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Sleep Medicine Reviews Oct 2012Gamma-hydroxybutyrate (GHB) is currently authorized by the European Medicines Agency (EMA) to treat narcolepsy with cataplexy in adults, and by the Food and Drug... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Gamma-hydroxybutyrate (GHB) is currently authorized by the European Medicines Agency (EMA) to treat narcolepsy with cataplexy in adults, and by the Food and Drug Administration (FDA) to treat cataplexy in patients with narcolepsy, with an expanded indication for the treatment of excessive daytime sleepiness. This study meta-analyses and reviews the effectiveness of GHB on the clinical features of narcolepsy and its neurophysiological correlates.
METHODS
A systematic review of the literature using Medline, Embase, Web of Science, Cochrane reviews, clinical-trials.gov, Scopus, Scirus, and a subsequent meta-analysis were performed. Considered outcomes were: cataplexy attacks, subjective daytime sleepiness, sleep attacks, clinical global impression change (CGI-c), quality of life (QoL), hypnagogic hallucinations, sleep paralysis, mean sleep latencies on the multiple sleep latency test (MSLT) and maintenance of wakefulness test (MWT), nocturnal polysomnographic data.
RESULTS
Nine randomized controlled trials reporting data on the effectiveness of GHB on narcolepsy were identified, for a total of 1,154 patients (771 patients in the GHB-treated group and 383 in the placebo group). The meta-analysis showed that GHB reduced cataplexy attacks both on a daily (weighted mean difference (WMD) -1.10; 95% confidence interval (CI) -1.29/-0.90, p < 0.00001) and a weekly basis (WMD -7.04; 95% CI -12.45/-1.63, p = 0.01), subjective nocturnal awakenings (WMD -1.33; 95% CI -1.78/-0.88, p < 0.00001), daytime sleep attacks on a weekly basis (WMD -9.30; 95% CI -15.92/-2.68, p = 0.006), subjective daytime sleepiness (WMD -2.81; 95% CI -4.13/-1.49, p < 0.0001) and sleep stage shifts (WMD -9.69; 95% CI -17.14/-2.24, p = 0.01). GHB increased sleep stages 3 + 4 (WMD 4.11; 95% CI 0.07/8.16, p = 0.05) and improved the CGI-c score (odds ratio (OR) 3.45; 95% CI 2.47/4.80, p < 0.00001). No significant changes were observed in night sleep latency, total sleep time, rapid-eye movement (REM) sleep and sleep stages 1 and 2.
CONCLUSIONS
This meta-analysis demonstrates the effectiveness of GHB in treating major, clinically relevant narcolepsy symptoms and sleep architecture abnormalities.
Topics: Adult; Cataplexy; GABA-B Receptor Agonists; Humans; Narcolepsy; Polysomnography; Randomized Controlled Trials as Topic; Sleep; Sleep Stages; Sodium Oxybate
PubMed: 22055895
DOI: 10.1016/j.smrv.2011.09.001 -
Pharmacology 2022Clonidine is a frequently prescribed long-term antihypertensive medication in hemodialysis (HD) patients in the USA, but its safety and efficacy has not been clearly... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Clonidine is a frequently prescribed long-term antihypertensive medication in hemodialysis (HD) patients in the USA, but its safety and efficacy has not been clearly established in the HD population.
OBJECTIVE
To evaluate, we conducted a systematic review and meta-analysis on the safety and efficacy of clonidine in HD patients.
METHODS
Keyword search of "clonidine" and "dialysis" was conducted through April 2021 in PubMed, Cochrane Library, Web of Science, Scopus, and ClinicalTrials.gov databases. Inclusion criteria were as follows - study design: randomized controlled trials, cohort studies, prospective studies, retrospective studies, or case series; subjects: adult HD patients; main outcome: blood pressure (BP) and safety; language: English; and article type: peer-reviewed publications. Studies that examined the effects of clonidine in populations other than adult HD patients were excluded. Meta-analysis was performed on BP reduction outcomes.
RESULTS
Eight studies met the inclusion criteria for the systematic review, including prospective pre-post studies (2), double-blind controlled trial (1), single-blinded placebo-controlled trial (1), crossover open-label clinical trial (1), retrospective analysis (1), and case report series (2). Three studies included in the meta-analysis ranged from 2 to 12 weeks duration, with a collective sample size of 24 (ages 12-77 years). Risk of bias, assessed using the ROBINS-1 tool, was high for all included studies. Significant adverse effects reported included hypotension, light-headedness, drowsiness, dry mouth, rebound hypertension, and contact dermatitis from patch application. Short-term clonidine use was associated with significant improvement in systolic BP (pooled effect: -12.985 mm Hg, 95% CI [-7.878, -18.092], p < 0.001), while changes in diastolic BP were not statistically significant (-11.119 mm Hg, 95% CI [-22.725, 0.487], p = 0.060). No data currently support the long-term efficacy of clonidine in HD patients. This study was unfunded and was developed using PRISMA guidelines and registered on PROSPERO (CRD42018112042).
