Mrad Rudy, Al Annan Karim, Sayegh Lea, Abboud Donna Maria, Razzak Farah Abdul, Kerbage Anthony, Murad Mohammad Hassan, Abu Dayyeh Barham, Brunaldi Vitor Ottoboni
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Division of Public Health, Infectious Diseases and Occupational Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Gastrointest Endosc. 2025 Mar;101(3):527.e1-527.e19. doi: 10.1016/j.gie.2024.10.039. Epub 2024 Oct 28.
Individual randomized controlled trials (RCTs) and pairwise meta-analyses do not compare all commercially available endoscopic bariatric therapies (EBTs) head-to-head. Therefore, the choice among them is currently made by inference or indirect data. We therefore assessed the comparative efficacy and safety of EBTs through a network meta-analysis.
We searched MEDLINE, EMBASE, and Cochrane CENTRAL from inception for intragastric balloons (IGBs) and from 2013 for endoscopic sleeve gastroplasty (ESG) until May 2023. Only RCTs comparing any of the currently commercially available EBTs with controls were considered eligible. Outcomes included percentage of total weight loss (%TWL), serious adverse events (SAEs), and intolerability.
We identified 821 citations, of which 10 and 8 were eligible for the qualitative and quantitative analysis, respectively. Considering %TWL at the time of IGB removal, all EBTs were associated with statistically higher %TWL than controls. There were no significant differences among EBTs. However, considering the %TWL at the follow-up closest to 12 months, both ESG and the Spatz3 gastric balloon (Spatz Medical, Fort Lauderdale, Fla, USA) were more effective than the Orbera gastric balloon (Apollo Endosurgery, Austin, Tex, USA), with no statistical difference between ESG and Spatz3. For both outcomes, P score and ranking score suggested that ESG was probably associated with a greater weight loss (.889272 and .899469, respectively), followed by Spatz3 (.822894 and .842773, respectively), and Orbera (.536968 and .507165, respectively).
All currently available EBTs approved by the U.S. Food and Drug Administration are more effective than both diet plus lifestyle intervention and sham procedures with an acceptable safety profile. ESG seems the most effective and may be prioritized for patients fit for both ESG and IGBs. Direct controlled trials between EBTs are warranted to confirm these findings.
个体随机对照试验(RCT)和两两荟萃分析并未对所有市售的内镜减重治疗(EBT)进行直接比较。因此,目前在这些治疗方法之间的选择是通过推断或间接数据做出的。因此,我们通过网状荟萃分析评估了EBT的比较疗效和安全性。
我们检索了MEDLINE、EMBASE和Cochrane CENTRAL数据库,自数据库创建起检索胃内球囊(IGB)相关文献,自2013年起检索内镜下袖状胃成形术(ESG)相关文献,直至2023年5月。仅纳入将任何一种市售EBT与对照进行比较的RCT。结局指标包括总体重减轻百分比(%TWL)、严重不良事件(SAE)和不耐受情况。
我们共识别出821篇文献,其中10篇和8篇分别符合定性和定量分析的标准。在移除IGB时考虑%TWL,所有EBT与对照相比,%TWL在统计学上均显著更高。EBT之间无显著差异。然而,在最接近12个月的随访时考虑%TWL,ESG和Spatz3胃球囊(美国佛罗里达州劳德代尔堡的Spatz Medical公司)均比Orbera胃球囊(美国德克萨斯州奥斯汀的Apollo Endosurgery公司)更有效,ESG和Spatz3之间无统计学差异。对于这两个结局指标,P评分和排序评分表明ESG可能与更大程度的体重减轻相关(分别为0.889272和0.899469),其次是Spatz3(分别为0.822894和0.842773),以及Orbera(分别为0.536968和0.507165)。
美国食品药品监督管理局批准的所有目前可用的EBT均比饮食加生活方式干预和假手术更有效,且安全性可接受。ESG似乎是最有效的,对于适合ESG和IGB的患者,ESG可能应优先考虑。有必要进行EBT之间的直接对照试验以证实这些发现。