Efficacy and Safety of Intragastric Balloon Therapy Compared to a Multidisciplinary Weight Loss Program (OPTIFAST) in a Real-World Population: A Propensity Score Matching Analysis

Abstract

Introduction: Obesity is a major global health problem associated with comorbidities such as diabetes, cardiovascular disease and cancer. Bariatric surgery is recognized to be the most effective weight loss intervention, but it is highly invasive, costly and can have serious side effects. Intragastric balloon placement by endoscopy and hypocaloric diets are among a number of techniques that have been used in patients unsuitable for or unwilling to undergo obesity surgery. In this study, we compared the efficacy, safety and cost-effectiveness of the hypocaloric OPTIFAST program (OPT) with endoscopic intragastric balloon (IGB) placement for weight loss. Methods: In this retrospective observational cohort propensity score-weighted comparison (performed May 2014 to December 2020), participants with a BMI of 30-55 kg/m2, aged 18 to 70 years, were randomized to OPT or IGB for 26 weeks, followed by a weight maintenance phase. Patients were matched according to age, gender and BMI. The study outcomes were percentage excess body weight lost (%EBWL), total body weight lost (TBWL), and percentage total body weight lost (%TBWL). Results: A total of 148 participants (75% of those randomized; 74 OPT, 74 IGB) made up the ITT population. Mean age was 44.1 ± 10.4 years and the patients were predominantly female (77%). Baseline BMI was 44.1 ± 10.4kg/m2. At 26 weeks, %TBWL in the OPT group was 19.6 ± 6.8% versus 11.9 ± 6.7% for IGB (P<0.001). At 52 weeks, %TBWL for OPT was 18.2 ± 9.0 % versus 12.0 ± 6.6% for IGB (P<0.001). The OPT cohort also experienced significantly fewer adverse events compared with the IGB group. Conclusion: IGB placement and OPT induce clinically meaningful weight loss. However, OPT appears to induce clinically superior weight loss and has economic advantages through lower rates of complications and adverse events.

The effectiveness of low-calorie dietary interventions in managing obesity in patients. A review

“…Через 26 нед исследователи оценили процент снижения массы тела: в группе ОПТИФАСТ -19,6±6,8%, а в группе бандажирования -11,9±6,7 (p<0,001). Оба метода являются эффективными при подготовке пациента к бариатрической хирургии, однако соблюдение программы сбалансированного низкокалорийного питания способствует клинически более эффективному снижению массы тела, обеспечивая низкую частоту осложнений [31].…”

Team-Based Approach to Reduce Malignancies in People with Diabetes and Obesity

“…A multidisciplinary weight management team should consist of obesity medicine physicians, dietitians, physical trainers, psychologists or behavioral therapists, and bariatric surgeons [ 37 ]. A randomized control trial conducted in Germany from 2014 to 2020 demonstrates that a medically supervised high-intensity program comprising meal replacements, behavioral education, and a supervised physical exercise program leads to clinically significantly greater weight loss at 26 and 52 weeks compared with invasive intragastric balloon therapy for patients with obesity [ 62 ]. Another example in Australia, the “Healthy Weight Clinic,” shows that multidisciplinary obesity service enables patients to achieve clinically meaningful weight loss and improve skeletal muscle mass to body fat ratio with the weight loss maintained at least 1 year post-intervention [ 20 ].…”