• Title/Summary/Keyword: Placebo-controlled Study

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The Effect of Sa-am Acupuncture Simjeongkyeok Treatment for Major Symptom of Hwa-byung (화병의 핵심증상에 대한 사암침 심정격 치료의 효과)

  • Jeong, In-Chul;Lee, Sang-Ryong;Park, Yang-Chun;Hong, Kwon-Eui;Lee, Young-Koo;Kang, Wee-Chang;Choi, Sun-Mi;Choi, Kang-Wook;Oh, Dal-Seok;Park, Ji-Eun
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.1-18
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    • 2008
  • The purpose of this research is to examine the effect of Simjeongkyeok Sa-am acupuncture treatment for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared Simjeongkyeok acupuncture with Sham acupuncture in the treatment for major symptoms of Hwa-byung. Likert scale for major symptom of Hwa-byung was measured as the 1st evaluative instrument, and STAXI-K, STAI-K, BDI-K and HRV were also measured as the 2nd evaluative instrument at the before treatment and after treatment. Results : In comparison of Likert scale for major symptoms, total score of after treatment decreased significantly at each point on both groups, but there was no significant difference between both groups. In comparison of STAXI-K, STAI-K, BDI-K, there was no significant difference in variation of score between both groups. But Simjeongkyeok group showed higher ratio variation of STAXI expression than that of Sham group, Also on subjects whose main complaint symptom were burning sensation and whose pattern identification were Qizhi, Simjeongkyeok group showed higher variation of Likert scale score and BDI-K than that of Sham group. The significance was border line around. Conclusion : We considered that Shimjeongkeok treatment will he likely to he recommended for treating Hwa-byung, especially on subjects in each group whose main complaint symptom were burning sensation or whose pattern identification were Qizhi. Also it may also be effective on the management of anger expression.

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The Effects of distilled Astragali Radix Herbal Acupuncture on the Heart Rate Variability(HRV) (황인 약침이 정산인의 심박변이도(HRV)에 미치는 영향)

  • Lim, Sung-Taek;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.107-124
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    • 2008
  • We investigated the effects of distilled Astragali Radix Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Astragali Radix Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 61 healthy volunteers consisted of 31 subjects in experiment(distilled Astragali Radix Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Astragali Radix Herbal Acupuncture at GB21(Kyonjong) and 30 subjects in control group were injected Normal Saline at GB21(Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 25 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t test(in group) and Student t test(between two groups) were used to verify the result. Results : I. After distilled Astragali Radix Herbal Acupuncture injection, SDNN is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute, Complexity is significantly low from 20 minute to 30minute. HRV index is significantly mgb for first 20 minute and from 25 minute to 30 minute, RMSSD is significantly high only from 15 minute to 20 minute. 2. HRV index of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, pNN50 of distilled Astragali Radix Herbal Acupuncture Group significantly decreased from 25 minute to 30 minute and RMSSD of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Astragali Radix Herbal Acupuncture injection, Ln(TP) is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute. Ln(VLF) is significantly high after 5 minute, Ln(LF) is significantly high after 15 minute and Ln(HF) is significantly high from 5 minute to 10 minute and 25 minute to 30 minute, but significantly low for first 5 minute and from 10 minute to 20 minute. Normalized LF is significantly high after 20 minute and Normalized LF is significantly low after 20 minute. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system within normal range. This result is derived from that parasympathetic nervous system was continuously activated and sympathetic nervous system was activated a little later.

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Clinical Practice Guideline for acupuncture in Post-stroke urinary incontinence (뇌졸중 후 요실금에 대한 침치료 임상진료지침)

  • Lee, Ji-Won;Shin, Byung-Cheul;Lee, Myeong-Soo;Lim, Sung-Min;Yoo, Jung-Hee;Cho, Chung-Sik;Moon, Sang-Kwan;Yook, Tae-Han;Joo, Jong-Cheon;Lee, Eui-Ju
    • Journal of Sasang Constitutional Medicine
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    • v.29 no.4
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    • pp.317-325
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    • 2017
  • Objectives This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the stroke patients with Post-stroke Urinary Incontinence(PSUI). Methods Experts committee, consisting of stroke or methodology specialists, searched Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and 19 Korean medicine journals. The search terms were selected to screen the randomized controlled trials (RCTs) or systematic reviews for the effectiveness of acupuncture on PSUI, compared with placebo or conventional group. Levels of evidence and grades of recommendations were appraised based on Recommendations for Development of Clinical Practice Guideline in Korean Medicine. Results & Conclusions 8 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of acupuncture treatment for PSUI. The moderate evidence was presented that over 3 times a week of the acupuncture should be performed over 4 weeks on the acupoints, such as BL23, CV3, SP6, CV4, CV6, ST28, BL28, BL32, GV20, BL22, GV4 or ST36, for 15-30 minutes. 1-150 Hz frequency is suggested if electro-acupuncture treatments is performed with. It was also suggested that the procedure should begin at the acute stage just after the vital signs of the patients are stabilized. There was a moderate evidence to support safety of acupuncture treatment for PSUI. We recommend acu-points of constitutional acupuncture for Sasangin on the healthy side.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • The Journal of Korean Medicine
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    • v.44 no.4
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    • pp.104-120
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    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

