically significant.ResultsNinety-seven patients were identified for inclusion. Improvements in HIT-6, MIDAS, EQ-5D-5L and SQS were observed at 1-, 3-, and 6-months (p < 0.005) follow-up. GAD-7 improved at 1- and 3-months (p < 0.050). Seventeen (17.5%) patients experienced a total of 113 (116.5%) adverse events.ConclusionImprovements in headache/migraine-specific PROMs and general health-related quality of life were associated with the initiation of CBMPs in patients with headache disorders. Cautious interpretation of results is necessary, and randomized control trials are required to ascertain causality.
Erridge S, Olsson F, Sodergren MH, 2023, Patient priorities for research: A focus group study of UK medical cannabis patients, Complementary Therapies in Clinical Practice, Vol: 50, ISSN: 1744-3881
INTRODUCTION: There has yet to be an evaluation of medical cannabis patient preferences with respect to future research. As such, prioritisation of research agendas has been largely driven by academia and industry. The primary aim of this study was to elicit priorities for research from medical cannabis patients in the United Kingdom (UK). METHODS: Patients undergoing active treatment for health conditions with medical cannabis in the UK were invited to take part in focus groups from December 2021 to February 2022. An inductive thematic analysis of responses was performed. Participants also completed a ranking exercise whereby they assigned ten counters (each equivalent to £1 million GBP) to competing research priorities. RESULTS: 30 medical cannabis patients participated across 3 focus groups. The following themes were identified as research priorities: adverse events, comparison between cannabis-based medicinal products, health conditions, pharmacology of cannabis, types of study, healthcare professionals' attitudes, social environment, agriculture and manufacturing, and the cannabis plant. Participants assigned the highest proportion of research funding to 'assessment of effect on specific symptoms' (26 counters; 8.7%). CONCLUSIONS: This study highlighted specific themes within which to focus future research on medical cannabis. Clinically, there was a directive towards ensuring that research is condition- or symptom-specific. Participants also emphasised themes on the social impact of medical cannabis, such as knowledge of medical cannabis among healthcare professionals, stigma, and effects on driving and in the workplace. These findings can guide both research funders and researchers into effectively conducting research which fits within a more patient-centric model.
Erridge S, Holvey C, Coomber R, et al., 2023, Clinical outcome data of children treated with cannabis-based medicinal products for treatment resistant epilepsy - analysis from the UK medical cannabis registry., Neuropediatrics: journal of pediatric neurobiology, neurology and neurosurgery, Vol: 54, Pages: 174-181, ISSN: 0028-3797
BACKGROUND: There is a paucity of high-quality evidence of the efficacy and safety of cannabis-based medicinal products in treatment of treatment-resistant epilepsy (TRE) in children. METHODS: A case series of children (<18 years old) with TRE from the UK Medical Cannabis Registry was analyzed. Primary outcomes were ≥50% reduction in seizure frequency, changes in the Impact of Pediatric Epilepsy Score (IPES), and incidence of adverse events. RESULTS: Thirty-five patients were included in the analysis. Patients were prescribed during their treatment with the following: CBD isolate oils (n = 19), CBD broad-spectrum oils (n = 17), and CBD/Δ9-THC combination therapy (n = 17). Twenty-three (65.7%) patients achieved a ≥50% reduction in seizure frequency. 94.1% (n = 16) of patients treated with CBD and Δ9-THC observed a ≥50% reduction in seizure frequency compared to 31.6% (n = 6) and 17.6% (n = 3) of patients treated with CBD isolates and broad-spectrum CBD products, respectively (p< 0.001). Twenty-six (74.3%) adverse events were reported by 16 patients (45.7%). The majority of these were mild (n = 12; 34.2%) and moderate (n = 10; 28.6%). CONCLUSION: The results of this study demonstrate a positive signal of improved seizure frequency in children treated with Cannabis-based medicinal products (CBMPs) for TRE. Moreover, the results suggest that CBMPs are well-tolerated in the short term. The limitations mean causation cannot be determined in this open-label, case series.
