• The Korean journal of internal medicine
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• v.39 no.4
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• pp.680-690
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• 2024

Background: To evaluate the effectiveness of Korean Red Ginseng (KRG) in managing fatigue in Korean patients with rheumatic diseases Methods: Patients were randomly assigned to KRG (2 g/day, n = 60) or placebo (n = 60) groups for 12 weeks of blind phase and then open-label KRG from weeks 12 to 24 (placebo-KRG, continuous-KRG). The primary outcome was the improvement rate in fatigue, defined by an increase in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores at 12 weeks. Secondary outcomes included changes in FACIT-Fatigue and fatigue visual analog scale (VAS) between 0 and 12 weeks and those changes in both indices at 24 weeks. Results: The study enrolled 120 patients (Sjogren syndrome [n = 53], rheumatoid arthritis [n = 43], or both diseases [n = 24]). The mean age was 50.9 ± 11.6 years, with 97.5% being female. Baseline characteristics were similar between the two groups. The improvement rate in FACIT-Fatigue after 12 weeks was higher in the KRG group than in the placebo group, but the difference was statistically insignificant (38.3% vs. 26.7%, p = 0.242). Improvement in fatigue was observed in both groups by increases in FACIT-F (4.6 vs. 4.0) and reductions in fatigue VAS (-16.0 vs. -12.2) scores at 12 weeks. The most frequently reported adverse events during KRG use were pruritus and urticarial, with no significant difference between the two groups. Conclusions: Both KRG and placebo groups showed significant reductions in fatigue. KRG treatment for 24 weeks did not reduce fatigue symptoms more than the placebo in patients with rheumatic diseases.

• Journal of Ginseng Research
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• v.42 no.4
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• pp.571-576
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• 2018

Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

• Osteoporosis and Sarcopenia
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• v.2 no.4
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• pp.228-237
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• 2016

Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.5
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• pp.379-396
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• 2021

Background: Trigeminal neuralgia (TN) is characterized by brief, unilateral, sharp, stabbing, and shooting pain of the fifth cranial nerve. The objective of this systematic review with meta-analysis was to determine the effect of medications compared to placebo in adult patients with TN. Methods: Review authors identified randomized placebo-controlled trials (RCTs) from PubMed, Web of Science, Cochrane, and EMBASE up to February 2021. We assessed the inclusion and exclusion criteria as well as the risk of bias of the studies based on the Cochrane Handbook. A total of 324 unduplicated references were scanned independently and reduced to eight relevant RCTs, with 89 patients included. Medications investigated included oral carbamazepine, subcutaneous sumatriptan, lidocaine (intranasal, 8% spray on the oral mucosa or intravenous), buprenorphine (ganglionic local opioid analgesia), and oral Nav1.7, a selective sodium channel blocker. Results: Meta-analyses showed that overall patients receiving lidocaine reported a significantly lower post-treatment intensity of pain -3.8 points on a 0-10 scale (95% Cl = -4.653 to -2.873; P < 0.001). Patients who received lidocaine were 8.62 times more likely to have pain improvement than patients on placebo (P < 0.001). In one RCT, patients receiving oral carbamazepine showed a significant improvement in pain intensity of -32% compared to the placebo (P < 0.001). In one trial, patients receiving 3 mg subcutaneous sumatriptan had a significantly lower intensity of pain on average -6.1 points on a scale of 0-10 compared to placebo (P < 0.001) and a significant improvement in pain intensity of -75% compared to the improvement in the placebo group (P < 0.001). Patients who received subcutaneous sumatriptan were 10 times more likely to have pain improvement than those who received placebo (P = 0.001) in one study. Due to the unclear/high risk of bias and small sample size, the quality of the evidence for lidocaine in the treatment of TN was low. Conclusion: Further studies are needed for carbamazepine, sumatriptan, buprenorphine, and oral Nav1.7 sodium channel blockers, as only one study reported outcomes.

• Microbiology and Biotechnology Letters
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• v.40 no.3
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• pp.237-242
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• 2012

In this study, the skin moisturing effect and stability of cream containing L. cuneata G. Don extract (ethyl acetate fraction) were evaluated. The skin hydrating effect of the cream containing extract was 1020% higher than the placebo cream, and the TWEL of the cream containing extracts was decreased to $7.7g/m^2h$ compared to the control ($10.2g/m^2$) and placebo cream ($8.9g/m^2$). The pH, viscosity, and absorbance were measured under the 4, 25, 37, $45^{\circ}C$ and the sun light during the 12 weeks. The pH change between cream containing extract and placebo cream did not show the significant difference under the 4, 25, 37, $45^{\circ}C$ except for the sun light. Both creams showed high decrease (about 59%) of viscosity at $45^{\circ}C$. However, there was no significant change under other conditions. The absorbance of the cream containing the extract and the placebo cream was decreased similarly at all conditions. This decrease in absorbance was relatively small compared to the decrease of absorbance of the extract in ethanol solution under the sun light (Fig. 7). In addition, any change in color or smell of the cream was not observed during the 12 weeks. Also physical changes as creaming and cohesion were not shown. These results indicate that the cream containing L. cuneata extract has the skin moisturizing effect and is relatively stable. Therefore, it is suggested that the ethyl acetate fraction of L. cuneata extract could be applicable to cosmetics as a new cosmetic material with its antioxidative and antibacterial activities reported previously.

