• Nutrition Research and Practice
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• v.17 no.5
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• pp.883-898
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• 2023

BACKGROUND/OBJECTIVES: Probiotics have been suggested as potent modulators of age-related disorders in immunological functions, yet little is known about sex-dependent effects of probiotic supplements. Therefore, we aimed to investigate sex-dependent effects of probiotics on profiles of the gut microbiota and peripheral immune cells in healthy older adults. SUBJECTS/METHODS: In a randomized, double-blind, placebo-controlled, multicenter trial, healthy elderly individuals ≥ 65 yrs old were administered probiotic capsules (or placebo) for 12 wk. Gut microbiota was analyzed using 16S rRNA gene sequencing and bioinformatic analyses. Peripheral immune cells were profiled using flow cytometry for lymphocytes (natural killer, B, CD4⁺ T, and CD8⁺ T cells), dendritic cells, monocytes, and their subpopulations. RESULTS: Compared with placebo, phylum Firmicutes was significantly reduced in the probiotic group in women, but not in men. At the genus level, sex-specific responses included reductions in the relative abundances of pro-inflammatory gut microbes, including Catabacter and unclassified_Coriobacteriales, and Burkholderia and unclassified Enterobacteriaceae, in men and women, respectively. Peripheral immune cell profiling analysis revealed that in men, probiotics significantly reduced the proportions of dendritic cells and CD14⁺ CD16^- monocytes; however, these effects were not observed in women. In contrast, the proportion of total CD4⁺ T cells was significantly reduced in women in the probiotic group. Additionally, serum lipopolysaccharide-binding protein levels showed a decreasing tendency that were positively associated with changes in gut bacteria, including Catabacter (ρ = 0.678, P < 0.05) and Burkholderia (ρ = 0.673, P < 0.05) in men and women, respectively. CONCLUSIONS: These results suggest that probiotic supplementation may reduce the incidence of inflammation-related diseases by regulating the profiles of the gut microbiota and peripheral immune cells in healthy elders in a sex-specific manner.

• Journal of Ginseng Research
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• v.43 no.4
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• pp.676-683
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• 2019

Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.

• Journal of Korean Medicine Rehabilitation
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• v.20 no.4
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• pp.197-213
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• 2010

Objectives : The clinical trial was designed to investigate the safety and effects of Taeeumjowui-tang(Taiyintiaowei-tang) extracts on the change of the weight, body compositions, serum in obese patients. Methods : This was a 12-weeks, randomized, double blind, placebo-controlled clinical trial. Patients with a body mass index of either greater than $30kg/m^2$ or between 27 and $30kg/m^2$ with controlled hypertension, diabetes, hyperlipidemia were considered eligible. Participants of 41 obese patients were randomized either to Taeeumjowui-tang(Taiyintiaowei-tang)(23) or placebo(18). After 12 weeks of treatment, we measured anthropometric factors(weight, height, waist circumference, BMI(body mass index) etc.), abdominal fat area by CT(computed tomography)scanning, serum lipid(total cholesterol, tryglyceride, HDL-cholesterol, LDL-cholesterol), blood lever of variety(AST, ALT, BUN, creatinine etc.). Adverse events also evaluated. Results : After 12 weeks of treatment mean weight, waist-circumference, total cholesterol, LDL-cholesterol and score of KEAT-26 were significant changed in Taeeumjowui-tang(Taiyintiaowei-tang). There were no serious adverse events in either groups. Conclusions : There were limited in this study that is conducted within a short period of 12 weeks. but its weight and WC(waist circumference), WHR(waist hip ratio), total cholesterol, LDL-cholesterol and score of KEAT-26 loss effect was significant and it had few adverse events.

