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The Cochrane Database of Systematic... Jun 2022Many people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not... (Review)
Review
BACKGROUND
Many people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not effective for pain in all people, neither are they well tolerated by all people. The aim of this review was to assess whether oxycodone is associated with better pain relief and tolerability than other analgesic options for adults with cancer pain. This is an updated Cochrane review previously published in 2017.
OBJECTIVES
To assess the effectiveness and tolerability of oxycodone by any route of administration for pain in adults with cancer.
SEARCH METHODS
For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and MEDLINE In-Process (Ovid), Embase (Ovid), Science Citation Index, Conference Proceedings Citation Index - Science (ISI Web of Science), BIOSIS (ISI), and PsycINFO (Ovid) to November 2021. We also searched four trial registries, checked the bibliographic references of relevant studies, and contacted the authors of the included studies. We applied no language, date, or publication status restrictions.
SELECTION CRITERIA
We included randomised controlled trials (parallel-group or cross-over) comparing oxycodone (any formulation or route of administration) with placebo or an active drug (including oxycodone) for cancer background pain in adults by examining pain intensity/relief, adverse events, quality of life, and participant preference.
DATA COLLECTION AND ANALYSIS
Two review authors independently sifted the search, extracted data and assessed the included studies using standard Cochrane methodology. We meta-analysed pain intensity data using the generic inverse variance method, and pain relief and adverse events using the Mantel-Haenszel method, or summarised these data narratively along with the quality of life and participant preference data. We assessed the overall certainty of the evidence using GRADE.
MAIN RESULTS
For this update, we identified 19 new studies (1836 participants) for inclusion. In total, we included 42 studies which enrolled/randomised 4485 participants, with 3945 of these analysed for efficacy and 4176 for safety. The studies examined a number of different drug comparisons. Controlled-release (CR; typically taken every 12 hours) oxycodone versus immediate-release (IR; taken every 4-6 hours) oxycodone Pooled analysis of three of the four studies comparing CR oxycodone to IR oxycodone suggest that there is little to no difference between CR and IR oxycodone in pain intensity (standardised mean difference (SMD) 0.12, 95% confidence interval (CI) -0.1 to 0.34; n = 319; very low-certainty evidence). The evidence is very uncertain about the effect on adverse events, including constipation (RR 0.71, 95% CI 0.45 to 1.13), drowsiness/somnolence (RR 1.03, 95% CI 0.69 to 1.54), nausea (RR 0.85, 95% CI 0.56 to 1.28), and vomiting (RR 0.66, 95% CI 0.38 to 1.15) (very low-certainty evidence). There were no data available for quality of life or participant preference, however, three studies suggested that treatment acceptability may be similar between groups (low-certainty evidence). CR oxycodone versus CR morphine The majority of the 24 studies comparing CR oxycodone to CR morphine reported either pain intensity (continuous variable), pain relief (dichotomous variable), or both. Pooled analysis indicated that pain intensity may be lower (better) after treatment with CR morphine than CR oxycodone (SMD 0.14, 95% CI 0.01 to 0.27; n = 882 in 7 studies; low-certainty evidence). This SMD is equivalent to a difference of 0.27 points on the Brief Pain Inventory scale (0-10 numerical rating scale), which is not clinically significant. Pooled analyses also suggested that there may be little to no difference in the proportion of participants achieving complete or significant pain relief (RR 1.02, 95% CI 0.95 to 1.10; n = 1249 in 13 studies; low-certainty evidence). The RR for constipation (RR 0.75, 95% CI 0.66 to 0.86) may be lower after treatment with CR oxycodone than after CR morphine. Pooled analyses showed that, for most of the adverse events, the CIs were wide, including no effect as well as potential benefit and harm: drowsiness/somnolence (RR 0.88, 95% CI 0.74 to 1.05), nausea (RR 0.93, 95% CI 0.77 to 1.12), and vomiting (RR 0.81, 95% CI 0.63 to 1.04) (low or very low-certainty evidence). No data were available for quality of life. The evidence is very uncertain about the treatment effects on treatment acceptability and participant preference. Other comparisons The remaining studies either compared oxycodone in various formulations or compared oxycodone to different alternative opioids. None found any clear superiority or inferiority of oxycodone for cancer pain, neither as an analgesic agent nor in terms of adverse event rates and treatment acceptability. The certainty of this evidence base was limited by the high or unclear risk of bias of the studies and by imprecision due to low or very low event rates or participant numbers for many outcomes.