Ciesluk B, Erridge S, Sodergren MH, et al., 2023, Cannabis use in the UK: a quantitative comparison of individual differences in medical and recreational cannabis users, Frontiers in Psychology, Vol: 14, ISSN: 1664-1078
There is a paucity of research, especially in the UK, that investigates individual differences in both medical and recreational cannabis users. A cross-sectional survey study design was used to assess recreational cannabis users and medical cannabis users currently living in the UK. Recreational cannabis users were invited to take part via social media. Medical cannabis users were recruited from Sapphire Medical Clinics, London, UK, which provides treatment with prescribed cannabis-based medicinal products. Demographic data and cannabis use frequency, as well as post-traumatic stress disorder symptoms (PCL-5), depression symptoms (Centre for Epidemiological Studies Depression Scale), trait and state anxiety (State-Trait Anxiety Inventory), and cannabis use motives [Comprehensive Marijuana Motives Questionnaire (CMMQ)] were collected. The Chi-square and independent-sample t-tests were used for the comparison of categorical variables and normally distributed continuous variables. Data were analyzed using analyses of variance (ANOVAs) and t-tests. Statistical significance was considered where the value of p was <0.05. The survey was completed by 161 participants. Medical cannabis users were older, consumed cannabis more often, had a higher "Sleep" motive on the CMMQ, and had a higher prevalence in self-reporting current diagnoses of neurological problems, mood disorders, and anxiety disorders (p < 0.05). Recreational cannabis users had higher scores on several motives for use (e.g., "Enjoyment," "Coping," "Experimentation," "Boredom," and "Celebration") and higher state anxiety scores (p < 0.05). The most common motives for cannabis use in both groups were "Enjoyment," "Low Risk," and "Sleep." There were no differences between groups in gender, "Low-Risk" motive, post-traumatic stress disorder symptoms, depression scores, trait anxiet
Mangoo S, Erridge S, Holvey C, et al., 2023, Assessment of clinical outcomes of medicinal cannabis therapy for depression: analysis from the UK Medical Cannabis Registry, Expert Review of Neurotherapeutics: a key contribution to decision making in the treatment of neurologic and neuropsychiatric disorders, Vol: 22, Pages: 995-1008, ISSN: 1473-7175
BackgroundAlthough pre-clinical experiments associate cannabinoids with reduced depressive symptoms, there is a paucity of clinical evidence. This study aims to analyze the health-related quality of life changes and safety outcomes in patients prescribed cannabis-based medicinal products (CBMPs) for depression.MethodsA series of uncontrolled cases from the UK Medical Cannabis Registry were analyzed. The primary outcomes were changes from baseline in the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5 L at 1, 3, and 6 months. Secondary outcomes included adverse events incidence.Results129 patients were identified for inclusion. Median PHQ-9 at baseline was 16.0 (IQR: 9.0–21.0). There were reductions in PHQ-9 at 1-month (median: 8.0; IQR: 4.0–14.0; p < 0.001), 3-months (7.0; 2.3–12.8; p < 0.001), and 6-months (7.0; 2.0–9.5; p < 0.001). Improvements were also observed in GAD-7, SQS, and EQ-5D-5L Index Value at 1, 3, and 6 months (p < 0.050). 153 (118.6%) adverse events were recorded by 14.0% (n = 18) of participants, 87% (n = 133) of which were mild or moderate.ConclusionCBMP treatment was associated with reductions in depression severity at 1, 3, and 6 months. Limitations of the study design mean that a causal relationship cannot be proven. This analysis provides insights for further study within clinical trial settings.
Dalavaye N, Erridge S, Nicholas M, et al., 2022, The effect of medical cannabis in inflammatory bowel disease: analysis from the UK Medical Cannabis Registry, Expert Review of Gastroenterology and Hepatology, Vol: 17, Pages: 85-98, ISSN: 1747-4124
ObjectivesCannabis-based medicinal products (CBMPs) have shown promising preclinical activity in inflammatory bowel disease (IBD). However, clinical trials have not demonstrated effects on inflammation. This study aims to analyze changes in health-related quality of life (HRQoL) and adverse events in IBD patients prescribed CBMPs.MethodsA case series from the UK Medical Cannabis Registry was performed. Primary outcomes included changes from baseline in the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Generalized Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), and EQ-5D-5L Index score at 1 and 3 months. Statistical significance was defined using p < 0.050.ResultsSeventy-six patients with Crohn’s disease (n = 51; 67.11%) and ulcerative colitis (n = 25; 32.89%) were included. The median baseline SIBDQ score improved at 1 and 3 months. EQ-5D-5L index values, GAD-7, and SQS also improved after 3 months (p < 0.050). Sixteen (21.05%) patients reported adverse events with the majority being classified as mild to moderate in severity.ConclusionPatients treated with CBMPs for refractory symptoms of Crohn’s disease and ulcerative colitis demonstrated a short-term improvement in IBD-specific and general HRQoL. Prior cannabis consumers reported greater improvement compared to cannabis-naïve individuals.
Pillai M, Erridge S, Bapir L, et al., 2022, Assessment of clinical outcomes in patients with post-traumatic stress disorder: analysis from the UK Medical Cannabis Registry, Expert Review of Neurotherapeutics: a key contribution to decision making in the treatment of neurologic and neuropsychiatric disorders, Vol: 22, Pages: 1009-1018, ISSN: 1473-7175
BackgroundThe 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.MethodsA 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.ResultsOf 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%). ConclusionsAssociated 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.
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