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The Cochrane Database of Systematic... Jan 2019Laparoscopy is a common procedure in many surgical specialties. Complications arising from laparoscopy are often related to initial entry into the abdomen.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Laparoscopy is a common procedure in many surgical specialties. Complications arising from laparoscopy are often related to initial entry into the abdomen. Life-threatening complications include injury to viscera (e.g. bowel, bladder) or to vasculature (e.g. major abdominal and anterior abdominal wall vessels). No clear consensus has been reached as to the optimal method of laparoscopic entry into the peritoneal cavity.
OBJECTIVES
To evaluate the benefits and risks of different laparoscopic entry techniques in gynaecological and non-gynaecological surgery.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, and trials registers in January 2018. We also checked the references of articles retrieved.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared one laparoscopic entry technique versus another. Primary outcomes were major complications including mortality, vascular injury of major vessels and abdominal wall vessels, visceral injury of bladder or bowel, gas embolism, solid organ injury, and failed entry (inability to access the peritoneal cavity). Secondary outcomes were extraperitoneal insufflation, trocar site bleeding, trocar site infection, incisional hernia, omentum injury, and uterine bleeding.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies, assessed risk of bias, and extracted data. We expressed findings as Peto odds ratios (Peto ORs) with 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We assessed the overall quality of evidence for the main comparisons using GRADE methods.
MAIN RESULTS
The review included 57 RCTs including four multi-arm trials, with a total of 9865 participants, and evaluated 25 different laparoscopic entry techniques. Most studies selected low-risk patients, and many studies excluded patients with high body mass index (BMI) and previous abdominal surgery. Researchers did not find evidence of differences in major vascular or visceral complications, as would be anticipated given that event rates were very low and sample sizes were far too small to identify plausible differences in rare but serious adverse events.Open-entry versus closed-entryTen RCTs investigating Veress needle entry reported vascular injury as an outcome. There was a total of 1086 participants and 10 events of vascular injury were reported. Four RCTs looking at open entry technique reported vascular injury as an outcome. There was a total of 376 participants and 0 events of vascular injury were reported. This was not a direct comparison. In the direct comparison of Veress needle and Open-entry technique, there was insufficient evidence to determine whether there was a difference in rates of vascular injury (Peto OR 0.14, 95% CI 0.00 to 6.82; 4 RCTs; n = 915; I² = N/A, very low-quality evidence). Evidence was insufficient to show whether there were differences between groups for visceral injury (Peto OR 0.61, 95% CI 0.06 to 6.08; 4 RCTs; n = 915: I² = 0%; very low-quality evidence), or failed entry (Peto OR 0.45, 95% CI 0.14 to 1.42; 3 RCTs; n = 865; I² = 63%; very low-quality evidence). Two studies reported mortality with no events in either group. No studies reported gas embolism or solid organ injury.Direct trocar versus Veress needle entryTrial results show a reduction in failed entry into the abdomen with the use of a direct trocar in comparison with Veress needle entry (OR 0.24, 95% CI 0.17 to 0.34; 8 RCTs; N = 3185; I² = 45%; moderate-quality evidence). Evidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.59, 95% CI 0.18 to 1.96; 6 RCTs; n = 1603; I² = 75%; very low-quality evidence), visceral injury (Peto OR 2.02, 95% CI 0.21 to 19.42; 5 RCTs; n = 1519; I² = 25%; very low-quality evidence), or solid organ injury (Peto OR 0.58, 95% Cl 0.06 to 5.65; 3 RCTs; n = 