Impact of a Mindfulness Mobile Application on Weight Loss and Eating Behavior in People with Metabolic Syndrome: a Pilot Randomized Controlled Trial.

BACKGROUND: Weight-loss approaches involving mindfulness have been reported to reduce overeating behavior. We conducted a preliminary evaluation of the feasibility and effectiveness of a mindfulness mobile application (MMA) combined with a comprehensive lifestyle intervention (CLI) focused on weight loss and eating behaviors for people with metabolic syndrome based on post-intervention follow-up data. METHOD: Participants were randomly assigned (1:1) to a CLI group or a CLI + MMA group. Participants received weekly CLI for 13 weeks, followed by telephone counseling for 13 weeks. The CLI + MMA group also had access to the MMA. Feasibility was assessed by the number of people who refused to participate, rate of adherence to the MMA, follow-up rate, and participant satisfaction. The preliminary endpoint was weight change (at 26 weeks). Participants completed the Dutch Eating Behavior Questionnaire (DEBQ). A mixed linear model was used for efficacy analysis. RESULTS: Eight of the 40 participants declined to participate. The MMA was used 4.4 ± 1.7 days per week, but the rate of adherence declined over time. The follow-up rate was 100%, and there was no difference in participant satisfaction between the groups. There was no significant group-by-time interaction for weight loss (p = 0.924), but there was a significant interaction for the DEBQ restrained eating score (p = 0.033). CONCLUSIONS: This study found that CLI plus MMA was highly feasible and moderately acceptable. There were no significant differences in weight loss between the groups, but the CLI + MMA group showed an increase in restrained eating. Further large-scale studies are needed. TRIAL REGISTRATION: Japanese University Hospital Medical Information Network (UMIN-ICDR). Clinical Trial identifier number UMIN000042626.

Effect of physician attire on patient perceptions of empathy in Japan: a quasi-randomized controlled trial in primary care.

BACKGROUND: There is limited quantitative research on the effect of physician attire on patient-physician relationships. This study aimed to measure the influence of Japanese family physicians' attire on the "human" aspects of medical care in terms of patient-perceived relational empathy. METHODS: This was a multicenter, prospective, controlled trial conducted in primary clinics in Japan. We explored the effects of family physician attire (white coat vs. casual attire) on patient-perceived empathy. Family physicians were allocated to alternate weeks of wearing a white coat or casual attire during consultations. Patients' perceptions of physician empathy were evaluated using the self-rated Japanese Consultation and Relational Empathy (CARE) Measure. We used a linear mixed model to analyze the CARE Measure scores, adjusting for cluster effects of patients nested within doctor, age, and sex of patients, and doctors' sex and years of clinical experience. We used the same method with Bonferroni adjustment to analyze patient sex differences in perceived empathy. RESULTS: A total of 632 patients of seven family physicians were allocated to white coat-wearing consultations (n = 328), and casual attire-wearing consultations (n = 304). There was no difference in CARE Measure scores between white coat and casual primary care consultations overall (p = 0.162). Subgroup analysis of patient sex showed that CARE Measure scores of male patients were significantly higher in the Casual group than in the White coat group (adjusted p-value = 0.044). There was no difference in female patient scores between White coat and Casual groups (adjusted p-value = 1.000). CONCLUSIONS: This study demonstrated that physician attire (white coat or casual attire) in a primary care setting did not affect patient-perceived relational empathy overall. However, male patients of physicians wearing casual attire reported higher physician empathy. Although empathy cannot be reduced to simple variables such as attire, white coats may have a negative effect on patients, depending on the context. Family physicians should choose their attire carefully. TRIAL REGISTRATION: Japanese University Hospital Medical Information Network (UMIN-ICDR). Clinical Trial identifier number UMIN000037687 (Registered August 14, 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042749 ). The study was prospectively registered.

Skills acquisition for novice learners after a point-of-care ultrasound course: does clinical rank matter?

