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The Cochrane Database of Systematic... May 2020Chronic obstructive pulmonary disease (COPD) is associated with cough, sputum production or dyspnoea, and a reduction in lung function, quality of life, and life... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic obstructive pulmonary disease (COPD) is associated with cough, sputum production or dyspnoea, and a reduction in lung function, quality of life, and life expectancy. Apart from smoking cessation, no other treatments that slow lung function decline are available. Roflumilast and cilomilast are oral phosphodiesterase-4 (PDE₄) inhibitors proposed to reduce the airway inflammation and bronchoconstriction seen in COPD. This Cochrane Review was first published in 2011, and was updated in 2017 and 2020.
OBJECTIVES
To evaluate the efficacy and safety of oral PDE₄ inhibitors for management of stable COPD.
SEARCH METHODS
We identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register (date of last search 9 March 2020). We found other trials at web-based clinical trials registers.
SELECTION CRITERIA
We included RCTs if they compared oral PDE₄ inhibitors with placebo in people with COPD. We allowed co-administration of standard COPD therapy.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Two independent review authors selected trials for inclusion, extracted data, and assessed risk of bias. We resolved discrepancies by involving a third review author. We assessed our confidence in the evidence by using GRADE recommendations. Primary outcomes were change in lung function (minimally important difference (MID) = 100 mL) and quality of life (scale 0 to 100; higher score indicates more limitations).
MAIN RESULTS
We found 42 RCTs that met the inclusion criteria and were included in the analyses for roflumilast (28 trials with 18,046 participants) or cilomilast (14 trials with 6457 participants) or tetomilast (1 trial with 84 participants), with a duration between six weeks and one year or longer. These trials included people across international study centres with moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades II to IV), with mean age of 64 years. We judged risks of selection bias, performance bias, and attrition bias as low overall amongst the 39 published and unpublished trials. Lung function Treatment with a PDE₄ inhibitor was associated with a small, clinically insignificant improvement in forced expiratory volume in one second (FEV₁) over a mean of 40 weeks compared with placebo (mean difference (MD) 49.33 mL, 95% confidence interval (CI) 44.17 to 54.49; participants = 20,815; studies = 29; moderate-certainty evidence). Forced vital capacity (FVC) and peak expiratory flow (PEF) were also improved over 40 weeks (FVC: MD 86.98 mL, 95% CI 74.65 to 99.31; participants = 22,108; studies = 17; high-certainty evidence; PEF: MD 6.54 L/min, 95% CI 3.95 to 9.13; participants = 4245; studies = 6; low-certainty evidence). Quality of life Trials reported improvements in quality of life over a mean of 33 weeks (St George's Respiratory Questionnaire (SGRQ) MD -1.06 units, 95% CI -1.68 to -0.43; participants = 7645 ; moderate-certainty evidence). Incidence of exacerbations Treatment with a PDE₄ inhibitor was associated with a reduced likelihood of COPD exacerbation over a mean of 40 weeks (odds ratio (OR) 0.78, 95% CI 0.73 to 0.84; participants = 20,382; studies = 27; high-certainty evidence), that is, for every 100 people treated with PDE₄ inhibitors, five more remained exacerbation-free during the study period compared with those given placebo (number needed to treat for an additional beneficial outcome (NNTB) 20, 95% CI 16 to 27). No change in COPD-related symptoms nor in exercise tolerance was found. Adverse events More participants in the treatment groups experienced an adverse effect compared with control participants over a mean of 39 weeks (OR 1.30, 95% CI 1.22 to 1.38; participants = 21,310; studies = 30; low-certainty evidence). Participants experienced a range of gastrointestinal symptoms such as diarrhoea, nausea, vomiting, or dyspepsia. Diarrhoea was more commonly reported with PDE₄ inhibitor treatment (OR 3.20, 95% CI 2.74 to 3.50; participants = 20,623; studies = 29; high-certainty evidence), that is, for every 100 people treated with PDE₄ inhibitors, seven more suffered from diarrhoea during the study period compared with those given placebo (number needed to treat for an additional harmful outcome (NNTH) 15, 95% CI 13 to 17). The likelihood of psychiatric adverse events was higher with roflumilast 500 µg than with placebo (OR 2.13, 95% CI 1.79 to 2.54; participants = 11,168; studies = 15 (COPD pool data); moderate-certainty evidence). Roflumilast in particular was associated with weight loss during the trial period and with an increase in insomnia and depressive mood symptoms. Participants treated with PDE₄ inhibitors were more likely to withdraw from trial participation; on average, 14% in the treatment groups withdrew compared with 8% in the control groups. Mortality No effect on mortality was found (OR 0.98, 95% CI 0.77 to 1.24; participants = 19,786; studies = 27; moderate-certainty evidence), although mortality was a rare event during these trials.