1079; I² = 61%; very low-quality evidence). Four studies reported mortality with no events in either group. Two studies reported gas embolism, with no events in either group.Direct vision entry versus Veress needle entryEvidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.39, 95% CI 0.05 to 2.85; 1 RCT; n = 186; very low-quality evidence) or visceral injury (Peto OR 0.15, 95% CI 0.01 to 2.34; 2 RCTs; n = 380; I² = N/A; very low-quality evidence). Trials did not report our other primary outcomes.Direct vision entry versus open entryEvidence was insufficient to show whether there were differences between groups in rates of visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.50; 2 RCTs; n = 392; I² = N/A; very low-quality evidence), solid organ injury (Peto OR 6.16, 95% CI 0.12 to 316.67; 1 RCT; n = 60; very low-quality evidence), or failed entry (Peto OR 0.40, 95% CI 0.04 to 4.09; 1 RCT; n = 60; very low-quality evidence). Two studies reported vascular injury with no events in either arm. Trials did not report our other primary outcomes.Radially expanding (STEP) trocars versus non-expanding trocarsEvidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.24, 95% Cl 0.05 to 1.21; 2 RCTs; n = 331; I² = 0%; very low-quality evidence), visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.37; 2 RCTs; n = 331; very low-quality evidence), or solid organ injury (Peto OR 1.05, 95% CI 0.07 to 16.91; 1 RCT; n = 244; very low-quality evidence). Trials did not report our other primary outcomes.Other studies compared a wide variety of other laparoscopic entry techniques, but all evidence was of very low quality and evidence was insufficient to support the use of one technique over another.
AUTHORS' CONCLUSIONS
Overall, evidence was insufficient to support the use of one laparoscopic entry technique over another. Researchers noted an advantage of direct trocar entry over Veress needle entry for failed entry. Most evidence was of very low quality; the main limitations were imprecision (due to small sample sizes and very low event rates) and risk of bias associated with poor reporting of study methods.
Topics: Abdominal Wall; Blood Vessels; Female; Gynecologic Surgical Procedures; Humans; Intestines; Intraoperative Complications; Laparoscopy; Male; Peritoneal Cavity; Randomized Controlled Trials as Topic; Urinary Bladder
PubMed: 30657163
DOI: 10.1002/14651858.CD006583.pub5 -
The Cochrane Database of Systematic... Mar 2019Polycystic ovary syndrome (PCOS) affects 8% to 13% of reproductive-aged women and is associated with reproductive and metabolic dysfunction. Obesity worsens the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Polycystic ovary syndrome (PCOS) affects 8% to 13% of reproductive-aged women and is associated with reproductive and metabolic dysfunction. Obesity worsens the presentation of PCOS and weight management (weight loss, maintenance or prevention of excess weight gain) is proposed as an initial treatment strategy, best achieved through lifestyle changes incorporating diet, exercise and behavioural interventions.
OBJECTIVES
To assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life factors in PCOS.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL and AMED (date of last search March 2018). We also searched controlled trials registries, conference abstracts, relevant journals, reference lists of relevant papers and reviews, and grey literature databases, with no language restrictions applied.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing lifestyle treatment (diet, exercise, behavioural or combined treatments) to minimal or no treatment in women with PCOS.
DATA COLLECTION AND ANALYSIS
Two authors independently selected trials, assessed evidence quality and risk of bias, and extracted data. Our primary outcomes were live birth, miscarriage and pregnancy. We used inverse variance and fixed-effect models in the meta-analyses. We reported dichotomous outcomes as an odds ratio and continuous outcomes as a mean difference (MD) or standardised mean difference (SMD).
