The author reviews and comments on the present state of safety evaluation and efficacy of functional foods in Japan: Dietary experience has been of great importance in food safety; however, when doses/concentrations of functional foods or their components considerably exceed levels in ordinary foods, safety can no longer be guaranteed. In the author’s view, such products thus need to be treated like drugs. In addition, when researching the efficacy of functional foods, randomized controlled trials are key, and findings obtained from observational epidemiology should also be taken into account.

Introduction
 On 8 March 2009, the Workshop on Infectious Diseases Control Programmes and Health System Strengthening (HSS) was conducted in the 24th East Japan Regional Conference of the Japan Association for International Health. This article reports the discussion in the Workshop and the internet-based open forum that followed.
Method
  After four presentations reflecting on the field-based experiences regarding the relation between disease-specific programmes and HSS, following three aspects were discussed: 1) health system-wide barriers perceived through the implementation of disease-specific programmes; 2) shortcomings of the disease-specific initiatives in light of the HSS; and 3) how the disease-specific initiatives can contribute to the HSS.
Results
 As the system-wide barriers, insufficient quantity and quality of health human resources, lack of health infrastructure and material resources and limitation of the technology applicable to community level of developing countries were commonly perceived. Shortfall of disease-specific programmes in light of the HSS included the lacked coordination between different programmes and donors, duplicated heavy workload put on community health workers especially in recording and reporting, dissociation between local health needs and programme priorities, lack of contributions to strengthening mid-level health administration, deviation of resources to the priority programmes and lack of sharing of potentially sharable material resources. It was proposed that the disease-specific initiatives should contribute to resource mobilization, programme management models, capacity building of mid-level health administration, supplementing personnel cost and presenting hardware and software outcome resources to the HSS.
Conclusions
 The disease-specific initiatives need to pursue the above mentioned practical contributions to the HSS. At the same time, a wider scope addressing political and policy-wise justifications of the form of the overall health system needs to be further discussed with developing countries stakeholders.

A 69-year-old woman had dysphagia, hoarseness, and asthma-like symptoms such as cough and wheeze. Inhaled corticosteroids and long-acting β₂ stimulants was not effective. Gastrointestinal endoscopy showed compression of the esophagus wall from outside. Enhanced computed tomography (CT) showed thoracic descending aortic aneurysm compressing esophagus and left lower lobe bronchus. Immediately thoracic endovascular aortic repair (TEVAR) was performed. After surgery, significant improvement of hoarseness and asthma-like attack was obtained at the time of 1 month after surgery. This is the first reported case of TEVAR which improved compression symptoms of both esophagus and bronchus due to thoracic aortic aneurysm in Japan.

Osaka City has the highest tuberculosis (TB) notification rates in Japan. In the period 1999–2003, the TB control programme was strengthened, and the Stop TB Strategy was implemented to reduce the number of notified cases. The objective of this study was to assess the effect of these control activities in Osaka City, including the implementation of directly observed treatment (DOT), by analysing TB surveillance and routinely collected data. We reviewed the surveillance data of all sputum smear-positive pulmonary tuberculosis (PTB) cases registered in the Osaka City Public Health Office from 2001 to 2008 and data collected from the routine TB programme. The DOT implementation rate increased from 0% in 2001 to 68% in 2008 for smear-positive PTB cases of the general public and to 61% for all PTB cases of the homeless. The proportion of smear-positive PTB cases that had treatment failure and default combined, declined from 8.0% (52 of 650) in 2001 to 3.6% (20 of 548) in 2006. The proportion of cases among the homeless with previous treatment declined from 28% in 2001 to 15% in 2008. The proportion of cases with multidrug resistant-TB (MDR-TB) among those without previous treatment declined from 1.7% in 2001 to 0.9% in 2008. It is logical that reduction in the failure and default rate would lead to the reduction of cases with previous treatment and TB transmission, including resistant TB, therefore to the reduction of MDR-TB rates.

