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Medicine Oct 2021Patients with long-term insomnia generally experience anxiety and depression. Traditional sleeping pills and anti-anxiety drugs have certain limitations. Xiao Yao San... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Patients with long-term insomnia generally experience anxiety and depression. Traditional sleeping pills and anti-anxiety drugs have certain limitations. Xiao Yao San (XYS), a complementary and alternative therapy, has been widely used to treat insomnia combined with anxiety. This study aims to evaluate the efficacy and safety of XYS in the treatment of insomnia combined with anxiety.
METHODS
Related literature was retrieved from 8 electronic databases from the establishment time to March 2021. The subjects were diagnosed with insomnia combined with anxiety. We assessed the methodological quality of randomized controlled trials (RCTs) according to the Cochrane Handbook. Data analysis was conducted using RevMan 5.3 software.
RESULTS
The analysis includes 9 RCTs involving 681 patients. Meta-analysis supported that as an auxiliary drug for Western medicine (WM), XYS could enhance the clinical efficacy of insomnia calculated according to the traditional Chinese medicine (TCM) syndrome score scale (risk ratio [RR]: 1.26; 95% confidence interval [CI]: 1.13-1.43; P = .0002) and reduced the scores of Hamilton Anxiety Scale (mean difference [MD]: -5.19; 95% CI: -7.78 to -2.60; P < .001), Pittsburgh Sleep Quality Index (MD: -3.35; 95% CI: -4.86 to -1.84; P < .001), Self-rating Anxiety Scale (MD: -9.38; 95% CI: -10.20 to -8.75; P < .001), TCM syndrome score scale for insomnia (MD: -4.45; 95% CI: -6.65 to -2.24; P < .001), and TCM syndrome score scale for anxiety (MD: -5.54; 95% CI: -9.48 to -1.6; P = .006). The summary analysis also shows that the separate use of XYS was advantageous in reducing the scores of the Hamilton Anxiety Scale (MD: -3.70; 95% CI: -6.31 to -1.09; P = .005), Pittsburgh Sleep Quality Index (MD: -1.82; 95% CI: -2.39 to -1.24; P < .001), and Self-rating Anxiety Scale (MD: -10.79; 95% CI: -14.09 to -7.49; P < .001). The incidence of adverse events with XYS as an ancillary drug or used separately was lower than that in the WM.
CONCLUSION
Our systematic evaluation and meta-analysis showed that XYS combined with WM or XYS alone was beneficial for improving sleep quality and relieving anxiety. Due to the low methodological quality, small sample size, and significant heterogeneity of RCTs, more rigorous and scientific clinical trials are required to further evaluate the efficacy and safety of XYS.
PROSPERO REGISTRATION NUMBER
CRD42020190613.
Topics: Adolescent; Adult; Aged; Anxiety; Drugs, Chinese Herbal; Female; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders; Young Adult
PubMed: 34713840
DOI: 10.1097/MD.0000000000027608 -
The Cochrane Database of Systematic... Apr 2016This review is one of a suite of six Cochrane reviews looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This review is one of a suite of six Cochrane reviews looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is a common condition involving inflammation of the lining of the nose and paranasal sinuses. It is characterised by nasal blockage and nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Oral corticosteroids are used to control the inflammatory response and improve symptoms.
