Fernandes M, Atallah A N, Soares B G O, Humberto S, Guimarães S, Matos D, Monteiro L, Richter B
University of Medicine of Petropolis, Department of Clinical Surgery, Rua Almirante Saldanha, 184, Cremerie, Petrópolis, Rio de Janeiro, Brazil, 25645-230.
Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD004931. doi: 10.1002/14651858.CD004931.pub2.
Obesity is one of the major public health problems of modern society. Intragastric balloon (IGB) treatment for obesity has been developed as a temporary aid. Its primary objective is the treatment of obese people, who have had unsatisfactory results in their clinical treatment for obesity, despite of being cared for by a multidisciplinary team, and super obese patients with a higher surgical risk. However, the effects of different IGB procedures compared with conventional treatments and with each other are uncertain.
To assess the effects of intragastric balloon in people with obesity.
Studies were obtained from computerised searches of MEDLINE, EMBASE, LILACS, The Cochrane Library and other electronic databases. Furthermore, reference lists of relevant articles and hand searches of selected journals were performed. Experts in the field were contacted.
Randomised and quasi-randomised controlled trials fulfilling the inclusion criteria were used. Short term weight loss is common, so studies were included if they reported measurements after a minimum of four weeks follow-up.
Data were extracted by one reviewer and checked independently by two reviewers. Two reviewers independently assessed the quality of trials.
Nine randomised controlled trials involving 395 patients were included. Six out of nine studies had a follow-up of less than one year, the longest study duration was 24 months. Only a third of the analysed studies revealed a low risk of bias. No information was available on quality of life, all-cause mortality and morbidity. Compared with conventional management, IGB did not show convincing evidence of a greater weight loss. On the other hand, complications of intragastric balloon placement occurred, however few of a serious nature. The relative risks for minor complications like gastric ulcers and erosions were significantly raised.
AUTHORS' CONCLUSIONS: Evidence from this review is limited for decision making, since there was large heterogeneity in IGB trials, regarding both methodological and clinical aspects. However, a co-adjuvant factor described by some authors in the loss and maintenance of weight has been the motivation and the encouragement to changing eating habits following a well-organized diet and a program of behavioural modification. The IGB alone and the technique of positioning appear to be safe. Despite the evidence for little additional benefit of the intragastric balloon in the loss of weight, its cost should be considered against a program of eating and behavioural modification.
肥胖是现代社会主要的公共卫生问题之一。胃内气球(IGB)治疗肥胖已发展成为一种临时辅助手段。其主要目标是治疗那些尽管接受了多学科团队的护理,但在肥胖临床治疗中效果不佳的肥胖患者,以及手术风险较高的超级肥胖患者。然而,不同IGB程序与传统治疗方法相比以及它们彼此之间的效果尚不确定。
评估胃内气球对肥胖人群的影响。
通过对MEDLINE、EMBASE、LILACS、考克兰图书馆及其他电子数据库进行计算机检索获取研究。此外,还查阅了相关文章的参考文献列表,并对选定期刊进行了手工检索。还联系了该领域的专家。
采用符合纳入标准的随机和半随机对照试验。短期体重减轻很常见,因此如果研究报告了至少四周随访后的测量结果,则纳入研究。
由一名 reviewer 提取数据,并由两名 reviewer 独立检查。两名 reviewer 独立评估试验质量。
纳入了9项涉及395名患者的随机对照试验。9项研究中有6项随访时间不足一年,最长研究持续时间为24个月。只有三分之一的分析研究显示偏倚风险较低。关于生活质量、全因死亡率和发病率没有可用信息。与传统管理相比,IGB没有显示出令人信服的证据表明体重减轻更多。另一方面,发生了胃内气球放置的并发症,然而严重的并发症很少。胃溃疡和糜烂等轻微并发症的相对风险显著升高。
由于IGB试验在方法学和临床方面存在很大异质性,本综述的证据有限,无法用于决策。然而,一些作者描述的在体重减轻和维持方面的一个辅助因素是在有组织的饮食和行为改变计划之后改变饮食习惯的动机和鼓励。单独的IGB及其定位技术似乎是安全的。尽管有证据表明胃内气球在体重减轻方面几乎没有额外益处,但应将其成本与饮食和行为改变计划进行权衡。