We developed three e-learning systems for endoscopists to acquire the necessary skills to improve the diagnosis of early gastric cancer (EGC) and demonstrated their usefulness using randomized controlled trials. The subjects of the three e-learning systems were “detec­tion”, “characterization”, and “preoperative assessment”. The contents of each e-learning system included “technique”, “knowledge”, and “obtaining experience”. All e-learning systems proved useful for endoscopists to learn how to diagnose EGC. Lecture videos describing “the technique” and “the knowledge” can be beneficial. In addition, repeating 100 self-study cases allows learners to gain “experience” and improve their diagnostic skills further. Web-based e-learning systems have more advantages than other teaching methods because the number of participants is unlimited. Histopathological diagnosis is the gold standard for the diagnosis of gastric cancer. Therefore, we developed a comprehensive diagnostic algorithm to standardize the histopathological diagnosis of gastric cancer. Once we have successfully shown that this algorithm is helpful for the accurate histopathological diagnosis of cancer, we will complete a series of e-learning systems designed to assess EGC accurately.

Background/Aims: Nutritional factors associated with gastric cancer (GC) are not completely understood. We aimed to determine the effect of nutrient intake on the incidence of GC. Methods: This was a post hoc analysis of a prospective trial that evaluated modalities for GC screening in participants aged 30 to 74 years living in high-risk areas for GC in Japan between June 2011 and March 2013. The patients were followed up for GC incidence for 6 years. All participants completed a self-administered food frequency questionnaire (FFQ) upon enrollment before GC screening. Daily nutrient intake was calculated from the FFQ and dichotomized at each cutoff value using receiver operating characteristic analysis. Risk factors associated with GC incidence were investigated in terms of nutrient intake and participant characteristics using Cox proportional hazards regression analysis. Results: Overall, 1,147 participants were included in this analysis. The median age was 62 years, and 50.7% of the participants were men. The median follow-up period was 2,184 days.GC was detected in 25 participants during the follow-up. Multivariate Cox proportional hazards regression analysis revealed that the intake of sodium (adjusted hazards ratio [aHR], 3.905; 95% confidence interval [CI], 1.520 to 10.035; p=0.005) and vitamin D (aHR, 2.747; 95% CI, 1.111 to 6.788, p=0.029) were positively associated with GC incidence, whereas the intake of soluble dietary fiber (aHR, 0.104; 95% CI, 0.012 to 0.905; p=0.040) was inversely associated with GC incidence. Conclusions Daily high intake of sodium and vitamin D and low soluble dietary fiber intake are associated with GC incidence.

Background/Aims: Since the usefulness of neoadjuvant chemo(radiation) therapy (NAT) for pancreatic cancer has been demonstrated, recurrent biliary obstruction (RBO) in patients with pancreatic cancer with a fully covered self-expandable metal stent (FCSEMS) during NAT is expected to increase. This study investigated the impact of sarcopenia on RBO in this setting. Methods: Patients were divided into normal and low skeletal muscle index (SMI) groups and retrospectively analyzed. Patient characteristics, overall survival, time to RBO (TRBO), stent-related adverse events, and postoperative complications were compared between the two groups. A Cox proportional hazard model was used to identify the risk factors for short TRBO. Results: A few significant differences were observed in patient characteristics, overall survival, stent-related adverse events, and postoperative complications between 38 patients in the normal SMI group and 17 in the low SMI group. The median TRBO was not reached in the normal SMI group and was 112 days in the low SMI group (p=0.004). In multivariate analysis, low SMI was the only risk factor for short TRBO, with a hazard ratio of 5.707 (95% confidence interval, 1.148–28.381; p=0.033). Conclusions Sarcopenia was identified as an independent risk factor for RBO in patients with pancreatic cancer with FCSEMS during NAT.

