Mühlhauser Ingrid
Z Evid Fortbild Qual Gesundhwes. 2014;108(4):208-18. doi: 10.1016/j.zefq.2013.11.006. Epub 2014 Jan 14.
Both pharmacological and non-pharmacological preventive interventions can do more harm than good. Health checks target a healthy or symptomless population. This is why randomised controlled trials (RCTs) must be conducted to provide high-quality evidence for the benefit of an intervention. The present article presents examples to demonstrate that the benefit of preventive interventions is usually overestimated.
Standard screening criteria are used to critically appraise selected preventive interventions. Screening criteria cover the disease, the test, the treatment and the whole programme including evaluation and quality assurance. Type-2 diabetes mellitus is used as an example to discuss specific criteria for preventive interventions. The current state of the evidence is outlined. The article is based primarily on systematic / Cochrane reviews of RCTs.
A recent Cochrane review including 16 RCTs concluded that there is no benefit of general health checks. High-quality evidence on individual components of health checks is frequently missing or inconclusive. Over the last 30 years reference values for normal blood glucose and normal blood pressure as well as treatment targets for patients with type-2 diabetes mellitus and hypertension have been repeatedly decreased though this is not supported by evidence. Recent high-quality RCTs have shown that these "hit hard and early" interventions are detrimental, particularly to those who were the primary target group. Consequently, treatment targets have again been raised and recent guidelines recommend individualisation of treatment goals taking age and comorbidities into account. Important criteria for the implementation of preventive interventions are not currently met. With regard to type-2 diabetes uncertainties remain as to the clinical significance of pre-diabetes, the treatment of pre-diabetes and early treatment of diabetes, the screening tests, and target groups. The ADDITION study was unable to prove the benefit of a diabetes screening. Intensive lifestyle interventions may result in modest reductions of body weight and fewer diabetes diagnoses. However, the clinical relevance of the underlying metabolic changes is doubtful or even negligible. After almost 10 years, the Look AHEAD study has been terminated early due to the ineffectiveness of its intensive lifestyle interventions and the lack of hope that the study will succeed in demonstrating any benefit on the primary cardiovascular endpoints during the originally planned study period of another 3 years.
The benefit of prevention is overestimated whereas harm is underestimated. It is most unlikely that medical preventive interventions targeting individual behaviour changes will result in better health for our population.
药物性和非药物性预防干预措施可能弊大于利。健康检查针对的是健康或无症状人群。这就是为什么必须进行随机对照试验(RCT),以提供关于某项干预措施益处的高质量证据。本文通过实例表明,预防干预措施的益处通常被高估了。
使用标准筛查标准对选定的预防干预措施进行严格评估。筛查标准涵盖疾病、检测、治疗以及包括评估和质量保证在内的整个项目。以2型糖尿病为例讨论预防干预措施的具体标准。概述了现有证据的状况。本文主要基于对随机对照试验的系统评价/Cochrane评价。
最近一项纳入16项随机对照试验的Cochrane评价得出结论,一般健康检查并无益处。关于健康检查各个组成部分的高质量证据常常缺失或无定论。在过去30年里,正常血糖和正常血压的参考值以及2型糖尿病和高血压患者的治疗目标一再降低,尽管这并无证据支持。最近的高质量随机对照试验表明,这些“尽早强化”干预措施有害,尤其是对那些主要目标群体。因此,治疗目标再次提高,最近的指南建议根据年龄和合并症对治疗目标进行个体化设定。目前尚未满足实施预防干预措施的重要标准。关于2型糖尿病,糖尿病前期的临床意义、糖尿病前期的治疗和糖尿病的早期治疗、筛查试验以及目标群体仍存在不确定性。ADDITION研究未能证明糖尿病筛查的益处。强化生活方式干预可能会使体重略有减轻,糖尿病诊断病例减少。然而,潜在代谢变化的临床相关性存疑甚至可忽略不计。经过近10年,“展望未来”(Look AHEAD)研究因强化生活方式干预无效且没有希望在最初计划的另外3年研究期内证明对主要心血管终点有任何益处而提前终止。
预防的益处被高估,而危害被低估。针对个体行为改变的医学预防干预措施极不可能为我们的人群带来更健康的结果。