Oriental medicine encompasses various areas including Kampo medicine, and alternative treatments such as acupuncture and massage. Special knowledge of statistics is not necessary to understand in oriental medicine, for which it is sufficient to master general statistics. This review describes statistic fundamentals and important issues for submitting an original article. It describes statistical thinking, data collection, study design, special considerations related to oriental medicine, fundamental statistical methods, multivariate analysis, and statistical software. In particular, it deals with the concept of sample variation, observational and experimental studies, rationale for randomization, sample size determination, t-tests, chi-square tests, paired tests, nonparametric methods, P-values, correlation coefficients, multiple regression, and logistic regression.

Oriental medicine encompasses various areas including Kampo medicine, and alternative treatments such as acupuncture and massage. Special knowledge of statistics is not necessary to understand in oriental medicine, for which it is sufficient to master general statistics. This review describes statistic fundamentals and important issues for submitting an original article. It describes statistical thinking, data collection, study design, special considerations related to oriental medicine, fundamental statistical methods, multivariate analysis, and statistical software. In particular, it deals with the concept of sample variation, observational and experimental studies, rationale for randomization, sample size determination, t-tests, chi-square tests, paired tests, nonparametric methods, P-values, correlation coefficients, multiple regression, and logistic regression.

Objectives : The objective of this study is to develop a Japanese version of the Constitution in Chinese Medicine Questionnaire (CCMQ) in Chinese, which is comprised of 60 items with 9 sub-scales, and evaluate its reliability and validity. Methods : We conducted a survey of 130 participants in the Toyama area of Japan from Dec. 2005, to Feb. 2006. A test-retest method was used. Feasibility was evaluated by the response times to the questionnaire, and the response rates of the CCMQ items. Internal consistency within the sub-scales was assessed by Cronbach's α coefficient. Reproducibility was confirmed between the first and second occasions using weighted kappa and Spearman correlation. Lastly, criterion validity was evaluated by correlation between CCMQ and SF-36 sub-scales. Results : Response time was 8 minutes on average and its rate was nearly 100%. Internal consistency was achieved for each of the 9 sub-scales with a 0.65 to 0.79 α coefficient. Reproducibility ranged from 0.41 to 0.81 for the items, and from 0.79 to 0.88 for the sub-scales. Regarding the criterion validity, the “Gentleness type” sub-scale was positively correlated with SF-36 (0.46, P<0.001), while other 8 pathological constitutional types of the CCMQ were negatively correlated with SF-36 (-0.35 to -0.50, P<0.001) as expected. Conclusions : We developed a Japanese version of the CCMQ and found acceptable levels of reliability and validity using a survey of 130 subjects in Japan. This suggests that the CCMQ could be a useful tool in comparing the constitution profiles between Chinese and Japanese.
Japanese language ; Chinese People ; Questionnaires ; SF Brand of Topical Fluoride ; Medicine

Objective : To examine the association between the combination therapy of calcium antagonists with angiotensin converting enzyme (ACE) inhibitors and underlying diseases for hypertensive patients.
Design : Cross-sectional survey of the drug utilization.
Methods : This survey included 603 hypertensive patients who had visited Toyama Medical and Pharmaceutical University Hospital, Toyama, Japan more than twice from January to June in 1996 and received the prescriptions of calcium antagonists and/or ACE inhibitors. Main outcome measure was the combined medication of calcium antagonists with ACE inhibitors. Underlying diseases under consideration were diabetes mellitus (DM), hyperlipidemia (LIPID), ischemic heart disease (IHD), chronic heart failure (CHF), and ischemic stroke (STROKE).
Results : Out of 603 hypertensive patients, 57.5% received only calcium antagonists, 23.7% received only ACE inhibitors, and 18.7% received both of them. Patients with either IHD or CHF tended to receive the combination therapy as compared to DM or LIPID. Although men tended to receive the combination therapy, a gender effect might be a confounder for the association. Logistic regression showed a 33% increase (P=0.265) in frequency of the combination therapy in patients with IHD after adjusting for age and gender.
Conclusion : Some underlying diseases were associated with more frequent prescriptions of the combination therapy for hypertensive patients, especially with ischemic heart diseases. This result should be regarded as an exploratory stage although the pattern of antihypertensive drug use could be reasonably explained from the pharmacological sense.

