Objective To observe the clinical effect of Guizhu Yikun Formula（ 归术益坤方） on polycystic ovary syndrome（ PCOS） with spleen and kidney deficiency and damp turbidity aggregation syndrome. Methods Modified Guizhu Yikun Formula were orally given to 62 patients of PCOS with spleen and kidney deficiency and damp turbidity aggregation syndrome

one dose a day for continuous 6 months or one dose a day except 5 days in menstruation until pregnancy confirmed. Patients who prepared pregnancy and conform to follow-up conditions took the formula for continuing 6 months. Main syndrome scores

body mass index（ BMI）

the level of sex hormones including estradiol 2（ E2）

testosterone（ T）

luteinizing hormone（ LH）

follicle stimulating hormone（ FSH）

prolactin（ PRL） were determined

and the size change of uterus and ovary by B-ultrasonography were detected before and after treatment.Pregnancy rate was calculated after treatment. Results The pregnancy rate of 39 patients with pregnancy plans was12 cases in 12 months’ treatment. BMI

delayed menstruation

menstrual quantity decreases

low back soreness and pain

dizziness

fatigue

spontaneous sweating

and abdominal distension were significantly decreased. Main syndrome scores were obviously decreased after treatment（ P < 0. 05 or P < 0. 01）. The level of T

LH and FSH were significantly decreased after treatment（ P < 0. 05 or P < 0. 01）. The size of uterus had no significant difference before and after the treatment

while the size of bilateral ovary were significantly smaller after treatment（ P < 0. 01）. Conclusion Guizhu Yikun Formula can obviously improve the syndrome of PCOS patients with spleen and kidney deficiency and damp turbidity aggregation syndrome

and increase pregnancy rate with certain clinical efficacy.