We analyzed the clinical features of 21 cases with drug-induced liver injury due to Kampo medicines between the years 2000 and 2009 in our institute. The mean age in these cases was 55.2 ± 13.4 years. Five of the cases were men, and 16 were women. In 17 of the 21 cases, drug-induced liver injury had occurred within 3 months after beginning Kampo medicines. There were no subjective symptoms in 11 cases. Nine cases of both hepatocellular injury, and of mixed-type injury were seen. Causative Kampo medicines included an Ogon (Scutellariae Radix) component in 19 cases. A drug-induced lymphocyte stimulation test (DLST) was performed in 5 cases. The test was positive for Kampo medicines in only one of the 5 cases. Liver injury improved or normalized in 18 cases (85.7%) after discontinuing causative Kampo medicines. In another 2 cases, liver injury normalized after changing a Kampo medicine to the same prescription without Ogon. These results suggest that even if patients complain of no symptoms we must perform blood tests to check liver function within 3 months of prescribing Kampo medicines, especially those including Ogon, to facilitate early diagnosis of drug-induced liver injury.

The patient was a 14 year-old female. She had been hospitalized repeatedly since infancy for suspected tonsillitis. During this time, she experienced high fever for about a week once a month. In her school years, she often had a recurrent fever with cervical adenitis, with only a mild inflammatory reaction. We diagnosed her symptom as one of a periodic fever syndrome, triggered by the frequent administered antipyretic drugs for fevers of unknown origin (FUO). We also suspected that there was liver tension, based on her abdominal and back examination, and we prescribed yokukansan. After a 3-month course of yokukansan, she no longer experienced these fevers. Most case reports of FUO describe the use of bupleurum root drugs and tonic formulas as treatment. Although yokukansan has traditionally been used for FUO in older texts, to our knowledge, there are no reports on such use clinically. In the present patient's case, the yokukansan may have reduced or eliminated some type of trigger for the fevers, or it may have affected the regulation of cytokines.

This report describes a case of cluster headaches that was successfully treated with Senkito. The patient was a 46-year-old female. She had been having attacks of cluster headaches that had continued for 3 days at the change of seasons since she was 30 years old. During an attack, she took a triptan preparation and non-steroid anti-inflammatory drug (NSAID), but they were not effective. Recently, the attacks had been increasing in frequency and continued for 1-2 weeks. She visited our hospital for Kampo treatment. We diagnosed her as having oketsu and kiutsu ; therefore, we prescribed tsudosan, and the frequency and strength of the attacks decreased. Even if NSAIDs were effective for headaches, they were not consistently effective. We re-examined her and found she had inside biryokotsu, which is tenderness in the orbital part of the frontal bone. We diagnosed her headache as including biryokotsu pain. We prescribed Senkito as required for her biryokotsu pain. It was very effective and the headache vanished after only 30 min. Generally, the potency of Kampo medicines with few structural components is higher than that of those with many structural components. Senkito has only five structural components ; therefore, we concluded that Senkito is effective not only for everyday use but also for use when required. Senkito is one of the most effective formulations for treatment of biryokotsu pain,especially the patient with inside of biryokotsu tenderness.

Reitakutsukito is a Kampo formulation that is applied for the treatment of olfaction disorder. There have been some reports that reitakutsukito improves nasal obstructions such as allergic rhinitis and chronic sinusitis, but none have reported a neurogenic olfaction disorder successfully treated with this formulation. We report a case of olfaction disorder that was neurogenic, successfully treated with reitakutsukito. The patient was a 43-year-old male. After being bruised on the head, he presented with olfaction disorder. He went to the otorhinolaryngology department at a university hospital and received a diagnosis of neurogenic olfaction disorder. However, he did not show any improvement. Fourteen months after the head trauma, he consulted our institution. We prescribed reitakutsukito for four weeks, and his subjective symptoms improved. Treatment with reitakutsukito for almost two years then resolved his symptoms. This case suggests that reitakutsukito could be a useful formulation for the treatment of not only respiratory olfaction disorder, but also neurogenic disorder.

We analyzed the clinical features of 21 cases with drug-induced liver injury due to Kampo medicines between the years 2000 and 2009 in our institute. The mean age in these cases was 55.2 ± 13.4 years. Five of the cases were men, and 16 were women. In 17 of the 21 cases, drug-induced liver injury had occurred within 3 months after beginning Kampo medicines. There were no subjective symptoms in 11 cases. Nine cases of both hepatocellular injury, and of mixed-type injury were seen. Causative Kampo medicines included an Ogon (Scutellariae Radix) component in 19 cases. A drug-induced lymphocyte stimulation test (DLST) was performed in 5 cases. The test was positive for Kampo medicines in only one of the 5 cases. Liver injury improved or normalized in 18 cases (85.7%) after discontinuing causative Kampo medicines. In another 2 cases, liver injury normalized after changing a Kampo medicine to the same prescription without Ogon. These results suggest that even if patients complain of no symptoms we must perform blood tests to check liver function within 3 months of prescribing Kampo medicines, especially those including Ogon, to facilitate early diagnosis of drug-induced liver injury.

