Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial

Authors

  • Lixing Lao,

    Corresponding author
    1. Center for Integrative Medicine, University of Maryland, School of Medicine, East Hall, 520 W. Lombard Street, Baltimore, MD 21201, U.S.A.
    • Center for Integrative Medicine, University of Maryland, School of Medicine, East Hall, 520 W. Lombard Street, Baltimore, MD 21201, U.S.A.

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  • Yi Huang,

    1. Department of Mathematics and Statistics, University of Maryland, Baltimore County, 1000 Hilltop Circle, Baltimore, MD 21250, U.S.A.
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  • Chiguang Feng,

    1. Department of Mathematics and Statistics, University of Maryland, Baltimore County, 1000 Hilltop Circle, Baltimore, MD 21250, U.S.A.
    2. Center for Vaccine Development, University of Maryland, School of Medicine, 685 Baltimore St., Baltimore, MD 21201, U.S.A.
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  • Brian M. Berman,

    1. Center for Integrative Medicine, University of Maryland, School of Medicine, East Hall, 520 W. Lombard Street, Baltimore, MD 21201, U.S.A.
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  • Ming T. Tan

    1. Division of Biostatistics, Department of Epidemiology and Preventive Medicine, University of Maryland, School of Medicine, 10 S Pine St., Baltimore, MD 21201, U.S.A.
    2. University of Maryland Marlene and Stewart Greenebaum Cancer Center, 20 S Greene St., Baltimore, MD 21201, U.S.A.
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Abstract

Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved. Copyright © 2011 John Wiley & Sons, Ltd.

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