Kampo Risk Management Based on a Survey on Incident and Accident Cases at Specialized Kampo Medicine Facilities / 日本東洋医学雑誌

The Medical Safety Committee has conducted various activities for patient safety in Japanese traditional Kampo medicines. In this study, we conducted a questionnaire survey to promote the prevention of medical accidents and their recurrence. We received responses from 15 of 19 facilities specializing in Kampo medicine and collected a total of 247 incident and accident cases in the field of Kampo medicine. Cases of side effects included interstitial pneumonia caused by Kampo prescriptions containing Scutellariae Radix, aconite poisoning, and licorice-induced pseudoaldosteronism. Furthermore, we also collected decoction-specific cases, which are unique to facilities specializing in Kampo medicine, for the first time. From the results, we included the following seven points for risk management in the field of Kampo medicine : 1) insufficient recognition to the side effects of Kampo medicines, 2) misunderstanding of the dosages of Kampo products, 3) errors due to similarities in Kampo formulas and crude drug names, 4) preconception of frequently used Kampo prescriptions, 5) contamination in the decoctions, 6) errors related to crude drug items and their dosages that are frequently added or subtracted, 7) errors in hospital wards.

A Case of Excessive Sweating and Hot Flushes Successfully Treated with Yokukansan / 日本東洋医学雑誌

We report a case of a 49-year-old woman who presented with 6-month period menopausal syndrome including excessive sweating and hot flushes in her face, chest and back. She was also frustrated with her sons, but she reflected on her own anger and wondered why she got so irritated with them. We prescribed yokukansan to her and her all symptoms improved one month later. We need to differentiate between yokukansan and kamishoyosan in the treatment of menopausal syndrome and irritation, and it may be useful to evaluate the detail of irritation in selecting formula.

Experience in Kanzobushito for Rheumatoid Arthritis and Headache with Hypersensitivity / 日本東洋医学雑誌

We report a case of a patient with rheumatoid arthritis who refused Western medical treatment and was able to improve concomitant symptoms including arthralgia and headache by using kanzobushito. The patient was a 35-year-old. Eight years previously, she was diagnosed with rheumatoid arthritis due to joint stiffness. Although receiving methotrexate therapy, she developed methotrexate-associated lymphoproliferative disorders and the treatment was discontinued. Due to a feeling of rejection for Western medical treatment, she visited our hospital and was hospitalized for Kampo therapy. We prescribed kanzobushito for qi imbalance, coldness, and severe pain. Her joint pain, headache, and secondary symptoms were improved.

A Case Report of Painful Legs and Moving Toes Syndrome and Painful Arms and Moving Fingers Syndrome with Severe Blood Stasis and Panic Disorder Successfully Treated with Tokakujokito-Based Kampo Prescriptions / 日本東洋医学雑誌

The patient was a 47-year-old woman. Four years previously, she began to suffer from left lower leg pain and numbness, and involuntary movements. She received further examination in the department of neurology at other hospitals, but had an uncertain etiology and was provisionally diagnosed with restless legs syndrome. She was treated with Western medicine such as gabapentin and gabapentin enacarbil, but they were ineffective. She subsequently visited our hospital and was hospitalized. She was diagnosed with painful legs and moving toes syndrome, and painful arms and moving fingers syndrome after further examination. We prescribed tokakujokito because she had severe blood stasis and panic disorder on Kamp medical findings. As a result, her left lower leg numbness disappeared and pain was reduced. We report a case of a patient who could not be effectively treated using Western medicine and was successfully treated with tokakujokito-based Kampo prescriptions.