AUTHORS' CONCLUSIONS
The conclusions have not changed since the previous version of this review (in 2017). We found low-certainty evidence that there may be little to no difference in pain intensity, pain relief and adverse events between oxycodone and other strong opioids including morphine, commonly considered the gold standard strong opioid. Although we identified a benefit for pain relief in favour of CR morphine over CR oxycodone, this was not clinically significant and did not persist following sensitivity analysis and so we do not consider this important. However, we found that constipation and hallucinations occurred less often with CR oxycodone than with CR morphine; but the certainty of this evidence was either very low or the finding did not persist following sensitivity analysis, so these findings should be treated with utmost caution. Our conclusions are consistent with other reviews and suggest that, while the reliability of the evidence base is low, given the absence of important differences within this analysis, it seems unlikely that larger head-to-head studies of oxycodone versus morphine are justified, although well-designed trials comparing oxycodone to other strong analgesics may well be useful. For clinical purposes, oxycodone or morphine can be used as first-line oral opioids for relief of cancer pain in adults.
Topics: Adult; Analgesics, Opioid; Cancer Pain; Constipation; Humans; Morphine; Nausea; Neoplasms; Oxycodone; Pain; Quality of Life; Reproducibility of Results; Sleepiness; Vomiting
PubMed: 35679121
DOI: 10.1002/14651858.CD003870.pub7 -
Revista de Neurologia Jul 2023Narcolepsy type 1 is a focal degenerative disease of the hypothalamus that selectively affects orexin (hypocretin)-producing neurons. It presents multiple clinical...
INTRODUCTION
Narcolepsy type 1 is a focal degenerative disease of the hypothalamus that selectively affects orexin (hypocretin)-producing neurons. It presents multiple clinical manifestations, both in wakefulness and in sleep. The symptoms are often so disruptive that they cause enormous suffering and impair patients' quality of life. Although a non-pharmacological approach is sometimes sufficient, the vast majority of patients need medication for adequate clinical management.
CASE REPORT
A male who, at 43 years of age, began to present acutely with excessive daytime sleepiness and episodes of cataplexy. After a thorough examination, he was diagnosed with narcolepsy type 1. Throughout the course of the disease, he was prescribed antidepressants, neurostimulants and sodium oxybate, in monotherapy or in combination. The response to pharmacological treatment was insufficient and accompanied by numerous side effects. Following the introduction of pitolisant, there was a marked improvement in his symptoms and a reduction in the dose of the other drugs and their adverse effects was achieved.
CONCLUSION
A number of measures are now available to address the cardinal symptoms of the disease, although there are still cases that are resistant to anti-narcoleptic treatment. Drugs with mechanisms of action that act upon receptors in the histaminergic system can be very useful in these cases.
Topics: Humans; Male; Antidepressive Agents; Cataplexy; Central Nervous System Stimulants; Narcolepsy; Quality of Life; Sodium Oxybate; Adult; Drug Resistance, Multiple; Sleepiness
PubMed: 37477029
DOI: 10.33588/rn.77s01.2023198 -
Child Development Mar 2022Reciprocal relations between sleep and adjustment were investigated. Participants included 246 adolescents (M = 15.80 years; 67.5% White, 32.5% Black/African...
