Objective:To observe the effects of Chinese herbal medicine of invigorating spleen and softening liver or bromocriptine combined with Bushen Huoxue Antai Recipe on pregnancy outcome in patients of recurrent spontaneous abortion(RSA)with hyperprolactinemia(HPRL). Methods326 RSA patients with HPRL were randomly divided into the treatment group and control group,163 cases in each group. Both groups were treated with Bushen Huoxue Antai Recipe. The treatment group was treated with Chinese herbal medicine of invigorating spleen and softening liver(unprocessed Fructus Hordei Germinatus,unprocessed Fructus Setariae Germinatus,Radix Paeoniae Alba,unprocessed Radix Glycyrrhizae)and the control group was treated with bromocriptine additionally. The total treatment course in both groups was 12 weeks. The normal rate of 12-week pregnancy and pregnancy outcome were observed and compared.  Results:①Finally 319 patients completed the trial,among 161 cases in the treatment group and 158 case in the control group. ②The normal rate of 12-week pregnancy was 86.3%in the treatment group and 85.3%in the control group. There was no statistically significant difference on the normal rate between the two groups(P>0.05).The non inferiority test for two sample rate was up to standard(P<0.01). ③The successful parturition rate was 83.2% in the treatment group and 81.5%in the control group. There was no statistically significant difference on the successful parturition rate between the two groups(P>0.05). The non inferiority test for two sample rate was up to standard(P<0.01).  Conclusion:After pregnancy confirmation,the tocolysis effects of Bushen Huoxue Antai Recipe combined with Chinese herbal medicine of invigorating spleen and softening liver are equivalent to the effects of Bushen Huoxue Antai Recipe combined with bromocriptine. Compared with bromocriptine,the side reactions of Chinese herbal medicine of invigorating spleen and softening liver are less,which accepted more easily by patients.