首页 > 最新文献

Medical Cannabis and Cannabinoids最新文献

英文 中文
Impact of Healthcare Provider Awareness and Guidance on the Medical Cannabis Experience.
Q1 Medicine Pub Date : 2025-02-18 eCollection Date: 2025-01-01 DOI: 10.1159/000544125
Thomas A Clobes, Marshall M Mee, Jenna M Jimenez, Jesus Maldonado, Joshua R Song

Introduction: Cannabis as a therapeutic agent is accessible to a growing number of people, though research suggests that many medical cannabis (MC) users undertake their cannabinoid therapy independently, without collaborating with a cannabis clinician or informing their primary care provider (PCP). The effects of medical collaboration or disclosure to PCP on outcomes of cannabinoid therapy are unknown. Researchers anticipate that those who collaborate with a cannabis clinician or disclose their medical cannabis use to their PCP will find MC to be more effective, use less delta-9-tetrahydrocannabinol (THC) and more cannabidiol (CBD), and experience fewer side effects.

Methods: Through an online survey, medical cannabis users reported their cannabis usage patterns, health outcomes, PCP awareness, and collaboration with cannabis clinicians. These responses were analyzed using a variety of statistical tests to search for differences in reported efficacy, specific cannabinoid, and side effects between different levels of medical professional involvement (n = 988).

Results: Patients who either worked with a cannabis clinician or reported their use of their PCP reported significantly higher efficacy (p < 0.001), and in the case of working specifically with a cannabis clinician, higher daily doses of cannabidiol were used (p < 0.001). CBD doses did not vary between those who had disclosed their MC use to their PCP and those who had not. There were no significant differences in THC doses or side effects identified between groups.

Conclusion: The results indicated that undertaking cannabinoid therapy with PCP awareness or guidance from a cannabis clinician is associated with better outcomes.

{"title":"Impact of Healthcare Provider Awareness and Guidance on the Medical Cannabis Experience.","authors":"Thomas A Clobes, Marshall M Mee, Jenna M Jimenez, Jesus Maldonado, Joshua R Song","doi":"10.1159/000544125","DOIUrl":"10.1159/000544125","url":null,"abstract":"<p><strong>Introduction: </strong>Cannabis as a therapeutic agent is accessible to a growing number of people, though research suggests that many medical cannabis (MC) users undertake their cannabinoid therapy independently, without collaborating with a cannabis clinician or informing their primary care provider (PCP). The effects of medical collaboration or disclosure to PCP on outcomes of cannabinoid therapy are unknown. Researchers anticipate that those who collaborate with a cannabis clinician or disclose their medical cannabis use to their PCP will find MC to be more effective, use less delta-9-tetrahydrocannabinol (THC) and more cannabidiol (CBD), and experience fewer side effects.</p><p><strong>Methods: </strong>Through an online survey, medical cannabis users reported their cannabis usage patterns, health outcomes, PCP awareness, and collaboration with cannabis clinicians. These responses were analyzed using a variety of statistical tests to search for differences in reported efficacy, specific cannabinoid, and side effects between different levels of medical professional involvement (<i>n</i> = 988).</p><p><strong>Results: </strong>Patients who either worked with a cannabis clinician or reported their use of their PCP reported significantly higher efficacy (<i>p</i> < 0.001), and in the case of working specifically with a cannabis clinician, higher daily doses of cannabidiol were used (<i>p</i> < 0.001). CBD doses did not vary between those who had disclosed their MC use to their PCP and those who had not. There were no significant differences in THC doses or side effects identified between groups.</p><p><strong>Conclusion: </strong>The results indicated that undertaking cannabinoid therapy with PCP awareness or guidance from a cannabis clinician is associated with better outcomes.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"8 1","pages":"47-57"},"PeriodicalIF":0.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11919312/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Pharmacology of Cannabinoids in Chronic Pain.
Q1 Medicine Pub Date : 2025-02-05 eCollection Date: 2025-01-01 DOI: 10.1159/000543813
Alonso Cortez-Resendiz, Timothy J Leiter, Steven M Riela, Nicholas M Graziane, Wesley M Raup-Konsavage, Kent E Vrana

Background: Our objective was to provide an overview of the currently available scientific and clinical data supporting the use of Cannabis and Cannabis-derived products for the treatment of chronic pain disorders. We also provide information for researchers, clinicians, and patients to be better informed and understand the approach behind the recommendation of Cannabis as a potential adjuvant in the treatment/control of chronic pain. Cannabis and its bioactive compounds have sparked interest in the field of pain treatment in spite of its controversial history and status as a controlled substance in many countries. With the increase in chronic pain, physicians and patients have started to look at alternative ways to treat pain aside from traditional treatments. One alternative is the use of cannabis to reduce/treat chronic pain disorders based on anecdotal accounts and the function of its phytocannabinoids. The two main cannabinoids in cannabis, tetrahydrocannabinol (THC) and cannabidiol, act on CB1 and CB2 receptors (in addition to several additional receptors). It is through these pleiotropic receptor interactions that these compounds elicit their biological function including the reduction of chronic pain. In this narrative review, we included the most recent evidence supporting the use of cannabis in the treatment of chronic pain disorders including chronic neuropathic pain, cancer-induced neuropathic pain, chronic musculoskeletal pain, and chronic headaches and migraines.

Summary: Evidence suggests that cannabis and cannabinoids have an analgesic effect that arises from a combination of compounds and various receptor systems. These effects may be maximized with the use of a combination of cannabinoids. At the same time, the combination of cannabinoids helps minimize the undesirable side effects of some cannabinoids such as the psychoactivity of THC. With these findings, further research is necessary to assess the analgesic properties of other cannabinoids like cannabichromene and cannabigerol and their contributions to the reduction of pain.

Key messages: Cannabis and its bioactive compounds show potential in the reduction of chronic pain.