A Case of Post Coronavirus Disease 2019 (COVID-19) Condition, in which the Patient Suffered from a Severe Sense of Fatigue and Brain fog Successfully Treated with Kampo Therapy / 日本東洋医学雑誌

We report a case of post coronavirus disease 2019 (COVID-19) condition, in which the patient suffered from a severe sense of fatigue and brain fog that was successfully treated with Kampo therapy. The patient was a 21-year-old man. He had been diagnosed with COVID-19 and hospitalized for follow-up examinations. He recovered without any complications and was discharged from the hospital, but continued to suffer from a severe sense of fatigue, coldness, dizziness, and a loss of concentration. Because of these symptoms, he had to spend most of the day lying down. One month later, he was hospitalized to receive Kampo therapy. We administered bukuryoshigyakuto for 2 weeks referring to his severe coldness and fatigue and then changed to renjuin for his fluid disturbance and blood deficiency. After starting Kampo therapy, his fatigue and dizziness gradually improved. He was discharged after 3 weeks of hospitalization and received Kampo therapy as an outpatient. One month later, he reported a dull feeling in his stomach and depression. We switched to kamikihitogohangekobokuto and added hachimigan. His activities of daily living improved and he could take 4.5-kilometer walk. He could return to work 4 months later. Kampo therapy may be useful for post COVID-19 condition that causes a sense of fatigue and brain fog.

A Case of Anorexia and Drooling Improved by Targeting “Excessive Saliva Secretion” Using Bushirichuto / 日本東洋医学雑誌

A 65-year-old man, with a history of surgery for esophagogastric junction cancer in X-3, was admitted to the Department of Internal Medicine in our hospital in March for anorexia that had developed since January X. The patient was diagnosed with adhesive small bowel obstruction, and underwent surgery to relieve the obstruction in early May. However, his symptoms did not improve, and he was referred to our department in mid-June. His drooling was considered to be due to “excessive saliva secretion.” He started taking a decoction of bushirichuto for epigastric discomfort and resistance and coldness of the hands and feet. On the 5th day, he started to feel more energetic, and on the 8th day, his saliva production decreased. Furthermore, on the 12th day, his sense of taste and appetite improved. As the oral intake increased, tube feeding could be reduced and rehabilitation progressed ; from an almost bedridden state, he was able to walk continuously for 150 m with a cane. On the 29th day, he was transferred to a chronic care hospital. His weight increased from 34.1 kg, when he was referred to our department, to 39.7 kg at the discharge time. Anorexia and drooling, which had otherwise continued for 5 months, were improved within a short period of time by using bushirichuto.

The Reason Why the Order of Shanghanlun (shōkanron) is the Early Yang Stage Pattern (taiyōbyō), the Late Yang Stage Pattern (shōyōbyō), and the Middle Yang Stage Pattern (yōmeibyō) in Japan / 日本東洋医学雑誌

Yang diseases of the Shanghanlun (shōkanron) list the Three Yangs in the order of early yang stage pattern (taiyōbyō), middle yang stage pattern (yōmeibyō) and late yang stage pattern (shōyōbyō). However, in Japan, the order is early yang stage pattern, late yang stage pattern, and middle yang stage pattern. A survey of Japanese disease history revealed that by the Edo period smallpox, measles, and influenza were infectious, febrile, and highly lethal. Furthermore, these diseases exhibited bimodal fever. We investigated and examined how Kampo doctors viewed the order of the Three Yangs in the Shōkanron from the literature of the Edo period, and found that the epidemic period of these three diseases coincided with the increase in the number of doctors advocating late yang stage pattern. It is thought that the Three Yangs in Japan came to be recognized in the order of early yang stage pattern, late yang stage pattern, and middle yang stage pattern through these three dis­eases that became prevalent from around 1700.

Report on the Actual Condition of Homemade Pill Manufacturing / 日本東洋医学雑誌

A questionnaire survey was conducted on the actual state of manufacturing homemade pill preparations. Of the 14 facilities that responded, there were 4 pharmacies producing pills of only one type and 4 pharmacies producing more than 11 types. There were 7 facilities for handmade, manufacturing, 5 facilities for machinery manufacturing, and 2 facilities for handmade and/or machinery. The manufacturing process consists of about 9 steps, and it is possible to do it in 2-3 hours if considering just the time to make the pills, but it requires several days or more including preparation, machine cleaning, maintenance, etc. Based on the above, it seems that the current technical fees for pill manufacturing are extremely low.

