189 results found
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 Rev Clin Pharmacol, Pages: 1-10
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 Rev Neurother, Pages: 1-15
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., J Pain Palliat Care Pharmacother, Pages: 1-8
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, ISSN: 1473-7175
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.
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.
Anand U, Pacchetti B, Anand P, et al., 2022, The endocannabinoid analgesic entourage effect: investigations in cultured DRG neurons, Journal of Pain Research, Vol: 15, Pages: 3493-3507, ISSN: 1178-7090
Background: The endocannabinoid 2-Arachidonyl glycerol (2-AG) exerts dose-related anti-nociceptive effects, which are potentiated by the related but inactive 2-palmitoyl glycerol (2-PG) and 2-linoleoyl glycerol (2-LG). This potentiation of analgesia and other in vivo measures was described as the “entourage effect”. We investigated this effect on TRPV1 signalling in cultured dorsal root ganglion (DRG) nociceptors.Methods: Adult rat DRG neurons were cultured in medium containing NGF and GDNF at 37°C. 48 h later cultures were loaded with 2 μM Fura2AM for calcium imaging, and treated with 2-AG, 2-PG and 2-LG, individually or combined, for 5 min, followed by 1 μMol capsaicin. The amplitude and latency of capsaicin responses were measured (N=3– 7 rats, controls N=16), and analysed.Results: In controls, 1 μMol capsaicin elicited immediate calcium influx in a subset of neurons, with average latency of 1.27 ± 0.2 s and amplitude of 0.15 ± 0.01 Units. 2-AG (10– 100 μMol) elicited calcium influx in some neurons. In the presence of 2-AG (0.001– 100 μMol), capsaicin responses were markedly delayed in 64% neurons by up to 320 s (P< 0.001). 2-PG increased capsaicin response latency at 0.1 nMol-100 μMol (P< 0.001), in 60% neurons, as did 2-LG at 0.1– 100 μMol (P< 0.001), in 76% neurons. Increased capsaicin response latency due to 2-AG and 2-PG was sensitive to the CB2 but not to the CB1 receptor antagonist. Combined application of 1 μMol 2-AG, 5 μMol 2-PG and 10 μMol 2-LG, also resulted in significantly increased capsaicin response latency up to 281.5 ± 41.5 s (P< 0.001), in 96% neurons, that was partially restored by the CB2, but not the CB1 antagonist.Conclusion: 2-AG, 2-LG and 2-PG significantly delayed TRPV1 signalling in the majority of capsaicin-sensitive DRG neurons, that was markedly increased following combined application. Further studies of these endocannabinoids are r
Erridge S, Coomber R, Sodergren MH, 2022, Medical cannabis, CBD wellness products and public awareness of evolving regulations in the United Kingdom, Journal of Cannabis Research, Vol: 4, ISSN: 2522-5782
Background:In the UK, legislation and regulations governing medical cannabis and over the counter cannabidiol (CBD) wellness products have rapidly evolved since 2018. This study aimed to assess the public awareness of the availability, regulations, and barriers to access medical cannabis and over the counter CBD wellness products.Methods:A cross-sectional survey study was performed through YouGov® using quota sampling methodology between March 22nd and March 31st 2021. Responses were matched and statistically weighted to UK adult population demographics, including those without internet access, and analysed according to percentage of respondents. Statistical significance was defined by p-value < 0.050.Results:Ten thousand six hundred eighty-four participants completed the survey. 5,494 (51.4%) respondents believed that medical cannabis is legal in the UK. 684 (6.4%) participants consumed CBD for wellness reasons, 286 (2.7%) were prescribed CBD for a medical reason and 222 (2.1%) consumed CBD for another reason. 10,076 (94.3%) respondents were unaware of April 2021 regulations meaning that all over the counter CBD wellness products in the UK must conform to European Novel Foods Regulations. The most frequently reported main barriers to accessing medical cannabis were its association with recreational cannabis (n = 2,686; 25.1%), being unsure if it was legal (n = 2,276; 21.3%) and being unsure what medical conditions its can be used for (n = 1,863; 17.4%).Conclusion:A large proportion of respondents are unaware of the legislation and regulations surrounding medical cannabis and over the counter CBD wellness products. Lack of knowledge may present a barrier to safe access to either product.
