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Nutrients Mar 2022Background: Vitamin D deficiency is associated with sleep disorders and poor sleep quality. Whether vitamin D supplementation (VDS) helps resolve these problems remains... (Meta-Analysis)
Meta-Analysis Review
Background: Vitamin D deficiency is associated with sleep disorders and poor sleep quality. Whether vitamin D supplementation (VDS) helps resolve these problems remains unclear. Objective: To systematically review the effect of VDS on sleep quantity, quality, and disorders, and perform a meta-analysis of available data. Methods: The reporting of this review followed the PRISMA statement. VDS human interventions studies that reported on sleep quality, quantity, or disorders were included. Medline, CINAHL, EMBASE, PsycInfo, the Cochrane Library, Clinicaltrials.gov, and the ICTRP were searched, in addition to the references of the included articles and previous relevant reviews, without language or time restrictions. Included studies were critically appraised, findings were narratively synthesized, and a meta-analysis was conducted. Furthermore, the overall certainty of the evidence was assessed. Results: A total of 19 studies were included (13 randomized controlled trials (RCTs), 1 opportunistic addition to an RCT, 4 pre−post studies, and 1 pre−post study analyzed as a case series); 3 RCTs were meta-analyses. The risk of bias was generally low. Pre−post studies showed a significant improvement in sleep quality with VDS. Similarly, the results of the meta-analysis revealed a statistically significant decrease in the Pittsburgh Sleep Quality Index with VDS compared with placebo (mean difference, −2.33 (95% CI, −3.09, −1.57); p < 0.001; I2 = 0%), with a moderate certainty of evidence. The results regarding the effect of VDS on sleep-related impairment, difficulty, and disorders, as well as sleepiness and restless legs syndrome, were not unanimous. Conclusions: VDS is promising in improving sleep quality; however, its effect on sleep quantity and disorders needs to be further investigated.
Topics: Dietary Supplements; Humans; Randomized Controlled Trials as Topic; Sleep; Sleep Wake Disorders; Vitamin D; Vitamin D Deficiency
PubMed: 35268051
DOI: 10.3390/nu14051076 -
Diseases (Basel, Switzerland) Dec 2021Obstructive sleep apnea (OSA) is a serious, potentially life-threatening condition. Epidemiologic studies show that sleep apnea increases cardiovascular diseases risk... (Review)
Review
Obstructive sleep apnea (OSA) is a serious, potentially life-threatening condition. Epidemiologic studies show that sleep apnea increases cardiovascular diseases risk factors including hypertension, obesity, and diabetes mellitus. OSA is also responsible for serious illnesses such as congestive heart failure, stroke, arrhythmias, and bronchial asthma. The aim of this systematic review is to evaluate evidence for the association between OSA and cardiovascular disease morbidities and identify risk factors for the conditions. In a review of 34 studies conducted in 28 countries with a sample of 37,599 people, several comorbidities were identified in patients with severe OSA-these were: heart disease, stroke, kidney disease, asthma, COPD, acute heart failure, chronic heart failure, hyperlipidemia, thyroid disease, cerebral infarct or embolism, myocardial infarction, and psychological comorbidities including stress and depression. Important risk factors contributing to OSA included: age > 35 years; BMI ≥ 25 kg/m; alcoholism; higher Epworth sleepiness scale (ESS); mean apnea duration; oxygen desaturation index (ODI); and nocturnal oxygen desaturation (NOD). Severe OSA (AHI ≥ 30) was significantly associated with excessive daytime sleepiness and oxygen desaturation index. The risk of OSA and associated disease morbidities can be reduced by controlling overweight/obesity, alcoholism, smoking, hypertension, diabetes mellitus, and hyperlipidemia.
