Revisiones sistemáticas que incluyen este estudio

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Revisión sistemática

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Revista Biomedicines
Año 2022
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Despite current therapeutic strategies for immunomodulation and relief of symptoms in multiple sclerosis (MS), remyelination falls short due to dynamic neuropathologic deterioration and relapses, leading to accrual of disability and associated patient dissatisfaction. The potential of cannabinoids includes add-on immunosuppressive, analgesic, neuroprotective, and remyelinative effects. This study evaluates the efficacy of medical marijuana in MS and its experimental animal models. A systematic review was conducted by a literature search through PubMed, ProQuest, and EBSCO electronic databases for studies reported since 2007 on the use of cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) in MS and in experimental autoimmune encephalomyelitis (EAE), Theiler's murine encephalomyelitis virus-induced demyelinating disease (TMEV-IDD), and toxin-induced demyelination models. Study selection and data extraction were performed by 3 reviewers, and 28 studies were selected for inclusion. The certainty of evidence was appraised using the Cochrane GRADE approach. In clinical studies, there was low- and moderate-quality evidence that treatment with ~1:1 CBD/THC mixtures as a nabiximols (Sativex®) oromucosal spray reduced numerical rating scale (NRS) scores for spasticity, pain, and sleep disturbance, diminished bladder overactivity, and decreased proinflammatory cytokine and transcription factor expression levels. Preclinical studies demonstrated decreases in disease severity, hindlimb stiffness, motor function, neuroinflammation, and demyelination. Other experimental systems showed the capacity of cannabinoids to promote remyelination in vitro and by electron microscopy. Modest short-term benefits were realized in MS responders to adjunctive therapy with CBD/THC mixtures. Future studies are recommended to investigate the cellular and molecular mechanisms of cannabinoid effects on MS lesions and to evaluate whether medical marijuana can accelerate remyelination and retard the accrual of disability over the long term.

Revisión sistemática

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Revista Expert review of neurotherapeutics
Año 2021
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INTRODUCTION: : Nabiximols oromucosal spray, a cannabis-based medicine containing a balanced ratio of Δ-9-tetrahydrocannabinol and cannabidiol, is approved widely as add-on therapy for symptomatic relief of spasticity in persons with multiple sclerosis (MS). Most safety data for nabiximols derive from its use in MS spasticity, with some data available from the analgesia area. AREAS COVERED: : This review compiles safety and tolerability data from all published observational studies, registry analyses and case reports identified in systematic searches in which nabiximols oromucosal spray was investigated for spasticity (n = 20) and/or chronic non-cancer pain (n = 4). Aligning with the known safety profile of nabiximols as demonstrated in randomised controlled trials, common adverse events reported consistently across studies conducted under clinical practice conditions were dizziness, fatigue and somnolence. The serious adverse events (SAE) rate with nabiximols in observational studies of MS spasticity was 3.1% (137/4351). A total of 39 treatment-related SAEs were reported in 32 patients with spasticity, all of which (where specified) were resolved. No treatment-related SAEs were recorded in studies of patients receiving nabiximols for pain. EXPERT OPINION: : Real-world experience with nabiximols oromucosal spray in treating spasticity and chronic pain indicates that, overall, it is well tolerated and has a good safety profile.

Revisión sistemática

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Revista The Annals of pharmacotherapy
Año 2020
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Objective: To compile and synthesize the available literature describing medical cannabis use across various disease states. Data Sources: PubMed, EBSCO, and Google Scholar searches were conducted using MeSH and/or keywords. Study Selection and Data Extraction: Studies were included if they described the use of cannabis-based products and medications in the treatment of a predefined list of disease states in humans and were published in English. The extraction period had no historical limit and spanned through April 2019. Data Synthesis: Evidence was compiled and summarized for the following medical conditions: Alzheimer disease, amyotrophic lateral sclerosis, autism, cancer and cancer-associated adverse effects, seizure disorders, human immunodeficiency virus, inflammatory bowel disease, multiple sclerosis (MS), nausea, pain, posttraumatic stress disorder, and hospice care. Relevance to Patient Care and Clinical Practice: Based on identified data, the most robust evidence suggests that medical cannabis may be effective in the treatment of chemotherapy-induced nausea and vomiting, seizure disorders, MS-related spasticity, and pain (excluding diabetic neuropathy). Overall, the evidence is inconsistent and generally limited by poor quality. The large variation in cannabis-based products evaluated in studies limits the ability to make direct comparisons. Regardless of the product, a gradual dose titration was utilized in most studies. Cannabis-based therapies were typically well tolerated, with the most common adverse effects being dizziness, somnolence, dry mouth, nausea, and euphoria. Conclusions: As more states authorize medical cannabis use, there is an increasing need for high-quality clinical evidence describing its efficacy and safety. This review is intended to serve as a reference for clinicians, so that the risks and realistic benefits of medical cannabis are better understood.

