• 제목/요약/키워드: Double-blind

검색결과 545건 처리시간 0.026초

The fruit of Acanthopanax senticosus Harms improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial

  • Oh, Eunkyoung;Kim, Youjin;Park, Soo-yeon;Lim, Yeni;Shin, Ji-yoon;Kim, Ji Yeon;Kim, Ji-Hyun;Rhee, Moo-Yong;Kwon, Oran
    • Nutrition Research and Practice
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    • 제14권4호
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    • pp.322-333
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    • 2020
  • BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

Visceral fat and body weight are reduced in overweight adults by the supplementation of Doenjang, a fermented soybean paste

  • Cha, Youn-Soo;Yang, Ji-Ae;Back, Hyang-Im;Kim, Soo-Ran;Kim, Min-Gul;Jung, Su-Jin;Song, Won O;Chae, Soo-Wan
    • Nutrition Research and Practice
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    • 제6권6호
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    • pp.520-526
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    • 2012
  • Various forms of fermented soybean products are well documented for their health benefits. The efficacy of anti-obesogenic effect of Doenjang, one of the most commonly used seasonings in Korean cuisine, has been reported only in animal models; thus, an evaluation of Doenjang needs to be conducted in human studies. We aimed to test the hypothesis that Doenjang supplementation reduces body weight and changes body composition in overweight adults. A total of 51 overweight adults participated in this study. A group of males with BMI ${\geq}23kg/m^2$ and waist to hip ratio (WHR) ${\geq}$ 0.90, and a group of females with BMI ${\geq}23kg/m^2$ and WHR ${\geq}$ 0.85 were randomly assigned to either a Doenjang supplement (9.9 g dry/day) group or a placebo group for a 12-week randomized, double-blind and placebo-controlled study. Anthropometric parameters, abdominal fat distribution by computerized tomography (CT) and blood components were measured before and after the intervention period. After the 12-week study, the Doenjang supplementation group had significant reductions in body weight (kg), body fat mass (kg) and body fat (%) compared to the placebo group, the supplementation of Doenjang resulted in a significant reduction in visceral fat ($cm^2$), although no changes were observed in total and subcutaneous fat are as ($cm^2$), serum lipid profiles and dietary intakes. The present study demonstrated that daily supplementation of 9.9 g dry/day of Doenjang for 12 weeks reduces body weight and visceral fat in overweight adults.

Effect of high-dose ginsenoside complex (UG0712) supplementation on physical performance of healthy adults during a 12-week supervised exercise program: A randomized placebo-controlled clinical trial

  • Lee, Eon Sook;Yang, Yun Jun;Lee, Jun Hyung;Yoon, Yeong Sook
    • Journal of Ginseng Research
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    • 제42권2호
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    • pp.192-198
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    • 2018
  • Background: Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance. Methods: Sedentary individuals (n = 117) were randomly assigned into one of three groups: low-dose ginsenoside supplementation (100 mg/d, n = 39), high-dose ginsenoside supplementation (500 mg/d, n = 39), or a placebo group (500 mg/d, n = 39). All participants underwent a supervised 12-wk aerobic and resistance exercise training course. To assess the effects of supplementation on physical performance, maximal oxygen consumption ($VO_2max$), anaerobic threshold (AT), lactic acid, and muscle strength of the dominant knee were measured at baseline, every visit, and after the training program. Results: Both ginsenoside groups showed significant increases in $VO_2max$ and muscular strength during exercise training. There were no definite changes in AT and lactic acid levels over time. After exercise training, there were definite differences in the $VO_2max$ (28.64.9 to $33.7{\pm}4.9ml/kg/min$ in high-dose group vs. $30.4{\pm}6.7$ to $32.8{\pm}6.6ml/kg/min$ in placebo, p = 0.029) and AT ($19.3{\pm}4.2$ to $20.9{\pm}3.5ml/kg/min$ in high-dose group vs. $20.0{\pm}5.1$ to $20.0{\pm}4.9ml/kg/min$ in placebo, p = 0.038) between the high-dose ginsenoside and placebo groups. However, there was no difference in $VO_2max$ between the low-dose ginsenoside and placebo groups (p = 0.254). There were no differences in muscular strength during exercise training among the three groups. Conclusion: High-dose ginsenoside supplementation (UG0712) augmented the improvement of aerobic capacity by exercise training.

