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The Cochrane Database of Systematic... Feb 2022Pit and fissure sealants are plastic materials that are used to seal deep pits and fissures on the occlusal surfaces of teeth, where decay occurs most often in children... (Review)
Review
BACKGROUND
Pit and fissure sealants are plastic materials that are used to seal deep pits and fissures on the occlusal surfaces of teeth, where decay occurs most often in children and adolescents. Deep pits and fissures can retain food debris and bacteria, making them difficult to clean, thereby causing them to be more susceptible to dental caries. The application of a pit and fissure sealant, a non-invasive preventive approach, can prevent dental caries by forming a protective barrier that reduces food entrapment and bacterial growth. Though moderate-certainty evidence shows that sealants are effective in preventing caries in permanent teeth, the effectiveness of applying pit and fissure sealants to primary teeth has yet to be established.
OBJECTIVES
To evaluate the effects of sealants compared to no sealant or a different sealant in preventing pit and fissure caries on the occlusal surfaces of primary molars in children and to report the adverse effects and the retention of different types of sealants.
SEARCH METHODS
An information specialist searched four bibliographic databases up to 11 February 2021 and used additional search methods to identify published, unpublished and ongoing studies. Review authors scanned the reference lists of included studies and relevant systematic reviews for further studies.
SELECTION CRITERIA
We included parallel-group and split-mouth randomised controlled trials (RCTs) that compared a sealant with no sealant, or different types of sealants, for the prevention of caries in primary molars, with no restriction on follow-up duration. We included studies in which co-interventions such as oral health preventive measures, oral health education or tooth brushing demonstrations were used, provided that the same adjunct was used with the intervention and comparator. We excluded studies with complex interventions for the prevention of dental caries in primary teeth such as preventive resin restorations, or studies that used sealants in cavitated carious lesions.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened search results, extracted data and assessed risk of bias of included studies. We presented outcomes for the development of new carious lesions on occlusal surfaces of primary molars as odds ratios (OR) with 95% confidence intervals (CIs). Where studies were similar in clinical and methodological characteristics, we planned to pool effect estimates using a random-effects model where appropriate. We used GRADE methodology to assess the certainty of the evidence.
MAIN RESULTS
We included nine studies that randomised 1120 children who ranged in age from 18 months to eight years at the start of the study. One study compared fluoride-releasing resin-based sealant with no sealant (139 tooth pairs in 90 children); two studies compared glass ionomer-based sealant with no sealant (619 children); two studies compared glass ionomer-based sealant with resin-based sealant (278 tooth pairs in 200 children); two studies compared fluoride-releasing resin-based sealant with resin-based sealant (113 tooth pairs in 69 children); one study compared composite with fluoride-releasing resin-based sealant (40 tooth pairs in 40 children); and one study compared autopolymerised sealant with light polymerised sealant (52 tooth pairs in 52 children). Three studies evaluated the effects of sealants versus no sealant and provided data for our primary outcome. Due to differences in study design such as age of participants and duration of follow-up, we elected not to pool the data. At 24 months, there was insufficient evidence of a difference in the development of new caries lesions for the fluoride-releasing sealants or no treatment groups (Becker Balagtas odds ratio (BB OR) 0.76, 95% CI 0.41 to 1.42; 1 study, 85 children, 255 tooth surfaces). For glass ionomer-based sealants, the evidence was equivocal; one study found insufficient evidence of a difference at follow-up between 12 and 30 months (OR 0.97, 95% CI 0.63 to 1.49; 449 children), while another with 12-month follow-up found a large, beneficial effect of sealants (OR 0.03, 95% CI 0.01 to 0.15; 107 children). We judged the certainty of the evidence to be low, downgrading two levels in total for study limitations, imprecision and inconsistency. We included six trials randomising 411 children that directly compared different sealant materials, four of which (221 children) provided data for our primary outcome. Differences in age of the participants and duration of follow-up precluded pooling of the data. The incidence of development of new caries lesions was typically low across the different sealant types evaluated. We judged the certainty of the evidence to be low or very low for the outcome of caries incidence. Only one study assessed and reported adverse events, the nature of which was gag reflex while placing the sealant material.
AUTHORS' CONCLUSIONS
The certainty of the evidence for the comparisons and outcomes in this review was low or very low, reflecting the fragility and uncertainty of the evidence base. The volume of evidence for this review was limited, which typically included small studies where the number of events was low. The majority of studies in this review were of split-mouth design, an efficient study design for this research question; however, there were often shortcomings in the analysis and reporting of results that made synthesising the evidence difficult. An important omission from the included studies was the reporting of adverse events. Given the importance of prevention for maintaining good oral health, there exists an important evidence gap pertaining to the caries-preventive effect and retention of sealants in the primary dentition, which should be addressed through robust RCTs.
Topics: Adolescent; Child; Dental Caries; Dentition, Permanent; Fluorides; Humans; Pit and Fissure Sealants; Tooth, Deciduous
PubMed: 35146744
DOI: 10.1002/14651858.CD012981.pub2 -
International Journal of Environmental... Oct 2021The load in resistance training is considered to be a critical variable for neuromuscular adaptations. Therefore, it is important to assess the effects of applying... (Review)
Review
Effects of Resistance Training Performed with Different Loads in Untrained and Trained Male Adult Individuals on Maximal Strength and Muscle Hypertrophy: A Systematic Review.
