Choice of comparison group in assessing the health effects of moderate alcohol consumption.
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Biomedical subjects
Publications and source records attributed to S Hisamichi.
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BACKGROUND: Although laboratory experiments and case-control studies have suggested that the consumption of green tea provides protection against gastric cancer, few prospective studies have been performed. METHODS: In January 1984, a total of 26,311 residents in three municipalities of Miyagi Prefecture, in northern Japan (11,902 men and 14,409 women 40 years of age or older), completed a self-administered questionnaire that included questions about the frequency of consumption of green tea. During 199,748 person-years of follow-up, through December 1992, we identified 419 cases of gastric cancer (in 296 men and 123 women). We used Cox regression to estimate the relative risk of gastric cancer according to the consumption of green tea. RESULTS: Green-tea consumption was not associated with the risk of gastric cancer. After adjustment for sex, age, presence or absence of a history of peptic ulcer smoking status, alcohol consumption, other dietary elements, and type of health insurance, the relative risks associated with drinking one or two, three or four, and five or more cups of green tea per day, as compared with less than one cup per day, were 1.1 (95 percent confidence interval, 0.8 to 1.6), 1.0 (95 percent confidence interval, 0.7 to 1.4), and 1.2 (95 percent confidence interval, 0.9 to 1.6), respectively (P for trend=0.13). The results were similar after the 117 cases of gastric cancer that were diagnosed in the first three years of follow-up had been excluded, with respective relative risks of 1.2 (95 percent confidence interval, 0.8 to 1.8) 1.0 (95 percent confidence interval, 0.7 to 1.5), and 1.4 (95 percent confidence interval, 1.0 to 1.9) (P for trend=0.07). CONCLUSIONS: In a population-based, prospective cohort study in Japan, we found no association between green-tea consumption and the risk of gastric cancer.
BACKGROUND: To quantify excess medical use associated with smoking, a large prospective cohort study is needed. The authors examined the impact of smoking on medical care use in a large population-based cohort with an accurate data collecting system in Japan. METHOD: The data were derived from a 30-month prospective cohort study of 43,408 National Health Insurance beneficiaries aged 40--79 years living in a rural Japanese community. The smoking habit of beneficiaries was assessed in a baseline survey at the end of 1994. Medical care use and its costs were monitored by linkage with the National Health Insurance claim history files since January 1995. RESULTS: Male smokers incurred 11% more medical costs (after adjustment for age, physical functioning status, alcohol consumption, body mass index and average time spent walking) than 'never smokers' but for female smokers and never smokers the costs were almost the same. This difference was mainly attributable to increased use of inpatient medical care among smokers, especially in males, where per month cost of inpatient care was 33% higher in smokers. Age-group specific analysis in men showed that excess mortality and excess medical cost ratio for smokers peaked in those aged 60--69 years. CONCLUSIONS: Smokers consume excess medical care. Among the population aged 45 years and over, about 4% of total medical costs were attributable to smoking. To pursue both better health and lower medical costs for the nation, a comprehensive programme to reduce tobacco use is needed.
OBJECTIVE: To establish the factors affecting the difference between screening and home blood pressure measurements. DESIGN: A cross-sectional study. SETTING: General population in a rural Japanese community, Ohasama, Japan. PARTICIPANTS: There were 1,789 community-based subjects aged > or =40 years, for whom blood pressure was measured at screening site (screening blood pressure) and at home (home blood pressure). RESULTS: Multiple stepwise regression analysis of all subjects demonstrated that screening pulse pressure was positively associated with the difference between screening and home blood pressure measurements for systolic blood pressure. Age, the use of antihypertensive medication, and smoking status were negatively associated with the difference between measurements of both systolic and diastolic blood pressure. CONCLUSION: We have demonstrated that age, smoking, antihypertensive medication, and screening pulse pressure are independent predictors of the magnitude of the difference between screening and home blood pressure measurements, suggesting that the necessity to consider these factors, for the detection of the subjects who may be inappropriately treated or misjudged following screening blood pressure measurements.
