Yoshihiro Imazu

Traditional Japanese Kampo Medicine: Clinical Research between Modernity and Traditional Medicine—The State of Research and Methodological Suggestions for the Future

The Japanese traditional herbal medicine, Kampo, has gradually reemerged and 148 different formulations (mainly herbal extracts) can be prescribed within the national health insurance system. The objective of this article is to introduce Kampo and to present information from previous clinical studies that tested Kampo formulae. In addition, suggestions on the design of future research will be stated. The literature search was based on a summary, up until January 2009, by the Japanese Society of Oriental Medicine and included only those trials which were also available in either Pubmed or ICHUSHI (Japan Medical Abstracts Society). We included 135 studies, half of these studies (n = 68) used a standard control and 28 a placebo control. Thirty-seven trials were published in English [all randomized controlled trials (RCTs)] and the remaining articles were in Japanese only. The sample size for most studies was small (two-third of the studies included less than 100 patients) and the overall methodological quality appeared to be low. None of the studies used Kampo diagnosis as the basis for the treatment. In order to evaluate Kampo as a whole treatment system, certain aspects should be taken into account while designing studies. RCTs are the appropriate study design to test efficacy or effectiveness; however, within the trial the treatment could be individualized according to the Kampo diagnosis. Kampo is a complex and individualized treatment with a long tradition, and it would be appropriate for further research on Kampo medicine to take this into account.

Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902)

Objective This exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer. Methods A total of 386 patients undergoing colectomy at 1 of the 51 clinical trial sites in Japan from January 2009 to June 2011 were registered for the study (JFMC39-0902). Patients received either placebo or Daikenchuto (15.0 g/day, t.i.d) between post-operative day 2 and post-operative day 8. Primary end-points included time to first bowel movement, frequency of bowel movement and stool form. The incidence of intestinal obstruction was evaluated post-operatively. The safety profile of Daikenchuto until post-operative day 8 was also evaluated. Results The results for 336 patients (Daikenchuto, n = 174; placebo, n = 162) were available for statistical analysis. The time to first bowel movement did not differ significantly between the two groups. All patients reported having diarrhea or soft stools immediately after surgery, and the time until stool normalization (50th percentile) in the Daikenchuto and placebo groups was 6 days and 7 days, respectively. The placebo group had a significantly greater number of hard stools at post-operative day 8 (P = 0.016), and bowel movement frequency continued to increase until post-operative day 8 as well. In contrast, bowel movement frequency in the Daikenchuto group increased until post-operative day 6, however decreased from post-operative day 7 and was significantly lower at post-operative day 8 compared with the placebo group (P = 0.024). Conclusion The moderate effects of Daikenchuto were observed ∼1 week after the operation. Although Daikenchuto had an effect on gastrointestinal function after open surgery in patients with colon cancer, this study did not show its clinical benefits adequately.

Enhanced motility of the vagotomized canine stomach by electrical stimulation

Functional impairment of the vagotomized stomach used as a substitute oesophagus seriously deteriorates the quality of life of patients following oesophageal cancer surgery. We speculated that if the enteric neurons of the reconstructed gastric tube survived functionally, the motility of the gastric tube could be facilitated and the recovery process after operation would improve as a consequence. In the present study we investigated whether direct electrical stimulation was effective for facilitating the motility of the canine vagotomized stomach. Dogs underwent truncal vagotomy by trahsabdominal approach and, in some cases, arteries to the upper stomach and the oesophagus were also ligated and resected to resemble the blood supply and surgical invasion of the reconstructed gastric tube. Electrical stimulation, a few minutes of positive rectangular current pulses, amplitude 20 V (or 15 mA), duration 0.5 ms and frequency between 0.2 and 7 Hz, was delivered on the greater curvature of the mid corpus. Changes in mechanical contractions were recorded using strain gauge force transducers. Electrical stimulation successfully enhanced the mechanical force of the phasic ring contractions of the vagotomized stomach in a frequency dependent manner. Aboral propagation and periodicity of the contractions, impaired by surgical procedures, were restored during stimulation. These excitatory effects were inhibited by atropine, hexamethonium and tetrodotoxin, suggesting that electrical stimulation acts on intramural cholinergic nerves that have survived functionally. These results suggest that electrical stimulation could be an effective method for improving the motility of the vagotomized stomach.

Recovery of upper gastrointestinal bowel movement after rectosigmoid cancer surgery: a pilot transit analysis.

