Meta-analysis of bariatric surgery versus non-surgical treatment for type 2 diabetes mellitus.
ABSTRACT: To compare short-term and long-term results of bariatric surgery vs non-surgical treatment for type 2 diabetes mellitus (T2DM).A systematic search was conducted in the PubMed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs). All statistical analysis was performed using Review Manager version 5.3. The dichotomous data was calculated using risk ratio (RR) and continuous data was using mean differences (MD) along with 95% confidence intervals (CI).A total of 8 RCTs with 619 T2DM patients were analyzed. Compared with non-surgical treatment group, bariatric surgery group was associated with higher rate T2DM remission (RR = 5.76, 95%CI:3.15-10.55, P < 0.00001), more reduction HbA1C (MD = 1.29, 95%CI: -1.70 to -0.87, P < 0.00001), more decrease fasting plasma glucose (MD = -36.38, 95%CI: -51.76 to -21.01, P < 0.00001), greater loss body weight (MD = -16.93, 95%CI: 19.78 to -14.08, P < 0.00001), more reduction body mass index (MD = -5.80, 95%CI: -6.95 to -4.64, P < 0.00001), more decrease triglyceride concentrations (MD = -51.27, 95%CI: -74.13 to -28.41, P < 0.0001), and higher increase density lipoprotein cholesterol (MD = 9.10, 95%CI: 7.99 to 10.21; P < 0.00001). But total and low density lipoprotein cholesterol were no significant changes.Bariatric surgery for T2DM is efficacious and improves short- and long-term outcomes as compared with non-surgical treatment.
Project description:The role of bariatric surgery in non-obese patients with type 2 diabetes (T2DM) remains unclear, and its use in clinical practice is controversial. We conducted a systemic review and meta-analysis to investigate the metabolic changes after surgical treatment in diabetic patients with body mass index (BMI) <30 kg/m2.We conducted a comprehensive search in MEDLINE (PubMed), EMBASE and the Cochrane Library of published articles from January 2000 to April 2013 reporting the clinical outcome changes in various metabolic outcomes in diabetic patients with BMI <30 kg/m2.Ten prospective studies including 290 patients were included in the meta-analysis. Bariatric surgery led to an overall 2.79 kg/m2 [95%CI 2.05~3.53, P<0.00001] reduction in BMI, a 1.88%[95%CI 1.32~2.43, P<0.00001] reduction in glycosylated hemoglobin, a 3.70 mmol/L [95%CI, 1.93~5.47, P<0.00001] reduction in fasting blood glucose, a 6.69 mmol/L [95%CI, 2.29~11.08, P=0.003] reduction in postprandial glucose, anda 3.37 [95%CI 0.55~6.18, P=0.02] reduction in homeostasis model assessment of insulin resistance (HOMA-IR). After surgical treatment, 76.2% of the patients were insulin free, and 61.8% patients were off medication. In total, 90(42.4%), 10(37%) and 34(37.2%) patients had post-surgical HbA1c levels of <6%,<6.5% and<7%, respectively. No deaths were observed in the included studies, and the major complication rate was 6.2%.Based on the currently available data, bariatric surgery might improve glycemic control and weight loss in a very limited range with a doubled surgical complication rate in drug-refractory T2DM patients with BMI <30 kg/m2. It remains too premature to suggest bariatric surgery for non-obese T2DM patients.