Lawrence P, Desai K, Wadsworth C, et al., 2022, A Case Report on Longitudinal Collection of Tumour Biopsies for Gene Expression-Based Tumour Microenvironment Analysis from Pancreatic Cancer Patients Treated with Endoscopic Ultrasound Guided Radiofrequency Ablation, CURRENT ONCOLOGY, Vol: 29, Pages: 6754-6763, ISSN: 1198-0052
Erridge S, Kerr-Gaffney J, Holvey C, et al., 2022, Clinical outcome analysis of patients with autism spectrum disorder: analysis from the UK Medical Cannabis Registry, Therapeutic Advances in Psychopharmacology, Vol: 12, Pages: 1-12, ISSN: 2045-1253
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. Objective: 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 1 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), 5-level version of the EQ-5D (EQ-5D-5L) index values] at 1, 3 and 6 months compared with baseline. Adverse events were recorded and analysed. Statistical significance was determined by p < 0.050.Results:Seventy-four 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%).Conclusion:This study demonstrated an associated improvement in general health-related quality of life, and anxiety- and sleep-specific symptoms following initiation of treatment with CBMPs in patients with ASD. These findings, while promising, are limited by the confines of the study which lacks a control arm and is subject to attrition bias. Therefore, further evaluation is requi
Cosentino M, Legnaro M, Luini A, et al., 2022, Effect of Cannabidiol on Cyclooxygenase Type 1 and 2 Expression and Function in Human Neutrophils, CANNABIS AND CANNABINOID RESEARCH, ISSN: 2578-5125
- Author Web Link
- Citations: 2
Mottarlini F, Fumagalli M, Castillo-Diaz F, et al., 2022, Single and Repeated Exposure to Cannabidiol Differently Modulate BDNF Expression and Signaling in the Cortico-Striatal Brain Network, BIOMEDICINES, Vol: 10
James NE, Chidambaram S, Gall TMH, et al., 2022, Quality of life after pancreatic surgery - A systematic review, HPB, Vol: 24, Pages: 1223-1237, ISSN: 1365-182X
Winter Beatty J, Chidambaram S, Erridge S, et al., 2022, O020 Does real-time surgical training on auxiliary screens affect performance and cognitive demands during surgery? a randomised crossover study on VR-simulated laparoscopic cholecystectomies., Annual Scientific Meeting of the Surgical-Research-Society, Publisher: OXFORD UNIV PRESS, ISSN: 0007-1323
D'Alessio A, Pai M, Spalding D, et al., 2022, PRIME-HCC: phase Ib study of neoadjuvant ipilimumab and nivolumab prior to liver resection for hepatocellular carcinoma, International Liver Congress, Publisher: ELSEVIER, Pages: S108-S109, ISSN: 0168-8278
Troup LJ, Erridge S, Ciesluk B, et al., 2022, Perceived stigma of patients undergoing treatment with cannabis-based medicinal products, International Journal of Environmental Research and Public Health, Vol: 19, Pages: 1-7, ISSN: 1660-4601
Cannabis-based medicinal products (CBMPs) are prescribed with increasing frequency. This study aimed to investigate the perceived stigma attached to patients prescribed CBMPs in the UK to establish its prevalence. A qualitative survey was developed by an expert multidisciplinary group and data were collected via Qualtrics. In total, 2319 patients on CBMP therapy were invited to take part in this study. 450 (19.4%) participants completed the questionnaire. In total, 81.3% (n = 366), 76.9% (n = 346), and 61.3% (n = 276) of participants reported feeling very comfortable or comfortable telling friends, family, and medical professionals, respectively, about their treatment. Participants thought that friends (n = 372; 82.7%) and family (n = 339; 75.3%) were very approving or somewhat approving of their CBMP prescription. However, participants thought that only 37.8% (n = 170) of healthcare professionals and 32.9% (n = 148) of society in general were very approving or somewhat approving of their CBMP prescription. 57.1% (n = 257), 55.3% (n = 249), and 40.2% (n = 181) of participants were afraid of what the police or criminal justice system, other government agencies, and healthcare professionals might think about their treatment. This study highlights those patients treated with CBMPs experience a high prevalence of perceived stigma from many corners of society. Future work should be undertaken to explore strategies to reduce perceived stigma at an individual and community level to avoid discrimination of patients, likely increasing appropriate access.
