• Proceedings of the Korean Society of Food Hygiene and Safety Conference
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• 2004.11a
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• pp.50-58
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• 2004

Valy-Tyrosine (VY) derived from alkaline pretense hydrolyzate of sardine muscles showed the in vitro Angiotensin I converting enzyme (ACE) inhibitory activity and the in vivo antihypertensive effect in SHR. We investigated the antihypertensive effect of the VY on mild hypertensive subjects including subjects with high-normal blood pressure using a randomized double-blind placebo-controlled study. (1) Nineteen subjects (Age 48.9${\pm}$4.3, M/F;18/1) took a 100ml drink either containing 125${\mu}$g of VY or placebo twice daily for 4 weeks. The reductions of the systolic (SBP) and diastolic blood pressure (DBP) were observed in mild hypertensive subjects (n=5) with averages of 17.8${\pm}$2.5 mmHg (p<0.01 vs placebo) and 11.0${\pm}$2.0 mmHg(p<0.05 vs placebo), respectively. Neither SBP nor DBP changed in the subjects of both the placebo group and the high-normal blood pressure group. (2) A randomized double-blind cross-over placebo-controlled study was carried out in 10 mild essential hypertensive subjects (Age 50.6${\pm}$4.6, M/F;10/0). They took a 100ml drink either containing 62.5${\mu}$g of VY or placebo twice daily for 4 weeks alternatively with a 6-week interval. The percent changes in SBP and DBP were -6.9 % and -5.8 % (p<0.05) one week after the VY drink administration, respectively. No adverse effects such as coughing or allergic phenomena could be observed in any of the subjects of drinking VY during the experimental period. These results suggest that the drink containing at least 125${\mu}$g/day of VY may have a significant antihypertensive effect on mild hypertensive subjects without any adverse effects.

• Proceedings of the Korean Society of Food Hygiene and Safety Conference
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• 2004.11a
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• pp.59-70
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• 2004

A randomized double-blind placebo-controlled study was conducted on 63 subjects to determine the antihypertensive effect of a vegetable drink in which sardine protein hydrolysates containing a dipeptide, Valyl-Tyrosine (VY), were incorporated. The subjects, consisting of people with mild hypertension, high-normal blood pressure and normal blood pressure, were randomly divided into test (male/female=25.6, average age 50.1${\pm}$10.4 years old) and control groups (26/6, 49.0${\pm}$5.0). Each subjects in the test group was given 195g of the vegetable drink containing 0.5g of sardine peptides (sardine protein hydrolysates) with 0.4 mg of VY (test drink) once a day for 13 weeks in a row, and subjects in the control group were given the same amount of the vegetable drink without sardine peptides (control drink) in the same manner. In the test group, 40 subjects with mild hypertension of high-normal blood pressure (130 mmHg${\leq}$systolic blood pressure (SBP)<160 mmHg and/or 80 mmHg${\leq}$diastolic blood the start of the test to 134.4${\pm}$11.1 mmHg during the first week of the test period, after which similar values were seen throughout the test period (13 weeks). Compared to the control group, the difference in SBP from vaseline was statistically significant in the test group throughout the intake period. DBP also decreased significantly from 88.0${\pm}$7.9 mmHg at baseline to 83.5${\pm}$8.6 mmHg after 13 weeks. In the control group, SBP and DBP were 140.8${\pm}$8.4 mmHg and 90.5${\pm}$6.6 mmHg respectively at the start of the test, and neither decreased during the test period. In subjects with normal blood pressure, neither those in the test group nor those in the control group showed a significant change in SBP and DBP during the test period. An excessive ingestion test was performed on 25 subjects with hypertension, mild hypertension, high-normal blood pressure, and normal blood pressure by giving 585g (3 times the recommended amount of intake) of the test drink for 14 days in a row. As a result, a significant decrease of blood pressure was observed in the hypertension, mild hypertension and high-normal blood pressure groups, but no excessive decline in blood pressure or any side-effects were associated with any subjects during the test period. In the groups with normal blood pressure, the excessive ingestion of the test drink did not affect blood pressure. In these two studies, physical check-ups and biochemical analyses of blood and urine were also conducted in all subjects, and no abnormalities were observed. These results suggest that the test drink containing sardine protein hydrolysates exhibited the antihypertensive effect in only the subjects with mild hypertension or high-normal blood pressure. No adverse effects were observed in either hypertensive of normotensive subjects.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.5 no.2
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• pp.174-180
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• 2002

