Author: Jerrine Fletcher, Ph.D. student, Florida A&M University College of Pharmacy and Pharmaceutical Sciences
How does intensive care therapy (IMT) improve patients’ quality of life compared to metabolic surgical treatment?
Improving patient quality of life (QoL) and survival is the primary goal of any treatment. Metabolic and bariatric surgery are very effective treatments in patients with type 2 diabetes. Several observational studies report that metabolic surgery reduces patient mortality by approximately 40% to 50%. Metabolic and bariatric surgery also benefits patients by helping them achieve weight loss, diabetes remission, and reduction in cardiometabolic risk. STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) was a single-centre, randomized controlled trial that compared intensive care therapy (IMT) with surgical treatment. The study reported that surgery was superior to IMT in achieving weight loss and glycemic control, with patients requiring less diabetes medication. However, a lack of data examines patient-reported outcomes after metabolic surgery and how they compare to medical management for obesity and type 2 diabetes. This study aims to compare the effects of these treatments by looking at patient-reported outcomes and quality of life to focus on reducing the burden of these chronic diseases and improving patient well-being.
The STAMPEDE study consisted of 150 diabetic patients in 3 groups. These groups had 26 patients with IMT alone, 41 with IMT and laparoscopic Roux-en-Y gastric bypass (RYGB), and 37 with laparoscopic sleeve gastrectomy (SG). The patients were between 20 and 60 years old and had a BMI of 27 to 43 kg/m2 and an HbA1c greater than 7%. Patients were not included in the study if they had prior metabolic surgery, other complex abdominal surgery, or poorly controlled medical or psychiatric disorders. The patients received treatments described by the American Diabetes Association.
The RAND 36-Item Health Survey and the European QoL 5 Dimensions (EQ-5D) were used to determine a patient’s QoL. The diabetes-specific instrument was a questionnaire formulated by Ron Hayes, Ph.D., used to assess quality of life.
This study used means and standard deviations to assess continuous variables and frequency counts. Clinical breakpoints of 6.0%, 6.5%, and 7% for HbA1c were assessed using Pearson’s chi-square test or Fisher’s exact test. The RAND-36, EQ-5D, and diabetes-specific questionnaire were analyzed using a mixed repeated measures model. Average scores were reported as least squares means and included each visit. Critical baseline and follow-up factors were determined by a stepwise multivariable logistic model for changes in RAND-36 scores at five years.
Participants in this study had comparable baseline characteristics across the three groups, with 55% of patients using insulin analogues at baseline and having a mean BMI of 36.5 kg/m2 at the baseline. Patients who had surgery had better outcomes for body weight, fasting plasma glucose, HbA1c, high-density lipoprotein-cholesterol, and triglycerides than patients who received IMT after the five-year randomization. The RAND-36 showed that scores of patients in the IMT group did not improve significantly from baseline, with the lowest scores coming from the pain, emotional well-being, and role limitations caused by emotional problems sections. However, the surgical group had significantly better scores on physical function, energy/fatigue, and general health. After five years, the metabolic surgery groups improved the overall health scores of 17.2 between RYGB and IMT, 13.4 difference between SG and IMT than the IMT group. Pain scores followed the same trend, with surgical procedures performing better than IMT. With the EQ-5D questionnaire, the changes in the index value were not statistically different. In the diabetes-specific instrument questionnaire, results show that RYGB was preferred over IMT when it came to dieting, going on vacation, planning meals, or eating out with others and in family life. RYGB and SG showed no difference in the assessment.
In patients with type 2 diabetes, metabolic surgery improved patients’ quality of life more than IMT alone in the categories of physical health and diabetes. Although metabolic surgery performed better than IMT in many categories, it did not significantly improve patients’ self-reported physical health and long-term improvements in psychological, emotional, and social aspects of their quality of life. One-third of patients who received surgery had long-term remission of their T2DM and more than half had adequate glycemic control. Although patients saw sustained beneficial effects from surgical procedures, the peak of beneficial outcomes was more evident in the first three years. This may be due to patients regaining weight, having diabetes recurrence, or having surgical side effects. Weight loss plays an important role in patients’ quality of life, as obesity is associated with mobility problems, pain and discomfort. This peak improvement in QoL in adolescents was followed by a gradual decline. Based on the results of this study, metabolic surgery has a positive long-term effect on the patient-related outcome and quality of life.
- Patients report better patient-related outcomes and quality of life with metabolic surgery compared to intensive care therapy.
- Many patients can achieve diabetes remission and maintain glycemic control with metabolic surgery.
- Weight loss improves patients’ quality of life by eliminating obesity-related problems.
Aminian, Ali et al. “Patient-reported outcomes after metabolic surgery versus drug therapy for diabetes: Insights from the randomized STAMPEDE study.” Annalen der Gesundheit Vol. 274.3 (2021): 524-532. doi:10.1097/SLA.0000000000005003
Jerrine Fletcher, fourth-year graduate student in pharmacy, Florida A&M University College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health