Project description:The aim of the study is to compare Roux-en-Y gastric bypass (RYGB) surgery versus medical treatment for type 2 diabetes mellitus (T2DM) in obese patients.Bariatric surgery can achieve remission of T2DM in obese patients. RYGB surgery has been performed as one of the most common surgical treatment options for obese patients with T2DM, but the efficacy of RYGB surgery comparing with medical treatment alone has not been conclusively determined.A systematic literature search identified randomized controlled trials (RCTs) evaluating RYGB surgery versus medical treatment for T2DM in obese patients was conducted in PubMed, Embase, Cochrane Database, and Cochrane Clinical Trials Registry. This systematic review and meta-analysis were performed according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. The primary outcome was T2DM remission. Additional analyses comprised hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), body mass index (BMI), waist circumference, serum lipid level, blood pressure, medication use, and adverse events. Random-effects meta-analyses were calculated and presented as weighted odds ratio (OR) or mean difference (MD) with 95% confidence intervals (CI).Six RCTs concerning 410 total obese T2DM patients were included. Follow-up ranged from 12 to 60 months. RYGB surgery was associated with a higher T2DM remission rate (OR: 76.37, 95% CI: 20.70-281.73, P?<?0.001) and serum level of high-density lipoprotein cholesterol (MD: 0.24?mmol/L, 95% CI 0.18-0.30?mmol/L, P?<?0.001) than medical treatment alone. HbA1c (MD: -1.25%, 95% CI: -1.88% to -0.63%, P?<?0.001), BMI (MD: -6.54?kg/m, 95% CI: -9.28 to -3.80?kg/m, P?<?0.001), waist circumference (MD: -15.60?cm, 95% CI: -18.21 to -13.00?cm, P?<?0.001), triglyceride (MD: -0.87?mmol/L, 95% CI: -1.17 to -0.57?mmol/L, P?<?0.001), low-density lipoprotein cholesterol (MD: -0.32?mmol/L, 95% CI: -0.62 to -0.02?mmol/L, P?=?0.04), systolic blood pressure (MD: -2.83 mm Hg, 95% CI: -4.88 to -0.78 mm Hg, P?<?0.01) were lower after RYGB surgery. However, FPG (MD: -1.58?mmol/L, 95% CI: -3.58 to 0.41?mmol/L, P?=?0.12), total cholesterol (MD: -0.40?mmol/L, 95% CI: -0.92 to 0.12?mmol/L, P?=?0.13), and diastolic blood pressure (MD: 0.28 mm Hg, 95% CI: -1.89 to 2.45?mm Hg, P?=?0.80) were not significantly different between the 2 treatment groups. The medicine use and quality of life were solely improved in the surgical group. Nutritional deficiencies and anemia were noted more frequently in the RYGB group.RYGB surgery is superior to medical treatment for short- to medium-term remission of T2DM, improvement of metabolic condition, and cardiovascular risk factors. Further RCTs should address the safety and long-term benefits of RYGB surgery on obese patients with T2DM.
Project description:Chromium-containing traditional Chinese medicine Tianmai Xiaoke tablet (TMXKT) is approved for treating newly diagnosed type 2 diabetes mellitus (T2DM) in China. This review aimed to compile the evidence from randomized clinical trials (RCTs) and quantify the effects of TMXKT on newly diagnosed T2DM.Seven online databases were investigated up to March 20, 2017. The meta-analysis included RCTs investigating the treatment of newly diagnosed T2DM, in which TMXKT combined with conventional therapy was compared with placebo or conventional therapy. The risk of bias was evaluated using the Cochrane Collaboration tool. The estimated mean difference (MD) and the standardized mean difference were within 95% confidence intervals (CI) with respect to the interstudy heterogeneity. The outcomes were measured using fasting blood glucose (FBG), 2-h postprandial blood glucose (2hPG), glycosylated hemoglobin A1c (HbA1c), and body mass index (BMI) levels.TMXKT combined with conventional therapy lowered FBG level (MD = -0.68, 95% CI -0.90 to -0.45, P < 0.00001), 2hPG (MD = -1.33, 95% CI -1.86 to -0.79, P < 0.00001), HbA1c (MD = -0.46, 95% CI -0.57 to -0.36, P < 0.00001), and BMI (MD = -0.77, 95% CI -1.12 to -0.41, P < 0.00001).TMXKT combined with conventional therapy is beneficial for patients with newly diagnosed T2DM. However, the effectiveness and safety of TMXKT are uncertain because of the limited number of trials and low methodological quality. Therefore, practitioners should be cautious when applying TMXKT in daily practice. Also, well-designed clinical trials are needed in the future.
Project description:Dexmedetomidine (DEX) has been used extensively for patients during surgery. Some studies found that DEX could reduce the incidence of postoperative side effects in laparoscopic surgical patients. However, no firm conclusions were made about it.The authors searched for randomized controlled trials (RCTs) in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials testing DEX administrated in laparoscopic surgical patients and reporting on postoperative nausea, vomiting, shivering, heart rate, mean arterial pressure (MAP), or extubation time after surgery or within 1 hour in postoperative care unit. Trial sequential analysis (TSA) was used for RCTs comparing DEX with placebo or no treatment in laparoscopic surgery patients. A protocol for this meta-analysis has been registered on PROSPERO (http://www.crd.york.ac.uk/prospero) and the registration number is CRD42015020226.Fifteen studies (899 patients) were included. DEX could significantly reduce the incidence of postoperative nausea (risk ratio [RR] and 95% confidence interval [CI], 0.43 [0.28, 0.66], P?<?0.0001), vomiting (RR and 95% CI, 0.36 [0.18, 0.72], P?=?0.004), shivering (RR and 95% CI, 0.19 [0.11, 0.35], P?<?0.00001), rescue antiemetic (RR and 95% CI, 0.18 [0.07, 0.47], P?=?0.0006), and increase the incidence of dry mouth (RR and 95% CI, 7.40 [2.07, 26.48], P?=?0.002) comparing with the control group. In addition, firm conclusions can be made on the results of postoperative nausea according to the TSA. Meta-analysis showed that DEX group had a significantly lower heart rate (mean difference [MD] and 95% CI, -14.21 [-18.85, -9.57], P?<?0.00001) and MAP (MD and 95% CI, -12.35 [-15.28, -9.42], P?<?0.00001) than the control group, and firm conclusions can be made according to the TSA. No significance was observed on extubation time between 2 groups (MD and 95% CI, 0.70 [-0.89, 2.28], P?=?0.39).The results from this meta-analysis indicated that perioperative DEX decreased postoperative nausea and shivering in laparoscopic surgical patients. However, common adverse effects were lower heart rate and MAP. Firm conclusions cannot be made on postoperative shivering, rescue antiemetic, and dry mouth until more RCTs were included.