Purpose: Ursodeoxycholic acid (UDCA) is known to decrease hepatic injury by promoting the biliary secretion of retained toxic endogenous bile acids in hepatobiliary diseases complicated by total parenteral nutrition (TPN). However, most studies have focused on treatment for complications after TPN. We investigated the preventive role of early administration of UDCA in TPN-induced hepatobiliary complications by a randomized, double-blind, placebo-controlled trial. Methods: Between May 2000 and May 2002, thirteen patients, who were given TPN more than 10 days in the hospital, were assigned randomly to two groups. One was the case group (7 patients) who were given UDCA simultaneously with TPN regimen, and the other, the control group (6 patients) who were given placebo. Their age ranged from 1 day to 13 years. They were affected with diseases impossible for enteral nutrition, such as prematurity, cerebral palsy, chronic diarrhea, anorexia nervosa, pancreatitis, and cyclic vomiting. The duration of TPN ranged from 10 to 70 days. Hematologic parameters including liver function test were measured at regular intervals, and the duration, composition, administration rate, total calorie of TPN were recorded. The serum levels of total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase were compared between groups after cessation of the study. Results: The autoregressive coefficient of the control group was 0.4419 (p=0.0651) in bilirubin, -0.0431 (p=0.7923) in AST, 0.2398 (p=0.2416) in ALT, and 0.2459 (p=0.1922) in alkaline phosphatase by mixed procedure model when the parameters were referred to the case group. Conclusion: The serum level of total bilirubin did not increase in comparison with that of the control group, but statistically insignificant, when both TPN and UDCA were administered simultaneously from the beginning.

• The Korean Journal of Pain
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• v.20 no.2
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• pp.169-173
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• 2007

Background: Although the use of intravenous patient controlled analgesia (IVPCA) has been compared to the use of patient conrolled epidural analgesia (PCEA), there is no optimal administration route of alfentanil for the treatment of postoperative pain. This randomized double-blind study compared the efficacy of the use of IVPCA and PCEA for postoperative pain and the side effects after a total abdominal hysterectomy (TAH). Methods: Sixty patients undergoing a TAH were randomly assigned to receive either IVPCA (Group I) or PCEA (Group E) for the infusion of alfentanil for postoperative pain control. In both groups, a loading dose of $750{\mu}g$ alfentanil was administered. All patients received the same continuous infusion rate (0.3 mg/h), bolus dose (0.15 mg), and lockout time (15 min). The incidence of side effects, the VAS (visual analog scale) of pain, blood pressure, and heart rate were checked for 20 hours after the loading dose injection. Results: The VAS of pain was not significantly different between the two groups of patients. The onset of the analgesic effect was significantly more rapid in the Group I patients than in the Group E patients. There was no difference in side effects for either group. Conclusions: When considering multiple factors such as the onset of analgesia, technical difficulties or infection after the procedure, IVPCA using alfentanil is more useful than PCEA for postoperative pain control after a TAH.

• Journal of Dental Anesthesia and Pain Medicine
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• v.19 no.1
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• pp.55-66
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• 2019

Background: Postoperative nausea and vomiting (PONV) frequently occurs following bimaxillary orthognathic surgeries. Compared to opioids, Nefopam is associated with lower incidences of PONV, and does not induce gastrointestinal tract injury, coagulopathy, nephrotoxicity, or fracture healing dysfunction, which are common side effects of Nonsteroidal anti-inflammatory drugs. We compared nefopam- and fentanyl-induced incidence of PONV in patients with access to patient-controlled analgesia (PCA) following bimaxillary orthognathic surgeries. Methods: Patients undergoing bimaxillary orthognathic surgeries were randomly divided into nefopam and fentanyl groups. Nefopam 120 mg or fentanyl $700{\mu}g$ was mixed with normal saline to a final volume of 120 mL. Patients were given access to nefopam or fentanyl via PCA. Postoperative pain intensity and PONV were measured at 30 minutes and 1 hour after surgery in the recovery room and at 8, 24, 48, and 72 hours after surgery in the ward. The frequency of bolus delivery was compared at each time point. Results: Eighty-nine patients were enrolled in this study, with 48 in the nefopam (N) group and 41 in the fentanyl (F) group. PONV occurred in 13 patients (27.7%) in the N group and 7 patients (17.1%) in the F group at 8 hours post-surgery (P = 0.568), and there were no significant differences between the two groups at any of the time points. VAS scores were $4.4{\pm}2.0$ and $3.7{\pm}1.9$ in the N and F groups, respectively, at 8 hours after surgery (P = 0.122), and cumulative bolus delivery was $10.7{\pm}13.7$ and $8.6{\pm}8.5$, respectively (P = 0.408). There were no significant differences in pain or bolus delivery at any of the remaining time points. Conclusion: Patients who underwent bimaxillary orthognathic surgery and were given nefopam via PCA did not experience a lower rate of PONV compared to those that received fentanyl via PCA. Furthermore, nefopam and fentanyl did not provide significantly different postoperative pain control.

• 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.