소음인(小陰人)의 장부경락론적(臟腑經絡論的) 고찰(考察) (Overview of four subgroups in Soeum(Lessor Yin) Constitution, Which are classified based on 'Chang(=Viscera) and Fu(=Bowels) meridian theory')

  • 염태환
    • 사상체질의학회지
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    • 제12권1호
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    • pp.10-23
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    • 2000
  • 이제마선생에 의해 제창된 사상체질론은 지난 백년간 후세 사상연구가들에 의하여 발전되어 왔다. 그 중 하나가 바로 권도원 선생에 의해 제창된 체질침(體質針)의 출현이었던 것이다. 체질침범에서는 종래의 방법과는 다른 새로운 맥법(脈法)과 맥도(脈圖) 그리고 체질에 따른 체질침방(體質針方)이 운용되고 있다. 이 체질침방의 경우 실제로는 장부경락(臟腑經絡)의 오행혈을 운용한 사암(舍岩)선생의 오행침을 체질침화(體質針化)한 것이다. 이제마 선생의 체질이론과 사암선생의 오행침이 결합된 것은 실로 역사적인 일이라 하지 않을 수 없다. 권도원 선생은 여덟 개의 맥도와 함께 8체질론을 내세웠으며 스물네개의 사암선생 침방 중 여덟 개를 체질침화하여 이 여덟 체질의 기본 치료처방으로 사용하였다. 본 논문의 저자인 염태환은 지남 1986년 미국 라스베가스에서 열린 동양의학 학술대회에서 이미 24체질론과 24체질 맥도를 제시한 바 있다. 본 논문은 우선 체질의학의 발달에 대한 역사를 간단히 정리하였다. 4체질론에서 시작하여 24체질론까지의 발전되어 온 단계 단계가 여기에 설명되어 있다. 이 설명 속에서 십이경락이 어떻게 사상의학과 이론적으로 결부되는가를 이해하게 되면, 24체질론의 출현이 쉽게 받아들여질 것이다. 본 논문은 이 24체질 중 특히 소음인에 속하는 네 체질에 대하여 초점이 맞추어져 있다. 이 네 개의 체질에 대한 체질맥진법, 맥도, 침법 그리고 한약처방 등이 이 논문에 다루어지고 있는 것이다. 그리고 이 논문의 뒷부분에는 이 네 체질에 대한 저자들의 임상 실례들이 실려 있다. 이 논문의 목적은 새로운 학설을 임상실례와 더불어 소개함으로써, 더욱 많은 한의사들이 관심을 가지고 체질침을 임상에 응용하게 하며 또한 앞으로 치료효과를 객관적으로 밝히기 위한 이중맹검시험(Double blind controlled study) 등이 시행될 수 있는 토대를 마련하고자 하는 것이다.

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Single buccal infiltration of high concentration lignocaine versus articaine in maxillary third molar surgery

  • Phyo, Hnin Ei;Chaiyasamut, Teeranut;Kiattavorncharoen, Sirichai;Pairuchvej, Verasak;Bhattarai, Bishwa Prakash;Wongsirichat, Natthamet
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권4호
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    • pp.203-212
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    • 2020
  • Background: This research evaluated the numbness produced by lignocaine at an equal or higher concentration than that of 4% articaine through a single point of injection for maxillary third molar surgery. This randomized double-blind study was conducted to compare the anesthetic efficiency of 4% lignocaine with that of 4% articaine in impacted maxillary third molar surgery using a single buccal infiltration alone. Methods: The study participants were 30 healthy patients requiring the bilateral surgical removal of symmetrically-positioned maxillary third molars. Using a split-mouth design, each patient randomly received buccal infiltration of 1.7 ml of 4% lignocaine and 1.7 ml of 4% articaine during two separate appointments. After 15 minutes of anesthetic injection, surgery was performed by the same surgeon using a consistent technique on both sides. Pinprick test pain scores of the buccal and palatal gingiva of the maxillary third molar after 10 minutes and 15 minutes latencies, pain scores during the surgery, the need for supplemental anesthesia, and patients' satisfaction with anesthetic efficiency were recorded. Surgery performed without supplemental anesthesia was categorized as successful. Results: The success rates of 4% lignocaine and 4% articaine (83.34% vs. 86.67%, P = 1.00) were not significantly different. Only 5 cases (4 cases in the articaine group and 1 case in the lignocaine group) reported mild pain and pressure sensation (NRS ≤ 1) on probing at the palatal side after 15 minutes of latency (P = 0.25). The pain scores of maxillary third molar surgery in the two groups were not significantly different (P > 0.05). Moreover, the statistical analysis confirmed the comparable patient satisfaction of two study groups (P = 0.284). Conclusion: This study provides evidence that single buccal infiltrations of 4% lignocaine and 4% articaine have comparable anesthetic efficacy and success rates for impacted maxillary third molar surgery. Both 4% lignocaine and 4% articaine can produce effective palatal anesthesia and pain control using buccal infiltration alone after 15 minutes of latency.