AUTHORS' CONCLUSIONS
For this current update, five new studies from the 2020 search contributed to existing findings but made little impact on outcomes described in earlier versions of this review. PDE₄ inhibitors offered a small benefit over placebo in improving lung function and reducing the likelihood of exacerbations in people with COPD; however, they had little impact on quality of life or on symptoms. Gastrointestinal adverse effects and weight loss were common, and the likelihood of psychiatric symptoms was higher, with roflumilast 500 µg. The findings of this review provide cautious support for the use of PDE₄ inhibitors in COPD. In accordance with GOLD 2020 guidelines, they may have a place as add-on therapy for a subgroup of people with persistent symptoms or exacerbations despite optimal COPD management (e.g. people whose condition is not controlled by fixed-dose long-acting beta₂-agonist (LABA) and inhaled corticosteroid (ICS) combinations). More longer-term trials are needed to determine whether or not PDE₄ inhibitors modify FEV₁ decline, hospitalisation, or mortality in COPD.
Topics: Administration, Oral; Aminopyridines; Benzamides; Cyclohexanecarboxylic Acids; Cyclopropanes; Diarrhea; Disease Progression; Forced Expiratory Volume; Humans; Middle Aged; Nitriles; Peak Expiratory Flow Rate; Phosphodiesterase 4 Inhibitors; Pulmonary Disease, Chronic Obstructive; Quality of Life; Randomized Controlled Trials as Topic; Thiazoles; Vital Capacity
PubMed: 32356609
DOI: 10.1002/14651858.CD002309.pub6 -
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 -
Social Psychiatry and Psychiatric... Feb 2020Neuroleptic (antipsychotic) drugs reduce psychotic symptoms, but how they achieve these effects and how the drugs' effects are experienced by people who take them are...
PURPOSE
Neuroleptic (antipsychotic) drugs reduce psychotic symptoms, but how they achieve these effects and how the drugs' effects are experienced by people who take them are less well understood. The present study describes a synthesis of qualitative data about mental and behavioural alterations associated with taking neuroleptics and how these interact with symptoms of psychosis and people's sense of self and agency.
METHODS
Nine databases were searched to identify qualitative literature concerning experiences of taking neuroleptic medication. A thematic synthesis was conducted.
RESULTS
Neuroleptics were commonly experienced as producing a distinctive state of lethargy, cognitive slowing, emotional blunting and reduced motivation, which impaired functioning but also had beneficial effects on symptoms of psychosis and some other symptoms (e.g. insomnia). For some people, symptom reduction helped restore a sense of normality and autonomy, but others experienced a loss of important aspects of their personality. Across studies, many people adopted a passive stance towards long-term medication, expressing a sense of resignation, endurance or loss of autonomy.
CONCLUSIONS
Neuroleptic drugs modify cognition, emotions and motivation. These effects may be associated with reducing the intensity and impact of symptoms, but also affect people's sense of self and agency. Understanding how the effects of neuroleptics are experienced by those who take them is important in developing a more collaborative approach to drug treatment in psychosis and schizophrenia.
