Wilhelmsen L, Berglund G, Elmfeldt D, Samuelsson O, Svardsudd K
Drugs. 1986;31 Suppl 1:47-51. doi: 10.2165/00003495-198600311-00009.
All male inhabitants of the city of Göteborg, who were born between 1915-1922 and 1924-1925 were included in the trial, and were 47 to 55 years of age on entry to the study in 1970 to 1973. One-third of these men were randomly allocated to an intervention group, whilst the other two-thirds acted as controls. Men of all social classes, employed as well as unemployed, health conscious as well as careless, were invited, with 75% of these responding to the invitation. The intervention group contained 10,000 men and the control group 20,000 men. The intervention group were given advice on diet, both individually and in groups, the type of advice depending upon serum cholesterol level. Smokers were advised to stop smoking, and men with elevated blood pressure were treated with antihypertensive drugs. Due to the large size of the groups and because they formed a random population sample, it was assumed that they had similar characteristics at the start of the trial. Risk factors were only measured in the intervention group at this time, followed by intervention. This design feature solved several ethical problems with regard to no treatment in the control group. These men were, however, subjected to health examinations and treatment as well as general health advice. Risk factor levels were measured in the intervention group, and also in random subsamples (11%) of the control group after 4 and 10 years. Serum cholesterol, blood pressure and smoking decreased among men in both groups, and only slightly more in the intervention group.(ABSTRACT TRUNCATED AT 250 WORDS)
哥德堡市所有出生于1915 - 1922年以及1924 - 1925年的男性居民被纳入该试验,在1970年至1973年开始研究时他们的年龄为47至55岁。这些男性中有三分之一被随机分配到干预组,另外三分之二则作为对照组。所有社会阶层的男性,无论就业与否,注重健康与否,均受到邀请,其中75%的人回应了邀请。干预组有10000名男性,对照组有20000名男性。干预组的男性在饮食方面得到了个体化和集体的建议,建议类型取决于血清胆固醇水平。吸烟者被建议戒烟,血压升高的男性接受抗高血压药物治疗。由于两组规模较大且构成随机人群样本,假定在试验开始时他们具有相似的特征。此时仅在干预组测量风险因素,随后进行干预。这一设计特点解决了对照组不接受治疗方面的几个伦理问题。然而,这些男性也接受了健康检查、治疗以及一般健康建议。4年和10年后,在干预组以及对照组的随机子样本(11%)中测量风险因素水平。两组男性的血清胆固醇、血压和吸烟情况均有所下降,干预组下降幅度略大。(摘要截取自250字)