BACKGROUND: Few studies have compared the effectiveness of brief training courses on point-of-care ultrasound (POCUS) skill acquisition of novice attending physicians vs. trainees. The purpose of this study was to evaluate the change in POCUS image interpretation skills and confidence of novice attending physicians vs. trainees after a 1-day POCUS training course. METHODS: A 1-day POCUS training course was held in March 2017 in Japan. A standardized training curriculum was developed that included online education, live lectures, and hands-on training. The pre-course assessment tools included a written examination to evaluate baseline knowledge and image interpretation skills, and a physician survey to assess confidence in performing specific ultrasound applications. The same assessment tools were administered post-course, along with a course evaluation. All learners were novices and were categorized as trainees or attending physicians. Data were analyzed using two-way analysis of variance. RESULTS: In total, 60 learners attended the course, and 51 learners (85%) completed all tests and surveys. The 51 novice learners included 29 trainees (4 medical students, 9 PGY 1-2 residents, 16 PGY 3-5 residents) and 22 attending physicians (6 PGY 6-10 physicians, and 16 physicians PGY 11 and higher). The mean pre- and post-course test scores of novice trainees improved from 65.5 to 83.9% while novice attending physicians improved from 66.7 to 81.5% (p < 0.001). The post-course physician confidence scores in using ultrasound significantly increased in all skill categories for both groups. Both trainees and attending physicians demonstrated similar improvement in their post-course test scores and confidence with no statistically significant differences between the groups. The course evaluation scores for overall satisfaction and satisfaction with faculty members' teaching skills were 4.5 and 4.6 on a 5-point scale, respectively. CONCLUSIONS: Both novice trainees and attending physicians showed similar improvement in point-of-care ultrasound image interpretation skills and confidence after a brief training course. Although separate training courses have traditionally been developed for attending physicians and trainees, novice learners of point-of-care ultrasound may acquire skills at similar rates, regardless of their ranking as an attending physician or trainee. Future studies are needed to compare the effectiveness of short training courses on image acquisition skills and determine the ideal course design.

Reliability and acceptability of six station multiple mini-interviews: past-behavioural versus situational questions in postgraduate medical admission.

BACKGROUND: The multiple mini-interview (MMI) is increasingly used for postgraduate medical admissions and in undergraduate settings. MMIs use mostly Situational Questions (SQs) rather than Past-Behavioural Questions (PBQs). A previous study of MMIs in this setting, where PBQs and SQs were asked in the same order, reported that the reliability of PBQs was non-inferior to SQs and that SQs were more acceptable to candidates. The order in which the questions are asked may affect reliability and acceptability of an MMI. This study investigated the reliability of an MMI using both PBQs and SQs, minimising question order bias. Acceptability of PBQs and SQs was also assessed. METHODS: Forty candidates applying for a postgraduate medical admission for 2016-2017 were included; 24 examiners were used. The MMI consisted of six stations with one examiner per station; a PBQ and a SQ were asked at every station, and the order of questions was alternated between stations. Reliability was analysed for scores obtained for PBQs or SQs separately, and for both questions. A post-MMI survey was used to assess the acceptability of PBQs and SQs. RESULTS: The generalisability (G) coefficients for PBQs only, SQs only, and both questions were 0.87, 0.96, and 0.80, respectively. Decision studies suggested that a four-station MMI would also be sufficiently reliable (G-coefficients 0.82 and 0.94 for PBQs and SQs, respectively). In total, 83% of participants were satisfied with the MMI. In terms of face validity, PBQs were more acceptable than SQs for candidates (p = 0.01), but equally acceptable for examiners (88% vs. 83% positive responses for PBQs vs. SQs; p = 0.377). Candidates preferred PBQs to SQs when asked to choose one, though this difference was not significant (p = 0.081); examiners showed a clear preference for PBQs (p = 0.007). CONCLUSIONS: Reliability and acceptability of six-station MMI were good among 40 postgraduate candidates; modelling suggested that four stations would also be reliable. SQs were more reliable than PBQs. Candidates found PBQs more acceptable than SQs and examiners preferred PBQs when they had to choose between the two. Our findings suggest that it is better to ask both PBQs and SQs during an MMI to maximise acceptability.

Validity and reliability of the Japanese version of the CARE measure in a general medicine outpatient setting.

