Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Faculty of Medicine, Western Sydney University, Sydney, New South Wales, Australia.
Obes Surg. 2021 Feb;31(2):781-786. doi: 10.1007/s11695-020-04986-3. Epub 2020 Oct 9.
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.
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.
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/m, 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).
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.
胃内球囊（IGB）治疗是肥胖症最成熟的内镜治疗方法，但关于长期疗效的文献很少。本研究旨在评估 IGB 的短期和长期减肥效果。
对 BMI 为 27-35 的患者进行为期 6 个月的 IGB 与假内镜对照的双盲 RCT。早期结果（最长 2 年）和 10 年随访包括人体测量、空腹血糖和血脂谱测量。主要结果是体重总减轻（kg）和 BMI。次要结果是新发糖尿病、其他新合并症和进一步干预的意愿。
最初的 RCT 招募了 99 名患者（50 名 IGB 与 49 名 sibutramine 组）。49 名患者（26 名 IGB 与 23 名对照组）参加了 10 年回顾（随访率为 51.6%）。6 个月时（9.75 与 7.48 kg，p=0.03）、12 个月时（6.52 与 4.42 kg，p=0.05）、18 个月时（5.42 与 3.57 kg，p=0.32）和 24 个月时（4.07 与 2.93 kg，p=0.56）IGB 组体重减轻更多。10 年时的总体重减轻（TWL）（0.03 与 -2.32 kg，p=0.05）和 %TWL（-0.16±12.8%与-2.84±5.6%，p=0.39）在两组间无显著差异。10 年时的随访 BMI（30.97±1.6 与 30.38±1.8 kg/m，p=1.00）相似。10 年时新发糖尿病、睡眠呼吸暂停、代谢综合征和关节炎无显著差异（p>0.05）。23 名（81%）IGB 组患者和 13 名（56%）对照组患者表示愿意进一步接受干预（p<0.01）。
IGB 可在 2 年内减轻体重，优于对照组。然而，10 年后新合并症的发展并无显著差异。接受 IGB 治疗的患者随后更愿意接受进一步的减重代谢干预。