MAIN RESULTS
We included 15 studies with 498 participants. Ten studies compared physical activity to minimal dietary and behavioural intervention or no intervention. Five studies compared combined dietary, exercise and behavioural intervention to minimal intervention. One study compared behavioural intervention to minimal intervention. Risk of bias varied: eight studies had adequate sequence generation, seven had adequate clinician or outcome assessor blinding, seven had adequate allocation concealment, six had complete outcome data and six were free of selective reporting. No studies assessed the fertility primary outcomes of live birth or miscarriage. No studies reported the secondary reproductive outcome of menstrual regularity, as defined in this review.Lifestyle intervention may improve a secondary (endocrine) reproductive outcome, the free androgen index (FAI) (MD -1.11, 95% confidence interval (CI) -1.96 to -0.26, 6 RCTs, N = 204, I = 71%, low-quality evidence). Lifestyle intervention may reduce weight (kg) (MD -1.68 kg, 95% CI -2.66 to -0.70, 9 RCTs, N = 353, I = 47%, low-quality evidence). Lifestyle intervention may reduce body mass index (BMI) (kg/m) (-0.34 kg/m, 95% CI -0.68 to -0.01, 12 RCTs, N = 434, I= 0%, low-quality evidence). We are uncertain of the effect of lifestyle intervention on glucose tolerance (glucose outcomes in oral glucose tolerance test) (mmol/L/minute) (SMD -0.02, 95% CI -0.38 to 0.33, 3 RCTs, N = 121, I = 0%, low-quality evidence).
AUTHORS' CONCLUSIONS
Lifestyle intervention may improve the free androgen index (FAI), weight and BMI in women with PCOS. We are uncertain of the effect of lifestyle intervention on glucose tolerance. There were no studies that looked at the effect of lifestyle intervention on live birth, miscarriage or menstrual regularity. Most studies in this review were of low quality mainly due to high or unclear risk of bias across most domains and high heterogeneity for the FAI outcome.
Topics: Abdominal Fat; Exercise; Female; Humans; Insulin Resistance; Life Style; Obesity; Polycystic Ovary Syndrome; Randomized Controlled Trials as Topic; Virilism; Waist Circumference; Weight Loss
PubMed: 30921477
DOI: 10.1002/14651858.CD007506.pub4 -
Minerva Urologica E Nefrologica = the... Aug 2018Currently, abdominal obesity has reached an epidemic stage and obesity represents an important challenge for worldwide health authorities. Epidemiologic studies have... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Currently, abdominal obesity has reached an epidemic stage and obesity represents an important challenge for worldwide health authorities. Epidemiologic studies have demonstrated that the stone risk incidence increases with Body Mass Index, through multiple pathways. Metabolic syndrome and diabetes are associated with an increased renal stones disease incidence. The aim of this systematic review was to investigate the prevalence, morbidity, risk factors involved in the association between obesity and urolithiasis.
EVIDENCE ACQUISITION
The search involved finding relevant studies from MEDLINE, EMBASE, Ovid, the Cochrane Central Register of Controlled Trials, CINAHL, Google Scholar, and individual urological journals between January 2001 and May 2017. The inclusion criteria were for studies written in the English language, reporting on the association between obesity and urinary stones.
EVIDENCE SYNTHESIS
The underlying pathophysiology of stone formation in obese patients is thought to be related to insulin resistance, dietary factors, and a lithogenic urinary profile. Uric acid stones and calcium oxalate stones are observed frequently in these patients. Insulin resistance is thought to alter the renal acid-base metabolism, resulting in a lower urine pH, and increasing the risk of uric acid stone disease. Obesity is also associated with excess nutritional intake of lithogenic substances and with an increase in urinary tract infection incidence. Recent studies highlighted that renal stone disease increases the risk of myocardial infarction, progression of chronic kidney disease, and diabetes. Contemporary, bariatric surgery has been shown to be associated with hyperoxaluria and oxalate nephropathy. Certainly, the many health risks of obesity, including nephrolithiasis, will add more burden on urologists and nephrologists.
CONCLUSIONS
Obesity related nephrolithiasis seems to necessitate weight loss as primary treatment, but the recognition of the associated complications is necessary to prevent induction of new and equally severe medical problems. The optimal approach to obesity control that minimizes stone risk needs to be determined in order to manage obesity-induced renal stones disease.
Topics: Body Mass Index; Humans; Kidney Calculi; Obesity; Prevalence; Risk Factors; Urolithiasis
PubMed: 29856171
DOI: 10.23736/S0393-2249.18.03113-2 -
The Journals of Gerontology. Series A,... Sep 2019There is increasing use of computed tomography (CT) in sarcopenia research using a wide variety of techniques. We performed a systematic review of the CT literature to...
