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MedRxiv : the Preprint Server For... Feb 2023In this review, we provide an updated assessment of available evidence on the pharmacokinetics (PK) of cannabidiol (CBD) and explore the impact of different factors on...
BACKGROUND
In this review, we provide an updated assessment of available evidence on the pharmacokinetics (PK) of cannabidiol (CBD) and explore the impact of different factors on PK outcomes.
MATERIALS AND METHODS
This systematic review and meta-regression analysis was pre-registered (PROSPERO: CRD42021269857). We systematically searched Medline, Embase, PsychInfo, and Web of Science Core Collection up to November 19, 2022. Trials of CBD in healthy adults were included if they reported at least one of the PK parameters of interest, including Tmax, Cmax, AUC0-t, AUC0-inf, and T , in serum or plasma. Studies of patient populations or CBD co-administration with other medications were excluded. The was used. Random-effects multivariable meta-regression analysis was conducted.
RESULTS
A total of 112 trial arms from 39 studies were included; 26 trial arms had a "Good" quality, 70 "Fair," and 16 "Poor." Eight arms used inhalation CBD, 29 oromucosal, 73 oral, and 2 intravenous. CBD formulations could be categorized to nanotech (n=14), oil-based (n=21), alcohol-based (n=10), water-based (n=12), Sativex (n=17), and Epidiolex (n=22). For single-dose studies, CBD doses ranged between 2-100mg in inhalation, 5-50mg in oromucosal, and 0.42-6000mg in oral administration. Sixty-six trial arms had only male participants or a higher number of males than females. The duration of the PK session was between 4h-164h. A higher CBD dose was associated with higher Cmax, AUC0-t, and AUC0-inf. Compared to oral administration, oromucosal administration was associated with lower Cmax, AUC0-t, and AUC0-inf. Fed status was associated with higher Cmax and AUC0-t when compared to the fasting status. A higher ratio of female participants was associated with lower Tmax in oral administration and higher Cmax.
CONCLUSION
As expected, CBD dose, route of administration, and diet were major determinants of CBD pharmacokinetics with oral routes providing higher bioavailability and nanotechnology formulations a faster onset. Though CBD appeared to have a faster onset and longer duration in females, more studies are required to delineate the role of biological sex. Factors that influence CBD PK have implications for medication development and appropriate dosing in clinical practice.
PubMed: 36778355
DOI: 10.1101/2023.02.01.23285341 -
Digestive and Liver Disease : Official... Jan 2023Surgical management in Ulcerative Colitis (UC) is typically utilised in medically refractory cases and, therefore, it is a useful marker for efficacy of medical... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Surgical management in Ulcerative Colitis (UC) is typically utilised in medically refractory cases and, therefore, it is a useful marker for efficacy of medical management.
AIMS
To understand the changing prevalence of colectomy in UC over time.
METHODS
A systematic review was conducted using MEDLINE (1946-2021), EMBASE and EMBASE classic (1947-2021) to identify studies with a population of n>500 that reported colectomy rates in UC patients >18 years old. The primary outcome was the prevalence of colectomy at 1-, 5- and 10-years post-diagnosis. Secondary outcomes included colectomy rates in the pre-biologics (defined as pre-2004) and post-biologics eras (defined as post-2004).
RESULTS
Thirty-one studies with 294,359 patients with UC were included for review and meta-analysis. The prevalence of colectomy at 1-, 5- and 10-years post-diagnosis were 3% (95% CI 2%-6%), 5% (95% CI 2%-9%), 10% (95% CI 6%-16%) respectively. The pooled relative risk for colectomy in the post-biologics era was 0.68 (95% CI 0.42 to 1.09, p=0.10) at 1-year and 0.71 (95% CI 0.56 to 0.91, p<0.01) at 5-years post-diagnosis.
CONCLUSION
The overall colectomy rate has decreased over the past three decades. Biologics may have played a role in reducing the risk of colectomy, however the relative risk reduction is likely to be modest.
Topics: Humans; Adolescent; Colitis, Ulcerative; Colectomy; Biological Products; Prevalence
PubMed: 36180365
DOI: 10.1016/j.dld.2022.08.039 -
Research in Social & Administrative... May 2020One of the strategies to promote patient safety in care transitions is medication reconciliation (MR), which is conducted by the pharmacist at the patient's discharge... (Review)
Review
BACKGROUND
One of the strategies to promote patient safety in care transitions is medication reconciliation (MR), which is conducted by the pharmacist at the patient's discharge from hospital. However, there are divergences about this process and about the pharmacist's role in conducting such intervention.
