• Title/Summary/Keyword: Placebo

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Weight Reduction Effect of Angook Cereal Mixture on Female College Students

  • Suh, Hyung-Joo;Kim, Young-Soon;Jung, Eun-Young;Chang, Un-Jae;Oh, Sung-Hoon
    • Preventive Nutrition and Food Science
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    • v.11 no.3
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    • pp.226-231
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    • 2006
  • This study evaluated the weight reduction effect of Angook cereal mixture. The cereal mixture was prepared with barley, unpolished rice, corn, soybean, Garcinia cambogia, guar-gum, maltodextrin, glucomannan and a vitamin mixture. Eighteen female college students participated in this 8 weeks weight control program. All subjects were randomly assigned to the treatment and placebo groups. Mean energy intake of the treatment group was $1,356.4{\pm}79.9\;kcal$ (carbohydrate: 67.1%, protein: 18.7%, fat: 14.2%) and placebo group consumed $1,367.6{\pm}71.8\;kcal$ (carbohydrate: 64.2%, protein: 19.7%, fat: 16.1%) during program. The placebo group lost $3.9{\pm}0.8\;kg$ of body weight and the treatment group lost $5.9{\pm}0.7\;kg$ of body weight. There were significant differences in the decrease of total body weight, absolute fat mass, waist circumference (WC) and hip circumference (HC) between the two groups (p<0.05), however, the lean body mass was not significantly decreased in the treatment group compared to the placebo group. There were no differences in the changes in blood glucose, total-cholesterol, HDL-choloesterol, LDL-cholesterol and triglycerides between groups. These findings suggest that the intake of Angook cereal mixture may be beneficial for the reduction of the body weight, absolute fat mass, WC and HC.

Comparison of the Effects of Pilocarpine Solution and Tablet on Salivary Flow Rate

  • Park, Jo-Eun;Song, Chan-Woo;Kim, Ki-Suk;Kim, Mee-Eun
    • Journal of Oral Medicine and Pain
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    • v.40 no.1
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    • pp.10-16
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    • 2015
  • Purpose: Pilocarpine has the effects on improvement of salivary flow and subjective symptoms for xerostomic patients. Because of unwanted side effects following its systemic administration, topical pilocarpine has been paid attention as an alternative. This study aimed to investigate effects of pilocarpine solution as mouthwash on salivary flow and adverse effects compared to systemic administration of 5 mg pilocarpine tablet in healthy subjects. Methods: The study was a double blind, placebo-controlled, crossover clinical trial. Five milligrams pilocarpine tablets, 4 mL of 2% pilocarpine solution and placebo solution were given to 12 healthy volunteers (6 males and 6 females) in a predetermined order with wash-out period of at least two days and unstimulated whole saliva was collected before and after administration of each drug. Blood pressure and pulse rate was also measured and subjective effect and potential side effects were evaluated by a self-administrated questionnaire. Results: Systemic (5 mg tablet) and topical (2% solution) use of pilocarpine significantly increased salivary flow rate in healthy subjects compared to placebo (p<0.001). In both the pilocarpine solution and tablet groups, salivary flow rates at 120 minutes after administration remained increased. Subjective effect on salivation was the largest in the pilocarpine tablet group, followed by the pilocarpine solution group (p<0.05). There was no significant difference in blood pressure and pulse rate after administration of all three drugs. Fewer side effects reported in the pilocarpine solution group than in the tablet group. Conclusions: Two percents pilocarpine solution as mouthwash increases salivary flow rate, definitely superior to placebo solution and comparable to pilocarpine tablet, with fewer side effects in healthy subjects. It indicates a possibility of pilocarpine solution as a useful alternative of pilocarpine tablets for the xerostomic patients with systemic diseases.

