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The Cochrane Database of Systematic... Apr 2017Essential tremor (ET) is one of the most common movement disorders. The management is primarily based on pharmacological agents and in clinical practice propranolol and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Essential tremor (ET) is one of the most common movement disorders. The management is primarily based on pharmacological agents and in clinical practice propranolol and primidone are considered the first-line therapy. However, these treatments can be ineffective in 25% to 55% of people and are frequently associated with serious adverse events (AEs). For these reasons, it is worthwhile evaluating other treatments for ET. Topiramate has been suggested as a potentially useful agent for the treatment of ET but there is uncertainty about its efficacy and safety.
OBJECTIVES
To assess the efficacy and safety of topiramate in the treatment of ET.
SEARCH METHODS
We carried out a systematic search without language restrictions to identify all relevant trials in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (January 1966 to January 2017), Embase (January 1988 to January 2017), National Institute for Health and Care Excellence (1999 to January 2017), ClinicalTrials.gov (1997 to January 2017) and World Health Organization International Clinical Trials Registry Platform (ICTRP; 2004 to January 2017). We searched BIOSIS Citation Index (2000 to January 2017) for conference proceedings. We handsearched grey literature and the reference lists of identified studies and reviews.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) of topiramate versus placebo/open control or any other treatments. We included studies in which the diagnosis of ET was made according to accepted and validated diagnostic criteria. We excluded studies conducted in people presenting with secondary forms of tremor or reporting only neurophysiological parameters to assess outcomes.
DATA COLLECTION AND ANALYSIS
Two review authors independently collected and extracted data using a data collection form. We assessed the risk of bias and the quality of evidence. We used a fixed-effect meta-analysis for data synthesis.
MAIN RESULTS
This review included three trials comparing topiramate to placebo (309 participants). They were all at high overall risk of bias. The quality of evidence ranged from very low to low. Compared to placebo, participants treated with topiramate showed a significant improvement in functional disability and an increased risk of withdrawal (risk ratio (RR) 1.78, 95% confidence interval (CI) 1.23 to 2.60). There were more AEs for topiramate-treated participants, particularly paraesthesia, weight loss, appetite decrease and memory difficulty.
AUTHORS' CONCLUSIONS
This systematic review highlighted the presence of limited data and very low to low quality evidence to support the apparent efficacy and the occurrence of treatment-limiting AEs in people with ET treated with topiramate. Further research to assess topiramate efficacy and safety on ET is needed.
Topics: Activities of Daily Living; Anticonvulsants; Essential Tremor; Fructose; Humans; Patient Dropouts; Publication Bias; Randomized Controlled Trials as Topic; Topiramate
PubMed: 28409827
DOI: 10.1002/14651858.CD009683.pub2 -
Metabolism: Clinical and Experimental Jul 2023Thiamine (vitamin B1) is an essential cofactor in glucose metabolism, but it remains unclear whether thiamine status is lower in individuals with diabetes compared to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Thiamine (vitamin B1) is an essential cofactor in glucose metabolism, but it remains unclear whether thiamine status is lower in individuals with diabetes compared to individuals with normal glucose metabolism.
AIMS
We conducted a systematic review and meta-analysis to study whether the circulating concentrations of various thiamine analytes differ between people with and those without diabetes.
METHODS
PubMed and the Cochrane Central Register of Controlled Trials were searched according to the study protocol. The standardized mean difference (SMD) and 95 % confidence intervals (CI) of thiamine markers between individuals with and without diabetes were used as effect size (random effects model). Subgroup analysis considered albuminuria as an additional variable.
RESULTS
Out of the 459 articles identified, 24 full-texts were eligible for the study, 20 of which qualified for the data analysis and four were evaluated for coherence. Compared to controls, individuals with diabetes showed lower concentrations of thiamine (pooled estimate SMD [95 % CI]: -0.97 [-1.89, -0.06]), thiamine monophosphate (-1.16 [-1.82, -0.50]), and total thiamine compounds (-1.01 [-1.48, -0.54]). Thiamine diphosphate (-0.72 [-1.54, 0.11] and erythrocyte transketolase activity (-0.42 [-0.90, 0.05]) tended to be lower in persons with diabetes than in controls without reaching statistical significance. Subgroup analysis showed that individuals with diabetes and albuminuria had lower thiamine levels than the controls (-2.68 [-5.34, -0.02]).
