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Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (9): 965-972.doi: 10.3736/jcim20110907

• Original Clinical Research • Previous Articles     Next Articles

Efficacy of Chinese patent medicine Tian Gui Capsule in patients with polycystic ovary syndrome: A randomized controlled trial

Susuana Kuek,  Wen-jun Wang(), Sui-qi Gui()   

  1. Department of Integrated Traditional Chinese and Western Medicine, Obstetrics and Gynecology Hospital, Fudan University, Shanghai 200011, China
  • Received:2011-01-12 Accepted:2011-04-25 Online:2011-09-20 Published:2011-09-15
  • Contact: Wang Wen-jun,Gui Sui-qi;

Background: Polycystic ovary syndrome (PCOS) is a complex hormonal disorder and one of the most common reproductive endocrinology abnormalities in women. Recently, many studies have been conducted assessing Chinese herbal medicine as an alternative treatment for women with PCOS, it is, therefore, worthwhile to analyze and observe the curative effects of traditional Chinese medicine treatment in PCOS.

Objective: To evaluate the efficacy of the Chinese patent medicine Tian Gui Capsule, in women with PCOS and compare its effects with metformin and ethinyl estradiol plus cyproterone acetate (Diane-35). Design, setting, participants and intervention: A total of 47 PCOS outpatients from the Obstetrics and Gynecology Hospital of Fudan University were randomly divided into 3 groups. Patients in group A (n=19) were given Tian Gui Capsule, patients in group B (n=17) were given metformin, and patients in group C (n=11) were given Diane-35. The 3 groups of patients were treated for 3 months. Main outcome measures: Serum testosterone (T), sex hormone binding globulin (SHBG) and dehydroepiandrosterone sulfate (DHEA-S) levels, free androgen index (FAI), fasting blood glucose (FPG), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR), insulin sensitive index (ISI) and left and right ovary volumes of the 3 groups were evaluated before and after treatment

Results:After 3 months of treatment, when compared with before treatment data, group A patients showed decreased serum T and SHBG levels, FAI, FINS, and left and right ovary volumes (P<0.05), and increased serum DHEA-S (P<0.05), while the FPG level showed no significant change. Although the level of serum T and FINS among the 3 groups after the treatment were similar, group A demonstrated better results than group B in reducing the FAI and increasing the serum SHBG, but less significant results than group C besides, group B was the only group showed improved insulin sensitivity. Although the level of FPG of the 3 groups after treatment were similar, group C had the most increased FPG.

Conclusion:The effects of Tian Gui Capsule on hyperandrogenism are not as significant as Diane-35, but more effective than metformin. The effects of Tian Gui Capsule on hyperinsulinemia are not as significant as metformin but better than Diane-35. Tian Gui Capsule treats PCOS by regulating ovarian functions and reducing blood insulin level without inhibiting the function of the hypothalamic-pituitary-ovarian axis. Further studies with larger sample size are needed to confirm the above results.

Key words: polycystic ovary syndrome, Chinese patent drugs, Tian Gui Capsule metformin, ethinylestradiol and cyproterone acetate tablet, hyperandrogenism, insulin resistance, randomized controlled trials

Figure 1

Flow diagram of this clinical trial"


Group n Height (m) Weight (kg) BMI (kg/m2) WHR
Before After Before After Before After
A 19 1.59±0.03 59.47±8.76 58.57±8.37* 23.26±3.34 22.90±3.09* 0.83±0.04 0.82±0.08
B 17 1.58±0.05 64.55±7.77 61.46±6.90 25.70±2.96 24.61±2.87 0.83±0.05 0.82±0.05
C 11 1.58±0.02 58.86±10.66 59.04±10.18 19.27±10.46 19.45±10.46 0.83±0.07 0.82±0.08


