• Title/Summary/Keyword: Placebo

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Blood Flow and Skin Temperature Increases by Monochromatic Infrared Energy Irradiation

  • Lee, Jae-Hyoung;Kim, Gi Won
    • The Journal of Korean Physical Therapy
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    • v.24 no.3
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    • pp.202-207
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    • 2012
  • Purpose: The purpose of this study was to determine the effect of monochromatic infrared energy (MIRE) on the blood flow of the superficial radial artery and local skin temperature in healthy subjects. Methods: Forty healthy volunteers were recruited and randomly assigned to MIRE group (n=20) and placebo group (n=20). The MIRE group received a 890 nm MIRE irradiation on the forearm using two therapy pads for 30 minutes. The therapy pad was composed of an array of 60 diodes. MIRE unit was set at bar 8, that corresponds to a diode power of 10 mW and a power density of $63mW/cm^2$. The placebo group received sham MIRE. Peak blood flow velocity (PBFV), mean blood flow velocity (MBFV), and skin temperature (ST) were measured pre- and post-MIRE irradiation. Results: There was a significant difference in PBFV (p<0.001), MBFV (p<0.001), and ST (p<0.001) between the pre- and post-treated values in the MIRE group. In contrast, no significant difference was found between the pre- and post-treated values in the placebo group. There was significant difference in mean change values from baseline of PBFV (p<0.001), MBFV (p<0.001), and ST (p<0.001) between the MIRE group and the placebo group. There was a significant increase in PBFV (p<0.001), MBFV (p<0.001), and ST (p<0.001) following MIRE irradiation. Conclusion: The arterial blood flow and local skin temperature of the forearm in the healthy subjects were significantly increased following MIRE irradiation.

Effects of Ephedra on Weight Loss and Heart Rate Variability: A Double-Blind Randomized Controlled Pilot Study (마황복용이 정상성인의 체중 감소와 심박변이도에 미치는 영향에 관한 예비 연구: 무작위배정 이중맹검시험)

  • Yang, Chang-Sop;Hsing, Li-Chang;Yeo, Jin-Ju;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.27 no.4
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    • pp.836-844
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    • 2006
  • Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

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Effects of Ephedra on the State-Trait Anxiety in Female Adults: A Double-Blind Randomized Controlled Study (마황복용이 성인여성의 상태-특성 불안에 미치는 영향: 무작위배정 이중맹검 임상연구)

  • Yang, Chang-Sop;Hsing, Li-Chang;Jeong, Hyun-Suk;Kim, Lak-Hyung;Kwak, Min-Jung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.28 no.2
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    • pp.346-353
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    • 2007
  • Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

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Lactobacillus rhamnosus GG Usage in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children with Gastroesophageal Reflux Disease Treated with Proton Pump Inhibitors: A Randomized Double-Blinded Placebo-Controlled Trial

  • Dziechciarz, Piotr;Krenke, Katarzyna;Szajewska, Hania;Horvath, Andrea
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.3
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    • pp.251-258
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    • 2020
  • Purpose: Proton-pump inhibitors (PPIs) are frequently used to treat gastroesophageal reflux disease (GERD) in children, but recent evidence suggests a potential association between PPI treatment and some types of infections. The aim of this study was to assess the effectiveness of Lactobacillus rhamnosus GG (LGG) for the prevention of gastrointestinal and respiratory tract infections in children with GERD treated with PPI (omeprazol). Methods: Children younger than 5 years with GERD were assigned by a computer-generated list to receive LGG (109 colony-forming units) or placebo, twice daily, concomitantly with PPI treatment for 4-6 weeks; they were followed up for 12 weeks after therapy. The primary outcome measures were the percentage of children with a minimum of one episode of respiratory tract infection and the percentage of children with a minimum of one episode of gastrointestinal infection during the study. Results: Of 61 randomized children, 59 patients (LGG n=30; placebo n=29, mean age 11.3 months) were analyzed. There was no significant difference found between the LGG and placebo groups, either for the proportion of children with at least one respiratory tract infection (22/30 vs. 25/29, respectively; relative risk [RR] 0.85, 95% confidence interval [CI] 0.66-1.10) or for the proportion of children with at least one gastrointestinal infection (9/30 vs. 9/29, respectively; RR 0.97, 95% CI 0.45-2.09). Conclusion: LGG was not effective in the prevention of infectious complications in children with GERD receiving PPI. Caution is needed in interpreting these results, as the study was terminated early due to slow subject recruitment.