CONCLUSIONS
There is no evidence supporting the long-term use of clonidine in the HD population and a significant side-effect profile. There is low-quality evidence demonstrating the efficacy of clonidine in lowering BP in HD patients in short-term use, but significant safety concerns remain. Fluid removal strategies and other antihypertensives should be used over clonidine for long-term BP control in the HD population.
Topics: Adult; Humans; Child; Adolescent; Young Adult; Middle Aged; Aged; Clonidine; Prospective Studies; Retrospective Studies; Antihypertensive Agents; Renal Dialysis; Randomized Controlled Trials as Topic
PubMed: 36075189
DOI: 10.1159/000525424 -
Pain Medicine (Malden, Mass.) Jan 2014This study was conducted to compare safety and efficacy outcomes between opioids formulated with technologies designed to deter or resist tampering (i.e.,... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
This study was conducted to compare safety and efficacy outcomes between opioids formulated with technologies designed to deter or resist tampering (i.e., abuse-deterrent formulations [ADFs]) and non-ADFs for commonly prescribed opioids for treatment of non-cancer pain in adults.
METHODS
PubMed and Cochrane Library databases were searched for opioid publications between September 1, 2001 and August 31, 2011, and pivotal clinical trials from all years; abstracts from key pain conferences (2010-2011) were also reviewed. One hundred and ninety-one publications were initially identified, 68 of which met eligibility criteria and were systematically reviewed; a subset of 16 involved a placebo group (13 non-ADFs vs placebo, 3 ADFs vs placebo) and reported both efficacy and safety outcomes, and were included for a meta-analysis. Summary estimates of standardized difference in mean change of pain intensity (DMCPI), standardized difference in sum of pain intensity difference (DSPID), and odds ratios (ORs) of each adverse event (AE) were computed through random-effects estimates for ADFs (and non-ADFs) vs placebo. Indirect treatment comparisons were conducted to compare ADFs and non-ADFs.
RESULTS
Summary estimates for standardized DMCPI and for standardized DSPID indicated that ADFs and non-ADFs showed significantly greater efficacy than placebo in reducing pain intensity. Indirect analyses assessing the efficacy outcomes between ADFs and non-ADFs indicated that they were not significantly different (standardized DMCPI [0.39 {95% confidence interval (CI) 0.00-0.76}]; standardized DSPID [-0.22 {95% CI -0.74 to 0.30}]). ADFs and non-ADFs both were associated with higher odds of AEs than placebo. Odds ratios from indirect analyses comparing AEs for ADFs vs non-ADFs were not significant (nausea, 0.87 [0.24-3.12]; vomiting, 1.54 [0.40-5.97]; dizziness/vertigo, 0.61 [0.21-1.76]; headache, 1.42 [0.57-3.53]; somnolence/drowsiness, 0.47 [0.09-2.58]; constipation, 0.64 [0.28-1.49]; pruritus 0.41 [0.05-3.51]).
CONCLUSION
ADFs and non-ADFs had comparable efficacy and safety profiles, while both were more efficacious than placebo in reducing pain intensity.
Topics: Adult; Chemistry, Pharmaceutical; Clinical Trials as Topic; Constipation; Delayed-Action Preparations; Headache Disorders, Secondary; Humans; Narcotics; Nausea; Opioid-Related Disorders; Pain Management; Pain, Postoperative; Substance-Related Disorders; Treatment Outcome
PubMed: 24112715
DOI: 10.1111/pme.12233 -
Frontiers in Aging Neuroscience 2022A growing body of evidence indicates that napping is common among older adults. However, a systematic review on the effect of napping on the elderly is lacking. The aim...
