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The Lancet. Gastroenterology &... Jan 2023The global burden of non-alcoholic fatty liver disease (NAFLD) parallels the increase in obesity rates across the world. Although overweight and obesity status are... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The global burden of non-alcoholic fatty liver disease (NAFLD) parallels the increase in obesity rates across the world. Although overweight and obesity status are thought to be an effective indicator for NAFLD screening, the exact prevalence of NAFLD in this population remains unknown. We aimed to report the prevalence of NAFLD, non-alcoholic fatty liver (NAFL), and non-alcoholic steatohepatitis (NASH) in the overweight and obese population.
METHODS
In this systematic review and meta-analysis, we searched Medline and Embase from database inception until March 6, 2022, using search terms including but not limited to "non-alcoholic fatty liver disease", "overweight", "obesity", and "prevalence". Cross-sectional and longitudinal observational studies published after Jan 1, 2000, written in or translated into English were eligible for inclusion; paediatric studies were excluded. Articles were included if the number of NAFLD, NAFL, or NASH events in an overweight and obese population could be extracted. Summary data were extracted from published reports. The primary outcomes were the prevalence of NAFLD, NAFL, and NASH in an overweight and obese population and the prevalence of fibrosis in individuals who were overweight or obese and who had NAFLD. A meta-analysis of proportions was done with the generalised linear mixed model. This study is registered with PROSPERO (CRD42022344526).
FINDINGS
The search identified 7389 articles. 151 studies met the inclusion criteria and were included in the meta-analysis. In the pooled analysis comprising 101 028 individuals, the prevalence of NAFLD in the overweight population was 69·99% (95% CI 65·40-74·21 I=99·10%), the prevalence of NAFL was 42·49% (32·55-53·08, I=96·40%), and the prevalence of NASH was 33·50% (28·38-39·04, I=95·60%). Similar prevalence estimates were reported in the obese population for NAFLD (75·27% [95% CI 70·90-79·18]; I=98·50%), NAFL (43·05% [32·78-53·97]; I=96·30%) and NASH (33·67% [28·45-39·31]; I=95·60%). The prevalence of NAFLD in the overweight population was the highest in the region of the Americas (75·34% [95% CI: 67·31-81·93]; I=99·00%). Clinically significant fibrosis (stages F2-4) was present in 20·27% (95% CI 11·32-33·62; I= 93·00%) of overweight individuals with NAFLD and in 21·60% (11·47-36·92; I=95·00%) of obese patients with NAFLD while 6·65% (4·35-10·01; I=58·00%) of overweight individuals with NAFLD and 6·85% (3·85-11·90; I=90·00%) of obese individuals with NAFLD had advanced fibrosis (stages F3-4).
INTERPRETATION
This study summarises the estimated global prevalence of NAFLD, NAFL, and NASH in overweight and obese individuals; these findings are important for improving the understanding of the global NAFLD burden and supporting disease management in the at-risk overweight and obese population.
FUNDING
None.
Topics: Humans; Child; Cross-Sectional Studies; Non-alcoholic Fatty Liver Disease; Obesity; Overweight; Fibrosis
PubMed: 36400097
DOI: 10.1016/S2468-1253(22)00317-X -
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... 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 -
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... Aug 2022Physical restraints, such as bedrails, belts in chairs or beds, and fixed tables, are commonly used for older people in general hospital settings. Reasons given for... (Review)
Review
BACKGROUND
Physical restraints, such as bedrails, belts in chairs or beds, and fixed tables, are commonly used for older people in general hospital settings. Reasons given for using physical restraints are to prevent falls and fall-related injuries, to control challenging behavior (such as agitation or wandering), and to ensure the delivery of medical treatments. Clear evidence of their effectiveness is lacking, and potential harms are recognised, including injuries associated with the use of physical restraints and a negative impact on people's well-being. There are widespread recommendations that their use should be reduced or eliminated.