An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

  • Park, Soo-Hyun;Oh, Mi-Ra;Choi, Eun-Kyung;Kim, Min-Gul;Ha, Ki-Chan;Lee, Seung-Kwon;Kim, Young-Gon;Park, Byung-Hyun;Kim, Dal-Sik;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.38 no.4
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    • pp.239-243
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    • 2014
  • Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

Effectiveness of Bee Venom Acupuncture on Shoulder Pain after Stroke (뇌졸중 환자의 견관절 통증에 대한 봉독약침의 임상효과)

  • Ko, Chang-Nam;Park, Sung-Wook;Jung, Woo-Sang;Moon, Sang-Kwan;Park, Jung-Mi;Cho, Ki-Ho;Kim, Young-Suk;Bae, Hyung-Sup;Min, In-Kyu
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.11-24
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    • 2007
  • Objectives : Hemiplegic shoulder pain is one of the common sequelae of stroke. Although many different methods of treatment are applied, none have yet been proved to be effective. In this study we assessed the effectiveness of bee venom in patients with shoulder pain after stroke. Methods : This study was a double blinded, randomized, placebo-controlled clinical trial. All subjects received either 0.6 ml bee venom injection (venom:saline = 1:10000) or 0.6ml physiological saline solution (placebo) at three acupoints. The effectiveness was assessed by visual analogue scale, pain rating score, Fugl-Meyer assessment and passive external rotation. Results : There were 24 patients in the venom group and 22 patients in the placebo group. The venom group5,hewed more effectiveness in VAS and PRS than the placebo group. Conclusions : This study suggests that bee venom injection has significant analgesic effect on hemiplegic shoulder pain. Further study based on multi-centers, larger population, and long term 1311ow-up is needed to confirm this suggestion.

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Efficacy of Korean Red Ginseng by Single Nucleotide Polymorphism in Obese Women: Randomized, Double-blind, Placebo-controlled Trial

  • Kwon, Dong-Hyun;Bose, Shambhunath;Song, Mi-Young;Lee, Myeong-Jong;Lim, Chi-Yeon;Kwon, Bum-Sun;Kim, Ho-Jun
    • Journal of Ginseng Research
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    • v.36 no.2
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    • pp.176-189
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    • 2012
  • This study examined the effects of Korean red ginseng (KRG) on obese women and aimed to confirm that the effects of KRG on obesity differ dependently on a gene. Fifty obese women were recruited and randomized to receive KRG (n=24) or placebo (n=26) for 8 wk. Measurements of blood pressure, height, weight, waist circumference, waist-hip ratio (WHR), total fat mass, percentage of body fat, resting metabolic rate, basal body temperature, and daily food intake (FI), blood test (serum lipid, liver and renal function), Korean version of obesity-related quality of life scale (KOQOL), and a gene examination were performed. Comparisons of subjects before and after the administration of KRG revealed significant improvements of obesity in terms of weight, body mass index (BMI), WHR, FI, and KOQOL. However, in the comparison between KRG group and placebo group, only KOQOL was significantly different. KRG displayed significant efficacy on BMI and KOQOL in the CT genotype of the G protein beta 3 gene, but not in the CC genotype, on blood sugar test in the Trp64/Arg genotype of the beta 3 adrenergic receptor gene, but not in Trp64/Trp genotype, on KOQOL in the DD genotype of the angiotensin I converting enzyme gene, but not in the ID and DD genotypes. The effects of KRG on obesity were confirmed to some extent. However, a distinct effect compared to placebo was not confirmed. KRG is more effective for improving the secondary issues of the quality of life derived from obesity rather than having direct effects on the obesity-related anthropometric assessment and blood test indices.

Effects of Korean Red Ginseng on Cognitive and Motor Function: A Double-blind, Randomized, Placebo-controlled Trial