OBJECTIVES
To assess the effects of a short course of oral corticosteroids as an adjunct ('add-on') therapy in people with chronic rhinosinusitis who are already on standard treatments.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing a short course (up to 21 days) of oral corticosteroids to placebo or no treatment, where all patients were also receiving pharmacological treatment for chronic rhinosinusitis.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity, and the adverse event of mood or behavioural disturbances. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score, and the adverse events of insomnia, gastrointestinal disturbances and osteoporosis. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
Two trials with a total of 78 participants met the inclusion criteria. Both the populations and the 'standard' treatments differed in the two studies. Oral steroids as an adjunct to intranasal corticosteroids One trial in adults with nasal polyps included 30 participants. All participants used intranasal corticosteroids and were randomised to either short-course oral steroids (oral methylprednisolone, 1 mg/kg and reduced progressively over a 21-day treatment course) or no additional treatment. None of the primary outcome measures of interest in this review were reported by the study. There may have been an important reduction in the size of the polyps (measured by the nasal polyps score, a secondary outcome measure) in patients receiving oral steroids and intranasal corticosteroids, compared to intranasal corticosteroids alone (mean difference (MD) -0.46, 95% confidence interval (CI) -0.87 to -0.05; 30 participants; scale 1 to 4) at the end of treatment (21 days). This corresponds to a large effect size, but we are very uncertain about this estimate as we judged the study to be at high risk of bias. Moreover, longer-term data were not available and the other outcomes of interest were not reported. Oral steroids as an adjunct to antibiotics One trial in children (mean age of eight years) without nasal polyps included 48 participants. The trial compared oral corticosteroids (oral methylprednisolone, 1 mg/kg and reduced progressively over a 15-day treatment course) with placebo in participants who also received a 30-day course of antibiotics. This study addressed one of the primary outcome measures (disease severity) and one secondary outcome (CT score). For disease severity the four key symptoms used to define chronic rhinosinusitis in children (nasal blockage, nasal discharge, facial pressure, cough) were combined into one score. There was a greater improvement in symptom severity 30 days after the start of treatment in patients who received oral steroids and antibiotics compared with placebo and antibiotics (MD -7.10, 95% CI -9.59 to -4.61; 45 participants; scale 0 to 40). The observed mean difference corresponds to a large effect size. At the same time point there was a difference in CT scan score (MD -2.90, 95% CI -4.91 to -0.89; 45 participants; scale 0 to 24). We assessed the quality of the evidence to be low.There were no data available for the longer term (three months).
AUTHORS' CONCLUSIONS
There might be an improvement in symptom severity, polyps size and condition of the sinuses when assessed using CT scans in patients taking oral corticosteroids when these are used as an adjunct therapy to antibiotics or intranasal corticosteroids, but the quality of the evidence supporting this is low or very low (we are uncertain about the effect estimate; the true effect may be substantially different from the estimate of the effect). It is unclear whether the benefits of oral corticosteroids as an adjunct therapy are sustained beyond the short follow-up period reported (up to 30 days), as no longer-term data were available.There were no data in this review about the adverse effects associated with short courses of oral corticosteroids as an adjunct therapy.More research in this area, particularly research evaluating longer-term outcomes and adverse effects, is required.
Topics: Administration, Intranasal; Administration, Oral; Adrenal Cortex Hormones; Adult; Chemotherapy, Adjuvant; Child; Chronic Disease; Humans; Methylprednisolone; Nasal Polyps; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Steroids; Time Factors
PubMed: 27115214
DOI: 10.1002/14651858.CD011992.pub2 -
Drug and Alcohol Dependence Jul 2020Hypnotics (HYP) and benzodiazepines (BZD) are medicines prescribed for the insomnia treatment. Many patients present difficulties in discontinuing the treatment once...
BACKGROUND
Hypnotics (HYP) and benzodiazepines (BZD) are medicines prescribed for the insomnia treatment. Many patients present difficulties in discontinuing the treatment once established. Melatonin (MLT) has been prescribed as a treatment for BZD/HYP detoxification.
AIMS
The primary objective of this systematic review is to assess the efficacy of MLT and MLT agonists (melatoninergics) in improving the rate of BZD and/or HYP discontinuation among adults with primary insomnia attempting to discontinue BZD and/or HYP. The secondary objective is to evaluate the partial efficacy of melatoninergic drugs in the discontinuation of BZD and/or HYP consumption in subjects that could not stop their consumption.
METHOD
A search on Web of Science and Scopus was carried out from database inception to July 1st, 2019.