OBJECTIVES: Reproducibility of home blood pressure measurements (HBP), and the placebo effect on HBP, were examined to establish the number of subjects required in order to observe a significant antihypertensive effect of a drug for a comparative study between placebo and active treatment. METHODS: Reproducibility of HBP (n = 172 for systolic blood pressure and n = 137 for diastolic blood pressure) and the placebo effect on HBP (n = 35 for systolic and n = 42 for diastolic blood pressure) were examined using a semi-automatic electronic device on untreated hypertensive subjects during 21 consecutive days of measurements. From these two studies, the number of subjects required in order to observe a significant antihypertensive drug effect was assessed. In both studies, measurements from the first 3 days were excluded from the analysis. RESULTS: Reproducibility, defined as the difference between the initial 5 day average (days 4-8) and the last 5 day average (days 17-21) was -1.9 +/- 7.0/-1.4 +/- 4.8 mmHg (mean +/- SD), indicating high reproducibility with a minimal regression to the mean effect. A placebo was administered after the 8 day run-in period. The difference between the initial 5 day average (days 4-8) and the last 5 day average (days 17-21) was compared. The mean difference was 1.1 +/- 6.2/0.2 +/- 5.7 mmHg, suggesting that there was a minimal, if any, placebo effect. As determined by the power calculations, based on the standard deviations of the tests for reproducibility and the placebo effect, nine of 13 subjects are required to show that a 9/5 mmHg decrease in systolic HBP/diastolic HBP (50% of estimated effective decrease in systolic HBP/diastolic HBP according to the guidelines for clinical trials in Japan) is statistically significant CONCLUSIONS: The results suggest that the HBP measurement is highly reproducible and that there is a minimal, if any, placebo effect. These characteristics of HBP contribute to minimizing the number of subjects necessary for assessment of antihypertensive drug effects in comparative studies between an active treatment and placebo.
OBJECTIVE: To determine the effects of exercise training on the blood pressure (BP) values of older adults, using home blood pressure measurement. DESIGN: Randomized controlled trial. PARTICIPANTS: A total of thirty-nine free-living older adults (including 19 men) aged from 60-81 years with home systolic blood pressure > 120 mmHg and without significant cardiopulmonary-musculoskeletal disease, were randomly allocated to either 25 weeks of exercise training (exercise group) or to a control program (control group). MAIN OUTCOME MEASUREMENTS: Change in the 2-week averages of home systolic and diastolic blood pressure values measured with a validated automatic device before, during and after the intervention period. RESULTS: Compared with the control group, the exercise group showed a significant decrease in values for home systolic blood pressure (maximum between-group difference = 7.7 mmHg, P = 0.003) and home diastolic blood pressure (4.2 mmHg, P = 0.001). These changes were observed for both genders. CONCLUSIONS: Exercise training was effective for older adults in lowering home blood pressure values. This is the first trial to demonstrate the usefulness of home blood pressure measurement in examining the effect of exercise training on blood pressure values.
We assessed the accuracy of a 141-item food frequency questionnaire as a screening test to detect high or low consumption of nutrients associated with cancer. Fifty-five men and 58 women participating in two population-based cohort studies in Miyagi, Japan, provided four three-day diet records over a one-year period and subsequently completed the questionnaire twice with a one-year interval. Pearson correlation coefficients between 17 nutrients measured by the diet records and the first questionnaire ranged from 0.24 to 0.85 (median 0.43), and those between the two questionnaires ranged from 0.47 to 0.91 (median 0.68). The sensitivity and specificity of the questionnaire for detecting high-alcohol, high-fat, low-calcium, and low-ascorbic acid consumers were 86.7% and 96.7%, 50.0% and 85.7%, 48.8% and 76.4%, and 61.9% and 70.0%, respectively. Receiver operating characteristic curves indicated comparable performance of the questionnaire and a three-day diet record, regarded as another screening test. The questionnaire performed poorly for other nutrients. The results indicate that our questionnaire is reasonably reproducible, comparable with the diet records, and useful as a screening test to detect high or low consumers of several nutrients associated with cancer for subsequent enrollment in dietary intervention trials or dietary counseling.
