This lecture was given on the occasion of the 1995th Award for Academic Encouragement of the Japan Society of Oriental Medicine (JSOM). It started by the author's experience and information he gained from various settings in different countries during his service as a Medical Officer for Traditional Medicine in the Western Pacific Regional Office of the World Health Organization (WHO). During that time, he was often caught in the controversy of promotion or assessment of traditional medicine. But even in China, where the government have had a strong policy in promoting Traditional Chinese Medicine (TCM), methods of clinical epidemiology has been introduced in TCM since the early 1990s. From the viewpoint of a clinical pharmacologist, the author described in this lecture, the current status of traditional medicine focusing on East Asia and proposed future plans. He discussed the relation between clinical pharmacology and clinical epidemiology and introduced basic concepts in these areas such as randomized controlled trial (RCT), placebo, bias and their prevention methods. He proposed the use of Evidence-based Oriental Medicine (EBOM) showing the strength of evidence according to study design including comparisons done before and after the study and discussed the cultural acceptability and practicability of clinical trials of oriental medicine as well as the use of RCT and the difference in the pattern of accumulation of information between classic Oriental medicine in olden times and modern Oriental medicine in the industrialized era. He stressed the difference in the meaning of efficacy on group and on individual using the concept of Number Needed to Treat (NNT) and the importance of using soft data as endpoints in evaluating oriental medicine. The applicability of evidence to the clinical setting was discussed and in the absence of strong evidence, the concept of Evidence-Biased Medicine (EBM) is recommended. The Ministry of Health and Welfare (MHW) of Japan initiated a review of the reevaluation of Kampo drugs in 1989 in line with current world trends in the evaluation of herbal medicine conducted by WHO and other organizations. In this review, disclosure of information from government sectors in areas such as clinical trials of Kampo medicine and adverse event (AE)/adverse drug reaction (ADR) was stressed. Methods of single case study (N of 1 trial) was introduced and future plans and actions by the JSOM on the evaluation of Kampoo drug were proposed.

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With the purpose of clarifying the influence of direct moxibustion on the cell count and proportion of leukocytes in peripheral blood, rabbits and humans were treated with direct moxibustion. The moxa cones were the size of a “rice grain”. In the rabbits 10 moxa cones were distributed among four points which were selected on the low back. Humans were treated with the same method except eight points were chosen on the back and legs. Peripheral blood was collected periodically following each treatment. Leukocyte counts and leukocyte differentials were then measured. Lymphocyte subpopulations were also analyzed with flow cytometry in humans.
In rabbits, the mean leukocyte count increased transiently after the treatment in both the moxibustion group and the control group. However, the greatest increase was observed in the moxibustion group. In humans, no change was found in leukocyte counts and leukocyte differentials in the moxibustion group. However, the mean T cell percentage in the moxibustion group decreased 24 hours after the moxibustion treatment. Moreover, the mean CD4/CD8 ratio of the moxibustion group increased 2 hours after the treatment, and decreased 24 hours after the treatment. These changes were statistically significant while no significant change was observed in the control group. No change was found in either rabbits or humans after the 4 weeks of treatment.
These results suggest that the immune system will be influenced by moxibustion at least transiently.

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Four cases which showed side effects caused by Syakuyaku-kanzo-to were reported. All the patients were women over 60 years old with “Chukan-sho” or “Kyo-sho”.
Hypopotassemia was noted in all 4 cases, muscular weakness in 3 and edema in 1. Treatment of side effects involved discontinuing administration of Syakuyaku-kanzo-to in all cases. Potassium administration was additionally required in 2 cases of severe hypopotassemia. Muscular weakness and edema disappeared with recovery from hypopotassemia.
Taking past reports into consideration, it is suggested that, in older woman, “Kyo-sho” and “Suidoku” are important risk factors for pseudoaldosteronism caused by Syakuyaku-kanzo-to.