Topics: Adult; Antipsychotic Agents; Emotions; Female; Humans; Lethargy; Male; Middle Aged; Motivation; Personal Autonomy; Psychotic Disorders; Qualitative Research; Self Concept; Treatment Outcome; Young Adult
PubMed: 31875238
DOI: 10.1007/s00127-019-01819-2 -
Sleep Health Feb 2020The Women's Health Initiative (WHI), a longitudinal study of more than 161,000 postmenopausal women across the United States, provides an opportunity to investigate the...
Contributions of the Women's Health Initiative to understanding associations between sleep duration, insomnia symptoms, and sleep-disordered breathing across a range of health outcomes in postmenopausal women.
The Women's Health Initiative (WHI), a longitudinal study of more than 161,000 postmenopausal women across the United States, provides an opportunity to investigate the link between sleep health and healthy aging. The purpose of this paper was to systematically review all published WHI articles examining sleep as a predictor of health outcomes and health behaviors/quality of life outcomes. A strength of the WHI is that for most participants, sleep measures were completed before a major health diagnosis, with a significant portion of participants also providing sleep measures after diagnosis. Twenty-three WHI articles were identified and examined for this review. The combination of sleep duration and insomnia symptoms was the most commonly investigated sleep measure. The results indicated that both short (≤6 hours) and long (≥9 hours) sleep duration were associated with a higher risk of cardiovascular disease, colorectal cancer, mortality, cognitive decline, and poor diet. Insomnia symptoms, frequent snoring, and risk of sleep-disordered breathing (SDB) were also associated with increased risk for ischemic stroke and cardiovascular disease. However, many significant results were attenuated after multivariable adjustment. Limitations of these WHI examinations include the use of different categories for sleep measures across studies and a lack of examination by race/ethnicity. Owing to the longitudinal study design, large sample size, and long-term follow-up for health outcomes, the WHI serves as a rich resource for examining associations between sleep characteristics, demographics, and health in postmenopausal women.
Topics: Aged; Clinical Trials as Topic; Female; Humans; Longitudinal Studies; Middle Aged; Postmenopause; Sleep; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Time Factors; Women's Health
PubMed: 31699635
DOI: 10.1016/j.sleh.2019.09.005 -
Revista Espanola de Geriatria Y... 2020The ageing process alters the stages of sleep, and the elderly that have this problem tend to be prescribed pharmacological treatment. This has long term side effects...
The ageing process alters the stages of sleep, and the elderly that have this problem tend to be prescribed pharmacological treatment. This has long term side effects and results in increased health costs. On the other hand, frequent or regular physical exercise could be an overall superior alternative, due to its multifactorial effects. It is also less expensive, thus more affordable and accessible. Furthermore, these benefits could be extrapolated to the quality of sleep. Taking this into account the purpose of this paper is to establish the proper amount of physical exercise using the FITT (frequency, intensity, time, type of exercise) principle, and its effect on the quality of sleep, insomnia, and daytime sleepiness in the elderly. This could lead us to a paradigm shift in the treatment of sleep disorders, and also may constitute an alternative method for treating the elderly.
Topics: Aged; Aged, 80 and over; Aging; Disorders of Excessive Somnolence; Exercise; Female; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Sleep; Sleep Initiation and Maintenance Disorders; Time Factors
PubMed: 31610889
DOI: 10.1016/j.regg.2019.07.003 -
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 -
Sleep Medicine Oct 2019In this study, we performed a systematic review and meta-analysis of double-blind, randomized, placebo-controlled trials to evaluate the efficacy and safety of... (Meta-Analysis)
Meta-Analysis
STUDY OBJECTIVE
In this study, we performed a systematic review and meta-analysis of double-blind, randomized, placebo-controlled trials to evaluate the efficacy and safety of eszopiclone for the treatment of primary insomnia.
