A pilot study on investigation of Chinese medicinal classification andits relationship with hormones in menopausal women

Objective: To develop a validated questionnaire for the assessment of menopausal syndrome in Chinese Medicine and through the analysis of the basic menopausal syndrome classification in Chinese Medicine to explore the use of objective hormone markers as one of the evidence for the Chinese Medicinal classification and guidance for application of herbal medicines by Chinese Medicine Practitioners. Methods: The major symptoms related to typical syndromes of menopause were extracted from Chinese Medicine textbook, international diagnostic guide of Chinese Medicine, classic and contemporary literature of Chinese Medicine and subjective symptoms were eliminated to facilitate the administrate of a self-reported outcome questionnaire. The symptoms related to menopause in Chinese Medicine were identified and redefined to improve the content validity. A total of 353 menopausal women were included in the study. Participants were assessed through face-to-face interview by registered Hong Kong Chinese Medicine Practitioner to complete the questionnaire and serum samples for hormones measurement were collected after an overnight fast in the morning of the assessment day. Serum Estradiol (E2), Testosterone (T), Progesterone (P), Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Sex-Hormone Binding Globulin (SHBG) were measured by electrochemiluminescence immunoassays (ECLIA). Free estradiol (fE2), non-Sex-Hormone Binding Globulin bound Estradiol (non-SHBG-E2), free Testosterone (fT), and non-Sex-Hormone Binding Globulin bound Testosterone (non-SHBG-T) were calculated to assess hormone availability and activity. E2/T ratio was also calculated to investigate the balance of E2 and T in the body. Results: Principal Component Analysis (PCA) was conducted. Symptoms related to Deficiency of Yin and symptoms related to Deficiency of Yang were extracted and the relationship between the syndromes and E2, T, P, LH, FSH, SHBG, fT, non-SHBG-T, fE2, non-SHBG-E2 and E2/T ratio were investigated. For symptoms related to Deficiency of Yin, E2 (p<0.000, p<0.000), P (p=0.004, p<0.000), fE2 (p<0.000, p<0.000), non-SHBG-E2 (p<0.000, p<0.000), E2/T (p<0.000, p<0.000)，SHBG (p=0.039, p=0.004) showed significant decrease while LH (p=0.013, p<0.000), FSH (p=0.041, p<0.000) showed increase by comparing hormones of mild or little with moderate and severe presentation of symptoms. For symptoms related to Deficiency of Yang, SHBG (p=0.042, p=0.002, p