• Journal of Ginseng Research
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• v.43 no.3
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• pp.402-407
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• 2019

Background: To investigate the neurobiological evidence supporting the adaptogenic effects of Korean Red Ginseng in reducing the harmful consequences of stress using a double-blind, placebo-controlled trial. Method: Sixty-three subjects with high stress levels were randomized to receive an orally administered, double-blind, 6-week treatment with Korean Red Ginseng (n = 32) or placebo (n = 31). All participants underwent a comprehensive psychological evaluation using Beck Depression Inventory and Stress Response Inventory, cognitive evaluation using the continuous performance test, biological evaluation by measuring blood levels of lipids, catecholamines, inflammation markers, and heart rate variability at baseline and after 6 weeks. Results: At baseline, both groups showed no significant differences in age, sex, years of education, Beck Depression Inventory, and Stress Response Inventory. After 6 weeks, triglyceride levels were significantly increased within the normal limit in the Korean Red Ginseng group (F = 4.11, p = 0.048), and the epinephrine level was decreased in this group (F = 4,35, p = 0.043). The triglyceride increase was significantly associated with epinephrine decrease (B = 0.087, p = 0.041), suggesting that Korean Red Ginseng may stabilize the sympathetic nervous system. In addition, we detected a significant group by time effect in the visually controlled continuous performance test, suggesting positive effects of Korean Red Ginseng on cognition. Conclusion: Korean Red Ginseng might help to stabilize the sympathetic nervous system and improve cognition in individuals with high stress.

• Journal of Pharmacopuncture
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• v.21 no.1
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• pp.7-13
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• 2018

Objective: Hwa-byung is one of the cultural concept of distress in Korea resulted from chronic accumulated anger. It is characterized by various symptoms like stuffy in the chest, hot or heat sensation, something pushing up in the chest, feeling of mortification, and a flush of anger. This protocol aims to explore the efficacy and safety of Huanglian-jie-du decoction on various somatic symptoms and insomnia in patients with Hwa-byung. Methods: This is study protocol for a randomized, double-blind, placebo-controlled trial. A total of 44 patients will be randomly assigned to the experimental group or the placebo group in a 1:1 ratio. All medications will be taken orally 3 times per day for 7 consecutive days. The primary outcomes are the mean changes in Patient Health Questionnaire of physical symptoms (PHQ-15) and Insomnia Severity Index (ISI) after the 7 days of administration. The secondary outcomes include the scales to assess stress response, symptoms of Hwa-byung, and state anger. Conclusion: The results of this study will provide high quality and explorative evidence to investigate the effect of Huanglian-jie-du decoction on Hwa-byung.

• Nutrition Research and Practice
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• v.11 no.5
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• pp.396-401
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• 2017

BACGROUND/OBJECTIVES: In this randomized, placebo-controlled, double-blind study, we evaluated the antihypertensive effects of enzymatic hydrolysate from Styela clava flesh tissue in patients with type 2 diabetes mellitus (T2DM) and hypertension. SUBJECTS/METHODS: S. clava flesh tissue hydrolysate (SFTH) (n = 34) and placebo (n = 22) were randomly allocated to the study subjects. Each subject ingested two test capsules (500 mg) containing powdered SFTH (SFTH group) or placebo capsules (placebo group) during four weeks. RESULTS: In the SFTH group, systolic and diastolic blood pressure decreased significantly 4 weeks after ingestion by 9.9 mmHg (P < 0.01) and 7.8 mmHg (P < 0.01), respectively. In addition, the SFTH group exhibited a significant decrease in hemoglobin $A_{1c}$ with a tendency toward improvement in homeostasis model assessment of insulin resistance, triglyceride, apolipoprotein B and plasma insulin levels after 4 weeks. No adverse effects were observed in other indexes, including biochemical and hematological parameters in both groups. CONCLUSION: The results of our study suggested that SFTH exerts a regulatory, antihypertensive effect in patients with T2DM and hypertension.