BACKGROUND: Empathy is an important attribute in medicine, influencing both the process and outcome of consultations. However, there are no validated tools available in Japan to gather patient feedback on physicians' empathy. The Consultation and Relational Empathy (CARE) Measure developed in the UK is widely used internationally. OBJECTIVES: To investigate the psychometric properties of a Japanese version of the CARE Measure. METHOD: Following two cycles of translation and back translation, the Japanese CARE Measure was completed by 317 patients in a primary medical care clinic in Japan. Tests of internal reliability and validity included Cronbach's alpha, item-total correlations and factor analysis. Predicted associations between CARE Measure score and other variables were assessed by Spearman's rho. RESULTS: Low numbers of missing values (8.2-9.8%) and 'not applicable' responses (0-1.3%) suggested high acceptability and face validity of the Japanese CARE Measure. Internal reliability was high (Cronbach's alpha 0.984) and was reduced by the removal of any of 10 items. High corrected item-total correlations (0.897-0.946) suggested homogeneity. Factor analysis showed a single solution with high item loadings (0.917-0.957). Construct validity was supported by a significant relationship (Spearman's rho 0.74, P < 0.001) with overall satisfaction with the consultation. CONCLUSION: The Japanese CARE Measure appears to be valid and reliable in a primary medical care setting. Further work is required to determine its ability to discriminate between doctors.

Limbic encephalitis associated with relapsing polychondritis responded to infliximab and maintained its condition without recurrence after discontinuation: a case report and review of the literature.

Central nervous system (CNS) manifestations are rare complications of relapsing polychondritis (RP). The majority of patients respond well to glucocorticoid therapy, but need to maintain it. Some patients are refractory to initial glucocorticoid therapy and to additional immunosuppressants, and end up with an outcome worse than at therapy initiation. The standardized therapeutic protocol for this condition has not been established. The effects of anti-tumor necrosis factor (TNF) -α agents have been reported recently. We experienced a patient with RP and limbic encephalitis who was refractory to initial high-dose glucocorticoid, but subsequently responded to infliximab and did not show deterioration of signs and symptoms after stopping therapy. We report this case together with a systematic literature review. This is the first case report of RP with CNS manifestations successfully treated by an anti-TNF-α agent without recurrence after discontinuation.

Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment.

BACKGROUND: Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach.The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. METHODS: For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. RESULTS: Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics between the study arms. CONCLUSION: We have launched J-DOIT1, a nation-wide trial to prevent the development of T2DM in high-risk individuals using telephone-delivered intervention. This trial is expected to contribute to evidence-based real-world preventive practices. TRIAL REGISTRATION: UMIN000000662.

Selective IgA deficiency mimicking Churg-Strauss syndrome and hypereosinophilic syndrome: a case report.

Selective IgA deficiency (SIgAD) is the most common type of primary immunoglobulin deficiency. Most individuals with SIgAD are asymptomatic. However, some patients are associated with allergic and autoimmune disease. SIgAD is included in the list of differential diagnoses of eosinophilia. We experienced a patient who initially presented with abdominal pain and eosinophilia. A >1-year follow-up revealed SIgAD, and we had difficulty differentiating it from Churg-Strauss syndrome (CSS) or hypereosinophilic syndrome (HES). A 66-year-old Japanese male presented with a history of recurrent abdominal pain. A diagnostic work-up revealed eosinophilia, eosinophilic gastritis, eosinophilic pneumonia, and SIgAD over 1 year of clinical observation. He also suffered from asthma and sinusitis. Anti-neutrophil cytoplasmic antibody was negative and vasculitis was not detected in the obtained tissue specimens of stomach, lung, nose and skin. The patient showed no evidence of drug ingestion, parasitic infections, or malignant neoplasms. Although we cannot rule out prevasculitic CSS and idiopathic HES, the whole clinical picture in this patient can be explained most consistently by SIgAD.

Strongyloidiasis presenting during treatment of low-dose glucocorticoid plus rituximab for anti-signal recognition particle antibody-positive polymyositis: A case report.