Effect of Sa-am Acupuncture Method for Chronic Tension-type Headache;A Randomized Controlled Trial (만성 긴장성 두통 환자에 대한 사암침 치료효과의 Pilot 임상연구)

  • Hong, Kwon-Eui;Park, Yang-Chun;Jo, Jeong-Hyo;Jo, Hyun-Gyeong;Jeong, In-Cheol;Kang, Wee-Chang;Lee, Sang-Bong;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.24 no.1
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    • pp.13-28
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    • 2007
  • Objectives : Clinical character of chronic tension-type headache is bilateral, moderate intensity, persistent and chronic, repeating disease and CTTH is a common prevalent disease, but pathophysiology and likely mechanism remain unclear. It impedes subjective quality of life. The purpose of this research is to examine the effect of sa-am acupuncture method for chronic tension-type headache. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture for the treatment of chronic tension-type headache. Volunteers who satisfied the requirements were enrolled in study. Evaluation of chronic tension-type headache was measured by VAS and Headache Disability Inventory(HDI), Six point Linkert Scale before and after treatments. Results : 26 subjects finished study. There were not difference between two groups on age, sex, weight, height, blood pressure, pulse, respiratory rate, Byeonjeung, sunrise of treatment. In change of VAS, there were not difference between two groups on before treatment. Before treatment per visit, VAS of 6th and 7th visit were significantly decreased in active acupuncture(each p=0.039, p=0.008) and were not decreased in sham acupuncture. In change of VAS on a withdrawing needling after treatment, VAS of 1st, 2nd, 6th and 7th visit were significantly decreased in active acupuncture (each p=0.001, 0.038, 0.035, 0.008) and VAS of 2nd, 4th and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.033, 0.032, 0.035, 0.031). In change of VAS on 2hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.014, 0.023, 0.027) and 5th visit were significantly decreased in sham acupuncture(each p=0.004, 0.009). In change of VAS on 4hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.018, 0.011, 0.015) and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.020, 0.015). In change of VAS on the next day after treatment, VAS of 3th and 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.032, 0.011, 0.005, 0.012) and 4th, 5th visit were significantly decreased in sham acupuncture(each p=0.001, 0.012). In change of VAS according to a current time(before treatment, after a withdrawing needling, 2hrs, 4hrs, the next day), total score of VAS was decreased more active acupuncture group than sham acupuncture group, but there were no statistical significance compared with sham acupuncture group. In change of HDI score, after treatment was decreased than before treatment in two group, but there were no statistical significance compared with two group. In change of Six point Linkert scale score, after treatment was decreased than before treatment in two group on 6th, 7th visit(active acupuncture 6th 7th each p=0.002, 0.003, sham acupuncture 6th 7th each 0.003, 0.009), but there were no statistical significance compared with tow group. Conclusion : Sa-am acupuncture treatment is effective to improve the symptoms and quality of life in patients with chronic tension-type headache.

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The Efficacy of Aspirin in Preventing the Recurrence of Colorectal Adenoma: a Renewed Meta-Analysis of Randomized Trials