Project description:There is currently no detailed evidence for the long-term effects of bariatric surgery on severely obese with type 2 diabetes, such as the risk of myocardial infarction and stroke. In order to provide evidence on the risks of macrovascular diseases and metabolic indicators of bariatric surgery follow-up for more than five years, we searched in the Cochrane library, Pubmed, and EMBASE databases from the earliest studies to January 31, 2019. Randomized clinical trials or cohort studies compared bariatric surgery and conventional medical therapy for long-term incidence of macrovascular events and metabolic outcomes in severely obese patients with T2DM. Fixed-effects and random-effects meta-analyses were performed to pool the relative risks (RRs), hazard ratios (HRs) and weighted mean difference (WMD). Publication bias and heterogeneity were examined. Four RCTs and six cohort studies were finally involved in this review. Patients in the bariatric surgery group as compared to the conventional treatment group had lower incidence of macrovascular complications (RR = 0.43, 95%CI = 0.27~0.70), cardiovascular events (CVEs) (HR = 0.52, 95%CI = 0.39~0.71), and myocardial infarction (MI) (RR = 0.40, 95%CI = 0.26~0.61). At the same time, the results demonstrate that bariatric surgery is associated with better weight and better glycemic control over the long-term than non-surgical therapies, and reveal that different surgical methods have different effects on various metabolic indicators. Bariatric surgery significantly decreases macrovascular complications over the long term and is associated with greater weight loss and better intermediate glucose outcomes among T2DM patients with severe obesity as compared to patients receiving only conservative medical measures.
Project description:OBJECTIVE:To evaluate the analgesic efficacy of dexamethasone added to local anesthetics in ultrasound-guided transversus abdominis plane (TAP) block for the patients after abdominal surgery. METHODS:PubMed, CENTRAL, EMBASE, Web of science were searched to identify eligible randomized controlled trials (RCTs) that compared dexamethasone added to local anesthetics in ultrasound-guided TAP block with control for postoperative analgesia in adult patients undergoing abdominal surgery. Primary outcomes included postoperative pain intensity, the time to the first request for additional analgesics, and opioid consumption over 24 h after surgery. Secondary outcome was the incidence of postoperative nausea and vomiting. Analysis was performed by RevMan 5.3 software and the quality of evidence was rated using GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. RESULTS:Nine RCTs involving 575 patients were included. Compared to the control, dexamethasone added to local anesthetics in ultrasound-guided TAP block significantly decreased visual analogue scale (VAS) scores at rest at 4h (mean difference [MD] = -1.01; 95% confidence intervals [CI], -1.29 to -0.73; P<0.00001; moderate quality of evidence), 6h (MD = -1.21; 95% CI, -1.74 to -0.69; P<0.00001; low quality of evidence), and 12h after surgery (MD = -0.79; 95% CI, -0.97 to -0.60; P<0.00001; moderate quality of evidence). No difference was found at 2h (MD = -0.64; 95% CI, -1.35 to 0.08; P = 0.08; low quality of evidence) and 24 h (MD = -0.41; 95% CI, -0.91 to 0.09; P = 0.11; moderate quality of evidence) in VAS scores. The time to the first request for additional analgesics was prolonged in the dexamethasone group (MD = 3.08; 95% CI, 2.37 to 3.78; P<0.00001; moderate quality of evidence). Opioid consumption over 24 h after surgery was also reduced (MD = -5.42; 95% CI, -8.20 to -2.63; P = 0.0001; low quality of evidence). Meanwhile, the incidence of postoperative nausea and vomiting was significantly decreased in the dexamethasone group (risk ratios [RR] = 0.40; 95% CI, 0.28 to 0.58; P<0.00001; high quality of evidence). No complications were reported in all the included studies. CONCLUSIONS:Dexamethasone added to local anesthetics in ultrasound-guided TAP block was a safe and effective strategy for postoperative analgesia in adult patients undergoing abdominal surgery.
