RESUMEN
Si-Wu-Tang (SWT), a traditional Chinese formula, is commonly used to relieve menstrual discomfort and climacteric syndrome. Water decoction (WD) and concentrated herbal extract (CHE) are the two most common formulations of traditional Chinese medicine (TCM). However, few studies have reported the equivalency of these two formulations. In this study, 23 healthy volunteers were included to determine the pharmacokinetic (PK) equivalent dosage of WD and CHE, and 25 infertile women with follicular maldevelopment to evaluate the pharmacodynamic (PD) effects on menstrual disorders. The randomized, two-way crossover comparative PK study of SWT-WD and SWT-CHE analyzed the active component, ferulic acid. The results showed that clinical doses of 170 mL SWT-WD and 18 g SWT-CHE produced the same amount of ferulic acid in the blood. The PD study showed that patients who took both of these formulations had an initial luteinizing hormone/follicle-stimulating hormone ratio of <1; however, the value returned to normal and their symptoms all improved after taken SWT. Our results showed that WD and CHE, both prepared from 40 g of SWT, displayed bioequivalence upon PK/PD analysis.
RESUMEN
Si-Wu Tang (SWT), a traditional Chinese formula, is commonly used for treating female diseases, such as relief of menstrual discomfort and climacteric syndrome. The aim of this study was to explore the synergistic effects between each herb in SWT on menstrual disorder patterns. Estradiol regulation and antioxidative effects were indicators that ameliorated menstrual disorder patterns and the total polyphenol and polysaccharide contents were quality markers. According to relationships of bioactivity and phytochemical contents, we discuss the effects of each herb in SWT. In a testosterone-treated MCF-7 cell model, Rehmannia glutinosa and catalpol significantly increased the estradiol content and aromatase upregulation in cell culture. We suggest that catalpol is an aromatase promoter in SWT, and R. glutinosa is a major actor. In terms of the antioxidant activity, pentagalloylglucose, gallic acid, and ferulic acid had stronger antioxidative effects than other compounds. We suggest that the antioxidative ability depends on polyphenols, and Paeonia lactiflora is a major contributor. Based on the prescribing principle of traditional Chinese medicine (TCM) theory, we suggest that R. glutinosa in SWT act as an aromatase promoter in the role of sovereign for ameliorating menstrual disorder patterns. As P. lactiflora has the strongest antioxidant effects and can prevent ROS damage ovarian; therefore, P. lactiflora could help R. glutinosa work as a minister for menstrual disorder patterns and R. glutinosa and P. lactiflora are a herbal pair in SWT.