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The Annals of Pharmacotherapy Oct 2023The objective of this systematic review is to determine the tolerability and safety of psilocybin in a variety of psychiatric and substance-dependence conditions. (Review)
Review
OBJECTIVE
The objective of this systematic review is to determine the tolerability and safety of psilocybin in a variety of psychiatric and substance-dependence conditions.
DATA SOURCES
A systematic review was conducted using Embase, PubMed, Cochrane Central, and Web of Science through September 2023 using the following terminology: "psilocybin" AND "mental-disease" OR "substance-dependence" AND "disease-therapy," in addition to other synonymous key words.
STUDY SELECTION AND DATA EXTRACTION
Literature reporting acute effects and safety data following the use of psilocybin as the pharmacologic intervention in a clinical trial in adult patients with a psychiatric or substance-dependence condition were included. Following the application of inclusion and exclusion criteria, 16 studies were ultimately included in this review.
DATA SYNTHESIS
The most common treatment-emergent adverse effects reported were transient nausea and headache. Transient anxiety was reported as a frequent psychiatric effect, and 3 participants received a benzodiazepine for refractory anxiety during the psilocybin session. Psilocybin demonstrated modest increases in blood pressure and heart rate, and 1 participant received an antihypertensive for sustained hypertension during the psilocybin session. No cases of psilocybin-induced psychosis or Hallucinogen Persisting Perception Disorder were reported.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Treatment resistance remains a concern for psychiatric patients and novel therapies are needed to help alleviate the burden of morbidity and mortality. Psilocybin demonstrates promising acute and long-term safety that may allow for its use in psychiatric or substance-dependence conditions as an alternative to standards of care or in treatment-resistant patients.
CONCLUSIONS
Psilocybin has demonstrated tolerability and safety in recent literature that has investigated its therapeutic potential in a variety of psychiatric or substance-dependence conditions.
PubMed: 37902038
DOI: 10.1177/10600280231205645 -
Journal of Biomedical Informatics Dec 2023Content coverage of patient safety ontology and classification systems should be evaluated to provide a guide for users to select appropriate ones for specific... (Review)
Review
BACKGROUND
Content coverage of patient safety ontology and classification systems should be evaluated to provide a guide for users to select appropriate ones for specific applications. In this review, we identified and compare content coverage of patient safety classifications and ontologies.
METHODS
We searched different databases and ontology/classification repositories to identify these classifications and ontologies. We included patient safety-related taxonomies, ontologies, classifications, and terminologies. We identified and extracted different concepts covered by these systems and mapped these concepts to international classification for patient safety (ICPS) and finally compared the content of these systems.
RESULTS
Finally, 89 papers (77 classifications or ontologies) were analyzed. Thirteen classifications have been developed to cover all medical domains. Among specific domain systems, most systems cover medication (16), surgery (8), medical devices (3), general practice (3), and primary care (3). The most common patient safety-related concepts covered in these systems include incident types (41), contributing factors/hazards (31), patient outcomes (29), degree of harm (25), and action (18). However, stage/phase (6), incident characteristics (5), detection (5), people involved (5), organizational outcomes (4), error type (4), and care setting (3) are some of the less covered concepts in these classifications/ontologies.
CONCLUSION
Among general systems, ICPS, World Health Organization's Adverse Reaction Terminology (WHO-ART), and Ontology of Adverse Events (OAE) cover most patient safety concepts and can be used as a gold standard for all medical domains. As a result, reporting systems could make use of these broad classifications, but the majority of their covered concepts are related to patient outcomes, with the exception of ICPS, which covers other patient safety concepts. However, the ICPS does not cover specialized domain concepts. For specific medical domains, MedDRA, NCC MERP, OPAE, ADRO, PPST, OCCME, TRTE, TSAHI, and PSIC-PC provide the broadest coverage of concepts. Many of the patient safety classifications and ontologies are not formally registered or available as formal classification/ontology in ontology repositories such as BioPortal. This study may be used as a guide for choosing appropriate classifications for various applications or expanding less developed patient safety classifications/ontologies. Furthermore, the same concepts are not represented by the same terms; therefore, the current study could be used to guide a harmonization process for existing or future patient safety classifications/ontologies.
