<b>Efficacy of Kampo Formula Tokishigyakukagoshuyushokyoto for Cold Syndrome Evaluated with a Novel Clinical Method using a Patient-based Questionnaire D</b><b>atabase </b> / 日本東洋医学雑誌

ABSTRACT

<b>Objectives</b> : Persistent coldness is a common complaint for which Kampo, traditional Japanese herbal medicine, is often tried, because there is no definition or objective measure of subjective coldness in Western medicine. The aim of this study was to evaluate the efficacy of a common Kampo agent, tokishigyakukagoshuyushokyoto, and to identify key symptoms that would predict positive treatment outcomes for coldness.<br><b>Design</b> : A retrospective cohort study.<br><b>Setting</b> : 181 patients who complained of coldness without any organic abnormalities self-surveyed their health using a Kampo questionnaire database system on their first visit. Another 28 patients were assigned to verify the discriminatory predictability of treatment efficacy.<br><b>Interventions</b> : Patients were treated with extract product, 7.5 grams a day for a month.<br><b>Outcome measures</b> : Treatment efficacy as a binary response.<br><b>Results</b> : Frequency and severity scales (0 to 4) for coldness decreased from 3.2 ± 0.7 to 2.1 ± 0.1 (<i>p </i>< 0.01)and from 3.1 ± 0.7 to 2.2 ± 0.9 (<i>p </i>< 0.01), respectively. Improvements in both frequency and severity of coldness were observed in 74.0% of patients. The status of tenderness in the iliac region, without upset stom ach or depression, was obtained as an appropriate model for the prediction of treatment effect, and its discrimi natory predictability was calculated as 84.4%. The predictive accuracy of the model was validated with 82.1% for the 28 new patients.<br><b>Conclusions</b> : Coldness susceptible to tokishigyakukagoshuyushokyoto was very frequently accompanied by tenderness in iliac region, without upset stomach or depression.