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Japanese Acupuncture and Moxibustion (Online)
2005; 1: 9-15
A Proposal for a Simple and Useful Research Design for Evaluating the Efficacy of Acupuncture: Multiple, Randomized n-of-1 Trials
KAWAKITA Kenji 1), SUZUKI Masao 2), NAMURA Kenji 2), TANZAWA Shouhachi 1)
1) Research Department of Japan Society of Acupuncture and Moxibustion
2) Department of Internal Medicine, Meiji University of Oriental Medicine
Fig. 3 A block diagram of the protocol of multiple randomized n-of-1 trials
Patients are randomly allocated to each group then the effect of acupuncture or control intervention in each patient is evaluated by an n-of-1 trial (the randomization test can be used). Incidences of positive or negative results are analyzed statistically. (using chi-square test ). In this case, chi square=6.3349 and p=0.0117. However, small samples require Yates' continuity correction, with which the results become, chi-square=4.063, p=0.0438. This result indicates the external validity of n-of-1 trials.

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