Topics: Humans; Patient Safety; Biological Ontologies
PubMed: 37984548
DOI: 10.1016/j.jbi.2023.104549 -
Cureus Dec 2023The off-label use of botulinum toxin type-A (BoNT-A) in treating rosacea seems encouraging, but the evidence is still lacking regarding its efficacy and safety. This... (Review)
Review
The off-label use of botulinum toxin type-A (BoNT-A) in treating rosacea seems encouraging, but the evidence is still lacking regarding its efficacy and safety. This study was conducted to summarize the evidence regarding the efficacy and safety of BoNT-A in the treatment of rosacea patients. A comprehensive literature search was conducted in several databases, and 17 studies were included. Before-after and split-face comparisons showed that BoNT-A significantly alleviated the symptoms of facial erythema and flushing and improved the patient's quality of life/satisfaction. However, the symptoms recurred three to six months post-injection, requiring repeated treatments in some patients. The pooled rates of post-injection localized erythema, ecchymosis, and facial muscle affection represented 24.6%, 5.1%, and 4.3%, respectively. BoNT-A seems to be effective in alleviating the symptoms of rosacea with a low rate of adverse events. However, the recurrence of the symptoms a few months after the injection requires repeated sessions, which may raise cost-effectiveness issues. Large-scale clinical trials are required to confirm the effectiveness and define the optimal dosing regimen and the rate of recurrence. Future studies should allow for an adequate follow-up after the treatment, with repeated measurements of the outcomes.
PubMed: 38288198
DOI: 10.7759/cureus.51304 -
Public Health Nov 2023Dengue is the most important human vector-borne disease in terms of disease burden. A first dengue vaccine has recently been licenced, and others are in advanced stages... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Dengue is the most important human vector-borne disease in terms of disease burden. A first dengue vaccine has recently been licenced, and others are in advanced stages of development. However, to date, none of these vaccines has achieved balanced efficacy and safety for all dengue serotypes. The aim of this systematic review and meta-analysis was to assess the global acceptance and willingness to pay for unspecified dengue vaccines.
METHODS
This systematic review and meta-analysis included cross-sectional and cohort studies that reported values for vaccine acceptance (percentage) and willingness to pay for currently available or hypothetical vaccines. These values were pooled using random-effects models for the acceptance, while weighted linear regression was chosen for willingness to pay. Heterogeneity between studies was assessed using prediction intervals (PIs), and a domain-based tool was used to assess the risk of bias. Subgroup and sensitivity analyses were performed where appropriate. This study was registered with PROSPERO (CRD42021255784).
RESULTS
We included 19 studies from the Americas and Asia in the quantitative meta-analysis. The risk of bias was mainly related to the selection of participants and to the assumptions about the safety and efficacy of the vaccines. The percentage of vaccine acceptance was 88.3% (95% CI: 81.0%-93.0%), with some heterogeneity between studies (80% PI: 52.9%-98.1%). Willingness to pay was US$ 46.7 (95% CI: 25.9-67.5) per vaccine recipient. There were differences between continents, with higher acceptance in the Americas.
CONCLUSIONS
We were able to obtain global estimates of vaccine acceptance and willingness to pay and identify the associated factors that influence these values. This knowledge is relevant for the planning of future vaccination strategies.
Topics: Humans; Dengue Vaccines; Dengue; Patient Acceptance of Health Care; Vaccination Hesitancy
PubMed: 37741155
DOI: 10.1016/j.puhe.2023.08.022 -
European Journal of Neurology Sep 2023Since the results of previous studies regarding the safety and efficacy of miglustat in GM2 gangliosidosis (GM2g) were inconsistent, we aimed to assess miglustat therapy... (Review)
Review
BACKGROUND
Since the results of previous studies regarding the safety and efficacy of miglustat in GM2 gangliosidosis (GM2g) were inconsistent, we aimed to assess miglustat therapy in GM2g patients.
METHODS
This study followed the latest version of PRISMA. We included the observational or interventional studies reporting GM2g patients under miglustat therapy by searching PubMed, Web of Science, and Scopus. Data extracted included the natural history of individual patient data, as well as the safety and efficacy of miglustat in GM2g patients. The quality assessment was performed using the Joanna Briggs Institute Critical Appraisal checklist.
RESULTS
A total of 1023 records were identified and reduced to 621 after removing duplicates. After screening and applying the eligibility criteria, 10 articles and 2 abstracts met the inclusion criteria. Overall, the studies represented 54 patients with GM2g under treatment with miglustat and 22 patients with GM2g in the control group. Among patients with available data, 14 and 54 have been diagnosed with Sandhoff disease and Tay-Sachs disease, respectively. Patients included in this review consisted of 23 infantile, 4 late-infantile, 18 juvenile, and 31 adult-onset GM2g.
CONCLUSIONS
Although miglustat should not be considered a definite treatment for GM2g, it appears that patients, particularly those with infantile or late-infantile GM2g, could benefit from miglustat therapy to some extent. We also make some suggestions regarding future studies presenting their findings in a standard format to facilitate pooling the available data in such rare diseases for a more comprehensive conclusion.
