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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 -
Medical Education Mar 2023The policies regarding resident physician work hours are constantly being evaluated and changed. However, the results of randomised control trials (RCTs) are mixed. This... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
The policies regarding resident physician work hours are constantly being evaluated and changed. However, the results of randomised control trials (RCTs) are mixed. This systematic review of RCTs aims to synthesise the evidence associated with resident duty hour restrictions and its impact on resident- and patient-based outcomes.
METHODS
A comprehensive search of the Cochrane Library, EMBASE and PubMed was conducted from inception until 31 July 2020. Any RCT evaluating the impact of longer resident physician work hours compared to shorter resident physician work hours on resident- and patient-based outcomes was eligible for inclusion. Two reviewers extracted data independently. The primary outcome was the impact of resident duty hour restrictions on emotional exhaustion, depersonalisation and personal accomplishment, as defined by the Maslach Burnout Inventory. The secondary patient-related outcomes were patient hospital length of stay, serious medical errors and preventable adverse events. Data were pooled using a random-effects model.
RESULTS
Of the 873 references, nine RCTs met the inclusion criteria. A shorter shift length compared with longer shift length was associated with significantly less emotional exhaustion (standardised mean difference [SMD] = -0.11, 95% CI = -0.21, -0.00) and less dissatisfaction with overall well-being (OR = 0.61, 95% CI 0.38, 0.99) but not with hospital length of stay (SMD = -0.01, 95% CI = -0.05, 0.02, p = 0.45) and serious medical errors per 1000 patient hours (OR = 1.07, 95% CI = 0.52, 2.21; p = 0.86).
CONCLUSIONS
Shorter resident duty hours is possibly associated with improvement in resident-based outcomes, specifically, emotional exhaustion, dissatisfaction with overall well-being, sleep duration and sleepiness. These findings may inform the policy change in support of reduced shift hours resulting in overall well-being for the residents with possible reduction in burnout without adverse impact on patient-based outcomes.
Topics: Humans; Internship and Residency; Burnout, Professional; Emotions
PubMed: 36181404
DOI: 10.1111/medu.14943 -
Clocks & Sleep Dec 2023The gut microbiota (GM) plays a crucial role in human health. The bidirectional interaction between GM and the central nervous system may occur via the... (Review)
Review
The gut microbiota (GM) plays a crucial role in human health. The bidirectional interaction between GM and the central nervous system may occur via the microbiota-gut-brain axis, possibly regulating the sleep/wake cycle. Recent reports highlight associations between intestinal dysbiosis and sleep disorders, suggesting that probiotics could ameliorate this condition. However, data are poor and inconsistent. The aim of this quantitative metanalytic study is to assess the GM composition in sleep disturbances and evaluate probiotics' effectiveness for managing sleep disorders. A systematic review was carried out until July 2022 in online databases, limiting the literature research to human studies and English language articles. No significant GM diversity between patients with sleep disturbances versus healthy controls was found, revealed by -diversity, while -diversity is missing due to lack of proper reporting. However, probiotics supplementation significantly reduced the self-assessed parameter of sleep quality and disturbances Pittsburgh Sleep Quality Index (PSQI) score compared with the placebo. No difference in the Epworth Sleepiness Scale (ESS) score was found. While available data suggest that GM diversity is not related to sleep disturbances, probiotics administration strongly improves sleep quality as a subjective perception. However, heterogeneity of data reporting in the scientific literature should be considered as a limitation.
