scholarly journals Systematic Review and Meta-analysis of Efficacy and Safety of Melatonin and Triclofos for Inducing Adequate Sedation for Sleep Electroencephalogram in Children

Author(s):  
Prateek K. Panda ◽  
Pragnya Panda ◽  
Lesa Dawman ◽  
Indar K. Sharawat

Abstract Introduction Triclofos and melatonin are commonly used oral sedatives in children for obtaining a sleep electroencephalogram (EEG) record. There has been no systematic review till now to compare the efficacy and safety of these two medications. Objectives The review intended to compare the efficacy of oral triclofos and melatonin in children <18 years of age for inducing adequate sedation for obtaining a sleep EEG record. We also attempted to compare the adverse effects, impact on EEG record, the yield of epileptiform abnormalities, and sleep onset latency in both groups. Methods A systematic search was conducted on “MEDLINE/PUBMED, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Web of Science, and Google Scholar” till November 30, 2020, with the following keywords/the Medical Subject Headings (MESH) terms while searching: “sleep EEG,” “electroencephalogram,” “triclofos,” “melatonin” OR “ramelteon” AND “epilepsy,” “seizure,” OR “convulsion.” ROB 2.0 and ROBINS-I tool was used to determine the risk of bias. To assess heterogeneity in studies, Higgins and Thompson's I 2 method was utilized. When I 2 was more than 50%, a random effects model was utilized and a fixed-effect model was used for other parameters. To assess the presence of publication bias, Egger's test was used. Results For describing the efficacy of triclofos in 1,284 and melatonin in 1,532 children, we selected 16 articles. The indirect comparison between the pooled estimate of all children receiving individual medications revealed comparable efficacy in obtaining successful sleep EEG record with a single dose (90 vs. 76%, p = 0.058) and repeat dose (p = 0.054), detection of epileptiform abnormalities (p = 0.06), and sleep onset latency (p = 0.06), but more proportion of children receiving triclofos had adverse effects (p = 0.001) and duration of sleep was also higher with triclofos (p = 0.001). Conclusion Efficacy of triclofos and melatonin are comparable in inducing sleep for recording EEG in children, although triclofos is more likely to cause adverse effects. However, the level of evidence is low for this conclusion and the weak strength of recommendation for the results of this review is likely to change in the future after completion of controlled trials exploring these two medications.

Author(s):  
Brendan J Nolan ◽  
Bonnie Liang ◽  
Ada S Cheung

Abstract Context Preclinical data has shown progesterone metabolites improve sleep parameters through positive allosteric modulation of the γ-aminobutyric acid type A receptor. We undertook a systematic review and meta-analysis of randomized controlled trials to assess micronized progesterone treatment on sleep outcomes. Evidence Acquisition Using preferred reporting items for systematic review and meta-analysis guidelines, we searched MEDLINE, Embase, PsycInfo, and the Cochrane Central Register of Controlled Trials for randomized controlled trials of micronized progesterone treatment on sleep outcomes up to March 31, 2020. This study is registered with the International Prospective Register of Systematic Reviews, number CRD42020165981. A random effects model was used for quantitative analysis. Evidence Synthesis Our search strategy retrieved 9 randomized controlled trials comprising 388 participants. One additional unpublished trial was found. Eight trials enrolled postmenopausal women. Compared with placebo, micronized progesterone improved various sleep parameters as measured by polysomnography, including total sleep time and sleep onset latency, though studies were inconsistent. Meta-analysis of 4 trials favored micronized progesterone for sleep onset latency (effect size, 7.10; confidence interval [CI] 1.30, 12.91) but not total sleep time (effect size, 20.72; CI -0.16, 41.59) or sleep efficiency (effect size, 1.31; CI -2.09, 4.70). Self-reported sleep outcomes improved in most trials. Concomitant estradiol administration and improvement in vasomotor symptoms limit conclusions in some studies. Conclusions Micronized progesterone improves various sleep outcomes in randomized controlled trials, predominantly in studies enrolling postmenopausal women. Further research could evaluate the efficacy of micronized progesterone monotherapy using polysomnography or validated questionnaires in larger cohorts.