{"title":"The Pharmacology of Cannabinoids in Chronic Pain.","authors":"Alonso Cortez-Resendiz, Timothy J Leiter, Steven M Riela, Nicholas M Graziane, Wesley M Raup-Konsavage, Kent E Vrana","doi":"10.1159/000543813","DOIUrl":"10.1159/000543813","url":null,"abstract":"<p><strong>Background: </strong>Our objective was to provide an overview of the currently available scientific and clinical data supporting the use of <i>Cannabis</i> and <i>Cannabis</i>-derived products for the treatment of chronic pain disorders. We also provide information for researchers, clinicians, and patients to be better informed and understand the approach behind the recommendation of <i>Cannabis</i> as a potential adjuvant in the treatment/control of chronic pain. Cannabis and its bioactive compounds have sparked interest in the field of pain treatment in spite of its controversial history and status as a controlled substance in many countries. With the increase in chronic pain, physicians and patients have started to look at alternative ways to treat pain aside from traditional treatments. One alternative is the use of cannabis to reduce/treat chronic pain disorders based on anecdotal accounts and the function of its phytocannabinoids. The two main cannabinoids in cannabis, tetrahydrocannabinol (THC) and cannabidiol, act on CB1 and CB2 receptors (in addition to several additional receptors). It is through these pleiotropic receptor interactions that these compounds elicit their biological function including the reduction of chronic pain. In this narrative review, we included the most recent evidence supporting the use of cannabis in the treatment of chronic pain disorders including chronic neuropathic pain, cancer-induced neuropathic pain, chronic musculoskeletal pain, and chronic headaches and migraines.</p><p><strong>Summary: </strong>Evidence suggests that cannabis and cannabinoids have an analgesic effect that arises from a combination of compounds and various receptor systems. These effects may be maximized with the use of a combination of cannabinoids. At the same time, the combination of cannabinoids helps minimize the undesirable side effects of some cannabinoids such as the psychoactivity of THC. With these findings, further research is necessary to assess the analgesic properties of other cannabinoids like cannabichromene and cannabigerol and their contributions to the reduction of pain.</p><p><strong>Key messages: </strong>Cannabis and its bioactive compounds show potential in the reduction of chronic pain.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"8 1","pages":"31-46"},"PeriodicalIF":0.0,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of Cannabis-Based Medical Products for Pediatric Health Conditions: A Systematic Review of the Recent Literature. 使用大麻为基础的医疗产品的儿童健康状况:近期文献的系统回顾。
Q1 Medicine Pub Date : 2024-12-10 eCollection Date: 2024-01-01 DOI: 10.1159/000542550
Mitchell L Doucette, Dipak Hemraj, David J Casarett, D Luke Macfarlan, Emily Fisher

Introduction: Cannabis policy is rapidly changing in the USA and across the globe, with 24 states legalizing cannabis for adult use and 38 states making medical cannabis available for those with qualified conditions. Building on prior evidence, we reviewed the recently published literature (from the past 5 years) focused on the treatment effects of naturally derived medical cannabis products within the pediatric population.

Methods: We conducted a systematic literature review of three electronic databases using MeSH terms and free-text. A study was eligible for inclusion if it investigated the efficacy of medical cannabis for any condition, it was published in 2019 or later, and the mean age of participants was under 21. We excluded studies that tested the effect of pharmaceutical cannabis-derived drug products.

Results: We identified a total of 10 studies that met our inclusion/exclusion criteria. Of the 10, 2 utilized a double-arm randomized control trial (RCT) design, 3 used a single-arm trial design, and the remaining were observational studies, a case series, or a qualitative design. Aside from autism spectrum disorder (ASD) (n = 4), studies focused on cancer, treatment-resistant epilepsy, and Sturge-Weber syndrome (SWS). Four of the five single- or double-arm trials used a CBD:THC compound in a specific ratio as treatment. Both RCTs found significant improvement in ASD-related validated measures. Other studies found general improvements in validated measures of efficacy for SWS and epilepsy. Minimal adverse events were reported.

Conclusion: In the pediatric population, emerging evidence, combined with existing literature, suggests medical cannabis may be beneficial for quality-of-life symptoms related to specific conditions, like cancer, ASD, treatment-resistant epilepsy, and SWS. More clinical trial data are necessary to establish medical cannabis as an addition to established medical guidelines.

