In 1944, Dr Takeshi Itakura, director of the Eastern Therapeutics Institute, intended to perform controlled clinical trials with Kampo extracts, but gave up following the defeat in the Second World War. Japanese public insurance coverage of Kampo treatment started in 1961. Permission for medical use of six Kampo extracts was granted in 1967. This was increased to 848 products made with 148 formulas in 2000. The book, Ippan-yo Kampo Shoho no Tebiki (guide to general Kampo prescriptions) describing approval standards for Kampo extracts was published in 1975 and revised in 2008.
The adverse effects of shosaikoto in 1996 forced the Japanese Society for Oriental medicine to establish the EBM Committee to prove that Kampo medicine was evidence-based. The first report on clinical evidence for Kampo was published in 2005. In 2001, the study of Japanese herbal medicine became compulsory in the medical education system. A petition against removing Kampo drugs from public insurance in 2009 showed that people hoped doctors would continue to be able to prescribe Kampo drugs under insurance systems.

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Modern Kampo medicine is mainly based on a restoration of ancient Chinese medicine which occurred in the Edo period in Japan. This historical event rose under the influence of a Confucian renaissance, resulting the exclusion of metaphysics. This report intends to clarify the correlation between these two new cultural movements, and to outline the characteristics of Kampo medicine from a historical perspective.

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Introduction : We evaluated the efficacy of keishito and maobushisaishinto with reference to keikyososooshinbuto, for patients feeling cold, by means of multiple regression analysis.
Case reports : We reported a patient with an upset stomach whose severe coldness was improved as the stomach condition was cured by adding keishito to maobushisaishinto. Moreover, the combination of keishito and maobushisaishinto was effective for a patient feeling cold, with appetite loss, general fatigue and stiffness of the joints (case 1), a patient feeling cold, with chill, general fatigue, heavy feeling in the stomach, and prone to catch colds (case 2), and a patient feeling extremely cold, with general fatigue and menstrual pain (case 3).
Subjects and Methods : In this study, the subjects were 43 patients who reported feeling cold. They were treated with keishito and maobushisaishinto according to their Sho for more than one month. The relationships between the improvement of cold sensation and 52 other factors, such as symptoms noted at their first medical examination, were evaluated by means of multi-dimensional cross-sectional analysis.
Results : The factors of chilly or unpleasant wind and coldness of the whole body were significant.
Discussion : The factors of coldness in the whole body with chill, and headache without diarrhea were important for improvement of cold feeling with keishito and maobushisaishinto.

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We report two cases successfully treated with tsumyakushigyakuto containing aconite root (uzu), instead of processed aconite root (bushi). The first case was a 33-year-old female. She had suffered from itching rashes in spite of being prescribed tsumyakushigyakuto with processed aconite root. Because she was in an extreme cold state, we changed the processed aconite root in her tsumyakushigyakuto to aconite root. Her itching rashes subsequently improved. The second case was a 42-year-old male. He had suffered from watery diarrhea and general fatigue in spite of being prescribed tsumyakushigyakuto with processed aconite root. Because he was in an extreme cold state, we changed the processed aconite root in his tsumyakushigyakuto to aconite root, and his watery diarrhea and general fatigue improved.
We consider that using tsumyakushigyakuto with aconite root may be more effective than using it with processed aconite root in an extreme cold state.

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We successfully treated 2 patients with ophthalmic symptoms due to post herpetic infection using chotosan. Case1was a 78-year-old woman who had been suffering from ophthalmic symptoms such as foreign body sensation and irritation pain due to post herpetic infection for almost 20 years, and had a history of hypertension. We treated her with stellate ganglion block every week and orally administered keishikajutsubuto, amitriptyline, and later mexiletine. Initially, stellate ganglion block was very effective, but its effect gradually decreased over about one month. Considering the same action of stellate ganglion block and chotosan, both of which might increase intracranial blood flow, we administered chotosan instead of keishikajutsubuto. Her ophthalmic symptoms subsided for 5 days, and had completely disappeared almost two and half months after initiating chotosan. Case 2 was a 65-year-old man who had also complained of foreign body sensation due to post herpetic infection for 11 months. He also had a history of hypertension. Initial stellate ganglion block was also effective for relieving his symptom, but the effect was transient as in Case 1. Taking into consideration of our experience in Case 1,we administered chotosan. His foreign body sensation gradually subsided for 2 weeks, and had almost disappeared 2 months after initiating chotosan. Our experiences suggest that chotosan may be an optimal formulation for the patients suffering from ophthalmic disorders due to post herpetic inflammation and hypertension.