Reciprocal relations between sleep and adjustment were investigated. Participants included 246 adolescents (M = 15.80 years; 67.5% White, 32.5% Black/African American; 53% female, 47% male) at Time 1 (data collected 2012-2013), 227 at Time 2 (M = 16.78 years) and 215 at Time 3 (M = 17.70 years). Sleep-wake variables were measured with self-reports (sleepiness) and actigraphy (average sleep minutes and efficiency, variability in sleep minutes and efficiency). Adolescents reported on depression and anxiety symptoms, and parents reported on externalizing problems. Greater variability in sleep duration and efficiency as well as sleepiness predicted adjustment problems (range of R : 36%-60%). Reciprocal relations were supported mostly for sleepiness (range of R : 16%-32%). Results help understand bidirectional relations between sleep and adjustment.
Topics: Actigraphy; Adolescent; Anxiety; Female; Humans; Male; Self Report; Sleep; Sleep Wake Disorders; Sleepiness
PubMed: 34757645
DOI: 10.1111/cdev.13703 -
Sleep Advances : a Journal of the Sleep... 2023Drowsiness associated with sleep loss and circadian misalignment is a risk factor for accidents and human error. The percentage of time that the eyes are more than 80%... (Review)
Review
Drowsiness associated with sleep loss and circadian misalignment is a risk factor for accidents and human error. The percentage of time that the eyes are more than 80% closed (PERCLOS) is one of the most validated indices used for the passive detection of drowsiness, which is increased with sleep deprivation, after partial sleep restriction, at nighttime, and by other drowsiness manipulations during vigilance tests, simulated driving, and on-road driving. However, some cases have been reported wherein PERCLOS was not affected by drowsiness manipulations, such as in moderate drowsiness conditions, in older adults, and during aviation-related tasks. Additionally, although PERCLOS is one of the most sensitive indices for detecting drowsiness-related performance impairments during the psychomotor vigilance test or behavioral maintenance of wakefulness test, no single index is currently available as an optimal marker for detecting drowsiness during driving or other real-world situations. Based on the current published evidence, this narrative review suggests that future studies should focus on: (1) standardization to minimize differences in the definition of PERCLOS between studies; (2) extensive validation using a single device that utilizes PERCLOS-based technology; (3) development and validation of technologies that integrate PERCLOS with other behavioral and/or physiological indices, because PERCLOS alone may not be sufficiently sensitive for detecting drowsiness caused by factors other than falling asleep, such as inattention or distraction; and (4) further validation studies and field trials targeting sleep disorders and trials in real-world environments. Through such studies, PERCLOS-based technology may contribute to preventing drowsiness-related accidents and human error.
PubMed: 37193281
DOI: 10.1093/sleepadvances/zpad006 -
Journal of Neurology Nov 2023Sleep abnormalities have been reported in Charcot-Marie-Tooth disease (CMT), but data are scanty. We investigated their presence and correlation in a large CMT patients'...
BACKGROUND
Sleep abnormalities have been reported in Charcot-Marie-Tooth disease (CMT), but data are scanty. We investigated their presence and correlation in a large CMT patients' series.
METHODS
Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI) were administered to CMT patients of the Italian registry and controls. ESS score > 10 indicated abnormal daytime somnolence, PSQI score > 5 bad sleep quality. We analyzed correlation with disease severity and characteristics, Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS), Body Mass Index, drug use.
RESULTS
ESS and PSQI questionnaires were filled by 257 and 253 CMT patients, respectively, and 58 controls. Median PSQI score was higher in CMT patients than controls (6 vs 4, p = 0.006), with no difference for ESS score. Abnormal somnolence and poor sleep quality occurred in 23% and 56% of patients; such patients had more frequently anxiety/depression, abnormal fatigue, and positive sensory symptoms than those with normal ESS/PSQI. Moreover, patients with PSQI score > 5 had more severe disease (median CMT Examination Score, CMTES, 8 vs 6, p = 0.006) and more frequent use of anxiolytic/antidepressant drugs (29% vs 7%, p < 0.001).
CONCLUSIONS
Bad sleep quality and daytime sleepiness are frequent in CMT and correlated with anxiety, depression and fatigue, confirming that different components affect sleep. Sleep disorders, such as sleep apnea and restless leg syndrome, not specifically investigated here, are other factors known to impact on sleep quality and somnolence. CMT patients' management must include sleep behavior assessment and evaluation of its correlated factors, including general distress and fatigue.