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Autores Überall MA
Revista Journal of pain research
Año 2020
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The 20% prevalence of chronic pain in the general population is a major health concern given the often profound associated impairment of daily activities, employment status, and health-related quality of life in sufferers. Resource utilization associated with chronic pain represents an enormous burden for healthcare systems. Although analgesia based on the World Health Organization's pain ladder continues to be the mainstay of chronic pain management, aside from chronic cancer pain or end-of-life care, prolonged use of non-steroidal anti-inflammatory drugs or opioids to manage chronic pain is rarely sustainable. As the endocannabinoid system is known to control pain at peripheral, spinal, and supraspinal levels, interest in medical use of cannabis is growing. A proprietary blend of cannabis plant extracts containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) as the principal cannabinoids is formulated as an oromucosal spray (USAN name: nabiximols) and standardized to ensure quality, consistency and stability. This review examines evidence for THC:CBD oromucosal spray (nabiximols) in the management of chronic pain conditions. Cumulative evidence from clinical trials and an exploratory analysis of the German Pain e-Registry suggests that add-on THC:CBD oromucosal spray (nabiximols) may have a role in managing chronic neuropathic pain, although further precise clinical trials are required to draw definitive conclusions.

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Revista Journal of central nervous system disease
Año 2019
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Background/purpose: Spasticity is one of the most common symptoms in people with multiple sclerosis (MS). Conventional anti-spasticity agents have limitations in their efficacy and tolerability. Delta-9-tetrahydrocannabinol: cannabidiol (THC:CBD) spray, a cannabinoid-based medicine, is approved as an add-on therapy for MS spasticity not adequately controlled by other anti-spasticity medications. The results from randomized controlled trials (RCTs) have demonstrated a reduction in the severity of spasticity and associated symptoms. However, RCTs do not always reflect real-life outcomes. We systematically reviewed the complementary evidence from non-interventional real-world studies. Methods: A systematic literature review was conducted to identify all non-RCT publications on THC:CBD spray between 2011 and 2017. Data on study design, patient characteristics, effectiveness, and safety outcomes were extracted from those publications meeting our inclusion criteria. Results: In total, we reviewed 14 real-world publications including observational studies and treatment registries. The proportion of patients reaching the threshold of minimal clinical important difference (MCID), with at least a 20% reduction of the spasticity Numeric Rating Scale (NRS) score after 4 weeks ranged from 41.9% to 82.9%. The reduction in the mean NRS spasticity score after 4 weeks was maintained over 6-12 months. The average daily dose was five to six sprays. Delta-9-tetrahydrocannabinol: cannabidiol was well tolerated in the evaluated studies in the same way as in the RCTs. No new or unexpected adverse events or safety signals were reported in everyday clinical practice. Conclusions: The data evaluated in this systematic review provide evidence for the efficacy and safety of THC:CBD in clinical practice and confirm results obtained in RCTs.

Revisión sistemática

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Revista Developmental medicine and child neurology
Año 2019
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This review summarizes studies that examined the effectiveness of cannabinoids in treating spasticity, with a focus on understanding the relevance of the existing evidence to paediatric populations. MEDLINE, Embase, PsycINFO, and the Cochrane Library were searched to identify studies that examined the use of cannabinoids in spasticity. We identified 32 studies in adult and paediatric populations. Results were summarized by condition, with adult and paediatric studies considered separately. There is evidence from randomized controlled clinical trials that cannabinoids are more effective than placebo in reducing symptoms of spasticity in adults with multiple sclerosis. Most positive effects were based on patient-rated rather than clinician-rated measures, were modest in size, and should be considered in the context of the narrow therapeutic index of cannabinoids for spasticity and adverse effects. There were comparatively few, and no large studies, of spasticity in conditions other than multiple sclerosis. Few studies have been conducted in paediatric populations. Paediatric studies of spasticity provide low quality evidence and are inadequate to inform clinical practice. Cannabinoids have modest efficacy in reducing muscle spasticity in adults with multiple sclerosis. There is limited evidence of efficacy for cannabinoid use in other conditions, particularly in paediatric populations. Studies in paediatric populations have been of low quality and are insufficient to inform clinical practice.