在美国和全球范围内,大麻政策正在迅速变化,有24个州将成人使用大麻合法化,38个州为符合条件的人提供医用大麻。在先前证据的基础上,我们审查了最近发表的文献(过去5年),重点关注天然衍生医用大麻产品在儿科人群中的治疗效果。方法:我们使用MeSH术语和自由文本对三个电子数据库进行了系统的文献综述。如果一项研究调查了医用大麻对任何疾病的功效,该研究发表于2019年或之后,且参与者的平均年龄在21岁以下,则该研究有资格入选。我们排除了测试药用大麻衍生药物产品效果的研究。结果:我们共确定了10项符合纳入/排除标准的研究。在这10项研究中,2项采用了双臂随机对照试验(RCT)设计,3项采用了单臂试验设计,其余为观察性研究、病例系列或定性设计。除了自闭症谱系障碍(ASD) (n = 4),研究还集中在癌症、治疗难治性癫痫和斯特奇-韦伯综合征(SWS)上。五项单臂或双臂试验中有四项使用CBD:THC化合物按特定比例进行治疗。两项随机对照试验均发现与自闭症相关的有效措施有显著改善。其他研究发现,经验证的SWS和癫痫疗效措施普遍有所改善。报告的不良事件最少。结论:在儿科人群中,新出现的证据与现有文献相结合,表明医用大麻可能有益于与特定疾病相关的生活质量症状,如癌症、ASD、难治性癫痫和SWS。需要更多的临床试验数据,才能将医用大麻作为既定医疗准则的补充。
{"title":"Use of Cannabis-Based Medical Products for Pediatric Health Conditions: A Systematic Review of the Recent Literature.","authors":"Mitchell L Doucette, Dipak Hemraj, David J Casarett, D Luke Macfarlan, Emily Fisher","doi":"10.1159/000542550","DOIUrl":"10.1159/000542550","url":null,"abstract":"<p><strong>Introduction: </strong>Cannabis policy is rapidly changing in the USA and across the globe, with 24 states legalizing cannabis for adult use and 38 states making medical cannabis available for those with qualified conditions. Building on prior evidence, we reviewed the recently published literature (from the past 5 years) focused on the treatment effects of naturally derived medical cannabis products within the pediatric population.</p><p><strong>Methods: </strong>We conducted a systematic literature review of three electronic databases using MeSH terms and free-text. A study was eligible for inclusion if it investigated the efficacy of medical cannabis for any condition, it was published in 2019 or later, and the mean age of participants was under 21. We excluded studies that tested the effect of pharmaceutical cannabis-derived drug products.</p><p><strong>Results: </strong>We identified a total of 10 studies that met our inclusion/exclusion criteria. Of the 10, 2 utilized a double-arm randomized control trial (RCT) design, 3 used a single-arm trial design, and the remaining were observational studies, a case series, or a qualitative design. Aside from autism spectrum disorder (ASD) (<i>n</i> = 4), studies focused on cancer, treatment-resistant epilepsy, and Sturge-Weber syndrome (SWS). Four of the five single- or double-arm trials used a CBD:THC compound in a specific ratio as treatment. Both RCTs found significant improvement in ASD-related validated measures. Other studies found general improvements in validated measures of efficacy for SWS and epilepsy. Minimal adverse events were reported.</p><p><strong>Conclusion: </strong>In the pediatric population, emerging evidence, combined with existing literature, suggests medical cannabis may be beneficial for quality-of-life symptoms related to specific conditions, like cancer, ASD, treatment-resistant epilepsy, and SWS. More clinical trial data are necessary to establish medical cannabis as an addition to established medical guidelines.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"7 1","pages":"257-267"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11631168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patients' Perceptions of Cannabis Contamination in Florida's Medical Program.
Q1 Medicine Pub Date : 2024-12-09 eCollection Date: 2025-01-01 DOI: 10.1159/000542929
Gabriel Spandau, Jamie Loizzo, Hannah Jury, James C Bunch, Nicole Stedman, Brian Pearson, Amie J Goodin

Introduction: As medical cannabis becomes more accessible, product quality must be evaluated. Researchers identified a social media community where Florida medical cannabis patients discuss personal experiences. The objective of this study was to analyze posts in this community to understand patient experience with products purchased from Florida medical dispensaries they believed to be contamination, perceptions of product quality, and desired changes to the Florida program.

Methods: Social networking theory acted as the underlying framework, and we employed a qualitative case study design to identify mentions of possible contamination and understand patient perceptions of contamination and the Florida medical cannabis program from the Reddit community FLMedicalTrees. The lead researcher conducted a social media analysis of posts identified as containing discussions relevant to product contamination. Constant comparison methods were used to code data, arrive at themes, and maintain validity and reliability of interpretation of coded themes.

Results: Of 300 post mentions of contamination, 98 posts were identified as relevant following review. Key results were as follows: (1) multiple mentions of possible contamination of products from medical cannabis dispensaries reported by Florida program patients; (2) patients sought second opinions when concerned about possible contamination and shared personal experiences as well as advice on what concerned patients should do if they believe they have contaminated products; (3) some patients expressed feelings of anxiety and worry about health, safety, and quality control, while others that described possible product contamination did not express concern; and (4) patients wanted changes regarding vertical integration, company accountability, state oversight, and home grow law.

Conclusions: Medical cannabis patients and providers could benefit from education on responding to possible contamination within medical cannabis products. Policymakers should consider these findings when setting regulations around contamination testing thresholds, dispensary oversight, and other regulations that directly impact patient safety, like allowing patients to see products before purchase.

{"title":"Patients' Perceptions of Cannabis Contamination in Florida's Medical Program.","authors":"Gabriel Spandau, Jamie Loizzo, Hannah Jury, James C Bunch, Nicole Stedman, Brian Pearson, Amie J Goodin","doi":"10.1159/000542929","DOIUrl":"10.1159/000542929","url":null,"abstract":"<p><strong>Introduction: </strong>As medical cannabis becomes more accessible, product quality must be evaluated. Researchers identified a social media community where Florida medical cannabis patients discuss personal experiences. The objective of this study was to analyze posts in this community to understand patient experience with products purchased from Florida medical dispensaries they believed to be contamination, perceptions of product quality, and desired changes to the Florida program.</p><p><strong>Methods: </strong>Social networking theory acted as the underlying framework, and we employed a qualitative case study design to identify mentions of possible contamination and understand patient perceptions of contamination and the Florida medical cannabis program from the Reddit community <i>FLMedicalTrees</i>. The lead researcher conducted a social media analysis of posts identified as containing discussions relevant to product contamination. Constant comparison methods were used to code data, arrive at themes, and maintain validity and reliability of interpretation of coded themes.</p><p><strong>Results: </strong>Of 300 post mentions of contamination, 98 posts were identified as relevant following review. Key results were as follows: (1) multiple mentions of possible contamination of products from medical cannabis dispensaries reported by Florida program patients; (2) patients sought second opinions when concerned about possible contamination and shared personal experiences as well as advice on what concerned patients should do if they believe they have contaminated products; (3) some patients expressed feelings of anxiety and worry about health, safety, and quality control, while others that described possible product contamination did not express concern; and (4) patients wanted changes regarding vertical integration, company accountability, state oversight, and home grow law.</p><p><strong>Conclusions: </strong>Medical cannabis patients and providers could benefit from education on responding to possible contamination within medical cannabis products. Policymakers should consider these findings when setting regulations around contamination testing thresholds, dispensary oversight, and other regulations that directly impact patient safety, like allowing patients to see products before purchase.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"8 1","pages":"15-30"},"PeriodicalIF":0.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11832188/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143441330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Transdermal Medical Cannabis (THC:CBD:CBN formula) to Treat Painful Diabetic Peripheral Neuropathy of Lower Extremities. 经皮医用大麻(THC:CBD:CBN配方)治疗疼痛性糖尿病下肢周围神经病变的疗效和安全性。
Q1 Medicine Pub Date : 2024-11-14 eCollection Date: 2025-01-01 DOI: 10.1159/000542511
Khachornsak Seevathee, Pattapong Kessomboon, Nuttaset Manimmanakorn, Suyan Luangphimai, Tewan Thaneerat, Kulthanit Wanaratna, Sirichada Plengphanich, Thanamet Thaenkham, Wijitra Sena

Introduction: Diabetic peripheral neuropathy (DPN) represents a prevalent neurological complication affecting millions of patients globally. This clinical investigation evaluated the therapeutic efficacy and safety profile of a novel transdermal medical cannabis formulation (THC:CBD:CBN) in treating painful DPN of the lower extremities.