Management of Infectious Epidermal Cyst (IEC) with Hainosankyuto (HST) / 日本東洋医学雑誌

Infectious epidermal cyst (IEC) is one of the most common cutaneous cysts. It sometimes causes severe bacterial infection and requires incisional drainage under local anesthesia. We reviewed the short-term outcome of the severe IEC patients with the Japanese traditional medicine, hainosankyuto, instead of surgical drainage. We retrospectively examined 125 patients of IEC (52 males and 73 females) administered hainosankyuto (HST). No recurrence for a year after the inflammatory symptoms disappeared was defined as short-term cure. We compared the cure rate and the internal use period by gender, age, affected area, premedication of antibiotics, and complications of immunosuppressive therapy. Overall, 88 cases (70%) were short-term cured and the average oral administration was 14.6 days. There was no gender difference. In age-related analysis, the cure rate tended to be lower in the 30s-50s because of many dropouts. In the examination by site, the cure rate was significantly higher in the other site group (63/78 cases : 80%) than back and buttock group. The average oral administration period was longer in the back and buttock group, respectively. The cure rate was higher in the antibiotic premedication group. The average oral administration period was significantly shorter in the no premedication group. In immunosuppressive group, 21 of 24 patients (87.5%) were cured, which was significantly higher than normal group. There was no difference in average oral administration period between the two groups. Hainosankyuto treatment was beneficial for short-term cure of severe IEC.

Cigarette Beetles (Lasioderma Serricorne) Occurring in Plantago Seed / 日本東洋医学雑誌

In the pharmaceutical department of Iizuka Hospital, larvae of the cigarette beetle (Lasioderma serricorne) were found in Plantago seed for the first time since the Department of Japanese Kampo Medicine started in 1992. The larvae grew into pupae and then adults. The plastic-packaged Plantago seed was left for about 3 months, during which several larvae and adult cigarette beetles appeared. Cigarette beetles are very common insects in summer and it is important that we store crude drugs in hard closed containers in our refrigerators. The larvae can bite strongly and puncture plastic packaging, however they cannot live under 15 ℃. Education of crude drug storage for patients is very important.

Five Cases of Breast Cancer-Related Therapy Complications Successfully Treated with Kampo Medicine / 日本東洋医学雑誌

Five cases of various diseases associated with breast cancer treatment including arthralgia, menopausal symptoms, chemotherapy-­associated symptoms (nausea, vomiting, numbness, pain, general fatigue), and anxi­ety neuroses during follow-­up were treated with Kampo medicine and a favorable course was obtained. Com­bined use of Kampo treatment can reduce the suffering caused by the side effects of breast cancer treatment, alleviate mental symptoms, prevent recurrence, and improve the patients' health. Kampo medicine plays a role in cancer supportive care for breast cancer.

Medical Safety Committee Report :Medical Accident Information and Minor Incidents from Medical Institutions Related to Kampo Products / 日本東洋医学雑誌

The Medical Safety Committee analyzed the case reports of minor incidents from the pharmacies last time as part of an activity to promote patient safety in Japanese traditional Kampo medicine. This time, we analyzed the case reports of medical accidents and minor incidents from the medical institutions. We extracted 626 reports related to Kampo products from the public database, which the Japan Council for Quality Health Care has established based on the collected information related to the medical accidents and minor incidents. The medical accident information includes case reports related to drug-induced liver injury. The minor incident reports include prescribing error due to misinterpretation related to the quantity of one sachet of Kampo extract product, dispensing error due to similarity of product appearance, number or name, and administration error due to judging the medicine only by Kanji characters or product company names without checking the Kampo formula name. Additionally, the minor incidents were often discovered by people belonging to different professions or patients themselves. In order to promote patient safety, knowledge about these incidents should be shared among the people involved in the same or different professions.

