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Randomized Controlled Trial
Patient Reported Outcomes after Metabolic Surgery Versus Medical Therapy for Diabetes: Insights from the STAMPEDE Randomized Trial.
- Ali Aminian, Sangeeta R Kashyap, Kathy E Wolski, Stacy A Brethauer, John P Kirwan, Steven E Nissen, Deepak L Bhatt, and Philip R Schauer.
- Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic, Cleveland, OH.
- Ann. Surg. 2021 Sep 1; 274 (3): 524532524-532.
ObjectiveThe aim of this study was to investigate the long-term effects of medical and surgical treatments of type 2 diabetes mellitus (T2DM) on patient-reported outcomes (PROs).BackgroundRobust data on PROs from randomized trials comparing medical and surgical treatments for T2DM are lacking.MethodsThe Surgical Treatment And Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial showed that 5 years after randomization, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) were superior to intensive medical therapy (IMT) alone in achieving glycemic control in patients with T2DM and obesity. A subset of 104 patients participating in the STAMPEDE trial were administered two generic health-related quality of life (QoL) questionnaires (RAND-36 and EQ-5D-3L) and a diabetes-specific instrument at baseline, and then on an annual basis up to 5 years after randomization.ResultsOn longitudinal analysis, RYGB and SG significantly improved the domains of physical functioning, general health perception, energy/fatigue, and diabetes-related QoL compared with IMT group. In the IMT group, none of the QoL components in the generic questionnaires improved significantly from baseline. No significant long-term differences were observed among the study groups in measures of psychological and social aspects of QoL. On multivariable analysis, independent factors associated with improved general health perception at long-term included baseline general health (P < 0.001), insulin independence at 5 years (P = 0.005), RYGB versus IMT (P = 0.005), and SG versus IMT (P = 0.034). Favorable changes following RYGB and SG were comparable.ConclusionsIn patients with T2DM, metabolic surgery is associated with long-term favorable changes in certain PROs compared with IMT, mainly on physical health and diabetes-related domains. Psychosocial well-being warrants greater attention after metabolic surgery.Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
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