Strongyloidiasis, an intestinal parasitic infection caused by Strongyloides stercoralis, rarely occurs in Japan. When treated with immunosuppressive drugs, two potentially lethal conditions, hyperinfection and dissemination, may develop in asymptomatic carriers of this parasite. We report the development of strongyloidiasis during treatment of polymyositis with glucocorticoids plus rituximab (RTX). A 44-year-old woman had been diagnosed with anti-signal recognition particle antibody-positive polymyositis with interstitial pneumonia 6 years previously, for which she had recently been receiving prednisolone at 5 mg/day and RTX at 375 mg/m2 twice every 3 months. Her condition appeared to be well controlled. She was admitted to our hospital with a 1-month history of chronic diarrhoea and epigastric pain. Standard microscopic examination of a sample of faeces revealed the presence of S. stercoralis; however, serologic testing for parasites was negative. Treatment with ivermectin alleviated her inflammatory diarrhoea and eradicated the faecal parasites. We believe that our patient had an exacerbation of S. stercoralis infection (hyperinfection syndrome) that was exacerbated by low-dose glucocorticoids plus RTX. Strongyloidiasis should be considered in immunocompromised individuals with unexplained diarrhoea, even in non-endemic areas.

A case of Erdheim-Chester disease with the BRAF V600E mutation diagnosed via endoscopic sinus surgery.

Erdheim-Chester disease is characterized by the infiltration of foamy histiocytes in tissues. Lesional tissue biopsy is recommended to confirm diagnosis and establish the BRAF mutational status. A 52-year-old man presented to our hospital with hydronephrosis. Computed tomography showed enhancement of soft shadows around the left renal pelvis transition area and the aorta. He was treated with prednisolone 0.2 mg/kg for 1 year; however, no improvement was observed. 18Fluorodeoxyglucose-positron emission tomography/computed tomography revealed increased fluorodeoxyglucose uptake in various body parts, including the maxillary sinuses, indicative of Erdheim-Chester disease. He refused further examination, and the maxillary sinus lesions were treated with antibiotics and intranasal steroids, but no improvement was observed. Two years later, he underwent biopsy with endoscopic sinus surgery of the maxillary sinus, which showed the highest increase in fluorodeoxyglucose uptake on repeat 18fluorodeoxyglucose-positron emission tomography/computed tomography. Endoscopic findings showed only nonspecific inflammatory findings, but pathological findings revealed the proliferation of cells with abundant foamy cytoplasms. Sufficient tumor volume was available to perform PCR for BRAF V600E mutation analysis, which was positive and resulted in a diagnosis of Erdheim-Chester disease with the BRAF V600E mutation. This is the first case of a patient with Erdheim-Chester disease with the BRAF V600E mutation identified in a sinus lesion. Endoscopic sinus surgery biopsy of the paranasal sinuses was considered to contribute to the histological and genetic diagnosis of Erdheim-Chester disease, particularly following the notable increase in fluorodeoxyglucose uptake.

＜Editors' Choice＞ Myelodysplastic syndrome with trisomy 8 presenting periodic fever and multiple MEFV gene variants outside exon 10: a case report.

Myelodysplastic syndrome is associated with the development of autoinflammatory conditions, such as recurrent fever, polymyalgia, arthralgia, and erythema. Trisomy 8 is a common chromosomal abnormality in patients with myelodysplastic syndrome. Myelodysplastic syndrome with trisomy 8 involves autoinflammatory conditions, especially Behçet's disease-like symptoms with intestinal mucosal damage. MEFV variants, particularly those in exon 10, are pathogenic in familial Mediterranean fever, the most common autoinflammatory disease, presenting typical symptoms such as periodic fever and pleuritis/pericarditis/peritonitis. MEFV variants outside exon 10 are common in Japanese patients with familial Mediterranean fever and are associated with atypical symptoms, including myalgia and erythema. MEFV variants in myelodysplastic syndrome with trisomy 8 have rarely been investigated, although myelodysplastic syndrome with trisomy 8 might develop autoinflammatory conditions similar to those in familial Mediterranean fever. We encountered a 67-year-old man who had myelodysplastic syndrome with trisomy 8 and multiple MEFV variants outside exon 10. He presented with periodic fever, as well as chest/abdominal pain, myalgia, and erythema, although the symptoms did not fulfill the diagnostic criteria of familial Mediterranean fever. We discussed the possibility that these symptoms are modified by MEFV variants outside exon 10 in myelodysplastic syndrome with trisomy 8.