OBJECTIVE
To systematically review the literature that reports the MR process led by pharmacists at patient discharge and map the different methods, strategies and tools used in the process.
METHODS
Relevant studies were searched in the following databases: EMBASE, MEDLINE (PubMed), The Cochrane Library, and LILACS. No language restriction or publication date was applied. The studies considered eligible were those involving and describing pharmacist-led MR processes at acute patient discharge from hospital, with an experimental, quasi-experimental, or observational design. The characteristics of the studies and the MR processes were identified and then a qualitative synthesis was performed.
RESULTS
Fifty studies were included. The majority of them were observational ones (82%), and the main outcome was medication discrepancies (42%). The studies were mostly conducted in university hospitals (70%) and in internal medicine wards (54%). Pharmacists were responsible mainly for gathering medication histories (72%), and identifying (96%) and solving (98%) pharmacotherapeutic problems. The main sources of information on pre-admission medications were patient/caregiver interviews (66%) and records from other care providers (40%). Only 30% of the studies described a patient discharge plan, and 14% shared information of the patient's pharmacotherapy with community pharmacists.
CONCLUSION
The concept of MR and the pharmacist-led activities in the process varied in the literature, as well as the pharmacotherapy assessment focus and the communication strategies towards patients and other care providers, showing that standardization of the process and concepts is necessary.
Topics: Hospitals; Humans; Medication Reconciliation; Patient Discharge; Patient Transfer; Pharmacists; Pharmacy Service, Hospital
PubMed: 31395445
DOI: 10.1016/j.sapharm.2019.08.001 -
Journal of Interprofessional Care 2023Safe medication use necessitates interprofessional working, with calls to enhance interprofessional education (IPE) focusing on medication safety (MS) in healthcare...
Safe medication use necessitates interprofessional working, with calls to enhance interprofessional education (IPE) focusing on medication safety (MS) in healthcare professional (HCP) curricula. Little is known about the design, delivery or evaluation of such activities. This systematic literature review describes MS-focused IPE activities in pre-qualification HCP programmes. MedLine, EMBASE, CINAHL and ERIC were searched, relevant studies identified and data extracted. The McGill Mixed Methods Appraisal Tool was employed. The 3P (presage-process-product) theory structured deductive analysis. Thirty-one studies were included, reporting on 30 activities, mostly undertaken in North America or United Kingdom. Presage/Design: Most reported activities involved pharmacy, nursing, medical or physician assistant students learning with one or more other HCP group. Few studies matched student groups' skills or experiences. Few studies reported theoretical underpinnings. Process/Delivery: Multiple pedagogical approaches were employed, mostly social construction, and low- and high-fidelity simulation-based learning. Few studies reported learning outcomes or summative assessment, more reported formative assessment. Product/evaluation: Outcomes measured were learners' opinions, satisfaction or attitudes toward interprofessional working and findings were generally positive. Few studies reported on student development or outcomes specific to medication safety. Lack of integration of qualitative/quantitative components of mixed methods studies and limited outcome measurements' validity or reliability weakened study quality. MS-focused IPE for pre-qualification HCPs is well received by students. Design of future activities could be enhanced by employing theory and ensuring matching of students' and groups' skills, professional identity and learner attributes to enhance learning in an interprofessional setting. Future delivery should embed MS-focused IPE into the standard curricula to optimize constructive alignment, learner engagement, quality and drive development. The required skillset in pre-qualification HCP programmes to facilitate future safe medication practice, together with the associated learning outcomes and assessment approaches, should be defined. The quality of scholarly studies examining these activities needs improvement.
Topics: Humans; Interprofessional Education; Reproducibility of Results; Interprofessional Relations; Learning; Health Personnel
PubMed: 35050843
DOI: 10.1080/13561820.2021.2015301 -
Bulletin of the World Health... May 2008A 7-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV7) was licensed in the United States of America in 2000, but no comprehensive postmarketing review... (Review)
Review
A 7-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV7) was licensed in the United States of America in 2000, but no comprehensive postmarketing review of safety has been carried out. We conducted a systematic review of the safety of PCV7 and other pneumococcal conjugate vaccines. A total of 42 studies were included in the review. Reactogenicity data from some randomized trials suggest that PCV7 may result in more local reactions and fever than certain comparison vaccines. However, the reactions were mild and self-limited, and PCV7 did not carry an increased risk of severe injection-site reactions or high fever. Some, although not all, of the randomized trials in children found that mild local and systemic reactions associated with PCV7 may increase with the number of doses, at least over the three-dose primary series. In addition, PCV7 and other pneumococcal conjugate vaccines were found to have tolerable reactogenicity in Native American and African populations and in medically high-risk groups for which pneumococcal vaccination is recommended. Two of the largest studies of PCVs, one involving PCV7 and the other, PCV9, found a statistically significant increased risk of hospitalization for reactive airway disease, including asthma. Another large trial of PCV9, however, did not find an increased risk of asthma. In conclusion, this review of the evidence did not identify any major safety problems with PCV7 or any other pneumococcal conjugate vaccine, with the possible exception of reactive airway disease, which may bear further scrutiny as additional data become available.
