I experienced two patients with liver cirrhosis accompanied by hepatic encephalopathy whose signs and symptoms improved with Kampo medicine, mainly using Daio.
Case 1 was that of a 54-year-old female patient who visited my department because of ascites caused by liver cirrhosis and chronic nephritis. Bunsho-to-kekko-kagen was administered, which subsequently cleared the ascites. However, her level of consciousness was depressed concomitantly with the development of constipation. Hyperammonemia was also noted. Daio was added to this Kampo formulation with the doses being increased gradually. When the dose of Daio reached 10g, constipation improved, and the level of consciousness returned to normal.
Case 2 was a 68-year-old female patient with liver cirrhosis and hypertension. She felt very giddy and had hyperammonemia. Shichimotsu-koka-to (15g) was administered, increasing the dose of Daio powder up to 5g. Blood ammonia concentrations decreased in proportion to an increase in the dose of Daio. Amino acid composition was not affected.
It seems that Daio decreases ammonia directly as well as indirectly via its cathartic action and its antibacterial action against intestinal bacteria. Further, its sedative effect is probably related to the improvement of cerebral signs and symptoms.

To determine the Kampo therapy indications for global infertility treatment, and the criteria for objective and rational evaluation of its efficacy, we analyzed the sho (Zheng), type of ovarian dysfunction, types of Western drugs used concomitantly, length of treatment, age upon pregnancy, etc., in 100 women with infertility due to ovarian dysfunction as diagnosed by Western medicine who succeeded in becoming pregnant and giving live births, after Kampo therapies diagnosed by sho based on Hakko, Ki, Ketsu and Sui. The diagnosis of the sho in these women was compared with that in 2737 control women. Their types of sho by frequency were Kyo (51%), Shoyo (Hanhyo-Hanri) (69%), Jonetsu-Gekan (52%), Kigyaku (47%), Oketsu (71%) and Suidoku (67%). When compared to the control group, the percentage of women whose Sho was rated as Jitsu, Taiyo, Shoyo, Jonetsu-Gekan, Oketsu or Suidoku was significantly higher. The sho type Hyonetsu-Rikan was lower. The preparation sho, rated on the basis of a general assessment, was most frequently Kamishoyosan(55%). The predominant type of ovarian dysfunction was luteal dysfunction (73%), whose frequency was significantly higher than that in the control group. Of all women studied, 46% were treated with Kampo alone and 54% were treated with Kampo + Western medicine. In terms of the percentage of each type of ovarian dysfunction, there was no significant difference between the two groups. The Western drugs used in combination with Kampo therapy were hCG preparations (33%), terguride preparations (18%), clomiphene preparations (3%) and hMG preparations (6%). The period of treatment until pregnancy was significantly shorter in the Kampo alone group (5.0 ± 4.4months) than in the combined therapy group (9.5 ± 6.8months). These results allow us to make the following conclusions:1.The type of infertility indicated for Kampo medicine is infertility due to ovarian dysfunction as diagnosed by methods of Western medicine.2.Women who successfully became pregnant following Kampo medicine were often cases of Shoyo disease complicated by sho with Jonetsu-Gekan, accompanied by Kigyaku, Oketsu and Suidoku.3.Uncombined Kampo medicine may be effective in cases of severe infertility.4.If pregnancy does not occur within 5 or 6 months after the start of Kampo therapy, combined use of Western medicines should be considered.
Medicine, Kampo ; Therapeutic procedure ; Infertility ; Western Herbs and Botanicals ; Functional disorder

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

For two infertile couples with normal tubal function and spermatogenesis, who were diagnosed with infertility attributed to lack of competent ovum with poor grade embryo in spite of having received timing therapy and step-up therapy (artificial fertilization from husband ; AIH and in vitro fertilization and embryo transfer ; IVF-ET), Kampo-only therapies diagnosed according to their “Zheng” syndrome-type consisting of one cycle of tokishigyakukagoshuyushokyoto, and two cycles of kamishoyosan and anchusan was performed. As a result, both women became pregnant and gave live births. The causes of infertility in these two cases were analyzed, and problems with step-up therapy, commonly used in Western medicine and efficacy of Kampo-therapy diagnosed according to their Zheng were evaluated from the standpoint of Western medicine.Kampo-therapy diagnosed by Zheng was found to improve the follicular and luteal functions as well as related functions. The two cases presented were diagnosed as infertile due to ovarian dysfunction on the basis of therapeutic diagnosis. The indications of IVF-ET are tubal and male infertilities, not to be ovarian dysfunctional infertility.For infertility due to ovarian dysfunction, Kampo-therapy diagnosed by Zheng with Kuoketsu and Risui effects are drugs of first choice, rather than clomiphene, which has an anti-estrogen activity.
Therapeutic procedure ; Medicine, Kampo ; Infertility ; Ovarian ; Ovum

