## Clinical Validation

In the experiment, 11 asymptomatic subjects (4 males and 7 females) aged 20-63 (average 41.9 years) were examined.

A total of five bilateral points were randomly chosen on different anatomical locations (helix, anthelix, triangular fossa, tragus, antitragus) (Fig. 6.6). This pattern was the same for all the 11 subjects for a total of 110 points. Further points to test were identified with the commercial device Agiscop which has been used for all the clinical investigations in this book and will be described in some detail in Appendix 2. The ears of all subjects were examined thoroughly with Agiscop (modality —) and a total of 118 points were found. The total number of points suitable for the experiment was therefore 228.

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Time (seconds) Fig. 6.5 Typical diagram of resistance as a function of time, measured on a logarithmic scale. Ten measurements are taken at 1 s intervals after the initial transient. The final average is shown. The clinical validation was designed by Dr Romoli, who had a special interest in comparing these results with the performance of commercially available devices such as the Agiscop, described in Appendix 2. There were two operators taking the ESR measurements: (A) a trained operator with 10 years experience in ear acupuncture diagnosis and (B) a professional medical operator with no previous experience in acupuncture. The computer was operated by a third independent researcher, who observed the contact time between the probe tip and the skin then waited 5 s and triggered the 10 measurement series. Neither operator A nor operator B had access to any results of any measurement during the session. At each point two measurements were taken by rater A, and the same number by rater B. The succession of measurements was A, B, A, B. The time lag between each measurement was 5-10 minutes. Neither A nor B knew what their own first measurement of a given point was. All measurements were taken during the months of May, June and July, with an indoor temperature varying from 22 to 27 degrees Celsius. A histogram of all 912 measurements by rater A and B, related to a total of 228 points, is given in Figure 6.7. It will be appreciated that the frequency is not distributed uniformly across the range, but is clustered around very high and very low values, with a difference of four orders of magnitude. A similar behavior was also found in the second session by rater A and in both sessions by rater B. The histograms of the random points and the points identified with the Agiscop are represented in Figures 6.8 and 6.9. It is possible to appreciate that Agiscop points tend to cluster around lower values in comparison with the random points. It is difficult to treat these data using parametric statistical analysis, since a few points acting differently from their neighbors can cause mean and standard deviations to vary wildly. For instance, following 10 points grouping together in the hundredths of kfi range, one point around 100 Mfi is enough to shift the mean to around 10 Mfi and cause the standard deviation to shoot up. In such a case the mean and standard deviation retain their mathematical meaning, 170 Auricular acupuncture diagnosis Kohm ^ <3* «S5 JS5 ,<3* JS5 ^ JS1 ^ JS1 ^ <3* «S5 ^ ,<3* ¿S5 ^ ^ ^ ^ <§> ¿Ç> ¿P <S> ¿P ¿9 a<O á? ¿e ^ ^ <3* «S5 JS5 ,<3* JS5 ^ JS1 ^ JS1 ^ <3* «S5 ^ ,<3* ¿S5 ^ ^ ^ ^ <§> ¿Ç> ¿P <S> ¿P ¿9 a<O á? ¿e ^ Kohm e' Classes of resistance Fig. 6.7 Histogram of all points measured in this experiment from 0 to 100 000 Kohm. Classes of resistance Fig. 6.8 Histogram of random points. Classes of resistance Fig. 6.8 Histogram of random points. but no longer give a good idea of the data distribution. It is thus opportune to adopt a threshold type of differentiation. In order to establish the threshold, a more refined histogram is traced for only the values below 10 000 kfi. It is possible to see that most values lie below 1500 kfi (Fig. 6.10). Therefore a value of 2 MO can be considered a reasonable separation point between points to be classified as either low or high resistance. In addition, it is relevant to observe that of the 118 points which were identified with the Agiscop, most were under the 2 MO threshold (109 for rater A and 105 for rater B). Classes of resistance Fig. 6.9 Histogram of points identified with the Agiscop. 250- 100-
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