Tokishakuyakusan has been used widely to treat various diseases including gynecological disorders. Currently, tokishakuyakusan is frequently used to treat female patients, while indications for use in male patients are unclear. Furthermore, there are few reports of male patients having been effectively treated with tokishakuyakusan or tokishakuyakusanryo. Here, we report four male patients successfully treated with tokishakuyakusanryo. Case 1 was an 84-year-old man who had uncontrolled nasal allergy, and treatment with tokishakuyakusanryo was effective in relieving the patient's allergy symptoms that were accompanied by chills and oketsu (blood stasis) findings. Case 2 was a 63-year-old man whose chief complaints were bronchial asthma, benign prostate hypertrophy, and nasal allergy. All his symptoms improved considerably with tokishakuyakusanryo and hangekobokuto, especially the symptoms of nasal allergy. Case 3 was a 70-year-old man whose chief complaint was persistent proteinuria. Tokishakuyakusanryo was prescribed, in consideration of his clinically observed condition, which included sensitivity to cold, blood stasis and fluid retention. His proteinuria disappeared four months later, along with his other complaints of chills, oketsu, and fluid retention. Case 4 was a 56-year-old man whose chief complaint was ulcerative colitis. He had responded well to treatment with ifuto, but he developed hypertension. His prescription was changed to tokishakuyakusanryo, a similar prescription that does not contain the Glycyrrhiza radix which can cause hypertension. Afterwards, his blood pressure decreased to normal levels and his abdominal symptoms remained stable. Nangai Yoshimasu published the opinion that tokishakuyakusan could be applied not only in female patients but also male patients. Additional reports on male cases would provide helpful information to clarify tokishakuyakusan indications in male patients.

Standardizing Kampo medical findings is a significant challenge in Kampo medical circles. These findings are fundamental to Kampo diagnosis. This paper introduces our attempt to standardize these findings in a specialized Kampo medical service facility.
We started our project with verbal standardization. Nine medical doctors, all of whom were Kampo advisors or Kampo specialists, discussed issues such as subjective and objective findings, including those of the tongue, pulse, and abdomen, as well as the selection of target items, criteria for judgments on each item, and associated issues. When discussing the above issues, descriptions in prominent traditional Kampo texts were given most importance, and the wisdom of famous Kampo doctors since the Showa period was also given weight. In addition, we focused attention on clarifying the criteria for making judgments.
One hundred and twenty items were selected as subjective Kampo findings. We selected 12, 6 and 10 items as objective Kampo findings in the tongue, pulse, and abdomen, respectively, and provided criteria for judgments with each.
Our next challenge is to spread these standardizations in Kampo medical circles.

We have limited evidence as to the clinical indications for Kampo medicines, especially as they relate to gastrointestinal function. Thus, we investigated the efficacy of the Kampo medicine hangekobokuto (HKT) on patients with functional dyspepsia (FD), with special reference to its clinical indications for gastrointestinal function, including gastric emptying and bowel gas volume.Gastric emptying rate (GER) in FD patients was significantly facilitated by HKT. HKT also improved the gastrointestinal symptoms of the patients. Among these, patients who had inchuusharen, or a symptom of globus sensation, and a representative indication for HKT, showed significant improvement of both their GER and gastrointestinal symptoms compared with patients who did not have inchuusharen. As for bowel gas, the bowel gas volume calculated from a plain abdominal radiogram (gas volume score, GVS) in FD patients decreased significantly, after administration of HKT. Patients who had fukuman, or a feeling that one's stomach is full or bloated, and another representative indication for HKT, showed significant decrease of their GVS to normal levels, compared with patients who did not present with fukuman.These results suggest that the presence of clinical indications, such as inchuusharen or fukuman, are strongly related to HKT efficacy in patients with FD, and that these are useful, scientifically validated markers for the efficient use of HKT.
Clinical ; Final diagnosis (discharge) ; Gases ; seconds ; Volume

Case reports of drug-induced liver injury caused by Kampo medicines are on the rise, but most of them are noted for related symptoms such as jaundice. Usually, severe liver injury is detected by chance upon routine medical checkup. Recently, we noted 3 cases of suspected drug-induced liver injury caused by orengedokuto, saikokeishikankyoto and bofutsushosan. In these 3 cases, maximum ALT was under 100 IU/l and no symptoms related to liver injury were observed. Early detection by blood test was useful, and appropriate treatment quickly improved and normalized the abnormal values associated with liver injury. We should always be alert for drug-induced liver injury caused by Kampo medicines, especially when prescribing formulations that include Scutellariae Radix. We also emphasize the importance of scheduling blood tests when prescribing these formulations.

The purpose of this study was to reevaluate the sho of goshuyuto, which has been established in an unscientific manner, and to create a new concept of the sho of goshuyuto. Eighty-four patients suffering from chronic headache were instructed to orally consume 7.5g. day of a spray-dried powder of goshuyuto (TJ-31) for 4 weeks. Before consuming the TJ-31, all subjects underwent Kampo examinations that were based on 43 diagnostic items. After the 4-week period of medication, all the subjects were classified as either responders or nonresponders. After excluding insignificant items from the 43 diagnostic items, discriminant analysis, which discriminated between responders and nonresponders, was conducted. Of the 80 subjects who completed the trial period, 57 were judged to be responders and 23 to be nonresponders. “Cold feet,” “fluid and gas retention in the stomach,” “kyokyo-kuman,” “tenderness at side of navel,” and “pulsation at abdomen” were selected by stepwise selection. The results of the discriminant analysis using these 5 items suggest that 28 subjects were misclassified and that the misclassification rate was 35%. Of the actual 23 nonresponders, 20 were accurately discriminated as nonresponders. The 5 selected items are suggested to be more useful in selecting the nonresponders than the responders. In conclusion, the empirically established sho of goshuyuto seemed to not be abele to completely explain the indication of goshuyuto. However, the inclusion of “tenderness at side of navel” and “pulsation at abdomen,” as new components comprising the sho of goshuyuto, may facilitate a more accurate indication of goshuyuto.
Statistical Analysis ; Emotional tenderness ; week ; Discriminant Analysis ; Abdomen