Background/Aims: The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response. Methods: In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled. Results: Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response. Conclusions Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.

Background/Aims: Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. Methods: This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Results: Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred. Conclusions The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

Background/Aims: Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. Methods: This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Results: Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred. Conclusions The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

Background/Aims: Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. Methods: This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Results: Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred. Conclusions The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic inflammatory disease of the gastrointestinal tract, with increasing prevalence worldwide. IBD Ahead is an international educational program that aims to explore questions commonly raised by clinicians about various areas of IBD care and to consolidate available published evidence and expert opinion into a consensus for the optimization of IBD management. Given differences in the epidemiology, clinical and genetic characteristics, management, and prognosis of IBD between patients in Japan and the rest of the world, this statement was formulated as the result of literature reviews and discussions among Japanese experts as part of the IBD Ahead program to consolidate statements of factors for disease prognosis in IBD. Evidence levels were assigned to summary statements in the following categories: disease progression in CD and UC; surgery, hospitalization, intestinal failure, and permanent stoma in CD; acute severe UC; colectomy in UC; and colorectal carcinoma and dysplasia in IBD. The goal is that this statement can aid in the optimization of the treatment strategy for Japanese patients with IBD and help identify high-risk patients that require early intervention, to provide a better long-term prognosis in these patients.
Asian Continental Ancestry Group ; Colectomy ; Colitis, Ulcerative ; Colorectal Neoplasms ; Consensus ; Crohn Disease ; Disease Management* ; Disease Progression ; Early Intervention (Education) ; Epidemiology ; Expert Testimony ; Gastrointestinal Tract ; Hospitalization ; Humans ; Inflammatory Bowel Diseases* ; Japan* ; Prevalence ; Prognosis

BACKGROUND/AIMS: The influences of Helicobacter pylori eradication therapy on the disease course of inflammatory bowel disease (IBD) are still unclear. We therefore conducted a multicenter, retrospective cohort study to evaluate the safety of H. pylori eradication therapy for IBD patients. METHODS: IBD patients with H. pylori eradication from 2005 to 2015 (eradication group) and control patients (non-eradication group; 2 paired IBD patients without H. pylori eradication matched with each eradicated patient) were included. IBD exacerbation (increased/additional IBD drug or IBD-associated hospitalization/surgery) and disease improvement based on the physicians’ global assessment were investigated at baseline, and at 2 and 6 months after eradication or observation. RESULTS: A total of 429 IBD (378 ulcerative colitis, 51 Crohn’s disease) patients, comprising 144 patients in the eradication group and 285 patients in the non-eradication group, were enrolled at 25 institutions. IBD exacerbation was comparable between groups (eradication group: 8.3% at 2 months [odds ratio, 1.76; 95% confidence interval, 0.78–3.92; P=0.170], 11.8% at 6 months [odds ratio, 1.60; 95% confidence interval, 0.81–3.11; P=0.172]). Based on the physicians’ global assessment at 2 months, none of the patients in the eradication group improved, whereas 3.2% of the patients in the non-eradication group improved (P=0.019). Multivariate analysis revealed that active disease at baseline, but not H. pylori eradication, was an independent factor for IBD exacerbation during 2 months’ observation period. The overall eradication rate was 84.0%–comparable to previous reports in non-IBD patients. CONCLUSIONS: H. pylori eradication therapy does not alter the short-term disease activity of IBD.
Clarithromycin ; Cohort Studies ; Colitis, Ulcerative ; Helicobacter pylori* ; Helicobacter* ; Humans ; Inflammatory Bowel Diseases* ; Metronidazole ; Multivariate Analysis ; Retrospective Studies

[Introduction] In 2006 the WHO and WPRO agreed on standard acupuncture point locations. To promotepagate these standards, in 2009 the Second Japan Acupuncture Standardization Committee published a Japanese edition of 'WHO STANDARD ACUPUNCTURE POINT LOCATIONS FOR THE WESTERN PACIFIC REGION.' Based on this Japanese edition, a new textbook was published by the Japan Association of Massage & Acupuncture Teachers and the Japan College Association of Oriental Medicine. Since one year has passed since the start of education based on standard acupuncture point locations at Japanese universities, colleges, vocational schools and training centers for anma (Japanese traditional massage), massage, and shiatsu (acupressure); acupuncture; and moxibustion therapies, we administered a questionnaire survey as an evaluation of international standardization and the problems of introducing standard acupuncture point locations .
[Subjects and methods] Subjects were mainly teachers and included a small number of researchers, clinicians, and other groups concerned with acupuncture and moxibustion. We used a questionnaire that we originally created at the Second Meeting of the Japan Standardization of Acupuncture Point Locations Committee.
[Results] Among the 180 institutions surveyed, we obtained answers from 149 people from 93 institutions in total. Agreement on the question of standard acupuncture points, "functional existence" (44.3%) was most common, and "anatomical existence" came next at 26.6%. For the question on acupuncture treatment, 82.4% replied with "use ofboth acupuncture points and reaction points." For the answers to agreeing with international standardization, "no opinion" was 41.7% and 51.7% for "appreciate." However, both of those groups appreciated globalization of acupuncture and moxibustion by a common　language. There were many opinions on proportional bone measurement. Specifically, opinions indicated a change "from the cubital crease to the wrist crease" (from 10B-cun to 12B-cun) and a need for proportional bone measurement of the upper arm. Whereas, for individual acupuncture points, opinions expressed the difficulty of locating application points and not understanding reasons for change and notations including body surface segments.
[Discussion] We were able to classify the opinions collected into the following groups: (1) problems that can be corrected immediately, including typographic errors, (2) problems that need to be reviewed at the next international gathering, and (3)problems that need to be understood by making full use of related documents.
[Conclusion] We were able to determine primarily for a wide range of teachers, problems understanding individual acupuncture point locations, including consideration of acupuncture points, evaluation of standardization of acupuncture point locations, and other guidelines

