• Title/Summary/Keyword: Double Blind

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Review of Research Trends and Evaluation Tools for Clinical Studies of Neck Pain and Cervical Spondylosis : Using the Pubmed Database (Pubmed분석을 통한 경추통과 경추 척추증의 임상연구 최신동향 및 평가도구에 관한 고찰)

  • Kim, Myung Kwan;Kim, Young-Il;Kim, Eun Seok;Jung, In Chul;Park, Yang-Chun;Jeon, Ju Hyun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.32 no.4
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    • pp.232-246
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    • 2018
  • The purpose of this research is to contribute to clinical researches on neck pain and cervical spondylosis by reviewing the latest research trends and evaluation tools through the analyses of clinical studies on neck pain and cervical spondylosis over the last 5 years. 70 papers satisfying the selection conditions among the RCT papers that had been searched as "neck pain" or "cervical spondylosis" at Pubmed(https://www.ncbi.nlm.nih.gov/pubmed) from March 2011 to February 2016 were targeted. Papers were numbered in order of their publication dates and analyzed by classifying their contents into 1) pain classification, 2) treatment type, 3) treatment duration, 4) treatment time, 5) number of participants, 6) evaluation tools and methods of research, and 7) evaluation duration. 55 papers targeted chronic neck pain, 6 papers acute and subacute neck pain, and 2 papers subacute and chronic neck pain. In comparison by intervention, 43 papers corresponded to physical therapy, 3 papers to acupuncture, 1 to herbal fomentation, 5 to medication, and 18 papers corresponded to multilateral comparisons comparing the efficacy by various interventions. In research period, there were 50 papers based on treatment period, 16 papers based on the number of treatments, and 4 papers based on different periods depending on each group. In treatment duration, the cases from 1 month or more to less than 3 months were most, followed by the cases of less than 1 month, and the cases from 3 months or more to less than 6 months. In treatment frequency, the number of treatments of the treatment group was the same as that of the control group in 51 papers, and many treatments were conducted by the methods of acupuncture, manual therapy, and injection therapy in cases of once or twice of treatments, and physical therapy and electroacupuncture corresponded mainly to the cases from 3 times or more to less than 10 times of treatments, and retrospective observation and exercise programs corresponded mainly to the cases of more than 30 times of treatments. In the number of subjects of the researches, the cases from 50 or more to less than 100 were most, followed by the cases from 20 or more to less than 50. There were 7 evaluation tools cited 10 times or more: VAS, NRS, PPT, NDI, NPQ, CROM, and SF-36. In evaluation period, 37 papers evaluated only during the treatment period, and 33 papers conducted follow-up. In follow-up period, the cases of less than 3 months were most, followed by the cases from 6 months or more to less than 1 year, and the cases from 3 months or more to less than 6 months. When planning clinical researches on cervical pain in the future, appropriate intervention methods, frequency and duration of treatment, period of follow-up, appropriate number of subjects and selection of evaluation tools for objective validity will have to be considered. In addition, randomization, double-blind, etc. will have to be considered for researches with high basis level.

Effects of Laminaria Japonica Extract Supplement on Blood Glucose, Serum Lipids and Antioxidant Systems in Type ll Diabetic Patients (다시마추출물이 제2형 당뇨병 환자의 혈당, 지질 및 항산화 체계에 미치는 영향)

  • Park, Min-Jung;Ryu, Ho-Kyung;Han, Ji-Sook
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.36 no.11
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    • pp.1391-1398
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    • 2007
  • We performed a randomized double-blind placebo-controlled trial to determine whether Laminaria japonica extract (LJE) supplement modulates blood glucose, serum lipids and antioxidant systems in type II diabetic patients. We also measured critical parameters assessing safety in liver and kidney functions after LJE supplement. A total of 37 patients (18 males and 19 females) were randomized to either LJE group or placebo group. The treatment group received four 350 mg of LJE capsules (1.4 g, total) per day for 12 weeks. The placebo group received the same dose of cellulose capsules. Baseline characteristics regarding general life style and dietary intake pattern were similar between the two groups. There were no significant influences of LJE supplement except for waist circumference on anthropometric parameters. As the whole, 12 weeks of LJE supplement resulted in a little decrease in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c), but a significant decrease was not observed. Total cholesterol, LDL-cholesterol and triglyceride concentrations were significantly (p<0.05) lowered in LJE group. The antioxidant enzymes, glutathion peroxidase (GSH-px) and superoxide dismutase (SOD) levels were elevated in the LJE group (p<0.05) compared to the placebo. The increase of these enzymes was associated significantly with the decrease of MDA concentration (p<0.05). Furthermore, LJE supplement showed no adverse effects on the functions of liver and kidney. Findings from this study suggest that LJE supplement can help improve serum lipid status in type II diabetic subjects without adverse effects.