BACKGROUND/OBJECTIVE
There is increasing use of computed tomography (CT) in sarcopenia research using a wide variety of techniques. We performed a systematic review of the CT literature to identify the differences between approaches used.
METHODS
A comprehensive search of PubMed from 1983 to 2017 was performed to identify studies that used CT muscle measurements to assess muscle mass and myosteatosis. The CT protocols were evaluated based on anatomic landmark(s), thresholding, muscle(s) segmented, key measurement (ie, muscle attenuation, cross-sectional area, volume), derived variables, and analysis software. From the described search, 657 articles were identified and 388 studies met inclusion criteria for this systematic review.
RESULTS
Muscle mass was more commonly assessed than myosteatosis (330 vs. 125). The most commonly assessed muscle or muscle groups were total abdominal wall musculature (142/330 and 49/125 for muscle mass and myosteatosis, respectively) and total thigh musculature (90/330 and 48/125). The most commonly used landmark in the abdomen was the L3 vertebra (123/142 and 45/49 for muscle mass and myosteatosis, respectively). Skeletal muscle index and intermuscular adipose tissue were the most commonly used measures of abdominal wall muscle mass (114/142) and myosteatosis (27/49), respectively. Cut points varied across studies. A significant majority of studies failed to report important CT technical parameters, such as use of intravenous contrast and slice thickness (94% and 63%, respectively).
CONCLUSIONS
There is considerable variation in the CT approaches used for the assessment of muscle mass and myosteatosis. There is a need to develop consensus for CT-based evaluation of sarcopenia and myosteatosis.
Topics: Adipose Tissue; Body Composition; Humans; Muscle, Skeletal; Sarcopenia; Tomography, X-Ray Computed
PubMed: 30726878
DOI: 10.1093/gerona/glz034 -
Advances in Nutrition (Bethesda, Md.) Jul 2023To our knowledge, no systematic review with meta-analysis has separately synthesized the effects of Mediterranean diet-based interventions in children and adolescents in... (Meta-Analysis)
Meta-Analysis Review
Mediterranean Diet-Based Interventions to Improve Anthropometric and Obesity Indicators in Children and Adolescents: A Systematic Review with Meta-Analysis of Randomized Controlled Trials.
To our knowledge, no systematic review with meta-analysis has separately synthesized the effects of Mediterranean diet-based interventions in children and adolescents in relation to the effects on anthropometric measures. A better understanding of the effects of Mediterranean diet-based interventions on anthropometric variables could facilitate their implementation in efforts to prevent obesity in the young population. The aim of the present meta-analysis was to evaluate the effects of Mediterranean diet-based interventions on anthropometric and obesity indicators among children and adolescents. Four databases were systematically searched (PubMed, Scopus, Web of Science, and Cochrane Database of Systematic Reviews), including all studies up until 15 March, 2023. Eligible articles were randomized controlled trials measuring the effect of an intervention based on the promotion of the Mediterranean diet and obesity-associated parameters. The effect size of each study was estimated by Cohen's d for continuous variables or risk difference for categorical variables. Compared to the control group, the Mediterranean diet-based interventions showed small and significant reductions in body mass index (d = -0.14; 95% CI: -0.26, -0.01; I = 77.52%). Participants in the Mediterranean diet-based interventions had a significant reduction in the percentage of obesity (risk difference = 0.12; 95% CI: 0.01, 0.23; I = 84.56%) in comparison with the control group. Interventions had greater effects when aiming at participants with excess weight (that is, overweight or obesity), both for body mass index, waist circumference, waist-to-height ratio, percentage of obesity, and percentage of abdominal obesity. Mediterranean diet-based interventions have a significant effect on reducing the body mass index as well as reducing obesity in children and adolescents (aged 3-18 y). This trial was registered at PROSPERO as CRD42023386789.