PubMed: 34940026
DOI: 10.3390/diseases9040088 -
International Journal of Geriatric... Oct 2022Lewy body dementia (LBD) refers to both dementia with Lewy bodies (DLB) and Parkinson's disease with dementia (PDD). Sleep disturbances are common in LBD, and can... (Review)
Review
BACKGROUND
Lewy body dementia (LBD) refers to both dementia with Lewy bodies (DLB) and Parkinson's disease with dementia (PDD). Sleep disturbances are common in LBD, and can include poor sleep quality, excessive daytime sleepiness (EDS), and rapid eye movement behaviour disorder (RBD). Despite the high clinical prevalence of sleep disturbances in LBD, they are under-studied relative to other dementias. The aim of the present systematic review was to examine the nature of sleep disturbances in LBD, summarise the effect of treatment studies upon sleep, and highlight specific and necessary directions for future research.
METHODS
Published studies in English were located by searching PubMED and PSYCArticles databases (until 10 June 2022). The search protocol was pre-registered in PROSPERO (CRD42021293490) and performed in accordance with PRISMA guidelines.
RESULTS
Following full-text review, a final total of 70 articles were included. These included 20 studies focussing on subjective sleep, 14 on RBD, 8 on EDS, 7 on objective sleep, and 1 on circadian rhythms. The majority of the 18 treatment studies used pharmacological interventions (n = 12), had an open-label design (n = 8), and were of low-to-moderate quality. Most studies (n = 55) included only patients with DLB. Due to the heterogeneity of the studies, we reported a narrative synthesis without meta-analysis.
CONCLUSIONS
At least one form of sleep disturbance may be present in as many as 90% of people with LBD. Subjectively poor sleep quality, excessive daytime sleepiness, and RBD are more common and severe in LBD relative to other dementias.
Topics: Alzheimer Disease; Disorders of Excessive Somnolence; Humans; Lewy Body Disease; Sleep; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
PubMed: 36168299
DOI: 10.1002/gps.5814 -
PloS One 2020This systematic review and meta-analysis examines the associations of allergic rhinitis with sleep duration and sleep impairment. Observational studies published before... (Meta-Analysis)
Meta-Analysis
This systematic review and meta-analysis examines the associations of allergic rhinitis with sleep duration and sleep impairment. Observational studies published before August 2019 were obtained through English language literature searches in the PubMed, Embase, and CINAHL databases. Mean differences and odds ratios with 95% confidence intervals were extracted and used for meta-analysis. Heterogeneity was confirmed by the I2-heterogeneity test. Subgroup analysis was conducted to evaluate the influence of study design. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to determine the level of evidence. In total, 2544 records were identified through database searches; 914 duplicate records were excluded, 1452 records were removed after screening of titles and abstracts, 151 records were excluded after full-text screening, and 27 articles were included in the final meta-analyses. A total of 240,706,026 patients (19,444,043 with allergic rhinitis) were considered. No significant difference in sleep duration between the allergic rhinitis and the control groups was found. Patients with allergic rhinitis presented with significantly higher sleep quality scores, sleep disturbances scores, and sleep latency scores; more frequent use of sleep medications; and lower sleep efficiency as measured by the Pittsburgh Sleep Quality Index and polysomnography. Meta-analyses for adjusted odds ratios showed that allergic rhinitis was also associated with higher risks of nocturnal dysfunctions, including insomnia, nocturnal enuresis, restless sleep, sleep-disordered breathing, obstructive sleep apnea, and snoring. Meta-analysis for adjusted odds ratio also showed that allergic rhinitis was associated with daytime dysfunction, including difficulty waking up, daytime sleepiness, morning headache, and the use of sleep medications. The overall quality of evidence ranged from low to very low, indicating that caution is required when interpreting these results. This study demonstrates that there is a significant association of AR with sleep characteristics.
