Daniel L Chan1,2,3, Josil R Cruz4, Wilfred L Mui5, Simon K H Wong1, Enders K W Ng6. 1. Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong. 2. Faculty of Medicine, Western Sydney University, Sydney, New South Wales, Australia. 3. Faculty of Medicine, The University of New South Wales, Sydney, New South Wales, Australia. 4. Department of Surgery, Southern Philippines Medical Center, Davao City, Philippines. 5. Hong Kong Bariatric and Metabolic Institute, Hong Kong, Hong Kong. 6. Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong. endersng@surgery.cuhk.edu.hk.
Abstract
PURPOSE:Intra-gastric balloon (IGB) therapy is the most established endoscopic treatment of obesity, but there is a paucity of literature on long-term efficacy. This study aims to evaluate the short- and long-term weight loss efficacy of IGB. MATERIALS AND METHODS: Double-blinded RCT with 6-month IGB vs with sham endoscopy, in body mass index (BMI) 27-35 patients. Anthropometric, fasting glucose, and lipid profile measurement as early outcomes (up to 2 years) and 10-year follow-up. Primary outcomes were total body weight loss (kg) and BMI. Secondary outcomes were new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention. RESULTS: Initial RCT recruited 99 patients (50 IGB vs 49 sibutramine group). Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6%). Total body weight loss at 6 (9.75 vs 7.48 kg, p = 0.03), 12 (6.52 vs 4.42 kg, p = 0.05), 18 (5.42 vs 3.57, p = 0.32), and 24 months (4.07 vs 2.93 kg, p = 0.56) favored the IGB group. Total weight loss (TWL) at 10 years (0.03 vs - 2.32 kg, p = 0.05) and %TWL (- 0.16 ± 12.8% vs - 2.84 ± 5.6%, p = 0.39) were not significantly different between groups. Follow-up BMI (30.97 ± 1.6 vs 30.38 ± 1.8 kg/m2, p = 1.00) was similar. At 10 years, new-onset diabetes mellitus, sleep apnoea, metabolic syndrome, and arthralgia were not significant (p > 0.05). Twenty-three (81%) IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01). CONCLUSION:IGB delivers weight loss to 2 years and is superior to control. However, new comorbidity development is not significantly different at 10 years. Patient that received IGB therapy were subsequently more willing for further bariatric metabolic intervention.
RCT Entities:
PURPOSE: Intra-gastric balloon (IGB) therapy is the most established endoscopic treatment of obesity, but there is a paucity of literature on long-term efficacy. This study aims to evaluate the short- and long-term weight loss efficacy of IGB. MATERIALS AND METHODS: Double-blinded RCT with 6-month IGB vs with sham endoscopy, in body mass index (BMI) 27-35 patients. Anthropometric, fasting glucose, and lipid profile measurement as early outcomes (up to 2 years) and 10-year follow-up. Primary outcomes were total body weight loss (kg) and BMI. Secondary outcomes were new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention. RESULTS: Initial RCT recruited 99 patients (50 IGB vs 49 sibutramine group). Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6%). Total body weight loss at 6 (9.75 vs 7.48 kg, p = 0.03), 12 (6.52 vs 4.42 kg, p = 0.05), 18 (5.42 vs 3.57, p = 0.32), and 24 months (4.07 vs 2.93 kg, p = 0.56) favored the IGB group. Total weight loss (TWL) at 10 years (0.03 vs - 2.32 kg, p = 0.05) and %TWL (- 0.16 ± 12.8% vs - 2.84 ± 5.6%, p = 0.39) were not significantly different between groups. Follow-up BMI (30.97 ± 1.6 vs 30.38 ± 1.8 kg/m2, p = 1.00) was similar. At 10 years, new-onset diabetes mellitus, sleep apnoea, metabolic syndrome, and arthralgia were not significant (p > 0.05). Twenty-three (81%) IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01). CONCLUSION: IGB delivers weight loss to 2 years and is superior to control. However, new comorbidity development is not significantly different at 10 years. Patient that received IGB therapy were subsequently more willing for further bariatric metabolic intervention.