Topics: AIDS-Related Opportunistic Infections; Age Factors; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Humans; Infant; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Product Surveillance, Postmarketing; Vaccines, Conjugate; World Health Organization
PubMed: 18545740
DOI: 10.2471/blt.07.048025 -
Journal of Advanced Nursing Dec 2016The aim of this study was to critically appraise and synthesize the best available evidence on the effectiveness of interventions suitable for delivery by nurses,... (Review)
Review
AIMS
The aim of this study was to critically appraise and synthesize the best available evidence on the effectiveness of interventions suitable for delivery by nurses, designed to enhance cardiac patients' adherence to their prescribed medications.
BACKGROUND
Cardiac medications have statistically significant health benefits for patients with heart disease, but patients' adherence to prescribed medications remains suboptimal.
DESIGN
A systematic quantitative review of intervention effects.
DATA SOURCES
We conducted systematic searches for English-language, peer-reviewed randomized controlled trial publications via Medline, EMBASE, CINAHL, the Cochrane Library, ProQuest, Web of Science and Google Scholar published between January 2004-December 2014.
REVIEW METHODS
According to pre-determined inclusion and exclusion criteria, eligible studies were identified and data extracted using a predefined form. Of 1962 identified papers; 14 studies met the study inclusion criteria, were assessed for risk of bias using the Cochrane Collaboration tool; and included in the review.
RESULTS
Study findings were presented descriptively; due to the heterogeneity of studies meta-analysis was not possible. Included papers described interventions categorized as: (1) multifaceted; and (2) behavioural and educational, comprising: (a) text message and mail message; (b) telephone calls; (c) motivational interviewing and (d) nurse-led counselling and education.
CONCLUSIONS
Substantial heterogeneity limited the robustness of conclusions, but this review indicated that motivational interviewing, education and phone or text messaging appeared promising as means to enhance cardiac medication adherence. Future research should integrate multifaceted interventions that target individual behaviour change to enhance adherence to cardiovascular medications, to build on the beneficial outcomes indicated by this review.
Topics: Heart Diseases; Humans; Medication Adherence; Text Messaging
PubMed: 27377689
DOI: 10.1111/jan.13062 -
Pharmacological Research Jul 2018To quantify the relationship between Citrus intake and risk of cancer of the oral cavity and pharynx. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To quantify the relationship between Citrus intake and risk of cancer of the oral cavity and pharynx.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Ovid MEDLINE, EMBASE, and Web of Science were searched until September 2017. Search terms included Citrus, Citrus aurantifolia, Citrus sinensis, Citrus paradisi, Citrus fruits, Citrus fruits extract, Citrus oil, fruits, oral cancer, mouth cancer, mouth neoplasm.
STUDY SELECTION
The selection of studies and the systematic review were carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. A pre-defined inclusion checklist resulted in the inclusion of articles which were (i) published in peer-reviewed scientific journals; (ii) English language; (iii) and included a measure of Citrus fruit intake and risk of oral and pharyngeal cancer. Studies were excluded if (i) preparations derived from other fruits were used, (ii) Citrus intake was combined with intake of other fruits; (iii) in vitro or animal models were used. We also excluded reviews, systematic reviews, meta-analyses, letters, personal opinions, conference abstracts and book chapters.
DATA EXTRACTION
Three reviewers independently performed the extraction of data from studies included.
RESULTS
Seventeen studies met our inclusion criteria and were included in the final review. Pooled analyses showed that those with the highest Citrus fruit intake compared to the lowest intake had a 50% reduction in risk of oral cavity and pharyngeal cancer (OR 0.50; 95% CI 0.43-0.59).
CONCLUSION
The studies included in this review and meta-analysis showed an inverse association between Citrus fruit intake and oral cancer.
Topics: Citrus; Fruit; Humans; Mouth Neoplasms; Risk Factors
PubMed: 29753688
DOI: 10.1016/j.phrs.2018.05.008 -
PM & R : the Journal of Injury,... Apr 2024The purpose of this systematic review was to ascertain guideline-recommended pharmaceutical approaches to lumbosacral radicular symptoms, assess the quality of the... (Review)
Review
OBJECTIVE
The purpose of this systematic review was to ascertain guideline-recommended pharmaceutical approaches to lumbosacral radicular symptoms, assess the quality of the clinical practice guidelines (CPGs) with the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool, and qualitatively synthesize the guideline recommendations.
