Am J Chin Med. 1994 ; 22(2): 127-36.

Further analysis of a pilot study for planning an extensive clinical trial in traditional medicine--with an example of acupuncture treatment for stroke.

Chen CH, Chou P, Hu HH, Tsuei JJ.

Institute of Statistical Science, Academia Sinica, Taipei, Taiwan.

Statistical methods for evaluating the effects of treatments and prognostic factors in clinical trials are discussed. Exploratory data analysis, nonparametric methods, regression modeling, and regression diagnostics of influential cases are applied to the analysis of a pilot 'randomized' controlled trial on the treatment of acute stroke with acupuncture. The utility of this analysis for modifying patient eligibility criteria, determining required sample size and utilizing stratified randomization in a future extensive stroke trial is discussed.