Review on the Efficacy of Omega-3 in the Treatment of Attention-Deficit Hyperactivity Disorder (주의력결핍 과잉행동장애에서 오메가-3의 효과에 대한 고찰)

  • Park, So-Young;Lee, Soyoung Irene;Lee, Moon-Soo
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.27 no.1
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    • pp.31-38
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    • 2016
  • Pharmacotherapy is considered the first line therapy in attention-deficit hyperactivity disorder (ADHD). Many patients also choose complementary medicine such as dietary supplements. Omega-3 has shown some efficacy for improving ADHD symptoms in several studies. The goal of this review is to integrate the previous research findings on omega-3 and understand the issues worth considering in the treatment of ADHD. The terms "attention deficit disorder with hyperactivity", "omega-3", and "dietary supplements" were searched on PubMed, Cochrane, and Google scholar. The search was further limited to clinical trials, reviews, and meta-analyses. Trials that examined treatments for ADHD, used randomized design, and placebo-controlled trials were included. Eighteen clinical trials with a total of 1,141 participants were included in this review. Fifteen trials had parallel designs, comparing an omega-3/6 polyunsaturated fatty acid (PUFAs) or a combination of both to a placebo and three compared omega-3/6 PUFAs to a placebo and psycho-stimulants. Seven of the included trials showed significant improvements in groups receiving omega-3/6 PUFAs compared to placebo groups, however, 11 trials showed no significant differences. Evidence that PUFAs supplementation provides benefits for ADHD was yet limited. Mixed results were due to selection variability criteria, variability of supplementation, and short follow-up intervals.

Balance trainer training with transcutaneous electrical nerve stimulation improves spasticity and balance in persons with chronic stroke

  • Yang, Youjin;Lee, Jungeun;Choi, Wonjae;Joo, Younglan;Lee, Seungwon
    • Physical Therapy Rehabilitation Science
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    • v.9 no.2
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    • pp.67-73
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    • 2020
  • Objective: The purpose of this study was determine the effect of Balance Trainer training with Transcutaneous Electrical Nerve Stimulation (TENS) on spasticity and balance in persons with chronic stroke. Design: Randomized controlled trial. Methods: A total of 30 subjects with hemiparetic stroke were recruited and randomly divided into the Balance Trainer training with TENS group (n=15) and Balance Trainer training with placebo TENS group (n=15). The Balance Trainer training with TENS group practiced additional Balance Trainer training with TENS for 30 minutes a day, 5 days per a week during 4 weeks and the Balance Trainer training with placebo TENS group practiced additional Balance Trainer training with placebo TENS for the same period. Spasticity and balance were assessed by ability (static balance, dynamic balance) and were measured before and after the 4-week programs. Results: The result of spasticity and dynamic balance were improved significantly in both groups (p<0.05). The Balance Trainer training with TENS group showed significantly greater improvement in spasticity of the gastrocnemius & dynamic balance, compared to the Balance Trainer training with placebo TENS group (p<0.05). The Balance trainer training with TENS group showed a significant improvement in static balance, especially during the eye-closed condition (p<0.05). Conclusions: The Balance Trainer training with TENS was effective in improving spasticity and balance in subjects with chronic stroke. Based on these results, it is suggested that Balance Trainer training with TENS could clinically be used more actively in conjunction with conventional physical therapy.

Evidence of an Epigenetic Modification in Cell-cycle Arrest Caused by the Use of Ultra-highly-diluted Gonolobus Condurango Extract

  • Bishayee, Kausik;Sikdar, Sourav;Khuda-Bukhsh, Anisur Rahman
    • Journal of Pharmacopuncture
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    • v.16 no.4
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    • pp.7-13
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    • 2013
  • Objectives: Whether the ultra-highly-diluted remedies used in homeopathy can effectively bring about modulations of gene expressions through acetylation/deacetylation of histones has not been explored. Therefore, in this study, we pointedly checked if the homeopathically-diluted anti-cancer remedy Condurango 30C (ethanolic extract of Gonolobus condurango diluted $10^{-60}$ times) was capable of arresting the cell cycles in cervical cancer cells HeLa by triggering an epigenetic modification through modulation of the activity of the key enzyme histone deacetylase 2 vis-a-vis the succussed alcohol (placebo) control. Methods: We checked the activity of different signal proteins (like $p21^{WAF}$, p53, Akt, STAT3) related to deacetylation, cell growth and differentiation by western blotting and analyzed cell-cycle arrest, if any, by fluorescence activated cell sorting. After viability assays had been performed with Condurango 30C and with a placebo, the activities of histone de-acetylase (HDAC) enzymes 1 and 2 were measured colorimetrically. Results: While Condurango 30C induced cytotoxicity in HeLa cells in vitro and reduced HDAC2 activity quite strikingly, it apparently did not alter the HDAC1 enzyme; the placebo had no or negligible cytotoxicity against HeLa cells and could not alter either the HDAC 1 or 2 activity. Data on $p21^{WAF}$, p53, Akt, and STAT3 activities and a cell-cycle analysis revealed a reduction in DNA synthesis and G1-phase cell-cycle arrest when Condurango 30C was used at a 2% dose. Conclusion: Condurango 30C appeared to trigger key epigenetic events of gene modulation in effectively combating cancer cells, which the placebo was unable to do.