RESULTS
Three hundred and forty-nine articles were identified but only four were included in the final review. Two were cohort prospective, one placebo-control double blind and one double blind placebo-control cross-over designed study. Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm. In cohort studies TW figures ranged from 30.8% to 65%. Partial withdrawal ranged between 20% and 30.8% of patients that did not achieve TW with reduction figures of diazepam equivalent dose ranging from 25% to 75%.
CONCLUSION
MLT has a place in the physician armamentarium to treat the suspension/reduction of BZD/HYP consumption in patients with primary insomnia.
Topics: Adult; Benzodiazepines; Clinical Trials as Topic; Cross-Over Studies; Double-Blind Method; Female; Humans; Hypnotics and Sedatives; Male; Melatonin; Middle Aged; Observational Studies as Topic; Prospective Studies; Sleep Initiation and Maintenance Disorders; Substance Withdrawal Syndrome
PubMed: 32409111
DOI: 10.1016/j.drugalcdep.2020.107994 -
JNCI Cancer Spectrum Apr 2024Patients with head and neck cancer present particularly considerable levels of emotional distress. However, the actual rates of clinically relevant mental health... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Patients with head and neck cancer present particularly considerable levels of emotional distress. However, the actual rates of clinically relevant mental health symptoms and disorders among this population remain unknown.
METHODS
A Preferred Reporting Items for Systematic Review and Meta-Analyses and Meta-analyses of Observational Studies in Epidemiology-compliant systematic review and quantitative random-effects meta-analysis was performed to determine suicide incidence and the prevalence of depression, anxiety, distress, posttraumatic stress, and insomnia in this population. MEDLINE, Web of Science, Cochrane Central Register, KCI Korean Journal database, SciELO, Russian Science Citation Index, and Ovid-PsycINFO databases were searched from database inception to August 1, 2023 (PROSPERO: CRD42023441432). Subgroup analyses and meta-regressions were performed to investigate the effect of clinical, therapeutical, and methodological factors.
RESULTS
A total of 208 studies (n = 654 413; median age = 60.7 years; 25.5% women) were identified. Among the patients, 19.5% reported depressive symptoms (95% confidence interval [CI] = 17% to 21%), 17.8% anxiety symptoms (95% CI = 14% to 21%), 34.3% distress (95% CI = 29% to 39%), 17.7% posttraumatic symptoms (95% CI = 6% to 41%), and 43.8% insomnia symptoms (95% CI = 35% to 52%). Diagnostic criteria assessments revealed lower prevalence of disorders: 10.3% depression (95% CI = 7% to 13%), 5.6% anxiety (95% CI = 2% to 10%), 9.6% insomnia (95% CI = 1% to 40%), and 1% posttraumatic stress (95% CI = 0% to 84.5%). Suicide pooled incidence was 161.16 per 100 000 individuals per year (95% CI = 82 to 239). Meta-regressions found a statistically significant higher prevalence of anxiety in patients undergoing primary chemoradiation compared with surgery and increased distress in smokers and advanced tumor staging. European samples exhibited lower prevalence of distress.
CONCLUSIONS
Patients with head and neck cancer presented notable prevalence of mental health concerns in all domains. Suicide remains a highly relevant concern. The prevalence of criteria-meeting disorders is significantly lower than clinically relevant symptoms. Investigating the effectiveness of targeted assessments for disorders in highly symptomatic patients is essential.
