Volume 45,
Issue 10,
2017
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扉・目次
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Source:
薬理と治療 45巻10号, 1599-1601 (2017);
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OPINION
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Source:
薬理と治療 45巻10号, 1605-1613 (2017);
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Source:
薬理と治療 45巻10号, 1615-1626 (2017);
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In clinical and epidemiological studies, poor conducts of statistical analyses produce biases in the results and sometimes cause fails of reproducibility. The current standards of statistical analyses in clinical studies have been established to prevent these biases and to maximize scientific validity and precision. In this article, we provide a gentle introduction to these biostatistical methodology for understanding research papers published in medical journals. In particular, we focus what is “confounding,” a typical bias in clinical studies and how it influences to results and interpretations of clinical researches. In addition, we explain how we can prevent or adjust the bias in designing and analyzing of clinical studies. Also, we review the development of the STROBE statement that is a guideline to improve reports of observational studies to gaining scientific validity and reproducibility.
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ORIGINAL ARTICLES
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薬理と治療 45巻10号, 1629-1636 (2017);
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Resistant glucan mixture(RGM), a synthetic form of dietary fiber, has been reported to have a laxative effect in humans. In this study, we determined the mechanism of this effect in rats. Rats were fed a control diet or one containing 2.5% or 5.0% RGM for 32 d and feces collected at 5-6 d(1 wk)and 26-27 d(4 wk). A reduction in gastrointestinal transit time was observed in the 5.0% RGM group. Ingestion of 5.0% RGM increased fecal number, wet weight, and water content at both time-points. There was similar fecal recovery of RGM at both time-points(25% and 31% at 1 wk and 19% and 23% at 4 wk for the 2.5% and 5.0% RGM groups, respectively), suggesting that RGM contributes to increased fecal water content by exerting an osmotic effect in the gut lumen. Because of the resistance of RGM to digestion and fermentation, it increased fecal water content, softened the feces, and enhanced ease of defecation, regardless of the period of ingestion. The numbers of lactobacilli and bifidobacteria in the cecum were greater in the 5.0% RGM group, without any increase in total bacterial numbers. Ingestion of 5.0% RGM lowered the cecal concentration of p-cresol andindole, which are mutagens. In conclusion, ingestion of RGM improved laxation passing intact through the large bowel and increasing fecal water content. In addition, RGM exerted a useful effect on the intestinal environment by stimulating the proliferation of lactic acid︱producing bacteria and reducing putrefactive products.
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Source:
薬理と治療 45巻10号, 1637-1648 (2017);
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Objectives A previous study has examined the antihypertensive effect of the bovine casein-derived peptide Met-Lys-Pro(MKP)in vitro and in vivo. We evaluated the effect of MKP in lowering blood pressure in subjects with high-normal blood pressure and grade 1 hypertension. Methods In total, 65 subjects with high-normal blood pressure and grade 1 hypertension participated in a randomized, double-blind, placebo-controlled, parallel-group trial for 12 weeks. Subjects were allocated to four groups: low-dose(50μg MKP), moderate-dose(100μg MKP), high-dose(200μg MKP), and placebo group. Results Systolic blood pressure(SBP)was significantly lower in the moderate-dose group than in the placebo group at 4 and 12 weeks. Diastolic blood pressure was significantly lower in the moderate-dose group than in the placebo group at 4, 8, and 12 weeks. In a subgroup analysis of subjects with high-normal blood pressure, SBP was significantly lower in the moderate-dose group than in the placebo group at 4 weeks. No serious adverse events related to test product ingestion were observed in any group. Conclusions These results suggest that MKP has a beneficial effect on lowering blood pressure in subjects with high-normal blood pressure and grade 1 hypertension.