UNLABELLED
A growing body of evidence indicates that napping is common among older adults. However, a systematic review on the effect of napping on the elderly is lacking. The aim of this systematic review was to (i) determine how studies evaluated napping behavior in older adults (frequency, duration and timing); (ii) explore how napping impacts perceptual measures, cognitive and psychomotor performance, night-time sleep and physiological parameters in the elderly (PROSPERO CRD42022299805). A total of 738 records were screened by two researchers using the PICOS criteria. Fifteen studies met our inclusion criteria with a mean age ranging from 60.8 to 78.3 years and a cumulative sample size of = 326. Daytime napping had an overall positive impact on subjective measures (i.e., sleepiness and fatigue), psychomotor performances (i.e., speed and accuracy) and learning abilities (i.e., declarative and motor learning). Additionally, studies showed (i) consistency between nap and control conditions regarding sleep duration, efficiency and latency, and proportion of sleep stages, and (ii) increase of 24 h sleep duration with nap compared to control condition. Based on the findings of the present review, there is minimal evidence to indicate that napping is detrimental for older adults' nighttime sleep. Future studies should consider involving repeated naps during a micro-cycle in order to investigate the chronic effect of napping on older adults.
SYSTEMATIC REVIEW REGISTRATION
identifier: CRD42022299805.
PubMed: 36337699
DOI: 10.3389/fnagi.2022.1000707 -
Sleep Medicine Reviews Jun 2021We sought to gain a better understanding of the relationship between epilepsy and sleep quality and daytime sleepiness by performing a literature search of PubMed for... (Meta-Analysis)
Meta-Analysis Review
We sought to gain a better understanding of the relationship between epilepsy and sleep quality and daytime sleepiness by performing a literature search of PubMed for case-control studies that compared patients with epilepsy to controls and reported the Pittsburgh sleep quality index (PSQI) and/or the Epworth sleepiness scale (ESS). Study-specific mean differences in the PSQI and ESS between cases and controls were extracted from the publications and pooled using random-effects meta-analysis. Twenty-five studies (2964 cases, 5232 controls) were included. Fifteen studies reported the PSQI and 24 the ESS. Mean age was 40 years; 50.4% were women. When comparing cases to controls, the pooled mean differences in the PSQI and ESS were 1.27 (95% confidence interval (CI): 0.76, 1.78; P < 0.001; I: 81.4%) and 0.38 (95% CI: -0.07, 0.84; P = 0.099; I: 81.0%). Subgroup analyses revealed that mean differences in the ESS were significantly lower in studies with a higher proportion of patients with focal epilepsy (P = 0.004). In this large-scale meta-analysis patients with epilepsy had a higher PSQI, close to the pathological cut-off, compared to controls, but a similar and unremarkable ESS. Further studies are needed to investigate potential effect modifiers, such as specific antiepileptic drugs or seizure frequency.
Topics: Adult; Anticonvulsants; Disorders of Excessive Somnolence; Epilepsy; Female; Humans; Sleep; Sleep Wake Disorders; Surveys and Questionnaires
PubMed: 33838598
DOI: 10.1016/j.smrv.2021.101466 -
Journal of Neurosciences in Rural... 2024Epilepsy poses a significant challenge in pediatric and adolescent populations, impacting not only seizures but also psychological and cognitive comorbidities, leading... (Review)
Review
OBJECTIVES
Epilepsy poses a significant challenge in pediatric and adolescent populations, impacting not only seizures but also psychological and cognitive comorbidities, leading to higher mortality rates than the general population. Drug-refractory epilepsy, resistant to conventional treatments, affects a range of 7-20% of pediatric patients. The search for alternative therapies has led to exploring the therapeutic potential of L. compounds, particularly cannabidiol (CBD). Examine the use of CBD for treating drug-refractory epilepsy in children and young adults, summarizing existing evidence on its efficacy.
MATERIALS AND METHODS
A systematic review, following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, assessed studies from 2018 to 2023, focusing on CBD's efficacy and safety for treatment-resistant epilepsy in pediatric and juvenile populations. The search spanned seven databases, and the studies underwent rigorous screening and data extraction.
RESULTS
Out of 6351 identified articles, eight were selected for review. The included studies reported positive outcomes, with CBD leading to a reduction in seizure frequency ranging from 50% to complete seizure freedom. Adverse effects were mostly mild and reversible, including drowsiness, diarrhea, and loss of appetite.
CONCLUSION
The CBD emerges as a promising tool for refractory epilepsy in pediatric patients, showing efficacy in reducing seizure frequency and improving overall quality of life. Despite mild and reversible adverse effects, CBD's benefits outweigh the risks. However, more research on long-term effects is needed to fully understand its implications.