Topics: Adolescent; Adult; Aged; Child; Child, Preschool; Humans; Middle Aged; Observational Studies as Topic; Polysomnography; Quality of Life; Rhinitis, Allergic; Sleep; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Snoring; Young Adult
PubMed: 32053609
DOI: 10.1371/journal.pone.0228533 -
Journal of Pineal Research Mar 2022Melatonin is commonly used for sleep and jetlag at low doses. However, there is less documentation on the safety of higher doses, which are being increasingly used for a... (Meta-Analysis)
Meta-Analysis Review
Melatonin is commonly used for sleep and jetlag at low doses. However, there is less documentation on the safety of higher doses, which are being increasingly used for a wide variety of conditions, including more recently COVID-19 prevention and treatment. The aim of this review was to investigate the safety of higher doses of melatonin in adults. Medline, Scopus, Embase and PsycINFO databases from inception until December 2019 with convenience searches until October 2020. Randomised controlled trials investigating high-dose melatonin (≥10 mg) in human adults over 30 years of age were included. Two investigators independently abstracted articles using PRISMA guidelines. Risk of bias was assessed by a committee of three investigators. 79 studies were identified with a total of 3861 participants. Studies included a large range of medical conditions. The meta-analysis was pooled data using a random effects model. The outcomes examined were the number of adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs. A total of 29 studies (37%) made no mention of the presence or absence of AEs. Overall, only four studies met the pre-specified low risk of bias criteria for meta-analysis. In that small subset, melatonin did not cause a detectable increase in SAEs (Rate Ratio = 0.88 [0.52, 1.50], p = .64) or withdrawals due to AEs (0.93 [0.24, 3.56], p = .92), but did appear to increase the risk of AEs such as drowsiness, headache and dizziness (1.40 [1.15, 1.69], p < .001). Overall, there has been limited AE reporting from high-dose melatonin studies. Based on this limited evidence, melatonin appears to have a good safety profile. Better safety reporting in future long-term trials is needed to confirm this as our confidence limits were very wide due to the paucity of suitable data.
Topics: Adult; COVID-19; Humans; Melatonin; SARS-CoV-2; Sleep
PubMed: 34923676
DOI: 10.1111/jpi.12782 -
Journal of Clinical Sleep Medicine :... Feb 2021The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of behavioral and psychological treatments for... (Meta-Analysis)
Meta-Analysis
Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.
INTRODUCTION
The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of behavioral and psychological treatments for chronic insomnia disorder in adult populations.
METHODS
The American Academy of Sleep Medicine commissioned a task force of 9 experts in sleep medicine and sleep psychology. A systematic review was conducted to identify randomized controlled trials that addressed behavioral and psychological interventions for the treatment of chronic insomnia disorder in adults. Statistical analyses were performed to determine if the treatments produced clinically significant improvements in a range of critical and important outcomes. Finally, the Grading of Recommendations Assessment, Development, and Evaluation process was used to evaluate the evidence for making specific treatment recommendations.
RESULTS
The literature search identified 1,244 studies; 124 studies met the inclusion criteria, and 89 studies provided data suitable for statistical analyses. Evidence for the following interventions is presented in this review: cognitive-behavioral therapy for insomnia, brief therapies for insomnia, stimulus control, sleep restriction therapy, relaxation training, sleep hygiene, biofeedback, paradoxical intention, intensive sleep retraining, and mindfulness. This review provides a detailed summary of the evidence along with the quality of evidence, the balance of benefits vs harms, patient values and preferences, and resource use considerations.
Topics: Academies and Institutes; Adult; Cognitive Behavioral Therapy; GRADE Approach; Humans; Sleep; Sleep Initiation and Maintenance Disorders; United States
PubMed: 33164741
DOI: 10.5664/jcsm.8988 -
The Cochrane Database of Systematic... Nov 2020Obstructive sleep apnoea (OSA) is a syndrome characterised by episodes of apnoea (complete cessation of breathing) or hypopnoea (insufficient breathing) during sleep.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Obstructive sleep apnoea (OSA) is a syndrome characterised by episodes of apnoea (complete cessation of breathing) or hypopnoea (insufficient breathing) during sleep. Classical symptoms of the disease - such as snoring, unsatisfactory rest and daytime sleepiness - are experienced mainly by men; women report more unspecific symptoms such as low energy or fatigue, tiredness, initial insomnia and morning headaches. OSA is associated with an increased risk of occupational injuries, metabolic diseases, cardiovascular diseases, mortality, and being involved in traffic accidents. Continuous positive airway pressure (CPAP) - delivered by a machine which uses a hose and mask or nosepiece to deliver constant and steady air pressure- is considered the first treatment option for most people with OSA. However, adherence to treatment is often suboptimal. Myofunctional therapy could be an alternative for many patients. Myofunctional therapy consists of combinations of oropharyngeal exercises - i.e. mouth and throat exercises. These combinations typically include both isotonic and isometric exercises involving several muscles and areas of the mouth, pharynx and upper respiratory tract, to work on functions such as speaking, breathing, blowing, sucking, chewing and swallowing.