OBJECTIVES
To assess the best evidence for the effects and safety of interventions aimed at preventing and reducing the use of physical restraint of older people in general hospital settings. To describe the content, components and processes of these interventions.
SEARCH METHODS
We searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register the International Clinical Trials Registry Portal on 20 April 2022.
SELECTION CRITERIA
We included randomised controlled trials and controlled clinical trials that investigated the effects of interventions that aimed to prevent or reduce the use of physical restraints in general hospital settings. Eligible settings were acute care and rehabilitation wards. We excluded emergency departments, intensive care and psychiatric units, as well as the use of restrictive measures for penal reasons (e.g. prisoners in general medical wards). We included studies with a mean age of study participants of at least 65 years. Control groups received usual care or active control interventions that were ineligible for inclusion as experimental interventions.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected the articles for inclusion, extracted data, and assessed the risk of bias of all included studies. Data were unsuitable for meta-analysis, and we reported results narratively. We used GRADE methods to describe our certainty in the results.
MAIN RESULTS
We included four studies: two randomised controlled trials (one individually-randomised, parallel-group trial and one clustered, stepped-wedge trial) and two controlled clinical trials (both with a clustered design). One study was conducted in general medical wards in Canada and three studies were conducted in rehabilitation hospitals in Hong Kong. A total of 1709 participants were included in three studies; in the fourth study the number of participants was not reported. The mean age ranged from 67 years to 84 years. The duration of follow-up covered the period of patients' hospitalisation in one study (21 days average length of stay) and ranged from 4 to 11 months in the other studies. The definition of physical restraints differed slightly, and one study did not include bedrails. Three studies investigated organisational interventions aimed at implementing a least-restraint policy to reduce physical restraints. The theoretical approach of the interventions and the content of the educational components was comparable across studies. The fourth study investigated the use of pressure sensors for participants with an increased falls risk, which gave an alarm if the participant left the bed or chair. Control groups in all studies received usual care. Three studies were at high risk of selection bias and risk of detection bias was unclear in all studies. Because of very low-certainty evidence, we are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on our primary efficacy outcome: the use of physical restraints in general hospital settings. One study found an increase in the number of participants with at least one physical restraint in the intervention and control groups, one study found a small reduction in both groups, and in the third study (the stepped-wedge study), the number of participants with at least one physical restraint decreased in all clusters after implementation of the intervention but no detailed information was reported. For the use of bed or chair pressure sensor alarms for people with an increased fall risk, we found moderate-certainty evidence of little to no effect of the intervention on the number of participants with at least one physical restraint compared with usual care. None of the studies systematically assessed adverse events related to use of physical restraint use, e.g. direct injuries, or reported such events. We are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on the number of participants with at least one fall (very low-certainty evidence), and there was no evidence that organisational interventions or the use of bed or chair pressure sensor alarms for people with an increased fall risk reduce the number of falls (low-certainty evidence from one study each). None of the studies reported fall-related injuries. We found low-certainty evidence that organisational interventions may result in little to no difference in functioning (including mobility), and moderate-certainty evidence that the use of bed or chair pressure sensor alarms has little to no effect on mobility. We are uncertain about the effect of organisational interventions on the use of psychotropic medication; one study found no difference in the prescription of psychotropic medication. We are uncertain about the effect of organisational interventions on nurses' attitudes and knowledge about the use of physical restraints (very low-certainty evidence).
AUTHORS' CONCLUSIONS
We are uncertain whether organisational interventions aimed at implementing a least-restraint policy can reduce physical restraints in general hospital settings. The use of pressure sensor alarms in beds or chairs for people with an increased fall risk has probably little to no effect on the use of physical restraints. Because of the small number of studies and the study limitations, the results should be interpreted with caution. Further research on effective strategies to implement a least-restraint policy and to overcome barriers to physical restraint reduction in general hospital settings is needed.
