CHOLESTEROL LOWERING TRIALS IN CORONARY HEART-DISEASE - FREQUENCY OF CITATION AND OUTCOME

CHOLESTEROL LOWERING TRIALS IN CORONARY HEART-DISEASE - FREQUENCY OF CITATION AND OUTCOME
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DOI:
10.1136/bmj.305.6844.15
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发表时间:
1992-07-04
影响因子:
105.7
通讯作者:
RAVNSKOV, U
RAVNSKOV, U
中科院分区:
医学1区
文献类型:
--
作者:
RAVNSKOV, U

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观察降低胆固醇值预防冠心病的说法是否正确,或者它是否仅基于支持性试验的引用。设计-比较引用频率与所有对照的降低胆固醇试验的结果,使用冠心病或死亡,或两者兼而有之,作为终点。受试者-22个对照胆固醇降低试验。结果-根据科学引文索引,被他们的主任认为支持这一论点的试验被引用的次数几乎是其他试验的六倍。除了由于治疗的副作用而中止的试验外,1970年以后没有引用不支持性试验,尽管它们的数量几乎等于被认为支持性的数量。在3项支持性综述中,所选试验的结局比排除和忽略的试验的结局更有利。在22个对照的降胆固醇试验中,总死亡率和冠心病死亡率在总体或任何亚组中均无显著变化。非致死性冠心病统计学显著性降低0-32%似乎是由于偏倚,因为事件频率与试验时间和胆固醇值平均净降低无关;胆固醇值的个体变化与结局无系统相关性或无关;在对干预组中非医疗死亡的小幅但显著增加进行校正后,总死亡率保持不变结论:降低血清胆固醇浓度不能降低死亡率,也不可能预防冠心病。相反的主张是基于支持性试验的优先引用。
Objective-To see if the claim that lowering cholesterol values prevents coronary heart disease is true or if it is based on citation of supportive trials only.Design-Comparison of frequency of citation with outcome of all controlled cholesterol lowering trials using coronary heart disease or death, or both, as end point.Subjects-22 controlled cholesterol lowering trials.Results-Trials considered by their directors as supportive of the contention were cited almost six times more often than others, according to Science Citation Index. Apart from trials discontinued because of alleged side effects of treatment, unsupportive trials were not cited after 1970, although their number almost equalled the number considered supportive. In three supportive reviews the outcome of the selected trials was more favourable than the outcome of the excluded and ignored trials. In the 22 controlled cholesterol lowering trials studied total and coronary heart disease mortality was not changed significantly either overall or in any subgroup. A statistically significant 0-32% reduction in non-fatal coronary heart disease seemed to be due to bias as event frequencies were unrelated to trial length and to mean net reduction in cholesterol value; individual changes in cholesterol values were unsystematically or not related to outcome; and after correction for a small but significant increase in non-medical deaths in the intervention groups total mortality remained unchanged (odds ratio 1.02).Conclusion-Lowering serum cholesterol concentrations does not reduce mortality and is unlikely to prevent coronary heart disease. Claims of the opposite are based on preferential citation of supportive trials.