PubMed: 38746511
DOI: 10.25259/JNRP_618_2023 -
Psychiatry Research Aug 2017The aims are to evaluate the efficacy and safety of aripiprazole for tic disorders (TDs) in children and adolescents. We searched PubMed, Embase, PsychINFO, Cochrane... (Meta-Analysis)
Meta-Analysis Review
The aims are to evaluate the efficacy and safety of aripiprazole for tic disorders (TDs) in children and adolescents. We searched PubMed, Embase, PsychINFO, Cochrane database as well as Chinese databases of CNKI, VIP, CBM and Wanfang from the database inception to October 2016, and 17 full-text studies (N=1305) were included in our article. The meta-analysis of 10 studies (N=817) showed that there was no significant difference in the reduction of total YGTSS score between aripiprazole and other drugs, and meta-analysis of 7 studies (n=324) which used tic symptom control ≧30% as outcome measure showed that there was no significant difference between aripiprazole and other treatments. The most common AEs of aripiprazole were the drowsiness, nausea/vomiting and increased appetite, and meta analysis which used the TESS scale as the outcome measurement showed that there was a significant difference between aripiprazole and haloperidol. In conclusion, these data provide moderate quality evidence that aripiprazole could be an effective and safe treatment option for TDs, and results from further trials are urgently needed to extend this evidence base.
Topics: Adolescent; Antipsychotic Agents; Aripiprazole; Child; Humans; Problem Behavior; Prospective Studies; Randomized Controlled Trials as Topic; Tic Disorders; Treatment Outcome
PubMed: 28441584
DOI: 10.1016/j.psychres.2017.04.013 -
Journal of the American Geriatrics... Jul 2011Experimental studies in healthy volunteers suggest that some antimuscarinic agents confer a risk of cognitive impairment, yet clinical trials of people with overactive... (Meta-Analysis)
Meta-Analysis Review
Experimental studies in healthy volunteers suggest that some antimuscarinic agents confer a risk of cognitive impairment, yet clinical trials of people with overactive bladder report only rare central nervous system (CNS) side effects. A lack of systematic measurement and reporting of CNS outcomes in clinical trials may partially explain this discrepancy. The purpose of this review and meta-analysis was to ascertain the reporting bias associated with adverse CNS events in clinical drug trials of younger and older adults with overactive bladder. Articles were identified from MEDLINE and EMBASE databases until 2010 using the search terms "clinical trial" AND (one of) "oxybutynin, tolterodine, fesoterodine, propiverine, solifenacin, darifenacin, and trospium." Eligibility criteria included original randomized trials involving adults with overactive bladder; standard doses of medication; reports of confusion, somnolence, sedation, dizziness, drowsiness, asthenia, insomnia, and vertigo; no evidence of dementia at baseline; and trials in English. Seventy-seven percent (242/314) of eligible trials identified in the search neither measured nor reported CNS outcomes. Of the remaining 23%, it was difficult to distinguish whether CNS adverse events were systematically measured or spontaneously reported. Only one of 72 trials that were retained objectively measured changes in cognitive performance (Mini-Mental State Examination). Dizziness was the most frequently reported side effect, in 3% of oxybutynin, 3.2% of propiverine, and 1.8% of tolterodine users, compared with 1.6% with placebo. Confusion was reported in fewer than 1% of cases. Age-stratified analyses of CNS outcomes from trials in adults aged 65 and older with overactive bladder were found in only eight publications. Meta-analyses were conducted with 33 randomized, double-blind, placebo-controlled trials to determine the effect of each drug and dose on different CNS outcomes. Study heterogeneity, dosing inconsistency, and reporting bias limited interpretation of the findings from the meta-analyses. More-detailed standardized measurement of age-stratified CNS outcomes in clinical trials is required to better inform patients and clinicians about CNS risks associated with antimuscarinic agents.
Topics: Aged; Brain; Clinical Trials as Topic; Humans; Muscarinic Antagonists; Research Design; Urinary Bladder, Overactive
PubMed: 21718264
DOI: 10.1111/j.1532-5415.2011.03473.x -
Chinese Journal of Traumatology =... Oct 2017To identify and appraise the published studies assessing interventions accounting for reducing fatigue and sleepiness while driving. (Review)
Review
PURPOSE
To identify and appraise the published studies assessing interventions accounting for reducing fatigue and sleepiness while driving.
METHODS
This systematic review searched the following electronic databases: Medline, Science direct, Scopus, EMBASE, PsycINFO, Transport Database, Cochrane, BIOSIS, ISI Web of Knowledge, specialist road injuries journals and the Australian Transport and Road Index database. Additional searches included websites of relevant organizations, reference lists of included studies, and issues of major injury journals published within the past 15 years. Studies were included if they investigated interventions/exposures accounting for reducing fatigue and sleepiness as the outcome, measured any potential interventions for mitigation of sleepiness and were written in English. Meta-analysis was not attempted because of the heterogeneity of the included studies.
