The effects of bariatric procedures versus medical therapy for obese patients with type 2 diabetes: meta-analysis of randomized controlled trials.
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ABSTRACT: Objective
To assess the effects of bariatric surgery versus medical therapy for type 2 diabetes mellitus.Methods
The Cochrane library, PubMed, Embase, Chinese biomedical literature database, and Wanfang database up to February 2012 were searched. The literature searches strategies contained terms ("diabetes*", "surg*", and "medic*" were used), combined with the medical subject headings. Randomized controlled trails (RCTs) of frequently used bariatric surgery for obese patients with type 2 diabetes were included. Study selection, data extraction, quality assessment, and data analyses were performed according to the Cochrane standards.Results
Three randomized controlled trials (RCTs) involving 170 patients in the bariatric surgery groups and 100 patients in the medical therapy group were selected. Compared with medical therapy, bariatric surgery for type 2 diabetes can significantly decrease the levels of HbA1c, FBG, weight, triglycerides, and the dose of hypoglycemic, antihypertensive, and lipid-lowering medicine, while increasing the rate of diabetes remission (RR = 9.74, 95%CI, (1.36, 69.66)) and the levels of high-density lipoprotein. However, there are no statistical differences in serious adverse events between the surgical and medical groups (RR = 1.23, 95%CI, (0.80, 1.87)).Conclusions
Surgical procedures were more likely to help patients achieve benefits than medical therapy alone. Further intensive RCTs of high-quality, multiple centers and long-term followup should be carried out to provide more reliable evidence.
SUBMITTER: Guo X
PROVIDER: S-EPMC3736516 | biostudies-literature | 2013
REPOSITORIES: biostudies-literature
Publications
The effects of bariatric procedures versus medical therapy for obese patients with type 2 diabetes: meta-analysis of randomized controlled trials.
Guo Xiaohu X Liu Xiaoyan X Wang Mancai M Wei Fengxian F Zhang Yawu Y Zhang Youcheng Y
BioMed research international 20130721
<h4>Objective</h4>To assess the effects of bariatric surgery versus medical therapy for type 2 diabetes mellitus.<h4>Methods</h4>The Cochrane library, PubMed, Embase, Chinese biomedical literature database, and Wanfang database up to February 2012 were searched. The literature searches strategies contained terms ("diabetes*", "surg*", and "medic*" were used), combined with the medical subject headings. Randomized controlled trails (RCTs) of frequently used bariatric surgery for obese patients wi ...[more]
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Project description:Bariatric surgery has proved to be an effective strategy in treating obesity. However, randomized controlled trials (RCTs) of 3 most common bariatric surgery procedures, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and laparoscopic adjustable gastric band (LAGB), reported inconsistent results. We performed a systematic review and network meta-analysis to synthesize evidence of effectiveness of the 3 common bariatric procedures from relevant RCTs.The present study was a systematic review and network meta-analysis of RCTs. All RCTs must meet the following criteria to be included in the analysis: patients with body mass index (BMI) ?30?kg/m, reported at least 1 outcome of interest, compared at least 2 of the 3 bariatric procedures, and had follow-ups of at least 1 year. Primary outcome was weight loss, expressed as differences in mean BMI reduction and percentage excess weight loss (%EWL) following 1 year after the surgery. Network meta-analysis was based on Bayesian framework with Markov Chain Monte Carlo simulation approach.Eleven RCTs that met the criteria were included in the review. Of 9 trials (n?=?765), the differences in mean BMI reduction were -0.76 (95% CI: -3.1 to 1.6) for RYGB versus SG, -5.8 (95% CI: -9.2 to -2.4) for RYGB versus LAGB, and -5.0 (95% CI: -9.0 to -1.0) for SG versus LAGB. Eight RCTs (n?=?656) reported percentage excess weight-loss (%EWL), the mean differences between RYGB and SG, RYGB and LAGB, and SG and LAGB were 3.8% (95% CI: -8.5% to 13.8%), -22.2% (95% CI: -34.7% to -6.5%), and -26.0% (95% CI: -40.6% to -6.4%), respectively. The meta-analysis indicated low heterogeneity between studies, and the node splitting analysis showed that the studies were consistent between direct and indirect comparisons (P?>?.05).The RYGB and SG yielded similar in weight-loss effect and both were superior to LAGB. Other factors such as complications and patient preference should be considered during surgical consultations.
