• 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.

• The Journal of Korean Medicine
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• v.29 no.2
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• pp.165-181
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• 2008

Objectives: This study was conducted to help clinical studies for treating the common cold with Oriental medicine. We inspected tendencies of clinical studies of the common cold in western medicine and analyzed the assessing instruments for it by scrutinizing PubMed publications for the last five years. Materials and Methods: We inspected 32 theses and scrutinized their objectives, periods, participants, materials and methods, the instrument of assessment for the studies, and validity, reliability, criteria and symptom score for questionnaires, results and JADAD score. Results: 1. The median for total period of study was 7 months, the median for days of treatment was 7.5, and most studies were carried out during the winter/spring period, because of the enhanced risk of cold infections. 2. The studies focused on unorthodox medicines or new drug products, such as antipyretic analgesics (e.g. paracetamol), decongestant and bronchodilator (e.g. ephedrine), echinacea, antioxidants (e.g. zinc), probiotic bacteria and so on. 3. All theses except one had subjectscomposed of cold patients who were infected naturally. The median number of subjects for final analysis was 187. 4. 27 studies used survey as the instrument of assessment. Among these, only one thesis was verified for validity. 5. The mean of JADAD score was 4.41, suggesting most of theses of worth. 7 studies were assessed as ineffective. Conclusion: Recent studies of the common cold are focused on unorthodox medicines or new drug products, and it is necessary to provide an objective instrument for assessing common cold treatments.

• Journal of Oriental Neuropsychiatry
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• v.28 no.2
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• pp.95-107
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• 2017

Objectives: This study was performed to review studies on Essential Tremor (ET) in Traditional Chinese medicine (TCM). Methods: We reviewed papers in the China National Knowledge Infrastructure (CNKI) from 2007~2016. Search keywords were 原发性震颤, 特发性震颤, essential tremor and idiopathic tremor, and excluded non-clinical studies, non-related to ET or TCM studies, theses for degrees and non-Randomized Controlled Trial (RCT). The quality of the articles was assessed by Jadad scale and the Risk of Bias (RoB). Results: Thirteen studies were selected. 'Criteria for the diagnosis of ET' was most frequently used as diagnostic criteria. 'Tremor rating scale' was primarily used for outcome measurement. Meta-analysis of nine trials revealed the effective rate of acupuncture and Western medicine (WM+Acu) groups was significantly higher compared to the WM group (RR: 1.48, 95 percent CI: 1.20 to 1.82, p=0.0002, $I^2=0$ percent) and tremor rating scale was also significantly decreased in the treatment group (MD: -1.35, 95 percent CI: -2.17 to -0.54, p=0.001, $I^2=0$ percent). Also, effective rates of Electro-acupuncture (EA) and Chinese herbal medicine (CHM) groups were significantly higher than that of the WM group {(RR: 1.53, 95 percent CI: 1.22 to 1.92, p=0.0003, $I^2=0$ percent) in EA vs. WM and (RR: 1.35, 95 percent CI: 1.16 to 1.57, p<0.0001, $I^2=0$ percent) in CHM vs. WM}. However, the quality of selected clinical studies was poor. Conclusions: Treatment of ET in TCM may be more effective and safe than in Western medicine. Therefore, we hope this study will lead to further clinical research on treatment of ET in Korean medicine.

• The Journal of Korean Medicine
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• v.34 no.3
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• pp.13-24
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• 2013

Objectives: The aims of this study were to investigate the availability of diagnosis of Yin-deficiency in the elderly with xerostomia and factors influencing subjective oral dryness. Methods: We surveyed 50 patients recruited by the clinical trial, 'Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized, Double-blind, Placebo-controlled, Two-center Trial'. The subjects were assessed on their subjective oral dryness using the Dry Mouth Symptom Questionnaire (DMSQ). Their salivary functions were measured by Unstimulated Salivary Flow Rate (USFR) measurements. In addition, the subjects were evaluated on their Qi-stagnation and Yin-deficiency conditions using the Qi-stagnation questionnaire and Yin-deficiency questionnaire. Results: There were statistically significant correlations between three variables (USFR, DMSQ score and Qi-stagnation score) and Yin-deficiency score. In the multiple regression analysis, the regression model was statistically significant (F = 10.273, p < .001). The factor most strongly influencing the subjective oral dryness was USFR (${\beta}$ = -0.386). Yin-deficiency had the next strongest impact on the subjective oral dryness (${\beta}$ = 0.371). Qi-stagnation affected the subjective oral dryness weakly (${\beta}$ = 0.075). In the simple regression analysis, Yin-deficiency had a statistically significant effect on each of six subscales of DMSQ (p < .01). Among the six subscales, DMSQ-1 ('Oral dryness at night or on awakening') was the most strongly influenced by Yin-deficiency. Conclusions: The results of this study show that the diagnosis of Yin-deficiency in the elderly with xerostomia was available and Yin-deficiency was an important factor influencing the subjective oral dryness. Therefore, the consideration of Yin-deficiency is significant for diagnosis and treatment in the elderly with xerostomia.

