scholarly journals Effect of adjunctive glucose-lowering drugs on body weight in people with type 1 diabetes: a systematic review and network meta-analysis protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038970
Author(s):  
Christian Laugesen ◽  
Ajenthen G. Ranjan ◽  
Signe Schmidt ◽  
Lauge Neimann Rasmussen ◽  
Ole Nørgaard ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Body Weight ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Glucose Lowering ◽  
Lowering Drug

IntroductionObesity increases the risk of comorbidities and diabetes-related complications and, consequently, efforts to prevent and reduce excess weight in people with type 1 diabetes are essential. The aim of this systematic review and network meta-analysis is to assess the effect of adjunctive glucose-lowering drugs on body weight and other important health outcomes in people with type 1 diabetes.Methods and analysisThis systematic review and network meta-analysis will include randomised controlled trials (RCTs) evaluating the use of adjunctive glucose-lowering drugs for treatment of people with type 1 diabetes. MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform will be searched from inception to present. Key eligibility criteria include: RCT study design; adult participants with type 1 diabetes; treatment with a glucose-lowering drug for ≥24 weeks; and comparison of the intervention to placebo, usual care or another glucose-lowering drug. The primary outcome is change in body weight. Other major outcomes include change in HbA1c and total daily insulin dose and risk of hypoglycaemia and other adverse events. Dual study selection, data extraction and risk of bias assessment will be performed. Results from the meta-analysis will be presented as weighted mean differences for continuous outcomes and risk ratios for dichotomous outcomes. Sources of heterogeneity will be explored by subgroup and sensitivity analysis. A network meta-analysis for the primary outcome will be performed using an arm-based random-effects model based on the Bayesian framework while assessing for transitivity across studies and consistency between direct and indirect estimates. The overall quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach for each outcome.Ethics and disseminationNo ethical assessment is required. The results of this review will be disseminated through peer-reviewed publication and conference presentation.PROSPERO registration numberCRD42020158676

scholarly journals A juxtaposition of safety outcomes between various doses of sodium-glucose co-transporter inhibitors, in insulin-treated type-1 diabetes mellitus patients: a protocol for systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 3 (2) ◽  
pp. 167-172
Author(s):  
Sumanta Saha
Keyword(s):  
Diabetes Mellitus ◽  
Systematic Review ◽  
Type 1 Diabetes ◽  
Randomized Controlled Trials ◽  
Type 1 Diabetes Mellitus ◽  
Safety Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

  Background: Several clinical trials have tested the safety profile of sodium-glucose co-transport inhibitors’ (SGLTis) in adult type 1 diabetes mellitus (T1DM) patients. However, no systematic review has yet compared its variation between large and low dose SGLTis. Henceforth, a review protocol is proposed here to review it. Methods: Different electronic databases will be searched for randomized-controlled trials (published in the English language) studying the above objective, irrespective of their publication date. After selecting the eligible trials, their data on the study design, population characteristics, compared interventions, and outcomes of interest will be extracted. Then, utilizing the Cochrane tool, each trial's risk of selection bias, detection bias, performance bias, attrition bias, reporting bias, and other bias will be judged. Next, depending on clinical heterogeneity among the trials, a random-effect or fixed-effect model meta-analysis will be used to compare the respective outcomes. Via the Chi2 and I2 statistics, the statistical inconsistency among the trials will be estimated. When this is substantial, subgroup analysis will follow. Publication bias will be evaluated by funnel plots and Egger’s test. A sensitivity analysis will be done to check different assumptions. If a quantitative juxtaposition is not possible, a narrative reporting will ensue. Conclusion: The proposed study will perform a dose-wise juxtaposition of the safety profile of SGLTis in insulin-treated T1DM patients. Registration: Prospective Register of Systematic Reviews (PROSPERO) (Registration no. CRD42019146578)    

scholarly journals A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing the Safety of Dapagliflozin in Type 1 Diabetes Patients