Topics: Aged; Emergency Service, Hospital; Hospitalization; Hospitals, General; Humans; Randomized Controlled Trials as Topic; Restraint, Physical
PubMed: 36004796
DOI: 10.1002/14651858.CD012476.pub2 -
The Cochrane Database of Systematic... May 2022Spasticity and chronic neuropathic pain are common and serious symptoms in people with multiple sclerosis (MS). These symptoms increase with disease progression and lead... (Review)
Review
BACKGROUND
Spasticity and chronic neuropathic pain are common and serious symptoms in people with multiple sclerosis (MS). These symptoms increase with disease progression and lead to worsening disability, impaired activities of daily living and quality of life. Anti-spasticity medications and analgesics are of limited benefit or poorly tolerated. Cannabinoids may reduce spasticity and pain in people with MS. Demand for symptomatic treatment with cannabinoids is high. A thorough understanding of the current body of evidence regarding benefits and harms of these drugs is required.
OBJECTIVES
To assess benefit and harms of cannabinoids, including synthetic, or herbal and plant-derived cannabinoids, for reducing symptoms for adults with MS.
SEARCH METHODS
We searched the following databases from inception to December 2021: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), CINAHL (EBSCO host), LILACS, the Physiotherapy Evidence Database (PEDro), the World Health Organisation International Clinical Trials Registry Platform, the US National Institutes of Health clinical trial register, the European Union Clinical Trials Register, the International Association for Cannabinoid Medicines databank. We hand searched citation lists of included studies and relevant reviews.
SELECTION CRITERIA
We included randomised parallel or cross-over trials (RCTs) evaluating any cannabinoid (including herbal Cannabis, Cannabis flowers, plant-based cannabinoids, or synthetic cannabinoids) irrespective of dose, route, frequency, or duration of use for adults with MS.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodology. To assess bias in included studies, we used the Cochrane Risk of bias 2 tool for parallel RCTs and crossover trials. We rated the certainty of evidence using the GRADE approach for the following outcomes: reduction of 30% in the spasticity Numeric Rating Scale, pain relief of 50% or greater in the Numeric Rating Scale-Pain Intensity, much or very much improvement in the Patient Global Impression of Change (PGIC), Health-Related Quality of Life (HRQoL), withdrawals due to adverse events (AEs) (tolerability), serious adverse events (SAEs), nervous system disorders, psychiatric disorders, physical dependence.
MAIN RESULTS
We included 25 RCTs with 3763 participants of whom 2290 received cannabinoids. Age ranged from 18 to 60 years, and between 50% and 88% participants across the studies were female. The included studies were 3 to 48 weeks long and compared nabiximols, an oromucosal spray with a plant derived equal (1:1) combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) (13 studies), synthetic cannabinoids mimicking THC (7 studies), an oral THC extract of Cannabis sativa (2 studies), inhaled herbal Cannabis (1 study) against placebo. One study compared dronabinol, THC extract of Cannabis sativa and placebo, one compared inhaled herbal Cannabis, dronabinol and placebo. We identified eight ongoing studies. Critical outcomes • Spasticity: nabiximols probably increases the number of people who report an important reduction of perceived severity of spasticity compared with placebo (odds ratio (OR) 2.51, 95% confidence interval (CI) 1.56 to 4.04; 5 RCTs, 1143 participants; I = 67%; moderate-certainty evidence). The absolute effect was 216 more people (95% CI 99 more to 332 more) per 1000 reporting benefit with cannabinoids than with placebo. • Chronic neuropathic pain: we found only one small trial that measured the number of participants reporting substantial pain relief with a synthetic cannabinoid compared with placebo (OR 