• Journal of Pharmacopuncture
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• v.12 no.3
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• pp.31-40
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• 2009

Objective : This study was to investigate the effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture have on the autonomic nervous system. Methods : 60 healthy male volunteers were divided into three groups which consist of two experimental groups such as Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture, and a control group. Study design was a randomized, placebo-controlled, double-blind clinical trial. 20 subjects in experimental group were injected distilled Cervi Pantotrichum Cornu Pharmacopuncture at $GB_{21}$(Kyonjong), 20 subjects in other experimental group were injected distilled Zizyphi Spinosi Semen Pharmacopuncture and 20 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). One volunteer of each groups were excluded from analysis because of error during measuring HRV. At the end of the study 57 volunteers completed HRV analysis. HRV was measured by QECG-3:LXC3203(LAXTHA Inc. Korea) at P0, P1, P2, P3, P4, P5 and P6 and its time-course dependent change in each group was analyzed using paired t-test, and the difference of HRV fluctuation among two experimental group and a control was evaluated by one way ANOVA(p<0.05). Results : A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased only at 20 minutes after injection. SDNN was significantly increased from 15 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Complexity was significantly decreased at 10, 15 and 30 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, pNN50 was significantly decreased at 15, 20 and 25 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture showed significant difference on HRV index and pNN50 at 5 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(VLF) After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at 15 and 30 minutes after injection. Ln(VLF) was significantly increased at 10, 15 and 30 minutes after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Ln(VLF) was significantly increased only at 30 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture showed significant difference on Ln(TP) after 5 minutes of injection. Conclusions : Our results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

• The Journal of Korean Medicine
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• v.33 no.3
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• pp.1-9
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• 2012

Objectives: This research was aimed 1) to find out various subjective symptoms cancer patients had, 2) to find out the quantitative difference of symptoms occurring according to the area of cancer, current treatment methods, and relapse of the cancer and 3) to analyze the relationship between the occurrence of symptoms. Methods: This study was a survey about the various subjective symptoms cancer patients had. The subjects were 48 cancer patients in a double-blinded randomized controlled trial about the effectiveness of Korean Red Ginseng (KRG) treatments. Surveys were examined before Korean Red Ginseng (KRG) treatments. The questionnaire consisted of demographic research, patient history and accompanying symptoms. The symptoms part consisted of 4 questions on general symptoms (vertigo, hot flush, rash, insomnia), 2 questions on digestion symptoms (anorexia, dyspepsia), 2 questions on excretions (diarrhea, constipation), and 5 questions on symptoms in different body parts (headache, dryness of lips, chest pain, aphthous ulcer, nose bleeding). The questionnaire was used to research presence of symptoms and relationships between the occurrence of symptoms. Results: A total of 48 patients took part in this survey. Dizziness was the most frequent subjective symptom patients had (64.58%), followed by dry mouth (43.75%), headache (43.75%), insomnia (41.67%), anorexia (37.5%) and chest discomfort (37.5%). The presence of these subjective symptoms was partially related to the patient's history details - type of cancer, method of cancer treatment (chemotherapy, radiotherapy), termination of treatment, presence of pain, fatigue and recurrence, etc. Factor analysis was conducted to analyze the relationship between the occurrence of symptoms. It suggested 5 factors as a result, but there was a limitation that only a low level of correlation was shown among them. Conclusions: We were able to analyze the occurrences and the relationships among them for accompanying subjective symptoms in cancer patients. However the results of the study are limited in that only 48 patients participated. The symptoms in cancer patients showed a tendency for clustering, occurring simultaneously or continuously rather than occurring alone. The study of these symptom clusters is worth further study, for it is similar to the Symptom Differentiation System in Traditional Korean Medicine. For effective approach to the treatment of cancer in Traditional Korean Medicine, further research on the Korean traditional view of cancer patients should be done based on this research, regarding various symptoms and those relationships on a larger scale.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.2
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• pp.151-164
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• 2024