CONCLUSIONS
Diabetes is associated with lower levels of various thiamine markers, suggesting that individuals with diabetes may have higher thiamine requirements than those without diabetes, but well-designed studies are required to confirm these findings.
Topics: Humans; Thiamine; Albuminuria; Diabetes Mellitus; Thiamine Pyrophosphate; Glucose
PubMed: 37094704
DOI: 10.1016/j.metabol.2023.155565 -
The Korean Journal of Gastroenterology... Jul 2022Dietary factors can aggravate the symptoms of irritable bowel syndrome (IBS). Many IBS patients try restrictive diets to relieve their symptoms, but the types of diets... (Meta-Analysis)
Meta-Analysis
BACKGROUND/AIMS
Dietary factors can aggravate the symptoms of irritable bowel syndrome (IBS). Many IBS patients try restrictive diets to relieve their symptoms, but the types of diets with an exacerbating factor are unknown. Therefore, this paper reports the results of a systematic review and network meta-analysis of randomized-controlled trials (RCTs) reviewing the efficacy of food restriction diets in IBS.
METHODS
The MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov databases were searched until July 21, 2021, to retrieve RCTs assessing the efficacy of restriction diets in adults with IBS. Two independent reviewers performed the eligibility assessment and data abstraction. RCTs that evaluated a restriction diet versus a control diet and assessed the improvement in global IBS symptoms were included. These trials reported a dichotomous assessment of the overall response to therapy.
RESULTS
A total of 1,949 citations were identified. After full-text screening, 14 RCTs were considered eligible for the systematic review and network meta-analysis. A starch- and sucrose-reduced diet and a diet with low-fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) showed significantly better results than a usual diet. Symptom flare-ups in patients on a gluten- free diet were also significantly lower than in those on high-gluten diets.
CONCLUSIONS
These findings showed that the starch- and sucrose-reduced, low FODMAP, and gluten-free diets had superior effects in reducing IBS symptoms. Further studies, including head-to-head trials will be needed to establish the effectiveness of dietary restrictions on IBS symptoms.
Topics: Adult; Diet; Diet, Carbohydrate-Restricted; Diet, Gluten-Free; Fermentation; Humans; Irritable Bowel Syndrome; Monosaccharides; Network Meta-Analysis; Oligosaccharides; Starch; Sucrose
PubMed: 35879058
DOI: 10.4166/kjg.2022.014 -
The Journal of Headache and Pain Dec 2023Migraine is the world's second most common disabling disorder, affecting 15% of UK adults and costing the UK over £1.5 billion per year. Several costly new drugs have... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Migraine is the world's second most common disabling disorder, affecting 15% of UK adults and costing the UK over £1.5 billion per year. Several costly new drugs have been approved by National Institute for Health and Care Excellence.
AIM
To assess the cost-effectiveness of drugs used to treat adults with chronic migraine.
METHODS
We did a systematic review of placebo-controlled trials of preventive drugs for chronic migraine. We then assessed the cost-effectiveness of the currently prescribable drugs included in the review: Onabotulinum toxin A (BTA), Eptinezumab (100mg or 300mg), Fremanezumab (monthly or quarterly dose), Galcanezumab or Topiramate, each compared to placebo, and we evaluated them jointly. We developed a Markov (state-transition) model with a three-month cycle length to estimate the costs and quality-adjusted life years (QALYs) for the different medications from a UK NHS and Personal Social Services perspective. We used a two-year time horizon with a starting age of 30 years for the patient cohort. We estimated transition probabilities based on monthly headache days using a network meta-analysis (NMA) developed by us, and from published literature. We obtained costs from published sources and applied discount rates of 3.5% to both costs and outcomes.
RESULTS
Deterministic results suggest Topiramate was the least costly option and generated slightly more QALYs than the placebo, whereas Eptinezumab 300mg was the more costly option and generated the most QALYs. After excluding dominated options, the incremental cost-effectiveness ratio (ICER) between BTA and Topiramate was £68,000 per QALY gained and the ICER between Eptinezumab 300mg and BTA was not within plausible cost-effectiveness thresholds. The cost-effectiveness acceptability frontier showed that Topiramate is the most cost-effective medication for any amount the decision maker is willing-to-pay per QALY.