D'Alessio A, Pai M, Spalding D, et al., 2022, Preliminary results from a phase Ib study of neoadjuvant ipilimumab plus nivolumab prior to liver resection for hepatocellular carcinoma: The PRIME-HCC trial., Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0732-183X
Papaefthymiou A, Laskaratos F-M, Koffas A, et al., 2022, State of the Art in Endoscopic Therapy for the Management of Gastroenteropancreatic Neuroendocrine Tumors, CURRENT TREATMENT OPTIONS IN ONCOLOGY, Vol: 23, Pages: 1014-1034, ISSN: 1527-2729
- Author Web Link
- Citations: 1
Karamchandani U, Erridge S, Evans-Harvey K, et al., 2022, Visual gaze patterns in trainee endoscopists - a novel assessment tool, Scandinavian Journal of Gastroenterology, Vol: 57, Pages: 1138-1146, ISSN: 0036-5521
BackgroundColonoscopy proficiency is significantly influenced by skills achieved during training. Although assessment scores exist, they do not evaluate the impact of visual search strategies and their use is time and labour intensive. Eye-tracking has shown significant differences in visual gaze patterns (VGPs) between expert endoscopists with varying polyp detection rates, so may provide a means of automated assessment and guidance for trainees. This study aimed to assess the feasibility of eye-tracking as a novel assessment method for trainee endoscopists.MethodsEye-tracking glasses were used to record 26 colonoscopies from 12 endoscopy trainees who were assessed with directly observed procedural scores (DOPS), devised by the Joint Advisory Group (JAG) on GI endoscopy, and a visual analogue score of overall competence. A ‘total weighted procedure score’ (TWPS) was calculated from 1 to 20. Primary outcomes of fixation duration (FixD) and fixation frequency (FixF) were analysed according to areas of interest (AOIs) with the bowel surface and lumen represented by three concentric rings. Correlation was assessed using Pearson’s coefficient. Significance was set at p<.050.ResultsTrainees displayed a significant positive correlation between TWPS and FixD (R = 0.943, p<.0001) and FixF (R = 0.936, p<.0001) in the anatomical bowel mucosa peripheries. Conversely, they had significant negative correlations between TWPS and the anatomical bowel lumen (FixD: R= −0.546, p=.004; FixF: R= −0.568, p=.002).ConclusionsHigher objective performance scores were associated with VGPs focussing on bowel mucosa. This is consistent with prior analysis showing peripheral VGPs correspond with higher polyp detection rates. Analysis of VGPs, therefore, has potential for training and assessment in colonoscopy.
Han J, Davids J, Ashrafian H, et al., 2022, A systematic review of robotic surgery: From supervised paradigms to fully autonomous robotic approaches, International Journal of Medical Robotics and Computer Assisted Surgery, Vol: 18, Pages: 1-11, ISSN: 1478-5951
BackgroundFrom traditional open surgery to laparoscopic surgery and robot-assisted surgery, advances in robotics, machine learning, and imaging are pushing the surgical approach to-wards better clinical outcomes. Pre-clinical and clinical evidence suggests that automation may standardise techniques, increase efficiency, and reduce clinical complications.MethodsA PRISMA-guided search was conducted across PubMed and OVID.ResultsOf the 89 screened articles, 51 met the inclusion criteria, with 10 included in the final review. Automatic data segmentation, trajectory planning, intra-operative registration, trajectory drilling, and soft tissue robotic surgery were discussed.ConclusionAlthough automated surgical systems remain conceptual, several research groups have developed supervised autonomous robotic surgical systems with increasing consideration for ethico-legal issues for automation. Automation paves the way for precision surgery and improved safety and opens new possibilities for deploying more robust artificial intelligence models, better imaging modalities and robotics to improve clinical outcomes.
