In order to determine the effectiveness of Orengedoku-to in the treatment of schizophrenia, Orengedoku-to was added to the drug regimens of 10 patients who had been hospitalized with onset episodes or acute exacerbation of this condition. Before Orengedoku-to was added, the schizophrenic symptoms associated with the active phase had already been ameliorated with administration of antipsychotic drugs such as haloperidol for 4-12 weeks, with administration continuing at least two weeks after these symptoms had stabilized. Symptoms were evaluated using the Brief Psychiatric Rating Scale (BPRS) three times: before Orengedoku-to was added, immediately following cessation of administration, and four weeks after administration had ended. The BPRS scores indicated significant decreases both immediately following cessation of administration and four weeks later (from 36.3±9.8 to 30.5±6.7). In particular, significant improvement was noted for the symptoms of guilt feelings, depressive mood, suspiciousness and excitement. These improvements were not thought to be due to haloperidol, because the plasma haloperridol levels did not change. No adverse effects were noted.

We investigated the change of “Kyo-kyo-kuman, ” after the administration of Saiko-zai (including Bupleuri Radix) or Non-saiko-zai (not including Bupleuri Radix). Subjects were 44 patients (7 males, 37 females, with a mean age of 42.8±16.4). We evaluated their levels of the Kyo-kyo-kuman, with blood biochemical tests, their depressive levels using Zung's Self Depression Scale (SDS), and their subjective well-being levels using the Subjective Well-being Inventory (SUBI) scale, at baseline and 3 and 6 months after the administration of Kampo formula. In the S-group (20 patients), administered Saiko-zai for 6 months, the K-scale (Keio's Kyo-kyo-kuman scale) scores showed significant decreases at 3 and 6 months. In the C-group (16 patients), administered Non-saiko-zai for 6 months, the K-scale scores did not change significantly. There was a statistically significant decrease in the K-scale scores of the patients of S-group as compared to the patients of C-group. The decreases in the left K-scale scores correlated significantly with the rises in plasma protein concentrations.

Eighteen untreated patients with schizophrenia and other psychotic disorders, all of whom had insomnia among their chief complaints, were randomly divided into two groups. For four weeks, nine patients (group A) were treated with neuroleptics (haloperidol) and Orengedokuto, and the remainder (group B) were treated with neuroleptics alone. Changes in schizophrenic symptoms and the number of doses of hypnotics (nitrazepam) were examined. In group A, the thought disturbance (conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content) aspect of schizophrenic symptoms improved (p=0.06), and the number of doses of hypnotics (mean=1.9) was smaller (p=0.06), as compared with group B (mean=7.7). These observations suggest that augmentation therapy with Orengedoku-to is potentially effective for the treatment of insomnia associated with schizophrenia and other psychotic disorders.

We attempted to analyze “Kyo-kyo-kuman, ” using biochemical and psychiatric approaches. One hundred and twenty patients (23 males, 97 females) with a mean age of 42.4±16.2 years were evaluated for their levels of Kyo-kyo-kuman, using blood biochemical tests, depression levels as measured by Zung's Self Depression Scale (SDS), and subjective well-being levels as measured by the Subjective Well-being Inventory (SUBI) scale. Ninety-three patients (77.5%) had the Kyo-kyo-kuman. Plasma creatinine level and a score of factor 11 (general well-being-negative affect) of SUBI were significantly lower in patients who had the right Kyo-kyo-kuman than in patients who did not have the right Kyo-kyo-kuman. Scores of factor 9 (perceived illhealth) and factor 11 of SUBI were significantly lower in patients who had the left Kyo-kyo-kuman than in patients who did not have the left Kyo-kyo-kuman. In conclusion, patients under the strong stressors tended to have Kyo-kyo-kuman.