CONCLUSIONS
Among the various prophylactic medications for managing chronic migraine, only Topiramate was within typical cost-effectiveness threshold ranges. Further research is needed, ideally an economic evaluation alongside a randomised trial, to compare these newer, expensive CGRP MAbs with the cheaper oral medications.
Topics: Adult; Humans; Topiramate; Migraine Disorders; Headache; Cost-Benefit Analysis; Decision Making; Quality-Adjusted Life Years
PubMed: 38053051
DOI: 10.1186/s10194-023-01686-y -
Scientific Reports Jul 2023Observational studies have shown a negative correlation between Vitamin D level and the likelihood of developing insulin resistance (IR) and/or diabetes over time, yet... (Meta-Analysis)
Meta-Analysis
Observational studies have shown a negative correlation between Vitamin D level and the likelihood of developing insulin resistance (IR) and/or diabetes over time, yet evidence remains inconsistent. In this meta-analysis and systematic review, we strive to define the potential association between serum or supplemental Vitamin D Levels and insulin resistance respectively, as well as the contribution of Vitamin D to type 2 diabetes, and to summarize the biologic plausibility of Vitamin D. Four databases (PubMed, Embase, Cochrane Library, and Web of Science) were searched for this Systematic Literature Review (SLR) to find appropriate observational studies and clinical trials published in English through to July 2022. EndNote (version X9) is used to manage the literature search results. We calculated Standard Mean Differences (SMDs) and Risk Ratios (RRs) with their 95% Confidence Intervals (CIs), separately, for continuous and dichotomous outcomes. The correlation coefficients were normalized to z values through Fisher's z-transformation to calculate the relevant statistics. Meta-analyses were carried out for all comparisons, based on a random-effects pooling model. Data analysis was performed using RevMan (version 5.3) and STATA (version 15.1). All statistical tests were two-sided, with P < 0.05 were regarded as significant. In our current meta-analysis, there are 18 RCTs and 20 observational studies including 1243 and 11,063 participants respectively. In the overall analysis, the diabetic with Vitamin D supplement treatment group showed significantly improve serum insulin (SMD = - 0.265, 95% CI - 0.394 to - 0.136, P < 0.05), glucose (SMD = - 0.17, 95% CI - 0.301to - 0.039, P < 0.05) and HOMA-IR (SMD = - 0.441, 95% CI - 0.582 to - 0.3, P < 0.05) compared with the routine treatment group. Correlation analysis results showed that all three outcomes were significantly correlated in a negative manner with raised Vitamin D (insulin: r = - 0.08 95% = - 0.12 to - 0.04; glucose: r = - 0.06 95% = - 0.11 to - 0.01; HOMA-IR: r = - 0.08 95% = - 0.09 to - 0.06). Results of overall analysis proved that vitamin D has shown significant effect on regulates insulin resistance, and there is a significant inverse association between serum Vitamin D level and IR. Vitamin D supplementation is expected to be integrated into conventional medical approaches to prevent type 2 diabetes and to mitigate the burden of diabetes for individuals and society.PROSPERO registration number: CRD42022348295.
Topics: Humans; Vitamin D; Insulin Resistance; Diabetes Mellitus, Type 2; Vitamins; Dietary Supplements; Insulin; Glucose; Observational Studies as Topic
PubMed: 37524765
DOI: 10.1038/s41598-023-39469-9 -
Diabetes Research and Clinical Practice Aug 2023The effect of fecal microbiota transplantation (FMT) on microbiota engraftment in patients with metabolic syndrome remains unclear. This systematic review employed a... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The effect of fecal microbiota transplantation (FMT) on microbiota engraftment in patients with metabolic syndrome remains unclear. This systematic review employed a meta-analysis of RCTs for assessment on the role of FMT in treating obesity and metabolic syndrome, and its impact on clinically relevant parameters.
METHOD
Major databases and grey literatures were searched identifying RCTs comparing FMT of lean donors with placebo in obese/metabolic syndrome patients. Studies using any form of placebo were included. Variations in the parameters before and after treatment were calculated followed by meta-analyses.
RESULT
Ten studies met the inclusion criteria and a total of 334 patients were included for further analysis. Clinically significant parameters associated with obesity and metabolic syndrome were explored and FMT was identified significantly and negatively associated with most indices of abdominal adiposity including caloric intake, fasting glucose, HOMA-IR, systolic blood pressure, diastolic blood pressure, total cholesterol, HDL, LDL, triglycerides and CRP, Obesity parameters including fasting glucose and acetic acid were increased following FMT.