Objectives: This review aims to introduce preoperative scoring systems to predict lymph node metastasis (LNM) and ongoing clinical trials to investigate the therapeutic role of lymphadenectomy for endometrial cancer. Methods: We summarized previous reports on the preoperative prediction models for LNM and evaluated their validity to omit lymphadenectomy in our recent cohorts. Next, we compared characteristics of two ongoing lymphadenectomy trials (JCOG1412, ECLAT) to examine the survival benefit of lymphadenectomy in endometrial cancer, and described the details of JCOG1412. Results: Lymphadenectomy has been omitted for 64 endometrial cancer patients who met lowrisk criteria to omit lymphadenectomy using our scoring system (LNM score) and no lymphatic failure has been observed. Other two models also produced comparable results. Two randomized phase III trials to evaluate survival benefit of lymphadenectomy are ongoing for endometrial cancer. JCOG1412 compares pelvic lymphadenectomy alone with pelvic and para-aortic lymphadenectomy to evaluate the therapeutic role of para-aortic lymphadenectomy for patients at risk of LNM. For quality assurance of lymphadenectomy, we defined several regulations, including lower limit of the number of resected nodes, and submission of photos of dissected area to evaluate thoroughness of lymphadenectomy in the protocol. The latest monitoring report showed that the quality of lymphadenectomy has been well-controlled in JCOG1412. Conclusion Our strategy seems reasonable to omit lymphadenectomy and could be generalized in clinical practice. JCOG1412 is a high-quality lymphadenectomy trial in terms of the quality of surgical procedures, which would draw the bona-fide conclusions regarding the therapeutic role of lymphadenectomy for endometrial cancer.

OBJECTIVESWith greater concern for efficient resource allocation and profiling of medical care, a case-mix classification was applied for the per-diem payment system in Japan. Many questions remain, one of which is the role of comorbidity and complication (CC) in grouping logic. We examined the association of the number of CC with the length of hospital stay (LOS) and hospital mortality as well as the proportion of LOS high outliers in 19 major diagnostic categories (MDCs).

METHODSThis study was a secondary data analysis embedded in a government research project, including anonymous claims and clinical data during a 4-month period from July 2002. Every 19 MDC, LOS, hospital mortality or proportion of LOS high outliers was compared by the number of CC and presence of any procedures.

RESULTSFrom 82 special function hospitals, 241,268 patients were enrolled in this study. Among all patients, 50.5% were identified without any CCs, 32.4% with one or two, 13.4% with three or four, and 3.7% with over five CCs. The overall mean LOS was 22.15 days and hospital mortality 26.05 cases per 1,000 admissions. In any MDC, LOS and the proportion of outliers increased as the number of CC rose. The mortality rate increased prominently in the respiratory system and the hematology system.

CONCLUSIONSThis study demonstrated that the occurrence of more CC caused longer LOS and higher mortality in some major disease categories. Further study will clarify the association of the weighted CC with resource use through controlling procedures specific for MDC.

PURPOSE: Pain from osteoarthritis (OA) is generally classified as nociceptive (inflammatory). Animal models of knee OA have shown that sensory nerve fibers innervating the knee are significantly damaged with destruction of subchondral bone junction, and induce neuropathic pain (NP). Our objective was to examine NP in the knees of OA patients using painDETECT (an NP questionnaire) and to evaluate the relationship between NP, pain intensity, and stage of OA. MATERIALS AND METHODS: Ninety-two knee OA patients were evaluated in this study. Pain scores using Visual Analogue Scales (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), painDETECT, duration of symptoms, severity of OA using the Kellgren-Lawrence (KL) system, and amount of joint fluid were evaluated and compared using a Spearman's correlation coefficient by rank test. RESULTS: Our study identified at least 5.4% of our knee OA patients as likely to have NP and 15.2% as possibly having NP. The painDETECT score was significantly correlated with the VAS and WOMAC pain severity. Compared with the painDETECT score, there was a tendency for positive correlation with the KL grade, and tendency for negative correlation with the existence and amount of joint fluid, but these correlations were not significant. CONCLUSION: PainDETECT scores classified 5.4% of pain from knee OA as NP. NP tended to be seen in patients with less joint fluid and increased KL grade, both of which corresponded to late stages of OA. It is important to consider the existence of NP in the treatment of knee OA pain.
Aged ; Aged, 80 and over ; Female ; Humans ; Knee/pathology/physiopathology ; Male ; Middle Aged ; Neuralgia/*physiopathology ; Osteoarthritis, Knee/*physiopathology