Methods: This phase III, double-blind, placebo-controlled, randomized clinical trial was conducted at Don Chan Hospital, Thailand, enrolling 100 participants over a 12-week intervention period. Using a computer-generated randomization sequence, participants were allocated to receive either the standardized cannabis formulation or a matched placebo. The primary outcome measure comprised pain intensity assessment using the validated Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T). Secondary outcomes encompassed treatment-emergent adverse events and dermatological manifestations. Statistical analyses were performed using SPSS Version 28.0, incorporating generalized estimating equation (GEE) modeling and Analysis of Covariance (ANCOVA). The study protocol received approval from the Institutional Review Board of Khon Kaen University and the Kalasin Provincial Public Health Office Ethics Committee, with trial registration in the Thai Clinical Trials Registry.

Results: The intervention group demonstrated statistically significant reductions in NPSI-T scores across all measured dimensions (p < 0.001). Mean total NPSI-T scores decreased markedly from 25.60 to 5.57 in the treatment cohort, contrasting with minimal reduction from 25.24 to 22.85 in the placebo group. GEE analysis revealed significant pain amelioration at weeks 4, 8, and 12 (p < 0.001). The cannabis formulation exhibited an excellent safety profile, with only 10% of participants reporting mild adverse events, comparable to placebo group outcomes.

Conclusion: This novel transdermal medical cannabis formulation (THC:CBD:CBN) demonstrated significant therapeutic efficacy in ameliorating painful DPN symptoms while maintaining a favorable safety profile. These findings provide robust clinical evidence supporting its potential as an innovative therapeutic option for managing painful DPN.

糖尿病周围神经病变(DPN)是一种影响全球数百万患者的普遍神经系统并发症。本临床研究评估了一种新型透皮医用大麻制剂(THC:CBD:CBN)治疗下肢疼痛性DPN的疗效和安全性。方法:这项III期、双盲、安慰剂对照、随机临床试验在泰国Don Chan医院进行,招募了100名参与者,干预期为12周。使用计算机生成的随机化序列,参与者被分配接受标准化大麻制剂或匹配的安慰剂。主要结果测量包括使用经过验证的泰国版神经性疼痛症状量表(NPSI-T)进行疼痛强度评估。次要结局包括治疗后出现的不良事件和皮肤病学表现。采用SPSS Version 28.0进行统计分析,采用广义估计方程(GEE)模型和协方差分析(ANCOVA)。该研究方案获得了Khon Kaen大学机构审查委员会和Kalasin省公共卫生办公室伦理委员会的批准,并在泰国临床试验登记处进行了试验注册。结果:干预组NPSI-T评分在所有测量维度上均有统计学显著降低(p < 0.001)。治疗组的NPSI-T平均总分从25.60显著下降到5.57,而安慰剂组的NPSI-T平均总分从25.24下降到22.85。GEE分析显示疼痛在第4、8和12周显著改善(p < 0.001)。大麻制剂显示出极好的安全性,只有10%的参与者报告轻度不良事件,与安慰剂组的结果相当。结论:这种新型透皮医用大麻制剂(THC:CBD:CBN)在改善疼痛DPN症状方面表现出显著的治疗效果,同时保持良好的安全性。这些发现提供了强有力的临床证据,支持其作为治疗疼痛性DPN的创新治疗选择的潜力。
{"title":"Efficacy and Safety of Transdermal Medical Cannabis (THC:CBD:CBN formula) to Treat Painful Diabetic Peripheral Neuropathy of Lower Extremities.","authors":"Khachornsak Seevathee, Pattapong Kessomboon, Nuttaset Manimmanakorn, Suyan Luangphimai, Tewan Thaneerat, Kulthanit Wanaratna, Sirichada Plengphanich, Thanamet Thaenkham, Wijitra Sena","doi":"10.1159/000542511","DOIUrl":"10.1159/000542511","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetic peripheral neuropathy (DPN) represents a prevalent neurological complication affecting millions of patients globally. This clinical investigation evaluated the therapeutic efficacy and safety profile of a novel transdermal medical cannabis formulation (THC:CBD:CBN) in treating painful DPN of the lower extremities.</p><p><strong>Methods: </strong>This phase III, double-blind, placebo-controlled, randomized clinical trial was conducted at Don Chan Hospital, Thailand, enrolling 100 participants over a 12-week intervention period. Using a computer-generated randomization sequence, participants were allocated to receive either the standardized cannabis formulation or a matched placebo. The primary outcome measure comprised pain intensity assessment using the validated Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T). Secondary outcomes encompassed treatment-emergent adverse events and dermatological manifestations. Statistical analyses were performed using SPSS Version 28.0, incorporating generalized estimating equation (GEE) modeling and Analysis of Covariance (ANCOVA). The study protocol received approval from the Institutional Review Board of Khon Kaen University and the Kalasin Provincial Public Health Office Ethics Committee, with trial registration in the Thai Clinical Trials Registry.</p><p><strong>Results: </strong>The intervention group demonstrated statistically significant reductions in NPSI-T scores across all measured dimensions (<i>p</i> < 0.001). Mean total NPSI-T scores decreased markedly from 25.60 to 5.57 in the treatment cohort, contrasting with minimal reduction from 25.24 to 22.85 in the placebo group. GEE analysis revealed significant pain amelioration at weeks 4, 8, and 12 (<i>p</i> < 0.001). The cannabis formulation exhibited an excellent safety profile, with only 10% of participants reporting mild adverse events, comparable to placebo group outcomes.</p><p><strong>Conclusion: </strong>This novel transdermal medical cannabis formulation (THC:CBD:CBN) demonstrated significant therapeutic efficacy in ameliorating painful DPN symptoms while maintaining a favorable safety profile. These findings provide robust clinical evidence supporting its potential as an innovative therapeutic option for managing painful DPN.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"8 1","pages":"1-14"},"PeriodicalIF":0.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11666268/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluations of State Medical Cannabis Programs in the USA: A Narrative Review. 美国国家医用大麻项目评估:叙述性回顾。
Q1 Medicine Pub Date : 2024-11-06 eCollection Date: 2024-01-01 DOI: 10.1159/000542472
Lirit Franks, Gerald Cochran, Carter Reeves, Michael A Incze, Clinton J Hardy, Adam J Gordon, A Taylor Kelley