LITERATURE SURVEY
Literature searches were performed in PubMed, Cochrane Database of Systematic Reviews, Index to Chiropractic Literature, Allied and Complementary Medicine Database (AMED), Cumulative Index for Nursing and Allied Health Literature (CINAHL), and Physiotherapy Evidence Database (PEDro). We included guidelines published between January 1, 2017, and January 9, 2022, written in the English language, related to radiculopathy, sciatica, and/or low back pain with leg pain, and that provided recommendations on oral medication.
METHODOLOGY
The review was performed in accordance with Preferred Reporting Items for Systemic Reviews and Meta-Analyses (PRISMA) and the protocol was pre-registered with the International Prospective Register of Systematic Reviews (PROSPERO). Eligibility screening, full-text review, extraction of information pertaining to pharmacological management, and synthesis of results were performed independently by two authors and a third investigator was recruited to arbitrate any disagreements. The AGREE II tool was administered by four authors to appraise CPG quality.
SYNTHESIS
After screening 413 citations and assessing 37 full-text articles, 11 CPGs met the inclusion criteria. They represented seven countries (Belgium, Canada, England, France, Japan, Korea, and United States) and three continents (Asia, Europe, and North America), as well as the Global Spine Care Initiative aimed at a worldwide presence. The mean overall AGREE II score was 87.1% (standard deviation [SD] 12.6%), generally reflecting high-quality CPGs. The highest domain mean score was for Clarity of Presentation (96.7%, SD 4.4%), and the lowest was Applicability (75.6%, SD 22.8%). Five classes of medications were recommended by at least one CPG: anticonvulsants, antidepressants, oral corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids.
CONCLUSIONS
The most common medication class recommended by the CPGs for lumbar radiculopathy was antidepressants. No CPGs recommended prescribing acetaminophen, benzodiazepines, muscle relaxants, or antibiotics. There was very little agreement between the CPGs, and all the medication classes had at least one CPG recommended against its use. Three guidelines reviewed did not recommend any medications due to lack of supporting literature, and instead recommended nonpharmacologic therapy.
PubMed: 38629664
DOI: 10.1002/pmrj.13142 -
Frontiers in Public Health 2023Empirical evidence has shown that light therapy (LT) can reduce depression symptoms by stimulating circadian rhythms. However, there is skepticism and inconclusive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Empirical evidence has shown that light therapy (LT) can reduce depression symptoms by stimulating circadian rhythms. However, there is skepticism and inconclusive results, along with confusion regarding dosing. The purpose of this study is to quantify light as a stimulus for the circadian system and create a dose-response relationship that can help reduce maladies among adolescents and young adults (AYAs). This will provide a reference for light exposure and neural response, which are crucial in the neuropsychological mechanism of light intervention. The study also aims to provide guidance for clinical application.
METHODS
The latest quantitative model of CL (circadian light) and CS (circadian stimulus) was adopted to quantify light dose for circadian phototransduction in youth depression-related light therapy. Articles published up to 2023 through Web of Science, Cochrane Library, Medline (OVID), CINAHL, APA PsycINFO, Embase, and Scholars were retrieved. A meta-analysis of 31 articles (1,031 subjects) was performed using Stata17.0, CMA3.0 (comprehensive meta-analysis version 3.0) software, and Python 3.9 platform for light therapy efficacy comparison and dose-response quantification.
RESULTS
Under various circadian stimulus conditions (0.1 < CS < 0.7) of light therapy (LT), malady reductions among AYAs were observed (pooled SMD = -1.59, 95%CI = -1.86 to -1.32; = -11.654, = 0.000; = 92.8%), with temporal pattern ( = 0.044) and co-medication ( = 0.000) suggested as main heterogeneity sources. For the efficacy advantage of LT with a higher circadian stimulus that is assumed to be influenced by visualization, co-medication, disease severity, and time pattern, sets of meta-analysis among random-controlled trials (RCTs) found evidence for significant efficacy of circadian-active bright light therapy (BLT) over circadian-inactive dim red light (SMD = -0.65, 95% CI = -0.96 to -0.34; = -4.101, = 0.000; = 84.9%) or circadian-active dimmer white light (SMD = -0.37, 95% CI = -0.68 to -0.06; = -2.318, = 0.02; = 33.8%), whereas green-blue, circadian-active BLT showed no significant superiority over circadian-inactive red/amber light controls (SMD = -0.21, 95% CI = -0.45 to 0.04; = -2.318, = 0.099; = 0%). Overall, circadian-active BLT showed a greater likelihood of clinical response than dim light controls, with increased superiority observed with co-medication. For pre-to-post-treatment amelioration and corresponding dose-response relationship, cumulative duration was found more influential than other categorical (co-medication, severity, study design) or continuous (CS) variables. Dose-response fitting indicated that the therapeutic effect would reach saturation among co-medicated patients at 32-42 days (900-1,000 min) and 58-59 days (1,100-1,500 min) among non-medicated AYAs. When exerting high circadian stimulus of light therapy (0.6 < CS < 0.7), there was a significantly greater effect size in 1,000-1,500 min of accumulative duration than <1,000 or >1,500 min of duration, indicating a threshold for practical guidance.