Ergisi M, Erridge S, Harris M, et al., 2022, An updated analysis of clinical outcome measures across patients from the UK medical cannabis registry, Cannabis and Cannabinoid Research, 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
Ergisi M, Erridge S, Harris M, et al., 2022, UK Medical Cannabis Registry: an analysis of clinical outcomes of medicinal cannabis therapy for generalized anxiety disorder, Expert Review of Clinical Pharmacology, ISSN: 1751-2433
ObjectivesAnxiety disorders are one of the most common reasons for seeking treatment with cannabis-based medicinal products (CBMPs). Current pharmacological treatments are variable in efficacy and the endocannabinoid system has been identified as a potential therapeutic target. This study aims to detail the changes in health-related quality-of-life (HRQoL) and clinical safety following CBMP therapy for generalized anxiety disorder.MethodsA case series from the UK Medical Cannabis Registry was performed. Primary outcomes included changes from baseline in patient-reported outcome measures (the General Anxiety Disorder Scale (GAD-7), EQ-5D-5L (a measure of health-related quality of life), and Sleep Quality Scale (SQS)) at 1, 3 and 6 months. Statistical significance was defined as p<0.050.ResultsSixty-seven patients were treated for generalized anxiety disorder. Statistically significant improvements were observed in GAD-7, EQ-5D-5L Index Value, EQ5D Visual Analog Scale, and SQS scores at 1, 3 and 6 months (p<0.050). Twenty-five (39.1%) patients reported adverse events during the follow-up period.ConclusionThis study suggests that CBMPs may be associated with improvements in HRQoL outcomes when used as a treatment for generalized anxiety disorder. These findings must be treated with caution considering limitations of study design; however this data may help inform future clinical studies and practice.
Nimalan D, Kawka M, Erridge S, et al., 2022, UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes, Journal of Cannabis Research, Vol: 4, ISSN: 2522-5782
IntroductionPalliative care aims to improve quality of life through optimal symptom control and pain management. Cannabis-based medicinal products (CBMPs) have a proven role in the treatment of chemotherapy-induced nausea and vomiting. However, there is a paucity of high-quality evidence with regards to the optimal therapeutic regimen, safety, and effectiveness of CBMPs in palliative care, as existing clinical trials are limited by methodological heterogeneity. The aim of this study is to summarise the outcomes of the initial subgroup of patients from the UK Medical Cannabis Registry who were prescribed CBMPs for a primary indication of palliative care, cancer pain and chemotherapy-induced nausea and vomiting, including effects on health-related quality of life and clinical safety.MethodsA case series from the UK Medical Cannabis Registry of patients, who were receiving CBMPs for the indication of palliative care was undertaken. The primary outcome consisted of changes in patient-reported outcome measures including EQ-5D-5L, General Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), Pain Visual Analog Scale (VAS) and the Australia-Modified Karnofsky Performance Scale at 1 and 3 months compared to baseline. Secondary outcomes included the incidence and characteristics of adverse events. Statistical significance was defined by p-value< 0.050.ResultsSixteen patients were included in the analysis, with a mean age of 63.25 years. Patients were predominantly prescribed CBMPs for cancer-related palliative care (n = 15, 94%). The median initial CBD and THC daily doses were 32.0 mg (Range: 20.0–384.0 mg) and 1.3 mg (Range: 1.0–16.0 mg) respectively. Improvements in patient reported health outcomes were observed according to SQS, EQ-5D-5L mobility, pain and discomfort, and anxiety and depression subdomains, EQ-5D-5L index, EQ-VAS and Pain VAS validated scales at both 1-month and 3-mo
Harris M, Erridge S, Ergisi M, et al., 2022, UK Medical Cannabis registry: an analysis of clinical outcomes of medicinal cannabis therapy for chronic pain conditions, Expert Review of Clinical Pharmacology, Pages: 1-13, ISSN: 1751-2433
ObjectivesTo explore pain-specific, general health-related quality of life (HRQoL), and safety outcomes of chronic pain patients prescribed cannabis-based medicinal products (CBMPs).MethodsA case series was performed using patients with chronic pain from the UK Medical Cannabis Registry. Primary outcomes were changes in Brief Pain Inventory short-form (BPI), Short-form McGill Pain Questionnaire-2 (SF-MPQ-2), Visual Analogue Scale-Pain (VAS), General Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5L, at 1, 3, and 6 months from baseline. Statistical significance was defined at p-value<0.050.Results190 patients were included. Median initial Δ9-tetrahydrocannabinol and cannabidiol daily doses were 2.0mg (range:0.0–442.0mg) and 20.0mg (range:0.0–188.0mg) respectively. Significant improvements were observed within BPI, SF-MPQ-2, GAD-7, SQS, EQ-5D-5 L index, and VAS measures at all timepoints (p<0.050). Seventy-five adverse events (39.47%) were reported, of which 37 (19.47%) were rated as mild, 23 (12.11%) as moderate, and 14 (7.37%) as severe. Nausea (n=11; 5.8%) was the most frequent adverse event.