The load in resistance training is considered to be a critical variable for neuromuscular adaptations. Therefore, it is important to assess the effects of applying different loads on the development of maximal strength and muscular hypertrophy. The aim of this study was to systematically review the literature and compare the effects of resistance training that was performed with low loads versus moderate and high loads in untrained and trained healthy adult males on the development of maximal strength and muscle hypertrophy during randomized experimental designs. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (2021) were followed with the eligibility criteria defined according to participants, interventions, comparators, outcomes, and study design (PICOS): (P) healthy males between 18 and 40 years old, (I) interventions performed with low loads, (C) interventions performed with moderate or high loads, (O) development of maximal strength and muscle hypertrophy, and (S) randomized experimental studies with between- or within-subject parallel designs. The literature search strategy was performed in three electronic databases (Embase, PubMed, and Web of Science) on 22 August 2021. Twenty-three studies with a total of 563 participants (80.6% untrained and 19.4% trained) were selected. The studies included both relative and absolute loads. All studies were classified as being moderate-to-high methodological quality, although only two studies had a score higher than six points. The main findings indicated that the load magnitude that was used during resistance training influenced the dynamic strength and isometric strength gains. In general, comparisons between the groups (i.e., low, moderate, and high loads) showed higher gains in 1RM and maximal voluntary isometric contraction when moderate and high loads were used. In contrast, regarding muscle hypertrophy, most studies showed that when resistance training was performed to muscle failure, the load used had less influence on muscle hypertrophy. The current literature shows that gains in maximal strength are more pronounced with high and moderate loads compared to low loads in healthy adult male populations. However, for muscle hypertrophy, studies indicate that a wide spectrum of loads (i.e., 30 to 90% 1RM) may be used for healthy adult male populations.
Topics: Adolescent; Adult; Humans; Hypertrophy; Male; Men; Muscle Strength; Muscle, Skeletal; Resistance Training; Young Adult
PubMed: 34769755
DOI: 10.3390/ijerph182111237 -
The Cochrane Database of Systematic... Apr 2022Glycaemic control is a key component in diabetes mellitus (diabetes) management. Periodontitis is the inflammation and destruction of the underlying supporting tissues... (Review)
Review
BACKGROUND
Glycaemic control is a key component in diabetes mellitus (diabetes) management. Periodontitis is the inflammation and destruction of the underlying supporting tissues of the teeth. Some studies have suggested a bidirectional relationship between glycaemic control and periodontitis. Treatment for periodontitis involves subgingival instrumentation, which is the professional removal of plaque, calculus, and debris from below the gumline using hand or ultrasonic instruments. This is known variously as scaling and root planing, mechanical debridement, or non-surgical periodontal treatment. Subgingival instrumentation is sometimes accompanied by local or systemic antimicrobials, and occasionally by surgical intervention to cut away gum tissue when periodontitis is severe. This review is part one of an update of a review published in 2010 and first updated in 2015, and evaluates periodontal treatment versus no intervention or usual care. OBJECTIVES: To investigate the effects of periodontal treatment on glycaemic control in people with diabetes mellitus and periodontitis.
SEARCH METHODS
An information specialist searched six bibliographic databases up to 7 September 2021 and additional search methods were used to identify published, unpublished, and ongoing studies. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) of people with type 1 or type 2 diabetes mellitus and a diagnosis of periodontitis that compared subgingival instrumentation (sometimes with surgical treatment or adjunctive antimicrobial therapy or both) to no active intervention or 'usual care' (oral hygiene instruction, education or support interventions, and/or supragingival scaling (also known as PMPR, professional mechanical plaque removal)). To be included, the RCTs had to have lasted at least 3 months and have measured HbA1c (glycated haemoglobin).
DATA COLLECTION AND ANALYSIS
At least two review authors independently examined the titles and abstracts retrieved by the search, selected the included trials, extracted data from included trials, and assessed included trials for risk of bias. Where necessary and possible, we attempted to contact study authors. Our primary outcome was blood glucose levels measured as glycated (glycosylated) haemoglobin assay (HbA1c), which can be reported as a percentage of total haemoglobin or as millimoles per mole (mmol/mol). Our secondary outcomes included adverse effects, periodontal indices (bleeding on probing, clinical attachment level, gingival index, plaque index, and probing pocket depth), quality of life, cost implications, and diabetic complications.
MAIN RESULTS
We included 35 studies, which randomised 3249 participants to periodontal treatment or control. All studies used a parallel-RCT design and followed up participants for between 3 and 12 months. The studies focused on people with type 2 diabetes, other than one study that included participants with type 1 or type 2 diabetes. Most studies were mixed in terms of whether metabolic control of participants at baseline was good, fair, or poor. Most studies were carried out in secondary care. We assessed two studies as being at low risk of bias, 14 studies at high risk of bias, and the risk of bias in 19 studies was unclear. We undertook a sensitivity analysis for our primary outcome based on studies at low risk of bias and this supported the main findings. Moderate-certainty evidence from 30 studies (2443 analysed participants) showed an absolute reduction in HbA1c of 0.43% (4.7 mmol/mol) 3 to 4 months after treatment of periodontitis (95% confidence interval (CI) -0.59% to -0.28%; -6.4 mmol/mol to -3.0 mmol/mol). Similarly, after 6 months, we found an absolute reduction in HbA1c of 0.30% (3.3 mmol/mol) (95% CI -0.52% to -0.08%; -5.7 mmol/mol to -0.9 mmol/mol; 12 studies, 1457 participants), and after 12 months, an absolute reduction of 0.50% (5.4 mmol/mol) (95% CI -0.55% to -0.45%; -6.0 mmol/mol to -4.9 mmol/mol; 1 study, 264 participants). Studies that measured adverse effects generally reported that no or only mild harms occurred, and any serious adverse events were similar in intervention and control arms. However, adverse effects of periodontal treatments were not evaluated in most studies.