RESULTS
Of 63 studies identified, 18 met the inclusion criteria. Based on results of our review, many interventions in the world have been used to reduce drowsiness while driving such as behavioral (talking to passengers, face washing, listening to the radio, no alcohol use, limiting the driving behavior at the time of 12 p.m. - 6 a.m. etc), educational interventions and also changes in the environment (such as rumble strips, chevrons, variable message signs, etc). Meta-analysis on the effect of all these interventions was impossible due to the high heterogeneity in methodology, effect size and interventions reported in the assessed studies.
CONCLUSION
Results of present review showed various interventions in different parts of the world have been used to decrease drowsy driving. Although these interventions can be used in countries with high incidence of road traffic accidents, precise effect of each intervention is still unknown. Further studies are required for comparison of the efficiency of each intervention and localization of each intervention according to the traffic patterns of each country.
Topics: Accidents, Traffic; Automobile Driving; Fatigue; Humans; Sleep Stages
PubMed: 28689801
DOI: 10.1016/j.cjtee.2017.03.005 -
JAMA Nov 2022Obstructive sleep apnea (OSA) is associated with adverse health outcomes. (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Obstructive sleep apnea (OSA) is associated with adverse health outcomes.
OBJECTIVE
To review the evidence on screening for OSA in asymptomatic adults or those with unrecognized OSA symptoms to inform the US Preventive Services Task Force.
DATA SOURCES
PubMed/MEDLINE, Cochrane Library, Embase, and trial registries through August 23, 2021; surveillance through September 23, 2022.
STUDY SELECTION
English-language studies of screening test accuracy, randomized clinical trials (RCTs) of screening or treatment of OSA reporting health outcomes or harms, and systematic reviews of treatment reporting changes in blood pressure and apnea-hypopnea index (AHI) scores.
DATA EXTRACTION AND SYNTHESIS
Dual review of abstracts, full-text articles, and study quality. Meta-analysis of intervention trials.
MAIN OUTCOMES AND MEASURES
Test accuracy, excessive daytime sleepiness, sleep-related and general health-related quality of life (QOL), and harms.
RESULTS
Eighty-six studies were included (N = 11 051). No study directly compared screening with no screening. Screening accuracy of the Multivariable Apnea Prediction score followed by unattended home sleep testing for detecting severe OSA syndrome (AHI ≥30 and Epworth Sleepiness Scale [ESS] score >10) measured as the area under the curve in 2 studies (n = 702) was 0.80 (95% CI, 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90). Five studies assessing the accuracy of other screening tools were heterogeneous and results were inconsistent. Compared with inactive control, positive airway pressure was associated with a significant improvement in ESS score from baseline (pooled mean difference, -2.33 [95% CI, -2.75 to -1.90]; 47 trials; n = 7024), sleep-related QOL (standardized mean difference, 0.30 [95% CI, 0.19 to 0.42]; 17 trials; n = 3083), and general health-related QOL measured by the 36-Item Short Form Health Survey (SF-36) mental health component summary score change (pooled mean difference, 2.20 [95% CI, 0.95 to 3.44]; 15 trials; n = 2345) and SF-36 physical health component summary score change (pooled mean difference, 1.53 [95% CI, 0.29 to 2.77]; 13 trials; n = 2031). Use of mandibular advancement devices was also associated with a significantly larger ESS score change compared with controls (pooled mean difference, -1.67 [95% CI, 2.09 to -1.25]; 10 trials; n = 1540). Reporting of other health outcomes was sparse; no included trial found significant benefit associated with treatment on mortality, cardiovascular events, or motor vehicle crashes. In 3 systematic reviews, positive airway pressure was significantly associated with reduced blood pressure; however, the difference was relatively small (2-3 mm Hg).
CONCLUSIONS AND RELEVANCE
The accuracy and clinical utility of OSA screening tools that could be used in primary care settings were uncertain. Positive airway pressure and mandibular advancement devices reduced ESS score. Trials of positive airway pressure found modest improvement in sleep-related and general health-related QOL but have not established whether treatment reduces mortality or improves most other health outcomes.
Topics: Adult; Humans; Advisory Committees; Continuous Positive Airway Pressure; Disorders of Excessive Somnolence; Quality of Life; Sleep Apnea, Obstructive; Randomized Controlled Trials as Topic; Mass Screening
PubMed: 36378203
DOI: 10.1001/jama.2022.18357