Two Cases Successfully Treated with Mokuboito on the Basis of Shinkahiken (Epigastric Stuffiness and Strong Resistance) / 日本東洋医学雑誌

Mokuboito is usually used for the treatment of patients with dyspnea and edema due to chronic heart failure. We herein report two cases successfully treated with mokuboito on the basis of shinkahiken (epigastric stuffiness and strong resistance). Case 1 was a 28-year-old woman. She had been experiencing occasional bouts of epigastralgia for 12 years, but they had worsened two months before the first visit to our department. When she was examined, however, the cause of epigastralgia could not be determined and she was diagnosed with functional gastroenteropathy. After being introduced to our department, she was treated with various Kampo formulas, but the symptom was poorly improved. Case 2 was a 74-year-old man who was prescribed hachimijiogan and shoseiryuto for an overactive bladder and perennial allergic rhinitis. His symptoms were stable, but suddenly deteriorated after two months. In both cases, when changing treatment to mokuboito on the basis of shinkahiken, the symptoms were improved. These results suggest that mokuboito can be used in a wide range of cases with shinkahiken.

A Case of Goreisan with hoketsuzai (Blood-Tonifying Formula) that was Remarkably Effective for Severe Malnutrition / 日本東洋医学雑誌

We report a case in which goreisan with hoketsuzai (blood-tonifying formula) was successful in the treatment of a marked nutritional disorder. A 17-year-old woman was screened for prominent emaciation of unknown cause. After the administration of goreisan, edema was reduced and her body weight increased. Subsequently, anemia improved and muscle mass increased with a combination of shimotsuto or sokeikakketsuto. It is possible that goreisan with hoketsuzai improved the water balance of the whole body including the digestive tract, and restored the digestive and absorptive function.

The Role of Kampo Therapy to Treat Cellulitis / 日本東洋医学雑誌

In this report, we present three cases of lower limb cellulitis. The first case was an 88-year-old woman and the second case was a 36-year-old man. In addition to standard therapy, both of them received Kampo therapies with keishinieppiitto and jidabokuippo during the acute phase of cellulitis and were promptly cured. The third case was a 52-year-old woman with severe obesity suffering from repeated and intractable cellulitis. She received Kampo therapy including keishibukuryogan. The redness and swelling in her leg gradually disappeared. Administration of adequate antibiotics and elevation of affected areas are important for the treatment of cellulitis. Even with appropriate therapy, some patients are slow to respond and difficult to treat. The skin findings in cellulitis are swelling, redness, heat, and pain, which can be recognized and treated as water imbalance, heat, and blood stasis in Kampo medicine. This case report suggests that cellulitis during the acute phase can be treated with keishinieppiitto and the treatment of water imbalance and heat is important. After the acute phase, the treatment of blood stasis is important. Considering the time of onset and skin findings in cellulitis, Kampo therapy can contribute to the rapid recovery of cellulitis.

Six Cases of Psychiatric Symptoms Successfully Treated with Shimotsuto-Containing Medication / 日本東洋医学雑誌

Six patients with psychiatric symptoms were successfully treated with shimotsuto-containing medication. Case 1 was a 13-year-old boy who complained of difficulty in getting up ; however, when he was treated with a focus on the decrease in his concentration, he was able to go to school after treatment. Case 2 was an 18-year-old girl who had also difficulty in getting up, but was able to go to school. Case 3 was a 10-year-old girl who was able to go to school partially after treatment. Case 4, a 42-year-old man with apprehension in socializing, showed improvement in socializing after taking medication containing shimotsuto. Case 5 had various complaints that were relieved after taking medication containing shimotsuto. Case 6 was a 56-year-old woman who had also multiple complaints ; however, the symptoms were alleviated with shimotsuto-containing medication. All patients experienced depression and anxiety. Four patients with decreased cortisol recovered after treatment with shimotsuto. From these results, shimotsuto is considered to improve concentration, judgment, and psychiatric symptoms by treating blood deficiency.