Background: Medical cannabis (MC) use is increasing across the USA, with functional MC programs now operating in 38 states. While program policies and practices vary widely, little is known about whether and how states evaluate their programs. Better characterization of state MC program evaluation to date could inform states, program officials, and providers about best practices and provide a roadmap for future program evaluation.

Summary: We conducted a narrative review of state MC program evaluations, including peer-reviewed literature and reports produced by independent state-based and non-state-based evaluators. Among 304 abstracts initially screened, seven evaluations met inclusion criteria. Within these evaluations, we report results according to three overarching themes: (1) evaluation characteristics, including comparison across evaluations; (2) program experience, including perceptions of providers and patients; and (3) assessment of cannabis use, including self-reported efficacy for qualifying medical conditions, patterns of medical and nonmedical cannabis use, and assessment of risk factors relevant to MC use. Additionally, we found that while goals and methods for state MC evaluations varied widely, evaluations that relied on independent, non-state entities tended to have more comprehensive and quantitatively rigorous results.

Key messages: Few states operating MC programs have completed a formal evaluation of their program. Among states that have completed an evaluation, approaches varied widely; however, common themes were also present, which may inform future state evaluation efforts. Evaluation through independent, non-state partners may provide an optimal strategy to ensure high-quality data and meaningful results.

背景:医用大麻(MC)的使用在美国各地正在增加,功能性MC项目目前在38个州开展。虽然项目政策和实践差异很大,但人们对各州是否以及如何评估他们的项目知之甚少。迄今为止,更好地描述州MC项目评估可以让各州、项目官员和供应商了解最佳实践,并为未来的项目评估提供路线图。摘要:我们对各州MC项目评估进行了叙述性回顾,包括同行评议的文献和由独立的州级和非州级评估人员撰写的报告。在初步筛选的304篇摘要中,有7项评价符合纳入标准。在这些评估中,我们根据三个总体主题报告结果:(1)评估特征,包括评估之间的比较;(2)项目经验,包括对提供者和患者的看法;(3)评估大麻使用情况,包括自我报告对符合条件的医疗条件的效力、医用和非医用大麻使用模式,以及评估与大麻使用有关的风险因素。此外,我们发现,虽然国家MC评估的目标和方法差异很大,但依赖于独立的非国家实体的评估往往具有更全面和定量严谨的结果。关键信息:很少有实施MC项目的州完成了对其项目的正式评估。在已完成评估的国家中,方法差别很大;然而,也存在共同的主题,这可能会为未来的州评估工作提供信息。通过独立的、非国家的合作伙伴进行评估可以提供最佳策略,以确保高质量的数据和有意义的结果。
{"title":"Evaluations of State Medical Cannabis Programs in the USA: A Narrative Review.","authors":"Lirit Franks, Gerald Cochran, Carter Reeves, Michael A Incze, Clinton J Hardy, Adam J Gordon, A Taylor Kelley","doi":"10.1159/000542472","DOIUrl":"10.1159/000542472","url":null,"abstract":"<p><strong>Background: </strong>Medical cannabis (MC) use is increasing across the USA, with functional MC programs now operating in 38 states. While program policies and practices vary widely, little is known about whether and how states evaluate their programs. Better characterization of state MC program evaluation to date could inform states, program officials, and providers about best practices and provide a roadmap for future program evaluation.</p><p><strong>Summary: </strong>We conducted a narrative review of state MC program evaluations, including peer-reviewed literature and reports produced by independent state-based and non-state-based evaluators. Among 304 abstracts initially screened, seven evaluations met inclusion criteria. Within these evaluations, we report results according to three overarching themes: (1) evaluation characteristics, including comparison across evaluations; (2) program experience, including perceptions of providers and patients; and (3) assessment of cannabis use, including self-reported efficacy for qualifying medical conditions, patterns of medical and nonmedical cannabis use, and assessment of risk factors relevant to MC use. Additionally, we found that while goals and methods for state MC evaluations varied widely, evaluations that relied on independent, non-state entities tended to have more comprehensive and quantitatively rigorous results.</p><p><strong>Key messages: </strong>Few states operating MC programs have completed a formal evaluation of their program. Among states that have completed an evaluation, approaches varied widely; however, common themes were also present, which may inform future state evaluation efforts. Evaluation through independent, non-state partners may provide an optimal strategy to ensure high-quality data and meaningful results.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"7 1","pages":"243-256"},"PeriodicalIF":0.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11620772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proceedings of the 2024 Cannabis Clinical Outcomes Research Conference. 2024 年大麻临床结果研究会议记录。
Q1 Medicine Pub Date : 2024-10-23 eCollection Date: 2024-01-01 DOI: 10.1159/000541327
Amie J Goodin, Jeevan Jyot, Robert L Cook, Yan Wang, Md Mahmudul Hasan, Almut G Winterstein
{"title":"Proceedings of the 2024 Cannabis Clinical Outcomes Research Conference.","authors":"Amie J Goodin, Jeevan Jyot, Robert L Cook, Yan Wang, Md Mahmudul Hasan, Almut G Winterstein","doi":"10.1159/000541327","DOIUrl":"10.1159/000541327","url":null,"abstract":"","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"7 1","pages":"213-217"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11498913/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142503565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and in vitro Evaluation of Cannabidiol Mucoadhesive Buccal Film Formulations Using Hot-Melt Extrusion Technology. 利用热熔挤压技术开发大麻二酚黏附性颊黏膜配方并进行体外评估
Q1 Medicine Pub Date : 2024-10-11 eCollection Date: 2024-01-01 DOI: 10.1159/000540353
Iman E Taha, Mahmsoud A ElSohly, Mohamed M Radwan, Sundus Omari, Michael A Repka, Eman A Ashour