AUTHORS' CONCLUSIONS
Our 2022 update of this review has doubled the number of included studies and participants, which has led to a change in our conclusions about the primary outcome of glycaemic control and in our level of certainty in this conclusion. We now have moderate-certainty evidence that periodontal treatment using subgingival instrumentation improves glycaemic control in people with both periodontitis and diabetes by a clinically significant amount when compared to no treatment or usual care. Further trials evaluating periodontal treatment versus no treatment/usual care are unlikely to change the overall conclusion reached in this review.
Topics: Diabetes Mellitus, Type 2; Glycated Hemoglobin; Glycemic Control; Humans; Periodontal Index; Periodontitis
PubMed: 35420698
DOI: 10.1002/14651858.CD004714.pub4 -
The Cochrane Database of Systematic... Sep 2021Dementia is a common chronic condition, mainly affecting older adults, characterised by a progressive decline in cognitive and functional abilities. Medical treatments... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dementia is a common chronic condition, mainly affecting older adults, characterised by a progressive decline in cognitive and functional abilities. Medical treatments for dementia are limited. Cannabinoids are being investigated for the treatment of dementia.
OBJECTIVES
To determine the efficacy and safety of cannabinoids for the treatment of dementia.
SEARCH METHODS
We searched ALOIS - the Cochrane Dementia and Cognitive Improvement Group's Specialised Register - on 8 July 2021, using the terms cannabis or cannabinoid or endocannabinoid or cannabidiol or THC or CBD or dronabinol or delta-9-tetrahydrocannabinol or marijuana or marihuana or hashish. The register contains records from all major healthcare databases (the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, LILACS), as well as from many clinical trials registries and grey literature sources.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) of cannabinoids for the treatment of dementia. We included participants of any age and of either sex with diagnosed dementia of any subtype, or with unspecified dementia of any severity, from any setting. We considered studies of cannabinoids administered by any route, at any dose, for any duration, compared with placebo, no treatment, or any active control intervention.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened and selected studies for inclusion, extracted data, and assessed the risk of bias in included studies. When necessary, other review authors were involved in reaching consensus decisions. We conducted meta-analyses using a generic inverse variance fixed-effect model to derive estimates of effect size. We used GRADE methods to assess our confidence in the effect estimates.
MAIN RESULTS
We included four studies (126 participants) in this review. Most participants had Alzheimer's disease; a few had vascular dementia or mixed dementia. Three studies had low risk of bias across all domains; one study had unclear risk of bias for the majority of domains. The included studies tested natural delta-9-tetrahydrocannabinol (THC) (Namisol) and two types of synthetic THC analogue (dronabinol and nabilone). Three trials had a cross-over design. Interventions were applied over 3 to 14 weeks; one study reported adverse events over 70 weeks of follow-up. One trial was undertaken in the USA, one in Canada, and two in The Netherlands. Two studies reported non-commercial funding, and two studies were conducted with the support of both commercial and non-commercial funding. Primary outcomes in this review were changes in global and specific cognitive function, overall behavioural and psychological symptoms of dementia (BPSD), and adverse events. We found very low-certainty evidence suggesting there may be little or no clinically important effect of a synthetic THC analogue on cognition assessed with the standardised Mini-Mental State Examination (sMMSE) (mean difference (MD) 1.1 points, 95% confidence interval (CI) 0.1 to 2.1; 1 cross-over trial, 28 participants). We found low-certainty evidence suggesting there may be little or no clinically important effect of cannabinoids on overall behavioural and psychological symptoms of dementia assessed with the Neuropsychiatric Inventory (or its modified nursing home version) (MD -1.97, 95% CI -3.87 to -0.07; 1 parallel group and 2 cross-over studies, 110 participants). All included studies reported data on adverse events. However, the total number of adverse events, the total numbers of mild and moderate adverse events, and the total number of serious adverse events (SAEs) were not reported in a way that permitted meta-analysis. There were no clear differences between groups in numbers of adverse events, with the exception of sedation (including lethargy), which was more frequent among participants taking nabilone (N = 17) than placebo (N = 6) (odds ratio (OR) 2.83, 95% CI 1.07 to 7.48; 1 cross-over study, 38 participants). We judged the certainty of evidence for adverse event outcomes to be low or very low due to serious concerns regarding imprecision and indirectness.
AUTHORS' CONCLUSIONS
Based on data from four small, short, and heterogeneous placebo-controlled trials, we cannot be certain whether cannabinoids have any beneficial or harmful effects on dementia. If there are benefits of cannabinoids for people with dementia, the effects may be too small to be clinically meaningful. Adequately powered, methodologically robust trials with longer follow-up are needed to properly assess the effects of cannabinoids in dementia.