Prevention of type 2 diabetes in a primary healthcare setting: three-year results of lifestyle intervention in Japanese subjects with impaired glucose tolerance.

BACKGROUND: A randomized control trial was performed to test whether a lifestyle intervention program, carried out in a primary healthcare setting using existing resources, can reduce the incidence of type 2 diabetes in Japanese with impaired glucose tolerance (IGT). The results of 3 years' intervention are summarized. METHODS: Through health checkups in communities and workplaces, 304 middle-aged IGT subjects with a mean body mass index (BMI) of 24.5 kg/m2 were recruited and randomized to the intervention group or control group. The lifestyle intervention was carried out for 3 years by public health nurses using the curriculum and educational materials provided by the study group. RESULTS: After 1 year, the intervention had significantly improved body weight (-1.5 ± 0.7 vs. -0.7 ± 2.5 kg in the control; p = 0.023) and daily non-exercise leisure time energy expenditure (25 ± 113 vs. -3 ± 98 kcal; p = 0.045). Insulin sensitivity assessed by the Matsuda index was improved by the intervention during the 3 years. The 3-year cumulative incidence tended to be lower in the intervention group (14.8% vs.8.2%, log-rank test: p = 0.097). In a sub-analysis for the subjects with a BMI > 22.5 kg/m2, a significant reduction in the cumulative incidence was found (p = 0.027). CONCLUSIONS: The present lifestyle intervention program using existing healthcare resources is beneficial in preventing diabetes in Japanese with IGT. This has important implications for primary healthcare-based diabetes prevention. TRIAL REGISTRATION NUMBER: UMIN000003136.

Clinical characteristics of Corynebacterium simulans.

Corynebacterium simulans was first reported in 2000. Its characteristics such as isolation frequency, specimen types, and antimicrobial susceptibilities are poorly understood, because identification is difficult using conventional methods. We performed a retrospective observational study of 13 and 317 strains of C. simulans and C. striatum, respectively, isolated from consecutive patients at Nagoya University Hospital from January 2017 to December 2018. We analyzed patients' backgrounds, types of specimens, and antimicrobial susceptibilities. Antimicrobial susceptibilities were compared with those of C. striatum. The frequencies of isolation of C. simulans and C. striatum were 3.9% and 96%, respectively. C. simulans was not detected in specimens associated with mucous membranes, such as sputum and secretions from the craniocervical region, which were frequent for C. striatum. C. simulans was mainly detected in the skin (61.5%). All C. simulans isolates were susceptible to anti-MRSA drugs, as well as to numerous other antibiotics, including those that are orally administered. For example, C. simulans was significantly more susceptible to penicillin G, ceftriaxone, and ciprofloxacin than C. striatum (respective susceptibilities: 66.7% vs 5.4%, 50.0% vs 4.0%, 66.7% vs 5.9%). There was no significant difference between meropenem and erythromycin, although susceptibility to each was relatively high (100.0% vs 31.7%, 50.0% vs 11.9%). C. simulans was susceptible to numerous orally administered antibiotics and more susceptible to antimicrobial drugs than C. striatum. C. simulans was detected less frequently than C. striatum and was infrequently detected in specimens associated with mucous membranes. These characteristics will aid the selection of optimal antimicrobial therapies.

Family Issues in Japanese Clinics: Concordance between Patients' and Physicians' Views.

INTRODUCTION: The objectives of the present study were to clarify the frequency and content of family issues for patients in Japanese clinics, and the concordance between physicians' and patients' views of family issues. METHODS: In this study, we used a cross-sectional design with a questionnaire survey. Participants were outpatients and their physicians in charge (four family physicians) at four Japanese clinics. The main body of research was conducted between April 5 and May 15, 2004. After obtaining oral informed consent, the physician in charge distributed questionnaires to participating patients to complete at home. The questionnaire comprised three items: 1) Do you have any worries about your family? 2) Are you comfortable consulting a physician regarding your family issue?, and 3) If possible, could you tell us why you feel like that?Participants provided written informed consent and answered the questionnaire before sealing it in an envelope and posting it back to the research center. Physicians in charge completed their version of the questionnaire and independently sent the data to the center. RESULTS: Of the 272 participating patients, 118 (45.6%) had family issues. "Health problems with family members" (28%) and "family life cycle issues" (19.5%) were the main content of these issues. Physicians indicated that 45.7% of patients had family issues. The rate of concordance between physicians' and patients' perspectives regarding family issues was 46.6%. CONCLUSIONS: Family issues can therefore be regarded as a common health problem due to the frequency. There was some inconsistency between physicians' and patients' views, but much of this discrepancy may be resolved by developing the specialty of family practice.