Perioperative duloxetine as part of a multimodal analgesia regime reduces postoperative pain in lumbar canal stenosis surgery: a randomized, triple blind, and placebo-controlled trial

  • Govil, Nishith;Parag, Kumar;Arora, Pankaj;Khandelwal, Hariom;Singh, Ashutosh;Ruchi, Ruchi
    • The Korean Journal of Pain
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    • v.33 no.1
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    • pp.40-47
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    • 2020
  • Background: Duloxetine is an antidepressant that is also useful in chronic neuropathic and central origin pain. In this study, the role of duloxetine in decreasing acute postoperative pain after lumbar canal stenosis surgery is explored. Methods: In this single center, triple blinded, and placebo-controlled trial, 96 patients were randomized for statistical analysis. The intervention group received oral duloxetine 30 mg once a day (OD) for 2 days before surgery, 60 mg OD from the day of surgery to the postoperative second day and 30 mg OD for the next 2 days (a total duration of 7 days). A placebo capsule was given in the other group for a similar time and schedule. The same standard perioperative analgesia protocols were followed in both groups. Results: Total morphine consumption up to 24 hours was significantly decreased in the duloxetine group (P < 0.01). The time to the first analgesia requirement was similar in both groups but the time to the second and third dose of rescue analgesia increased significantly in the duloxetine group. The time to ambulation was decreased significantly (P < 0.01) in the duloxetine group as compared to the placebo group. Pain scores remained similar during most of the time interval. No significant difference was observed in the complication rate and patient satisfaction score recorded. Conclusions: Duloxetine reduces postoperative pain after lumbar canal stenosis surgery with no increase in adverse effects.

Effect of Aspartate and Asparagine on Metabolism and Central Nervous System Effect of Alcohol in Healthy Male Volunteers (Aspartate 및 Asparagine 투여가 알코올 대사 및 중추신경계 효과에 미치는 영향)

  • Yim, Dong-Seok;Lee, Kyung-Hun;Jang, In-Jin;Shin, Sang-Goo;Lee, Yoon-Sung;Park, Sang-Chul
    • The Korean Journal of Pharmacology
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    • v.31 no.2
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    • pp.261-269
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    • 1995
  • Background; To explore the efficacy of aspartate as NAD regenerating agent for ethanol and acetaldehyde oxidation, we performed crossover challenge in two groups of volunteers by coadministration of various doses of aspartate, asparagine and ethanol. Methods; 18 healthy male volunteers were randomly divided into two groups. 6 volunteers of the first group were administered 5 gm monosodium aspartate(MSA), 5 gm asparagine or placebo with 100 ml of $40^{\circ}$ whiskey by the 3 way-crossover design, while 12 volunteers of the other group were administered placebo, 1, 2 or 5 bottles of $Aspar^(circledR)$ containing 1 gm of MSA per bottle with 100 ml of $40^{\circ}$ whiskey by the 4 way-crossover design. Ethanol(and acetaldehyde) concentrations in venous blood drawn at 0, 0.25, 0.5, 1, 2, 4, 8th hour after ethanol ingestion were analysed by gas chromatogaphy. Subjective symptoms, liver function tests and psychomotor function tests were also performed during the study periods. Result; Plasma concentration and AUC of acetaldehyde in asparagine and MSA trials on ethanol ingestion were significantly lower than those of placebo trial in the 1st group. Plasma ethanol concentration of 5 bottle $Aspar^(circledR)$ trial was significantly lower than that of placebo trial in the 2nd group. Improvement of subjective symptoms or psychomotor performance by the treatment was not statistically significant. Conclusion; Aspartate and asparagine may be prospective candidates for acceleration of ethanol metabolism and prevention of ethanol toxicity.