Fetal development of the cartilage of the pharyngotympanic tube (PTT) is characterized by its late start. We examined semiserial histological sections of 20 human fetuses at 14-18 weeks of gestation. As controls, we also observed sections of 5 large fetuses at around 30 weeks. At and around 14 weeks, the tubal cartilage first appeared in the posterior side of the pharyngeal opening of the PTT. The levator veli palatini muscle used a mucosal fold containing the initial cartilage for its downward path to the palate. Moreover, the cartilage is a limited hard attachment for the muscle. Therefore, the PTT and its cartilage seemed to play a critical role in early development of levator veli muscle. In contrast, the cartilage developed so that it extended laterally, along a fascia-like structure that connected with the tensor tympani muscle. This muscle appeared to exert mechanical stress on the initial cartilage. The internal carotid artery was exposed to a loose tissue facing the tubal cartilage. In large fetuses, this loose tissue was occupied by an inferior extension of the temporal bone to cover the artery. This later-developing anterior wall of the carotid canal provided the final bony origin of the levator veli palatini muscle. The tubal cartilage seemed to determine the anterior and inferior margins of the canal. Consequently, the tubal cartilage development seemed to be accelerated by a surrounding muscle, and conversely, the cartilage was likely to determine the other muscular and bony structures.
Arteries ; Carotid Artery, Internal ; Cartilage ; Eustachian Tube ; Fetal Development ; Fetus ; Humans ; Muscles ; Palate ; Pregnancy ; Stress, Mechanical ; Temporal Bone ; Tensor Tympani

The (First) Japan Acupuncture Point Committee was established in 1965 and the nomenclature for meridians and acupuncture points was standardized at the meeting in Geneva in 1989. After that the first Informal Consultation on Development of International Standard Acupuncture Points Locations was organized by WHO/WPRO and held in Beijing (2003). In Japan the (second) Japan Acupuncture Point committee started April in 2004. Japan, China and Korea held nine meetings and made a draft for the Locations of Acupuncture Points. According to the draft made at the official meeting of 'the Development of Standard Acupuncture Point Locations'held in Tsukuba, Japan (2006), Acupuncture Point Locations were further standardized. Finaly, the book "WHO Standard Acupuncture Point Locations in the Western Pacific Region"was published on May 16th, 2008. Here, we want to report on the Commemorative Lecture Meeting for Publication of WHO Standard Acupuncture Point Locations held on May 30th, 2008.

1. Introduction
The Meeting on Development of International Standard Acupuncture Point Locations hosted by WHO/WPRO was held between Oct. 31 th and Nov. 2 nd in 2006 at the International Congress Center in Tsukuba City, Japan. The delegates came from nine countries, e.g. Australia, China, Japan, Korea, Mongolia, Singapore, UK, USA, Vietnam, and two organizations, e.g. WFAS (World Federation of Acupuncture Societies), AAOM (American Association of Oriental Medicine). The total number of delegates was twenty. The draft of Standard Acupuncture Point Locations, which had been discussed between three countries, Japan, China and Korea during the previous three years, was officially decided.
2. Agreement for Acupuncture Point Locations
Three hundred and sixty one Acupuncture Point Locations were decided at the meeting, the number is 7 more than the number that has been taught so far in the educational field of Japanese acupuncture. The points which differ from the current Japanese text book are 7. These points had been considered “extra points” located along meridians as well as points requiring special attention. 6 points had been the subject of debate, and as a result two locations for each point have been decided. These are LI 19, LI 20, CV 24, PC 8, PC 9, and GB 31.
3. Future Plan of WPRO
We attempted to standardize the Acupuncture Point Locations at the official meeting in Tsukuba. Moreover WHO/WPRO intends to standardize (1) Oriental Medical Terminology, (2) Oriental Medical Information, (3) Guidelines for research of Acupuncture and Moxibustion, and general thoughts, points of view, and an outline of Oriental Medicine. Then WHO hopes to encourage application of these standards to research and practice of Oriental Medicine.
4. The themes after deciding the Acupuncture Point Locations
Subjects for further discussion include: (1) Research on acupuncture point locations, (2). Encouraging the use of Standardized locations, (3). Clarifying “Japanese Acupuncture” and its supporting its use all over the world, etc.