Objective: To evaluate the clinical efficacy of Danbie capsule combined with mifepristone in treatment of uterine fibroids. Method: Sixty-eight patients with uterine fibroids were randomly divided into observation group and control group (n=34 each). The control group was orally given 12.5 mg of mifepristone

qd; except mifepristone

the observation group was given Danbie capsule

5 capsules tid for 12 weeks. The fibroid volume was observed by B-ultrasound

sex hormone levels and qi stagnation and blood stasis scores were also investigated. Result: After treatment

the uterine fibroids volume in the observation group was reduced by 68.7% than before while the control group reduced by 60.6% than before

and the average fibroids volume in the observation group was less than that in the control group (P<0.05); the serum follicle-stimulating hormone (FSH)

luteinizing hormone (LH)

estrogen 2 (E2) and progestin (P) levels had decreased than those before

and the FSH

LH

E2 in the observation group were lower than those in the control group (P<0.05 or P<0.01); after treatment

qi stagnation and blood stasis scores of the observation group was (5.9±2.87)

lower than (9.4±3.69) of the control group (P<0.01);the clinical efficacy of the observation group was better than the control group (P<0.05). Conclusion: Danbie capsule combined with mifepristone for treating uterine fibroids is effective and it can significantly reduce FSH

LH and E2 level

reduce the symptoms

improve clinical outcomes

and it has significant short-term effect.