A combination of herbal formulas, acupuncture, and novel pine-needle stimulation for recurrent alopecia areata: A case report.

INTRODUCTION: Head hair is a symbol of vitality, and hair loss by alopecia areata (AA) presents a burden on patients. Although traditional Japanese Kampo medicine (JKM) formulas, acupuncture, and moxibustion have historically been used for treating AA, no studies have utilized a combination of these modalities. PATIENT CONCERNS: A 34-year-old male with a history of childhood asthma presented with a sudden hair loss at the top of his head without any preceding symptoms. Except for a hairless patch of 5 cm × 6 cm, his general appearance was otherwise good. The patient underwent topical immunotherapy on visiting a dermatologist. However, the patient noticed an exacerbation of his hairless lesion. DIAGNOSIS: The AA diagnosis was established based on clinical appearance and dermatological findings. The Severity of Alopecia Tool (SALT) score for alopecia was 19% at diagnosis. INTERVENTIONS: The patient received 2 JKM formulas (saikokaryukotsuboreito and shichimotsukokato) in combination with acupuncture. When relapse occurred, a novel self-administration of pine-needle acupuncture was initiated in combination with the JKM formulas. OUTCOMES: A 50% recovery from the baseline SALT score was achieved using JKM formulas in combination with acupuncture for 4 months. The patient achieved complete remission for 5 months. However, another stressful event induced an AA relapse with multiple lesions harboring a SALT score of 13%. Pine-needle acupuncture was initiated, resulting in faster resolution than the first treatment. Recoveries of 50% and 75% were achieved 3 and 4 months after relapse, respectively, and a long-lasting response without relapse was obtained for at least 3 years. CONCLUSION: A combination of multimodal traditional therapies, including JKM formulas, acupuncture, and self-administered pine-needle stimulation, represents an effective integrative treatment for patients with AA.

Impact of telephone support programme using telemonitoring on stage of change towards healthy eating and active exercise in people with prediabetes.

INTRODUCTION: This study evaluated the impact of a telephone support programme with telemonitoring on changes in healthy eating and active exercise in adults with prediabetes using the stage of change framework. METHODS: We performed a post hoc analysis using data from the Japan Diabetes Outcome Trial-1. A total of 2607 participants aged 20-65 years with impaired fasting glucose were recruited from the workplace/community in Japan and randomized to a one year telephone support programme intervention arm (n = 1240) or self-directed control arm (n = 1367). Participants in both arms received monthly data feedback from a weight scale and pedometer. The main outcome measure was the stages of change toward healthy eating and active exercise. The secondary outcome was fasting plasma glucose (FPG). RESULTS: After the one year intervention, the adjusted odds ratio of progressing to the action/maintenance stage in the intervention vs. control arm for healthy eating was 1.31 (95% confidence interval (CI) 1.21-1.43; p < 0.001), but that for active exercise was 1.07 (95% CI 0.99-1.15; p = 0.062). The intervention decreased FPG levels in participants in the contemplation stage, but not in the precontemplation, preparation and action/maintenance stages. DISCUSSION: These findings suggest that the telephone support programme by healthcare providers advanced the stage of changes toward healthy eating in people with prediabetes. In particular, it decreased FPG levels in the contemplation stage.

A structured summary of a study protocol for a multi-center, randomized controlled trial (RCT) of COVID-19 prevention with Kampo medicines (Integrative Management in Japan for Epidemic Disease by prophylactic study: IMJEDI P1 study).