Postoperative gastrointestinal bowel transit right after colorectal resection has not yet been clarified. Thirty patients with rectosigmoid cancer were treated in this pilot study. The nasogastric tube was removed on the first postoperative day. One Sitzmarks capsule was given to each patient on the second postoperative day. Abdominal X-rays were taken at 3, 6, 8, 24, 48, and 72 hours after capsule intake. Distribution of the remaining Sitzmarks capsules were counted on X-ray films to clarify postoperative gastrointestinal movement after bowel resection. All Sitzmarks capsules were observed in the stomach at 3 and 6 hours after capsule intake. At 8 hours (second postoperative day), the Sitzmarks capsules were distributed from the stomach to the small intestine. Sitzmarks capsules were distributed in the right side colon at 24 hours (third postoperative day) after intake. Although the main distribution was still in the right side colon, several patients had evacuations accompanied by the disappearance of the Sitzmarks capsules. In 50% of the patients, it took approximately 72 hours (fifth postoperative day) for the first defecation after intake of the capsules. However, the Sitzmarks capsules remained mainly in the right side colon. Eight hours after intake, the majority of the Sitzmarks capsules shifted to the small intestine. Therefore, medication or feeding should be safely possible starting on the second postoperative day. There was no particular impact of bowel resection on upper gastrointestinal transit in patients with rectosigmoid cancer.

Current Status of Kampo Medicine Learning by Japanese Physicians for Cancer Treatment

a Aoyama Pharmacy, 2-10-9 Minami-Aoyama, Minato-ku, Tokyo 107-0062, Japan b Kanagawa Academy of Science and Technology, 3-2-1 Sakado Takatsu-ku, Kawasaki-shi, Kanagawa 213-0012, Japan c Keio Research Institute at SFC, 5322 Endo Hujisawa-shi, Kanagawa 252-8520, Japan d Shiba daimon Imazu Clinic, 1-1-14 Shibadaimon Minato-ku, Tokyo 105-0012, Japan e Center for Kampo Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

International Classification of Diseases

受付:2009年11月6日,受理:2010年7月11日 Abstract Traditional East Asian medicines, Kampo included, are to be incorporated into International Classification of Diseases 11 (ICD-11) which will be released in 2015. To understand the significance of this plan, ICD itself needs to be understood. In this article, we describe ICD history, its significance and problems, and why the WHO became interested in traditional medicine. In the beginning, the ICD was only for classifying causes of mortality, and has since expanded to cover disease information according to the diverse needs of a changing society. And in Japan today, it is widely used not only for death certificate and disease information, but also for research purposes. There are many problems with the ICD, however : e.g. it is not clinically convenient, and it lacks certain terminology. Revision from IDC-10 to ICD-11 is now ongoing. It will be expanded and electronic. At the same time, plans are to have it broadly implemented in Asia by including traditional East Asian medicine.

Symbolic hierarchical clustering for visual analogue scale data

We propose a hierarchical clustering in the framework of Symbolic Data Analysis(SDA). SDA was proposed by Diday at the end of the 1980s and is a new approach for analysing huge and complex data. In SDA, an observation is described by not only numerical values but also “higher-level units”; sets, intervals, distributions, etc. Most SDA works have dealt with only intervals as the descriptions. In this paper, we define “pain distribution” as new type data in SDA and propose a hierarchical clustering for this new type data.

Current Problems of the Compound Fee for Herbal Medicine

2006年度に改定された漢方生薬の調剤である湯薬調剤料が適正であるか否かを検討した。調剤時間を指標に湯薬調剤と一般調剤を比較した。1～15日処方で一般調剤が平均4．4分／枚のところ湯薬調剤は平均13．4分／枚と約3倍の時間を要し，30日を超過する処方では一般調剤に比べ約7倍の時間を要した。次に調剤業務1分間あたりの調剤報酬を湯薬調剤と一般調剤で比較検討した。1～15日処方では大きな差はなかったが，15日を超える処方日数の湯薬調剤では一般調剤に比べ，調剤報酬が約1／3から1／5ほど低い結果となった。大学病院における処方日数の変移の調査では，30日を超過する処方件数は2003年度では全体の2．7％であったが，2008年度の件数は約14倍に増えて全体の42％であった。長期投薬が増えつつある現状を考慮すると，湯薬調剤料も内服調剤料同様，処方日数に応じた調剤報酬にする必要がある。