PubMed: 38131749
DOI: 10.3390/clockssleep5040050 -
Accident; Analysis and Prevention Jun 2022Drowsiness and distraction are major factors of road crashes and responsible of>35% of road fatalities. Automated driving could solve or minimize their impact, yet it is... (Meta-Analysis)
Meta-Analysis
Drowsiness and distraction are major factors of road crashes and responsible of>35% of road fatalities. Automated driving could solve or minimize their impact, yet it is also in itself a way to promote them. Previous literature reviews and meta-analysis regarding take-overs during automated driving primarily focused on distraction rather than drowsiness. We thus present a systematic and meta-analysis literature review focused on the effect of distraction and drowsiness on take-over performance. From an initial selection of 1896 articles from databases, we obtained by applying systematic review methodology a total of 58 articles with 42 articles dedicated to distraction and 17 articles related to drowsiness. According to our analysis, we demonstrated that distraction and drowsiness increased the take-over request reaction time (TOR-RT), which could also lead to a reduction of the quality of take-overs. In addition, this longer reaction time was even more important in the case of handheld non-driving related tasks, which is important to consider as phone use is among the most frequent tasks done during automated driving. On a more methodological aspect, we also demonstrated that take-over time budget had a significant effect on TOR-RT. However, it is difficult to estimate to what extend distraction and drowsiness could impact the take-over quality, even if several elements supported safety issues. We underpinned several limits of the current methodologies applied in the study of distraction and drowsiness such as (i) the lack of additional measures related to the take-over quality (e.g., accelerations, collision rate), (ii) the many different methodologies applied to the determination of the TOR-RT (e.g., deactivation by the steering wheel, pedals, button), (iii) the high frequency of take-over requests which can lead to habituation effects, (iv) the lack of control conditions, (v) the fact that the level of drowsiness was relatively low in most studies. We thus highlighted recommendations for a better estimation of the effect of distraction and drowsiness on take-over performance. Further studies should adopt more standardized measures of TOR-RT and additional take-over quality measures, try minimizing the number of take-over requests, and carefully consider the time budget available for the use case since it influences the TOR-RT. Regarding distraction, researchers should consider the impact of tasks requiring handholding items. Concerning drowsiness, further protocols should consider the non-linearity of drowsiness and presence of micro sleeps and favor take-over requests based on drowsiness level protocols rather than on fixed duration protocols.
Topics: Accidents, Traffic; Automobile Driving; Humans; Reaction Time; Wakefulness
PubMed: 34969510
DOI: 10.1016/j.aap.2021.106536 -
Journal of Sleep Research Jan 2024Insufficient sleep is a growing global problem, with poor sleep associated with many negative health and performance outcomes. Previous reviews investigating the effect... (Review)
Review
Insufficient sleep is a growing global problem, with poor sleep associated with many negative health and performance outcomes. Previous reviews investigating the effect of diet on sleep have highlighted the amino acid tryptophan as a promising sleep-promoting nutrient, with the richest food source of tryptophan, ⍺-lactalbumin, requiring further investigation. Therefore, this systematic review aimed to review the existing evidence of association between ⍺-lactalbumin and sleep. Four electronic databases (CINAHL Complete, Embase, MEDLINE Complete, and SPORTDiscus with Full Text) were searched from database inception to March 2023, with primary research articles included if they contained α-lactalbumin as an independent variable, an outcome measure of sleep or sleepiness, and participants were ≥ 18 years old. Eight studies were reviewed, with four studies recruiting athletic populations (50%) and four recruiting healthy participants (50%). Sleep or sleepiness was measured objectively in six studies (75%), with two studies employing polysomnography and four utilizing actigraphy to assess sleep. Across the studies, 20-60 g of ⍺-lactalbumin was supplemented, with five studies (63%) observing a positive association between α-lactalbumin and sleep. Sleep-onset latency was the primary sleep metric improved following evening supplementation of α-lactalbumin (≤ 3.5 hr pre-sleep), with no studies observing any negative associations with sleep. Data from this review suggest that individuals that have difficulty initiating sleep may benefit most from pre-sleep α-lactalbumin supplementation. Further research is required to establish the effect that α-lactalbumin has on sleep architecture, through the use of more comprehensive sleep analysis tools such as portable electroencephalography or polysomnography, in combination with stringent dietary controls.
PubMed: 38185736
DOI: 10.1111/jsr.14141 -
Sleep & Breathing = Schlaf & Atmung Sep 2020Studies on the association between sleep and frailty risk have yielded contradictory outcomes. Therefore, a systematic review and meta-analysis were designed to examine... (Meta-Analysis)
Meta-Analysis
PURPOSE
Studies on the association between sleep and frailty risk have yielded contradictory outcomes. Therefore, a systematic review and meta-analysis were designed to examine the relationship between sleep and frailty risk.
METHODS
Relevant studies were identified by searching PubMed, Embase, and Scopus databases until 30 November 2019. Data were available from ten studies. Selected articles were published between 2009 and 2019. The odds ratios of 41,233 individuals were used for the meta-analysis.
RESULTS
Pooled analysis demonstrated that when compared to the reference category of 6 to 8 hours nightly sleep duration, both the highest category (more than 8 hours, OR 1.21; 95% CI 1.10-1.32) and lowest category of sleep (under 6 hours, OR 1.13; 95% CI 1.08-1.18), were significantly correlated with increased risk of frailty. Furthermore, daytime drowsiness (OR 1.25; 95% CI 1.02-1.52), sleep disordered breathing (OR 1.28; 95% CI 1.03-1.58), and prolonged sleep latency (OR 1.18; 95% CI 1.06-1.31) enhanced the risk of frailty. Subgroup analyses by frailty status suggest that a shorter sleep duration was associated with risk of frailty but not pre-frailty. However, prolonged sleep time was significantly related with enhanced risk of pre-frailty and frailty. In addition, subgroup analyses via sex revealed that longer and shorter sleep durations increased risk of frailty in both men and women.
