The purpose of this study is to explore the efficacy of GFW in the treatment of climacteric syndrome in women with blood stasis pattern. The study will also serve to monitor the safety of GFW.
Traditional Chinese medicine (TCM) has been adopted in a modified form in East Asian countries such as Japan and Korea [
32,
33]. The system of pattern identification—the process of overall analysis of clinical data to determine the location, cause, and nature of disease in a patient and diagnosing a pattern/syndrome [
34]—practiced in the three countries varies to a certain extent. In TCM, a practitioner recognizes the “Zheng” (clinical diagnosis based on analysis of medical history, symptoms, and signs) and confirms the treatment principle. In traditional Japanese medicine (Kampo), a practitioner chooses the most appropriate formula from among approximately 150 ready-to-use formulas, according to the “Sho” (pattern of symptoms) of the patient [
32,
35]. Kampo can be characterized as a simplified and pragmatic version of Chinese herbal medicine [
36]. In traditional Korean medicine (TKM), disease and pattern identification are made simultaneously as described in
Dongui Bogam [
37], which was compiled in the 17th century. TKM has been developed to include various modified methods involving the application of existing principles, methods, and formulas [
38]. The diagnostic system of TKM includes the determination of diagnostic criteria based on indications for prescription of herbal medicines for a certain disease or its etiology [
39‐
42]. Standardization of diverse pattern identification systems has been inadequate until now, which has made it challenging to apply pattern identification to clinical research on traditional medicine [
43‐
46]. For the findings of clinical studies to be of direct aid in medical decision-making in traditional clinical practice, pattern identification systems used in routine practice need to be accurately reflected in the study design [
44,
45]. The present trial was planned in consideration of the target symptoms for herbal formulas, with Western medical methods for participant selection and outcome measurement. This approach is in agreement with a previous proposal for complementation of clinical research methods in traditional medicine [
39].
Although the pattern identification and outcome measurement methods of this study are not ideal, they could serve as a reference for planning clinical trials that reflect the characteristics of traditional medicine. The results of this study will provide basic data for the designing of a large-scale trial evaluating the efficacy of GFW for the treatment of climacteric syndrome in women.