Topics: Child; Humans; Adolescent; Pediatric Obesity; Diet, Mediterranean; Exercise; Randomized Controlled Trials as Topic; Overweight; Body Mass Index
PubMed: 37127186
DOI: 10.1016/j.advnut.2023.04.011 -
BMJ (Clinical Research Ed.) Sep 2020To quantify the association of indices of central obesity, including waist circumference, hip circumference, thigh circumference, waist-to-hip ratio, waist-to-height... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To quantify the association of indices of central obesity, including waist circumference, hip circumference, thigh circumference, waist-to-hip ratio, waist-to-height ratio, waist-to-thigh ratio, body adiposity index, and A body shape index, with the risk of all cause mortality in the general population, and to clarify the shape of the dose-response relations.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
PubMed and Scopus from inception to July 2019, and the reference lists of all related articles and reviews.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Prospective cohort studies reporting the risk estimates of all cause mortality across at least three categories of indices of central fatness. Studies that reported continuous estimation of the associations were also included.
DATA SYNTHESIS
A random effects dose-response meta-analysis was conducted to assess linear trend estimations. A one stage linear mixed effects meta-analysis was used for estimating dose-response curves.
RESULTS
Of 98 745 studies screened, 1950 full texts were fully reviewed for eligibility. The final analyses consisted of 72 prospective cohort studies with 2 528 297 participants. The summary hazard ratios were as follows: waist circumference (10 cm, 3.94 inch increase): 1.11 (95% confidence interval 1.08 to 1.13, I=88%, n=50); hip circumference (10 cm, 3.94 inch increase): 0.90 (0.81 to 0.99, I=95%, n=9); thigh circumference (5 cm, 1.97 inch increase): 0.82 (0.75 to 0.89, I=54%, n=3); waist-to-hip ratio (0.1 unit increase): 1.20 (1.15 to 1.25, I=90%, n=31); waist-to-height ratio (0.1 unit increase): 1.24 (1.12 to 1.36, I=94%, n=11); waist-to-thigh ratio (0.1 unit increase): 1.21 (1.03 to 1.39, I=97%, n=2); body adiposity index (10% increase): 1.17 (1.00 to 1.33, I=75%, n=4); and A body shape index (0.005 unit increase): 1.15 (1.10 to 1.20, I=87%, n=9). Positive associations persisted after accounting for body mass index. A nearly J shaped association was found between waist circumference and waist-to-height ratio and the risk of all cause mortality in men and women. A positive monotonic association was observed for waist-to-hip ratio and A body shape index. The association was U shaped for body adiposity index.
CONCLUSIONS
Indices of central fatness including waist circumference, waist-to-hip ratio, waist-to-height ratio, waist-to-thigh ratio, body adiposity index, and A body shape index, independent of overall adiposity, were positively and significantly associated with a higher all cause mortality risk. Larger hip circumference and thigh circumference were associated with a lower risk. The results suggest that measures of central adiposity could be used with body mass index as a supplementary approach to determine the risk of premature death.