CONCLUSION
FMT is more advantageous for obese patients with elevated blood pressure, disordered glucose and insulin metabolism, and elevated blood lipids. The study of metabolic factors in obese patients will be our starting point in the future.
Topics: Humans; Fecal Microbiota Transplantation; Metabolic Syndrome; Obesity; Glucose; Lipids
PubMed: 37356723
DOI: 10.1016/j.diabres.2023.110803 -
PloS One 2023Whether food source or energy mediates the effect of fructose-containing sugars on blood pressure (BP) is unclear. We conducted a systematic review and meta-analysis of... (Meta-Analysis)
Meta-Analysis
Whether food source or energy mediates the effect of fructose-containing sugars on blood pressure (BP) is unclear. We conducted a systematic review and meta-analysis of the effect of different food sources of fructose-containing sugars at different levels of energy control on BP. We searched MEDLINE, Embase and the Cochrane Library through June 2021 for controlled trials ≥7-days. We prespecified 4 trial designs: substitution (energy matched substitution of sugars); addition (excess energy from sugars added); subtraction (excess energy from sugars subtracted); and ad libitum (energy from sugars freely replaced). Outcomes were systolic and diastolic BP. Independent reviewers extracted data. GRADE assessed the certainty of evidence. We included 93 reports (147 trial comparisons, N = 5,213) assessing 12 different food sources across 4 energy control levels in adults with and without hypertension or at risk for hypertension. Total fructose-containing sugars had no effect in substitution, subtraction, or ad libitum trials but decreased systolic and diastolic BP in addition trials (P<0.05). There was evidence of interaction/influence by food source: fruit and 100% fruit juice decreased and mixed sources (with sugar-sweetened beverages [SSBs]) increased BP in addition trials and the removal of SSBs (linear dose response gradient) and mixed sources (with SSBs) decreased BP in subtraction trials. The certainty of evidence was generally moderate. Food source and energy control appear to mediate the effect of fructose-containing sugars on BP. The evidence provides a good indication that fruit and 100% fruit juice at low doses (up to or less than the public health threshold of ~10% E) lead to small, but important reductions in BP, while the addition of excess energy of mixed sources (with SSBs) at high doses (up to 23%) leads to moderate increases and their removal or the removal of SSBs alone (up to ~20% E) leads to small, but important decreases in BP in adults with and without hypertension or at risk for hypertension. Trial registration: Clinicaltrials.gov: NCT02716870.
Topics: Adult; Humans; Fructose; Blood Pressure; Fruit; Sugars; Hypertension
PubMed: 37582096
DOI: 10.1371/journal.pone.0264802 -
Archives of Endocrinology and Metabolism Nov 2023FGF21 is a hormone produced primarily by the liver with several metabolic functions, such as induction of heat production, control of glucose homeostasis, and regulation... (Meta-Analysis)
Meta-Analysis Review
FGF21 is a hormone produced primarily by the liver with several metabolic functions, such as induction of heat production, control of glucose homeostasis, and regulation of blood lipid levels. Due to these actions, several laboratories have developed FGF21 analogs to treat patients with metabolic disorders such as obesity and diabetes. Here, we performed a systematic review and meta-analysis of randomized controlled trials that used FGF21 analogs and analyzed metabolic outcomes. Our search yielded 236 articles, and we included eight randomized clinical trials in the meta-analysis. The use of FGF21 analogs exhibited no effect on fasting blood glucose, glycated hemoglobin, HOMA index, blood free fatty acids or systolic blood pressure. However, the treatment significantly reduced fasting insulinemia, body weight and total cholesterolemia. None of the included studies were at high risk of bias. The quality of the evidence ranged from moderate to very low, especially due to imprecision and indirection issues. These results indicate that FGF21 analogs can potentially treat metabolic syndrome. However, more clinical trials are needed to increase the quality of evidence and confirm the effects seen thus far.
Topics: Humans; Blood Glucose; Metabolic Diseases; Metabolic Syndrome; Obesity; Diabetes Mellitus
PubMed: 37948566
DOI: 10.20945/2359-4292-2022-0493 -
Frontiers in Endocrinology 2022This study evaluates the efficacy and safety of the free up-titration of basal insulin and fixed-ratio combination (FRC) of basal insulin and glucagon-like peptide-1...