Group n FSH (IU/L) LH (IU/L) E2 (pmol/L)
Before After Before After Before After
A 19 6.47±1.33 6.53±1.36 9.03±5.05 9.49±7.19 138.88±76.71 146.22±80.02*
B 17 7.54±1.98 7.14±1.59 9.79±4.88 8.48±5.22 157.16±65.02 172.26±130.10
C 11 8.27±2.64 7.08±3.39 11.40±4.00 5.45±2.74 164.48±52.77 175.82±69.00
Group n T (nmol/L) DHEA-S (μmol/L) SHBG (nmol/mL)
Before After Before After Before After
A 19 2.06±0.53 1.94±0.50* 5.52±1.94 6.25±1.86*□ 64.74±46.46 56.17±29.81*□□
B 17 2.30±0.59 1.97±0.47 6.98±2.18 7.46±2.32△□ 61.75±22.15 60.30±40.85△□□
C 11 2.19±0.80 1.63±0.43 4.57±1.89 4.19±1.43 73.15±45.22 258.02±101.00▲▲


Group n FPG (mmol/L) FINS (IU/L) HOMA-IR
Before After Before After Before After
A 19 4.25±0.39 4.36±0.40 11.36±7.37 10.74±6.04* 0.46±0.96 0.49±0.87
B 17 4.47±0.45 4.57±0.45 14.60±4.35 12.61±8.38△△ 1.01±0.33 0.74±0.66△△
C 11 4.28±0.36 4.65±0.26 12.01±8.81 9.99±4.51 0.64±0.60 0.51±0.56
Group n ISI FAI
Before After Before After
A 19 0.05±0.10 0.05±0.10 4.83±3.27 4.68±3.08*
B 17 0.01±0.05 0.02±0.01△△ 4.83±3.83 5.19±4.85△△
C 11 0.02±0.01 0.02±0.01 3.79±1.77 0.77±0.55▲▲