Topics: Body Mass Index; Humans; Obesity, Abdominal; Waist Circumference; Waist-Hip Ratio
PubMed: 32967840
DOI: 10.1136/bmj.m3324 -
Obesity Reviews : An Official Journal... Aug 2022Excess visceral adiposity contributes to elevated cardiometabolic risk, and waist circumference is commonly used as a surrogate measure of visceral adipose tissue.... (Meta-Analysis)
Meta-Analysis Review
Excess visceral adiposity contributes to elevated cardiometabolic risk, and waist circumference is commonly used as a surrogate measure of visceral adipose tissue. Although regular aerobic exercise is known to improve abdominal obesity, its effect on waist circumference is unclear. A systematic review and meta-analysis was performed to determine (1) the effect of aerobic exercise on waist circumference in adults with overweight or obesity; (2) the association between any change in waist circumference and change in visceral adipose tissue and/or bodyweight with aerobic exercise interventions; and (3) if reductions in waist circumference with exercise are moderated by clinical characteristics or components of aerobic exercise prescription. Twenty-five randomized controlled trials (1686 participants) were included. Regular aerobic exercise significantly reduced waist circumference by 3.2 cm (95% confidence interval [CI] -3.86, -2.51, p ≤ 0.001) versus control. Change in waist circumference was associated with change in visceral adipose tissue (β = 4.02; 95% CI 1.37, 6.66, p = 0.004), and vigorous intensity produced superior reduction (-4.2 cm, 95% CI -4.99, -3.42, p < 0.0001) in waist circumference compared with moderate intensity (-2.50 cm, 95% CI -3.22, -1.79, p = 0.058). These findings suggest regular aerobic exercise results in modest reductions in waist circumference and associated visceral adipose tissue and that higher intensity exercise may offer superior benefit to moderate intensity.
Topics: Adult; Body Mass Index; Exercise; Humans; Obesity; Obesity, Abdominal; Overweight; Waist Circumference; Weight Loss
PubMed: 35383401
DOI: 10.1111/obr.13446 -
BMJ Open Apr 2019Inadequate postoperative pain control is common and is associated with poor clinical outcomes. This study aimed to identify preoperative predictors of poor postoperative... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Inadequate postoperative pain control is common and is associated with poor clinical outcomes. This study aimed to identify preoperative predictors of poor postoperative pain control in adults undergoing inpatient surgery.
DESIGN
Systematic review and meta-analysis DATA SOURCES: MEDLINE, Embase, CINAHL and PsycINFO were searched through October 2017.
ELIGIBILITY CRITERIA
Studies in any language were included if they evaluated postoperative pain using a validated instrument in adults (≥18 years) and reported a measure of association between poor postoperative pain control (defined by study authors) and at least one preoperative predictor during the hospital stay.
DATA EXTRACTION AND SYNTHESIS
Two reviewers screened articles, extracted data and assessed study quality. Measures of association for each preoperative predictor were pooled using random effects models.
RESULTS
Thirty-three studies representing 53 362 patients were included in this review. Significant preoperative predictors of poor postoperative pain control included younger age (OR 1.18 [95% CI 1.05 to 1.32], number of studies, n=14), female sex (OR 1.29 [95% CI 1.17 to 1.43], n=20), smoking (OR 1.33 [95% CI 1.09 to 1.61], n=9), history of depressive symptoms (OR 1.71 [95% CI 1.32 to 2.22], n=8), history of anxiety symptoms (OR 1.22 [95% CI 1.09 to 1.36], n=10), sleep difficulties (OR 2.32 [95% CI 1.46 to 3.69], n=2), higher body mass index (OR 1.02 [95% CI 1.01 to 1.03], n=2), presence of preoperative pain (OR 1.21 [95% CI 1.10 to 1.32], n=13) and use of preoperative analgesia (OR 1.54 [95% CI 1.18 to 2.03], n=6). Pain catastrophising, American Society of Anesthesiologists status, chronic pain, marital status, socioeconomic status, education, surgical history, preoperative pressure pain tolerance and orthopaedic surgery (vs abdominal surgery) were not associated with increased odds of poor pain control. Study quality was generally high, although appropriate blinding of predictor during outcome ascertainment was often limited.
CONCLUSIONS
Nine predictors of poor postoperative pain control were identified. These should be recognised as potentially important factors when developing discipline-specific clinical care pathways to improve pain outcomes and to guide future surgical pain research.
PROSPERO REGISTRATION NUMBER
CRD42017080682.