LIMITATIONS
The results have been based on limited samples and influenced by a small sample effect. The placebo effect could not be ignored.
CONCLUSIONS
Although the superiority of LT with higher circadian stimulus over dimmer light controls remains unproven, greater response potentials of circadian-active BLT have been noticed among AYAs, taking co-medication, disease severity, time pattern, and visual characteristics into consideration. The dose-response relationship with quantified circadian stimulus and temporal pattern had been elaborated under various conditions to support clinical depression treatment and LT device application in the post-pandemic era.
Topics: Adolescent; Young Adult; Humans; Phototherapy; Pandemics; Probability
PubMed: 38259764
DOI: 10.3389/fpubh.2023.1257093 -
Human Reproduction Update Aug 2022Globally, the ages at pubertal onset for girls and boys have been decreasing during recent decades, partly attributed to excess body fat accumulation. However, a growing... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Globally, the ages at pubertal onset for girls and boys have been decreasing during recent decades, partly attributed to excess body fat accumulation. However, a growing body of literature has recognized that endocrine disrupting chemicals (EDCs) may play an important role in this global trend, but the association has not yet been fully established.
OBJECTIVE AND RATIONALE
EDCs can interfere with normal hormone function and metabolism and play a role in pubertal onset. We aimed to systematically identify and evaluate the current evidence on the timing of pubertal onset in girls and boys following prenatal or postnatal exposures to xenobiotic EDCs.
SEARCH METHODS
Following PRISMA guidelines, we performed a systematic literature search of original peer-reviewed publications in the PubMed database through a block search approach using a combination of index MeSH and free text search terms. Publications were considered if they covered biomarkers of prenatal or postnatal exposures to xenobiotic EDCs (European Commission's list of category 1 EDCs) measured in maternal or child biospecimen and pubertal onset defined by the progression of the following milestones (and assessed in terms of the following measures): menarche (age), thelarche (Tanner staging) and pubarche (Tanner staging), in girls, and genital stage (Tanner staging), testicular volume (ml) and pubarche (Tanner staging), in boys.
OUTCOMES
The literature search resulted in 703 references, of which we identified 52 publications fulfilling the eligibility criteria for the qualitative trend synthesis and 23 publications for the meta-analysis. The qualitative trend synthesis provided data on 103 combinations of associations between prenatal or postnatal exposure to EDC compounds groups and puberty outcomes and the meta-analysis enabled 18 summary risk estimates of meta-associations.
WIDER IMPLICATIONS
Statistically significant associations in the qualitative trend synthesis suggested that postnatal exposure to phthalates may be associated with earlier thelarche and later pubarche. However, we did not find consistent evidence in the meta-analysis for associations between timing of pubertal onset in girls and boys and exposures to any of the studied xenobiotic EDCs. We were not able to identify specific pre- or postnatal windows of exposure as particularly critical and susceptible for effects of EDCs. Current evidence is subject to several methodological challenges and inconsistencies and evidence on specific exposure-outcome associations remains too scarce to firmly confirm EDC exposure as a risk factor for changes in age of pubertal onset in the general child population. To create a more uniform foundation for future comparison of evidence and to strengthen pooled studies, we recommend the use of more standardized approaches in the choice of statistical analyses, with exposure transformations, and in the definitions and assessments of puberty outcomes. The impact of mixtures of EDC exposures on the association also remains unestablished and would be valuable to elucidate for prenatal and postnatal windows of exposure. Future large, longitudinal epidemiological studies are needed to clarify the overall association.
Topics: Child; Endocrine Disruptors; Female; Humans; Longitudinal Studies; Male; Menarche; Pregnancy; Puberty; Xenobiotics
PubMed: 35466359
DOI: 10.1093/humupd/dmac013