OBJECTIVE: We aimed to test our hypothesis that traditional Japanese (Kampo) medicine, hochuekkito (Hochu-ekki-to: HET) has a preventive effect for the symptoms on COVID-19. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator sponsored, two-arm study. PARTICIPANTS: Six thousand participants will be recruited from healthy hospital workers in 7 Japanese University Hospitals. INCLUSION CRITERIA: 1. Age from 20 to 75 years old at the time of registration 2. Asymptomatic and body temperature below 37°C at the time of registration 3. Capable of eating orally Exclusion criteria: 1. Previous upper respiratory inflammation due to viral infection (including suspected COVID-19) 2. Taking immunosuppressants 3. Allergic to the Kampo medicines used in this study 4. History of hypokalaemia, severe hypertension, severe liver dysfunction, and interstitial pneumonia 5. Regularly taking other Kampo medicines 6. Pregnant or possibly pregnant 7. Participating in other research 8. Judged to be unsuitable for this study by the doctor in charge INTERVENTION AND COMPARATOR: Kampo group: participants receive HET in 9 tablets 2 times per day for 8 weeks. CONTROL GROUP: participants receive placebo in the same dosage as the Intervention group - 9 tablets 2 times per day for 8 weeks. Placebo tablets are identical in appearance and package to HET. Taste of placebo is different from that of HET. The Ohsugi Pharmaceutical Co. Ltd, Osaka, Japan manufactured the placebo and HET. MAIN OUTCOMES: Primary outcome: Number of patients with a SARS-CoV-2 RNA by ploymerase chain reaction (PCR) positive result with at least one symptom (fever, cough, sputum, malaise, shortness of breath) during the 12-week study period (including the 4-week observation period after oral administration). SECONDARY OUTCOMES: 1. Period from infection to onset 2. Period from the appearance of symptoms to the disappearance of PCR positive 3. Number of days until the appearance or improvement of symptoms 4. Severe stage: presence of hospitalization 5. Shock stage: ICU management required for mechanical ventilation, shock vitals or failure of organ(s) other than lungs Safety endpoints include numbness in the hands and/or feet, edema, skin rash or other allergic symptoms, and gastric discomfort. RANDOMISATION: Patients are randomized (1:1 ratio) to each group using minimization implemented with the Electric data capture system (DATATRAK Enterprise Cloud), with balancing of the arms with age range (under 50 years of age or not) and having a history of risk factors for COVID-19 (cardiovascular disease, hypertension, diabetes, respiratory diseases). BLINDING (MASKING): Only participants will be randomized. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The main research hypothesis of this study is that Kampo medicines significantly prevent the onset of COVID-19. It is assumed that the infection rate before the administration of the drug under consideration will be 0% and that the incidence of COVID-19 thereafter will be 2- 3%, of which 70%-80% will show symptoms of COVID-19. Assuming that the pharmaceutical effect of the drug will be effective in 50% of patients and that the incidence rates in the placebo and drug groups will be 1.4%-2.4% and 0.7%-1.2%, respectively, the placebo is calculated at 2%, and the study drug at 1%. Since the frequency of verification is low and the number of cases will be large, we set a total of 10 analyses (9 interim analyses and a final analysis). Since the number of cases at the time of the final analysis will be 4,986 under the conditions of α = 0.05 and a power of 80% by the Peto method. We set at 600 cases in each interim analysis with an estimated dropout rate of 16.9%. Finally, the total number of cases is set to 6,000 with 3,000 in the placebo group and 3,000 in the HET group. TRIAL STATUS: Protocol version 1.3 of October 23rd , 2020. Recruitment start (expected): December 1st, 2020. Recruitment finish (expected): December 31st, 2022. TRIAL REGISTRATION: This trial is registered in the Japan Registry of Clinical Trials (jRCT) ( jRCTs031200150 ) on 14 October 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Goshajinkigan (Chinese herbal medicine niu-che-sen-qi-wan) improves insulin resistance in diabetic rats via the nitric oxide pathway.