Topics: Adult; Analgesia; Anesthesia, Conduction; Elective Surgical Procedures; Humans; Pain, Postoperative; Preoperative Care; Risk Assessment
PubMed: 30940757
DOI: 10.1136/bmjopen-2018-025091 -
Therapeutic Potential of Electromyostimulation (EMS) in Critically Ill Patients-A Systematic Review.Frontiers in Physiology 2022Ample evidence exists that intensive care unit (ICU) treatment and invasive ventilation induce a transient or permanent decline in muscle mass and function. The...
Ample evidence exists that intensive care unit (ICU) treatment and invasive ventilation induce a transient or permanent decline in muscle mass and function. The functional deficit is often called ICU-acquired weakness with critical illness polyneuropathy (CIP) and/or myopathy (CIM) being the major underlying causes. Histopathological studies in ICU patients indicate loss of myosin filaments, muscle fiber necrosis, atrophy of both muscle fiber types as well as axonal degeneration. Besides medical prevention of risk factors such as sepsis, hyperglycemia and pneumonia, treatment is limited to early passive and active mobilization and one third of CIP/CIM patients discharged from ICU never regain their pre-hospitalization constitution. Electromyostimulation [EMS, also termed neuromuscular electrical stimulation (NMES)] is known to improve strength and function of healthy and already atrophied muscle, and may increase muscle blood flow and induce angiogenesis as well as beneficial systemic vascular adaptations. This systematic review aimed to investigate evidence from randomized controlled trails (RCTs) on the efficacy of EMS to improve the condition of critically ill patients treated on ICU. A systematic search of the literature was conducted using PubMed (Medline), CENTRAL (including Embase and CINAHL), and Google Scholar. Out of 1,917 identified records, 26 articles (1,312 patients) fulfilled the eligibility criteria of investigating at least one functional measure including muscle function, functional independence, or weaning outcomes using a RCT design in critically ill ICU patients. A qualitative approach was used, and results were structured by 1) stimulated muscles/muscle area (quadriceps muscle only; two to four leg muscle groups; legs and arms; chest and abdomen) and 2) treatment duration (≤10 days, >10 days). Stimulation parameters (impulse frequency, pulse width, intensity, duty cycle) were also collected and the net EMS treatment time was calculated. A high grade of heterogeneity between studies was detected with major cofactors being the analyzed patient group and selected outcome variable. The overall efficacy of EMS was inconclusive and neither treatment duration, stimulation site or net EMS treatment time had clear effects on study outcomes. Based on our findings, we provide practical recommendations and suggestions for future studies investigating the therapeutic efficacy of EMS in critically ill patients. : [https://www.crd.york.ac.uk/prospero/], identifier [CRD42021262287].
PubMed: 35615672
DOI: 10.3389/fphys.2022.865437 -
The Cochrane Database of Systematic... Nov 2016Child and adolescent obesity has increased globally, and can be associated with significant short- and long-term health consequences. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Child and adolescent obesity has increased globally, and can be associated with significant short- and long-term health consequences.
OBJECTIVES
To assess the efficacy of drug interventions for the treatment of obesity in children and adolescents.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, PubMed (subsets not available on Ovid), LILACS as well as the trial registers ICTRP (WHO) and ClinicalTrials.gov. Searches were undertaken from inception to March 2016. We checked references and applied no language restrictions.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) of pharmacological interventions for treating obesity (licensed and unlicensed for this indication) in children and adolescents (mean age under 18 years) with or without support of family members, with a minimum of three months' pharmacological intervention and six months' follow-up from baseline. We excluded interventions that specifically dealt with the treatment of eating disorders or type 2 diabetes, or included participants with a secondary or syndromic cause of obesity. In addition, we excluded trials which included growth hormone therapies and pregnant participants.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data following standard Cochrane methodology. Where necessary we contacted authors for additional information.
