Effects of switching to wen-jing-tang (unkei-to) from preceding herbal preparations selected by eight-principle pattern identification on endocrinological status and ovulatory induction in women with polycystic ovary syndrome.

The objective of this study was to investigate the effects of switching therapy to wen-jing-tang (unkei-to) from previous selected herbal preparations on endocrine levels and induction of ovulation in women with polycystic ovary syndrome (PCOS). Sixty-four anovulatory women diagnosed with PCOS were enrolled in the study. After Kampo diagnosis, subjects received matched Kampo preparations (43 cases: dang-gui-shao-yao-san, 21 cases: gui-zhi-fu-ling-wan) selected by the matching theory of eight-principle pattern identification and Kampo diagnosis based on concepts of the qi, blood, and fluids as the physiologic activity. Fifty-four women who failed to ovulate after an 8-week treatment were randomly allocated to continuation of treatment with the preceding Kampo prescription (continuation group, n = 27) or treatment with wen-jing-tang (switching group, n = 27). Plasma FSH, LH and estradiol levels were measured and ovulation rates were determined at the beginning and after an 8-week treatment with the preceding Kampo prescription, as well as after the subsequent 8-week treatment with the same preparation or wen-jing-tang. No decrease in mean plasma LH level was observed in the 54 women who failed to ovulate among the 64 treated with a Kampo preparation. After the 8-week treatment with wen-jing-tang, plasma LH levels were decreased by 58.2% (p < 0.0001) and 49.4% (p = 0.0005) in the groups switched from dang-gui-shao-yao-san and gui-zhi-fu-ling-wan, respectively. In the group switched from dang-gui-shao-yao-san, a tendency towards increase in plasma estradiol level was observed (1.51-fold, p = 0.055), which was significant compared with that in the group switched from gui-zhi-fu-ling-wan (p = 0.032). The ovulation rate with switching of treatment to wen-jing-tang was significantly higher (59.3%) than that with continued use of the same preparation (7.4%, p = 0.0036). This study confirmed that wen-jing-tang was effective in improving endocrine condition in the treatment of disturbances of ovulation in patients with PCOS without taking eight-principle pattern identification into consideration. This finding indicates that wen-jing-tang is appropriate for use in treating PCOS in women with various constitutions (as determined by the matching theory of eight-principle pattern identification) in clinical practice and may prove to be a potent therapeutic agent with a wide therapeutic spectrum.

RCT Entities:   Population Interventions Outcomes