• Journal of Ginseng Research
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• v.42 no.2
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• pp.192-198
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• 2018

Background: Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance. Methods: Sedentary individuals (n = 117) were randomly assigned into one of three groups: low-dose ginsenoside supplementation (100 mg/d, n = 39), high-dose ginsenoside supplementation (500 mg/d, n = 39), or a placebo group (500 mg/d, n = 39). All participants underwent a supervised 12-wk aerobic and resistance exercise training course. To assess the effects of supplementation on physical performance, maximal oxygen consumption ($VO_2max$), anaerobic threshold (AT), lactic acid, and muscle strength of the dominant knee were measured at baseline, every visit, and after the training program. Results: Both ginsenoside groups showed significant increases in $VO_2max$ and muscular strength during exercise training. There were no definite changes in AT and lactic acid levels over time. After exercise training, there were definite differences in the $VO_2max$ (28.64.9 to $33.7{\pm}4.9ml/kg/min$ in high-dose group vs. $30.4{\pm}6.7$ to $32.8{\pm}6.6ml/kg/min$ in placebo, p = 0.029) and AT ($19.3{\pm}4.2$ to $20.9{\pm}3.5ml/kg/min$ in high-dose group vs. $20.0{\pm}5.1$ to $20.0{\pm}4.9ml/kg/min$ in placebo, p = 0.038) between the high-dose ginsenoside and placebo groups. However, there was no difference in $VO_2max$ between the low-dose ginsenoside and placebo groups (p = 0.254). There were no differences in muscular strength during exercise training among the three groups. Conclusion: High-dose ginsenoside supplementation (UG0712) augmented the improvement of aerobic capacity by exercise training.

• Korean Journal of Food Science and Technology
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• v.41 no.3
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• pp.307-312
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• 2009

To investigate the effects of conjugated linoleic acid (CLA) and/or exercise on body fat mass and weight, college women of normal weight (2130%) were recruited for this study. The participants were divided into 4 groups: placebo-no exercise, placebo-exercise, CLA-no exercise, and CLA-exercise groups. Three grams of either a placebo (corn oil) or CLA were taken every day for 12 weeks, and the exercise groups performed 80 minutes of aerobic and anaerobic exercise three times a week for 12 weeks. There were no differences in nutrient intakes among the groups. The CLA-exercise group had significantly lower body weight, BMI and body fat mass compared to the placebo-no exercise group. In addition, the HDL-cholesterol levels of subjects in the CLA-no exercise and CLA-exercise groups significantly increased compared to those in the placebo-no exercise group. These results suggest that a combination of CLA supplementation with exercise could efficiently reduce body fat mass and body weight compared to CLA supplementation or exercise alone.

• Journal of Gastric Cancer
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• v.17 no.2
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.33 no.3
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• pp.27-44
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• 2020

Objectives : The authors conducted randomized, Double-blinded, and placebo-controlled parallel-group clinical experiment study to evaluate efficacy of fermented soybean(Bio-Peptone)cream in pruritus. Methods : The research had been conducted for 4 months from the date of IRB approval(May 26 in 2017) to Sept 2017. The experiment started by randomly distributing 25 subjects with pruritus into experimental group and control group, respectively. The experimental group applied fermented soybean(Bio-Peptone)cream twice a day, in the morning and evening, for one week on itchy area. The effect of the product was evaluated by comparing the PSS(Patient subjective score), moisture level by measuring skin moisture content(Corneometer) and transepidermal water loss(Tewameter), and the Korean version of Skindex-29(index of quality of life improvement) before applying the cream, after applying the cream for one week and after stop applying the cream for one week. The control group conducted identical experiment with the experimental group, except the control group applied placebo instead of the fermented soybean(Bio-Peptone)cream. Results : Pruritus, criterion of the first validation testing, indicates fermented soybean(Bio-Peptone)cream tend to reduce pruritus compare to placebo, although the result is not statistically noticeable. Significant difference in reduction of prutitus, the second validation test was not discovered in both groups. Corneometer and life quality tend to be improved with soy cream than placebo, but not statistically effective and both groups did not show any difference in terms of Tewameter measurement. Conclusions : The result of clinical experiment didn't prove that the fermented soybean(Bio-Peptone)cream is more effective in reducing pruritus than placebo, statistically. The clinical use of soybean product for pruritus requires further studies to be verified.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.24 no.5
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• pp.423-431
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• 2021

Purpose: To assess the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in outpatient management of acute watery diarrhea in children. Methods: A randomized double-blind placebo-controlled study was conducted in 180 participants aged six months to five years with acute mild to moderate diarrhea. All were enrolled from six centers across India and centrally randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo along with oral rehydration salts and zinc supplementation. Each participant was followed up for three months to assess recurrence of diarrhea. Results: The mean duration of diarrhea in the probiotic and placebo groups were 54.16 hours and 59.48 hours, respectively. The difference in the duration of diarrhea in those administered with probiotic or placebo within 24 hours of diarrhea onset was 25.21 hours. Furthermore, the difference in duration of diarrhea was 13.84 hours (p<0.05) for participants who were administered with probiotics within 48 hours. There were no significant differences in the stool frequencies between the two arms. After three months, 15% in the probiotic group and 18.5% in the placebo group reported episodes of diarrhea. The mean duration of diarrhea was considerably lower in the probiotic group, 31.02 hours versus 48 hours in placebo (p=0.017). Conclusion: S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was effective in reducing the duration of diarrhea when administered within 48 hours of diarrhea onset. Similarly, it reduced recurrence of diarrhea and its intensity in the subsequent three months.