Topics: Activities of Daily Living; Aged; Alzheimer Disease; Cannabidiol; Cannabinoids; Dementia, Vascular; Humans
PubMed: 34532852
DOI: 10.1002/14651858.CD012820.pub2 -
The Cochrane Database of Systematic... Aug 2021Traditionally, amalgam has been used for filling cavities in posterior teeth, and it continues to be the restorative material of choice in some low- and middle-income... (Review)
Review
BACKGROUND
Traditionally, amalgam has been used for filling cavities in posterior teeth, and it continues to be the restorative material of choice in some low- and middle-income countries due to its effectiveness and relatively low cost. However, there are concerns over the use of amalgam restorations (fillings) with regard to mercury release in the body and the environmental impact of mercury disposal. Dental composite resin materials are an aesthetic alternative to amalgam, and their mechanical properties have developed sufficiently to make them suitable for restoring posterior teeth. Nevertheless, composite resin materials may have potential for toxicity to human health and the environment. The United Nations Environment Programme has established the Minamata Convention on Mercury, which is an international treaty that aims "to protect the [sic] human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds". It entered into force in August 2017, and as of February 2021 had been ratified by 127 governments. Ratification involves committing to the adoption of at least two of nine proposed measures to phase down the use of mercury, including amalgam in dentistry. In light of this, we have updated a review originally published in 2014, expanding the scope of the review by undertaking an additional search for harms outcomes. Our review synthesises the results of studies that evaluate the long-term effectiveness and safety of amalgam versus composite resin restorations, and evaluates the level of certainty we can have in that evidence.
OBJECTIVES
To examine the effects (i.e. efficacy and safety) of direct composite resin fillings versus amalgam fillings.
SEARCH METHODS
An information specialist searched five bibliographic databases up to 16 February 2021 and used additional search methods to identify published, unpublished and ongoing studies SELECTION CRITERIA: To assess efficacy, we included randomised controlled trials (RCTs) comparing dental composite resin with amalgam restorations in permanent posterior teeth that assessed restoration failure or survival at follow-up of at least three years. To assess safety, we sought non-randomised studies in addition to RCTs that directly compared composite resin and amalgam restorative materials and measured toxicity, sensitivity, allergy, or injury.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included a total of eight studies in this updated review, all of which were RCTs. Two studies used a parallel-group design, and six used a split-mouth design. We judged all of the included studies to be at high risk of bias due to lack of blinding and issues related to unit of analysis. We identified one new trial since the previous version of this review (2014), as well as eight additional papers that assessed safety, all of which related to the two parallel-group studies that were already included in the review. For our primary meta-analyses, we combined data from the two parallel-group trials, which involved 1645 composite restorations and 1365 amalgam restorations in 921 children. We found low-certainty evidence that composite resin restorations had almost double the risk of failure compared to amalgam restorations (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.52 to 2.35; P < 0.001), and were at much higher risk of secondary caries (RR 2.14, 95% CI 1.67 to 2.74; P < 0.001). We found low-certainty evidence that composite resin restorations were not more likely to result in restoration fracture (RR 0.87, 95% CI 0.46 to 1.64; P = 0.66). Six trials used a split-mouth design. We considered these studies separately, as their reliability was compromised due to poor reporting, unit of analysis errors, and variability in methods and findings. Subgroup analysis showed that the findings were consistent with the results of the parallel-group studies. Three trials investigated possible harms of dental restorations. Higher urinary mercury levels were reported amongst children with amalgam restorations in two trials, but the levels were lower than what is known to be toxic. Some differences between amalgam and composite resin groups were observed on certain measures of renal, neuropsychological, and psychosocial function, physical development, and postoperative sensitivity; however, no consistent or clinically important harms were found. We considered that the vast number of comparisons made false-positive results likely. There was no evidence of differences between the amalgam and composite resin groups in neurological symptoms, immune function, and urinary porphyrin excretion. The evidence is of very low certainty, with most harms outcomes reported in only one trial.
AUTHORS' CONCLUSIONS
Low-certainty evidence suggests that composite resin restorations may have almost double the failure rate of amalgam restorations. The risk of restoration fracture does not seem to be higher with composite resin restorations, but there is a much higher risk of developing secondary caries. Very low-certainty evidence suggests that there may be no clinically important differences in the safety profile of amalgam compared with composite resin dental restorations. This review supports the utility of amalgam restorations, and the results may be particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries. Of note, however, is that composite resin materials have undergone important improvements in the years since the trials informing the primary analyses for this review were conducted. The global phase-down of dental amalgam via the Minamata Convention on Mercury is an important consideration when deciding between amalgam and composite resin dental materials. The choice of which dental material to use will depend on shared decision-making between dental providers and patients in the clinic setting, and local directives and protocols.
Topics: Bias; Child; Composite Resins; Dental Amalgam; Dental Caries; Dentition, Permanent; Humans; Randomized Controlled Trials as Topic
PubMed: 34387873
DOI: 10.1002/14651858.CD005620.pub3 -
The Cochrane Database of Systematic... Feb 2023Myopia is a common refractive error, where elongation of the eyeball causes distant objects to appear blurred. The increasing prevalence of myopia is a growing global... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Myopia is a common refractive error, where elongation of the eyeball causes distant objects to appear blurred. The increasing prevalence of myopia is a growing global public health problem, in terms of rates of uncorrected refractive error and significantly, an increased risk of visual impairment due to myopia-related ocular morbidity. Since myopia is usually detected in children before 10 years of age and can progress rapidly, interventions to slow its progression need to be delivered in childhood.
OBJECTIVES
To assess the comparative efficacy of optical, pharmacological and environmental interventions for slowing myopia progression in children using network meta-analysis (NMA). To generate a relative ranking of myopia control interventions according to their efficacy. To produce a brief economic commentary, summarising the economic evaluations assessing myopia control interventions in children. To maintain the currency of the evidence using a living systematic review approach. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE; Embase; and three trials registers. The search date was 26 February 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of optical, pharmacological and environmental interventions for slowing myopia progression in children aged 18 years or younger. Critical outcomes were progression of myopia (defined as the difference in the change in spherical equivalent refraction (SER, dioptres (D)) and axial length (mm) in the intervention and control groups at one year or longer) and difference in the change in SER and axial length following cessation of treatment ('rebound'). DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. We assessed bias using RoB 2 for parallel RCTs. We rated the certainty of evidence using the GRADE approach for the outcomes: change in SER and axial length at one and two years. Most comparisons were with inactive controls.