Revisión sistemática

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Revista PharmacoEconomics
Año 2018
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INTRODUCTION: Cannabis-based medicines (CBMs) may offer relief from symptoms of disease; however, their additional cost needs to be considered alongside their effectiveness. We sought to review the economic costs and benefits of prescribed CBMs in any chronic illness, and the frameworks used for their economic evaluation. METHODS: A systematic review of eight medical and economic databases, from inception to mid-December 2016, was undertaken. MeSH headings and text words relating to economic costs and benefits, and CBMs were combined. Study quality was assessed using relevant checklists and results were synthesised in narrative form. RESULTS: Of 2514 identified records, ten studies met the eligibility criteria, all for the management of multiple sclerosis (MS). Six contained economic evaluations, four studies reported utility-based quality of life, and one was a willingness-to-pay study. Four of five industry-sponsored cost-utility analyses for MS spasticity reported nabiximols as being cost-effective from a European health system perspective. Incremental cost-effectiveness ratios per quality-adjusted life-year (QALY) gained for these five studies were £49,257 (UK); £10,891 (Wales); €11,214 (Germany); €4968 (Italy); and dominant (Spain). Nabiximols for the management of MS spasticity was not associated with statistically significant improvements in EQ-5D scores compared with standard care. Study quality was moderate overall, with limited inclusion of both relevant societal costs and discussions of potential bias. CONCLUSIONS: Prescribed CBMs are a potentially cost-effective add-on treatment for MS spasticity; however, this evidence is uncertain. Further investment in randomised trials with in-built economic evaluations is warranted for a wider range of clinical indications. SYSTEMATIC REVIEW REGISTRATION: PROSPERO Registration Number: CRD42014006370.

Revisión sistemática

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Revista Drug & Alcohol Dependence
Año 2017
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INTRODUCCIÓN: El uso de cannabis o cannabinoides para tratar condiciones médicas y / o aliviar síntomas es cada vez más frecuente. Sin embargo, el impacto de este uso en los resultados informados por los pacientes, como la calidad de vida relacionada con la salud (CVRS), sigue siendo poco claro. MÉTODOS: Realizamos una revisión sistemática y metanálisis, empleando directrices de Preferred Reporting Items for Systematic Reviews and Meta -Analyses (PRISMA). Se categorizaron los estudios basados ​​en el diseño, la condición de enfermedad objetivo, y el tipo de cannabis o cannabinoide utilizado. Se realizaron estudios basados ​​en la calidad y el riesgo de sesgo. Después de eliminar algunos estudios debido a la mala calidad o la insuficiencia de datos, realizamos meta-análisis de los estudios restantes basados ​​en el diseño. Resultados: Veinte estudios cumplieron con nuestros criterios de selección predefinidos. Once estudios fueron ensayos controlados aleatorios (ECA, 2322 participantes); Los estudios restantes fueron de cohorte y diseño transversal. Los estudios de cannabinoides fueron en su mayoría ECA de mayor calidad de diseño que los estudios de cannabis, que utilizaron muestras auto-seleccionadas más pequeñas en estudios observacionales. Aunque no descubrimos una asociación significativa entre el cannabis y los cannabinoides para las condiciones médicas y la CVRS, algunos pacientes que los usaron para tratar el dolor, la esclerosis múltiple y los trastornos inflamatorios de la orilla han informado pequeñas mejoras en la CVRS, mientras que algunos pacientes con VIH han reportado una HRQoL reducida. CONCLUSIÓN: La relación entre la CVRS y el uso de cannabis o cannabinoides para condiciones médicas no es concluyente. Algunas poblaciones de pacientes informan mejoras, mientras que otras informan reducciones en la CVRS. Con el fin de informar a los usuarios, profesionales y formuladores de políticas más claramente, los estudios futuros deben cumplir con directrices de calidad de investigación más estrictas y más claramente informar los resultados de los pacientes.