4.23, 95% CI 1.11 to 16.17; 1 study, 48 participants; very low-certainty evidence). We are uncertain whether cannabinoids reduce chronic neuropathic pain intensity. • Treatment discontinuation due to AEs: cannabinoids may increase slightly the number of participants who discontinue treatment compared with placebo (OR 2.41, 95% CI 1.51 to 3.84; 21 studies, 3110 participants; I² = 17%; low-certainty evidence); the absolute effect is 39 more people (95% CI 15 more to 76 more) per 1000 people. Important outcomes • PGIC: cannabinoids probably increase the number of people who report 'very much' or 'much' improvement in health status compared with placebo (OR 1.80, 95% CI 1.37 to 2.36; 8 studies, 1215 participants; I² = 0%; moderate-certainty evidence). The absolute effect is 113 more people (95% CI 57 more to 175 more) per 1000 people reporting improvement. • HRQoL: cannabinoids may have little to no effect on HRQoL (SMD -0.08, 95% CI -0.17 to 0.02; 8 studies, 1942 participants; I = 0%; low-certainty evidence); • SAEs: cannabinoids may result in little to no difference in the number of participants who have SAEs compared with placebo (OR 1.38, 95% CI 0.96 to 1.99; 20 studies, 3124 participants; I² = 0%; low-certainty evidence); • AEs of the nervous system: cannabinoids may increase nervous system disorders compared with placebo (OR 2.61, 95% CI 1.53 to 4.44; 7 studies, 1154 participants; I² = 63%; low-certainty evidence); • Psychiatric disorders: cannabinoids may increase psychiatric disorders compared with placebo (OR 1.94, 95% CI 1.31 to 2.88; 6 studies, 1122 participants; I² = 0%; low-certainty evidence); • Drug tolerance: the evidence is very uncertain about the effect of cannabinoids on drug tolerance (OR 3.07, 95% CI 0.12 to 75.95; 2 studies, 458 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
Compared with placebo, nabiximols probably reduces the severity of spasticity in the short-term in people with MS. We are uncertain about the effect on chronic neurological pain and health-related quality of life. Cannabinoids may increase slightly treatment discontinuation due to AEs, nervous system and psychiatric disorders compared with placebo. We are uncertain about the effect on drug tolerance. The overall certainty of evidence is limited by short-term duration of the included studies.
Topics: Activities of Daily Living; Adolescent; Adult; Analgesics; Cannabinoids; Cannabis; Chronic Pain; Dronabinol; Female; Humans; Male; Middle Aged; Multiple Sclerosis; Neuralgia; Plant Extracts; Quality of Life; Young Adult
PubMed: 35510826
DOI: 10.1002/14651858.CD013444.pub2 -
Frontiers in Psychiatry 2020Duloxetine is a serotonin-norepinephrine reuptake inhibitor approved for the treatment of patients affected by major depressive disorder (MDD), generalized anxiety...
Duloxetine is a serotonin-norepinephrine reuptake inhibitor approved for the treatment of patients affected by major depressive disorder (MDD), generalized anxiety disorder (GAD), neuropathic pain (NP), fibromyalgia (FMS), and stress incontinence urinary (SUI). These conditions share parallel pathophysiological pathways, and duloxetine treatment might be an effective and safe alternative. Thus, a systematic review was conducted following the 2009 Preferred Reporting Items (PRISMA) recommendations and Joanna Briggs Institute Critical (JBI) Appraisals guidelines. Eighty-five studies focused on efficacy, safety, and tolerability of duloxetine were included in our systematic review. Studies were subdivided by clinical condition and evaluated individually. Thus, 32 studies of MDD, 11 studies of GAD, 19 studies of NP, 9 studies of FMS, and 14 studies of SUI demonstrated that the measured outcomes indicate the suitability of duloxetine in the treatment of these clinical conditions. This systematic review confirms that the dual mechanism of duloxetine benefits the treatment of comorbid clinical conditions, and supports the efficacy, safety, and tolerability of duloxetine in short- and long-term treatments.