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Hansen's disease (HD) is a chronic infectious disease caused by the Mycobacterium leprae, which parasitizes skin macrophages and Schwann cells of peripheral nerves. Left untreated, leprosy can be progressive, causing permanent damage to the skin, nerves, limbs and eyes due to sensory disturbance and neuritis. Many HD patients suffer from refractory neuralgia for which neither painkillers nor other western medicine are usually effective. Here, we will report the case of an 85 year-old male, whose refractory neuralgia remarkably improved with goreisan. The mechanisms by which goreisan was effective may be as follows : (1) neuralgia pathology is an interstitial edema of peripheral nerves, and can explain as a local Sui-doku, a specific Sho for goreisan ; (2) peripheral nerve ischemia, caused by scar formation from chronic inflammation, leads to dysfunction of Na⁺/K⁺ ATPase, and extracellular potassium concentration increases. This environmental change leads a neural hypersensitivity, and goreisan is known to decrease extracellular potassium concentrations. This case suggests goreisan might be worth considering for use in refractory neuralgia, not only in HD patients, but also in other neuropathies.

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It is difficult to treat vulvar pain of an unknown cause. We report a case of vulvodynia with dysuria treated effectively with goshajinkigan. The case was 92 years-old female who could not sleep well because of vulvar pain. She did not have inflammation of the vulva or vagina. Moreover, she was sometimes treated with urethral catheterization for urinary retention. Goshajinkigan was prescribed, and her pain was decreased so much, that she could sleep well. Furthermore, she was relieved of her urinary retention.

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Schamberg disease is a subtype of idiopathic pigmentary purpura, which manifests with petechiae. It is assumed to be caused by venous microcirculatory disturbance, or an immunological and allergic mechanism. We report a 55-year-old Japanese male with Schamberg disease successfully treated with keishibukuryogan prepared at a hospital pharmacy. The patient had purpuric eruptions in his both lower legs at first, and brownish pigmentation enlarged with purpura. A dermatologist had diagnosed this, from the clinical findings, as Schamberg disease. We administered keishibukuryogan to the patient because his pathological condition was considered as oketsu. In order to improve effectiveness, keishibukuryogan was manufactured according to our own modification. The eruptions have reduced gradually, and about four months later, have mostly resolved. A Kampo therapy utilizing unseiin has been reported to be effective against idiopathic pigmentary purpura in previous studies. We suggest that a Kampo treatment with keishibukuryogan seems to be effective against idiopathic pigmentary purpura through improvements of microcirculation and inflammation.

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To investigate the difficulties of taking Japanese traditional (Kampo) medicines, questionnaires were filled out by patients under 19 years old or their families. Forty-six questionnaires were valid for analysis. The mean age of the patients was 9.7 &qlusmn; 5.3 years old (2 to 19 years old) and the percentage of male patients was high (65%). They took extract granules (n = 40) or decoction (n = 6) and most of the patients (n = 38, 83%) took medicines twice a day. Though 69% of patients under 5 years old needed direct assistance from their family to take medicines, none of over 6 years of age needed any help except to dissolve medicines in hot water, while notably 77% of the patients over 13 years old took their medicines un-aided. It was found that patients' families gave them the concrete explanations on the necessity of their medicines regardless of patients' age, so it is important for pharmacist to guide not only families but also patients themselves. Furthermore, pharmacists should understand the taste and the constituent crude drugs of Kampo medicines to improve patients' adherence in taking medicines.

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Keijyuro Wada's Ikaino-tettsui (The Iron Hammer of the Medical World) was first published in 1910, just a hundred years ago. This book admonishes against the influence of modern Western medicine, which is based on the theory of element reductionism. Wada insisted that a reevaluation of Kampo medicine was essential to create a holistic medical system. Immediately after the book was published, Dr. Ryuken Hirade proposed a bitter criticism of it in a medical journal. Dr. Hirade, at that time, was leader of a well-respected medical society in Nagoya. His bitter criticism is very meaningful for us who engaged in Kampo medicine today. There is a conflict between the two different paradigms of Western and Eastern medicine. This lecture intends to discuss our challenges facing Kampo medicine based on Ryuken Hirade's opinions.

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In late 2009, drastic budget cuts were recommended by a new cabinet-level government advisory unit. As part of these budget cuts, the Second Working Group of the Government Revitalization Unit moved to exclude Kampo medicines (traditional Japanese medicines) from reimbursement under the National Health Insurance program on Nov.11. A petition opposing the reform was initiated by Kampo physicians and patients on Nov.20. Three weeks later, 924,808 signatures had been collected and submitted to the Ministry of Health, Labor, and Welfare, and cancellation of the reform was announced on Dec.25. A total of 95,362 signatures were gathered on the web (http://kampo.umin.jp/). I report here an outline of signature-collecting campaign on the internet.

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