Topics: Humans; Head and Neck Neoplasms; Depression; Anxiety; Stress Disorders, Post-Traumatic; Mental Health; Sleep Initiation and Maintenance Disorders; Suicide; Female; Male; Prevalence; Middle Aged; Psychological Distress; Incidence; Aged
PubMed: 38702757
DOI: 10.1093/jncics/pkae031 -
Journal of Sleep Research Apr 2024The study objective was to estimate the efficacy and safety of chlormethiazole in older adults experiencing insomnia (sleep disorder). We therefore systematically... (Meta-Analysis)
Meta-Analysis Review
The study objective was to estimate the efficacy and safety of chlormethiazole in older adults experiencing insomnia (sleep disorder). We therefore systematically searched Medline, Scopus, the Cochrane Library, PsycINFO, Ovid, ZB MED and PMC through December 2021 for randomized-controlled trials including patients > 60 years old with insomnia treated with chlormethiazole. Standardized mean differences or odds ratios with 95% confidence intervals were calculated for the main outcome parameters: sleep duration, onset of sleep, quality of sleep, adverse events or drop-out rates compared with placebo and other drugs. Risk of bias was assessed using the Cochrane tool. Eight randomized-controlled trials with 424 patients were included. Chlormethiazole significantly increased the duration of sleep when compared with placebo (standardized mean difference = 0.61; 95% confidence interval = 0.11-1.11; p = 0.02). More patients receiving chlormethiazole had adequate quality of sleep than those receiving other drugs (odds ratio = 1.44; 95% confidence interval = 1.04-1.98; p = 0.03). No differences were found regarding the onset of sleep (standardized mean difference = 1.07; 95% confidence interval = 0.79-1.46; p = 0.65). Drop-out rates were significantly lower under chlormethiazole treatment when compared with other drugs (odds ratio = 0.51; 95% confidence interval = 0.26-0.99; p = 0.05) and did not differ from placebo treatment (odds ratio = 1.37; 95% confidence interval = 0.23-8.21; p = 0.73). Side-effects such as "hangover" and daytime drowsiness occurred less frequently during chlormethiazole treatment compared with other drugs in three out of four studies, but differences were not significant (odds ratio = 0.24; 95% confidence interval = 0.04-1.48; p = 0.12). In conclusion, chlormethiazole showed significant effects on the duration and the quality of sleep with better tolerability if compared with other drugs in older adults with insomnia.
Topics: Humans; Aged; Middle Aged; Chlormethiazole; Hypnotics and Sedatives; Sleep Initiation and Maintenance Disorders; Randomized Controlled Trials as Topic
PubMed: 37658716
DOI: 10.1111/jsr.14018 -
Journal of Advanced Nursing Jan 2020To examine the relationship between sleep-wake disturbances and frailty among older adults.
AIM
To examine the relationship between sleep-wake disturbances and frailty among older adults.
DESIGN
A systematic review.
DATA SOURCES
Peer-reviewed and English-written studies were sourced in CINAHL Complete, PsycINFO, Ovid-Medline, and by hand searching from inception to December 2018.
REVIEW METHODS
This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The Cochrane Collaboration Risk of Bias Tool was used to appraise the methodological quality. A quantitative meta-analysis was not conducted due to the heterogeneous effect estimates statistics and measurements of sleep-wake disturbances. Instead, a narrative synthesis was carried out conforming to the Centre for Reviews and Dissemination's guidance.
RESULTS
Six cross-sectional studies and one longitudinal study were included in this review. There was consistent evidence on the association between perceived sleep quality and frailty among older adults; whereas the results for insomnia symptoms, excessive daytime sleepiness, and sleep-wake pattern were inconclusive.
CONCLUSION
Despite a comprehensive search, this review has identified limited research in this field of study. Nevertheless, this review has identified consistent evidence on the relationship between perceived sleep quality and frailty. Future rigorous research with more validated use of measurement tools are needed to explore whether insomnia symptoms, excessive daytime sleepiness, and sleep-wake pattern are related to frailty.
IMPACT
Due to the indefinite role of sleep-wake disturbances in the pathophysiology of frailty, nearly all nurse-led care programmes for frail older adults did not include any sleep-related screening and interventions. Nevertheless, the consistent evidence on the association between poor sleep quality and higher risk of frailty shows the need of incorporating assessments and interventions for improving sleep quality in nurse-led care programmes for frail older adults. Moreover, such evidence also generates casual hypothesis for future prospective longitudinal studies that explore the causality of this relationship.