Topics: Humans; Sleep Quality; Sleepiness; Charcot-Marie-Tooth Disease; Disorders of Excessive Somnolence; Sleep; Fatigue; Surveys and Questionnaires; Sleep Wake Disorders
PubMed: 37540277
DOI: 10.1007/s00415-023-11911-y -
Annals of the American Thoracic Society Aug 2023Positive airway pressure (PAP) is the first-choice treatment for obstructive sleep apnea (OSA). However, its real-world effectiveness is often questioned because of...
Positive airway pressure (PAP) is the first-choice treatment for obstructive sleep apnea (OSA). However, its real-world effectiveness is often questioned because of usage issues. The relationship between patient sleepiness and PAP usage has been assessed in relatively small and selected populations within the research context. To assess the impact of patient-reported sleep outcomes, particularly self-reported sleepiness and its change during therapy, on PAP usage in the real-world setting. Deidentified data for U.S.-based patients receiving PAP therapy were examined. Eligible patients were registered in the myAir app and provided self-reported sleepiness at baseline and after 7, 14, 21, and 28 days of PAP between November 2019 and April 2020. A total of 95,397 registered patients met all eligibility criteria and were included in the analysis (mean age, 49.6 ± 13.0 yr; 61.6% male). Daytime sleepiness was the most common reason for PAP therapy initiation (57.1% of patients), and 42.2% of all patients had self-reported moderate to severe OSA. Self-reported sleepiness improved with PAP therapy in most patients over the assessment period, with 62.1% of patients reporting "no" or "slight" sleepiness at Day 28. There was a dose-dependent association between improvement in self-reported sleepiness at Day 28 and PAP usage, and this finding was maintained at Day 360. Self-reported sleepiness at Day 28 was associated with achieving U.S. Centers for Medicare & Medicaid Services compliance at 90 days (approximately 90% for those with no or slight sleepiness vs. <70% for those with residual very or extreme sleepiness); average daily PAP usage over 360 days was ⩾5.0 and ⩽3.7 hours, respectively, for those with no or slight versus very or extreme sleepiness. This study demonstrates the feasibility of capturing patient-reported outcomes via a digital platform. Patient-reported outcomes appear to be associated with PAP usage, especially self-reported sleepiness and its response to therapy. Capturing patient-reported outcomes using digital solutions during the course of treatment has the potential to enhance patient outcomes by providing actionable insights.
Topics: Humans; Male; Aged; United States; Adult; Middle Aged; Female; Continuous Positive Airway Pressure; Self Report; Sleepiness; Medicare; Sleep Apnea, Obstructive; Patient Compliance
PubMed: 37126852
DOI: 10.1513/AnnalsATS.202206-482OC -
Sleep Nov 2023To examine whether drivers are aware of sleepiness and associated symptoms, and how subjective reports predict driving impairment and physiological drowsiness.
STUDY OBJECTIVES
To examine whether drivers are aware of sleepiness and associated symptoms, and how subjective reports predict driving impairment and physiological drowsiness.
METHODS
Sixteen shift workers (19-65 years; 9 women) drove an instrumented vehicle for 2 hours on a closed-loop track after a night of sleep and a night of work. Subjective sleepiness/symptoms were rated every 15 minutes. Severe and moderate driving impairment was defined by emergency brake maneuvers and lane deviations, respectively. Physiological drowsiness was defined by eye closures (Johns drowsiness scores) and EEG-based microsleep events.
