The number and the nature of reported side effects caused by over-the-counter Kampo formulations (OKF), as well as their changes over 10 years (fiscal years 2005 through 2014), were investigated using the data published on the website of the Japanese Ministry of Health, Labour and Welfare. The total number of side effects reports regarding OKF was 367 during the period, including 151 reports of liver dysfunction, 54 reports of drug eruption/hypersensitivity, and 51 reports of lung injury. Annual incidence of reported side effects increased nearly threefold over the period, from 16 in 2005 to 43 in 2014. Bofutsushosan was involved in 110 cases, kakkonto in 45 cases, hachimijiogan in 15 cases, and daisaikoto in 14 cases. The number of side effects due to bofutsushosan and kakkonto showed an increasing trend during the period from 2005 to 2014. Bofutsushosan was associated with 65 cases of liver dysfunction and 23 cases of lung injury. Kakkonto was associated with 21 cases of drug eruption/hypersensitivity. Under the current circumstances, severe side effects requiring medical treatments such as liver dysfunction and lung injury are showing a tendency to increase. To improve safety, we recommend tighter control over the sale of OKF, especially bofutsushosan and kakkonto,which accounted for nearly half of all reported side effects.

We describe three cases of calf cramps successfully treated with shimbuto. Case 1 was a 74-year-old female who suffered from calf cramps and knee pain caused by gonarthrosis. She was treated with boiohito, but did not respond. When she complained of diarrhea, shimbuto was substituted for boiohito. After taking shimbuto, her knee pain improved, and her cramps disappeared. Case 2 was a 77-year-old female who suffered from leg edema and calf cramps. Tokishakuyakusan was prescribed, but she complained of an upset stomach. Tokishakuyakusan was replaced with shimbuto, and her cramps improved together with a decrease in the coldness and edema in her legs. Case 3 was a 79-year-old female who took kososan for uneasiness and restlessness after the death of her husband. She had edema and coldness in her legs, and suffered from calf cramps during the daytime and early in the morning. Shimbuto was added to kososan, and her coldness improved ; subsequently the leg edema diminished, and finally her cramps disappeared.
These cases suggest that shimbuto is indicated for patients with calf cramps, who report internal coldness caused by kidney deficiency with gastrointestinal dysfunction.

Tokito is used to treat patients with an asthenic, cold constitution, who have symptoms of chronic pleuritic pain, epigastralgia, and backache. There is no previous report on treatment of pruritus cutaneus with tokito. However, here we report a case of combined cutaneus pruritus and coldness, successfully treated with tokito. Our patient was a 38-year-old female, who reported having had facial pruritus cutaneus for one year. She attended our clinic in May of the year, because she had taken a turn for the worse. She was sensitive to cold, had poor circulation, felt cold in the abdomen, and reported that sleeping was difficult due to a cold back. We prescribed tokito (5.0 g/day). Her symptoms improved within six days. However, her symptoms, especially cold abdomen and cold back, returned when she drank cold water or stopped taking tokito. She was quite informative in that she prepared detailed records of her symptoms on visiting our clinic.
Tokito contains herbal medicines common to daikenchuto and tokikenchuto and hangekobokuto. Therefore, tokito could be a suitable herbal medicine for patients with pruritus cutaneus caused by coldness and qi stagnation and spleen deficiency.

In Kampo, respiratory symptoms are treated with prescriptions related not only to “lung”, but also other parenchymatous viscera. We report 2 patients whose stress-induced chronic cough was ameliorated by hachimijiogan. Case 1 was a 25-year-old female who was working under stressful circumstances at her company and reported an oppressive feeling in the chest. She was initially prescribed hangekobokuto because of a feeling that something was stuck in the pit of her stomach on abdominal examination, but her cough did not get better. As she also noted a dull feeling in her back ; she was switched to hachimigan, and her cough disappeared. Case 2 was 42-year-old female who suffered from depression, sore throat and an obstructive feeling in the throat ; she had been receiving infertility treatment for several years. Hangekobokuto and bakumondoto showed insufficient effect on her persistent cough. Her coughing stopped when she was prescribed hachimigan for back pain. Neither of these patients showed lack of resistance of the lower abdomen on abdominal examination.
Chronic ki (qi) stagnation under stressful conditions may cause ki deficiency, especially kidney deficiency. The symptom of stress-induced cough in our cases was considered to be due to kidney deficiency, and therefore hachimijiogan, but not hangekobokuto, was effective. The short duration of the complaints and relatively young age (20-40's) of the patients may account for the absence of the typical abdominal sign of kidney deficiency. Back stiffness and pain may also be important signs for cough due to kidney deficiency.