Effects of Antioxidant Nutrient Supplementation on the Lipid Peroxidation and Antioxidative Enzyme Activities in Patients with Coronary Heart Disease

  • Joung, Hyojee;Chun, Byung Yeol;Choi, Young Sun;Kim, Sueun;Park, Wee Hyun;Jun, Jae Eun;Chae, Shung Chull;Song, Kyung Eun;Cho, Sung Hee;Oh, Hee Sook
    • Preventive Nutrition and Food Science
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    • 제6권1호
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    • pp.51-56
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    • 2001
  • This study was carried out to evaluate whether antioxidant nutrient suppplementation with $\alpha$-tocopherol, vitamin C, $\beta$-carotene, and selenium reduces the lipid peroxide levels and increases the antioxidative enzyme activities in patients with coronary hart disease. Eighty nine patients participated in a randomized, double-blind, placebo-controlled trial. The antioxidant group (45 patients) was given daily doses of $\alpha$-tocopherol (400 IU), vitamin C (50 mg), $\beta$-carotene (15 mg), and selenium (50 $\mu\textrm{g}$) and forty four patients received a placebo. Thirty eight subjects (84.4%) of the antioxidant group and thirty nine subjects (88.6%) of the placebo group completed the three-month supplementation. Serum levels of tocopherol, vitamin C and $\beta$-carotene significantly increased in the antioxidant group compared with the baseline (p<0.05). Thiobarbituric acid-reactive substances(TBARS) decreased significantly (0.6 nmol MDA/mL) in the antioxidant group compared with that (0.09 nmol MDA/mL) in the placebo group (p=0.03). However, antioxidant supplementation did not affect the level of oxidized-LDL measured as autoantibodies against oxidized-LDL. The superoxide dimutase activity in red blood cells increased in the antioxidant group compared with the baseline (p<0.05). However, glutathione peroxidase activities did not change after supplementation in both groups, and catalase activity significantly decreased in the placebo group (p<0.05). These results suggest that antioxidant supplementation for 3 months with $\alpha$-tocopherol, vitamin C, $\beta$-carotene and selenium in patients with coronary heat disease may be partially protective against oxidative stress.

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한의약소재 스포츠음료수 섭취가 운동-유발성 피로의 단시간 회복에 미치는 영향 (Effect of Oral Sport Beverages with Medicinal Herbs Added on Short-term Recovery from Exercise-induced Fatigue)

  • 나현종;이규락;강호율
    • 대한한의학회지
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    • 제27권1호
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    • pp.36-46
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    • 2006
  • Objectives : Ginseng Research Group in Korea Food Research Institute developed Saeng Mac San (KFRI-2)and Je Ho Tang (KFRI-3) with their sensory factors more acceptable. And we examined their effects on the short-term recovery capacity for cycling exercise (EX) maintained to all-out. Methods : Seven healthy young subjects (aged $24.0{\pm}2.1yr$) were volunteered at this double blind test. Each of KFRI-2, 3, a commercial sport beverage and control (CON) was offered randomly on a series of EX protocol including 65% VO2max-90min EX (D-ride). 1h-recovery and 85% VO2max EX to all-out (P-ride) under the control of their heart rate (HR) and rating perception of exertion (RPE). Blood samples were collected before D-ride, 30, 60 and 90min in D-ride, 30 and 60min in the recovery period and each 10min in P-ride. Plasma analysis items were glucose, insulin, cortisol (CORT), testosterone (TEST), free fatty acid (FFA), $Na^+$, Cl-and $K^+$. The collected data (Means${\pm}$SE) were analysed by two-way ANOVA and statistically significant differences between treatments (p<0.05) by LSD.; the significant level in FFA, $Na^+$, Cl-and $Na^+$ was p<0.01 Results : At 30min during recovery. plasma glucose level in KFRI-3 was significantly higher than CON, and also insulin in KFRI-3 was than CON and KFRI-2. FFA in KFRI-3 was significantly lower than CON during recovery. $Na^+$ in KFRI-3 significantly higher than CON at 90min in D-ride, and also KFRI-2 was at 60min during recovery. However CORT, TEST, Cl-and $Na^+$ in treated beverages were not significant. KFRI-2, 3 elevated the time for P-ride more than CON did. Conclusions : KFRI-2, 3 elevated the time for P-ride about 12% more than CON did. It is based on rapid recovery of plasma glucose level and inhibition of lipolysis during recovery.

