In order to determine the pharmacological effects of Crocus (traditionally classified as an herb helpful in eliminating Blood Stagnation), the 11-dehydro TXB₂, platelet aggregation, blood viscosity and laboratory data of 12 healthy sexually mature females were examined during the menstrual, follicle and corpus luteum phases before the test substance was administered. Compared with the follicle or corpus luteum phases, higher levels of 11-dehydro TXB₂ and increased mean cell volume (MCV) were found during the menstrual phases. This suggested that the increase in blood viscosity may be due to a lowering of erythrocyte deformation resulting from increased mean cell volume. From the fact that the highest endometrial PGE₂ value was exhibited during the menstrual Phase, PGE₂ was thought to be involved in the MCV increase. Next, plain hot water was administered to the six cases in the control group (for four weeks), and Crocus infusion administered to the other six cases (for four weeks), after which a comparative study was made of their indicators. The significant lowering of the MCV and blood viscosity during the menstrual phase upon Crocus administration suggested that an improvement in erythrocyte deformation brought about by decreased MCV played a role in the reduction of blood viscosity. Moreover, a decrease in 11-dehydro TXB₂ was observed during the low blood estrogen follicle phase. It has been reported that there is an overall increase in blood viscosity and acceleration of platelet and thrombin synthesis associated with the disease state known as “Blood Stagnation”. From the clear effects of Crocus upon these indicators, its effectiveness as an herb useful in eliminating Blood Stagnation in healthy sexually mature females was indicated.

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Compared with normal mice, the concentration of serum zinc in zinc-deficient mice was significantly increased after oral administration of 1ml of 1000ppm ZnSO₄ solution, while that of zinc-deficient mice treated with Kampo (Pogostemi Folium et Rhizoma, Perilla Herba, Saussureae Radix, Aurantii Nobilis Pericarpium, Anemarrhena Rhizoma, etc.) was not increased. The intestinal mucosa of zinc-deficient mice was also remarkably injured with administration of ZnSO₄ but the Kampo formula inhibited its injury.

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The relationship between the fur of the tongue and dysfunctions of Ki, Blood, Body Fluids, Spleen and Stomach was investigated in 167 cases by analyzing both subjective and objective symptoms. The mean score of Ki-deficiency increased with the degree of both thickness and yellowness of the tongue fur. The mean score of upper gastrointestinal tract symptoms also increased with the degree of thickness of the tongue fur. These results suggest that when examining the tongue fur during Oriental Medical diagnosis, it is important to keep in mind its relationship with dysfunction of the Spleen and Stomach and Ki-deficiency.

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Up until the present, the primary treatment for threatened premature labor has been bed rest, with drug therapy as a supplement. However, with drug therapy the problems of side effects and dosage limitations have made it difficult to achieve therapeutic effectiveness. In this paper, the authors report the favorable results obtained in such cases when moxibustion and a microwave emitter were used for stimulation therapy based on Oriental medical theory. Moxibustion was carried out on Shim, Yusen and Saninko (acupuncture points) in cases of threatened premature labor beyond the 24th week. Despite the short duration of treatment, uterine tension was relieved, fetal movement increased, and resistance in the umbilical artery and uterine artery reduced. Similar results were achieved with multiple microwave stimulation treatments; the effects lasted for long periods and were not accompanied by side effects. Thus, the results showed that through the use of moxibustion therapy in conjunction with drug therapy, the dosage could be reduced, and the frequency of side-effect appearance lowered. These results suggest that moxibustion therapy has potential as an effective and safe new treatment for threatened premature labor.