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In Oriental medicine, atopic dermatitis is referred to as Fu-shitsu-netsu (wind-wetness heat), Ketsu-netsu (blood heat), Ketsu-kyo (blood deficiency) and Oketsu (blood stagnation). Though formulations such as Unsei-in (Wen-qing-yin), Ji-zuso-ippo (Zhi-tou-chuang-yi-fang), Shofu-san (Xiao-feng-san), Jumihaidoku-to (Shi-wei-bai-du-tang), Eppi-ka-jutsu-to (Yue-bi-jia-shu-tang), Byakko-ka-ninjin-to (Bai-hu jia-ren-shen-tang), and ku-Oketsu-zai (drugs for overcoming blood stagnation) are widely used, actually the treatment of adult atopic dermatitis is not an easy matter. The failure to improve dry skin in conventional treatments of atopic dermatitis has been the subject of many clinical trials.
In this study when changing to a modified formulation of Kagen-ichiinsen-ka-kiban-kyo in five cases of dry erythema, which we had been having difficulties in treating, a therapeutic effect was achieved. As Kagenichiinsen-ka-kiban-kyo has the effects of moisturizing dryness by nourishing blood, nourishing Yin to promote the production of body fluid, and clearing away heat-evil by nourishing Yin, dry skin was improved as well as skin inflammation, and it was relatively easy to withdraw external steroids.
Because of dry skin, the barrier function of the epidermis of patients with atopic dermatitis is hindered, and it becomes sensitive to mechanical stimulation from such things as sweat, clothing, and abrasion, or to allergens in the environment like mites. Therefore, as well as anti-inflammation, dry skin must be improved in treatment of atopic dermatitis. The cause of dry skin is loss of moisture in the corneal layer of epidermis, and this is an important point which must be considered in treatment.

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Literature on Bukuryo-shigyaku-to describes it as “those who perspire, have diarrhea, do not recover from disease and are afflicted by restlessness.” In this study we examined 4 cases where the administration of Bukuryo-shigyaku-to had an effect, where complaints which accompanied autonomic disorder and psychoneurosis brought about by automobile accidents were diagnosed as restlessness. With the experience of these cases and consideration of the literature, we consider the following to be appropriate states of illness for the administration of Bukuryo-shigyaku-to in psychoneural sicknesses.
1) states of illness where conditions of psychological introversion caused by such things as fear, heart palpitations, and depression exist, and it is necessary to lift spirits.
2) states of illness where such Ki-depressions as whole body weariness and lack of appetite exist.3) states of illness where such stasis of body fluids as dull headache and dizziness exist.
4) where epigastric region tenderness and abdominal palpitations exist.

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Oral administration of Yokuinin-to was added to the previous drugs in 4 patients with psoriatic arthritis. All of the cases responded to the therapy without adverse effects. In 3 of 4 cases, the previous drugs, i. e, corticosteroids, etretinate, or non-steroidal anti-inflammatory drugs (NSAIDs), were able to be discontinued after the beginning of the Yokuinin-to therapy. The remainder had favorable control of arthralgia with Yokuinin-to alone. During the course of the therapy, there were no considerable changes in skin eruption in all 4 cases. We consider Yokuinin-to one of the first drugs of choice in the treatment of arthralgia in patients with psoriatic arthritis.

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Oketsu-night sweat was first mentioned in the “Yi lin gai cuo” by Wang Qing ren and the “Xue zheng lun” by? Tang Rong chuan, but there are few explanations of its disease condition. Thus we made pathological studies in Oriental medicine based on three cases (women), where Oketsu-sho was alleviated with Keppu-chikuo-to modification, and Teitou-gan and Tokaku-joki-to (Tao he cheng qi tang) modification. Common disease conditions were Netsu-sho or heat syndrome (summer incidences, redness, flushing during night sweat), and lower Oketsu symptoms (lower abdominal distention, distention and cramping of the lower abdomen, and increased urinary frequency). The theory of these disease conditions is as follows: During sleep, Wei-energy enters the blood. Because of this, Wei-energy of the body surface becomes asthenia making it easier to break out in sweat. The Wei-energy in the blood is depressed by Oketsu, and heat of Oketsu becomes stronger during the night. This fever heats and evaporates bodily fluids, and as a result fluids are pushed outward and cause night sweat. Therefore heat syndrome appears to be a pre-condition of Oketsu-night sweat. If the lower aspect of the body is taken to mean the liver, one would hypothesize that Oketsu-night sweat is more likely to emerge because blood accumulates in the lower area because it returns to the liver at night. Thus, it is thought to be necessary to consider Oketsu as one of the causes of night sweat.

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