PubMed · 4582751
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M Weiner. 1973-11-01. Sounding board: raw vs. cooked data.. https://doi.org/10.1056/nejm197311012891812
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The process of evaluating medicinal herbs is complex, and there is a need to carefully define a research strategy that addresses a solution to safe and efficacious herbal products. Notwithstanding the immense value of distilling the pharmacological activity of an herb into a chemical suitable for drug development, another approach is to develop a standardized herbal extract that yields consistent pharmacological activity. However, it frequently is forgotten that even in an extract several active ingredients contribute to the pharmacological action. Sufficient evidence exists to suggest that extracts of medicinal herbs, once isolated in their pure state, can produce pharmacological effects that differ significantly from that of the whole herb. This article discusses a research-based strategy that may be suitable for validating, in part, the putative health benefits of medicinal herbs. Additionally, the body of scientific evidence that underpins the pharmacological activity of several herbs is reviewed briefly.
We consider multivariate tests for comparing two treatments with multiple endpoints. The test decision is drawn from the simultaneous consideration of the univariate tests for the single endpoints. A general class of these tests, called cut-off tests, can be given, which, however, can lead to highly conservative procedures because the dependencies among the endpoints are not taken into account. In applying resampling-based methods considerable improvements for these tests can be achieved. Resampling-based cut-off tests are proposed which are sensitive against a treatment difference in a single endpoint, in a subgroup of endpoints, or in all endpoints. The results of Monte Carlo simulations demonstrate that a remarkable gain in statistical power as compared to the crude simultaneous consideration can be reached. In particular, for the multivariate one-sided test situation the proposed tests can be recommended. As an example the application of the tests is demonstrated by data from a clinical trial.
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