OBJECTIVES
To evaluate the benefits and harms of myofunctional therapy (oropharyngeal exercises) for the treatment of obstructive sleep apnoea.
SEARCH METHODS
We identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register (date of last search 1 May 2020). We found other trials at web-based clinical trials registers.
SELECTION CRITERIA
We included RCTs that recruited adults and children with a diagnosis of OSA.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We assessed our confidence in the evidence by using GRADE recommendations. Primary outcomes were daytime sleepiness, morbidity and mortality.
MAIN RESULTS
We found nine studies eligible for inclusion in this review and nine ongoing studies. The nine included RCTs analysed a total of 347 participants, 69 of them women and 13 children. The adults' mean ages ranged from 46 to 51, daytime sleepiness scores from eight to 14, and severity of the condition from mild to severe OSA. The studies' duration ranged from two to four months. None of the studies assessed accidents, cardiovascular diseases or mortality outcomes. We sought data about adverse events, but none of the included studies reported these. In adults, compared to sham therapy, myofunctional therapy: probably reduces daytime sleepiness (Epworth Sleepiness Scale (ESS), MD (mean difference) -4.52 points, 95% Confidence Interval (CI) -6.67 to -2.36; two studies, 82 participants; moderate-certainty evidence); may increase sleep quality (MD -3.90 points, 95% CI -6.31 to -1.49; one study, 31 participants; low-certainty evidence); may result in a large reduction in Apnoea-Hypopnoea Index (AHI, MD -13.20 points, 95% CI -18.48 to -7.93; two studies, 82 participants; low-certainty evidence); may have little to no effect in reduction of snoring frequency but the evidence is very uncertain (Standardised Mean Difference (SMD) -0.53 points, 95% CI -1.03 to -0.03; two studies, 67 participants; very low-certainty evidence); and probably reduces subjective snoring intensity slightly (MD -1.9 points, 95% CI -3.69 to -0.11 one study, 51 participants; moderate-certainty evidence). Compared to waiting list, myofunctional therapy may: reduce daytime sleepiness (ESS, change from baseline MD -3.00 points, 95% CI -5.47 to -0.53; one study, 25 participants; low-certainty evidence); result in little to no difference in sleep quality (MD -0.70 points, 95% CI -2.01 to 0.61; one study, 25 participants; low-certainty evidence); and reduce AHI (MD -6.20 points, 95% CI -11.94 to -0.46; one study, 25 participants; low-certainty evidence). Compared to CPAP, myofunctional therapy may result in little to no difference in daytime sleepiness (MD 0.30 points, 95% CI -1.65 to 2.25; one study, 54 participants; low-certainty evidence); and may increase AHI (MD 9.60 points, 95% CI 2.46 to 16.74; one study, 54 participants; low-certainty evidence). Compared to CPAP plus myofunctional therapy, myofunctional therapy alone may result in little to no difference in daytime sleepiness (MD 0.20 points, 95% CI -2.56 to 2.96; one study, 49 participants; low-certainty evidence) and may increase AHI (MD 10.50 points, 95% CI 3.43 to 17.57; one study, 49 participants; low-certainty evidence). Compared to respiratory exercises plus nasal dilator strip, myofunctional therapy may result in little to no difference in daytime sleepiness (MD 0.20 points, 95% CI -2.46 to 2.86; one study, 58 participants; low-certainty evidence); probably increases sleep quality slightly (-1.94 points, 95% CI -3.17 to -0.72; two studies, 97 participants; moderate-certainty evidence); and may result in little to no difference in AHI (MD -3.80 points, 95% CI -9.05 to 1.45; one study, 58 participants; low-certainty evidence). Compared to standard medical treatment, myofunctional therapy may reduce daytime sleepiness (MD -6.40 points, 95% CI -9.82 to -2.98; one study, 26 participants; low-certainty evidence) and may increase sleep quality (MD -3.10 points, 95% CI -5.12 to -1.08; one study, 26 participants; low-certainty evidence). In children, compared to nasal washing alone, myofunctional therapy and nasal washing may result in little to no difference in AHI (MD 3.00, 95% CI -0.26 to 6.26; one study, 13 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS
Compared to sham therapy, myofunctional therapy probably reduces daytime sleepiness and may increase sleep quality in the short term. The certainty of the evidence for all comparisons ranges from moderate to very low, mainly due to lack of blinding of the assessors of subjective outcomes, incomplete outcome data and imprecision. More studies are needed. In future studies, outcome assessors should be blinded. New trials should recruit more participants, including more women and children, and have longer treatment and follow-up periods.