  • Zhao, Tai-Yun;Tu, Jing;Wang, Yin;Cheng, Da-Wei;Gao, Xian-Kui;Luo, Hao;Yan, Bi-Chun;Xu, Xiao-Li;Zhang, Hong-Ling;Lu, Xing-Jun;Wang, Yao-Jun
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.5
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    • pp.2711-2717
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    • 2016
  • Background: Through search the possible randomized control trials, we make a renewed meta-analysis in order to assess the impact of aspirin in preventing the recurrence of colorectal adenoma. Materials and Methods: The Medicine/PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese biomedical literature service system (SinoMed) databases were searched for the related randomized controlled trials until to the April 2016. Three different authors respectively evaluated the quality of studies and extracted data, and we used the STATA software to analyze, investigate heterogeneity between the data, using the fixed-effects model to calculate and merge data. Results: 7 papers were included the renewed meta-analysis, among these studies, two pairs were identified as representing the same study population, with the only difference being the duration of follow-up. Thus there were only five papers included our meta-analysis, and one Chinese paper were also included the work. Results were categorized by the length of follow-up, different kinds of people, varied dose of oral aspirin. The relative of adenoma in patients taking aspirin vs placebo were 0.73 (95% CI 0.55-0.98, P=0.039) with 1 year follow up; 0.84 (95% CI 0.72-0.98, P=0.484) with greater than 1 year follow up; for the advanced adenoma, the RR 0.68 (95% CI 0.49-0.94, P=0.582),for one year; RR=0.75 (95% CI 0.52-1.07, P=0.552) for greater one year. Furthermore the white population could divided into two subgroups according to the different length of follow-up time. When the length of follow-up time less than 3-year, The RR of two subgroups respective were RR=0.86 (95% CI 0.76-0.98, P=0.332), $I^2=0%$, RR=0.68 (95% CI 0.47-0.98, P=0.552), $I^2=64.6%$, But with the extension of follow-up time greater than 2-year, with the white, oral aspirin without considering dose had no efficacy on preventing the recurrence of any adenoma, the RR was 0.86 (95% CI 0.71-1.05, P=0.302), $I^2=16.4%$. Conclusions: This meta-analysis indicated that oral aspirin is associated with a remarkable decrease in the recurrence of any adenoma and advanced adenomas in patients follow-up for 1 year without concerning the dose of aspirin, but with the extension of follow-up time for greater than 1 year, oral aspirin can be effective on preventing the recurrence of any adenoma, but for the advanced adenoma, the result indicated that oral aspirin had no efficacy, According to the inclusion of ethnic groups, we also divided relevant papers into two subgroups as the yellow and white group. Then the follow-up time was less than 3 years, oral aspirin without considering the dose, had an significant efficacy on preventing the recurrence of any adenoma. But with the follow-up greater than 2 years, oral aspirin had no effect in the white.

Effect of Bright Light Exposure on Adaptation to Rapid Night Shift : A Field Study of Shift Work Nurses in Psychiatric Ward (순환제교대근무자에서 야간 근무 적응에 대한 광치료 효과)

  • Ko, Young-Hoon;Joe, Sook-Haeng
    • Sleep Medicine and Psychophysiology
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    • v.9 no.1
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    • pp.41-47
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    • 2002
  • Objectives: In a number of simulated night shift studies, timed exposure to bright light improves sleep quality and work performance. We evaluated the effect of bright light on adaptation to night shift work with a field study. Methods: Five female nurses working shifts at Korea University Hospital were recruited for participation in this study. We investigated two series of six consecutive shift rotations comprising three day and three night shifts, using wrist Actigraphy, the Stanford Sleepiness Scale, Visual-analogue scales, STIM and tympanic membrane temperature for daytime sleep quality, alertness, subjective feeling, attention performance, and temperature rhythm. The subjects were exposed to bright light (2,500 lux) from 24:00 to 04:00 a.m. on three consecutive night shifts during the second series, whereas they worked under normal lightening (650 lux) conditions during the first series. Results: Actigraphic assessment of daytime sleep showed no significant difference between the first and third night shift in both baseline and light exposure phase. The mean lowest temperature shifted earlier during baseline phase but not during the light exposure phase. Also, the score for subjective feelings of depression, anxiety, physical discomfort and sleepiness was significantly higher in the third night shift than the first during baseline phase but not during the light exposure phase. Attention and attention switching ability was significantly improved in the third night shift compared to the first night during the light exposure phase but there were no significant changes during the baseline phase. Conclusion: This result suggests that there were no significant differences between the two phases in measures of quality of daytime sleep, but subjective feelings, attention and alertness were enhanced during light exposure. Although some placebo effects and learning effects might influence this result, bright light exposure between midnight and 4:00 a.m. may improve adaptation to night shift. In future, further controlled studies with a larger sample size, including melatonin measurement, are needed for real shift workers.

