Potential hypotensive effects of Umezu polyphenols: a 14-week community-based, double-masked and placebo-controlled trial.

OBJECTIVE: To evaluate blood pressure (BP)-lowering effects of Umezu polyphenols, polyphenols contained in Japanese plums, in a community-based sample by double-masked and placebo-controlled design. METHODS: Seventy-two Japanese community-dwellers who were interested in prevention or control of their BP (preferably high-normal BP or grade I hypertension) but without antihypertensive medication were randomized into Umezu polyphenols or placebo groups. Each subject took 800 mg/day of Umezu polyphenols or placebo for 12 weeks, followed by a 2-week washout period. Their home and office BP were monitored for 14 weeks in a double-masked manner. We analyzed 56 subjects who met the inclusion criteria. RESULTS: Home BP increased gradually in both the groups during the intervention period, while diastolic office BP insignificantly decreased in the intervention group. During the washout period, home systolic BP in the morning elevated only in the intervention group. CONCLUSIONS: The study failed to collect consistent evidence of a clear persistent hypotensive effect of Umezu polyphenols.

Influence of Biomedical Factors on the Five Viscera Score (FVS) on Middle-Aged and Elderly Individuals: Application of Structural Equation Modeling.

The five viscera score (FVS) is a diagnostic scale for traditional Chinese medicine (TCM). The purposes of current study are to elucidate the characteristics of FVS obtained from middle-aged to elderly individuals and to investigate the validity of FVS using biological medical data of middle-aged and elderly individuals. Structural equation modeling (SEM) was used to conduct assessments between FVS and medical data. Eighty men and 99 women participated in this study, whose mean ages (SD) were 58 ± 7 years in both genders showing no significant difference. FVS of women was significantly higher than that of men in the spleen of the 50s (P = 0.019) and liver of the 60s age group (P = 0.030). By SEM, the following biomedical factors were found to influence viscera: gender, diastolic blood pressure, and HDL-C for the liver; GLU, GOT, and γ-GTP for the spleen; age, BMI, and HCRP for the lungs; and HbA1c and creatinine clearance for the kidneys. These results provide objective evidence that FVS can be used for TCM diagnosis in middle-aged and elderly individuals.

Safety and adherence of Umezu polyphenols in the Japanese plum (Prunus mume) in a 12-week double-blind randomized placebo-controlled pilot trial to evaluate antihypertensive effects.

OBJECTIVES: Medications or lifestyle changes to prevent or improve hypertension often press considerable efforts on patients suffering from mild hypertension. Capsules including Umezu polyphenols (UP), polyphenols in Japanese plums, may help them to control their blood pressure (BP). The aim of this study is to evaluate the effectiveness of UP on BP and its safety. METHODS: A total of 15 healthy workers without antihypertensive medication who had some concerns about their BP, preferably normal-high BP or hypertension level 1, were randomized in a double-blind manner into UP ingesting and placebo groups. Each subject was instructed to take four capsules daily for 12 weeks (daily UP dose, 800 mg for the UP ingesting group; and 0 mg for the placebo group). These subjects were followed for 12 weeks, and their BP both at home and at the examination site, as well as self-perceived quality-of-life outcomes and possible side effects, was monitored during that period. Group × time interactions on BP changes were examined. RESULTS: All of the 15 subjects completed the 12-week intervention trial. The BP changes did not significantly differ between the UP ingesting and placebo groups, neither at the examination site nor at home. But during the study period, no adverse effects were observed. CONCLUSIONS: No remarkable effect of UP on BP was observed. However, a higher dose of UP was confirmed safe and high in adherence in this 12-week randomized controlled trial. Its effect on BP and other outcomes shall be confirmed in a larger sample.

Validity of a diagnostic scale for acupuncture: application of the item response theory to the five viscera score.

In acupuncture therapy, diagnosis, acupoints, and stimulation for patients with the same illness are often inconsistent among between Traditional Chinese Medicine (TCM) practitioners. This is in part due to the paucity of evidence-based diagnostic methods in TCM. To solve this problem, establishment of validated diagnostic tool is inevitable. We first applied the Item Response Theory (IRT) model to the Five Viscera Score (FVS) to test its validity by evaluating the ability of the questionnaire items to identify an individual's latent traits. Next, the health-related QOL scale (SF-36), a suitable instrument for evaluating acupuncture therapy, was administered to evaluate whether the FVS can be used to make a health-related diagnosis. All 20 items of the FVS had adequate item discrimination, and 13 items had high item discrimination power. Measurement accuracy was suited for application in a range of individuals, from healthy to symptomatic. When the FVS and SF-36 were administered to other subjects, a part of which overlap with the first subjects, we found an association between the two scales, and the same findings were obtained when symptomatic and asymptomatic subjects were compared regardless of age and sex. In conclusion, the FVS may be effective in clinical diagnosis.