Introduction: Cannabidiol (CBD) has sparked considerable interest because of its wide range of pharmacological uses and the fact that it does not induce psychoactive effects. CBD formulation development presents significant challenges due to its limited water solubility and susceptibility to first-pass metabolism, both of which restrict its overall bioavailability. The current research aimed to use hot-melt extrusion (HME) technology to develop mucoadhesive buccal films to improve CBD solubility and reduce first-pass metabolism.

Methods: Five formulations containing 10% w/w CBD were extruded using a counter-rotating twin-screw extruder (Haake Minilab II, Thermo Fisher Scientific). Different characterization studies were conducted on the developed formulations.

Results: Differential scanning calorimetry (DSC) revealed that the CBD endothermic peak disappeared in some of the developed films, indicating that CBD was converted from crystalline to amorphous form. A bio-adhesion study showed that the formulations containing Carbopol® (BF2, BF3, BF4, and BF5) had higher adhesiveness properties. In vitro release and solubility studies showed an increase in CBD release and water solubility in the developed formulations when compared to pure CBD. Stability studies revealed that CBD content and release in the lead formulation (BF2) was stable over 15 months.

Conclusion: The current study demonstrates that HME was successfully used as an approach to develop CBD mucoadhesive buccal films and CBD solubility was enhanced.

简介:大麻二酚(CBD)具有广泛的药理用途,而且不会产生精神作用,因此引起了人们的极大兴趣。由于大麻二酚的水溶性有限且易发生首过代谢,限制了其总体生物利用率,因此大麻二酚制剂的开发面临巨大挑战。目前的研究旨在利用热熔挤出(HME)技术开发粘液粘附性口腔膜,以提高 CBD 的溶解度并减少首过代谢:使用反向旋转双螺杆挤出机(Haake Minilab II,赛默飞世尔科技公司)挤出了五种含有10% w/w CBD的配方。对所开发的配方进行了不同的表征研究:结果:差示扫描量热法(DSC)显示,在一些已开发的薄膜中,CBD 的内热峰消失了,这表明 CBD 已从结晶形态转化为无定形形态。生物粘附性研究表明,含有Carbopol®(BF2、BF3、BF4和BF5)的配方具有更高的粘附性。体外释放和溶解度研究表明,与纯生物多样性物质相比,所开发的制剂中生物多样性物质的释放量和水溶性都有所增加。稳定性研究表明,主要配方(BF2)中的 CBD 含量和释放量在 15 个月内保持稳定:目前的研究表明,HME 成功地用作开发 CBD 粘附性口腔胶片的方法,并提高了 CBD 的溶解度。
{"title":"Development and in vitro Evaluation of Cannabidiol Mucoadhesive Buccal Film Formulations Using Hot-Melt Extrusion Technology.","authors":"Iman E Taha, Mahmsoud A ElSohly, Mohamed M Radwan, Sundus Omari, Michael A Repka, Eman A Ashour","doi":"10.1159/000540353","DOIUrl":"https://doi.org/10.1159/000540353","url":null,"abstract":"<p><strong>Introduction: </strong>Cannabidiol (CBD) has sparked considerable interest because of its wide range of pharmacological uses and the fact that it does not induce psychoactive effects. CBD formulation development presents significant challenges due to its limited water solubility and susceptibility to first-pass metabolism, both of which restrict its overall bioavailability. The current research aimed to use hot-melt extrusion (HME) technology to develop mucoadhesive buccal films to improve CBD solubility and reduce first-pass metabolism.</p><p><strong>Methods: </strong>Five formulations containing 10% w/w CBD were extruded using a counter-rotating twin-screw extruder (Haake Minilab II, Thermo Fisher Scientific). Different characterization studies were conducted on the developed formulations.</p><p><strong>Results: </strong>Differential scanning calorimetry (DSC) revealed that the CBD endothermic peak disappeared in some of the developed films, indicating that CBD was converted from crystalline to amorphous form. A bio-adhesion study showed that the formulations containing Carbopol<sup>®</sup> (BF2, BF3, BF4, and BF5) had higher adhesiveness properties. In vitro release and solubility studies showed an increase in CBD release and water solubility in the developed formulations when compared to pure CBD. Stability studies revealed that CBD content and release in the lead formulation (BF2) was stable over 15 months.</p><p><strong>Conclusion: </strong>The current study demonstrates that HME was successfully used as an approach to develop CBD mucoadhesive buccal films and CBD solubility was enhanced.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"7 1","pages":"171-182"},"PeriodicalIF":0.0,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11521429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142546327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cannabinoids for the Treatment of Glaucoma: A Review. 治疗青光眼的大麻素:综述。
Q1 Medicine Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1159/000541461
Neeraj Joshi, Haifa Mariam, Ashwin Kamath

Background: Glaucoma is an ocular disease with significant health burden. Despite the availability of many antiglaucoma drugs, a significant proportion of patients may experience worsening of the disease. Hence, there is a need for newer antiglaucoma drugs.

Summary: Natural and synthetic derivatives of cannabis plants have been studied in the treatment of glaucoma since the 1970s. This review describes the potential mechanisms of the cannabinoids in the treatment of glaucoma, summarizes the findings of clinical studies describing the efficacy of these compounds, and describes the adverse effects observed with the various cannabinoid formulations evaluated in clinical studies of glaucoma in healthy volunteers and patients. The implications of these findings in terms of the potential clinical status of cannabinoids in the treatment of glaucoma and the challenges involved have also been described.