MAIN RESULTS
We included 64 studies that randomised 11,617 children, aged 4 to 18 years. Studies were mostly conducted in China or other Asian countries (39 studies, 60.9%) and North America (13 studies, 20.3%). Fifty-seven studies (89%) compared myopia control interventions (multifocal spectacles, peripheral plus spectacles (PPSL), undercorrected single vision spectacles (SVLs), multifocal soft contact lenses (MFSCL), orthokeratology, rigid gas-permeable contact lenses (RGP); or pharmacological interventions (including high- (HDA), moderate- (MDA) and low-dose (LDA) atropine, pirenzipine or 7-methylxanthine) against an inactive control. Study duration was 12 to 36 months. The overall certainty of the evidence ranged from very low to moderate. Since the networks in the NMA were poorly connected, most estimates versus control were as, or more, imprecise than the corresponding direct estimates. Consequently, we mostly report estimates based on direct (pairwise) comparisons below. At one year, in 38 studies (6525 participants analysed), the median change in SER for controls was -0.65 D. The following interventions may reduce SER progression compared to controls: HDA (mean difference (MD) 0.90 D, 95% confidence interval (CI) 0.62 to 1.18), MDA (MD 0.65 D, 95% CI 0.27 to 1.03), LDA (MD 0.38 D, 95% CI 0.10 to 0.66), pirenzipine (MD 0.32 D, 95% CI 0.15 to 0.49), MFSCL (MD 0.26 D, 95% CI 0.17 to 0.35), PPSLs (MD 0.51 D, 95% CI 0.19 to 0.82), and multifocal spectacles (MD 0.14 D, 95% CI 0.08 to 0.21). By contrast, there was little or no evidence that RGP (MD 0.02 D, 95% CI -0.05 to 0.10), 7-methylxanthine (MD 0.07 D, 95% CI -0.09 to 0.24) or undercorrected SVLs (MD -0.15 D, 95% CI -0.29 to 0.00) reduce progression. At two years, in 26 studies (4949 participants), the median change in SER for controls was -1.02 D. The following interventions may reduce SER progression compared to controls: HDA (MD 1.26 D, 95% CI 1.17 to 1.36), MDA (MD 0.45 D, 95% CI 0.08 to 0.83), LDA (MD 0.24 D, 95% CI 0.17 to 0.31), pirenzipine (MD 0.41 D, 95% CI 0.13 to 0.69), MFSCL (MD 0.30 D, 95% CI 0.19 to 0.41), and multifocal spectacles (MD 0.19 D, 95% CI 0.08 to 0.30). PPSLs (MD 0.34 D, 95% CI -0.08 to 0.76) may also reduce progression, but the results were inconsistent. For RGP, one study found a benefit and another found no difference with control. We found no difference in SER change for undercorrected SVLs (MD 0.02 D, 95% CI -0.05 to 0.09). At one year, in 36 studies (6263 participants), the median change in axial length for controls was 0.31 mm. The following interventions may reduce axial elongation compared to controls: HDA (MD -0.33 mm, 95% CI -0.35 to 0.30), MDA (MD -0.28 mm, 95% CI -0.38 to -0.17), LDA (MD -0.13 mm, 95% CI -0.21 to -0.05), orthokeratology (MD -0.19 mm, 95% CI -0.23 to -0.15), MFSCL (MD -0.11 mm, 95% CI -0.13 to -0.09), pirenzipine (MD -0.10 mm, 95% CI -0.18 to -0.02), PPSLs (MD -0.13 mm, 95% CI -0.24 to -0.03), and multifocal spectacles (MD -0.06 mm, 95% CI -0.09 to -0.04). We found little or no evidence that RGP (MD 0.02 mm, 95% CI -0.05 to 0.10), 7-methylxanthine (MD 0.03 mm, 95% CI -0.10 to 0.03) or undercorrected SVLs (MD 0.05 mm, 95% CI -0.01 to 0.11) reduce axial length. At two years, in 21 studies (4169 participants), the median change in axial length for controls was 0.56 mm. The following interventions may reduce axial elongation compared to controls: HDA (MD -0.47mm, 95% CI -0.61 to -0.34), MDA (MD -0.33 mm, 95% CI -0.46 to -0.20), orthokeratology (MD -0.28 mm, (95% CI -0.38 to -0.19), LDA (MD -0.16 mm, 95% CI -0.20 to -0.12), MFSCL (MD -0.15 mm, 95% CI -0.19 to -0.12), and multifocal spectacles (MD -0.07 mm, 95% CI -0.12 to -0.03). PPSL may reduce progression (MD -0.20 mm, 95% CI -0.45 to 0.05) but results were inconsistent. We found little or no evidence that undercorrected SVLs (MD -0.01 mm, 95% CI -0.06 to 0.03) or RGP (MD 0.03 mm, 95% CI -0.05 to 0.12) reduce axial length. There was inconclusive evidence on whether treatment cessation increases myopia progression. Adverse events and treatment adherence were not consistently reported, and only one study reported quality of life. No studies reported environmental interventions reporting progression in children with myopia, and no economic evaluations assessed interventions for myopia control in children.