PubMed: 33192668
DOI: 10.3389/fpsyt.2020.554899 -
The Cochrane Database of Systematic... Jul 2020Pathology relating to mandibular wisdom teeth is a frequent presentation to oral and maxillofacial surgeons, and surgical removal of mandibular wisdom teeth is a common... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pathology relating to mandibular wisdom teeth is a frequent presentation to oral and maxillofacial surgeons, and surgical removal of mandibular wisdom teeth is a common operation. The indications for surgical removal of these teeth are alleviation of local pain, swelling and trismus, and also the prevention of spread of infection that may occasionally threaten life. Surgery is commonly associated with short-term postoperative pain, swelling and trismus. Less frequently, infection, dry socket (alveolar osteitis) and trigeminal nerve injuries may occur. This review focuses on the optimal methods in order to improve patient experience and minimise postoperative morbidity.
OBJECTIVES
To compare the relative benefits and risks of different techniques for surgical removal of mandibular wisdom teeth.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health Trials Register (to 8 July 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; 2019, Issue 6), MEDLINE Ovid (1946 to 8 July 2019), and Embase Ovid (1980 to 8 July 2019). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication.
SELECTION CRITERIA
Randomised controlled trials comparing different surgical techniques for the removal of mandibular wisdom teeth.
DATA COLLECTION AND ANALYSIS
Three review authors were involved in assessing the relevance of identified studies, evaluated the risk of bias in included studies and extracted data. We used risk ratios (RRs) for dichotomous data in parallel-group trials (or Peto odds ratios if the event rate was low), odds ratios (ORs) for dichotomous data in cross-over or split-mouth studies, and mean differences (MDs) for continuous data. We took into account the pairing of the split-mouth studies in our analyses, and combined parallel-group and split-mouth studies using the generic inverse-variance method. We used the fixed-effect model for three studies or fewer, and random-effects model for more than three studies.
MAIN RESULTS
We included 62 trials with 4643 participants. Several of the trials excluded individuals who were not in excellent health. We assessed 33 of the studies (53%) as being at high risk of bias and 29 as unclear. We report results for our primary outcomes below. Comparisons of different suturing techniques and of drain versus no drain did not report any of our primary outcomes. No studies provided useable data for any of our primary outcomes in relation to coronectomy. There is insufficient evidence to determine whether envelope or triangular flap designs led to more alveolar osteitis (OR 0.33, 95% confidence interval (CI) 0.09 to 1.23; 5 studies; low-certainty evidence), wound infection (OR 0.29, 95% CI 0.04 to 2.06; 2 studies; low-certainty evidence), or permanent altered tongue sensation (Peto OR 4.48, 95% CI 0.07 to 286.49; 1 study; very low-certainty evidence). In terms of other adverse effects, two studies reported wound dehiscence at up to 30 days after surgery, but found no difference in risk between interventions. There is insufficient evidence to determine whether the use of a lingual retractor affected the risk of permanent altered sensation compared to not using one (Peto OR 0.14, 95% CI 0.00 to 6.82; 1 study; very low-certainty evidence). None of our other primary outcomes were reported by studies included in this comparison. There is insufficient evidence to determine whether lingual split with chisel is better than a surgical hand-piece for bone removal in terms of wound infection (OR 1.00, 95% CI 0.31 to 3.21; 1 study; very low-certainty evidence). Alveolar osteitis, permanent altered sensation, and other adverse effects were not reported. There is insufficient evidence to determine whether there is any difference in alveolar osteitis according to irrigation method (mechanical versus manual: RR 0.33, 95% CI 0.01 to 8.09; 1 study) or irrigation volume (high versus low; RR 0.52, 95% CI 0.27 to 1.02; 1 study), or whether there is any difference in postoperative infection according to irrigation method (mechanical versus manual: RR 0.50, 95% CI 0.05 to 5.43; 1 study) or irrigation volume (low versus high; RR 0.17, 95% CI 0.02 to 1.37; 1 study) (all very low-certainty evidence). These studies did not report permanent altered sensation and adverse effects. There is insufficient evidence to determine whether primary or secondary wound closure led to more alveolar osteitis (RR 0.99, 95% CI 0.41 to 2.40; 3 studies; low-certainty evidence), wound infection (RR 4.77, 95% CI 0.24 to 96.34; 1 study; very low-certainty evidence), or adverse effects (bleeding) (RR 0.41, 95% CI 0.11 to 1.47; 1 study; very low-certainty evidence). These studies did not report permanent sensation changes. Placing platelet rich plasma (PRP) or platelet rich fibrin (PRF) in sockets may reduce the incidence of alveolar osteitis (OR 0.39, 95% CI 0.22 to 0.67; 2 studies), but the evidence is of low certainty. Our other primary outcomes were not reported.