Key messages: Cannabinoids lower intraocular pressure. However, the effect is short-lived. There is also a lack of well-formulated ocular delivery system. The available evidence is inadequate to recommend the use of cannabinoids for the routine treatment of glaucoma.

背景:青光眼是一种严重影响健康的眼科疾病。尽管有许多抗青光眼药物,但相当一部分患者的病情可能会恶化。摘要:自 20 世纪 70 年代以来,人们一直在研究大麻植物的天然和合成衍生物对青光眼的治疗作用。这篇综述描述了大麻素治疗青光眼的潜在机制,总结了描述这些化合物疗效的临床研究结果,并描述了在健康志愿者和患者青光眼临床研究中评估的各种大麻素制剂所观察到的不良反应。此外,还介绍了这些研究结果对大麻素治疗青光眼的潜在临床地位的影响以及所面临的挑战:大麻素能降低眼压。关键信息:大麻素能降低眼压,但效果短暂。目前还缺乏配方完善的眼部给药系统。现有证据不足以建议将大麻素用于青光眼的常规治疗。
{"title":"Cannabinoids for the Treatment of Glaucoma: A Review.","authors":"Neeraj Joshi, Haifa Mariam, Ashwin Kamath","doi":"10.1159/000541461","DOIUrl":"https://doi.org/10.1159/000541461","url":null,"abstract":"<p><strong>Background: </strong>Glaucoma is an ocular disease with significant health burden. Despite the availability of many antiglaucoma drugs, a significant proportion of patients may experience worsening of the disease. Hence, there is a need for newer antiglaucoma drugs.</p><p><strong>Summary: </strong>Natural and synthetic derivatives of cannabis plants have been studied in the treatment of glaucoma since the 1970s. This review describes the potential mechanisms of the cannabinoids in the treatment of glaucoma, summarizes the findings of clinical studies describing the efficacy of these compounds, and describes the adverse effects observed with the various cannabinoid formulations evaluated in clinical studies of glaucoma in healthy volunteers and patients. The implications of these findings in terms of the potential clinical status of cannabinoids in the treatment of glaucoma and the challenges involved have also been described.</p><p><strong>Key messages: </strong>Cannabinoids lower intraocular pressure. However, the effect is short-lived. There is also a lack of well-formulated ocular delivery system. The available evidence is inadequate to recommend the use of cannabinoids for the routine treatment of glaucoma.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"7 1","pages":"183-192"},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11521503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142546325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-Term Treatment for Unspecified Anxiety Disorders with Cannabidiol: A Retrospective Case Series from Real-World Evidence in Colombia. 用大麻二酚长期治疗不明焦虑症:来自哥伦比亚真实世界证据的回顾性病例系列。
Q1 Medicine Pub Date : 2024-09-14 eCollection Date: 2024-01-01 DOI: 10.1159/000539754
Juan F Galvez-Florez, Hernan F Guillen-Burgos, Camilo A Flórez-Puentes, Cristian E Navarro, Guillermo Moreno-Sanz
<p><strong>Introduction: </strong>Preclinical and clinical evidence has elucidated that cannabis-based medical formulations (CBMFs) may display anxiolytic, antidepressive, and neuroprotective properties. CBMFs are often considered as novel therapeutic anxiolytic agents that can be prescribed as pharmacotherapy for symptomatic domains in anxiety disorders (ADs). Our aim was to explore effectiveness and tolerability of enriched cannabidiol (CBD) oil extract formulations in adults with anxiety symptoms in an outpatient mental health program in Colombia during the COVID-19 pandemic.</p><p><strong>Methods: </strong>We conducted an observational, retrospective, real-world evidence case series from electronic health records at Zerenia Clinic in Bogotá, Colombia between June 2021 and December 2022. Our convenience sample consisted of people searching for CBMFs for the treatment of anxiety symptoms. A cohort of 24 adults was prescribed with enriched CBD in the form of non-sterile oral liquids suspended in sesame seed oil extracts for DSM-5 unspecified anxiety disorder and followed throughout the first year of treatment. CBMFs were prepared by dissolving full-spectrum cannabis extracts in sesame seed oil to a standardized concentration of active ingredients which is CBD-enriched. The oil extract contained 100 mg/mL of CBD and less than 1.9 mg/mL of THC. Primary outcome measures established were the anxiety subscale in the Hospital Anxiety and Depression Scale (HADS-A), and the clinical global impression scale with regard to severity (CGI-S) and improvement (CGI-I) at baseline, 6 months, and 12 months during follow-up. Secondary outcome measures established were HADS depression subscale (HADS-D) and the Epworth Sleepiness Scale (ESS), respectively. Participants also completed the patient-reported outcome measures (PROMs) during each visit throughout the 12-month follow-up. PROMs documented both participant's subjective improvement experience and progressive adverse effects.</p><p><strong>Results: </strong>After 6 months of treatment with sublingually administered enriched CBD oil extracts in a median dosage of 100 mg, more than half (54.17%) of the sample continued to report significant anxiety symptoms. After 12 months, only 37.50% persisted with significant anxiety symptoms with a median dose of 120 mg of enriched CBD oil extracts. Similar subjective improvements were reported with regard to sleep disturbances (SDs) as a secondary outcome. At baseline, less than half (46.83%) of the sample reported significant daytime sleepiness. After 6 months of enriched CBD oil extract treatment, less than one third (29.17%) continued to report SDs. At end point, a high proportion of the sample (87.50%) were considered to have normal daytime sleepiness. The cohort showed no clinically relevant depressive symptoms at baseline based on HADS-D scores; therefore, no improvement could be reported throughout the 12-month follow-up. Minimal gender differences with regard to H