CONCLUSION
The present study revealed that longer and shorter sleep durations are associated with increased risk of frailty.
Topics: Aged; Aged, 80 and over; Female; Frail Elderly; Frailty; Humans; Male; Risk; Sleep Wake Disorders; Time Factors
PubMed: 32215833
DOI: 10.1007/s11325-020-02061-w -
BMC Women's Health Sep 2023Menstrual disturbances harm women's health, and general well-being. As growing evidence highlights the relationship between sleep and menstrual disturbances, it is...
BACKGROUND
Menstrual disturbances harm women's health, and general well-being. As growing evidence highlights the relationship between sleep and menstrual disturbances, it is imperative to comprehensively examine the association between sleep and menstrual disturbance considering the multiple dimensions of sleep. This systematic review aims to identify the association between sleep and menstrual disturbances by evaluating using Buysse's sleep health framework.
METHODS
A comprehensive search of the literature was conducted in PubMed, EMBASE, psychINFO, and CINAHL to identify publications describing any types of menstrual disturbances, and their associations with sleep published between January 1, 1988 to June 2, 2022. Quality assessment was conducted using the Joanna Briggs Institute Critical Appraisal Checklist for Analytical Cross-Sectional Studies. The findings were iteratively evaluated menstrual disturbances and their association with sleep using Buysse's sleep health framework. This framework understands sleep as multidimensional concept and provides a holistic framing of sleep including Satisfaction, Alertness during waking hours, Timing of sleep, Efficiency, and Sleep duration. Menstrual disturbances were grouped into three categories: premenstrual syndrome, dysmenorrhea, and abnormal menstrual cycle/heavy bleeding during periods.
RESULTS
Thirty-five studies were reviewed to examine the association between sleep and menstrual disturbances. Premenstrual syndrome and dysmenorrhea were associated with sleep disturbances in sleep health domains of Satisfaction (e.g., poor sleep quality), Alertness during waking hours (e.g., daytime sleepiness), Efficiency (e.g., difficulty initiating/maintaining sleep), and Duration (e.g., short sleep duration). Abnormal menstrual cycle and heavy bleeding during the period were related to Satisfaction, Efficiency, and Duration. There were no studies which investigated the timing of sleep.
CONCLUSIONS/IMPLICATIONS
Sleep disturbances within most dimensions of the sleep health framework negatively impact on menstrual disturbances. Future research should longitudinally examine the effects of sleep disturbances in all dimensions of sleep health with the additional objective sleep measure on menstrual disturbances. This review gives insight in that it can be recommended to provide interventions for improving sleep disturbances in women with menstrual disturbance.
Topics: Female; Humans; Dysmenorrhea; Cross-Sectional Studies; Menstruation Disturbances; Premenstrual Syndrome; Sleep; Sleep Wake Disorders
PubMed: 37658359
DOI: 10.1186/s12905-023-02629-0 -
Pharmaceuticals (Basel, Switzerland) Jan 2022Dronabinol, a natural cannabinoid, and its semi-synthetic derivative, nabilone, are marketed as medicines in several countries. The aim of our work was to systematically... (Review)
Review
Dronabinol, a natural cannabinoid, and its semi-synthetic derivative, nabilone, are marketed as medicines in several countries. The aim of our work was to systematically evaluate the frequency of adverse events related to dronabinol or nabilone treatment compared to placebo. Scientific databases were searched for placebo-controlled clinical studies of patients receiving either dronabinol or nabilone therapy with placebo control groups. This meta-analysis was reported following the PRISMA guidelines using the PICO format, and it was registered with the PROSPERO register. There were 16 trials included in the meta-analysis. In the nabilone studies, drowsiness was more than 7 times as frequent in patients treated with nabilone than in the placebo group (OR: 7.25; 95% CI: 1.64-31.95), and the risk of dizziness (OR: 21.14; 95% CI: 2.92-152.75) and dry mouth was also higher (OR: 17.23; 95% CI: 4.33-68.55). The frequency of headache was not different in the two groups. In case of dronabinol, the frequency of dry mouth (OR: 5.58; 95% CI: 3.19-9.78), dizziness (OR: 4.60 95% CI: 2.39-8.83) and headache (OR: 2.90; 95% CI: 1.07-7.85) was significantly higher in the dronabinol groups, whereas in case of nausea, drowsiness and fatigue there was no difference. The severity of adverse events was typically mild-to-moderate and transient. In a risk-benefit assessment, these adverse effects are acceptable compared to the achievable benefit. However, considering the diversity of the adverse effects, more studies are needed to provide a more accurate assessment on the side effect profiles of these two compounds.