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The authors investigated the efficacy, safety and usefulness of the Kampo extract Shoseiryu-to (TJ-19) in the treatment of adult bronchial asthma. The multi-center study used the same methods presently in use in Japan for clinical evaluation of Western drugs and included a total of 69 patients in an open trial.
After long-term (4-8 weeks) administration of the Kampo formula in conjunction with conventional bronchial dilators, a significant improvement was seen in the frequency score, clinical score and asthma score. Significant improvement was observed in individual symptoms such as phlegm viscosity and amount, daily life, sleep, sneezing and nasal discharge. Overall, the results indicated marked improvement in 13 patients (18.8%), moderate improvement in 23 patients (33.3%) and slight improvement in 19 patients (27.5%). Thus, the authors obtained the favorable results of moderate or better improvement in 52.2% and slight or better improvement in 79.9% of the patients. We observed almost no abnormal findings in laboratory examinations due to the drugs. Side effects developed only in a few patients in the form of a slight cough. Symptoms of nasal allergy improved most frequently according to the impressions of the physicians in charge. Recently, combination therapy using various Kampo extracts has increased in Japan in order to improve treatment quality.

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In order to study the effectiveness of Choreito in the removal of ureteral stones, 7.5g/day of Choreito was administered to 52 patients who had been diagnosed as having ureteral stones. For stones of a diameter less than 4mm, 63.2% were passed within two weeks, and 78.9% within four weeks. The rates for stones between 4 and 10mm was 10% in two weeks and 33.3% in four weeks. For the 52 cases overall, the rate of stone excretion was 28.8% within two weeks and 50% within four weeks.
There were no side effects observed in conjunction with Choreito administration.

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In 1984 a 42-year-old female complaining of general malaise and loss of strength in the proximal muscles of the limbs came to the 2nd Department of Internal Medicine for an examination. From her high CPK value, electromyogram, muscle biopsy, etc., she was diagnosed as having polymyositis. Initially she responded well to steroids, but a year later the condition recurred. Treatment with various methods such as the immunosuppressants methotrexate and azathioprine, steroid pulse therapy and plasma replacement were tried without success. In September 1991, the patient's CPK value remained abnormal at about 800mU/ml. According to the Oriental Medical viewpoint, the condition was diagnosed as Kidney yin Deficiency. Rokumi-gan was therefore administered daily (7.5g/day) for a period of 80 days. The CPK value was brought down to the vicinity of 200mU/ml, and the feeling of general malaise and lack of strength in the proximal muscles of the limbs was improved. However, due to the persistence of edema in the lower limbs, the Kampo formula was changed from Rokumigan to Chorei-to, also administered at a dosage of 7.5g/day. This reduced the edema and normalized the CPK value to the 100mU/ml range. During this period, steroid administration was maintained with prednisolone (30mg/day). At present, with the improvement in the CPK value, steroid administration is gradually being reduced.

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The levels of stress-related hormones in the blood were measured before and after doing Qi Gong health-maintenance exercises, and a control group of walkers with a similar level of movement selected for the basis of a comparative study. The adrenaline, noradrenaline and growth hormone responses of the Qi Gong group were compared with the pre-exercise values. Although no significant difference was observed immediately after exercise, there was a significant drop in all values 30 minutes after exercising. Similar changes in the blood cortisol were noted in the Qi Gong group and walker group. Compared with the pre-exercise value, both group exhibited significant reduction in blood cortisol both immediately following exercise and 30 minutes after exercise, with the lowest value occurring 30 minutes after exercise. In contrast to the increase in stress-related hormones typical after light exercise that was seen in the walker group, the significant reduction response seen in the stress-related hormones of the Qi Gong group with the similar amount of movement was seen as unusual. This suggested that Qi Gong may be a positive means of stress-reduction and a useful health-maintenance method in today's stressful society.