METHODS
We searched MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials and PubMed from inception to June 2018. Additionally, we searched the ClinicalTrials.gov trials register for other relevant trials. According to participants, intervention, comparison, outcome (PICO) criteria, studies were included that focused on: adults diagnosed with primary insomnia, aged 18-65 and > 65 years; eszopiclone for the treatment of primary insomnia; comparison were made between eszopiclone and placebo; as well as primary outcomes, secondary outcomes, and adverse effects.
RESULTS
A total of six randomized trials involving 2809 patients with primary insomnia were included in our analysis. Our analysis suggested that eszopiclone was associated with significant improvements in subjective sleep latency, wake after sleep onset, number of awakenings, total sleep time at one week, two weeks, one month, three months and six months. Meanwhile, eszopiclone was associated with increased quality of sleep, ability to function, daytime alertness and sense of physical well-being at one week, one month, three months and six months. Dizziness and unpleasant taste were the most common adverse effects in elderly subgroup. Alternately, non-elderly patients may be more prone to adverse effects such as infection, pharyngitis, somnolence, unpleasant taste and dry mouth.
CONCLUSION
This meta-analysis showed that eszopiclone is an effective and safe therapy option for patients with primary insomnia, especially in elderly patients. However, due to the high clinical heterogeneity in some outcomes, further standardized preparation, large-scale and rigorously designed trials are needed.
Topics: Adult; Aged; Aged, 80 and over; Case-Control Studies; Double-Blind Method; Eszopiclone; Female; Humans; Hypnotics and Sedatives; Male; Middle Aged; Placebos; Randomized Controlled Trials as Topic; Safety; Sleep; Sleep Initiation and Maintenance Disorders; Sleep Latency; Treatment Outcome
PubMed: 31518944
DOI: 10.1016/j.sleep.2019.03.016 -
International Journal of Colorectal... Sep 2019Anal cancer is a mainly treated with chemoradiotherapy. A small number of patients undergo salvage surgery. There are few published studies investigating quality of life...
PURPOSE
Anal cancer is a mainly treated with chemoradiotherapy. A small number of patients undergo salvage surgery. There are few published studies investigating quality of life and functional outcome after treatment for anal cancer. The aim of this review was to explore the literature and identify areas for further research.
METHODS
A search was conducted in Medline using MESH terms related to anal cancer and quality of life. Two investigators selected and reviewed articles based on titles and abstracts. Three investigators read and reviewed the included articles and collected relevant data. The included articles were evaluated using the minimum standard checklist, and key findings were summarised in a chart.
RESULTS
Some 15 articles, and a total of 802 patients, were deemed eligible. The results differed slightly among the studies. The incidence of symptoms such as fatigue, nausea, insomnia and appetite loss was higher than among healthy volunteers. Bowel function, urinary function and sexual function were negatively affected. Some studies found that, compared with the normal population, anal cancer survivors scored clinically significant worse in the functional scales in QLQ-C30.
CONCLUSION
In conclusion, it is apparent that several functional problems affect the quality of life of patients with anal cancer. There are few studies which have investigated quality of life after treatment for anal cancer. Interventions to address issues related to anal cancer treatment may improve long-term quality of life in this patient group.
TRIAL REGISTRATION
CRD42017059787.
Topics: Aged; Anus Neoplasms; Humans; Middle Aged; Publication Bias; Quality of Life; Risk; Surveys and Questionnaires
PubMed: 31324957
DOI: 10.1007/s00384-019-03342-x -
Phytotherapy Research : PTR Jun 2019This systematic review and meta-analysis aimed to study the efficacy and safety of chamomile for the treatment of state anxiety, generalized anxiety disorders (GADs),... (Meta-Analysis)
Meta-Analysis
Therapeutic efficacy and safety of chamomile for state anxiety, generalized anxiety disorder, insomnia, and sleep quality: A systematic review and meta-analysis of randomized trials and quasi-randomized trials.
