Bockelbrink Angelina, Stöber Yvonne, Roll Stefanie, Vauth Cristoph, Willich Stefan N, von der Schulenburg Johann-Matthias
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
GMS Health Technol Assess. 2008 Jul 29;4:Doc06.
Obesity with its associated medical, psychological, social, and economic complications is considered a chronic, multifactorial disorder. Given the magnitude of the challenge obesity, there is a clear need for preventive as well as therapeutic measures and strategies on an individual and a public health level.
The goal of this health technology assessment (HTA)-report is to summarise the current literature on bariatric surgery, to evaluate their medical effectiveness/efficacy and cost-effectiveness as well as the ethical, social and legal implications of these procedures in comparison to conventional therapies and compared to each other.
Relevant publications are identified by means of a structured search of databases accessed on 13.11.2006 and an update conducted on 12.11.2007. In addition, a manual search of identified reference lists is conducted. The present report includes German and English literature published since 2001 and targeting adult subjects with morbid obesity (body mass index (BMI) >=40 kg/m² or BMI >=35 kg/m² with severe comorbidities). The methodological quality of studies included is assessed according to pre-defined quality criteria by two independent scientists.
Among 5910 retrieved publications, 25 medical articles, as well as seven health economic studies meet the inclusion criteria. The medical studies show a superior weight loss following bariatric surgery compared to conventional therapy. Malabsorptive procedures lead to a more profound weight loss than purely restrictive procedures. Weight reduction in general is accompanied by a reduced frequency of comorbidities (mostly diabetes type 2). The evidence is not sufficient to quantify these effects for individual procedures or to assess long-term outcomes. However, recent studies show a profound survival benefit for surgically treated patients up to a period of eleven years. The economic studies illustrate that bariatric surgery is cost-effective compared to no treatment or conservative treatment. The comparison between surgical therapies does not allow to draw any conclusions on cost-effectiveness. Appropriate studies/surveys, which are concerned with ethical, legal and social aspects, are not available.
Concerning clinical outcomes as well as cost-effectiveness, there is a lack of high quality studies. Clinical effectiveness and safety as well as cost-effectiveness of bariatric procedures in the short- and medium-term course are agreed on, but long-term evaluations that focus not exclusively on weight loss, but also on comorbidities and patient relevant outcomes such as quality of life, are needed. Also within the economic views are missing long-term evaluation particularly for the German health care system.
Based upon the available literature the short- and medium-term effectiveness of bariatric procedures on weight loss, comorbidities, e. g. diabetes, and mortality can be assumed and also seems to be cost-effective. No recommendation can be given with respect to the choice of a certain bariatric procedure or to the selection of particular groups of patients.
肥胖及其相关的医学、心理、社会和经济并发症被认为是一种慢性多因素疾病。鉴于肥胖问题的严峻挑战，在个人和公共卫生层面显然需要预防和治疗措施及策略。
本卫生技术评估（HTA）报告的目的是总结目前关于减肥手术的文献，评估其医学有效性/效能和成本效益，以及与传统疗法相比和相互比较时这些手术的伦理、社会和法律影响。
通过对2006年11月13日访问的数据库进行结构化搜索，并于2007年11月12日进行更新，确定相关出版物。此外，对已识别的参考文献列表进行人工搜索。本报告包括自2001年以来发表的针对患有病态肥胖（体重指数（BMI）≥40kg/m²或BMI≥35kg/m²且伴有严重合并症）的成年受试者的德语和英语文献。两名独立科学家根据预先定义的质量标准评估纳入研究的方法学质量。
在检索到的5910篇出版物中，25篇医学文章以及7项卫生经济学研究符合纳入标准。医学研究表明，与传统疗法相比，减肥手术后体重减轻更明显。吸收不良手术导致的体重减轻比单纯限制手术更显著。总体而言，体重减轻伴随着合并症（主要是2型糖尿病）发生率的降低。证据不足以量化这些影响对个体手术的作用或评估长期结果。然而，最近的研究表明，接受手术治疗的患者在长达11年的时间里有显著的生存益处。经济学研究表明，与不治疗或保守治疗相比，减肥手术具有成本效益。手术疗法之间的比较无法得出关于成本效益的任何结论。缺乏涉及伦理、法律和社会方面的适当研究/调查。
在临床结果和成本效益方面，缺乏高质量研究。减肥手术在短期和中期过程中的临床有效性、安全性以及成本效益是公认的，但需要长期评估，不仅关注体重减轻，还关注合并症和患者相关结果，如生活质量。在经济学观点方面，也缺乏特别是针对德国医疗保健系统的长期评估。
根据现有文献，可以假定减肥手术在短期和中期对体重减轻、合并症（如糖尿病）和死亡率的有效性，并且似乎具有成本效益。对于选择某种减肥手术或特定患者群体，无法给出建议。