RESULTS
All subjective ratings increased post night-shift (p < 0.001). No severe drive events occurred without noticeable symptoms beforehand. All subjective sleepiness ratings, and specific symptoms, predicted a severe (emergency brake) driving event occurring in the next 15 minutes (OR: 1.76-2.4, AUC > 0.81, p < 0.009), except "head dropping down". Karolinska Sleepiness Scale (KSS), ocular symptoms, difficulty keeping to center of the road, and nodding off to sleep, were associated with a lane deviation in the next 15 minutes (OR: 1.17-1.24, p<0.029), although accuracy was only "fair" (AUC 0.59-0.65). All sleepiness ratings predicted severe ocular-based drowsiness (OR: 1.30-2.81, p < 0.001), with very good-to-excellent accuracy (AUC > 0.8), while moderate ocular-based drowsiness was predicted with fair-to-good accuracy (AUC > 0.62). KSS, likelihood of falling asleep, ocular symptoms, and "nodding off" predicted microsleep events, with fair-to-good accuracy (AUC 0.65-0.73).
CONCLUSIONS
Drivers are aware of sleepiness, and many self-reported sleepiness symptoms predicted subsequent driving impairment/physiological drowsiness. Drivers should self-assess a wide range of sleepiness symptoms and stop driving when these occur to reduce the escalating risk of road crashes due to drowsiness.
Topics: Humans; Female; Accidents, Traffic; Automobile Driving; Sleepiness; Wakefulness; Sleep
PubMed: 37158173
DOI: 10.1093/sleep/zsad136 -
BMC Public Health Aug 2023Insomnia disorder is a highly prevalent, significant public health concern associated with substantial and growing health burden. There are limited real-world data...
BACKGROUND
Insomnia disorder is a highly prevalent, significant public health concern associated with substantial and growing health burden. There are limited real-world data assessing the burden of insomnia disorder on daytime functioning and its association with comorbidities. The objective of this study was to leverage large-scale, real-world data to assess the burden of untreated insomnia disorder in terms of daytime impairment and clinical outcomes.
METHODS
This United States medical claims database study compares patients diagnosed with insomnia disorder but not receiving treatment ('untreated insomnia' cohort) to patients without an insomnia disorder diagnosis and without treatment ('non-insomnia' cohort). International Classification of Disease, Tenth Revision codes were used as a proxy to represent the three symptom domains (Sleepiness, Alert/Cognition, Mood) of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a newly developed and validated tool used in clinical studies to assess daytime functioning in insomnia disorder. Chronic Fatigue (R53.83) and Other Fatigue (R53.83), Somnolence (R40.0) and Disorientation (R41.0) were selected as categories representing one or more IDSIQ domains. Clinical outcomes included cardiovascular events, psychiatric disorders, cognitive impairment and metabolic disorders.
RESULTS
Approximately 1 million patients were included (untreated insomnia: n = 139,959; non-insomnia: n = 836,975). Compared with the 'non-insomnia' cohort, the 'untreated insomnia' cohort was more likely to experience daytime impairments, with mean differences in occurrences per 100 patient-years for: (a) fatigue, at 27.35 (95% confidence interval [CI] 26.81, 27.77, p < 0.01); (b) dizziness, at 4.66 (95% CI 4.40, 4.90, p < 0.01); (c) somnolence, at 4.18 (95% CI 3.94, 4.43, p < 0.01); and (d) disorientation, at 0.92 (95% CI 0.77, 1.06, p < 0.01). During the 1-year look-back period, patients in the 'untreated insomnia' cohort were also more likely to have been diagnosed with arterial hypertension (40.9% vs. 26.3%), psychiatric comorbidities (40.1% vs. 13.2%), anxiety (29.2% vs. 8.5%), depression (26.1% vs. 8.1%) or obesity (21.3% vs. 11.1%) compared with those in the 'non-insomnia' cohort.
CONCLUSIONS
This large-scale study confirms the substantial burden of insomnia disorder on patients in a real-world setting, with significant daytime impairment and numerous comorbidities. This reinforces the need for timely insomnia disorder diagnosis and treatments that improve both sleep, as well as daytime functioning.
Topics: Humans; Adult; Sleep Initiation and Maintenance Disorders; Sleepiness; Cohort Studies; Wakefulness; Sleep
PubMed: 37537544
DOI: 10.1186/s12889-023-16329-9 -
Sensors (Basel, Switzerland) Jul 2021Drowsiness when in command of a vehicle leads to a decline in cognitive performance that affects driver behavior, potentially causing accidents. Drowsiness-related road...