Goshajinkigan (GJG), an aqueous extract of a combination of 10 herbal medicines, is widely used for the treatment of diabetic neuropathy in Japan. In this study, the effect of GJG on insulin-induced glucose disposal in normal and streptozotocin (STZ) diabetic rats was analyzed using the euglycemic clamp technique. Male Wistar rats, aged 9 weeks, were randomly assigned to six groups: group NS, normal rats receiving saline; group NG, normal rats receiving GJG (800 mg x kg(-1) x day(-1), p.o.); group NGL, normal rats receiving GJG + N(G)-monomethyl-L-arginine (L-NMMA, 1 mg x kg(-1) x min(-1), i.v.); group DS, diabetic rats receiving saline; group DG, diabetic rats receiving GJG; group DGL, diabetic rats receiving GJG + L-NMMA. After daily oral administrations of saline or GJG for one week, euglycemic clamp experiments were performed. The metabolic clearance rates of glucose (MCR) in the DS, DG, and DGL groups (8.7 +/- 2.9, 18.2 +/- 2.5, and 8.1 +/- 1.8 ml x kg(-1) x min(-1), respectively) were significantly lower than those in the NS, NG, and NGL groups (24.1 +/- 4.5, 24.5 +/- 3.1, and 22.2 +/- 2.1 ml x kg(-1) x min(-1), respectively). In addition, the MCR in the DG group was significantly higher than that in the DS and DGL groups, while no significant difference was detected among the NS, NG, and NGL groups. Furthermore, the amelioration of insulin resistance by GJG in diabetic rats was hampered by L-NMMA infusion. These results suggest that daily GJG administrations ameliorate insulin resistance in STZ-diabetic rats, and that the nitric oxide pathway may mediate the effect of GJG.

Abdominal circumference should not be a required criterion for the diagnosis of metabolic syndrome.

BACKGROUND: Metabolic syndrome (MetS) is an established concept. However, it is characterized by a number of different definitions as well as different cut-off points (COPs) for waist circumference (WC) and different modes for incorporating WC into the diagnostic criteria. METHODS: Abdominal ultrasonography was performed in 2,333 subjects who also underwent comprehensive medical examinations between April and July 2006. The odds ratios for the number of MetS components were calculated by taking central obesity status into account and considering concurrent fatty liver as an independent variable. We compared the areas under the receiver operating characteristic (ROC) curves for fatty liver and MetS using several MetS criteria. RESULTS: Regardless of the WC criterion selected, we observed a strong linear trend for an association (trend P < 0.0001) between MetS and the number of components. The odds ratio (OR) of subjects without central obesity but with all three MetS components was 9.69 (95% confidence interval 3.11-30.2) in men and 55.3 (6.34-483) in women. The COP for the largest area under the curve in men and women was ≥82 cm (OR 0.701) and ≥77 cm (OR 0.699), respectively, when WC was considered as a component. When WC distribution is taken into consideration, practical and appropriate COPs should be ≥85 cm for men and ≥80 cm for women. CONCLUSION: We suggest that a WC of ≥85 cm for men and ≥80 cm for women would be optimal COPs for the central obesity criteria in the Japanese population. In addition, central obesity should be incorporated as a component of MetS rather than an essential requirement for the diagnosis of MetS.

A survey of Japanese physician preference for attire: what to wear and why.

Many studies have examined the impression made on patients by physicians' attire. Regardless of practice location, many patients express most confidence in physicians who wear white coats. The number of physicians in Japan who choose not to wear white coats in practice has been increasing, particularly in primary care settings. However, very few studies have examined physician preference for attire. To clarify Japanese general practitioners' preference for attire by practice setting, we conducted a survey of physician preferences and reasons for attire selection. Subjects were 794 general practitioners certified by the Japan Primary Care Association and recruited from a mailing list. We conducted a web-based questionnaire survey. Physicians were asked to choose one of four different dress styles (semi-formal, white coat, scrubs, and casual) for different practice settings and state the reasons for selection. The response rate was 19.3% (n = 153; men 112). Most subjects chose white coats as usual attire for hospital practice (52%), mainly because of custom and professionalism. In contrast, most subjects chose non-white coats for clinics (59%) and home care (hospital-provided, 58%; clinic-provided, 71%). More subjects chose casual dress for clinic and home care practice, mainly to appear empathic. Most subjects chose white coats as the most appropriate hospital attire (54%), mainly because of patient perceptions of this attire being professional. Most subjects considered non-white coat attire more appropriate for clinic and home care practice. The findings indicate that general practitioners choose their clothes depending on practice location.