This systematic review and meta-analysis aimed to study the efficacy and safety of chamomile for the treatment of state anxiety, generalized anxiety disorders (GADs), sleep quality, and insomnia in human. Eleven databases including PubMed, Science Direct, Cochrane Central, and Scopus were searched to retrieve relevant randomized control trials (RCTs), and 12 RCTs were included. Random effect meta-analysis was performed by meta package of R statistical software version 3.4.3 and RevMan version 5.3. Our meta-analysis of three RCTs did not show any difference in case of anxiety (standardized mean difference = -0.15, 95% CI [-0.46, 0.16], P = 0.4214). Moreover, there is only one RCT that evaluated the effect of chamomile on insomnia and it found no significant change in insomnia severity index (P > 0.05). By using HAM-A scale, there was a significant improvement in GAD after 2 and 4 weeks of treatment (mean difference = -1.43, 95% CI [-2.47, -0.39], P = 0.007), (MD = -1.79, 95% CI [-3.14, -0.43], P = 0.0097), respectively. Noteworthy, our meta-analysis showed a significant improvement in sleep quality after chamomile administration (standardized mean difference = -0.73, 95% CI [-1.23, -0.23], P < 0.005). Mild adverse events were only reported by three RCTs. Chamomile appears to be efficacious and safe for sleep quality and GAD. Little evidence is there to show its effect on anxiety and insomnia. Larger RCTs are needed to ascertain these findings.
Topics: Adult; Aged; Anxiety; Anxiety Disorders; Chamomile; Female; Humans; Male; Middle Aged; Plant Extracts; Randomized Controlled Trials as Topic; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 31006899
DOI: 10.1002/ptr.6349 -
Advances in Therapy Jun 2019To evaluate the comparative efficacy and safety of ropinirole and pramipexole as adjunctive therapies to levodopa (L-dopa) for the management of advanced Parkinson's... (Comparative Study)
Comparative Study Meta-Analysis
INTRODUCTION
To evaluate the comparative efficacy and safety of ropinirole and pramipexole as adjunctive therapies to levodopa (L-dopa) for the management of advanced Parkinson's disease (PD), via a systematic review and network meta-analysis.
METHODS
Twenty-one double-blind randomised controlled trials of patients with advanced PD with motor fluctuations receiving L-dopa comparing ropinirole or pramipexole with comparators were identified from 2550 publications. Bayesian indirect comparison methods were applied to independently review efficacy outcomes including off-time reduction, Unified Parkinson's Disease Rating Scale-Activity of Daily Living (UPDRS-ADL) and UPDRS-motor scores, and safety outcomes including adverse events (AE) and patient withdrawals, to determine indirect treatment comparison mean differences (MD) or hazard ratios (HR) with 95% confidence intervals (CI).
RESULTS
The indirect efficacy comparison resulted in a statistically nonsignificant off-time reduction difference (hours) of ropinirole-sustained release (SR) versus pramipexole-immediate release (MD - 0.25; 95% CI - 0.71, 0.21) and ropinirole-SR versus pramipexole-extended release (ER) (MD 0.18; 95% CI - 0.40, 0.76). Ropinirole-SR adjunctive treatment showed a tendency towards more improvement in UPDRS-ADL score (MD 1.24; 95% CI 0.23, 2.24) than adjunctive treatment of pramipexole-ER. Pramipexole-ER may be less likely to induce somnolence as an AE compared with ropinirole-SR (HR 0.46; 95% CI 0.23, 0.89). However, there were no statistically significant differences in UPDRS-motor score reduction, incidence of dyskinesia, hallucination, hypotension, insomnia and nausea, or withdrawals due to AE, for any reason.
CONCLUSION
Adjunctive therapy with ropinirole-SR or pramipexole appears to offer similar efficacy and tolerability in patients with advanced PD on the basis of this indirect comparison.
FUNDING
GSK.
Topics: Adult; Aged; Aged, 80 and over; Antiparkinson Agents; Combined Modality Therapy; Female; Humans; Indoles; Levodopa; Male; Middle Aged; Parkinson Disease; Pramipexole
PubMed: 30963514
DOI: 10.1007/s12325-019-00938-1