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.

The Efficacy of Nebulized 3 Percent Hypertonic Saline Solution and Fenoterol in Infants with Bronchiolitis (영아 세기관지염에서 3% 고장성 식염액과 Fenoterol 병용흡입 치료의 효과)

  • Park, Joon Young;Jeong, Young Mi;Jeong, Soo Jin;Seo, Son Sang
    • Clinical and Experimental Pediatrics
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    • v.48 no.5
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    • pp.518-522
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    • 2005
  • Purpose : To evaluate the effect of inhaled hypertonic saline solution in hospitalized infants with bronchiolitis. Methods : A randomized double blind trial was performed from October 2003 to May 2004. A total of eighty patients <1 year of age with a clinical diagnosis of acute viral bronchiolitis were enrolled and assigned to receive either of the following : inhalation of 2 mL(0.5 mg) fenoterol added to 2 mL of 0.9 percent saline solution(group 1; n=40) or 2 mL(0.5 mg) fenoterol added to 2 mL of 3 percent saline solution(group 2; n=40). This therapy was repeated at six hours interval after admission. They were evaluated daily just before and 20 minutes after nebulization. The outcome measures included changes in clinical severity score(based on respiratory rate, presence of wheezing, retraction, and general condition) after nebulization and duration of hospitalization. Results : In the clinical severity score, a significant improvement was observed during the 72 hours of hospitalization in both groups(P<0.05). The basic clinical severity scores before inhalation were decreased significantly faster in group 2 as compared to group 1 on each day of treatment(P<0.05). The mean duration of hospital stay was significantly reduced in group 2 than group 1($5.9{\pm}1.9days$ versus $7.4{\pm}2.0days$, P<0.05). No adverse effects were associated with inhaled therapy. Conclusion : These results suggest that a nebulized 3 percent saline solution plus 0.5 mg fenoterol may be more effective than a 0.9 percent saline solution plus 0.5 mg fenoterol in accelerating the clinical recovery of infants with viral bronchiolitis.

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 the Mixture of Vitamin C, Vitamin E, Pycnogenol and Evening Primrose Oil on the UV-Induced Pigmentation and Wrinkle Reductions in Human Skin (비타민과 불포화지방산, 그리고 피크노제놀을 함유한 복합제제의 주름 완화 및 자외선에 의한 색소침착 개선 효과)

  • Chang, Min-Youl;Park, Sang-Ki;Kwak, Taek-Jong;Park, Hyoung-Kook;Lee, Cheon-Koo;Lee, Heon-Sik;Ly, Sun-Yung;Kim, Seong-Jin
    • Journal of Nutrition and Health
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    • v.42 no.6
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    • pp.516-522
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    • 2009
  • In this study, the effects of a mixture consisting of vitamin E, vitamin C, pycnogenol and evening primrose oil (mixture LGNC-5) on ultraviolet light (UV) induced pigmentation and wrinkle reductions of normal healthy volunteers were studied. In a double-blind placebo-controlled study, each of 54 subjects took daily either 4 capsules of the mixture LGNC-5 (Group ABC; 282.5 mg/capsule) or placebo (Group Ganada). We irradiated 2.5 MED UV on the upper arms and measured the whitening effect by colorimeter-based L value. The level of wrinkle reduction was determined by image analysis using skin replica around the crow' feet, and the level of serum vitamin E was determined at baseline and 12 weeks. After 12-week oral administration, the treated group showed a significant reduction in skin pigmentation and wrinkles compared with the placebo group (p = 0.011 and p = 0.000005, respectively). Also, the level of serum vitamin E was significantly increased in the treated group after 12-week oral adminstration of the mixture compared with that in the placebo group (p = 0.0001). In conclusion, 12-week oral administration of LGNC-5 as a dietary supplement could be effective to reduce both UV induced pigmentation and skin wrinkle without side effects.

Is Premedication Necessary for Outpatient Fiberoptic Bronchoscopy (외래환자의 기관지내시경검사시 전처치의 필요성)