Topics: Aged; Cross-Sectional Studies; Female; Frail Elderly; Humans; Longitudinal Studies; Male; Middle Aged; Risk Assessment; Sleep Wake Disorders
PubMed: 31588595
DOI: 10.1111/jan.14231 -
Current Pharmaceutical Design 2015New antipsychotics continuously arrive on the market, which thereby influences the approved and off-label prescribing (OLP) schemes. We aimed to identify the recent... (Review)
Review
INTRODUCTION
New antipsychotics continuously arrive on the market, which thereby influences the approved and off-label prescribing (OLP) schemes. We aimed to identify the recent trends in the OLP of antipsychotics. We conducted a literature review based on three different populations: adult, pediatric, and elderly patients.
METHODS
A literature search was performed in the PubMed and ScienceDirect databases using the following keyword algorithm: "offlabel" AND ("antipsychotic*" OR "neuroleptic*"). The period investigated ranged from January 2000 to January 2015. Only Englishwritten pharmacoepidemiological studies were included.
RESULTS
Seventy-seven relevant results were identified. Among adults, OLP consisted of 40 to 75% of all antipsychotic prescriptions. The main indications were mood disorders, anxiety disorders, insomnia and agitation. Quetiapine was the most frequently prescribed offlabel antipsychotic, especially for anxiety and insomnia. Among children, OLP was estimated between 36 and 93.2% of all antipsychotic prescriptions. Risperidone and aripiprazole were primarily used and were most often prescribed for attention deficit hyperactivity disorder, anxiety, or mood disorders. Among elderly individuals, OLP consisted of 22 to 86% of all antipsychotic prescriptions. Antipsychotic OLP was particularly frequent for agitation; however, a recent decrease in this OLP was identified.
DISCUSSION
Antipsychotics have largely been prescribed off-label in recent years. The types of antipsychotic OLP practices differ according to the age category of patients. OLP is often used in cases of therapeutic dead-ends or for specific disorders with few or no currently approved medications. However, other OLP practices only reflect temporary prescription trends for mild symptoms, which may induce safety concerns.
Topics: Adolescent; Adult; Age Factors; Aged; Antipsychotic Agents; Child; Drug Prescriptions; Humans; Inappropriate Prescribing; Mental Disorders; Middle Aged; Off-Label Use; Patient Safety; Practice Patterns, Physicians'; Risk Assessment; Risk Factors; Treatment Outcome; Young Adult
PubMed: 26088115
DOI: 10.2174/1381612821666150619092903 -
Journal of Intellectual Disability... Jan 2017Behavioural interventions are frequently used to address sleep problems in people with intellectual disabilities (ID). The current study aimed to systematically review... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Behavioural interventions are frequently used to address sleep problems in people with intellectual disabilities (ID). The current study aimed to systematically review evidence on the efficacy of behavioural interventions for children and adults with ID and sleep problems.
METHOD
Electronic and hand searches identified seven studies for inclusion (N = 169). Standardised mean difference effect sizes (d) were calculated for group studies (N = 4). Non-overlap effect sizes (Tau-U) were calculated for single case experimental design studies (SCEDs; N = 3).
RESULTS
A large effect size (weighted d = 0.923, confidence interval: 0.705 to 1.151) across group studies indicated large improvements in sleep problems following behavioural intervention. Effect size across SCEDs (weighted Tau-U: 0.528, confidence interval: 0.351 to 0.705) indicated a 53% improvement compared with baseline. Sleep initiation and sleep maintenance problems showed significant improvements post-intervention. Follow-up effects were less consistent across study designs and suggested that some sleep problems maintain gains better than others.
CONCLUSION
Meta-analytic evidence from group and SCEDs can provide complementary information about efficacy. Findings propose that behavioural interventions are a promising evidence-based practice for improving sleep problems in people with ID.
Topics: Adolescent; Adult; Aged; Behavior Therapy; Child; Child, Preschool; Female; Humans; Intellectual Disability; Male; Middle Aged; Sleep Wake Disorders; Young Adult
PubMed: 26952339
DOI: 10.1111/jir.12265 -
Rheumatology (Oxford, England) Apr 2017To identify whether sleep disturbances are more prevalent in primary SS (pSS) patients compared with the general population and to recognize which specific sleep... (Review)
Review
OBJECTIVES
To identify whether sleep disturbances are more prevalent in primary SS (pSS) patients compared with the general population and to recognize which specific sleep symptoms are particularly problematic in this population.