AUTHORS' CONCLUSIONS
Studies mostly compared pharmacological and optical treatments to slow the progression of myopia with an inactive comparator. Effects at one year provided evidence that these interventions may slow refractive change and reduce axial elongation, although results were often heterogeneous. A smaller body of evidence is available at two or three years, and uncertainty remains about the sustained effect of these interventions. Longer-term and better-quality studies comparing myopia control interventions used alone or in combination are needed, and improved methods for monitoring and reporting adverse effects.
Topics: Humans; Child; Network Meta-Analysis; Myopia; Refractive Errors; Atropine; Refraction, Ocular
PubMed: 36809645
DOI: 10.1002/14651858.CD014758.pub2 -
Breast Cancer Research and Treatment Jan 2023Breast cancer is the most prevalent malignancy in women. Prehabilitation may offer improvements in physical and psychological wellbeing among participants prior to... (Review)
Review
PURPOSE
Breast cancer is the most prevalent malignancy in women. Prehabilitation may offer improvements in physical and psychological wellbeing among participants prior to treatment. This systematic review aimed to determine the efficacy of prehabilitation in participants diagnosed with breast cancer.
METHODS
A systematic review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Guidelines. Studies exploring the impact of prehabilitation in participants with breast cancer were included. Studies were assessed independently according to pre-eligibility criteria, with data extraction and methodological quality assessed in parallel.
RESULTS
3184 records were identified according to our search criteria, and 14 articles were included. Articles comprised of quantitative randomised controlled trials (n = 7), quantitative non-randomised studies (n = 5), a qualitative study (n = 1), and a mixed-method study (n = 1). The majority of selected studies completed exercise programs (n = 4) or had exercise components (n = 2), with two focusing on upper-limb exercise. Five articles reported complementary and alternative therapies (n = 5). Two articles reported smoking cessation (n = 2), with a single study reporting multi-modal prehabilitation (n = 1). Mostly, prehabilitation improved outcomes including physical function, quality of life, and psychosocial variables (P < 0.05). The qualitative data identified preferences for multimodal prehabilitation, compared to unimodal with an interest in receiving support for longer.
CONCLUSIONS
Prehabilitation for patients with breast cancer is an emerging research area that appears to improve outcomes, however, ensuring that adequate intervention timeframes, follow-up, and population groups should be considered for future investigations.
IMPLICATIONS FOR CANCER SURVIVORS
The implementation of prehabilitation interventions for individuals diagnosed with breast cancer should be utilised by multidisciplinary teams to provide holistic care to patients as it has the potential to improve outcomes across the cancer care trajectory.
Topics: Female; Humans; Breast Neoplasms; Delivery of Health Care; Exercise; Preoperative Exercise; Quality of Life; Randomized Controlled Trials as Topic; Controlled Clinical Trials as Topic
PubMed: 36269525
DOI: 10.1007/s10549-022-06759-1 -
The Cochrane Database of Systematic... Apr 2022Tracheal intubation is a common procedure performed to secure the airway in adults undergoing surgery or those who are critically ill. Intubation is sometimes associated... (Review)
Review
BACKGROUND
Tracheal intubation is a common procedure performed to secure the airway in adults undergoing surgery or those who are critically ill. Intubation is sometimes associated with difficulties and complications that may result in patient harm. While it is traditionally achieved by performing direct laryngoscopy, the past three decades have seen the advent of rigid indirect videolaryngoscopes (VLs). A mounting body of evidence comparing the two approaches to tracheal intubation has been acquired over this period of time. This is an update of a Cochrane Review first published in 2016.
OBJECTIVES
To assess whether use of different designs of VLs in adults requiring tracheal intubation reduces the failure rate compared with direct laryngoscopy, and assess the benefits and risks of these devices in selected population groups, users and settings.
SEARCH METHODS
We searched MEDLINE, Embase, CENTRAL and Web of Science on 27 February 2021. We also searched clinical trials databases, conference proceedings and conducted forward and backward citation searches.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs with adults undergoing laryngoscopy performed with either a VL or a Macintosh direct laryngoscope (DL) in any clinical setting. We included parallel and cross-over study designs.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We collected data for the following outcomes: failed intubation, hypoxaemia, successful first attempt at tracheal intubation, oesophageal intubation, dental trauma, Cormack-Lehane grade, and time for tracheal intubation.