  • Won, Jun-Hee;Park, Jae-Yong;Cha, Seung-Ick;Kang, Tae-Kyong;Park, Ki-Su;Kim, Yeon-Jee;Kim, Chang-Ho;Jung, Tee-Hoon
    • Tuberculosis and Respiratory Diseases
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    • v.46 no.2
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    • pp.251-259
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    • 1999
  • Background: Even though the necessity for premedication has been questioned, some combinations of antisialogogues, sedatives and analgesics are usually employed by most bronchoscopists. The goal of this study was to determine whether fiberoptic bronchoscopy(FOB) could be performed safely and effectively without premedication while using a standardized topical anesthetic. Method: Eighty outpatients were randomized in a double-blind manner into group I(n=20) with 1 ml normal saline, group II(n=20) with 0.5mg of atropine, group III(n=20) with 0.5mg of atropine plus 5mg of midazolam, and group IV(n=20) with 0.5mg of atropine plus 50mg of meperidine, given intramuscularly 30 minutes before FOB as premedication Topical anesthetics administered were same in each group. Each patient was given 5ml(200mg) of 4% nebulized lidocaine and additional intratracheobronchial 2% lidocaine. Oxygen saturation, pulse rate and electrocardiogram were monitored and recorded before, during, just after and 2 minutes after FOB. Immediately after FOB, the bronchoscopists answered four questions such as ease of procedure, extent of coughing, extent of secretion, and overall impression. Before leaving bronchoscopy suite, patients completed similar questions on discomfort during procedure, and willingness to return for a repeat procedure. Results: Age, gender, baseline pulmonary function, dose of 2% lidocaine used for topical anesthesia, and duration of FOB were not significantly different. There was no statistical difference among group I to IV with regard to extent of coughing answered by bronchoscopist. But extent of secretion was significantly different between group I without atropine and group II-IV with atropine. And there was also significant difference in ease of procedure and overall impression among groups. There was no statistical difference in patient's willingness and level of discomfort among the groups. Thirteen patients(16%) showed hypoxemia(arterial oxygen saturation: <90%), and 3 patients(4%) showed significant tachyarrhythmia(heart rate: > l60/min), but the rate of complication was not statistically different among the groups. Conclusion: These results suggest that the value of premedication is questionable for outpatient FOB, although it may be necessary in excessively anxious patient.

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Changes of Sputum Matrix Metalloproteinases and Tissue Inhibitor of Matrix Metalloproteinase-1 by Antibiotic Treatment in Acute Exacerbation of Chronic Bronchitis (만성 기관지염의 급성 악화에서 항생제 투여에 의한 유도객담 내 Matrix metalloproteinase와 Tissue inhibitor of matrix metalloproteinase의 변화)

  • Yoon, Hyoung-Kyu;Ahn, Joong-Hyun;Kim, Chi-Hong;Kwon, Soon-Seog;Kim, Young-Kyoon;Kim, Kwan-Hyung;Moon, Hwa-Sik;Park, Sung-Hak;Song, Jeong-Sup
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.4
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    • pp.420-430
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    • 2002
  • Background : Excessive extracellular matrix (ECM) deposition by airway inflammation is presumed to play an important role in the pathogenesis of worsening airflow obstruction (Ed- acceptable three-word noun) seen during acute exacerbations of chronic bronchitis. Although many proteases can cleave ECM molecules, matrix metalloproteinases (MMPs) and their inhibitors are likely to be the physiologically relevant mediators of ECM degradation. Objectives ; The purpose of this study was to demonstrate that antibiotic treatment can change airway MMPs and TIMP-1 concentrations/levels by controlling airway inflammation in acute exacerbation of chronic bronchitis. Methods : We studied 40 patients, all of whom had an acute exacerbation of chronic bronchitis. The patients were treated with two different antibiotics, moxifloxacin and clarithromycin, in a double-blind manner for 7 days. Sputum samples were induced and collected before and after antibiotic therapy. We measured the sputum concentration of MMP-1,-9, TIMP-1, IL-8 and secretory leukocyte proteinase inhibitor (SLPI) in sputum supernatants by ELISA method. Results : There was no difference after antibiotic treatment in the sputum concentrations of MMP-1,-9, TIMP-1, IL-8 and SLPI between the patients treated with moxifloxacin and those treated with clarithromycin. But the sputum concentrations of TIMP-1, and SLPI, and the TIMP-1/MMP-1 ratio were significantly reduced by the antibiotic therapy. There were significant positive correlations between sputum TIMP-1 levels and IL-8 levels (p<0.01, r=0.751), and between the sputum TIMP-1/MMP-1 ratio and IL-8 levels (p<0.01, r=0.752). The sputum SLPI levels were significantly elevated by antibiotic treatment and were negatively correlated with sputum TIMP-1 levels (p<0.01, r=-0.496) and TIMP-1/MMP-1 levels (p<0.01, r=-0.456). Conclusion : The study shows that the worsening of airway inflammation in acute exacerbation of chronic bronchitis is associated with an imbalance between the concentrations/levels of TIMP-1 and MMPs. Antibiotic treatment can prevent progression of airway narrowing in acute exacerbation of chronic bronchitis by modulation of the protease and anti-protease imbalance.