2020 ◽  
Author(s):  
Sumanta Saha ◽  
Sujata Saha
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

Background and Purpose: The dapagliflozin’s safety profile in insulin-treated adult type-1 diabetes mellites (T1DM) patients remains poorly explored. Therefore, this systematic review and meta-analysis compared the risk of all-cause side effects, study discontinuation of participants due to side effects, urinary tract infection (UTI), diabetic ketoacidosis, and hypoglycemia between dapagliflozin 10 mg and dapagliflozin 5 mg, dapagliflozin 10 mg and placebo, and dapagliflozin 5 mg and placebo.Materials and Methods: Parallel-arm randomized controlled trials juxtaposing the above outcomes between the afore-mentioned interventions were eligible for inclusion in this study and were searched in PubMed, Embase, and Scopus. Utilizing the Cochrane tool, the risk of bias was assessed in the recruited trials. Finally, by random-effect meta-analysis, each outcome was compared among the above interventions, and the risk ratio was estimated.Results: Four trials of varying length (1-52 weeks) sourcing data from almost 1760 participants from about 32 nations were reviewed. Overall, the trials had a low or unclear risk of bias, and only one was at a high risk of bias.  Compared to the placebo, the risk of side effects was higher in those treated with dapagliflozin 5 mg (RR=1.10; 95% CI=1.02-1.18; p=0.014; I2=0%). UTI risk was less with the 10mg dapagliflozin than its lower dose (RR=0.50; 95% CI=0.32-0.79; p-value=0.003; I2=0%). All the remaining comparisons were statistically not significantly different between the juxtaposed intervention pairs.Conclusion: In contrast to placebo, dapagliflozin 5mg increased the risk of overall adversities in insulin-treated type-1 diabetes, and dapagliflozin 10 mg had a reduced risk of UTI than its 5mg preparation.

scholarly journals Exercise for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials

BJGP Open ◽  
2020 ◽  
Vol 4 (3) ◽  
pp. bjgpopen20X101032 ◽  
Author(s):  
Emma Pearce ◽  
Kate Jolly ◽  
Laura L Jones ◽  
Gemma Matthewman ◽  
Mandana Zanganeh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Premenstrual Syndrome ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Current Evidence ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Exercise Interventions ◽  
Randomised Controlled

BackgroundExercise is recommended as a treatment for premenstrual syndrome (PMS) in clinical guidelines, but this is currently based on poor-quality trial evidence.AimTo systematically review the evidence for the effectiveness of exercise as a treatment for PMS.Design & settingThis systematic review searched eight major databases, including MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), and two trial registries from inception until April 2019.MethodRandomised controlled trials (RCTs) comparing exercise interventions of a minimum of 8-weeks duration with non-exercise comparator groups in women with PMS were included. Mean change scores for any continuous PMS outcome measure were extracted from eligible trials and standardised mean differences (SMDs) were calculated where possible. Random-effects meta-analysis of the effect of exercise on global PMS symptoms was the primary outcome. Secondary analyses examined the effects of exercise on predetermined clusters of psychological, physical, and behavioural symptoms.ResultsA total of 436 non-duplicate returns were screened, with 15 RCTs eligible for inclusion (n = 717). Seven trials contributed data to the primary outcome meta-analysis (n = 265); participants randomised to an exercise intervention reported reduced global PMS symptom scores (SMD = -1.08; 95% confidence interval [CI] = -1.88 to -0.29) versus comparator, but with substantial heterogeneity (I2 = 87%). Secondary results for psychological (SMD = -1.67; 95% CI = -2.38 to -0.96), physical (SMD = -1.62; 95% CI = -2.41 to -0.83) and behavioural (SMD = -1.94; 95% CI = -2.45 to -1.44) symptom groupings displayed similar findings. Most trials (87%) were considered at high risk of bias.ConclusionBased on current evidence, exercise may be an effective treatment for PMS, but some uncertainty remains.

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