简介:临床前和临床证据表明,以大麻为基础的医疗制剂(CBMFs)具有抗焦虑、抗抑郁和神经保护特性。CBMFs 通常被视为新型抗焦虑治疗药物,可作为药物疗法用于焦虑症(ADs)的症状领域。我们的目的是探讨在 COVID-19 大流行期间,富含大麻二酚(CBD)的精油配方对哥伦比亚门诊精神健康项目中焦虑症状成人的有效性和耐受性:2021 年 6 月至 2022 年 12 月期间,我们在哥伦比亚波哥大的 Zerenia 诊所通过电子健康记录开展了一项观察性、回顾性、真实世界证据病例系列研究。我们的方便样本包括为治疗焦虑症状而搜索CBMF的人。我们为 24 名成年人开具了富含 CBD 的处方,其形式为悬浮在芝麻油提取物中的非无菌口服液,用于治疗 DSM-5 未指定的焦虑症,并在治疗的第一年对其进行了跟踪随访。CBMF 的制备方法是将全谱大麻提取物溶解在芝麻油中,以达到富含 CBD 的标准化活性成分浓度。油提取物中含有 100 毫克/毫升的 CBD 和低于 1.9 毫克/毫升的 THC。主要结果指标包括医院焦虑和抑郁量表(HADS-A)中的焦虑分量表,以及基线、6 个月和 12 个月随访期间严重程度(CGI-S)和改善程度(CGI-I)的临床总体印象量表。次要结果测量指标分别为 HADS 抑郁症分量表(HADS-D)和埃普沃斯嗜睡量表(ESS)。在为期 12 个月的随访期间,参与者还在每次就诊时填写了患者报告的结果测量(PROMs)。PROMs记录了参与者的主观改善体验和渐进性不良反应:舌下含服中位剂量为 100 毫克的富集 CBD 油提取物治疗 6 个月后,一半以上(54.17%)的样本仍报告有明显的焦虑症状。12 个月后,在服用中位剂量为 120 毫克的富集 CBD 油提取物后,只有 37.50% 的人仍有明显的焦虑症状。作为次要结果,睡眠障碍(SDs)也有类似的主观改善。基线时,不到一半的样本(46.83%)报告有明显的白天嗜睡症状。经过 6 个月的富集 CBD 油提取物治疗后,不到三分之一(29.17%)的样本继续报告有睡眠障碍。在治疗结束时,大部分样本(87.50%)被认为白天嗜睡情况正常。根据HADS-D评分,基线人群没有出现临床相关的抑郁症状;因此,在为期12个月的随访中,没有任何改善。HADS-D 评分的性别差异很小,这可能是由于更年期相关症状的影响。在为期12个月的随访中,没有发现明显的药物不良反应或死亡病例:进一步的研究应确定富集的 CBD 油提取物在治疗特定 ADs 而非广泛和不明焦虑症状方面的长期疗效、安全性和适当剂量。未来的随机对照试验应能证明 CBMF 治疗注意力缺失症的技术水平。下一阶段大麻研究的重点应是进行头对头试验,比较富集的 CBD 提取物或胶囊与经证实对注意力缺失症有效的一线治疗方法。
{"title":"Long-Term Treatment for Unspecified Anxiety Disorders with Cannabidiol: A Retrospective Case Series from Real-World Evidence in Colombia.","authors":"Juan F Galvez-Florez, Hernan F Guillen-Burgos, Camilo A Flórez-Puentes, Cristian E Navarro, Guillermo Moreno-Sanz","doi":"10.1159/000539754","DOIUrl":"https://doi.org/10.1159/000539754","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Preclinical and clinical evidence has elucidated that cannabis-based medical formulations (CBMFs) may display anxiolytic, antidepressive, and neuroprotective properties. CBMFs are often considered as novel therapeutic anxiolytic agents that can be prescribed as pharmacotherapy for symptomatic domains in anxiety disorders (ADs). Our aim was to explore effectiveness and tolerability of enriched cannabidiol (CBD) oil extract formulations in adults with anxiety symptoms in an outpatient mental health program in Colombia during the COVID-19 pandemic.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted an observational, retrospective, real-world evidence case series from electronic health records at Zerenia Clinic in Bogotá, Colombia between June 2021 and December 2022. Our convenience sample consisted of people searching for CBMFs for the treatment of anxiety symptoms. A cohort of 24 adults was prescribed with enriched CBD in the form of non-sterile oral liquids suspended in sesame seed oil extracts for DSM-5 unspecified anxiety disorder and followed throughout the first year of treatment. CBMFs were prepared by dissolving full-spectrum cannabis extracts in sesame seed oil to a standardized concentration of active ingredients which is CBD-enriched. The oil extract contained 100 mg/mL of CBD and less than 1.9 mg/mL of THC. Primary outcome measures established were the anxiety subscale in the Hospital Anxiety and Depression Scale (HADS-A), and the clinical global impression scale with regard to severity (CGI-S) and improvement (CGI-I) at baseline, 6 months, and 12 months during follow-up. Secondary outcome measures established were HADS depression subscale (HADS-D) and the Epworth Sleepiness Scale (ESS), respectively. Participants also completed the patient-reported outcome measures (PROMs) during each visit throughout the 12-month follow-up. PROMs documented both participant's subjective improvement experience and progressive adverse effects.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;After 6 months of treatment with sublingually administered enriched CBD oil extracts in a median dosage of 100 mg, more than half (54.17%) of the sample continued to report significant anxiety symptoms. After 12 months, only 37.50% persisted with significant anxiety symptoms with a median dose of 120 mg of enriched CBD oil extracts. Similar subjective improvements were reported with regard to sleep disturbances (SDs) as a secondary outcome. At baseline, less than half (46.83%) of the sample reported significant daytime sleepiness. After 6 months of enriched CBD oil extract treatment, less than one third (29.17%) continued to report SDs. At end point, a high proportion of the sample (87.50%) were considered to have normal daytime sleepiness. The cohort showed no clinically relevant depressive symptoms at baseline based on HADS-D scores; therefore, no improvement could be reported throughout the 12-month follow-up. Minimal gender differences with regard to H","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"7 1","pages":"193-205"},"PeriodicalIF":0.0,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11521412/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142546328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Medical Cannabis and Cannabinoids
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1