Reliability and Validity of a Cold–Heat Pattern Questionnaire for Traditional Chinese Medicine

Abstract

The aim of this study was to develop and evaluate a questionnaire for Cold and Heat pathologic pattern identification in the context of Traditional Chinese Medicine (TCM). This questionnaire was intended to classify subjects into Cold or Heat pattern groups, a distinction that is useful in clinical trials of both herbal and acupuncture treatments. A questionnaire that had been developed in a previous study was completed by 63 patients (Group A) and 64 patients (Group B) from TCM hospitals. Each patient was diagnosed by a TCM doctor as one of three patterns: Cold, Heat, and Complex. The questionnaire results were analyzed for internal reliability and validity based on the doctor's diagnosis. Cronbach's alpha coefficients were 0.579 for the 10 Cold items and 0.718 for the 10 Heat items. There were significant differences in the mean questionnaire scores between the Cold and Heat groups. The classification accuracy of this questionnaire for Group A was 94.9%, and for Group B it was 92.3%. Our results suggest that the questionnaire meets certain basic and fundamental requirements and that it may be useful as an adjunct diagnostic tool. Further studies using a greater number and variety of patients will be needed to evaluate its usefulness in clinical trials and in basic physiologic research.