McLean KA, Kamarajah SK, Chaudhry D, et al., 2021, Death following pulmonary complications of surgery before and during the SARS-CoV-2 pandemic, BRITISH JOURNAL OF SURGERY, Vol: 108, Pages: 1448-1464, ISSN: 0007-1323
- Author Web Link
- Citations: 7
Anand U, Oldfield C, Pacchetti B, et al., 2021, Dose-related inhibition of capsaicin responses by cannabinoids CBG, CBD, THC and their combination in cultured sensory neurons, Journal of Pain Research, Vol: 14, Pages: 3603-3614, ISSN: 1178-7090
AbstractBackground: The analgesic effects of Cannabis sativa are mediated by ∆9 tetrahydrocannabinol (THC), but the contributions of other bioactive complex components, including cannabigerol (CBG) and cannabidiol (CBD), are unclear. We describe the individual and combined effects of CBG, CBD and THC, on blocking capsaicin responses in dorsal root ganglion (DRG), neurons, in an in vitro model of nociceptor hypersensitivity.Materials and Methods: Adult rat DRG were dissected and enzyme digested to obtain a neuronal suspension in BSF2 medium containing 2% fetal calf serum, and the neurotrophic factors NGF and GDNF. After 48 h, cultured neurons were loaded with Fura-2 AM, to determine the effects of cannabinoids on capsaicin responses using calcium imaging. In control experiments, neurons were treated with vehicle, followed by 1 µM capsaicin. In cannabinoid treated cultures, CBG, CBD or THC were applied individually, or combined (1:1:1 ratio), followed by 1 µM capsaicin. Data from n=6 experiments were analysed with Student’s t-test, and Pearson’s correlation coefficient. Results: CBG, CBD and THC, applied individually, elicited dose-related calcium influx in a subset of DRG neurons, and a corresponding dose-related reduction of subsequent responses to capsaicin. Maximum inhibition of capsaicin responses was observed at 30 µM CBG, 100 µM CBD, and 100 µM THC individually, and with combined CBD+CBG+THC (1:1:1) at 90 µM. THC+CBD+CBG combined in a 1:1:1 proportion has the potential to enhance the potency of these compounds applied individually. There was a high correlation between cannabinoid-mediated calcium influx and reduction of capsaicin responses: CBG = -0.88, THC = -0.97, CBD = -0.99 and combined CBG + THC + CBD = -1.00. Conclusions: CBG, CBD and THC demonstrated potent dose-related inhibition of capsaicin responses in DRG neurons when applied individually in vitro, and enhanced when applied in combination
Banerjee R, Erridge S, Salazar O, et al., 2021, Real world evidence in medical cannabis research, Therapeutic Innovation & Regulatory Science, Vol: 56, Pages: 8-14, ISSN: 2168-4790
BackgroundWhilst access to cannabis-based medicinal products (CBMPs) has increased globally subject to relaxation of scheduling laws globally, one of the main barriers to appropriate patient access remains a paucity of high-quality evidence surrounding their clinical effects.DiscussionWhilst randomised controlled trials (RCTs) remain the gold-standard for clinical evaluation, there are notable barriers to their implementation. Development of CBMPs requires novel approaches of evidence collection to address these challenges. Real world evidence (RWE) presents a solution to not only both provide immediate impact on clinical care, but also inform well-conducted RCTs. RWE is defined as evidence derived from health data sourced from non-interventional studies, registries, electronic health records and insurance data. Currently it is used mostly to monitor post-approval safety requirements allowing for long-term pharmacovigilance. However, RWE has the potential to be used in conjunction or as an extension to RCTs to both broaden and streamline the process of evidence generation.ConclusionNovel approaches of data collection and analysis will be integral to improving clinical evidence on CBMPs. RWE can be used in conjunction or as an extension to RCTs to increase the speed of evidence generation, as well as reduce costs. Currently, there is an abundance of potential data however, whilst a number of platforms now exist to capture real world data it is important the right tools and analysis are utilised to unlock potential insights from these.
Plummer R, Sodergren M, Pinato D, et al., 2021, A PHASE 1 STUDY OF MYELOID MODULATING AGENT MTL-CEBPA IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PATIENTS WITH ADVANCED SOLID TUMOURS, Publisher: BMJ PUBLISHING GROUP, Pages: A545-A545
- Author Web Link
- Citations: 1
This data is extracted from the Web of Science and reproduced under a licence from Thomson Reuters. You may not copy or re-distribute this data in whole or in part without the written consent of the Science business of Thomson Reuters.