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아토피 피부염 외용제에 관련된 국내 임상 및 실험 논문 고찰 (Review of Clinical and Experimental Studies on External Application Treatment for Atopic Dermatitis in the Korean Literature)

  • 민들레;박은정;강경하
    • 대한한방소아과학회지
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    • 제27권1호
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    • pp.36-49
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    • 2013
  • Objectives The goal of this review is to investigate clinical and experimental studies on external application treatment for atopic dermatitis in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Methods Electronic researches were performed with KTKP, OASIS, National Assembly Library, Korean Medicine Database, KISS, DBpia, and KISTI. Results and Conclusions In Twenty six studies, the numbers of clinical and experimental studies are respectively 10 (38.46%) and 16 (61.54%). The numbers of studies that used herbal complex were 20 (76.92%), and out of that, 6 studies had used a single herbal medicine (23.08%). The external application with oriental medicine for the atopic dermatitis used with Phellodendri Cortex (7), Sophorae Radix (6), Scutellariae Radix (6), Lonicerae Flos (5), Coptidis Rhizoma (5) and so on. Among the clinical studies, the 5 studies were double-blind and randomized-controlled study (50%). The numbers of studies that used Hanifin and Rajka Diagnostic Criteria (1980) were 6 (60%), and that used the Diagnostic Criteria in Korean Atopic Dermatitis (2005) were 4 (40%). Among the clinical studies, categories to evaluate of atopic dermatitis are respectively SCORAD Index (80%), Total IgE (80%), Eosinophil count (70%) and so on. All of the clinical studies (100%) showed a statistically significant decline in atopic dermatitis according to the SCORAD Index, Modified SCORAD Index, the Clinic index score. Among the experimental studies, the numbers of studies that used NC/Nga mice were 9 (56.25%), and out of that 5 studies used BALB/c mice (31.25%). Most of the studies (68.75%) used DNCB as allergy inducing materials. The scales for evaluation of atopic dermatitis were Clinical skin severity score, Histopathologic examination, Immunohematologic examination, safety test and so on. In 12 cases (75%) of experimental studies, the IgE level of experimental group showed a statistically significant decline after using external application. In 8 study cases (50%), Clinical skin severity score of experimental group showed a statistically significant decline after using external application.

Clinical Comparison of Low-dose and High-dose Steroid in Pediatric Cardiac Surgery with Cardiopulmonary Bypass