MAIN RESULTS
We included 222 studies (219 RCTs, three quasi-RCTs) with 26,149 participants undergoing tracheal intubation. Most studies recruited adults undergoing elective surgery requiring tracheal intubation. Twenty-one studies recruited participants with a known or predicted difficult airway, and an additional 25 studies simulated a difficult airway. Twenty-one studies were conducted outside the operating theatre environment; of these, six were in the prehospital setting, seven in the emergency department and eight in the intensive care unit. We report here the findings of the three main comparisons according to videolaryngoscopy device type. We downgraded the certainty of the outcomes for imprecision, study limitations (e.g. high or unclear risks of bias), inconsistency when we noted substantial levels of statistical heterogeneity and publication bias. Macintosh-style videolaryngoscopy versus direct laryngoscopy (61 studies, 9883 participants) We found moderate-certainty evidence that a Macintosh-style VL probably reduces rates of failed intubation (risk ratio (RR) 0.41, 95% confidence interval (CI) 0.26 to 0.65; 41 studies, 4615 participants) and hypoxaemia (RR 0.72, 95% CI 0.52 to 0.99; 16 studies, 2127 participants). These devices may also increase rates of success on the first intubation attempt (RR 1.05, 95% CI 1.02 to 1.09; 42 studies, 7311 participants; low-certainty evidence) and probably improve glottic view when assessed as Cormack-Lehane grade 3 and 4 (RR 0.38, 95% CI 0.29 to 0.48; 38 studies, 4368 participants; moderate-certainty evidence). We found little or no clear difference in rates of oesophageal intubation (RR 0.51, 95% CI 0.22 to 1.21; 14 studies, 2404 participants) but this finding was supported by low-certainty evidence. We were unsure of the findings for dental trauma because the certainty of this evidence was very low (RR 0.68, 95% CI 0.16 to 2.89; 18 studies, 2297 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I = 96%). Hyperangulated videolaryngoscopy versus direct laryngoscopy (96 studies, 11,438 participants) We found moderate-certainty evidence that hyperangulated VLs probably reduce rates of failed intubation (RR 0.51, 95% CI 0.34 to 0.76; 63 studies, 7146 participants) and oesophageal intubation (RR 0.39, 95% CI 0.18 to 0.81; 14 studies, 1968 participants). In subgroup analysis, we noted that hyperangulated VLs were more likely to reduce failed intubation when used on known or predicted difficult airways (RR 0.29, 95% CI 0.17 to 0.48; P = 0.03 for subgroup differences; 15 studies, 1520 participants). We also found that these devices may increase rates of success on the first intubation attempt (RR 1.03, 95% CI 1.00 to 1.05; 66 studies, 8086 participants; low-certainty evidence) and the glottic view is probably also improved (RR 0.15, 95% CI 0.10 to 0.24; 54 studies, 6058 participants; data for Cormack-Lehane grade 3/4 views; moderate-certainty evidence). However, we found low-certainty evidence of little or no clear difference in rates of hypoxaemia (RR 0.49, 95% CI 0.22 to 1.11; 15 studies, 1691 participants), and the findings for dental trauma were unclear because the certainty of this evidence was very low (RR 0.51, 95% CI 0.16 to 1.59; 30 studies, 3497 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I = 99%). Channelled videolaryngoscopy versus direct laryngoscopy (73 studies, 7165 participants) We found moderate-certainty evidence that channelled VLs probably reduce rates of failed intubation (RR 0.43, 95% CI 0.30 to 0.61; 53 studies, 5367 participants) and hypoxaemia (RR 0.25, 95% CI 0.12 to 0.50; 15 studies, 1966 participants). They may also increase rates of success on the first intubation attempt (RR 1.10, 95% CI 1.05 to 1.15; 47 studies, 5210 participants; very low-certainty evidence) and probably improve glottic view (RR 0.14, 95% CI 0.09 to 0.21; 40 studies, 3955 participants; data for Cormack-Lehane grade 3/4 views; moderate-certainty evidence). We found little or no clear difference in rates of oesophageal intubation (RR 0.54, 95% CI 0.17 to 1.75; 16 studies, 1756 participants) but this was supported by low-certainty evidence. We were unsure of the findings for dental trauma because the certainty of the evidence was very low (RR 0.52, 95% CI 0.13 to 2.12; 29 studies, 2375 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I = 98%).
AUTHORS' CONCLUSIONS
VLs of all designs likely reduce rates of failed intubation and result in higher rates of successful intubation on the first attempt with improved glottic views. Macintosh-style and channelled VLs likely reduce rates of hypoxaemic events, while hyperangulated VLs probably reduce rates of oesophageal intubation. We conclude that videolaryngoscopy likely provides a safer risk profile compared to direct laryngoscopy for all adults undergoing tracheal intubation.
Topics: Adult; Critical Illness; Humans; Intubation, Intratracheal; Laryngoscopes; Laryngoscopy
PubMed: 35373840
DOI: 10.1002/14651858.CD011136.pub3 -
The Cochrane Database of Systematic... Feb 2021Coenzyme Q10, or ubiquinone, is a non-prescription nutritional supplement. It is a fat-soluble molecule that acts as an electron carrier in mitochondria, and as a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Coenzyme Q10, or ubiquinone, is a non-prescription nutritional supplement. It is a fat-soluble molecule that acts as an electron carrier in mitochondria, and as a coenzyme for mitochondrial enzymes. Coenzyme Q10 deficiency may be associated with a multitude of diseases, including heart failure. The severity of heart failure correlates with the severity of coenzyme Q10 deficiency. Emerging data suggest that the harmful effects of reactive oxygen species are increased in people with heart failure, and coenzyme Q10 may help to reduce these toxic effects because of its antioxidant activity. Coenzyme Q10 may also have a role in stabilising myocardial calcium-dependent ion channels, and in preventing the consumption of metabolites essential for adenosine-5'-triphosphate (ATP) synthesis. Coenzyme Q10, although not a primary recommended treatment, could be beneficial to people with heart failure. Several randomised controlled trials have compared coenzyme Q10 to other therapeutic modalities, but no systematic review of existing randomised trials was conducted prior to the original version of this Cochrane Review, in 2014.
OBJECTIVES
To review the safety and efficacy of coenzyme Q10 in heart failure.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, Web of Science, CINAHL Plus, and AMED on 16 October 2020; ClinicalTrials.gov on 16 July 2020, and the ISRCTN Registry on 11 November 2019. We applied no language restrictions.