A case-control study was performed to clarify the cause of ischemic heart disease (IHD), such as acute myocardial infarction and angina pectoris, in Japanese employees. Among 122,051 workers from 31 industries, 94 cases of IHD were the subjects of the study, and a total of 191 age-matched subjects from the same department, but who did not develop IHD, served as the controls. Compared with the control group, body mass index, blood pressure, fasting plasma glucose, serum total cholesterol and serum triglyceride were significantly higher, and cigarette consumption and serum uric acid also tended to be higher, in the patient group from at least 10 years prior to onset. The frequency of moderate-drinkers tended to be lower in the case group. Electrocardiograms showed that, compared with the control group, the frequency of myocardial ischemia was higher in the case group from 9 years prior to onset and further rapidly increased from 3 years prior. The frequency of subjects with arrhythmia was the same as the control group until 3 years before onset and increased rapidly from 2 years prior. The frequency of subjects with multiple risk factors, particularly obesity, hypertension, hyperlipidemia and hyperglycemia, was consistently higher in the case group compared with the control group from 10 years prior to onset. Conditional logistic regression analysis demonstrated that having more than one risk factor greatly increased the risk; in particular, the combination of 3 or more factors increased the relative risk to 10.56 (95% confidence interval: 3.30-33.78). These findings suggest that a long duration of multiple risks is involved in the onset of IHD in Japanese employees, and that annual ECG monitoring as part of the medical examination was important in the prognosis.
To see how different foods were selected depending on family-togetherness at breakfast and dinner, we investigated the meals of eight thousand primary and four thousand junior high school students by questionnaire. About 70% of primary school children but less than 50% of junior high school children ate breakfast with their family. The food, eaten by children who ate meals together with their family, took more time for cooking and was more traditional with rice as the staple. Food eaten by children who did not eat with their family lacked both preparation time and staple base. Family-togetherness affects the foods of primary school children more than those of junior high school students.
The Japan Collaborative Cohort Study for Evaluation of Cancer Risk Sponsored by Monbusho (JACC Study) included in its self-administered questionnaires some single-item questions concerning physical activity. We examined the validity of the questions among 1,730 Japanese adults and the reliability of the questions among 1,075 Japanese adults. The validity of the sports and physical exercise questions was estimated by comparing the self-administered questionnaire responses with the time spent on the activity and the energy expenditure index for the previous 12-month period, elicited by the interviewing method used in the Japan Lifestyle Monitoring Study with a minor modification. The Spearman's rank correlation coefficients ranged from 0.43 to 0.60, showing moderate correlations. On the other hand, test-retest reliability was estimated by comparing the responses from two separate surveys conducted roughly one year apart. Weighted kappa coefficients of sports and physical exercise questions, classified according to sex and age, ranged from 0.39 to 0.56, showing moderate reliability; and those of a question about walking ranged from 0.25 to 0.39, showing fair reliability. We suggest that measuring physical activity level with these single-item questions may be appropriate for establishing baseline data that reflects long-term physical activity in a large-scale cohort study targeting lifestyle-related diseases.
Active life expectancy (ALE) is defined as an expected duration to be spent with a certain level of physical/mental function. The objectives of this article are to indicate ALE values based on our prospective observation, and to discuss factors influencing regional and gender differences in ALE values. We estimated ALE without disability in basic activities of daily living (ADL) on a 5% random sample (n = 3,459) of the residents aged 65 years and over in Sendai City between 1988 and 1991. At the age 65, ALE was 14.7 years for men and 17.7 years for women. ALE occupied 91% of the total life expectancy for men and 87% for women. As compared with the reports for the American elderly, ALE was longer in Sendai than in the United States. The duration to be spent with disability was shorter among the subjects in Sendai. We estimated ALEs in three functional areas: basic ADL, instrumental ADL, and mobility, on all the residents aged 65 years and over (n = 3,590) at Wakuya Town between 1994 and 1996. For both sexes, ALE in IADL was shorter than those in basic ADL and mobility. The development and progression of disability were different between sexes: men experienced disability at a younger age and progressed at a faster rate than women.