AUTHORS' CONCLUSIONS
In this 2020 update, we added 27 new studies to the original 35 in the 2014 review. Unfortunately, even with the addition of these studies, we have been unable to draw many meaningful conclusions. The small number of trials evaluating each comparison and reporting our primary outcomes, along with methodological biases in the included trials, means that the body of evidence for each of the nine comparisons evaluated is of low or very low certainty. Participant populations in the trials may not be representative of the general population, or even the population undergoing third molar surgery. Many trials excluded individuals who were not in good health, and several excluded those with active infection or who had deep impactions of their third molars. Consequently, we are unable to make firm recommendations to surgeons to inform their techniques for removal of mandibular third molars. The evidence is uncertain, though we note that there is some limited evidence that placing PRP or PRF in sockets may reduce the incidence of dry socket. The evidence provided in this review may be used as a guide for surgeons when selecting and refining their surgical techniques. Ongoing studies may allow us to provide more definitive conclusions in the future.
Topics: Adult; Bias; Drainage; Dry Socket; Humans; Lip; Mandible; Middle Aged; Molar, Third; Postoperative Complications; Randomized Controlled Trials as Topic; Sensation Disorders; Surgical Flaps; Surgical Wound Infection; Therapeutic Irrigation; Tongue; Tooth Extraction; Tooth, Impacted; Wound Closure Techniques; Young Adult
PubMed: 32712962
DOI: 10.1002/14651858.CD004345.pub3 -
Journal of the American Dental... Feb 2023The goal of restoring caries lesions is to protect the pulp, prevent progression of the disease process, and restore the form and function of the tooth. The purpose of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The goal of restoring caries lesions is to protect the pulp, prevent progression of the disease process, and restore the form and function of the tooth. The purpose of this systematic review was to determine the effect of different direct restorative materials for treating cavitated caries lesions on anterior and posterior primary and permanent teeth.
TYPE OF STUDIES REVIEWED
The authors included parallel and split-mouth randomized controlled trials comparing the effectiveness of direct restorative materials commercially available in the United States placed in vital, nonendodontically treated primary and permanent teeth. Pairs of reviewers independently conducted study selection, data extraction, and assessments of risk of bias and certainty of the evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. The authors conducted pair-wise meta-analyses to summarize the evidence and calculated measures of association and their 95% CIs.
RESULTS
Thirty-eight randomized controlled trials were eligible for analysis, which included data on Class I and Class II restorations on primary teeth and Class I, Class II, Class III, Class V, and root surface restorations on permanent teeth. Included studies assessed the effect of amalgam, resin composite, compomer, conventional glass ionomer cement, resin-modified glass isomer cement, and preformed metal crowns. Moderate to very low certainty evidence suggested varying levels of effectiveness across restorative materials.
CONCLUSIONS AND PRACTICAL IMPLICATIONS
Owing to a relatively low event rate across various outcomes indicating restoration failure, there was limited evidence to support important differences between direct restorative materials used in practice.
Topics: United States; Humans; Dental Restoration, Permanent; American Dental Association; Dental Caries Susceptibility; Dental Materials; Dental Caries; Composite Resins; Tooth, Deciduous; Glass Ionomer Cements
PubMed: 36610925
DOI: 10.1016/j.adaj.2022.09.012