  • Yeo, Hye-Bin;Yoon, Ho-Kyoung;Lee, Heon-Jeong;Kang, Seung-Gul;Jung, Ki-Young;Kim, Leen
    • Journal of Ginseng Research
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    • v.36 no.2
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    • pp.190-197
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    • 2012
  • Ginseng has a long history of use for health enhancement, and there is some evidence from animal studies that it has a beneficial effect on cognitive performance. The purpose of this study was to investigate the effect of Korean red ginseng on cognitive performance in humans. A total of 15 healthy young males with no psychiatric or cognitive problems were selected based on an interview with a board-certified psychiatrist. The subjects were randomly assigned to receive a daily dose of 4,500 mg red ginseng or placebo for a 2-week trial. There were 8 subjects in the red ginseng group and 7 subjects in the placebo group. All of the subjects were analyzed with the Vienna test system and a P300 event-related potential (ERP) test. There were no significant differences in the Vienna test system scores between the red ginseng group and the placebo group. In the event-related potential test, the C3 latency of the red ginseng group tended to decrease during the study period (p=0.005). After 2 wk, significant decreases were observed in the P300 latencies at Cz (p=0.008), C3 (p=0.005), C4 (p=0.002), and C mean (p=0.003) in the red ginseng group. Our results suggest that the decreased latency in ERP is associated with improved cognitive function. Further studies with a higher dosage of ginseng, a larger sample size, and a longer follow-up period are necessary to confirm the clinical efficacy of Korean red ginseng.

Effect of Korean Red Ginseng Supplementation on Ocular Blood Flow in Patients with Glaucoma

  • Kim, Na-Rae;Kim, Ji-Hyun;Kim, Chan-Yun
    • Journal of Ginseng Research
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    • v.34 no.3
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    • pp.237-245
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    • 2010
  • The purpose of this study was to evaluate the effect of Korean red ginseng (KRG) on ocular blood flow in patients with glaucoma. In a prospective, randomized, placebo-controlled, double-masked crossover trial, 36 patients with open-angle glaucoma were consecutively recruited. Subjects were randomly assigned into two groups. Group A received 1.5 g KRG, administered orally three times daily for 12 weeks, followed by a wash-out period of 8 weeks and 12 weeks of placebo treatment (identical capsules filled with 1.5 g corn starch). Group B underwent the same regimen, but took the placebo first and then KRG. Blood pressure, heart rate, and intraocular pressure were measured at baseline and at the end of each phase of the study. Visual field examination and ocular blood flow measurements by the Heidelberg Retina Flowmeter were performed at baseline and at the end of each phase of the study. Changes in blood pressure, heart rate, intraocular pressure, visual field indices, and retinal peripapillary blood flow were evaluated. Blood pressure, heart rate, intraocular pressure, and visual field indices did not change after placebo or KRG treatment. After KRG treatment, retinal peripapillary blood flow in the temporal peripapillary region significantly improved (p=0.005). No significant changes were found in retinal peripapillary blood flow in either the rim region or the nasal peripapillary region (p=0.051 and 0.278, respectively). KRG ingestion appears to improve retinal peripapillary blood flow in patients with open-angle glaucoma. These results imply that KRG ingestion might be helpful for glaucoma management.

Effect of Lactobacilli Oral Supplement on the Vaginal Microflora of Antibiotic Treated Patients: Randomized, Placebo-Controlled Study

  • Reid,Gregor;Hammond, Jo-Anne;Bruce, Andrew W.
    • Preventive Nutrition and Food Science
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    • v.8 no.2
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    • pp.145-148
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    • 2003
  • Many antibiotic monographs cite the induction of vaginal infections as a possible side effect. Invariably, this is believed to be due to Candide albicans, and empirical therapy is given. However, recent studies raise the question of the extent to which yeast do infect the host after antibiotic use. A double-blind, randomized, placebo-controlled study was undertaken on female patients to determine how many yeast infections occurred following 10 days antibiotic use. In addition, the study was designed to examine whether oval use of probiotic lactobacilli can reduce the risk of vaginal infection. Twenty four patients diagnosed with respiratory, oval or throat infections received one of several types of antibiotic for 10 days, and two capsules containing 10$^{9}$ dried Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 from the day of commencement of antibiotic therapy for 21 days. The most commonly prescribed antibiotic was biaxin (clarithromycin). All but one patient had lactobacilli in the vagina upon entry to the study, and none developed yeast vaginitis or diarrhea during treatment or 20 days after completion of antibiotics. The mean Nugent score was higher in the placebo than the lactobacilli group (4.1 versus 2.4), and three cases of bacterial vaginosis arose (25 % incidence compared to 0% in the lactobacilli group) in the placebo group (2 receiving cefuroxime, 1 on biaxin). The study suggested that current antibiotic use is not necessarily associated with either diarrhea or yeast infection, as is often surmised. Nevertheless, daily use of probiotics was safe and could potentially reduce the risk of patients developing bacterial vaginosis after antibiotic use.