| S-EPMC5704829 | biostudies-other
Project description:BackgroundObservational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery.MethodsIn this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment.ResultsOf the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications.ConclusionsIn obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).
| S-EPMC3372918 | biostudies-literature
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.
| S-EPMC4998704 | biostudies-literature
Project description:PurposeThe aim of this study was to show that bariatric surgery (BS) is more effective than medical therapy (MT) in Asian obese patients.MethodsIn this prospective, multicenter, nonrandomized, controlled trial, obese patients with body mass index of ≥35 kg/m2 or 30.0-34.9 kg/m2 with obesity-related comorbidities were assigned to undergo BS, such as laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass, or MT. Patients who underwent BS were evaluated 4, 12, 24, and 48 weeks after surgery, whereas patients who received MT were monitored at a hospital every 6 weeks for 1 year. At each visit, weight, waist and hip circumference, and blood pressure were measured, and patients underwent physical examination and laboratory testing. Health-related quality of life (HQOL) was investigated using Euro QOL-5 Dimension, Impact of Weight on Quality of Life questionnaire-Lite and Obesity-related Problems scale.ResultsThe study included 264 patients from 13 institutions; of these, 64 underwent BS and 200 received MT. Of the patients who underwent BS, 6.3% experienced early complications. Relative weight changes from baseline to 48 weeks were significantly greater in the BS than in the MT group (26.9% vs. 2.1%, P < 0.001), as were the rates of remission of diabetes (47.8% vs. 16.7%, P = 0.014), hypertension (60.0% vs. 26.1%, P < 0.001), and dyslipidemia (63.2% vs. 22.0%, P < 0.001). HQOL was better in the BS than in the MT group at 48 weeks.ConclusionBS was safe and effective in Korean obese patients, with greater weight reduction, remission of comorbidities, and quality of life improvement than MT.
| S-EPMC8506022 | biostudies-literature
Project description:BACKGROUND:Carpal tunnel syndrome is a common compressive neuropathy of the median nerve. The efficacy and safety of endoscopic versus open carpal tunnel release remain controversial. QUESTIONS/PURPOSES:The purpose of this study was to determine whether endoscopic compared with open carpal tunnel release provides better symptom relief, validated outcome scores, short- and long-term strength, and/or digital sensibility; entails a differential risk of complications such as nerve injury, scar tenderness, pillar pain, and reoperation; allows an earlier return to work; and takes less operative time. METHODS:The English-language literature was searched using MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials. Randomized controlled trials that compared endoscopic and open carpal tunnel release were included in the meta-analysis. Methodologic quality was assessed with the Consolidated Standards Of Reporting Trials (CONSORT) checklist, and a sensitivity analysis was performed. Symptom relief, Boston Carpal Tunnel Questionnaire (BCTQ) scores, strength, digital sensibility, complications, reoperation, interval to return to work, and operative time were analyzed. Twenty-one randomized controlled trials containing 1859 hands were included. RESULTS:Endoscopically treated patients showed similar symptom relief and BCTQ scores; better early recovery of grip strength (mean difference [MD], 3.03 kg [0.08-5.98]; p = 0.04) and pinch strength (MD, 0.77 kg [0.33-1.22]; p < 0.001) but no advantage after 6 months; lower risk of scar tenderness (risk ratio [RR], 0.53 [0.35-0.82]; p = 0.005); higher risk of nerve injury (RR, 2.84 [1.08-7.46]; p = 0.03), most of which were transient neurapraxias. Similar risk of pillar pain and reoperation; an earlier return to work (MD, -8.73 days [-12.82 to -4.65]; p < 0.001); and reduced operative time (MD, -4.81 minutes [-9.23 to -0.39]; p = 0.03). CONCLUSIONS:High-level evidence from randomized controlled trials indicates that endoscopic release allows earlier return to work and improved strength during the early postoperative period. Results at 6 months or later are similar according to current data except that patients undergoing endoscopic release are at greater risk of nerve injury and lower risk of scar tenderness compared with open release. While endoscopic release may appeal to patients who require an early return to work and activities, surgeons should be cognizant of its elevated incidence of transient nerve injury amid its similar overall efficacy to open carpal tunnel release. Additional research is required to define the learning curve of endoscopic release and clarify the influence of surgeon volume on its safety.