Topics: Apnea; Child; Continuous Positive Airway Pressure; Disorders of Excessive Somnolence; Exercise; Female; Humans; Isotonic Contraction; Male; Middle Aged; Myofunctional Therapy; Oropharynx; Randomized Controlled Trials as Topic; Sleep Apnea, Obstructive; Snoring; Therapeutic Irrigation; Waiting Lists
PubMed: 33141943
DOI: 10.1002/14651858.CD013449.pub2 -
Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data.The Cochrane Database of Systematic... Apr 2022This is an updated version of the original Cochrane Review published in 2017. Epilepsy is a common neurological condition with a worldwide prevalence of around 1%.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an updated version of the original Cochrane Review published in 2017. Epilepsy is a common neurological condition with a worldwide prevalence of around 1%. Approximately 60% to 70% of people with epilepsy will achieve a longer-term remission from seizures, and most achieve that remission shortly after starting antiepileptic drug treatment. Most people with epilepsy are treated with a single antiepileptic drug (monotherapy) and current guidelines from the National Institute for Health and Care Excellence (NICE) in the United Kingdom for adults and children recommend carbamazepine or lamotrigine as first-line treatment for focal onset seizures and sodium valproate for generalised onset seizures; however, a range of other antiepileptic drug (AED) treatments are available, and evidence is needed regarding their comparative effectiveness in order to inform treatment choices.
OBJECTIVES
To compare the time to treatment failure, remission and first seizure of 12 AEDs (carbamazepine, phenytoin, sodium valproate, phenobarbitone, oxcarbazepine, lamotrigine, gabapentin, topiramate, eventrate, zonisamide, eslicarbazepine acetate, lacosamide) currently used as monotherapy in children and adults with focal onset seizures (simple focal, complex focal or secondary generalised) or generalised tonic-clonic seizures with or without other generalised seizure types (absence, myoclonus).
SEARCH METHODS
For the latest update, we searched the following databases on 12 April 2021: the Cochrane Register of Studies (CRS Web), which includes PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Epilepsy Group Specialised Register and MEDLINE (Ovid, 1946 to April 09, 2021). We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators and experts in the field.
SELECTION CRITERIA
We included randomised controlled trials of a monotherapy design in adults or children with focal onset seizures or generalised onset tonic-clonic seizures (with or without other generalised seizure types).
DATA COLLECTION AND ANALYSIS
This was an individual participant data (IPD) and network meta-analysis (NMA) review. Our primary outcome was 'time to treatment failure', and our secondary outcomes were 'time to achieve 12-month remission', 'time to achieve six-month remission', and 'time to first seizure post-randomisation'. We performed frequentist NMA to combine direct evidence with indirect evidence across the treatment network of 12 drugs. We investigated inconsistency between direct 'pairwise' estimates and NMA results via node splitting. Results are presented as hazard ratios (HRs) with 95% confidence intervals (CIs) and we assessed the certainty of the evidence using the CiNeMA approach, based on the GRADE framework. We have also provided a narrative summary of the most commonly reported adverse events.
