Efficacy of the Xiong-Gui-Jiao-Ai-Tang Herbal Medicine, in the Treatment of Threatened Abortion in Early Pregnancy

The American Journal of Chinese Medicine, Vol. 34, No. 5, 731–740 © 2006 World Scientific Publishing Company Institute for Advanced Research in Asian Science and Medicine

Takahisa Ushiroyama Department of Nursing, Aino Gakuin College 3-9-25 Oda Ibaraki, Osaka 567-0018, Japan
Ryoji Araki Department of Obstetrics and Gynecology, Takatsuki Red Cross Hospital Takatsuki, Osaka 569-1045, JapanKou Sakuma, Sakura Nosaka, Yoshiki Yamashita and Hideki Kamegai Department of Obstetrics and Gynecology, Osaka Medical College Takatsuki, Osaka 569-8686, Japan

Abstract: This study was carried out to evaluate the clinical efficacy of Xiong-gui-jiao-aitang
(Kyuki-kyogai-to), a traditional Chinese herbal medicine, in the treatment of threatened
abortion in early pregnancy. We enrolled 72 women diagnosed with threatened abortion at
Osaka Medical College Hospital and assigned them at random to the following two groups:
a group of 36 women who received Xiong-gui-jiao-ai-tang at a dose of 7.5 g/day and another
group of 36 women who received human chorionic gonadotropin (hCG) (control group). We
found that in the Xiong-gui-jiao-ai-tang group (2.9 ± 3.5 days), the number of days required
before hemostasis was reached in the uterus was significantly shorter than in the control group
(10.8 ± 8.2 days, p 0.0001). Furthermore, the number of days required for retroplacental
hematoma in the vicinity of the gestational sac to disappear was significantly shorter in the
Xiong-gui-jiao-ai-tang group (9.9 ± 7.1 days) than in the control group (23.2 ± 12.8 days)
(p 0.0001). In retroplacental hematoma size, significant rates of reduction were obtained in
both major and minor axis measurements at the 7th day of treatment for the Xiong-gui-jiaoai-
tang group compared to the control group (control vs Xiong-gui-jiao-ai-tang: major axis:
7.5 ± 3.8% vs 42.3 ± 10.5%; minor axis: 15.3 ± 16.8% vs 71.5 ± 48.2%) (p 0.0001, each
case). The results of this study demonstrated the beneficial effects of Xiong-gui-jiao-ai-tang
in stabilizing early pregnancy.

The Herbal Preparation
Xiong-gui-jiao-ai-tang (Kyuki-kyogai-to) is composed of 7 herbal ingredients (Table 2). It
is a combination of the following: 5 g of Rehmannia root (di huang), 4 g each of Peony root
(shao yao), and Japanese Angelica root (dang gui), and 3 g each of Roasted Glycyrrhiza
root (zhi gan cao), Cnidium rhizome (chuang xiong), Mugwort leaf (ai te), and Gelatin
(e jiao). A mixture consisting of these chopped ingredients was extracted with 1 liter of hot
water, condensed by boiling to 600 ml, then filtered and lyophilized to prepare a powder
which was stored at 4°C as 4 g lots of Xiong-gui-jiao-ai-tang extract. Four grams of extract
was transformed to 7.5 g of granular-type agent (with addition of 3.5 g of drug additive,
i.e. lactose) as a commercial drug (TSUMURA & Co., Tokyo, Japan).

Components of Herbal Drugs in Xiong-Gui-Jiao-Ai-Tang
Rehmannia root 5.0 g
Peony root 4.0 g
Japanese angelica root 4.0 g
Roasted Glycyrrhiza root 3.0 g
Cnidium rhizome 3.0 g
Mugwort leaf 3.0 g
Gelatin 3.0 g

Protocol
After giving fully informed consent, patients were randomly allocated to either of two
groups (envelope method). Thirty-six patients received 7.5 g of extracted granules of
Kampo preparation each day (2.5 g of the commercial preparation in 100 ml of hot water
taken about 30 minutes before every meal) for 8 weeks. For the remaining 36 patients, the
fixed dose of 5,000 IU of human chorionic gonadotropin (hCG) was given intramuscularly
3 times a week. A hemostatic agent was also administered as required. Specific Kampo
examinations (inspection, the listening and smelling, inquiry, and palpation: (four
examinations in all) were not carried out in this study. Neither was the eight-principle
pattern identification, the process of determining optimum patient status, considered
in treatment with Xiong-gui-jiao-ai-tang. Three patients in the Xiong-gui-jiao-ai-tang
group dropped out of the study by the second day of administration, leaving a total of
69 patients as the final total for the study (hCG group: 36 patients; Xiong-gui-jiao-ai-tang
group: 33 patients). Ultrasonographic studies were performed at the beginning of and after 7-day
administration of Xiong-gui-jiao-ai-tang.