  • Choi Seok-Cheol;Kim Song-Myung;Kim Yang-Weon
    • 대한의생명과학회지
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    • 제12권3호
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    • pp.289-301
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    • 2006
  • Cardiopulmonary bypass (CPB) for cardiac surgery triggers the production and release of numerous chemotactic substances and cytokines, ensuing systemic inflammatory response that leads to postoperative major organ dysfunction. Traditionally, corticosteroids (steroid) have been administered to patients undergoing cardiac surgery to ward off these detrimental physiologic alterations. However, the majority of the studies have been performed on adult patients with high-dose steroid. We carried out a randomized, prospective, double-blind study to compare the efficacy of low-dose steroid with that of high-dose steroid and to determine the adequate dose of pretreated-steroid for prophylactic effects in pediatric cardiac surgery. Thirty pediatric patients scheduled for elective cardiac surgery were randomly assigned to two groups; fifteen patients received low-dose methylprednisolone (10mg/kg intravenously, n=15, low-dose group) and the others received high-dose methylprednisolone (30mg/kg intravenously, n=15, high-dose group) 1 hour prior to CPB. Arterial blood samples were taken before CPB (Pre-CPB), 10 minutes after start of CPB (CPB-10), and immediately after CPB-end (CPB-OFF) for measuring total leukocyte counts (T-WBC) and diff-counts, platelet counts, interleukin-6 (IL-6), myeloperoxidase (MPO), total antioxidant (TAO), neuron-specific enolase (NSE), troponin I (TNI), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, and blood urea nitrogen (BUN) levels. Other parameters such as volumes of urine output, pulmonary index $(PI,\;PaO_2/FiO_2)$, mechanical ventilating period, intensive care unit (ICU)-staying period, postoperative complications (fever, wound problem), postoperative 24 hrs and total volumes in blood loss, and hospitalized days were also assessed. All parameters were compared between two groups. There were no significant differences in T-WBC counts, monocyte fraction, platelet counts, TA levels, NSE levels, creatinine levels, BUN levels, the volumes of total urine output, PI, the incidences of fever and wound problem, postoperative 24hrs- and total-blood loss volumes and ICU-staying period between two groups (P>0.05). At CPB-OFF, neutrophil fraction, MPO level, TNI level, and AST level were higher in the high-dose group than in the low-dose group (P<0.05). IL-6 level at CPB-10 was higher in the high dose-group than in the low-dose group (P<0.05). Furthermore, mechanical ventilating periods and hospitalized days of the high-dose group were significantly longer than those of low-dose group (P<0.05). The high-dose group had significantly low lymphocyte fi-action at CPB-OFF compared with the low-dose group (P<0.001). These findings suggest that pretreatment of high-dose steroid is not superior to that of low-dose steroid regrading its potential benefits in pediatric cardiac surgery. Therefore, the conventional strategy of steroid treatment, high-dose pretreatment, should be modified in the cardiac surgery with CPB. However, further studies must be performed on the larger number of patients in as much as small number of patients in this study.

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The Effect of CYP2D6/3A5 Genotypes on Plasma Concentrations of Haloperidol after Adjunctive Treatment of Aripiprazole

  • Shim, Joo-Cheol;Ahn, Jung-Mi;Jung, Do-Un;Kong, Bo-Geum;Kang, Jae-Wook;Liu, Kwang-Hyeon;Shin, Jae-Gook
    • 생물정신의학
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    • 제18권2호
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    • pp.95-100
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    • 2011
  • Objectives To evaluate the drug interactions between aripiprazole and haloperidol, authors investigated plasma concentrations of those drugs by genotypes. Method Fifty six patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders 4th edition diagnosis of schizophrenia were enrolled in this eight-week, double blind, placebo-controlled study. Twenty-eight patients received adjunctive aripiprazole treatment and twenty-eight patients received placebo while being maintained on haloperidol treatment. Aripiprazole was dosed at 15 mg/day for the first 4 weeks, and then 30 mg for the next 4 weeks. The haloperidol dose remained fixed throughout the study. Plasma concentrations of haloperidol and aripiprazole were measured by high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline, week 1, 2, 4 and 8. $^*1$, $^*5$, and $^*10$ B alleles of CYP2D6 and $^*1$ and $^*3$ alleles of CYP3A5 were determined. The Student's T-test, Pearson's Chi-square test, Wilcoxon Rank Sum test and Logistic Regression analysis were used for data analysis. All tests were two-tailed and significance was defined as an alpha < 0.05. Results In the frequency of CYP2D6 genotype, $^*1/^*10$ B type was most frequent (36.5%) and $^*1/^*1$ (30.8%), $^*10B/^*10B$ (17.3%) types followed. In the frequency of CYP3A5 genotype, $^*3/^*3$ type was found in 63.5% of subjects, and $^*1/^*3$ type and $^*1/^*1$ were 30.8% and 5.8% respectively. The plasma levels of haloperidol and its metabolites did not demonstrate significant time effects and time-group interactions after adjunctive treatment of aripiprazole. The genotypes of CYP2D6 and 3A5 did not affect the plasma concentration of haloperidol in this trial. No serious adverse event was found after adding aripiprazole to haloperidol. Conclusion No significant drug interaction was found between haloperidol and aripiprazole. Genotypes of CYP2D6 and 3A5 did not affect the concentration of haloperidol after adding aripiprazole.