Free Versus Fixed-Ratio Combination of Basal Insulin and GLP-1 Receptor Agonists in Type 2 Diabetes Uncontrolled With GLP-1 Receptor Agonists: A Systematic Review and Indirect Treatment Comparison.
INTRODUCTION
This study evaluates the efficacy and safety of the free up-titration of basal insulin and fixed-ratio combination (FRC) of basal insulin and glucagon-like peptide-1 receptor agonists (GLP-1RAs) in type 2 diabetes mellitus (T2DM) patients inadequately controlled with GLP-1RA.
METHODS
With the use of a systematic literature review of PubMed, Embase, Web of Science, and the Cochrane Library databases through July 2021, randomized controlled trials that compared the free up-titration or FRC with remaining on GLP-1RA in T2DM patients uncontrolled with GLP-1RA were included. A comparison of adding basal insulin to maintaining GLP-1RA and an indirect comparison between the two strategies were conducted on the change in HbA1c, fasting plasma glucose (FPG), target achievement [HbA1c < 7.0%], and the risk of confirmed hypoglycemia. The Cochrane Collaboration's tool was used to assess the risk of bias.
RESULTS
Two free up-titration and two FRC trials involving 1,612 participants, all lasting 26 weeks, were included. Both approaches significantly lowered HbA1c levels (weighted mean difference [WMD] -0.75%, 95% CI -0.97 to -0.53) but increased hypoglycemic risk [risk ratio (RR) 7.59, 95% CI 3.35-17.17] compared to the unchanged GLP-1RA. No significant differences were discovered between the two methods regarding the decrease in HbA1c (WMD 0.08%, 95% CI -1.07% to 1.23%), FPG (WMD -2.29 mg/dl, 95% CI -45.07 to 40.49 mg/dl), target achievement (RR 1.03, 95% CI 0.50-2.14), and hypoglycemic risk (RR 0.32, 95% CI 0.03-3.59).
CONCLUSION
In patients who failed to reach target HbA1c levels despite the GLP-1RA treatment, both strategies of adding basal insulin, free up-titration and FRC, are comparable options are comparable options.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Insulins
PubMed: 35669682
DOI: 10.3389/fendo.2022.870722 -
Nutrients Apr 2023Metabolic Syndrome (MetS) is characterized by a group of dysmetabolic conditions, including abdominal obesity, dyslipidemia, glucose intolerance and/or insulin... (Review)
Review
Metabolic Syndrome (MetS) is characterized by a group of dysmetabolic conditions, including abdominal obesity, dyslipidemia, glucose intolerance and/or insulin resistance, and hypertension. Generally, MetS is accompanied by an exacerbation of oxidative stress, inflammation, and vascular dysfunction. Increasing evidence suggests that berries and berry bioactives could play a potential role in the prevention and mitigation of the risk factors associated with MetS. The present systematic review summarizes the more recently available evidence deriving from human intervention studies investigating the effect of berries in subjects with at least three out of five MetS parameters. The PubMed, Scopus, and Embase databases were systematically searched from January 2010 until December 2022. A total of 17 human intervention trials met the inclusion criteria. Most of them were focused on blueberry (n = 6), cranberry (n = 3), and chokeberry (n = 3), while very few or none were available for the other berries. If considering MetS features, the main positive effects were related to lipid profile (low and high-density lipoproteins, cholesterol, and triglycerides) following blueberries and chokeberries, while conflicting results were documented for anthropometric parameters, blood pressure, and fasting blood glucose levels. Other markers analyzed within the studies included vascular function, oxidative stress, and inflammation. Here, the main positive effects were related to inflammation with a reduction in interleukin 6 and tumor necrosis factor-alpha following the intake of different berries. In conclusion, although limited, the evidence seems to support a potential role for berries in the modulation of lipid profile and inflammation in subjects with MetS. Furthermore, high-quality intervention trials are mandatory to demonstrate the role of berries in reducing risk factors for MetS and related conditions. In the future, such a demonstration could bring the adoption of berries as a potential dietary strategy to prevent/counteract MetS and related risk factors.
Topics: Humans; Metabolic Syndrome; Fruit; Blood Pressure; Inflammation; Triglycerides; Blood Glucose
PubMed: 37111125
DOI: 10.3390/nu15081906