| S-EPMC4317413 | biostudies-other
Project description:It is unclear whether or not ultrasound-guided cannulation (UGC) of the femoral artery is superior to the standard approach (SA) in reducing vascular complications and improving access success. We sought to compare procedural and clinical outcomes of femoral UGC versus SA in patients undergoing percutaneous cardiovascular intervention (PCvI). We searched EMBASE, MEDLINE, Scopus and web sources for randomized trials comparing UGC versus SA. We estimated risk ratio (RR) and standardized mean differences (SMDs) with 95% confidence intervals (CIs) for categorical and continuous variables, respectively. Primary efficacy endpoint was the success rate at the first attempt, while secondary efficacy endpoints were access time and number of attempts. Primary safety endpoints were the rates of vascular complications, while secondary endpoints were major bleeding, as well as access site hematoma, venepuncture, pseudoaneurysms and retroperitoneal hematoma. This meta-analysis has been registered on Centre for Open Science (OSF) (osf.io/fy82e). Seven trials were included, randomizing 3180 patients to UGC (n = 1564) or SA (n = 1616). Efficacy between UGC and SA was the main metric assessed in most of the trials, in which one third of the enrolled patients underwent interventional procedures. The success rate of the first attempt was significantly higher with UGC compared to SA, (82.0% vs. 58.7%; RR: 1.36; 95% CI: 1.17 to 1.57; p < 0.0001; I2 = 88%). Time to access and number of attempts were significantly reduced with UGC compared to SA (SMD: -0.19; 95% CI: -0.28 to -0.10; p < 0.0001; I2 = 22%) and (SMD: -0.40; 95% CI: -0.58 to -0.21; p < 0.0001; I2 = 82%), respectively. Compared with SA, use of UGC was associated with a significant reduction in vascular complications (1.3% vs. 3.0%; RR: 0.48; CI 95%: 0.25 to 0.91; p = 0.02; I2 = 0%) and access-site hematoma (1.2% vs. 3.3%; RR: 0.41; CI 95%: 0.20 to 0.83; p = 0.01; I2 = 27%), but there were non-significant differences in major bleeding (0.7% vs. 1.4%; RR: 0.57; CI 95%: 0.24 to 1.32; p = 0.19; I2 = 0%). Rates of venepuncture were lower with UGC (3.6% vs. 12.1%; RR: 0.32; CI 95%: 0.20 to 0.52; p < 0.00001; I2 = 55%). This study, which included all available data to date, demonstrated that, compared to a standard approach, ultrasound-guided cannulation of the femoral artery is associated with lower access-related complications and higher efficacy rates. These results could be of great clinical relevance especially in the femoral cannulation of high risk patients.
| S-EPMC7141204 | biostudies-literature
Project description:BackgroundIn short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus.MethodsWe assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point was a glycated hemoglobin level of 6.0% or less.ResultsThe mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated hemoglobin level was 9.3±1.5%, and the mean baseline body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.0±3.5. A total of 91% of the patients completed 36 months of follow-up. At 3 years, the criterion for the primary end point was met by 5% of the patients in the medical-therapy group, as compared with 38% of those in the gastric-bypass group (P<0.001) and 24% of those in the sleeve-gastrectomy group (P=0.01). The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group. Patients in the surgical groups had greater mean percentage reductions in weight from baseline, with reductions of 24.5±9.1% in the gastric-bypass group and 21.1±8.9% in the sleeve-gastrectomy group, as compared with a reduction of 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons). Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group. There were no major late surgical complications.ConclusionsAmong obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. Analyses of secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone. (Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.).
| S-EPMC5451259 | biostudies-literature
Project description:BackgroundLong-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited.MethodsWe assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications.ResultsOf the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (-23%, -19%, and -5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (-40%, -29%, and -8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (-35%, -34%, and -13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation.ConclusionsFive-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo-Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809 .).