SELECTION CRITERIA
We included randomised controlled trials of either parallel or cross-over design that assessed the beneficial and harmful effects of coenzyme Q10 in people with heart failure. When we identified cross-over studies, we considered data only from the first phase.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods, assessed study risk of bias using the Cochrane 'Risk of bias' tool, and GRADE methods to assess the quality of the evidence. For dichotomous data, we calculated the risk ratio (RR); for continuous data, the mean difference (MD), both with 95% confidence intervals (CI). Where appropriate data were available, we conducted meta-analysis. When meta-analysis was not possible, we wrote a narrative synthesis. We provided a PRISMA flow chart to show the flow of study selection.
MAIN RESULTS
We included eleven studies, with 1573 participants, comparing coenzyme Q10 to placebo or conventional therapy (control). In the majority of the studies, sample size was relatively small. There were important differences among studies in daily coenzyme Q10 dose, follow-up period, and the measures of treatment effect. All studies had unclear, or high risk of bias, or both, in one or more bias domains. We were only able to conduct meta-analysis for some of the outcomes. None of the included trials considered quality of life, measured on a validated scale, exercise variables (exercise haemodynamics), or cost-effectiveness. Coenzyme Q10 probably reduces the risk of all-cause mortality more than control (RR 0.58, 95% CI 0.35 to 0.95; 1 study, 420 participants; number needed to treat for an additional beneficial outcome (NNTB) 13.3; moderate-quality evidence). There was low-quality evidence of inconclusive results between the coenzyme Q10 and control groups for the risk of myocardial infarction (RR 1.62, 95% CI 0.27 to 9.59; 1 study, 420 participants), and stroke (RR 0.18, 95% CI 0.02 to 1.48; 1 study, 420 participants). Coenzyme Q10 probably reduces hospitalisation related to heart failure (RR 0.62, 95% CI 0.49 to 0.78; 2 studies, 1061 participants; NNTB 9.7; moderate-quality evidence). Very low-quality evidence suggests that coenzyme Q10 may improve the left ventricular ejection fraction (MD 1.77, 95% CI 0.09 to 3.44; 7 studies, 650 participants), but the results are inconclusive for exercise capacity (MD 48.23, 95% CI -24.75 to 121.20; 3 studies, 91 participants); and the risk of developing adverse events (RR 0.70, 95% CI 0.45 to 1.10; 2 studies, 568 participants). We downgraded the quality of the evidence mainly due to high risk of bias and imprecision.
AUTHORS' CONCLUSIONS
The included studies provide moderate-quality evidence that coenzyme Q10 probably reduces all-cause mortality and hospitalisation for heart failure. There is low-quality evidence of inconclusive results as to whether coenzyme Q10 has an effect on the risk of myocardial infarction, or stroke. Because of very low-quality evidence, it is very uncertain whether coenzyme Q10 has an effect on either left ventricular ejection fraction or exercise capacity. There is low-quality evidence that coenzyme Q10 may increase the risk of adverse effects, or have little to no difference. There is currently no convincing evidence to support or refute the use of coenzyme Q10 for heart failure. Future trials are needed to confirm our findings.
Topics: Ataxia; Heart Failure; Humans; Mitochondrial Diseases; Muscle Weakness; Myocardial Infarction; Quality of Life; Stroke; Stroke Volume; Ubiquinone; Ventricular Function, Left
PubMed: 35608922
DOI: 10.1002/14651858.CD008684.pub3 -
European Journal of Nutrition Sep 2021This review provides an updated overview of observational and intervention studies investigating the effect of a low-FODMAP (fermentable oligo-, di- and monosaccharides,... (Meta-Analysis)
Meta-Analysis
PURPOSE
This review provides an updated overview of observational and intervention studies investigating the effect of a low-FODMAP (fermentable oligo-, di- and monosaccharides, and polyols) diet (LFD) on gastrointestinal (GI) symptoms, quality of life (QoL), nutritional adequacy, and gut microbiome in irritable bowel syndrome (IBS) patients.
METHODS
We systematically searched available literature until October 2020 for studies that investigated the effect of LFDs on GI symptoms, QoL, nutritional adequacy, and the gut microbiome in IBS patients. The data were represented as standardized mean differences (SMD) for IBS severity, and as mean differences (MD) for IBS-QoL. Meta-analyses were performed for the quantitative analyses using random effects models with inverse variance weighing.
RESULTS
Twelve papers (nine parallel trials, three crossover studies) were included for the meta-analysis. The LFD reduced IBS severity by a moderate-to-large extent as compared to a control diet (SMD - 0.66, 95% CI - 0.88, - 0.44, I = 54%). When analyzing only studies that used the validated IBS-SSS questionnaire, a mean reduction of 45 points (95% CI - 77, - 14; I = 89%) was observed. Subgroup analyses on adherence, age, intervention duration, IBS subtype, outcome measure, and risk of bias revealed no significantly different results. The LFD also increased IBS-QoL scores, when compared with a control diet (MD 4.93; 95% CI 1.77, 8.08; I = 42%).
CONCLUSIONS
The low-FODMAP diet reduces GI symptoms and improves quality of life in IBS subjects as compared to control diets. Future work is required to obtain definitive answers regarding potential long-term effects of such diets on nutritional adequacy and the gut microbiome.
PROSPERO REGISTRATION NUMBER
CRD42020175157.
Topics: Adult; Diet; Diet, Carbohydrate-Restricted; Disaccharides; Fermentation; Humans; Irritable Bowel Syndrome; Monosaccharides; Oligosaccharides; Quality of Life
PubMed: 33585949
DOI: 10.1007/s00394-020-02473-0