Drowsiness when in command of a vehicle leads to a decline in cognitive performance that affects driver behavior, potentially causing accidents. Drowsiness-related road accidents lead to severe trauma, economic consequences, impact on others, physical injury and/or even death. Real-time and accurate driver drowsiness detection and warnings systems are necessary schemes to reduce tiredness-related driving accident rates. The research presented here aims at the classification of drowsy and non-drowsy driver states based on respiration rate detection by non-invasive, non-touch, impulsive radio ultra-wideband (IR-UWB) radar. Chest movements of 40 subjects were acquired for 5 m using a lab-placed IR-UWB radar system, and respiration per minute was extracted from the resulting signals. A structured dataset was obtained comprising respiration per minute, age and label (drowsy/non-drowsy). Different machine learning models, namely, Support Vector Machine, Decision Tree, Logistic regression, Gradient Boosting Machine, Extra Tree Classifier and Multilayer Perceptron were trained on the dataset, amongst which the Support Vector Machine shows the best accuracy of 87%. This research provides a ground truth for verification and assessment of UWB to be used effectively for driver drowsiness detection based on respiration.
Topics: Automobile Driving; Humans; Neural Networks, Computer; Respiratory Rate; Support Vector Machine; Wakefulness
PubMed: 34300572
DOI: 10.3390/s21144833 -
BMC Public Health Feb 2024Low-quality sleep and obstructive sleep apnea (OSA) can result in series of chronic diseases. Healthy diet has been considered as an effective and simple strategy to...
BACKGROUND
Low-quality sleep and obstructive sleep apnea (OSA) can result in series of chronic diseases. Healthy diet has been considered as an effective and simple strategy to optimize sleep quality. However, current evidence on the correlation of dietary composite antioxidant intake with sleep health remained obscure.
AIM OF THE STUDY
To determine the relationship of composite dietary antioxidant index (CDAI) and sleep health.
METHODS
Cross-sectional analyses were based on National Health and Nutrition Examination Survey (NHANES) 2005-2008. Dietary consumption was assessed by trained staff using 24-h diet recall method and CDAI was calculated based on previous validated approach that included six antioxidants. Sleep-related outcomes were self-reported by a set of questionnaires and classified into OSA, day sleepiness, and insufficient sleep. Weighted logistic regression was conducted to calculate odds ratios (ORs) and 95% confidence intervals (CIs). Restricted cubic spline (RCS) regressions were also used to evaluate the dose-response of CDAI and three sleep-related outcomes.
RESULTS
A total of 7274 subjects included (mean age: 46.97 years) were enrolled in our study, including 3658 were females (52.54%) and 3616 were males (47.46%). Of them, 70.6%, 29.51%, and 35.57% of the subjects reported that they had OSA, day sleepiness and insufficient sleep, respectively. Logistic regression showed the highest quartile of CDAI was inversely associated with the risk of OSA (OR: 0.69, 95%CI: 0.49-0.97), day sleepiness (OR: 0.64, 95%CI: 0.44-0.94) and insufficient sleep (OR: 0.68, 95%CI: 0.50-0.92) compared with the lowest quartile. RCS showed linear relationship of CDAI and insufficient sleep but non-linear relationship of CDAI with OSA and day sleepiness.
CONCLUSIONS
Our results show that CDAI was non-linearly associated with lower risk of OSA and day sleepiness whereas a linear inverse association between CDAI and insufficient sleep was observed. These findings implicate that combined intake of antioxidants could be a promising and effective approach to optimize sleep quality for public.
Topics: Male; Female; Humans; Middle Aged; Antioxidants; Cross-Sectional Studies; Nutrition Surveys; Sleep Deprivation; Sleepiness; Sleep; Sleep Apnea, Obstructive; Diet
PubMed: 38408934
DOI: 10.1186/s12889-024-18047-2