We present a 35-year-old male with palpebral hemispasm, which often occurred while at work. Because there were no ophthalmological findings, he consulted our clinic to receive Kampo therapy. He easily became fatigued and he had subchondral resistance and discomfort (kyo-kyo-kuman), so we treated him with saikokeishito and shakuyakukanzoto. However, they were ineffective, and therefore we reconsidered his symptoms.
Although he complained of fatigue, he was well built and had been a heavy drinker until a few years before presenting. Furthermore, he easily blushed and sweated in the upper body during the daytime, and his palpebral hemispasm often occurred during this blushing and sweating, and was accompanied by headache. We considered that this represented an excess-heat pattern rather than a deficiency pattern, and prescribed orengedokuto. His symptoms improved, and disappeared after six months.
There has been no detailed report of orengedokuto for the treatment of palpebral hemispasm. Orengedokuto may be useful for palpebral hemispasm in the context of symptoms of excess-heat pattern, such as blushing, sweating in the upper body and headache.

Mental health represents a critical indicator of human development, serving as a key determinant of well-being, quality of life, and hope. As such, mental health has an impact on a range of development outcomes. There is growing recognition within the international community that mental health is one of the most neglected yet essential development issues. The adoption of the Convention on the Rights of Persons with Disabilities in 2006 by the United Nations General Assembly provided momentum to highlight the importance of the nexus between disabilities and mental health in the context of human rights, peace and security, humanitarian activities and in development work including response to AIDS. In addition, the Ministerial Declaration on Implementing the Internationally Agreed Goals and Commitments in Regard to Global Public Health, in the high-level segment of the substantive session of the Economic and Social Council in July 2009, highlighted the importance of integrating mental health into the implementation of the MDGs and other internationally agreed development goals and commitments, in order to achieve development outcomes. Based on these new developments, the Department of Economic and Social Affairs (DESA) of the Untied Nations and the World Health Organisation (WHO) issued the “United Nations-WHO Policy Analysis: Mental Health and Development: Integrating Mental Health into All Development Efforts including MDGs” in 2010. This document serves as a foundation for further mainstreaming of mental health into the development agenda including response to AIDS in the United Nations system and the broader international community. In the area of HIV, the United Nations Population Fund (UNFPA) integrated mental health into one of three goals and an outcome of its Strategic Plan: Universal access to reproductive health and comprehensive HIV prevention for improved quality of life. Based on this, UNFPA started to integrate mental health into its fund-wide policies and guidelines, and programmes at regional and country levels. In addition, the United Nations Children‟s Fund held a round table on adolescent mental health with partners in April 2011, and placed an emphasis on mental health and AIDS among adolescents. Poor mental health is both a cause and a consequence of ill-health including issues related to HIV, poverty, compromised education, gender inequality, violence and other global challenges. It impedes the individual's capacity to realize their potential and make a contribution to their community. On the other hand, positive mental health is linked to a range of development outcomes. Dialogue and consultations on a post-MDGs framework will present critical opportunities to ensure the explicit inclusion of mental health in any emerging development framework for 2015 and beyond. In addition, utilizing best practices from UNFPA and others, it is also important to continue efforts to integrate mental health into strategic plans and other policies and programmes of the United Nations implementing entities. Now is the time to include mental health as an integral part of development through increased recognition of the link between development and mental/emotional well-being, as well as the inclusion of persons with mental and intellectual disabilities, to achieve development for all.

