Department of Constitutional Biology and Medical Engineering Research Center, Korea Institute of Oriental Medicine, Daejeon, South Korea.
J Altern Complement Med. 2010 Jun;16(6):663-7. doi: 10.1089/acm.2009.0331.
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.
本研究旨在开发和评估一种中医寒证热证辨证问卷。该问卷旨在将受试者分为寒证或热证组，这在中药和针灸治疗的临床试验中很有用。
在之前的一项研究中开发的问卷由来自中医院的 63 名患者（A 组）和 64 名患者（B 组）填写。每位患者均由中医医生诊断为寒证、热证或复杂证三种证型之一。根据医生的诊断，对问卷结果进行内部可靠性和有效性分析。
10 项寒证条目和 10 项热证条目的 Cronbach's alpha 系数分别为 0.579 和 0.718。寒证组和热证组的问卷平均得分存在显著差异。该问卷对 A 组的分类准确率为 94.9%，对 B 组的分类准确率为 92.3%。
我们的结果表明，该问卷满足某些基本要求，可能作为辅助诊断工具有用。需要进一步使用更多数量和类型的患者进行研究，以评估其在临床试验和基础生理研究中的有用性。