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Source:
薬理と治療 45巻10号, 1649-1665 (2017);
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Objective This study was carried out to investigate the relieving effects of collagen peptide ingestion on knee pain. Methods A randomized placebo-controlled double-blind trial was conducted in 56 Japanese subjects(45-70 years of age)of Kellgren-Lawrence grades of 0 or Ⅰ, not affected with osteoarthritis. They were randomly divided to two groups and ingested 5 g of either fish-derived collagen peptide(FCP)as the test food or dextrin as the placebo food, twice a day for 12 weeks. Knee pain was assessed with according to Japanese Orthopaedic Association(JOA)criteria and the Japan Knee Osteoarthritis Measure(JKOM)criteria. The safety was evaluated by blood and urine test. Results Out of the 56 subjects, 4 dropped due to personal reasons and the remaining 52 subjects were evaluated. Knee pain assessed with JOA score observed by the doctor, JKOMⅠVAS and JKOMⅡ score improved in the each groups. However, as for each questionnaire of JKOM Ⅱ, the score of knee stiffness right after waking up, knee pain during walking on flat surface, knee pain during ascending stairs and knee pain during standing significantly decreased in the test food-group but not in the placebo food-group. Also, the score of physical condition and bad influence on physical condition of JKOMⅤ decreased in the test food-group but not in the placebo food-group. The blood and urine test showed no health hazard. Conclusions These results suggest that collagen peptide ingestion relieves knee pain of healthy subject not affected with osteoarthritis, to improve physical condition.
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Source:
薬理と治療 45巻10号, 1667-1678 (2017);
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Background and aim White rice intake is associated with higher risk of type 2 diabetes. Here, we clinically evaluated whether coingestion of persimmon leaf extract(PLE)or powder (PLP)and white rice suppresses the postprandial blood glucose(PBG)increase induced by white rice in healthy subjects. Methods In the first trial of three-treatment three-period crossover design, fasting blood glucose levels were recorded in 9 healthy subjects. Within 10 min, they ingested white rice(147 g, 50 g of carbohydrate)with one 350-mL beverage: low-dose PLE(PLE4g, from 4 g of dried leaves), high-dose PLE(PLE8g, from 8 g of dried leaves), or water with caramel color(polyphenols: 280, 560, and 0 mg, respectively). Finger-prick blood measurements at 15-120 min post-intake provided the corresponding PBG levels. In the second trial of two-treatment two-period crossover design, the PBG levels after coingestion of aqueous suspension of PLP(4 g, 292 mg of polyphenol)and white rice were measured in 15 subjects with high incremental area under the curve(IAUC)response to white rice in the same manner as the first trial. In in vitro digestion methods, suppressive effect of persimmon leaf polyphenols on the digestion of starchy food materials were investigated. Results In the first trial, the PBG levels at 30 min post-intake were significantly lower with PLE4g and PLE8g coingestion compared with the control(136.9±19.5 and 130.7±24.2 mg╱dL vs. 142.7±23.2 mg╱dL, P=0.036 and 0.009, respectively). Strong negative correlations were found between IAUC of white rice and water group and the delta IAUC values in the PLE4g and PLE8g coingestion groups, indicating that PLE coingestion resulted in a larger IAUC reduction in participants with a higher IAUC response to white rice. Subgroup analysis revealed the values of PGE levels, the delta, and IAUC were significantly lower in both groups of PLE4g and PLE8g coingestion than in the control group of high IAUC responder subgroups(n=5), but no significant difference was evident in a PLE4g group of the low-responder subgroup(n=4). In the second trial using 15 subjects with high IAUC responses to white rice, PLP(4 g)coingestion caused significant suppression in the responses of the PBG levels, the delta, and IAUC compared with the control. In in vitro digestion of five kinds of starchy food materials including rice flour, the glucose liberation were found to be suppressed to the same degree in the presence of PLE or PLP. Conclusions Coingestion of white rice and PLE(from 4 g of dried leaves)or PLP (4 g)suppressed PBG elevation compared with white rice and H2O, and the suppressive effect was particularly prominent in high IAUC responders to white rice.