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BACKGROUND: Although the clinical significance of systolic-diastolic hypertension and isolated systolic hypertension has been established, the significance of isolated diastolic hypertension has not been fully investigated. OBJECTIVE: To clarify the prognostic significance of isolated systolic and isolated diastolic hypertension as assessed by self-measurement of blood pressure (BP) at home (home BP measurements), which has a better reproducibility and prognostic value than casual BP measurements in the general population. SUBJECTS AND METHODS: We obtained home BP measurements for 1913 subjects aged 40 years or older, then followed up their survival status (mean, 8.6 years). We classified the subjects into the following 4 groups according to their home BP levels: systolic-diastolic hypertension, isolated systolic hypertension, isolated diastolic hypertension, and normotension. The prognostic significance of each type of hypertension for the risk of cardiovascular mortality risk was investigated using a Cox proportional hazards regression model adjusted for possible confounding factors. RESULTS: The risk for isolated systolic hypertension and systolic-diastolic hypertension were significantly higher than the relative hazard for normotension, while isolated diastolic hypertension was associated with no significant increase in risk. Home pulse pressure measurement was also independently associated with an increase in the risk of cardiovascular mortality. CONCLUSIONS: Isolated diastolic hypertension, as assessed by home BP measurements, carried a low risk of cardiovascular mortality, similar to that found in subjects with normotension, suggesting that the prognosis of hypertension would be improved by treatment focused on systolic rather than on diastolic home BP measurements. To our knowledge, this study is the first to demonstrate the clinical significance of pulse pressure as assessed by home BP measurement. Arch Intern Med. 2000;160:3301-3306.
BACKGROUND: Breastfeeding is considered to be an important factor for maternal and children's health. However, the epidemiological findings related to the effect of breastfeeding on women's health, especially with respect to breast cancer development, are inconsistent. Determinants of infant feeding method may contribute to the inconsistency. METHODS: A total of 24,769 women aged 40-64 in Miyagi Prefecture, Japan, responded to a self-administered questionnaire survey in 1990. Using the data obtained from 22,085 parous women, we calculated odds ratios (ORs) for the choice of "breastfeeding only" during reproductive period. RESULTS: Late age at menarche (> or = 16 years, OR = 1.57) and high body mass index (BMI) at 20 years of age (> or = 24, OR = 1.31) were associated with the choice of breastfeeding only. Late age at birth of first child (> or = 28 years, OR = 0.29), history of breast cancer in mother (OR = 0.68), and high educational level (more than a high school education, OR = 0.53) reduced the possibility of choosing breastfeeding only. CONCLUSION: The results indicate that the choice of infant feeding method is associated with several breast cancer risk factors. Based on this finding, we should construct appropriate breast cancer risk models for parous women and investigate the changes in the effects of breastfeeding and other breast cancer risk factors among these risk models. Especially in a risk model controlling for breastfeeding, the effects of other breast cancer risk factors should be reevaluated. Through comparisons among different risk models, we may find the best-fitted risk model and identify the true effect of breastfeeding.
To investigate the risks of mortality and cancer incidence in Parkinson's disease (PD) we studied the prognosis of 246 PD patients in a community. The cohort of PD patients was identified in 1984, and survival, mortality, relocation, and cancer incidence during 1984-1992 were examined retrospectively in 1994. The risk was measured by a standard effect estimate, i.e., the standardized mortality ratio (SMR) or the standardized incidence ratio (SIR), compared with the rates in the general population. During the observation period 696 person-years in PD men and 1018 person-years in PD women were accumulated, and 49 PD men and 53 PD women died. The risk of mortality in PD was significantly increased in both sexes (SMR: men 1.74, women 1.97). In addition, the risk of cancer incidence was evaluated in 228 patients aged under 80 years; 8 PD men and 7 PD women developed cancer. The risk of overall cancer incidence in PD was less than 1 in either sex, but not significantly. The risk of breast cancer in PD women was significantly increased (SIR: 5.49), but the 95% confidence interval was wide (1.10-16.03). The results indicate that PD patients in a community have a twofold higher risk of mortality, and that PD may be associated with an increased risk of breast cancer in women.