PubMed: 35056154
DOI: 10.3390/ph15010100 -
Journal of the European Academy of... Feb 2024There are only a few clinical trials which address the treatment of acute urticaria (AU). Especially, the added value of systemic corticosteroids to antihistamines is... (Review)
Review
There are only a few clinical trials which address the treatment of acute urticaria (AU). Especially, the added value of systemic corticosteroids to antihistamines is unclear in treatment of severe AU. To review the existing evidence-based approaches for AU treatment. A systematic electronic search was done in PubMed and Web of Science to retrieve all studies on the treatment of patients with AU. A descriptive synthesis was conducted based on the PRISMA statement. Quality assessment was independently performed by both reviewers ('Cochrane risk-of-bias tool' for RCTs). Ten randomized controlled trials (RCTs) (n = 857 participants) were included. Four studies assessed corticosteroid effectiveness added to antihistamines and six studies compared the efficacy of H and/ or H -antihistamines. The addition of corticosteroid (prednisone) to an antihistamine (levo)cetirizine did not improve symptoms of AU compared to antihistamine alone in two out of three RCTs. The combination of diphenhydramine (50 mg, IV) and ranitidine (50 mg, IV) or cimetidine (300 mg, IV) was most efficient for relief of urticaria in two out of five studies. Most frequent adverse effects were sedation and drowsiness. Recent guidelines on urticaria treatment mainly focus on chronic urticaria rather than on AU. Moreover, only few, small RCTs provide evidence for the management of AU. Thus, the state-of-the-art management of this frequent condition remains unclear. The addition of corticosteroids to an antihistamine as treatment for AU needs to be further investigated. Well-designed, high-quality interventional trials are needed to establish evidence-based treatment guidelines for AU.
PubMed: 38420865
DOI: 10.1111/jdv.19904 -
Sleep & Breathing = Schlaf & Atmung Oct 2023Insomnia is highly prevalent in modern society. However, the hierarchical selection of hypnotics in young and middle-aged adults with insomnia remains unclear. We aimed... (Meta-Analysis)
Meta-Analysis
OBJECTIVE/BACKGROUND
Insomnia is highly prevalent in modern society. However, the hierarchical selection of hypnotics in young and middle-aged adults with insomnia remains unclear. We aimed to compare the efficacy and daytime drowsiness associated with different hypnotics for treating insomnia in young and middle-aged adults.
METHODS
We searched Embase, PubMed, Cochrane Library, and ProQuest Dissertations and Theses A&I databases from inception until December 15, 2021. We also manually searched reference lists and relevant publications. The literature search, data collection, and risk of bias evaluation were all carried out separately by pairs of reviewers. We included randomized control trials (RCTs) that compared hypnotics approved by the Food and Drug Administration. The R and Stata software were both used to perform the meta-analysis.
RESULTS
In total, 117 RCTs comprising 22,508 participants with the age of 18 to 65 years were included. Assessment of the efficacy of the hypnotics and adverse events (drowsiness) revealed that zolpidem improved all objective sleep parameters (oTST, oSOL, oWASO, and oSE), zopiclone increased oTST and oSE and reduced oSOL, and daridorexant increased oTST and reduced oWASO. Regarding subjective sleep outcomes, zolpidem exhibited beneficial effects on sTST, sSOL, and sWASO. Zaleplon reduced sSOL, and zopiclone was the recommended hypnotic for improving SQ. Zolpidem was associated with drowsiness effect (odds ratio = 1.82; 95% confidence interval = 1.25 to 2.65). The results of sensitivity analysis remained unchanged after the exclusion of studies reporting long-term effects.
CONCLUSION
Zolpidem is recommended for managing sleep-onset insomnia and sleep maintenance insomnia but should be used with caution because of daytime drowsiness effects. Daridorexant is recommended as a promising agent for managing sleep maintenance insomnia.
Topics: Middle Aged; Adult; Humans; Adolescent; Young Adult; Aged; Sleep Initiation and Maintenance Disorders; Hypnotics and Sedatives; Zolpidem; Network Meta-Analysis
PubMed: 36928548
DOI: 10.1007/s11325-023-02812-5