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Source:
薬理と治療 45巻10号, 1679-1685 (2017);
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Objective The effect of ingesting a supplement containing Chlorella pyrenoidosa on defecation was evaluated. Methods We conducted a randomized, placebo-controlled, double-blind, cross-over study for forty healthy adult women who have mild constipation tendencies with 3 to 5 defecation frequency per week. Subjects consumed either fifteen tablets containing Chlorella pyrenoidosa as test food, or fifteen tablets containing maltodextrin instead of Chlorella pyrenoidosa as placebo food twice a day(thirty tablets in a day)for four consecutive weeks. Defecation frequency, fecal amount, fecal characteristics, and abdominal symptoms were recorded by the subjects themselves throughout the duration of the experiment. Result During both period of the test food or the placebo food consuming, the defecation frequency significantly increased compared to those in the baseline period. The defecation frequency in the test food group was significantly increased compared with the placebo food group after three weeks. In addition, no clinical concerns such as changes in body weight, BMI, vital signs were noted during the ingestion period. No adverse events attributed to the test food or the placebo food were found in the study. Conclusion These results suggested that daily ingestion of the supplement containing Chlorella pyrenoidosa improved defecation conditions.
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Source:
薬理と治療 45巻10号, 1687-1695 (2017);
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Objectives The aim of the present study was to elucidate the effect of Lactobacillus acidophilus L-92 intakes on upper respiratory tract subjective symptoms and immune parameters(NK cell activity and salivary IgA)in healthy subjects by a randomized, double-blind, placebo-controlled, parallel-group comparison study. Methods Subjects were divided into 2 groups which consumed a L-92(2⊠1010 cells╱drink)containing drink or placebo once a day for 8 weeks. The discomfort of upper respiratory tract was recorded weekly by the subjects throughout the study, and medical examinations to analyze immune parameters and to assess safety parameters were carried out at weeks 0(baseline), 4, and 8.Results Throat and cough discomfort scores were significantly elevated in the placebo group but not in the L-92 group. A significant difference in baseline changes in throat discomfort scores was also observed between the placebo and L-92 groups. Additionally, the change in NK cell activity in peripheral blood was significantly higher in the L-92 group compared with the control throughout the study period. Conclusions These results suggest that L-92 ingestion enhances NK cell activity and may reduce throat discomfort, which occurs in the early stage of the common cold. Safety parameters did not differ significantly between the groups.
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Source:
薬理と治療 45巻10号, 1697-1708 (2017);
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目的 本研究はHGH Crystal MD(R) 摂取時の抗老化作用を非盲検試験にて評価した。方法 試験責任医師の判断により日本人女性11 名を選抜した。試験参加者はHGH Crystal MD(R) を1 日3 包,8 週間摂取した。摂取前および摂取8 週後に血中IGF-1 濃度,血中DHEA-S 濃度,CT 検査,身体測定,糖化度測定,自覚症状により有効性を評価し,身体測定,尿検査,末梢血液検査により安全性を評価した。結果 摂取8 週間後には摂取前と比較して,骨および体細胞における成長ホルモンの成長促進作用を仲介する因子であるIGF-1 の血中濃度の増加(P=0.011),上腕部骨髄脂肪体積の低減(P=0.016)が認められた。さらに,「眠りが浅い」という自覚症状が有意に減少し(P=0.031),睡眠の質が向上した。試験責任医師による診断の結果,摂取前後のいずれにおいても試験参加者の健康状態に問題はなく,介入期間を通じて重篤な疾病や有害事象は認められなかった。結論 本研究においてHGH Crystal MD(R) の摂取により,血中IGF-1 濃度の増加をはじめとする抗老化作用が期待できると示唆された。また,本試験の条件下においてHGH Crystal MD(R) は安全な食品であった。
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COLUMN
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Source:
薬理と治療 45巻10号, 1711-1712 (2017);
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INFORMATION
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Source:
薬理と治療 45巻10号, 1713-1715 (2017);
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Source:
薬理と治療 45巻10号, 1717-1727 (2017);
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Source:
薬理と治療 45巻10号, 1729-1734 (2017);
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Source:
薬理と治療 45巻10号, 1737-1738 (2017);
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