Objective : To evaluate the effect of beraprost sodium (beraprost) on the vascular events occurring in patients with peripheral arterial disease (PAD) in a meta-analysis of placebo-controlled, randomized trials.
Design : Meta-analysis
Methods : Among the clinical trials of beraprost in patients with intermittent claudication associated with PAD, placebo-controlled, randomized trials with vascular events as outcome measures were selected. Two trials met the criteria, each of which was a comparative trial of beraprost (40 μg t.i.d.) and placebo (t.i.d.), with a six-month follow-up period.
Results : With both trials combined, the analysis included 594 patients in the beraprost group and 590 in the placebo group. The risk ratio was 0.608 (95%CI : 0.41 to 0.90, p =0.012), demonstrating the efficacy of beraprost on all vascular events. The risk ratio for lower limb deterioration was 0.598 (95% CI : 0.34 to 1.06, p =0.079), which was similar to that for all vascular events. A statistically insignificant but similar result was also obtained for cardio/cerebrovascular events with a risk ratio of 0.619 (95%CI : 0.36 to 1.07, p = 0.085). Heterogeneity between the two studies was not found for any of the events.
Conclusion : The results demonstrated the efficacy of beraprost on the vascular events in patients with PAD. The potential benefit of beraprost on vascular events will require evaluation in a larger prospective investigation.

To compare the responsiveness of a newly designed symptom scale, the Chinese Medical Symptom Rating Scale for Heart Failure (CMSRS-HF), with the Chinese version of Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Medical Outcomes Study Short-form 36 (SF-36), and provide basis for the selection of subjective outcome measures for clinical evaluation of treatment of chronic heart failure by integrated traditional Chinese and Western medicine.

BACKGROUND: The dietary pattern of pregnant women is known to be associated with preterm birth (PTB). We investigated whether PTB was associated with intake of fermented food by using data from the Japan Environment and Children's Study. METHODS: From a data set of 103,099 pregnancies, 77,667 cases at low risk for PTB were analyzed. The primary outcome measurements were based on PTB. Fermented food (miso soup, yogurt, cheese, and fermented soybeans) consumption was assessed by using a semi-quantitative food frequency questionnaire. RESULTS: Intake of miso soup, yogurt, and fermented soybeans before pregnancy significantly reduced the risk of early PTB (< 34 weeks). The adjusted odds ratio (OR) for early PTB in women who had miso soup 1-2 days/week, 3-4 days/week, or ≥ 5 days/week were 0.58, 0.69, and 0.62, respectively, compared with those who had miso soup < 1 day/week (95% confidence interval (CI) 0.40-0.85, 0.49-0.98, and 0.44-0.87). The adjusted OR for early PTB in women who ate yogurt ≥ 3 times/week was 0.62 (95% CI, 0.44-0.87) compared to those who ate yogurt < 1 time/week. The adjusted OR for early PTB in women who ate fermented soybeans ≥ 3 times/week was 0.60 (95% CI, 0.43-0.84) compared to those who ate < 1 time/week. However, the incidence of overall PTB and late PTB (34-36 weeks) was not associated with fermented food intake. CONCLUSION PTB low-risk women with a high consumption of miso soup, yogurt, and fermented soybeans before pregnancy have a reduced risk of early PTB.
Adult ; Cohort Studies ; Diet ; statistics & numerical data ; Feeding Behavior ; Female ; Fermented Foods ; analysis ; Gestational Age ; Humans ; Japan ; epidemiology ; Odds Ratio ; Pregnancy ; Premature Birth ; epidemiology ; Protective Factors ; Surveys and Questionnaires

We are planning a study focused on the gathering of clinical data for the purpose of formalizing diagnostic logic at 6 institutions specialized in Kampo-based medical examinations. However, during the planning stage, it has been recognized that there are a large number of Kampo formulas to be studied, and differences among faculties and individuals exist regarding how to identify each Kampo formula, methods of gathering findings, and the evaluation of efficacy. Here we report the solution proposal reached after building consensus among all participating faculties on these issues. After raising the issues, conferences were held for each of them, until a unanimous consensus was obtained. As a result, the following conclusions were reached. Thirty-three Kampo formulas were selected as targets for the formalization of diagnostic logic. In addition, the range of dosage forms, crude drug ingredients, and permissible dosages for each Kampo formula were determined. Regarding clinical findings for these Kampo medicines, the items to be collected and evaluation criteria were also established. The criteria for evaluating the validity and safety of each Kampo medicine were decided, together with the grading and timing of evaluation. We hope that our solution proposal reached after building consensus becomes the basis for Kampo research in the future.