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首页> 美国卫生研究院文献>other >Proper interpretation of chronic toxicity studies and theirstatistics: A critique of Which level of evidence does the US NationalToxicology Program provide? Statistical considerations using the TechnicalReport 578 on Ginkgo biloba as anexample
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Proper interpretation of chronic toxicity studies and theirstatistics: A critique of Which level of evidence does the US NationalToxicology Program provide? Statistical considerations using the TechnicalReport 578 on Ginkgo biloba as anexample

机译：正确解释慢性毒性研究及其统计资料：对美国国民的证据水平有批评毒理学计划提供什么？使用技术的统计考虑报告578关于银杏叶例

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摘要

A recent article by demonstrates a serious misunderstanding of the NTP’s statistical analysis and interpretation of rodent carcinogenicity data as reported in Technical Report 578 (Ginkgo biloba) (), as well as a failure to acknowledge the abundant literature on false positive rates in rodent carcinogenicity studies. The NTP reported Ginkgo biloba extract to be carcinogenic in mice and rats. Gaus claims that, in this study, 4800 statistical comparisons were possible, and that 209 of them were statistically significant (p<0.05) compared with 240 (4800 × 0.05) expected by chance alone; thus, the carcinogenicity of Ginkgo biloba extract cannot be definitively established. However, his assumptions and calculations are flawed since he incorrectly assumes that the NTP uses no correction for multiple comparisons, and that significance tests for discrete data operate at exactly the nominal level. He also misrepresents the NTP’s decision making process, overstates the number of statistical comparisons made, and ignores that fact that that the mouse liver tumor effects were so striking (e.g., p<0.0000000000001) that it is virtually impossible that theycould be false positive outcomes. Gaus’ conclusion that such obviousresponses merely “generate a hypothesis” rather than demonstratea real carcinogenic effect has no scientific credibility. Moreover, his claimsregarding the high frequency of false positive outcomes in carcinogenicitystudies are misleading because of his methodological misconceptions anderrors.
机译：最近的一篇文章作者对技术报告578（Ginkgo biloba）（）中报道的NTP的统计分析和对啮齿动物致癌性数据的解释有严重的误解，并且未能承认有关啮齿动物致癌性研究中假阳性率的大量文献。 。 NTP报道银杏叶提取物对小鼠和大鼠具有致癌性。高斯声称，在这项研究中，可以进行4800次统计比较，其中有209次具有统计学意义（p <0.05），而仅靠偶然性就可以预期达到240次（4800×0.05）。因此，不能确切地确定银杏叶提取物的致癌性。但是，他的假设和计算有缺陷，因为他错误地假设NTP不对多个比较使用校正，并且离散数据的显着性测试恰好在名义水平上进行。他还歪曲了NTP的决策过程，夸大了进行统计比较的次数，并忽略了小鼠肝脏肿瘤的影响如此惊人（例如p <0.0000000000001）以至于几乎不可能可能是假阳性结果。高斯的结论是，如此明显回应仅“产生假设”而不是证明真正的致癌作用没有科学可信度。而且，他的主张关于致癌性假阳性结果的高频率由于他的方法论上的误解而使研究产生误导错误。

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