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Monocyte chemoattractant protein-1 polymorphism interaction with spirulina immunomodulatory effects in healthy Korean elderly: A 16-week, double-blind randomized clinical trial

  • Park, Hee Jung;Lee, Hyun Sook
    • Nutrition Research and Practice
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    • v.11 no.4
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    • pp.290-299
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    • 2017
  • BACKGROUND/OBJECTIVES: Spirulina is a known a functional food related to lipid profiles, immune functions, and antioxidant capacity. Circulating monocyte chemoattractant protein-1 (MCP-1) level is associated with inflammation markers. Single nucleotide polymorphism in the MCP-1 promoter region -2518 have been identified and shown to affect gene transcription. Gene variation may also impact functional food supplementary effects. The current study investigated the interaction of MCP-1 -2518 polymorphism with spirulina supplements on anti-inflammatory capacity in Korean elderly. SUBJECTS/METHODS: After genotyping, healthy elderly subjects (n = 78) were included in a randomized, double blind, and placebo controlled study. Baseline characteristic, body composition, and dietary intake were measured twice (baseline vs. week 16). For 16 weeks, subjects consumed 8 g either spirulina or placebo daily. Plasma MCP-1, interleukin (IL) -2, IL-6, tumor necrosis factor (TNF)-${\alpha}$, complement (C) 3, immunoglobulin (Ig) G, and Ig A concentrations and lymphocyte proliferation rate (LPR) were analyzed as inflammatory markers. RESULTS: In the placebo group with A/A genotype, MCP-1 level was significantly increased, but the spirulina group with A/A genotype was unchanged. IL-2 was significantly increased only in subjects with spirulina supplementation. TNF-${\alpha}$ was significantly reduced in subjects with the G carrier. C3 was significantly increased in the placebo group, particularly when A/A increased more than G, but not when spirulina was ingested. LPR was significantly different only in subjects with A/A genotype; there was a significant increase in phytohemagglutinin and lipopolysaccharide induced LPR in the spirulina group. CONCLUSION: In healthy Korean elderly, spirulina supplementation may influence different inflammatory markers by the MCP-1 genotype. These results may be useful for customized dietary guidelines to improve immune function in Koreans.

Lactobacillus reuteri DSM 17938 Improves Feeding Intolerance in Preterm Infants

  • Kaban, Risma K.;Wardhana, Wardhana;Hegar, Badriul;Rohsiswatmo, Rinawati;Handryastuti, Setyo;Amelia, Novie;Muktiarti, Dina;Indrio, Flavia;Vandenplas, Yvan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.22 no.6
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    • pp.545-553
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    • 2019
  • Purpose: Feeding tolerance is extremely important in preterm infants. This study aimed to evaluate whether preterm infants receiving Lactobacillus reuteri DSM 17938 would develop fewer symptoms of feeding intolerance. Secondary outcomes were duration of parenteral nutrition, time to reach full feeding, length of hospital stay, sepsis, necrotizing enterocolitis (NEC), diarrhea, and mortality. Methods: This double-blind randomized controlled trial of L. reuteri DSM 17938 versus placebo included 94 neonates with a gestational age of 28-34 weeks and birth weight of 1,000-1,800 g. Results: Feeding intolerance (vomiting and/or distension) was less common in the probiotic group than in the placebo group (8.5% vs. 25.5%; relative risk, 0.33; 95% confidence interval, 0.12-0.96; p=0.03). No significant intergroup differences were found in proven sepsis, time to reach full feeding, length of hospital stay, or diarrhea. The prevalence of NEC (stages 2 and 3) was 6.4% in the placebo group vs. 0% in the probiotic group (relative risk, 1.07; 95% confidence interval, 0.99-1.15; p=0.24). Mortality rates were 2.1% in the probiotic group and 8.5% in the placebo group, p=0.36). Conclusion: The administration of L. reuteri DSM 17938 to preterm infants was safe and significantly reduced feeding intolerance. No significant differences were found in any other secondary outcomes.

Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol (발효굴추출물의 경구 섭취가 소아 신장 성장에 미치는 효과 및 안전성 평가를 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜)

  • Kim, Hee-Yeon;Park, Beom-Chan;Cheon, Jin-Hong;Choi, Jun-Yong;An, Byeong-Min;Park, Joung-Hyun;Lee, Bae-Jin;Kim, Kibong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.4
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    • pp.37-46
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    • 2019
  • Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.