Topics: Adult; Humans; Gangliosidoses, GM2; 1-Deoxynojirimycin
PubMed: 37209042
DOI: 10.1111/ene.15871 -
Cureus Sep 2023The neuropeptide calcitonin gene-related peptide (CGRP) is an essential pathophysiological treatment for migraines. A unique class of medications called CGRP monoclonal... (Review)
Review
The neuropeptide calcitonin gene-related peptide (CGRP) is an essential pathophysiological treatment for migraines. A unique class of medications called CGRP monoclonal antibodies target CGRP and its receptor and have demonstrated promising benefits in the treatment and prevention of migraines. This study sought to identify and assess the quality of existing systematic reviews about the effectiveness of CGRP antibodies for preventing migraines, as well as systematically review and synthesize the evidence on these topics. This included the four Food and Drug Administration (FDA)-approved medications erenumab, galcanezumab, fremanezumab, and eptinezumab. The effectiveness and safety of these monoclonal antibodies in preventing migraines should also be examined in light of patient characteristics, and any gaps in the body of knowledge should be noted in order to suggest new lines of investigation. Data gathering included a thorough search of internet databases (PubMed, Cochrane Library, Web of Science, and Scopus) for relevant research released between 2018 and 2023. The findings imply that CGRP monoclonal antibodies are efficient and secure for preventing migraines and may be considered a first-line alternative for treating migraines and drug misuse. The results further imply that combination treatment with CGRP antibodies and onabotulinumtoxinA may enhance the prevention of migraine in adults. With suggestions for more studies to find and address these variables, the significance of genetic and epigenetic factors in the progression of pediatric patients' acute postoperative pain to chronic postsurgical pain is underlined. All four anti-CGRP monoclonal antibodies, erenumab, fremanezumab, galcanezumab, and eptinezumab, were shown to be safe and effective for the prevention of migraine when the research additionally looked at their individual effectiveness and safety. Additionally, the study discovered considerable variances in effectiveness amongst various groups. However, further investigation is required to establish the best time and dosage and the effect of patient characteristics on the effectiveness and safety of these medications.
PubMed: 37868560
DOI: 10.7759/cureus.45560 -
Cureus Dec 2023Severe eosinophilic asthma (SEA) is characterized by persistent airway inflammation and frequent exacerbations despite standard treatments. Mepolizumab, a monoclonal... (Review)
Review
Severe eosinophilic asthma (SEA) is characterized by persistent airway inflammation and frequent exacerbations despite standard treatments. Mepolizumab, a monoclonal antibody that reduces eosinophil levels by targeting interleukin-5, has emerged as an add-on therapy for patients with SEA. This systematic review evaluated mepolizumab's efficacy and safety for treating SEA. A comprehensive literature search was conducted across major databases. Thirty-two studies with over 6,000 patients were included, comprising randomized controlled trials, open-label extensions, and real-world observational analyses. Study quality and risk of bias were assessed using standard tools. Meta-analysis was deemed inappropriate due to heterogeneity. Instead, a narrative synthesis was performed. Mepolizumab significantly reduced exacerbation rates by around 50% and improved symptoms and lung function compared to placebo in pivotal trials. Long-term open-label studies showed sustained reductions in exacerbations and stable lung function for up to 4.5 years. Real-world data demonstrated consistent 50%-90% exacerbation decreases across diverse patient populations over 6-24 months. Mepolizumab exhibited an acceptable safety profile, with mild injection site reactions and headaches as most common adverse events. While specific subgroups may show enhanced responses, mepolizumab displayed broad efficacy regardless of patient demographics or phenotypes. The extensive evidence provides robust support for mepolizumab as an efficacious and safe add-on treatment option for patients with severe, refractory eosinophilic asthma. Further high-quality comparative effectiveness research is warranted to optimize patient selection and positioning among emerging biologics.
PubMed: 38161547
DOI: 10.7759/cureus.49781 -
Social Psychiatry and Psychiatric... Nov 2023This systematic review of systematic reviews aims to provide the first global picture of the prevalence and correlates of perinatal depression, and to explore the... (Review)
Review
PURPOSE
This systematic review of systematic reviews aims to provide the first global picture of the prevalence and correlates of perinatal depression, and to explore the commonalities and discrepancies of the literature.
METHODS
Seven databases were searched from inception until April 2022. Full-text screening and data extraction were performed independently by two researchers and the AMSTAR tool was used to assess the methodological quality.