MAIN RESULTS
IPD were provided for at least one outcome of this review for 14,789 out of a total of 22,049 eligible participants (67% of total data) from 39 out of the 89 eligible trials (43% of total trials). We could not include IPD from the remaining 50 trials in analysis for a variety of reasons, such as being unable to contact an author or sponsor to request data, data being lost or no longer available, cost and resources required to prepare data being prohibitive, or local authority or country-specific restrictions. No IPD were available from a single trial of eslicarbazepine acetate, so this AED could not be included in the NMA. Network meta-analysis showed high-certainty evidence that for our primary outcome, 'time to treatment failure', for individuals with focal seizures; lamotrigine performs better than most other treatments in terms of treatment failure for any reason and due to adverse events, including the other first-line treatment carbamazepine; HRs (95% CIs) for treatment failure for any reason for lamotrigine versus: eventrate 1.01 (0.88 to 1.20), zonisamide 1.18 (0.96 to 1.44), lacosamide 1.19 (0.90 to 1.58), carbamazepine 1.26 (1.10 to 1.44), oxcarbazepine 1.30 (1.02 to 1.66), sodium valproate 1.35 (1.09 to 1.69), phenytoin 1.44 (1.11 to 1.85), topiramate 1.50 (1.23 to 1.81), gabapentin 1.53 (1.26 to 1.85), phenobarbitone 1.97 (1.45 to 2.67). No significant difference between lamotrigine and eventrate was shown for any treatment failure outcome, and both AEDs seemed to perform better than all other AEDs. For people with generalised onset seizures, evidence was more limited and of moderate certainty; no other treatment performed better than first-line treatment sodium valproate, but there were no differences between sodium valproate, lamotrigine or eventrate in terms of treatment failure; HRs (95% CIs) for treatment failure for any reason for sodium valproate versus: lamotrigine 1.06 (0.81 to 1.37), eventrate 1.13 (0.89 to 1.42), gabapentin 1.13 (0.61 to 2.11), phenytoin 1.17 (0.80 to 1.73), oxcarbazepine 1.24 (0.72 to 2.14), topiramate 1.37 (1.06 to 1.77), carbamazepine 1.52 (1.18 to 1.96), phenobarbitone 2.13 (1.20 to 3.79), lacosamide 2.64 (1.14 to 6.09). Network meta-analysis also showed high-certainty evidence that for secondary remission outcomes, few notable differences were shown for either seizure type; for individuals with focal seizures, carbamazepine performed better than gabapentin (12-month remission) and sodium valproate (six-month remission). No differences between lamotrigine and any AED were shown for individuals with focal seizures, or between sodium valproate and other AEDs for individuals with generalised onset seizures. Network meta-analysis also showed high- to moderate-certainty evidence that, for 'time to first seizure,' in general, the earliest licensed treatments (phenytoin and phenobarbitone) performed better than the other treatments for individuals with focal seizures; phenobarbitone performed better than both first-line treatments carbamazepine and lamotrigine. There were no notable differences between the newer drugs (oxcarbazepine, topiramate, gabapentin, eventrate, zonisamide and lacosamide) for either seizure type. Generally, direct evidence (where available) and network meta-analysis estimates were numerically similar and consistent with confidence intervals of effect sizes overlapping. There was no important indication of inconsistency between direct and network meta-analysis results. The most commonly reported adverse events across all drugs were drowsiness/fatigue, headache or migraine, gastrointestinal disturbances, dizziness/faintness and rash or skin disorders; however, reporting of adverse events was highly variable across AEDs and across studies.
AUTHORS' CONCLUSIONS
High-certainty evidence demonstrates that for people with focal onset seizures, current first-line treatment options carbamazepine and lamotrigine, as well as newer drug eventrate, show the best profile in terms of treatment failure and seizure control as first-line treatments. For people with generalised tonic-clonic seizures (with or without other seizure types), current first-line treatment sodium valproate has the best profile compared to all other treatments, but lamotrigine and eventrate would be the most suitable alternative first-line treatments, particularly for those for whom sodium valproate may not be an appropriate treatment option. Further evidence from randomised controlled trials recruiting individuals with generalised tonic-clonic seizures (with or without other seizure types) is needed.
