• The Journal of Korean Medicine
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• v.28 no.1 s.69
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• pp.105-116
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• 2007

Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

• The Korean journal of internal medicine
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• v.33 no.6
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• pp.1224-1233
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• 2018

Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

• Tuberculosis and Respiratory Diseases
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• v.80 no.3
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• pp.265-269
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• 2017

Background: The first line of anti-tuberculosis (TB) drugs are the most effective standard of drugs for TB. However, the use of these drugs is associated with hepatotoxicity. Silymarin has protective effects against hepatotoxicity of anti-TB drugs in animal models. This study aims to investigate the protective effect of silymarin on hepatotoxicity caused by anti-TB drugs. Methods: This is a prospective, randomized, double-blind and placebo-controlled study. Patients were eligible if they were 20 years of age or order and started the first-line anti-tuberculosis drugs. Eligible patients were randomized for receiving silymarin or a placebo for the first 4 weeks. The primary outcome was the proportion of patients who showed elevated serum liver enzymes more than 3 times the upper normal limit (UNL) or total bilirubin (TBil) > $2{\times}UNL$ within the first 8 weeks of anti-TB treatment. Results: We enrolled a total of 121 patients who silymarin or a placebo to start their anti-TB treatment, for the first 8 weeks. The proportions of elevated serum liver enzymes more than 3 times of UNL at week 2, week 4, and week 8 did not show any significant difference between the silymarin and placebo groups, at 0% versus 3.6% (p>0.999); 4.4% versus 3.6% (p>0.999); and 8.7% versus 10.8% (p=0.630), respectively. However, patients with TBil >$2{\times}UNL$ at week 8 were significantly low in the silymarin group (0% versus 8.7%, p=0.043). Conclusion: Our findings did not show silymarin had any significant preventive effect on the hepatotoxicity of anti-TB drugs.

• The Journal of the Society of Stroke on Korean Medicine
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• v.6 no.1
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• pp.9-16
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• 2005

Objective : The heart rate variability is very useful indicator to study the function of the autonomic nervous system(ANS), and the physiologic signals can be observed based on the changes of the ANS of the heart. In order to assay the effects of the laser exposing to healthy subjects, the double blind test has been performed. Methods : This study included 62 healthy adults who have not any ANS disease and had normal sinus rhythm in electrocardiogram. The control group consisted of 31 subjects, laser group consisted of 31 subject. HRV was measured for 5 minutes before laser irradiation, sham and real laser irradiated for 30 minutes and than HRV remeasured for 5 minutes. Statistical significance was evaluated by independent T-test. Results : Mean HRV, Ln(VLF), Ln(HF), Ln(TP) of both groups at post-laser period decreased compared with that of the pre-laser period. Ln(LF) of both groups at post-laser period increased compared with that of the pre-laser period. LF/HF, SDNN of real laser group decreased and sham group decreased. Conclusions : There is no difference between two groups. The reason is presumed that all the studied subjects are healthy adults, and also the short and single transcutaneous laser irradiation would not influence upon changes of the ANS. The further study must be followed.

• Clinics in Shoulder and Elbow
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• v.18 no.3
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• pp.120-127
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• 2015

Background: We prospectively compared the response to blind and ultrasound-guided glenohumeral injection of corticosteroids for treatment of shoulder stiffness. Methods: A total of 77 patients with shoulder stiffness between April 2008 and March 2012 were recruited. Patients were randomized to receive either a blind (group 1, n=39) or ultrasound-guided (group 2, n=38) glenohumeral injection of 40 mg triamcinolone. The clinical outcomes and shoulder range of motion (ROM) before injection, at 3, 6, and 12 months after injection and at the last follow-up were assessed. The same rehabilitation program was applied in both groups during the follow-up period. Results: There was no significant difference in demographic data on age, sex, ROM, and symptom duration before injection between groups (p>0.05). There were no significant differences in ROM including forward flexion, external rotation at the side, external rotation at $90^{\circ}$ abduction, and internal rotation, visual analogue scale for pain and functional outcomes including American Shoulder and Elbow Surgeons score, Simple Shoulder test between the two groups at any time point (p>0.05). Conclusions: Based on the current data, the result of ultrasound-guided glenohumeral injection was not superior to that of blind injection in the treatment of shoulder stiffness. We suggest that ultrasound-guided glenohumeral injection could be performed according to the patient's compliance and the surgeon's preference. Once familiar with the non-imaging-guided glenohumeral injection, it is an efficient and reliable method for the experienced surgeon. Ultrasound could be performed according to the surgeon's preference.