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Effect of Glucose Control, SDSCA and Quality of Life of D-chiro-inositol(DCI) in patients with type 2 diabetes: A Path Analysis (제2형 당뇨병 환자의 D-chiro-inositol의 혈당강하 효과와 당뇨 자가관리 및 삶의 질: 경로분석)

  • Kang, Young Mi;Kim, Hyun Jin;Lee, Tae-Yong;Ku, Bon-Jeong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.10
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    • pp.243-253
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    • 2018
  • This study aimed to investigate the effects of DCI on glucose control, quality of life(SF-36 Version 2.0, Korean) and SDSCA(Summary of Diabetes Self-Care Activities) in patients with type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled study was performed on 46 patients with HbA1c 7.0% taking triple anti-diabetic drug regimen who visited the department of Endocrinology and Metabolism in Chungnam National University Hospital between March 2015 and May 2016. As a result, DCI treatment in the intervention group resulted in significantly reduced HbA1c levels $8.75{\pm}0.79%$(baseline), $8.36{\pm}1.03%$(after 12weeks), and $8.65{\pm}0.81%$(after 24weeks). However, patients in the control group did not show any significant change. Interestingly, both DCI treatment group and the control group significantly showed improvements in SDSCA. Participants in the intervention group showed a small yet significant improvement in their only fasting blood glucose test in SDSCA and revealed significant increase in the quantitative levels of quality of life, from $73.05{\pm}16.85$ to $82.74{\pm}10.68$. By using pathway analysis, improvement of SDSCA scores(${\beta}=-0.505$, t=-2.743) was the most influential factor to the fasting blood glucose. The quality of life of patients with type 2 diabetes mellitus was affected by changes of SDSCA scores(${\beta}=0.411$, t=2.024) and fasting c-peptide(${\beta}=-0.445$, t=-2.668) in DCI treatment group. In conclusion, treatment of DCI effectively improved glucose control in patients with type 2 DM(HbA1c level>7.0%) after 12 weeks of treatment, although it had no impact on glucose control after 24 weeks of treatment. Improved glucose control may encourage diabetic patients to conduct self-care activities and improve the quality of life. Based on the present study, we suggest that diabetes self-management, as well as consideration of comprehensive laboratory findings, may be important factor in regulating the quality of life in type 2 DM patients.

Analgesic Effect of Sugar Solution in Infantile Colic (설탕물이 영아 산통의 통증 감소에 미치는 영향)

  • Kim, Jong Seok;Kwon, Kyung Ho;Lee, Young A;Kim, Hyeon Jeong;Lee, Kyun Woo
    • Clinical and Experimental Pediatrics
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    • v.45 no.6
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    • pp.712-718
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    • 2002
  • Purpose : Infantile colic is one of the most commonly encountered problems, characterized by excessive crying in apparently healthy young infants within the first 3 months of life. It is commonly assumed that the infant with colic has distress and possible pain. In recent investigations, it has been found that sucrose has an analgesic effect in newborn infants. The purpose of this study is to examine if sugar solution as sucrose also has an analgesic effect on infant colic. Methods : This prospective randomized, double-blind placebo controlled study examined healthy term infants aged 4 to 12 weeks with colic. A total of 40 infants were randomly assigned into two groups who visited Daedong Hospital from June 1999 to June 2001. Each group received sugar solution or sterile water. All data from parental diaries and interviews were recorded and analysed blindly. Results : The daily crying time and the colic improvement score were significantly better in sugar solution group as compared with the control(P=0.019, 0.045). No significant differences were noted between groups regarding the number of night wakenings(P=0.173). Conclusion : We conclude that sugar solution has an analgesic effect on infantile colic.

Effects of Onion Peel Extracts on Blood Circulation in Male Smokers (양파껍질추출물의 섭취가 남성 흡연자의 혈행개선에 미치는 효과)

  • Lee, Hye-Jin;Lee, Kyung-Hea;Cha, Young-Jun;Park, Eun-Ju;Shin, Min-Jeong
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.12
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    • pp.1790-1799
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    • 2010
  • A controlled and double blinded trial was performed to evaluate the effects of OPE supplementation on blood circulation in healthy male smokers. The study population consisted of 92 healthy male smokers aged $44.4{\pm}7.8$ years. The supplement group (n=49) received OPE containing 100 mg quercetin/day for 10 weeks, while the control group (n=43) received placebo powders. The prothrombin time and activated partial thromboplastin time increased significantly after OPE consumption, indicating the attenuated blood clot formation by OPE. In conclusion, these results indicate that the daily consumption of OPE (containing 100 mg quercetin) for 10 weeks exerts significant health benefits through the modulation of physiological functions including the blood circulation in male smokers.