This report describes 20 women who underwent in vitro fertilization or microinsemination while receiving a regimen of herbal medicine, of which contents varied according to the treatment stage. Until the ova were harvested, in order to promote maturation, patients were treated with hachimijiogan for reinforcing kidney yang, and keishibukuryogan for removing blood stasis. Following this, during the period between harvesting and implantation, they were treated either exclusively with unkeito for warming meridians, dissipates cold, and replenishes blood, or with unkeito in combination with keishibukuryogan. Following implantation, they were treated with tokishakuyakusan to induce uterine relaxation. The treatment regimen was determined based on traditional herbal evidence of infertile patient's blood stasis and kidney deficiency. We adjusted applied dose depending on the conditions of patients. Fourteen of the 20 women tested positive for pregnancy; 10 of them carried to term, whereas in 4 of them, the pregnancy ended in abortion or miscarriage. Anti-Müllerian hormone concentration, endometrial thickness, estimated follicle count, recovered ova count, fertilized ova count, and numbers of ova to reach the early-embryo stage and blastocyst stage were compared between the continuing pregnancy and the non-pregnancy groups. Improvements were observed in all values after combined use of traditional herbal medicines, except in the case of endometrial thickness, and significant differences appeared in recovered ova count and fertilized ova count. These observations suggest that a regimen of herbal medicine adapted to the various stages of in vitro fertilization may be a useful complementary therapy during pregnancy.

We experienced a case of palmoplantar pustulosis in which the patient's dermatological symptoms im­proved after treatment with a combination of bofutsushosan and keishibukuryogan. The patient was a 42-year-old woman. She had been prescribed biotin and a steroid ointment, but her condition did not improve. At her first visit to our Kampo clinic, we observed impetigo, cracks, and scaling on both palms and plantar surfaces. We determined that the patient was of the poisoned organ (zodoku) and stagnant blood (oketsu) constitutions,as outlined in the Ikkando school of medical thought. We prescribed bofutsushosan and keishibukuryogan as fundamental treatment and then in a few days, the patient's dermatological symptoms resolved. The patient later developed hyperthyroidism, which caused her symptoms to worsen again, we therefore switched to shofusan and eppikajutsuto as local and symptomatic treatment, and then she once again improved. Soon after, we returned to keishibukuryogan and bofutsusho for her to maintain remission. Since poisoned organ and stagnant blood constitutions contribute greatly to the Kampo pathology of palmoplantar pustulosis, we believe bofutsushosan and keishibukuryogan are effective formulations for the treatment of this condition. As far as we searched, there were no papers that selected bofutsushosan or blood stasis agents as the main cure from the viewpoint of the poisoned organ constitution and the stagnant blood constitution. Therefore, this case was considered to be a valuable case.

Background: Gingyo-gedoku-san (GGGS) is an herbal medicine approved for upper respiratory infections in Japan. We conducted an open-label, multi-center, prospective trial, comparing GGGS with oseltamivir in patients with influenza and influenza-like illness (ILI) as a pilot study.
Methods: Subjects were healthy persons aged between 16 and 40, and were enrolled from January 12, 2010 to March 24, 2011. Fifteen patients were enrolled in this trial (8 and 7 for GGGS and oseltamivir, respectively). RT-PCR was positive for pandemic influenza A (H1N1) in 10 patients. The patients were provided with either GGGS or oseltamivir for 5 days. The primary outcome was mortality and/or hospitalization 7 days after the initial diagnosis. Body temperature and other clinical characteristics were also evaluated.
Results: All patients recovered from illness without complication or hospitalization. The mean time to resolve symptoms for the GGGS and oseltamivir groups was 3.9 days and 3.3 days, respectively (p=0.43). The GGGS group appeared to have a smaller symptom score AUC than the oseltamivir group, (p=0.26). Time to recover activity level appeared to be shorter in the GGGS group (p=0.10), with shorter time to recover health status (p=0.02). Sub-group analysis on patients with positive PCR showed similar results between the two groups.
Conclusion: GGGS was associated with symptom improvements resembling oseltamivir for both influenza and ILI. Randomized controlled trials involving larger sample sizes are needed to confirm these results.