| S-EPMC5451258 | biostudies-literature
Project description:Background and purposeEndovascular treatment has emerged as a minimally invasive technique for patients with acute ischemic stroke to achieve recanalization. Our aim was to determine the effects of endovascular treatment on clinical and safety outcomes compared with best medical treatment.Materials and methodsFifteen randomized trials that compared endovascular treatment with best medical treatment in patients with acute ischemic stroke met the inclusion criteria. We calculated pooled odds ratios and 95% CIs by using random-effects models. The primary end point was a favorable outcome defined by a modified Rankin Scale score of 0 (no symptoms), 1 (no significant disability), or 2 (slight disability) at 90 days postrandomization.ResultsOf the 2980 subjects randomized, the proportion of subjects who achieved a favorable outcome was significantly greater among those randomized to endovascular treatment compared with best medical treatment (2949 subjects analyzed; odds ratio, 1.82; 95% CI, 1.38-2.40; P < .001). Excellent outcome (modified Rankin Scale score of 0 or 1) was also significantly greater among those randomized to endovascular treatment (2791 subjects analyzed; odds ratio, 1.77; 95% CI, 1.29-2.43, P < .001). Risk of symptomatic intracranial hemorrhage was similar between endovascular treatment and best medical treatment (2906 subjects analyzed; odds ratio, 1.19; 95% CI, 0.84-1.68; P = .34).ConclusionsCompared with best medical treatment, the odds of achieving a favorable outcome or excellent outcome at 3 months postrandomization are approximately 80% higher with endovascular treatment among patients with acute ischemic stroke.
| S-EPMC7963548 | biostudies-literature
Project description:BackgroundAlthough laparoscopic surgery has been available for a long time and laparoscopic cholecystectomy has been performed universally, it is still not clear whether open appendectomy (OA) or laparoscopic appendectomy (LA) is the most appropriate surgical approach to acute appendicitis. The purpose of this work is to compare the therapeutic effects and safety of laparoscopic and conventional "open" appendectomy by means of a meta-analysis.MethodsA meta-analysis was performed of all randomized controlled trials published in English that compared LA and OA in adults and children between 1990 and 2009. Calculations were made of the effect sizes of: operating time, postoperative length of hospital stay, postoperative pain, return to normal activity, resumption of diet, complications rates, and conversion to open surgery. The effect sizes were then pooled by a fixed or random-effects model.ResultsForty-four randomized controlled trials with 5292 patients were included in the meta-analysis. Operating time was 12.35 min longer for LA (95% CI: 7.99 to 16.72, p < 0.00001). Hospital stay after LA was 0.60 days shorter (95% CI: -0.85 to -0.36, p < 0.00001). Patients returned to their normal activity 4.52 days earlier after LA (95% CI: -5.95 to -3.10, p < 0.00001), and resumed their diet 0.34 days earlier(95% CI: -0.46 to -0.21, p < 0.00001). Pain after LA on the first postoperative day was significantly less (p = 0.008). The overall conversion rate from LA to OA was 9.51%. With regard to the rate of complications, wound infection after LA was definitely reduced (OR = 0.45, 95% CI: 0.34 to 0.59, p < 0.00001), while postoperative ileus was not significantly reduced(OR = 0.91, 95% CI: 0.57 to 1.47, p = 0.71). However, intra-abdominal abscess (IAA), intraoperative bleeding and urinary tract infection (UIT) after LA, occurred slightly more frequently(OR = 1.56, 95% CI: 1.01 to 2.43, p = 0.05; OR = 1.56, 95% CI: 0.54 to 4.48, p = 0.41; OR = 1.76, 95% CI: 0.58 to 5.29, p = 0.32).ConclusionLA provides considerable benefits over OA, including a shorter length of hospital stay, less postoperative pain, earlier postoperative recovery, and a lower complication rate. Furthermore, over the study period it was obvious that there had been a trend toward fewer differences in operating time for the two procedures. Although LA was associated with a slight increase in the incidence of IAA, intraoperative bleeding and UIT, it is a safe procedure. It may be that the widespread use of LA is due to its better therapeutic effect.
| S-EPMC2988072 | biostudies-literature