• Child Health Nursing Research
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• v.12 no.2
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• pp.253-259
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• 2006

Purposes: Venipuncture is one of the most painful and frequently performed invasive procedure for children by nurses. The purpose of this study was to investigate the effect of EMLA cream(eutectic mixture of local anesthetics: 2.5% lidocaine and 2.5% prilocaine) to decrease venipuncture related pain and anxiety in children. Methods: A randomized, double blinded, placebo-controlled study was conducted. Sixty children scheduled venipuncture were recruited, and randomly allocated to receive either EMLA or a placebo cream 1 hour before venipuncture. Venipuncture was carried out by one nurse investigator. Pain and anxiety was measured by parent, nurse investigator, and nurse observer. Results: Pain in the EMLA group was significantly lower than that of placebo group. However, there was no significant difference in anxiety score between the EMLA and placebo groups. Local side effect of EMLA cream were negligible. Conclusions: EMLA cream was found to be an effective local anesthetic for pediatric venipuncture pain. Further studies should continue to evaluate the facilitators and barriers of EMLA cream application in pediatric nursing practice.

• The Journal of Korean Medicine
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• v.31 no.5
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• pp.146-166
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• 2010

Objective: Few data were available on glycemic control at the early prediabetic stage, though it is the important stage to prevent diabetes mellitus. The purpose of this research was to examine the glycemic control effects of herb medicine treatment (DA-9802) in prediabetic stage patients Methods: In this randomized, single blind, placebo-controlled study, we compared Sanyak extract (DA-9802) with placebo for the treatment of glycemic control effects in prediabetic stage patients. 45 volunteers who satisfied the requirements were enrolled in the study. They took Sanyak extract (DA-9802) or placebo treatment three times a day for 8 weeks. Blood sugar, Total Symptom Score (TSS) and blood serum were measured at weeks 0, 4, and 8. Results: In the DA-9802 group, fasting blood sugar changes between before 8 weeks significantly decreased. Fasting blood sugar, fasting blood sugar gaps between before and after treatment for 8 weeks, insulin changes and C-peptide significantly decreased at 8 weeks compared with those of the placebo group. Conclusion: Herb medicine treatment (DA-9802) is effective in glycemic control on prediabetic stage.

• International Journal of Contents
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• v.7 no.2
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• pp.59-63
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• 2011

The aim of our study was to evaluate the immediate effects of an 830-nm Aluminium gallium arsenide (GaAlAs) laser, by examining the changes, in pressure-pain threshold (PPT) and tenderness at 3 kg of the myofascial trigger point (MTrP) of the upper trapezius muscle in visual display terminal (VDT) workers in comparison with placebo treatment. Thirty VDT workers (13 males, 17 females) with complaints of upper trapezius muscle were recruited. All participants were given either active GaAlAs laser (830 nm wavelength, 450 mW, 9 J at point) or placebo GaAlAs laser, according to the double-blinded and placebo-controlled trial. Both active and placebo low-level laser therapy (LLLT) treatments showed no significant effect on PPT and tenderness at 3 kg. These results suggest that a higher dosage may be necessary to produce immediate effects when applying LLLT to the MTrP of relatively large muscles such as the upper trapezius muscle.

• Korean Journal of Clinical Pharmacy
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• v.29 no.4
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• pp.247-253
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• 2019

Background: Glutamate is implicated in the pathophysiology of migraine, a common neurological disorder. Therefore, glutamate receptor antagonists (GluRAs) have been suggested as a novel migraine treatment that are able to overcome the limitations of triptans. Objective: The aim of this study was to perform a meta-analysis to assess the efficacy of GluRAs for patients with migraine. Method: The PubMed, Cochrane Library, CINAHL, and Clinical Trial.gov databases were searched for randomized placebo-controlled trials of the efficacy of GluRAs for patients with migraine conducted up to August 2019. Two independent reviewers screened the literature according to inclusion and exclusion criteria and performed quality assessment and data extraction. Review Manager 5.3 software was used for the meta-analysis. Results: Three studies involving a total of 206 patients were included in the final analysis. Compared with placebo, GluRAs significantly improved the pain-free response at 2 hours (odds ratio [OR]=3.85, 95% confidence intervals [CIs]=1.63-9.09) and the 24-hour sustained pain freedom (OR=7.40; 95% CIs=2.36-23.20). The use of rescue medications with GluRAs was lower compared to that with placebo, but the difference was not significant (OR=0.39, 95% CI=0.10-1.47). Conclusion: Our meta-analysis showed that GluRAs were more effective than placebo for patients with migraine.