The activity of a sodium-proton exchanger is enhanced in the patients with essential hypertension and regulated via G-protein, which is a signal transducer between receptors and intracellular effectors. A recent study has revealed that a novel variant (C825T) in exon 10 of the gene encoding the beta3 subunit of heterotrimetric G proteins (GNB3) is a genetic factor predisposing to hypertension in Caucasians. We examined the association between GNB3/ C825T and blood pressure, lipids, electrolytes, and other parameters in a Japanese population. Subjects (n = 352) were selected from the Ohasama Study, the population of which is regarded as from a rural community in Japan. To obtain precise clinical measurements, 24-h ambulatory blood pressure monitoring (ABPM), brain magnetic resonance imaging (MRI), and carotid ultrasonography (CUS) were conducted in this population. In addition, we recruited 762 subjects from outpatients at the Osaka University Medical School to carry out the association study between hypertension and GNB3. The GNB3 genotype distribution did not differ significantly between normotensives and hypertensives in either of the two studies. The T825 allele of GNB3 was not associated with the presence of hypertension, blood pressure level, the number of brain lacunae or carotid wall thickness. However, the serum potassium and total cholesterol levels were significantly higher in subjects with the T allele (P < .005). The T825 allele of GNB3 is associated with increased serum potassium and total cholesterol levels but not with blood pressure in a Japanese population.
The polymorphism of the angiotensin-converting enzyme gene is considered to be associated with increased risk for stroke, but there is a diversity in the results obtained. The genetic involvement of the renin-angiotensin system in stroke also remains unclear. To predict the genetic risk of lacunar infarction, we conducted an association study in an Ohasama population, which is the cohort in a rural region of northern Japan. A total of 134 subjects without major neurological, cardiovascular, or metabolic disorders were recruited. Using brain magnetic resonance imaging, the number of lacunae in each of four brain regions were calculated, and periventricular hyperintensity was classified into five grades. We used the following four candidate gene polymorphisms: angiotensin converting enzyme (ACE)/Insertion(I)-Deletion(D), angiotensinogen (AGT)/M235T, angiotensin II type 1 receptor (AT1)/ A1166C, type 2 receptor (AT2)/C3123A, to examine the association between polymorphisms and the severity of lacunar infarction. AGT/M235T was significantly associated with the number of lacunae in the brain stem, the basal ganglia (P < .05), and whole brain (P < .005) regions. The AT1 polymorphism was also significantly associated with the number of lacunae in the basal ganglia and whole brain regions (P < .05), and with periventricular hyperintensity grade (P < .005) in the younger population. However, ACE and AT2 polymorphisms failed to show an association with either the number of lacunae or the PVH grade. We concluded that AGT and AT1 polymorphisms are independent genetic risk factors for lacunar infarction.
A controlled trial was conducted to compare the efficacy of interferon (IFN) between two groups of patients with type C liver. Thirty-five patients were randomly assigned to group A (17 patients) or group B (18 patients). The former received 3 megaunits (MU) of human lymphoblastoid IFN six days per week for two weeks, followed by three days per week for 50 weeks; the latter group received 6 MU six days per week for two weeks followed by three days per week for 24 weeks. The percentages of biological sustained responders (B-SR) and virological sustained responders (V-SR) were 29.4 and 23.5%, respectively, in group B, and 17.6% for both in group A. The therapeutic effects were not different between two groups. HCV genotype 2 accounted for significantly higher percentage of B-SR and V-SR (both 57.1%, respectively). These findings indicate that IFN is effective in type C cirrhosis with genotype 2.