MAIN RESULTS
We included 21 trials and identified eight ongoing trials. The included trials evaluated metformin (11 trials), sibutramine (six trials), orlistat (four trials), and one trial arm investigated the combination of metformin and fluoxetine. The ongoing trials evaluated metformin (four trials), topiramate (two trials) and exenatide (two trials). A total of 2484 people participated in the included trials, 1478 participants were randomised to drug intervention and 904 to comparator groups (91 participants took part in two cross-over trials; 11 participants not specified). Eighteen trials used a placebo in the comparator group. Two trials had a cross-over design while the remaining 19 trials were parallel RCTs. The length of the intervention period ranged from 12 weeks to 48 weeks, and the length of follow-up from baseline ranged from six months to 100 weeks.Trials generally had a low risk of bias for random sequence generation, allocation concealment and blinding (participants, personnel and assessors) for subjective and objective outcomes. We judged approximately half of the trials as having a high risk of bias in one or more domain such as selective reporting.The primary outcomes of this review were change in body mass index (BMI), change in weight and adverse events. All 21 trials measured these outcomes. The secondary outcomes were health-related quality of life (only one trial reported results showing no marked differences; very low certainty evidence), body fat distribution (measured in 18 trials), behaviour change (measured in six trials), participants' views of the intervention (not reported), morbidity associated with the intervention (measured in one orlistat trial only reporting more new gallstones following the intervention; very low certainty evidence), all-cause mortality (one suicide in the orlistat intervention group; low certainty evidence) and socioeconomic effects (not reported).Intervention versus comparator for mean difference (MD) in BMI change was -1.3 kg/m (95% confidence interval (CI) -1.9 to -0.8; P < 0.00001; 16 trials; 1884 participants; low certainty evidence). When split by drug type, sibutramine, metformin and orlistat all showed reductions in BMI in favour of the intervention.Intervention versus comparator for change in weight showed a MD of -3.9 kg (95% CI -5.9 to -1.9; P < 0.00001; 11 trials; 1180 participants; low certainty evidence). As with BMI, when the trials were split by drug type, sibutramine, metformin and orlistat all showed reductions in weight in favour of the intervention.Five trials reported serious adverse events: 24/878 (2.7%) participants in the intervention groups versus 8/469 (1.7%) participants in the comparator groups (risk ratio (RR) 1.43, 95% CI 0.63 to 3.25; 1347 participants; low certainty evidence). A total 52/1043 (5.0%) participants in the intervention groups versus 17/621 (2.7%) in the comparator groups discontinued the trial because of adverse events (RR 1.45, 95% CI 0.83 to 2.52; 10 trials; 1664 participants; low certainty evidence). The most common adverse events in orlistat and metformin trials were gastrointestinal (such as diarrhoea, mild abdominal pain or discomfort, fatty stools). The most frequent adverse events in sibutramine trials included tachycardia, constipation and hypertension. The single fluoxetine trial reported dry mouth and loose stools. No trial investigated drug treatment for overweight children.
AUTHORS' CONCLUSIONS
This systematic review is part of a series of associated Cochrane reviews on interventions for obese children and adolescents and has shown that pharmacological interventions (metformin, sibutramine, orlistat and fluoxetine) may have small effects in reduction in BMI and bodyweight in obese children and adolescents. However, many of these drugs are not licensed for the treatment of obesity in children and adolescents, or have been withdrawn. Trials were generally of low quality with many having a short or no post-intervention follow-up period and high dropout rates (overall dropout of 25%). Future research should focus on conducting trials with sufficient power and long-term follow-up, to ensure the long-term effects of any pharmacological intervention are comprehensively assessed. Adverse events should be reported in a more standardised manner specifying amongst other things the number of participants experiencing at least one adverse event. The requirement of regulatory authorities (US Food and Drug Administration and European Medicines Agency) for trials of all new medications to be used in children and adolescents should drive an increase in the number of high quality trials.
Topics: Adolescent; Anti-Obesity Agents; Body Mass Index; Child; Cyclobutanes; Fluoxetine; Humans; Lactones; Metformin; Orlistat; Pediatric Obesity; Randomized Controlled Trials as Topic
PubMed: 27899001
DOI: 10.1002/14651858.CD012436