Project description:We performed a meta-analysis of weight loss and remission of type 2 diabetes mellitus (T2DM) evaluated in randomized controlled trials (RCTs) and observational studies of bariatric surgery vs conventional medical therapy. English articles published through June 10, 2013 that compared bariatric surgery with conventional therapy and included T2DM endpoints with ?12-month follow-up were systematically reviewed. Body mass index (BMI, in kilogram per square meter), glycated hemoglobin (HbA1C, in degree), and fasting plasma glucose (FPG, in milligram per deciliter) were analyzed by calculating weighted mean differences (WMDs) and pooled standardized mean differences and associated 95 % confidence intervals (95 % CI). Aggregated T2DM remission event data were analyzed by calculating the pooled odds ratio (POR) and 95 % CI. Random effects assumptions were applied throughout; I(2)???75.0 % was considered indicative of significant heterogeneity. Systematic review identified 512 articles: 47 duplicates were removed, 446 failed inclusion criteria (i.e., n?<?10 per arm, animal studies, reviews, case reports, abstracts, and kin studies). Of 19 eligible articles, two not focused on diagnosed T2DM and one with insufficient T2DM data were excluded. In the final 16 included papers, 3,076 patients (mean BMI, 40.9; age, 47.0; 72.0 % female) underwent bariatric surgery; 3,055 (39.4; 48.6, 69.0 %) received conventional or no weight-loss therapy. In bariatric surgery vs conventional therapy groups, the mean 17.3?±?5.7 month BMI WMD was 8.3 (7.0, 9.6; p?<?0.001; I(2)?=?91.8), HbA(1C) was 1.1 (0.6, 1.6; p?<?0.001; I(2)?=?91.9), and FPG, 24.9 (15.9, 33.9; p?<?0.001; I(2)?=?84.8), with significant differences favoring surgery. The overall T2DM remission rate for surgery vs conventional group was 63.5 vs 15.6 % (p?<?0.001). The Peto summary POR was 9.8 (6.1, 15.9); inverse variance summary POR was 15.8 (7.9, 31.4). Of the included studies, 94.0 % demonstrated a significant statistical advantage favoring surgery. In a meta-analysis of 16 studies (5 RCTs) with 6,131 patients and mean 17.3-month follow-up, bariatric surgery was significantly more effective than conventional medical therapy in achieving weight loss, HbA(1C) and FPG reduction, and diabetes remission. The odds of bariatric surgery patients reaching T2DM remission ranged from 9.8 to 15.8 times the odds of patients treated with conventional therapy.
Project description:Background:Bariatric surgery improves glycemic control in patients with type 2 diabetes mellitus (T2DM), but less is known about microvascular outcomes. Objective:To investigate the relationship between bariatric surgery and incident microvascular complications of T2DM. Design:Retrospective matched cohort study from 2005 to 2011 with follow-up through September 2015. Setting:4 integrated health systems in the United States. Participants:Patients aged 19 to 79 years with T2DM who had bariatric surgery (n = 4024) were matched on age, sex, body mass index, hemoglobin A1c level, insulin use, diabetes duration, and intensity of health care use up to 3 nonsurgical participants (n = 11 059). Intervention:Bariatric procedures (76% gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) compared with usual care. Measurements:Adjusted Cox regression analysis investigated time to incident microvascular disease, defined as first occurrence of diabetic retinopathy, neuropathy, or nephropathy. Results:Median follow-up was 4.3 years for both surgical and nonsurgical patients. Bariatric surgery was associated with significantly lower risk for incident microvascular disease at 5 years (16.9% for surgical vs. 34.7% for nonsurgical patients; adjusted hazard ratio [HR], 0.41 [95% CI, 0.34 to 0.48]). Bariatric surgery was associated with lower cumulative incidence at 5 years of diabetic neuropathy (7.2% for surgical vs. 21.4% for nonsurgical patients; HR, 0.37 [CI, 0.30 to 0.47]), nephropathy (4.9% for surgical vs. 10.0% for nonsurgical patients; HR, 0.41 [CI, 0.29 to 0.58]), and retinopathy (7.2% for surgical vs. 11.2% for nonsurgical patients; HR, 0.55 [CI, 0.42 to 0.73]). Limitation:Electronic health record databases could misclassify microvascular disease status for some patients. Conclusion:In this large, multicenter study of adults with T2DM, bariatric surgery was associated with lower overall incidence of microvascular disease (including lower risk for neuropathy, nephropathy, and retinopathy) than usual care. Primary Funding Source:National Institute of Diabetes and Digestive and Kidney Diseases.