RESULTS
128 systematic reviews were included in the analysis. Mean overall prevalence of perinatal depression, antenatal depression and postnatal depression was 26.3%, 28.5% and 27.6%, respectively. Mean prevalence was significantly higher (27.4%; SD = 12.6) in studies using self-reported measures compared with structured interviews (17.0%, SD = 4.5; d = 1.0) and among potentially vulnerable populations (32.5%; SD = 16.7, e.g. HIV-infected African women) compared to the general population (24.5%; SD = 8.1; d = 0.6). Personal history of mental illness, experiencing stressful life events, lack of social support, lifetime history of abuse, marital conflicts, maternity blues, child care stress, chronic physical health conditions, preeclampsia, gestational diabetes mellitus, being exposed to second-hand smoke and sleep disturbance were among the major correlates of perinatal depression.
CONCLUSION
Although the included systematic reviews were all of medium-high quality, improvements in the quality of primary research in this area should be encouraged. The standardisation of perinatal depression assessment, diagnosis and measurement, the implementation of longitudinal designs in studies, inclusions of samples that better represent the population and better control of potentially confounding variables are encouraged.
Topics: Female; Humans; Pregnancy; Child; Depression; Prevalence; Systematic Reviews as Topic; Depression, Postpartum; Pregnancy Complications
PubMed: 36646936
DOI: 10.1007/s00127-022-02386-9 -
In Vivo (Athens, Greece) 2023Awake surgery has become a valid alternative to general anesthesia in many surgery fields. This technique played a very important role during the COVID-19 period. The... (Review)
Review
BACKGROUND/AIM
Awake surgery has become a valid alternative to general anesthesia in many surgery fields. This technique played a very important role during the COVID-19 period. The growing use of this technique has many advantages. We performed a systematic review to study the potentialities of awake breast surgery.
MATERIALS AND METHODS
We searched Pubmed, Embase, and Cochrane library database and retrieved a total of 109 records. Forty-nine of them were excluded as unsuitable. Finally, we selected a total of 12 records concerning different types of studies for topic appropriateness. Three reviewers reviewed independently each record.
RESULTS
Five articles analyzing the sustainability of awake surgery during the COVID-19 period were selected. In addition, one article analyzing the impact on the immune system and six articles and eight case reports analyzing anesthetic techniques were also selected. The studies analyzing awake breast surgery during the COVID-19 period showed advantages in terms of sustainability and length of hospitalization. The study analyzing the immune response after awake breast surgery showed lesser lymphocyte response than the general anesthesia group. The studies analyzing anesthetic techniques in awake breast surgery showed that the nerve blocks allow good level of safety and postoperative pain control.
CONCLUSION
The awake breast surgery and fast track implementation shortened hospital stays and reduced costs, without influencing the surgical results. Furthermore, awake breast surgery reduced surgical stress compared to general anesthesia. Among the various anesthetic techniques, nerve blocks are the most advantageous in terms of safety and efficacy compared to epidural anesthesia.
Topics: Humans; Female; Wakefulness; Brain Neoplasms; COVID-19; Nerve Block; Breast Neoplasms
PubMed: 37369489
DOI: 10.21873/invivo.13225 -
PloS One 2023Biosimilars are increasingly available for the treatment of many serious disorders, however some concerns persist about switching a patient to a biosimilar whose... (Meta-Analysis)
Meta-Analysis
Biosimilars are increasingly available for the treatment of many serious disorders, however some concerns persist about switching a patient to a biosimilar whose condition is stable while on the reference biologic. Randomized controlled studies and extension studies with a switch treatment period (STP) to or from a biosimilar and its reference biologic were identified from publicly available information maintained by the U.S. Food and Drug Administration (FDA). These findings were augmented with data from peer reviewed publications containing information not captured in FDA reviews. Forty-four STPs were identified from 31 unique studies for 21 different biosimilars. Data were extracted and synthesized following PRISMA guidelines. Meta-analysis was conducted to estimate the overall risk difference across studies. A total of 5,252 patients who were switched to or from a biosimilar and its reference biologic were identified. Safety data including deaths, serious adverse events, and treatment discontinuation showed an overall risk difference (95% CI) of -0.00 (-0.00, 0.00), 0.00 (-0.01, 0.01), -0.00 (-0.01, 0.00) across STPs, respectively. Immunogenicity data showed similar incidence of anti-drug antibodies and neutralizing antibodies in patients within a STP who were switched to or from a biosimilar to its reference biologic and patients who were not switched. Immune related adverse events such as anaphylaxis, hypersensitivity reactions, and injections site reactions were similar in switched and non-switched patients. This first systematic review using statistical methods to address the risk of switching patients between reference biologics and biosimilars finds no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar.
Topics: Humans; Biosimilar Pharmaceuticals; Biological Factors; Research Design; Anaphylaxis; Antibodies
PubMed: 37788264
DOI: 10.1371/journal.pone.0292231