METHODS
Electronic searches of the literature were conducted in PubMed, Medline (Ovid), Embase (Ovid), PsychINFO (Ovid) and Web of Science and the search strategy registered a priori . Titles and abstracts were reviewed by two authors independently against a set of prespecified inclusion/exclusion criteria, reference lists were examined and a narrative synthesis of the included articles was conducted.
RESULTS
Eight whole-text papers containing nine separate studies met the inclusion criteria and were included in the narrative analysis. Few of these studies met all of the quality assessment criteria. The studies used a range of self-reported measures and objective measures, including polysomnography. Mixed evidence was obtained for some of the individual sleep outcomes, but overall compared with controls, pSS patients reported greater subjective sleep disturbances and daytime somnolence and demonstrated more night awakenings and pre-existing obstructive sleep apnoea.
CONCLUSIONS
A range of sleep disturbances are commonly reported in pSS patients. Further polysomnography studies are recommended to confirm the increased prevalence of night awakenings and obstructive sleep apnoea in this patient group. pSS patients with excessive daytime somnolence should be screened for co-morbid sleep disorders and treated appropriately. Interventions targeted at sleep difficulties in pSS, such as cognitive behavioural therapy for insomnia and nocturnal humidification devices, have the potential to improve quality of life in this patient group and warrant further investigation.
Topics: Cognitive Behavioral Therapy; Epidemiologic Studies; Female; Humans; Male; Middle Aged; Polysomnography; Quality of Life; Sjogren's Syndrome; Sleep Wake Disorders
PubMed: 28013207
DOI: 10.1093/rheumatology/kew443 -
BMJ Open Jul 2022This review assesses interventions and their effectiveness in mitigating psychological consequences from pandemic.
OBJECTIVE
This review assesses interventions and their effectiveness in mitigating psychological consequences from pandemic.
METHOD
Published English literatures were searched from four databases (Medline, PubMed, Embase and PsycINFO) from January 2020 and September 2021. A total of 27 papers with 29 studies (one paper reported three studies) met inclusion criteria. Cochrane risk-of-bias tool is applied to assess the quality of all randomised controlled trials (RCT).
RESULTS
All studies were recently conducted in 2020. Publications were from high-income (13, 44.8%), upper middle-income (12, 41.4%) and lower middle-income countries (3, 10.3%) and global (1, 3.5%). Half of the studies conducted for general population (51.7%). One-third of studies (8, 27.6%) provided interventions to patients with COVID-19 and 20.7% to healthcare workers. Of the 29 studies, 14 (48.3%) were RCT. All RCTs were assessed for risk of biases; five studies (15, 35.7%) had low risk as measured against all six dimensions reflecting high-quality study.Of these 29 studies, 26 diagnostic or screening measures were applied; 8 (30.9%) for anxiety, 7 (26.9%) for depression, 5 (19.2%) for stress, 5 (19.2%) for insomnia and 1 (3.8%) for suicide. Measures used to assess the baseline and outcomes of interventions were standardised and widely applied by other studies with high level of reliability and validity. Of 11 RCT studies, 10 (90.9%) showed that anxiety interventions significantly lowered anxiety in intervention groups. Five of the six RCT studies (83.3%) had significantly reduced the level of depression. Most interventions for anxiety and stress were mindfulness and meditation based.
CONCLUSIONS
Results from RCT studies (11%, 78.6%) were effective in mitigating psychological consequences from COVID-19 pandemic when applied to healthcare workers, patients with COVID-19 and general population. These effective interventions can be applied and scaled up in other country settings through adaptation of modes of delivery suitable to country resources, pandemic and health system context.
Topics: Anxiety; Anxiety Disorders; COVID-19; Health Personnel; Humans; Pandemics
PubMed: 35882462
DOI: 10.1136/bmjopen-2022-060804