Clinical efficacy of tokishakuyakusan against immunologic recurrent abortion was evaluated using methods of diagnostic statistics. The subjects of this study were 38 women with recurrent abortion who had experienced a spontaneous abortion during their first trimester (within 12 weeks of pregnancy) twice, and who took tokishakuyakusan (extract granules) after development of their third pregnancy, but experienced spontaneous abortion again during their first trimester, with the karyotype of the aborted fetus being rated as 46, XX or 46, XY. The control group consisted of 244 women who had experienced 3 or more spontaneous abortions during their first trimester of pregnancy. The detection rates of autoimmune disorders and alloimmune disorders were compared statistically between the two groups. Neither the detection rate of autoimmune recurrent abortion nor the detection rate of alloimmune recurrent abortion differed significantly between the two groups, suggesting that tokishakuyakusan is not clinically effective against immunologic recurrent abortion. Tokishakuyakusan is estimated to prevent abortion caused by compromised luteal insufficiency of the uterus. Thus, saireito seems to provide a more rational means of Kampo therapy for immunologic recurrent abortion.
Unspecified Abortion ; immunologic ; tokishakuyakusan ; Therapeutic procedure ; Pregnancy Trimester, First

The efficacy of Saireito (a herbal preparation) against autoimmune recurrent abortion was evaluated clinically and immunologically. Saireito therapy was performed with 87 women having experienced 3 or more recurrent abortions in the early stages of pregnancy (less than 12 weeks gestation), and whose antinuclear antibody (ANA) and anti-cardiolipine antibody (ACA) test results were positive. The effects of this therapy on the percentage of women in whom abortion was successfully prevented (the abortion prevention rate), and on the antibody titer were investigated. Among the 49 women who became pregnant during the study period, the abortion prevention rate was 63.3%, the percentage of ANA positive cases was 65.6%(32/49), the percentage of ACA IgG and/or IgM positive cases (as evaluated by SRL methods) was 65.5%(29/49) and the percentage of both ANA and ACA IgG and /or IgM positive cases was 75.0%(12/49). Although the titer of ANA was not significantly reduced by this therapy, the titer of ACA IgM was reduced significantly.These results suggest that Saireito exerts its efficacy by suppressing humoral immunity through its adjustment of the Th1/Th 2 cytokine balance. This therapy is expected to be effective against ACA-positive recurrent abortion by reducing the effects of ACA. Furthermore, in 2 observed child birth cases whose ACA titer were not decreased by Saireito, different effective mechanisms were speculated; for example, suppression of platelet aggregation via saireito's component herbs (ninjin and bukuryou) similar to the effect seen with low-dose aspirin therapy, or its “risui” effect via its components (bukuryou, soujyutu, takusha and chorei).
Therapeutic procedure ; Unspecified Abortion ; Antinuclear Antibody Assay ; Antibodies ; Immunoglobulin M measurement