2020 ◽  
Vol 54 (1) ◽  
Author(s):  
Daisy-Mae Alegado-Bagaoisan ◽  
Mary Christine R. Castro ◽  
Jaime M. Purificacion

Objective. The aim of this systematic review was to evaluate the efficacy and safety of Vitex negundo (lagundi) for the treatment of acute cough of mild to moderate severity among pediatric patients.Methods. A systematic review of randomized controlled trials (RCTs) comparing lagundi to placebo for acute cough of mild to moderate severity in children and adolescents aged two to twenty one years in ambulatory settings was performed. Authors of unpublished clinical trials with existing patent numbers were contacted and permission was obtained to access and include their studies in this review. Results. Seven studies were included, with a total of 308 participants. Lagundi increased the peak exploratory flow rate (PEFR) at the end of therapy compared with placebo but this was not statistically significant (p=0.36). The increase in PEFR was consistent with the results of the mechanistic isolated tissue studies that showed bronchodilating effect of lagundi. Studies using lagundi syrup showed decrease in the frequency of cough by 44–71%. Conclusion. Lagundi therapy in acute cough of mild to moderate severity among pediatric patients has a bronchodilating effect and decreases the frequency and duration of coughing, with no serious adverse effects.


2018 ◽  
Vol 103 (12) ◽  
pp. 1155-1162 ◽  
Author(s):  
Ibtihal Siddiq Abdelgadir ◽  
Morris A Gordon ◽  
Anthony K Akobeng

ImportanceChildren with neurodevelopmental disorders have a higher prevalence of sleep disturbances. Currently there is variation in the use of melatonin; hence, an up-to-date systematic review is indicated to summarise the current available evidence.ObjectiveTo determine the efficacy and safety of melatonin as therapy for sleep problems in children with neurodevelopmental disorders.Data sources and study selectionsPubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature and the Cochrane Central Register of Controlled Trials were searched from inception up to January 2018. Two reviewers performed data assessment and extraction. We assessed randomised controlled trials that compared melatonin with placebo or other intervention for the management of sleep disorders in children (<18 years) with neurodevelopmental disorders.Data extraction and synthesisWe identified 3262 citations and included 13 studies in this meta-analysis.Main outcomesMain outcomes included total sleep time, sleep onset latency, frequency of nocturnal awakenings and adverse events.ResultsThirteen randomised controlled trials (n=682) met the inclusion criteria. A meta-analysis of nine studies (n=541) showed that melatonin significantly improved total sleep time compared with placebo (mean difference (MD)=48.26 min, 95% CI 36.78 to 59.73, I2=31%). In 11 studies (n=581), sleep onset latency improved significantly with melatonin use (MD=−28.97, 95% CI −39.78 to −18.17). No difference was noted in the frequency of nocturnal awakenings (MD=−0.49, 95% CI −1.71 to 0.73). No medication-related serious adverse event was reported.ConclusionMelatonin appeared safe and effective in improving sleep in the studied children. The overall quality of the evidence is limited due to heterogeneity and inconsistency. Further research is needed.


SLEEP ◽  
2020 ◽  
Author(s):  
Hsiao-Yean Chiu ◽  
Hsin-Chien Lee ◽  
Jen-Wei Liu ◽  
Shi-Jun Hua ◽  
Pin-Yuan Chen ◽  
...  

Abstract Study Objectives To compare the efficacy and safety of various hypnotics for identifying the best treatments for insomnia in older adults. Methods We searched the EMBASE, PubMed, ClinicalTrials.gov, and ProQuest Dissertations and Theses A&I databases from the inception to September 12, 2020. Only randomized controlled trials comparing hypnotics with either another hypnotic or placebo for insomnia treatment in elderly people were included. Sleep outcomes, including total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, were derived from polysomnography, valid questionnaires, or sleep diaries. Results We identified 24 articles with 5917 older adults. Eszopiclone and low-dose doxepin were ranked the optimal therapy for prolonging objective and subjective total sleep time (26.69 and 28.19 min), respectively, compared to placebo. Zaleplon was the most effective therapy in reducing objective and subjective sleep onset latency (–21.63 and –15.86 min) compared with control. Temazepam was the best treatment for objective and subjective wake after sleep onset (–25.29 and –22.25 min) compared with control. Low-dose doxepin appeared to be the effective treatment for increasing objective sleep efficiency (6.08%) Triazolam showed the higher risk of overall adverse events (odds ratio, 1.96, 95% confidence interval 1.03–3.74) when compared to zaleplon. Conclusions Considering study quality and the potential adverse effects of benzodiazepines and nonbenzodiazepines, low-dose doxepin seems to be the optimal pharmacotherapy for the improvements in total sleep time and sleep efficiency. Future RCTs investigating the treatment effects of hypnotics, particularly low-dose doxepin, on insomnia in older adults are warranted. PROSPERO Registration number: CRD42016046301.