A 19 -0.62±5.76 0.03±0.52
B 17 -2.19±7.87 -0.29±0.61
C 11 -2.01±6.92 -0.02±0.33


Group n Left ovary volume Right ovary volume
Before After Before After
A 19 11.42±4.24 9.02±4.00*□ 12.17±3.71 11.79±4.41*□
B 17 10.24±4.33 9.96±4.07△□ 12.23±6.99 12.43±4.36
C 11 11.18±3.31 8.90±3.59▲▲ 13.71±5.75 10.24±4.65▲▲
[1] Wang FF, Hou LH, Li N . A review on related factors of polycystic ovary syndrome[J]. Yi Xue Yan Jiu Za Zhi, 2009,38(11):10-12
王芳芳, 侯丽辉, 李楠 . 多囊卵巢综合征发病相关因素的研究进展[J]. 医学研究杂志, 2009,38(11):10-12
[2] Diamanti-Kandarakis E, Kouli CR, Bergiele AT, Filandra FA, Tsianateli TC, Spina GG, Zapanti ED, Bartzis MI . A survey of the polycystic ovary syndrome in the Greek island of Lesbos: hormonal and metabolic profile[J]. J Clin Endocrinol Metab, 1999,84(11):4006-4011
doi: 10.1210/jcem.84.11.6148
[3] Li MZ . Diagnosis and treatment of polycystic ovary syndrome[J]. Zhonghua Fu Chan Ke Za Zhi, 2002,37(7):444-446
doi: 10.3760/j.issn:0529-567X.2002.07.029
李美芝 . 多囊卵巢综合征的诊断与治疗[J]. 中华妇产科杂志, 2002,37(7):444-446
doi: 10.3760/j.issn:0529-567X.2002.07.029
[4] Azziz R . Controversy in clinical endocrinology: diagnosis of polycystic ovarian syndrome: the Rotterdam criteria are premature[J]. J Clin Endocrinol Metab, 2006,91(3):781-785
doi: 10.1210/jc.2005-2153
[5] Wei MJ, Yu J . Clinical observation of Tian Gui prescription in treating hyperandrogenism anovulatory patients[J]. Zhonghua Nei Fen Mi Dai Xie Za Zhi, 2001,17(2):105-106
doi: 10.3760/j.issn:1000-6699.2001.02.015
魏美娟, 俞瑾 . 天癸方治疗高雄激素无排卵症临床观察[J]. 中华内分泌代谢杂志, 2001,17(2):105-106
doi: 10.3760/j.issn:1000-6699.2001.02.015
[6] Zhou LR, Yu J . Clinical observation on treatment of hyperinsulinemia and hyperandrogenism anovulatory patients with replenishing kidney-yin drugs[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 1996,16(9):515-518
周丽蓉, 俞瑾 . 补肾阴药治疗高胰岛素高雄激素无排卵症的临床观察[J]. 中国中西医结合杂志, 1996,16(9):515-518
[7] Veith I. The Yellow Emperor’s classic of internal medicine(第2版)[M]. Selangor Darul Ehsan, Malaysia: Pelanduk Publications, 1992,( 第2版):98-99
[8] Wang XJ, Shen ZY . Treating polycystic ovary syndrome by nourishing yin and clearing fire[J]. Shanghai Zhong Yi Yao Za Zhi, 1999,33(12):22-23
王兴娟, 沈自尹 . 承师心悟——滋阴降火法治疗多囊卵巢综合征[J]. 上海中医药杂志, 1999,33(12):22-23
[9] Yu J, Sun YL, Shao GQ . Regulation of hypothalamus-pituitary-ovary function in polycystic ovary syndrome by invigorating kidney and eliminating phlegm[J]. Zhong Xi Yi Jie He Za Zhi, 1986,6(4):218-221
俞瑾, 孙月丽, 邵公权 . 补肾化痰治疗多囊卵巢综合征中对下丘脑-垂体-卵巢功能的调节[J]. 中西医结合杂志, 1986,6(4):218-221
[10] Zhang YP, Yu J, Gui SQ . Studies on the validity of the androgen sterilized rat and ovulation-inducing effect of Zi Shen Yin herbs[J]. Zhonghua Nei Fen Mi Dai Xie Za Zhi, 1994,10(2):98-101
张月萍, 俞瑾, 归绥琪 . 雄激素致不孕大鼠发病机制及滋肾阴药对其促排卵的作用[J]. 中华内分泌代谢杂志, 1994,10(2):98-101
[11] Li GH, Huang W . Application of metformin in polycystic ovary syndrome[J]. Shi Yong Fu Chan Ke Za Zhi, 2005,21(9):534-536
doi: 10.3969/j.issn.1003-6946.2005.09.009
李国华, 黄薇 . 二甲双胍在多囊卵巢综合征的应用[J]. 实用妇产科杂志, 2005,21(9):534-536
doi: 10.3969/j.issn.1003-6946.2005.09.009
[12] Sharpless JL . Polycystic ovary syndrome and the metabolic syndrome[J]. Clin Diabetes, 2001,21(4):154-161
doi: 10.3109/9780849379581.036 pmid: 21213522
[13] Xia ZL, Hua K . The role of metformin in polycystic ovary syndrome[J]. Guo Wai Yi Xue Fu Chan Ke Xue Fen Ce, 2004,31(2):73-76
夏舟岚, 华凯 . 二甲双胍在多囊卵巢综合征中的作用[J]. 国外医学妇产科学分册, 2004,31(2):73-76
[14] Zhang MY, Li GG, Cai HD, Zeng QR, Yang YS, Li MS, Song YK. Infertility and reproductive endocrinology(2nd ed)[M]. Beijing: Peking University Medical Press, 2005,( 2nd ed):97-102
张明扬, 李国光, 蔡鸿德, 曾启瑞, 杨友仕, 李茂盛, 宋勇奎 . 不孕症及生殖内分泌学(第2版)[M]. 北京: 北京大学医学出版社, 2005,( 第2版):97-102
[15] Han XM, Jiang K . Clinical observation of 35 cases of polycystic ovary syndrome treated with Diane-35[J]. Zhi Ye Yu Jian Kang, 2007,23(23):2222
doi: 10.3969/j.issn.1672-3422.2007.21.040
韩雪梅, 姜坤 . 达英-35治疗多囊卵巢综合征30例临床观察[J]. 职业与健康, 2007,23(23):2222
doi: 10.3969/j.issn.1672-3422.2007.21.040
[16] Livingstone C, Collison M . Sex steroids and insulin resistance[J]. Clin Sci (Lond), 2002,102(2):151-166
doi: 10.1042/CS20010197 pmid: 11834135
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