Project description:Emergency surgical practice constitutes 50% of the workload for surgeons, but there is a lack of high quality randomised controlled trials (RCTs) in emergency surgery. This study aims to establish the differences between the registration, completion and publication of emergency and elective surgical trials.The clinicaltrials.gov and ISRCTN.com trials registry databases were searched for RCTs between 12 July 2010 and 12 July 2012 using the keyword 'surgery'. Publications were systematically searched for in Pubmed, MEDLINE and EMBASE.Results with no surgical interventions were excluded. The remaining results were manually categorised into 'emergency' or 'elective' and 'surgical' or 'adjunct' by two reviewers.Number of RCTs registered in emergency versus elective surgery.Number of RCTs published in emergency versus elective surgery; reasons why trials remain unpublished; funding, sponsorship and impact of published articles; number of adjunct trials registered in emergency and elective surgery.2700 randomised trials were registered. 1173 trials were on a surgical population and of these, 414 trials were studying surgery. Only 9.4% (39/414) of surgical trials were in emergency surgery. The proportion of trials successfully published did not significantly differ between emergency and elective surgery (0.46 vs 0.52; mean difference (MD) -0.06, 95%?CI -0.24 to 0.12). Unpublished emergency surgical trials were statistically equally likely to be terminated early compared with elective trials (0.33 vs 0.16; MD -0.18, 95%?CI -0.06 to 0.41). Low accrual accounted for a similar majority in both groups (0.43 vs 0.46; MD -0.04, 95%?CI -0.48 to 0.41). Unpublished trials in both groups were statistically equally likely to still be planning publication (0.52 vs 0.71; MD -0.18, 95%?CI -0.43 to 0.07).Fewer RCTs are registered in emergency than elective surgery. Once trials are registered both groups are equally likely to be published.
Project description:Importance:Bariatric surgery can lead to substantial improvements in type 2 diabetes (T2DM), but outcomes vary across procedures and populations. It is unclear which bariatric procedure has the most benefits for patients with T2DM. Objective:To evaluate associations of bariatric surgery with T2DM outcomes. Design, Setting, and Participants:This cohort study was conducted in 34 US health system sites in the National Patient-Centered Clinical Research Network Bariatric Study. Adult patients with T2DM who had bariatric surgery between January 1, 2005, and September 30, 2015, were included. Data analysis was conducted from April 2017 to August 2019. Interventions:Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Main Outcome and Measures:Type 2 diabetes remission, T2DM relapse, percentage of total weight lost, and change in glycosylated hemoglobin (hemoglobin A1c). Results:A total of 9710 patients were included (median [interquartile range] follow-up time, 2.7 [2.9] years; 7051 female patients [72.6%]; mean [SD] age, 49.8 [10.5] years; mean [SD] BMI, 49.0 [8.4]; 6040 white patients [72.2%]). Weight loss was significantly greater with RYGB than SG at 1 year (mean difference, 6.3 [95% CI, 5.8-6.7] percentage points) and 5 years (mean difference, 8.1 [95% CI, 6.6-9.6] percentage points). The T2DM remission rate was approximately 10% higher in patients who had RYGB (hazard ratio, 1.10 [95% CI, 1.04-1.16]) than those who had SG. Estimated adjusted cumulative T2DM remission rates for patients who had RYGB and SG were 59.2% (95% CI, 57.7%-60.7%) and 55.9% (95% CI, 53.9%-57.9%), respectively, at 1 year and 86.1% (95% CI, 84.7%-87.3%) and 83.5% (95% CI, 81.6%-85.1%) at 5 years postsurgery. Among 6141 patients who experienced T2DM remission, the subsequent T2DM relapse rate was lower for those who had RYGB than those who had SG (hazard ratio, 0.75 [95% CI, 0.67-0.84]). Estimated relapse rates for those who had RYGB and SG were 8.4% (95% CI, 7.4%-9.3%) and 11.0% (95% CI, 9.6%-12.4%) at 1 year and 33.1% (95% CI, 29.6%-36.5%) and 41.6% (95% CI, 36.8%-46.1%) at 5 years after surgery. At 5 years, compared with baseline, hemoglobin A1c was reduced 0.45 (95% CI, 0.27-0.63) percentage points more for patients who had RYGB vs patients who had SG. Conclusions and Relevance:In this large multicenter study, patients who had RYGB had greater weight loss, a slightly higher T2DM remission rate, less T2DM relapse, and better long-term glycemic control compared with those who had SG. These findings can help inform patient-centered surgical decision-making.