2018 ◽  
Author(s):  
Rex Park ◽  
Anthony M-H Ho ◽  
Gisèle Pickering ◽  
Lars Arendt-Nielsen ◽  
Mohammed Mohiuddin ◽  
...  

BACKGROUND Chronic pain is a highly prevalent and complex health problem that is associated with a severe symptom burden, as well as substantial economic and social impact. Many patients with chronic pain still suffer from unrelieved or undertreated pain due to the incomplete efficacy and dose-limiting adverse effects of current therapies. Long-term and high-dose opioid use has considerably increased in the past 20 years despite limited evidence supporting its effectiveness in several chronic pain conditions, and serious concerns have emerged regarding adverse effects and potential misuse. Until recently, the steady increase in opioid prescribing rates has been associated with rising opioid-related mortality and other serious problems, emphasizing the need for better nonopioid therapies. Emerging evidence supports the safe use of magnesium in controlling chronic pain, but its overall efficacy and safety is still unclear. OBJECTIVE This paper aims to assess the efficacy and safety of magnesium compared with a placebo for the treatment of chronic noncancer pain. METHODS We will conduct a detailed search on Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from their inception until the date the searches are run to identify relevant randomized controlled trials. The reference lists of retrieved studies as well as Web-based trial registries will also be searched. We will include randomized double-blind trials comparing magnesium (at any dose, frequency, or route of administration) with placebo using participant-reported pain assessment. Two reviewers will independently evaluate studies for eligibility, extract data, and assess trial quality and potential bias. Risk of bias will be assessed using criteria outlined in the Cochrane Handbook for Systematic Review of Interventions. Primary outcomes for this review will include any validated measure of pain intensity or pain relief. Dichotomous data will be used to calculate the risk ratio and number needed to treat or harm. The quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS This protocol is grant-funded and has undergone a peer-review process through the Queen’s University Department of Anesthesiology and Perioperative Medicine Vandewater Endowed Studentship. This project is also supported, in part, by the Chronic Pain Network of the Canadian Institutes of Health Research Strategy for Patient-Oriented Research. The electronic database search strategies are currently being developed and modified. The entire review is expected to be completed by January 1, 2019. CONCLUSIONS The completion of this review is expected to identify available high-quality evidence describing the efficacy and safety of magnesium for the treatment of chronic noncancer pain. INTERNATIONAL REGISTERED REPOR PRR1-10.2196/11654


ORL ro ◽  
2016 ◽  
Vol 4 (1) ◽  
pp. 56-59
Author(s):  
Raluca Ioana Teleanu ◽  
Magdalena Sandu ◽  
Eugenia Roza

Melatonin  is a hormone produced by the pineal gland during the night, as a response to the light-darkness variation. The endogenous melatonin levels have a cyclic evolution throughout the entire life. Various roles have been cited such as the in utero developement of the fetus through its action on the placenta, neurons and glial cells, a major role in the regulation of the cyrcadian rhythm, antioxidative, antiinflammatory roles, as well as celullar and umoral immunity modulation. In the European Union, exogenous melatonin has been evaluated by the European Food Safety Authority (EFSA) for reducing sleep onset latency and the conclusion was that it has efficacy studies in this regard.  


2020 ◽  
Vol 4 (2) ◽  
pp. 167-176
Author(s):  
Achim Elfering ◽  
Christin Gerhardt ◽  
Diana Pereira ◽  
Anna Schenker ◽  
Maria U. Kottwitz

Abstract Purpose Accidents are more likely to occur during the morning hours of Mondays (Monday effect). This might be due to a higher level of cognitive failure on Monday morning at work. Methods In a pilot actigraphy study across one working week, we explored this Monday effect and regressed daily self-reported workplace cognitive failure on weekdays (Monday versus other days), background social stressors at work, delayed sleep onset and sleep duration. Diary data were gathered from 40 full-time employees. Results Confirming our assumptions, results revealed work-related cognitive failure and sleep-onset latency on the previous night to be higher on Mondays compared to other workdays. Work-related cognitive failure correlated positively with delayed sleep-onset latency and background social stressors. In multilevel regression analysis, Monday significantly explained variations in workplace cognitive failure. The addition of background social stressors at work and sleep-onset latency to the regression model showed unique contributions to the prediction of workplace cognitive failure. No significant two-way or three-way interactions between working days, sleep-onset latency or sleep duration, and background social stressors were found. Conclusion Peak levels of cognitive failure on Monday morning and the association of cognitive failure with social stressors at work contribute to understanding the mechanisms involved in the increased prevalence of occupational accidents on Monday morning. Occupational safety interventions should address both social stressors at work and individual sleep hygiene.


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