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Fifty-two cases of herpes zoster were treated with acupuncture and moxibustion and a control group of 49 cases was treated with traditional Chinese medicine (Kampo). The Visual Analogue scale (VAS) was used as an index of the analgesic effects. The acupuncture and moxibustion groups were treated according to the differentiation of symptoms and signs of traditional Chinese medicine. Acupuncture was also applied around the area of affected skin, followed by 30 minutes of moxibustion. Cases in the Kampo group were given the following formulas: Ryutan-shakan-to (containing Gentianae) was administered for Damp-Heat in the Liver and Gall Bladder, Shoyosan (Pulvis ambulatorius) for Stagnation of Liver Qi and Irei-to (Formula hoelen stomachi) for Damp-Heat in the Spleen meridian. It took an average of 3.8 treatments for the pain to disappear in the 52 cases of the acupuncture group, and an average of five days for the Kampo group. Kampo was ineffective in three cases. There was a significantly higher rate of appearance of analgesic effects in the acupuncture group. Acupuncture is thought to control pain by improving the circulation of the Qi and blood. It also enhances immune function, thereby suppressing virus activity and helping reduce pain. Acupuncture and moxibustion significantly reduced pain in herpes zoster patients, and can be said to have analgesic effects.

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In two periodic ACTH-ADH discharge syndrome cases, symptoms associated with Gorei-san were reported, such as thirst, infrequent urination and vomiting upon fluid intake. Upon administration of Gorei-san extract granules during episodes, an improvement was observed in clinical symptoms such as thirst, infrequent urination, vomiting of fluids, salivation, perspiration, drowsiness, symptoms of depression and hypertension, as well as immediate normalization of the plasma ACTH, ADH, cortisol, serum electrolytes, and urine 17-OHCS and 17-ks. When administration of Gorei-san was continued through the symptom-free phase, symptoms were less severe during the next episode, and after several months no further episodes were reported.

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The results of a trial treatment of primary biliary cirrhosis using combined Kampo and conventional drug therapy are reported.
A 79-year-old female with a chief complaint of pruritis was diagnosed as having primary biliary cirrhosis because of elevations in serum alkaline phosphatase, serum bilirubin, serum IgM, and positive tests for antimitochondrial antibodies and anti-M2.
In accordance with the Kampo diagnosis, she was first treated with Shinbu-to, which, however, did not cause any clinical alleviaton of the itching. Shishihakuhi-to was then given concomitantly, which resulted in the disappearance of the pruritis on the second day. Ursodeoxycholic acid was also added to her treatment from the 2nd month on. The serum level of bilirubin was observed to decrease gradually thereafter.
This case suggests that Kampo therapy, combined with the Western medical drug ursodeoxycholic acid, may be effective in the treatment of primary biliary cirrhosis.

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Although there are many treatment methods for proteinuria in renal transplanted patients, none have been found to be definitively effective.
We examined the clinical effects of the administration of Sairei-to on 11 renal transplanted patients with proteinuria. Clinical evaluation was carried out over six months of administration. The patients were divided into the chronic rejection group, consisting of four patients, and the non-chronic rejection group. Although no improvement was seen in the chronic rejection group, three out of seven patients in the non-chronic rejection group showed improvement in proteinuria, and one exhibited improved kidney function. In one of the improved proteinuria cases, a reduction in nephrotoxicity of the immunosuppressor FK506 was suggested.
According to these results, Sairei-to may be effective in the treatment of proteinuria in renal transplanted patients without chronic rejection.

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The relationship between coldness of the hands and feet (“Hiesho”) and Blood Stagnation (“Oketsu”), a disorder description unique to Oriental Medicine, was examined using the Oketsu score of five Hiesho cases based on the Terasawa Oketsu Diagnostic Criteria. The effects of acupuncture treatment were studied by evaluating Oketsu symptoms and accompanying complaints, the Visual Analogue Scale (VAS) and subjective evaluation of coldness of the hands and feet.
The results were as follows:
1) 100% of the five females with Hiesho were also positive for the Oketsu factor.
2) The Oketsu score showed a significant decrease (P<0.05) upon treatment with acupuncture.
3) An improvement in subjective Hiesho symptoms (VAS) was seen in three of the five cases upon acupuncture treatment.
4) It was suggested that the subjective improvement in Hiesho symptoms, i. e., coldness of the hands and feet, was related to the disappearance of the resistance and pain upon pressure in the ileocecal region that is characteristic of Oketsu, and the improvement in menstrual disorders.