• The Journal of Internal Korean Medicine
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• v.41 no.3
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• pp.326-338
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• 2020

Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.1
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• pp.204-208
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• 2008

This study was performed to investigate the effect of the extracts from Injinoryng-San on liver injury patients induced by alcohol. Injinoryung-San was recorded the drug for jaundice at Hwang-Je-Nae-Kyung. Twenty-seven patients who have intaked alcohol above 40 g, every day, 5 years, twenty-seventy ages were selected. After take a written consent, we divide them into experimental groups and control groups by double blind test. Each groups was evaluated every 2 weeks(2,4,6 weeks). After 2 weeks, Injinoryung-San groups significantly decreased GGT in comparison with control groups(p<0.05). After 4 weeks, Injinoryung-San groups significantly decreased MCV, GGT in comparison with control groups(p<0,05). After 6 weeks, Injinoryung-San groups significantly decreased MCV in comparison with control groups(p<0.05). Reviewing these experimental results, it appears that extracts of Injinoryung-San have pharmaceutical efficacy in GGT, MCV on liver injury patients induced by alcohol. But it has not efficacy in AST, ALT. According to drinking alcohol has becomes social problems, we should effort to make efficacious oriental medicines on alcoholic hepatitis.

• Tuberculosis and Respiratory Diseases
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• v.58 no.5
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• pp.498-506
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• 2005

Background : This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules ($18{\mu}g$ once daily) with a ipratropium metered dose inhaler (2 puffs of $20{\mu}g$ q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium $18{\mu}g$ once daily or ipratropium $40{\mu}g$ four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second ($FEV_1$) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted $FEV_1$ of 42 (12)% were analyzed. The trough $FEV_1$ response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.

• Journal of Ginseng Research
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• v.34 no.3
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• pp.183-191
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• 2010

Dry mouth is easily neglected if not associated with oral diseases. Consequently, xerostomatic patients often use unconventional therapies. In traditional Korean medicine, Korean red ginseng (KRG) has long been used to relieve dry mouth. However, no clinical trials have investigated whether KRG actually has an effect on dry mouth. This study was performed to evaluate the efficacy of KRG for dry mouth. We enrolled 100 volunteers with no obvious oral or salivary gland diseases and divided them into KRG and placebo groups. Each group was divided into six subgroups according to age and gender. The subjects received 6 g/day of KRG or placebo for 8 weeks. The dry mouth visual analog scale (VAS), salivary flow rate, and a dry mouth-related symptom questionnaire were evaluated at baseline and at 4 and 8 weeks. KRG treatment did not show any significant differences for any of the variables. However, KRG improved the dry mouth VAS at 4 weeks and dry mouthrelated symptoms at 8 weeks in women, but not in men. Subgroup analyses revealed that KRG markedly improved the dry mouth VAS in women of menopausal age (40 to 59 years) at 4 and 8 weeks. KRG may have beneficial effects for dry mouth in women, especially those of menopausal age, but not in men. Further investigation in post- and perimenopausal women is required to elaborate on these findings.

• Journal of Acupuncture Research
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• v.32 no.1
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• pp.37-51
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• 2015

Objectives : This study aimed to evaluate influential factors affecting patients' surveyed medical service perception of Traditional Korean Medicine(TKM). Methods : This study was a randomized single blind parallel design and 335 patients were participated. After treatment, we carried out a survey about medical service perception index from April 1st 2013 to January 31th 2014. We evaluated and analyzed the difference between Korean internal medicine and acupuncture & moxibustion, and also between the age groups of younger than 30s and older than 40s. Results : As the results of the analysis, acupuncture & moxibustion group had higher points on medical service perception sub factors than Korean internal medicine group. There was no meaningful difference between the age groups. Conclusions : The study showed higher satisfaction with acupuncture & moxibustion than Korean internal medicine, and as variable, department was more influential than age for medical service perception.