Representative Side Effects Caused by Kampo prescriptions :Pseudoaldosteronism, Drug-induced Liver Injury and Drug-Induced Lung Injury / 日本東洋医学雑誌

The Japan society of oriental medicine created a committee of medical safety in 2017. The first activity was to summarize the representative side effects of Kampo medicine and to enlighten members of our society about them. In this report, we documented the knowledge to keep in mind at present on pseudoaldosteronism, drug-induced liver injury, and drug-induced lung injury. Since these three major side effects may cause clinically severe conditions, it is very important to detect them early and take appropriate measures. Therefore, proper examinations at the right time are necessary while taking Kampo medicine.

Committee for Medical Safety Report : Example of Minor Incidents in the Preparation of Kampo Products in Pharmacy / 日本東洋医学雑誌

We collected and analyzed the case reports of minor incidents in the preparation of Kampo products in Japanese pharmacies in order to manage the medical safety control in Japanese traditional Kampo medicine. We extracted 2,166 reports that are related to Kampo products from the database of minor incidents in pharmacies supplied from The Japan Council for Quality Health Care from 2009 to 2019. Among the reports, we found the cases that pharmacists could find the mistakes about the name, dosage and administration of Kampo products or could prevent the appearance of adverse reaction when pharmacists check the prescription and ask prescription question for doctors. It is suggested that the system of separation of dispensing and prescribing functions would be well working in medical safety control. At the same time, we also found many cases that pharmacists have actually made mistakes by confusing the name of Kampo products and dosage. In this report, we summarized the cases of these minor incidents and frequently appearing confusions about the names of Kampo products.

Prediction Model for Deficiency-Excess Patterns, Including Medium Pattern / 日本東洋医学雑誌

We have previously reported on a predictive model for deficiency-excess pattern diagnosis that was unable to predict the medium pattern. In this study, we aimed to develop predictive models for deficiency, medium,and excess pattern diagnosis, and to confirm whether cutoff values for diagnosis differed between the clinics. We collected data from patients' first visit to one of six Kampo clinics in Japan from January 2012 to February 2015. Exclusion criteria included unwillingness to participate in the study, missing data, duplicate data, under 20 years old, 20 or less subjective symptoms, and irrelevant patterns. In total, 1,068 participants were included. Participants were surveyed using a 153-item questionnaire. We constructed a predictive model for deficiency, medium, and excess pattern diagnosis using a random forest algorithm from training data, and extracted the most important items. We calculated predictive values for each participant by applying their data to the predictive model, and created receiver operating characteristic (ROC) curves with excess-medium and medium-deficiency patterns. Furthermore, we calculated the cutoff value for these patterns in each clinic using ROC curves, and compared them. Body mass index and blood pressure were the most important items. In all clinics, the cutoff values for diagnosis of excess-medium and medium-deficiency patterns was > 0.5 and < 0.5, respectively. We created a predictive model for deficiency, medium, and excess pattern diagnosis from the data of six Kampo clinics in Japan. The cutoff values for these patterns fell within a narrow range in the six clinics.

Applications of Orento Based on“Upper Heat and Middle Cold” / 日本東洋医学雑誌

Orento is generally used for upper gastrointestinal symptoms. We have used orento for various diseases based on “upper heat and middle cold”. As a result of the evaluation of 30 responders to orento, the most frequent sign of “upper heat” was “yellow tongue coating” (29/30 responders), while the most frequent sign of “middle cold” was “preference for warm foods and beverages” (27/30 responders). Compared with the non-­responder group, the responder group showed significantly higher frequencies of “gastrointestinal cold”, which is the sum of “preference for warm foods and beverages” and “aggravation of gastrointestinal symptoms by cold foods and beverages” (29/30 responders, p = 0.047), and “upper/lower gastrointestinal symptoms” (29/30 responders, p = 0.014). These results suggest that “yellow tongue coating” is the most important sign for “upper heat” while “gastrointestinal cold” is the most important sign for “middle cold”. As Kampo patterns for orento, gastrointestinal symptoms often occur, but there is a possibility of upper or lower gastrointestinal symptoms, skin disorders, and sleep disorders.