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The results of three cases involving administration of “Shien”, a Kampo formula containing Crotonis Semen, are reported here. The first case was a 48-year-old female, in whom orthopnea had appeared two years previously. She was diagnosed as having congestive heart failure. During the treatment period, the above symptom reappeared when she was fatigued. Based on a lessening of the symptoms after diarrhea, Shien was administered. After over ten abouts of diarrhea, the difficult breathing was eased and the cardiothoracic ratio decreased, as confirmed by chest x-ray.
The second case was a 64-year-old female. After the appearance of hyposarca and inappetence a year ago, she had been diagnosed as having amyloidosis brought on by nephrotic syndrome. The edema was reduced with combined administration of the Kampo formulas Hokikenchu-to and Bukuryoshigyaku-to. However, due to the persistence of poor appetite, and the marked presence of the (Oriental Medical) indicator of upper abdominal fullness, Shien was administered. After frequent bouts of diarrhea and vomiting, an improvement in the appetite and a decrease in abdominal fullness were seen.
The third case involved a 71-year-old female. After undergoing surgery for breast cancer eight years ago, edema appeared in her upper left arm. Due to the presence of the edema and constipation, both indicators for Shien, administration of this Kampo formula was commenced. Diarrhea occurred every day Shien was administered. A decrease in the upper arm diameter and weight was reported.
The results achieved in these three cases suggest that Shien is an effective treatment formula that can be used in cases of “Suidoku” (water metabolism disorders) when indicators such as upper abdominal fullness and constipation are present. Careful distinction between the “deficient” and “excessive” manifestation types (standard in Kampo theory) did not seem necessary.

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Keishininjin-to (Formula Ginseng and Cinnamomi) can be used to treat colds where internal digestive system symptoms such as diarrhea and abdominal pain accompany the symptoms of the exterior or superficies. This use of Keishininjin-to is probably based on the concept that there is external heat complicating the typical internal cold indicating use of Ninjin-to (Formula Ginseng), or it may be induced from the crude herbs comprising Keishininjin-to.
In Kampo medicine, the concept of complications is one of the pathophysiological theories governing treatment principles. The treatment principles regarding complications are: 1. Sengo (a system of priorities consisting of Senhyokori (treating exterior symptoms before interior), Senkyu kokan (acute before chronic) and Sengai konai (external before internal); 2. Goho (combining formulas according to stage, i. e., Dobyoinai (in the same stage) or Ibyoikan (between stage); 3. Creation of a special formula. Keishininjin-to follows the third principle; it is a special formula created by slightly increasing the Glycyrrhizae Radix in Ninjin-to and adding Cinnamomi Cortex. It is intended to treat both exterior and interior symptoms in complications of Taiyo-keishi-to-sho and Taiin-ninjin-to-sho. Of the four patients involved in this study, cases one, two and three were treated according to this principle. Case four was treated with Keikyososooshinbu-to, as the symptoms were thought to indicate a combination of Taiyo-keishi-kyoshakuyaku-to-sho and Shoin-maosaishinbushi-to-sho. In all cases, improvement in the patients' condition was seen shortly after commencement of the Kampo formula administration.

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In order to determine the correlation between anatomicopathological changes in Western medicine and functional disturbances in Oriental medicine, the distribution of accessory changes in 114 autopsy cases with primary pathological changes in digestive organs other than the liver was studied. This was done by classifying these changes into seven groups of structural organs and tissues that corresponded with the function of the Five Internal Organs of Oriental medicine. The distribution frequency of these groups was then compared statistically using the T-test. An overwhelmingly high frequency of accessory changes was seen in the organs and tissues of Group VI, i. e., skeletal and smooth muscle, connective tissue including adipose tissue, bone and cartilage, bone marrow and blood, lymphatic apparatus including lymph nodes and splenic white pulp, lymph, etc., which corresponded with the Oriental Medical Classification (“Iwayuru Kiniku, Shishi”) Skin and Muscle-Four Limbs. These results support the Oriental Medical insight that there is an intimate relationship between the organs with digestive function, namely the Spleen and Stomach, and the Skin and Muscle-Four Limbs group corresponding to the supportive, locomotive and immune systems.