• Stress
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• v.26 no.4
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• pp.305-311
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• 2018

Background: The purpose of the study was to explore whether the effect of Huanglian-jie-du granule depends on the baseline heart rate variability in patients with Hwa-byung. Methods: We used the supplementary data from a randomized, double-blind, placebo-controlled trial of Huanglian-jie-du granule for Hwa-byung patients. Study drugs were taken orally three times per day for one week. Heart rate variability was measured three times; before the treatment, after the treatment, and month follow-up period. Spearman's rho test was done to explore the role of the baseline heart rate variability to the effect of Huanglian-jie-du granule. Results: Baseline low frequency power of heart rate variability was negatively correlated with the reduction of the insomnia severity index in experimental group (r=-0.493 p=0.02). Also, Huanglian-jie-de granule significantly decreased the low frequency power of heart rate variability in patients with Hwa-byung compared to placebo (mean difference 266 [95% CI: 29~503], p=0.028). In Hwa-byung symptoms, stuffy, pushing up in the chest, and flush of anger were correlated with low frequency power of heart rate variability (p=0.010, p=0.000, and p=0.016, respectively). Conclusions: The effect of the Huanglian-jie-de granule for insomnia seems to be lower when the baseline low frequency power of heart rate variability is higher in Hwa-byung patients. Also, Huanglian-jie-de granule is likely to decrease the sympathetic activity in patients with Hwa-byung. Measurement of heart rate variability may be the useful to understand the state of Hwa-byung patients.

• Dementia and Neurocognitive Disorders
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• v.22 no.3
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• pp.100-108
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• 2023

Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

• Clinics in Shoulder and Elbow
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• v.8 no.2
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• pp.141-147
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• 2005

Purpose: The purpose of this study was to compare the effectiveness of postoperative pain control by intravenous patient-controlled analgesia (IV) to the effectiveness of postoperative pain control by continuous intra-lesional infusion of local anesthetics (IL) with or without an interscalene brachial plexus block (ISB) after arthroscopic shoulder surgery. Materials and Methods: We designed this prospective randomized case-controlled double-blind study, and allocated 84 consecutive patients to four groups according to postoperative analgesic method, i.e., Group IV, Group ISBIV, Group IL, and Group ISB-IL after arthroscopic shoulder surgery. Postoperative pain, side effects and supplemental analgesics were recorded at 1 hour and then at every 8 hours for 2 days. Result: The demographic and clinical characteristics of four groups were identical statistically. Interscalene block (Group ISB-IV, Group ISB-IL) was found to be effective at relieving pain and at reducing supplemental analgesic amounts at 1 and 8 hours postoperatively (p<0.05). Patients in the Group ISB-IL had less pain at 16 and 48 hours postoperatively than the other groups (p<0.05). Continuous intra-lesional infusion (Group IL, Group ISB-IL) was superior in reducing analgesic-related side effects (p<0.05). Conclusion: This study suggests that a combination of an interscalene brachial plexus block and continuous intralesional infusion of ropivacaine is an effective and safe method of postoperative pain control in patients after arthroscopic shoulder surgery.

• Preventive Nutrition and Food Science
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• v.6 no.1
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• pp.51-56
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• 2001

This study was carried out to evaluate whether antioxidant nutrient suppplementation with $\alpha$-tocopherol, vitamin C, $\beta$-carotene, and selenium reduces the lipid peroxide levels and increases the antioxidative enzyme activities in patients with coronary hart disease. Eighty nine patients participated in a randomized, double-blind, placebo-controlled trial. The antioxidant group (45 patients) was given daily doses of $\alpha$-tocopherol (400 IU), vitamin C (50 mg), $\beta$-carotene (15 mg), and selenium (50 $\mu\textrm{g}$) and forty four patients received a placebo. Thirty eight subjects (84.4%) of the antioxidant group and thirty nine subjects (88.6%) of the placebo group completed the three-month supplementation. Serum levels of tocopherol, vitamin C and $\beta$-carotene significantly increased in the antioxidant group compared with the baseline (p<0.05). Thiobarbituric acid-reactive substances(TBARS) decreased significantly (0.6 nmol MDA/mL) in the antioxidant group compared with that (0.09 nmol MDA/mL) in the placebo group (p=0.03). However, antioxidant supplementation did not affect the level of oxidized-LDL measured as autoantibodies against oxidized-LDL. The superoxide dimutase activity in red blood cells increased in the antioxidant group compared with the baseline (p<0.05). However, glutathione peroxidase activities did not change after supplementation in both groups, and catalase activity significantly decreased in the placebo group (p<0.05). These results suggest that antioxidant supplementation for 3 months with $\alpha$-tocopherol, vitamin C, $\beta$-carotene and selenium in patients with coronary heat disease may be partially protective against oxidative stress.