The purpose of this study was to investigate the differences and effects of positional loading (arm position change) and image loading in Budo (martial arts) competitors, mainly kendo (Japanese fencing) masters. The microcirculatory responses were measured by differential digital photoplethys-mography (ΔDPG) using the characteristics of Budo mental attitude, experience and skill as para-meters.
The subjects were 7 kendo masters of the fifth grade or higher with mean experience of 29 years, 7 kendo athletes, 7 kyudo (Japanese archery) athletes, 5 karate athletes in university sports clubs and 9 middle-aged controls. Positional loading induced myogenic responses and image loading for examining sympathetic effects via the central nervous system on peripheral circulation were mea-sured in the subjects at rest in a sitting position. The following results were obtained
The increase in the . ΔPG-P wave height in response to positional loading was markedly larger in the kendo masters. In particular, the increase when raising the right arm was significantly higher in the kendo masters than in the kyudo and karate athletes (P<0.05) . The decrease in the ΔDPG-P wave height when lowering the right arm was smallest in the kendo masters. There were differences in the peripheral vascular responses between kinds of Budo and levels of skill, which were induced by differences at the time of arm raising.
The DPG-P wave height was significantly lower during stress imaging than before loading in all subjects. The effect of stress imaging was smallest in the kendo masters, and markedly large in the kyudo athletes (P<0.05) . During relaxation imaging, an increase in the ΔDPG-P wave height was observed in the kendo masters alone, and the occurrence of vascular dilation was confirmed.
These results suggest that arteriolar responses of kendo masters are flexible and stable despite their long training period ; and the control and regulation of muscle vascular tone is well-maintained via the central nerve-sympathetic and myogenic coupling.

Four cases of atopic dermatitis successfully treated with the Kampo formula Tokaku-joki-to are reported. Case 1 was a 25-year-old woman who had been suffering from atopic dermatitis since she was in lower elementary school. She came to our clinic in July of 1992. She complained of intense itching of the neck and area around the mouth. Her abdominal tension was moderate, and there was para-umbilical and caecal tenderness. The patient complained of constipation and dysmenorrhea. After four weeks of Tokaku-joki-to administration, the dermatitis improved markedly. After two years of treatment with this formula, she is progressing favorably.
Case 2 was a 14-year-old girl, who had suffered from atopic dermatitis since she was 3 months old. She first came to our clinic in January of 1993. The dermatitis was located in the upper extremities, face and neck. She also had experienced flushing, para-umbilical tenderness and constipation. After two weeks of administration of Tokaku-joki-to, her dermatitis improved remarkably, although she still experienced flushing. Ryokei-mikan-to was added to the formula for the flushing.
Case 3 was a 28-year-old woman who had suffered from atopic dermatitis since she was 3 years old. She consulted our clinic in October, 1993. The dermatitis was located on her face and elbow. She had tenderness around the paraumbilical, caecal and sigmoid regions. The patient is progressing favorably with Tokaku-joki-to administration.
Case 4 was a 26-year-old woman. She had had atopic dermatitis since she was young, and came to our clinic in October of 1993. The dermatitis was on the upper extremities, face and back. At first we prescribed Toki-inshi, but this formula was not effective. The formula was changed to Tokaku-joki-to and the dermatitis improved remarkably after about three months of treatment.
This is the first report of administering Tokaku-joki-to for atopic dermatitis. Based on the clinical study involving the four cases described above, we propose the following indications for use of Tokaku-joki-to for atopic dermatitis: 1) the dermatitis is located on the upper part of the body, 2) there is flushing, with a feeling of coldness in the lower extremities, 3) there is tenderness around the para-umbilical, caecal and sigmoid regions, and 4) there is a tendency towards constipation.

In Kampo therapy for rheumatoid arthritis (RA), Keishi-ka-ryojutsubu-to, Keishini-eppi-itto and Keishi-shakuyaku-chimo-to are considered to be the primary formulas. However, it is often difficult to control arthritis with the primary formula alone. In this study, we administered 7.5g/day of Ji-daboku-ippo to 12 patients with RA, who had not responded sufficiently to the primary formula alone. Administration of the primary formula and other anti-rheumatoid drugs was also continued.
After three months of this supplemental administration of Ji-daboku-ippo, the mean±SE of the Lansbury's index significantly decreased from 45.3±5.8% to 33.3±3.8% (p<0. 01). After treatment for one year, a decrement in the Lensbury's index (of more than 20%) was seen in the four patients. These results suggest that supplemental administration of Ji-daboku-ippo is effective for patients who fail to respond sufficiently to the primary Kampo formulas used for RA.