Topics: Adult; Anticonvulsants; Child; Epilepsies, Partial; Epilepsy; Humans; Network Meta-Analysis; Phenytoin
PubMed: 35363878
DOI: 10.1002/14651858.CD011412.pub4 -
The Cochrane Database of Systematic... Jan 2022Although combination formulas containing antihistamines, decongestants, and/or analgesics are sold over-the-counter in large quantities for the common cold, the evidence... (Review)
Review
BACKGROUND
Although combination formulas containing antihistamines, decongestants, and/or analgesics are sold over-the-counter in large quantities for the common cold, the evidence for their effectiveness is limited. This is an update of a review first published in 2012.
OBJECTIVES
To assess the effectiveness of antihistamine-decongestant-analgesic combinations compared with placebo or other active controls (excluding antibiotics) in reducing the duration of symptoms and alleviating symptoms (general feeling of illness, nasal congestion, rhinorrhoea, sneezing, and cough) in children and adults with the common cold.
SEARCH METHODS
We searched CENTRAL, MEDLINE via EBSCOhost, Embase, CINAHL via EBSCOhost, LILACS, and Web of Science to 10 June 2021. We searched the WHO ICTRP and ClinicalTrials.gov on 10 June 2021.
SELECTION CRITERIA
Randomised controlled trials investigating the effectiveness of antihistamine-decongestant-analgesic combinations compared with placebo, other active treatment (excluding antibiotics), or no treatment in children and adults with the common cold.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach. We categorised the included trials according to the active ingredients.
MAIN RESULTS
We identified 30 studies (6304 participants) including 31 treatment comparisons. The control intervention was placebo in 26 trials and an active substance (paracetamol, chlorphenindione + phenylpropanolamine + belladonna, diphenhydramine) in six trials (two trials had placebo as well as active treatment arms). Reporting of methods was generally poor, and there were large differences in study design, participants, interventions, and outcomes. Most of the included trials involved adult participants. Children were included in nine trials. Three trials included very young children (from six months to five years), and five trials included children aged 2 to 16. One trial included adults and children aged 12 years or older. The trials took place in different settings: university clinics, paediatric departments, family medicine departments, and general practice surgeries. Antihistamine-decongestant: 14 trials (1298 participants). Eight trials reported on global effectiveness, of which six studies were pooled (281 participants on active treatment and 284 participants on placebo). The odds ratio (OR) of treatment failure was 0.31 (95% confidence interval (CI) 0.20 to 0.48; moderate certainty evidence); number needed to treat for an additional beneficial outcome (NNTB) 3.9 (95% CI 3.03 to 5.2). On the final evaluation day (follow-up: 3 to 10 days), 55% of participants in the placebo group had a favourable response compared to 70% on active treatment. Of the two trials not pooled, one showed some global effect, whilst the other showed no effect. Adverse effects: the antihistamine-decongestant group experienced more adverse effects than the control group: 128/419 (31%) versus 100/423 (13%) participants suffered one or more adverse effects (OR 1.58, 95%CI 0.78 to 3.21; moderate certainty of evidence). Antihistamine-analgesic: four trials (1608 participants). Two trials reported on global effectiveness; data from one trial were presented (290 participants on active treatment and 292 participants on ascorbic acid). The OR of treatment failure was 0.33 (95% CI 0.23 to 0.46; moderate certainty evidence); NNTB 6.67 (95% CI 4.76 to 12.5). Forty-three per cent of participants in the control group and 70% in the active treatment group were cured after six days of treatment. The second trial also showed an effect in favour of the active treatment. Adverse effects: there were not significantly more adverse effects in the active treatment group compared to placebo (drowsiness, hypersomnia, sleepiness 10/152 versus 4/120; OR 1.64 (95 % CI 0.48 to 5.59; low certainty evidence). Analgesic-decongestant: seven trials (2575 participants). One trial reported on global effectiveness: 73% of participants in the analgesic-decongestant group reported a benefit compared with 52% in the control group (paracetamol) (OR of treatment failure 0.28, 95% CI 0.15 to 0.52; moderate certainty evidence; NNTB 4.7). Adverse effects: the decongestant-analgesic group experienced significantly more adverse effects than the control group (199/1122 versus 75/675; OR 1.62 95% CI 1.18 to 2.23; high certainty evidence; number needed to treat for an additional harmful outcome (NNTH 17). Antihistamine-analgesic-decongestant: six trials (1014 participants). Five trials reported on global effectiveness, of which two studies in adults could be pooled: global effect reported with active treatment (52%) and placebo (34%) was equivalent to a difference of less than one point on a four- or five-point scale; the OR of treatment failure was 0.47 (95% CI 0.33 to 0.67; low certainty evidence); NNTB 5.6 (95% CI 3.8 to 10.2). One trial in children aged 2 to 12 years, and two trials in adults found no beneficial effect. Adverse effects: in one trial 5/224 (2%) suffered adverse effects with the active treatment versus 9/208 (4%) with placebo. Two other trials reported no differences between treatment groups.
AUTHORS' CONCLUSIONS
We found a lack of data on the effectiveness of antihistamine-analgesic-decongestant combinations for the common cold. Based on these scarce data, the effect on individual symptoms is probably too small to be clinically relevant. The current evidence suggests that antihistamine-analgesic-decongestant combinations have some general benefit in adults and older children. These benefits must be weighed against the risk of adverse effects. There is no evidence of effectiveness in young children. In 2005, the US Food and Drug Administration issued a warning about adverse effects associated with the use of over-the-counter nasal preparations containing phenylpropanolamine.
Topics: Adolescent; Adult; Analgesics; Child; Child, Preschool; Common Cold; Cough; Histamine Antagonists; Humans; Nasal Decongestants; United States
PubMed: 35060618
DOI: 10.1002/14651858.CD004976.pub4 -
Brain Stimulation 2022Transcranial ultrasound stimulation (TUS) is gaining traction as a safe and non-invasive technique in human studies. There has been a rapid increase in TUS human studies... (Review)
Review
BACKGROUND
Transcranial ultrasound stimulation (TUS) is gaining traction as a safe and non-invasive technique in human studies. There has been a rapid increase in TUS human studies in recent years, with more than half of studies to date published after 2020. This rapid growth in the relevant body of literature necessitates comprehensive reviews to update clinicians and researchers.
OBJECTIVE
The aim of this work is to review human studies with an emphasis on TUS devices, sonication parameters, outcome measures, results, and adverse effects, as well as highlight future directions of investigation.
METHODS
A systematic review was conducted by searching the Web of Science and PubMed databases on January 12, 2022. Human studies of TUS were included.
RESULTS
A total of 35 studies were identified using focused/unfocused ultrasound devices. A total of 677 subjects belonging to diverse cohorts (i.e., healthy, chronic pain, dementia, epilepsy, traumatic brain injury, depression) were enrolled. The stimulation effects vary in a sonication parameter-dependant fashion. Clinical, neurophysiological, radiological and histological outcome measures were assessed. No severe adverse effects were reported in any of the studies surveyed. Mild symptoms were observed in 3.4% (14/425) of the subjects, including headache, mood deterioration, scalp heating, cognitive problems, neck pain, muscle twitches, anxiety, sleepiness and pruritis.
CONCLUSIONS
Although increasingly being used, TUS is still in its early phases. TUS can change short-term brain excitability and connectivity, induce long-term plasticity, and modulate behavior. New techniques should be used to further elucidate its underlying mechanisms and identify its application in novel populations.
Topics: Affect; Brain; Chronic Pain; Epilepsy; Humans; Ultrasonography
PubMed: 35533835
DOI: 10.1016/j.brs.2022.05.002