Objectives : Using MMSE and MoCA cognitive tools, this study tried to measure the effect of acupuncture differing by cognitive types. Through the method of PRISMA literature review, this study aimed to understand and improve the acupuncture's effectiveness in its application. Methods : The research method was a literature review and Cochrane meta-analysis of papers on the effectiveness of acupuncture treatments for mild cognitive impairment conducted from 2012 to 2023. The Cochrane risk of bias (RoB) tool was used as a quality analysis tool, and the meta-analysis tool was Cochrane RevMan V5.4.1 software. Results : As a result of the study, a total of 967 subjects were used for analysis, and 16 papers on randomized acupuncture trials were analyzed. The results are as follows: As a result of meta-analysis of acupuncture intervention for mild cognitive impairment, the MMSE score had an average of 1.61 with a 95% confidence interval ranging from 0.14 to 3.07, and a statistically significant result with p<0.001. The Z-score was 2.15, which corresponded to a p-value of 0.03. The MoCA score had an average range between 0.39 and 2.49, also showing statistical significance with p<0.001, and a Z-score of 2.70 (p=0.007). The effect of acupuncture in subjects with mild cognitive impairment was significant. Conclusion : The suggestions and conclusion indicate that acupuncture intervention has a significant effect on mild cognitive impairment. This study propose future experimental research on various types of acupuncture interventions for mild cognitive impairment. The significance of this study is that it presented basic data for the development of a preventive convergence cognitive intervention program for patients with mild cognitive impairment in the community.

• 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.

• Journal of Dental Rehabilitation and Applied Science
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• v.33 no.2
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• pp.119-126
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• 2017

Purpose: The aim of the present study was to compare clinical antiplaque and antigingivitis effect between Light Emitting Diode (LED) electronic toothbrush and electronic toothbrush without LED for gingivitis and mild periodontitis patients. Materials and Methods: 30 patients included in this study. 15 patients in experimental group used LED electronic tooth brush which has red and white LED within its head, and other 15 patients in control group used same product which specially modified that function without LED. Clinical parameters ($L{\ddot{o}}e-Silness$ gingival index (GI), Quigley-Hein plaque index (PI)) were measured at the baseline, 2 weeks and 4 weeks later. Wilcoxon signed rank test and Mann-Whitney test were used for statistical analysis. Results: Compare of GI change between experimental and control group with time, both groups showed that reduced GI, but lower GI values detected at 2 weeks and 4 weeks later in experimental group than control group. And lower PI values detected at 4 weeks later in experimental group than control group, but not statistically significant. Conclusion: Based on these results and within the limits of this study, the electronic toothbrush with LED could reducing gingivitis in a short period and infer that decreasing plaque accumulation in a long period.

• The Journal of Korean Medicine
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• v.26 no.2 s.62
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• pp.77-84
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• 2005

Objectives: Chunghyul-dan is a combinatorial herbal medicine, and previous studies reported it had therapeutic effects for microangiopathy, which is a major part. in the progression of stroke, as well as having anti-hypertensive, anti-hyperlipidemic, anti-apoptotic, anti-oxidative, and anti-inflammatory activities, Therefore, we examined the inhibitory effect of Chunghyul-dan on stroke occurrence in patients with silent brain infarction. Methods: We prescribed Chunghyul-dan at 600 mg a day to patients with silent brain infarction confirmed by brain MRI, and monitored stroke occurrence, drug compliances, and adverse effects for 1 year, We then performed follow-up brain MRI to detect new vascular lesions after 1 year of Chunghyul-dan medication. As for the subjects lost to follow-up, we assessed their prognosis after 1 year by telephone. Results: There were twenty-one subjects who were treated with Chunghyul-dan for more than 1 year, None of them experienced new clinical syndromes characterized by rapidly developing clinical symptoms and signs of focal and at times global loss of brain function, which could be accompanied with evidence of stroke occurrence, or any adverse effects during the Chunghyul-dan medication period. These results might be explained by various biochemical effects of Chunghyul-dan on microangiopathy, which is closely related with cell cycle progression, hypertension, hyperlipidemia, vascular inflammation, and oxidative damage. Of the 10 subjects lost to follow-up, six were reached; two of them had stroke occurrence. Conclusions: We suggest Chunghyul-dan could be useful for prevention of stroke occurrence in patients with silent brain infarction by preventing the progression of microangiopathy. Further study with a randomized controlled trial is needed to confirm this suggestion.