Effects of Korean Ginseng, Korean Red Ginseng and Fermented Korean Red Ginseng on Cerebral Blood Flow, Cerebrovascular Reactivity, Systemic Blood Pressure and Pulse Rate in Humans (인삼, 홍삼 및 발효 홍삼이 정상인의 뇌혈류, 평균혈압, 맥박수에 미치는 영향)

  • Jeong, Dong-Won;Hong, Jin-Woo;Shin, Won-Jun;Park, Young-Min;Jung, Jae-Han;Kim, Chang-Hyun;Min, In-Kyu;Park, Seong-Uk;Jung, Woo-Sang;Park, Jung-Mi;Go, Chang-Nam;Cho, Ki-Ho;Moon, Sang-Kwan
    • The Journal of Korean Medicine
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    • v.27 no.3 s.67
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    • pp.38-50
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    • 2006
  • Objectives: The aim of this study was to evaluate the effects of Korean ginseng (KG), Korean red ginseng (KRG) and fermented Korean red ginseng (FKRG) extracts on cerebral hemodynamics and to compare distinction of each extract. Methods: Ten healthy male volunteers $(26.0{\pm}1.8yrs)$ participated in the study according to double-blind and cross-over protocols. Each volunteer was blindly administered 500mg of KG, KRG, FKRG extract or placebo (Dextrin). Blinded researchers measured changes of hyperventilation-induced cerebrovascular reactivity (CVR), mean blood flow velocity (MBFV) of middle cerebral arteries (MCAs) and corrected blood flow velocity at $P_{ETCO2}=40mmHg$ (CV40) using transcranial Doppler ultrasound (DWL Co., Germany). Researchers also observed changes of mean blood pressure (MBP), pulse rate (PR) and expiratory $CO_2$ using S/5 Collector (Datex-Ohmeda Co., Finland). The evaluation was performed at basal condition, and repeated at 1, 2, 3, 4 and 5 hours after administration. Results: MBFV and CV40 in the KRG group tended to rise at I hour after administration, while those of the FKRG group tended to rise at 2 hours after administration. CVR increased significantly after 1 hour in the KRG group (p=0.009) and after 2 hours in the FKRG group (p=0.035), respectively. The KG group showed increasing tendency at 4 hours after administration. No group showed significant difference from the placebo in changes of MBP and PR. Conclusions: It is suggested that KG, KRG and FKRG extracts have effects of enhancing CVR and thus of increasing cerebral blood flow in human subjects.

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The Effect of Red-Yeast-Rice Supplement on Serum Lipid Profile and Glucose Control in Subjects with Impaired Fasting Glucose or Impaired Glucose Tolerance (공복 혈당장애 및 내당능장애자에서 홍국의 섭취가 혈중지질 및 혈당 조절에 미치는 영향)

  • Kang, Mi-Ran;Kim, Ji-Young;Hyun, Yae-Jung;Kim, Hyae-Jin;Yeo, Hyun-Yang;Song, Young-Duk;Lee, Jong-Ho
    • Journal of Nutrition and Health
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    • v.41 no.1
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    • pp.31-40
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    • 2008
  • This study was aimed at evaluating the effect of red-yeast-rice supplementation on cholesterol-lowering and glucose control in subjects with impaired fasting glucose (IFT) or impaired glucose tolerance (IGT). We conducted a doubleblind, placebo-controlled study with 3 groups; placebo, low dose group (red yeast rice 210.0mg/capsule, 2.52g/day) and high dose group (red yeast rice 420.0mg/capsule, 5.04g/day), which were randomly assigned to subjects with impaired fasting glucose or impaired glucose tolerance. We measured fasting serum concentrations of total-, LDL-, HDL-cholesterol, triglyceride, glucose, insulin, free fatty acid (FFA) and 2 h oral glucose tolerence test (OGTT) before and after the supplementation. Both low dose and high dose groups had significant decrease in LDL cholesterol and atherogenic index (AI) compared with placebo group (p<0.05). Additionally, total and HDL cholesterol improved significantly in high dose group compared with placebo group (p<0.05). Fasting serum glucose decreased in test groups and increased in placebo group after intervention. However, it was not significant differences. In subjects which fasting blood glucose is more than 110mg/dL, fasting glucose had a tendency to decrease in high dose group (p<0.1) and Hemoglobin A1c (HbA1c) had significant decrease in low dose group (p<0.05), while insulin and HOMA-IR had a tendency to increase in placebo group after intervention. Mean changes of glucose related parameters (fasting glucose, insulin, HOMA-IR) compared with placebo group did not show significant differences. In conclusion, subjects with impaired fasting glucose or impaired glucose tolerance were significantly improved in serum lipid profile by red yeast rice supplementation without serious side effects. These are more effective in the case of a high dose. The effects of red yeast rice supplementation on glucose control were insignificant.