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There has been little basic research done on the number of times it is possible to measure the presence or degree of tenderness at the same location, or on the variation in the degree of tenderness with the diameter of the pressure attachments.
Changes in the degree of tenderness resulting from alterations in the area of compression were evaluated using a highly-precise digital pressure algometer developed by the authors. The results of a basic study of the relationship between the number of times pressure was applied and the changes in the degree of tenderness are also reported.

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The term “half exterior half interior” is not found in the Oriental Medical Classic, the ‘Shang Han Lun’. Rather, the phrase “half outside and half inside” appears. It was Cheng Wu Ji that first used the term “half exterior half interior” in the phrase “Those in whom the disease-causing agent is half in the exterior and half in the interior are considered to be of the fever manifestation-type” appearing in his ‘Shang Han Ming Li Lun’. In the ‘Zhu Jie Shang Han Lun’ which Cheng Wu Ji wrote shortly afterwards, he explains that the phrase “half outside and half inside” found in the ‘Shang Han Lun’ means half exterior and half interior. Since this commentary on the ‘Shang Han Lun’ was more frequently published and more widely circulated than the original text, it is thought to be this explanation that accounts for the popularization of the term “half exterior half interior”.

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As is evident from the Oriental Medical phrase “the mind and body are one”, the body and mind are thought to mutually influence each other. Based on this assumption, the authors studied the psychotropic effects of Kampo formulas that are commonly used for physical disorders. The effects were rapid and remarkable. However, just as individual Kampo formulas are effective for specific organs, the effect of each formula was found to be limited to a certain mental state. Since each mental state was thought to correspond to one of the elements in the Five Element theory there were five mental states identified, i. e.: 1. Will, 2. Anxiety, 3. Irritation, 4. Manic mood, 5. Sociability. Tonifying Kampo formulas seemed to affect two states, one of which was suppressed. The Mutually Destructive Aspects (Sokoku) of the Five Element theory was useful in explaining this. Further studies were made of the psychotropic effects of one Kampo formula, Hachimi-jio-gan. The results indicated that Hachimi-jio-gan had the mutually opposing psychotropic effects of facilitating the will and suppressing the irritation. From these results and the study of various other Kampo formulas, it was suggested that the Mutually Destructive Aspects of the Five Element theory may be useful in gaining an understanding of their psychotropic effects.
In this study, since we were afraid that the psychotropic effects of Hachimi-jio-gan might be due to the presence of Aconiti Tuber, it was removed from the formula, along with the Cinnamomi Cortex. The effects of the remaining formula, Rokumi-gan, were then studied. Twelve patients suffering mainly from depressive neurosis were given Rokumi-gan, and the five mental states evaluated. The states affected were thought to be the loss of will and irritation. After two weeks (four weeks), the efficacy rates were 66.7% (91.7%) and 66.7% (83.3%), but after four weeks, slight mood deterioration (depression) was seen in five of the twelve cases.
Long administration of such tonifying formulas seemed to bring about another improvement without the two mental states. From these findings and a summary of the results obtained from this stuby, the Mutually Creative Aspects (Sosei) of the Five Element theory seems to be useful after the 2-4 week point. In addition, from the study of many formulas, the psychotropic effect of Aconiti Tuber was thought to be a tonifyer of the Five element. Some observations were also made concerning the mutual relationship between the Yin/Yang Deficient/Excessive table and the Five Element theory.
*1 The Five Element theory: In ancient China, the universe was thought to consist of five elements. Mental states were also considered to correspond to the five elements. The five elements are: Wood (Moku), Fire (Ka), Earth (Do), Metal (Kon) and Water (Sui).
*2 The Mutually Destructive Aspect of the Five Element theory: The five elements were thought to have a special relationship. Wood suppresses Earth, Fire suppresses Metal, Earth suppresses Water, Metal suppresses Wood and Water suppresses Fire. This relationship keeps the universe in balance.

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