• Title/Summary/Keyword: patient global assessment

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Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

Anti-Obesity Effect of Panax Ginseng in Animal Models: Study Protocol for a Systematic Review and Meta-Analysis (동물실험에서 인삼의 항비만 효과: 체계적 고찰과 메타분석을 위한 연구 프로토콜)

  • Cho, Jae-Heung;Kim, Koh-Woon;Park, Hye-Sung;Yoon, Ye-Ji;Song, Mi-Yeon
    • Journal of Korean Medicine for Obesity Research
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    • v.17 no.1
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    • pp.37-45
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    • 2017
  • Recently the global epidemic problem of obesity has stimulated intense interest in the study of physiological mechanisms using animal models as a way to gain crucial data required for translation to human studies. Panax ginseng has been reported to have anti-obesity or antidiabetic effects in many animal studies; however, there have been few studies investigating human obesity. Herein, we will assess and examine the evidence supporting the anti-obesity effect of Panax ginseng in animal models with respect to anthropometric and metabolic outcomes. We will include controlled, comparative studies assessing the effect of Panax ginseng in preclinical studies of obesity. Panax ginseng will be administered during or following the induction of experimental obesity. The primary outcome measure will be anthropometric assessment and the secondary outcome measures will include adipose tissue weight, total amount of food consumed and metabolic parameters. We will search MEDLINE, Embase, PubMed, Web of Science, and Scopus without language, publication date, or other restrictions. Ethical approval will not be necessary as the data collected in this study will not be individual patient data, consequently there will be no concerns about violations of privacy. After finishing the whole procedure, the results will be disseminated by publication in a peer-reviewed journal or presented at a relevant conference. This protocol has been registered on the Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES) website (http://www.camarades.info).

A Clinical Trial to Assess the Efficacy of Acupuncture on Hot Flashes in Postmenopausal Women;Focusing on the comparison of the effects of Traditional Korean medical acupuncture (TKMA) and Minimal Acupuncture (MA)

  • Kim, Dong-Il;Roh, Jin-Ju;Choi, Min-Sun;Lee, Seung-Deok;Roh, Ju-Won;Yoon, Sang-Ho;Ahn, Hong-Yup;Oh, Dal-Seok;Choi, Sun-Mi
    • The Journal of Korean Medicine
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    • v.28 no.4
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    • pp.74-85
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    • 2007
  • Objective : In this study we wanted to confirm if proper stimulation and de-Qi of traditional Korean medical acupuncture could increase hot flash relief efficacy. Design : A randomized controlled, single blind study. We used two modalities of acupuncture, one with optimal stimulation [Study group; Korean medical acupuncture (TKMA)] and one with minimal stimulation [Control group; Minimal acupuncture (MA)]. Same acupoints [PC6(內關), HT8(少府), HT7(神門), LI4(合谷), ST36(足三里), SP6(三陰交), Ren4(關元)] were used in both groups. Fifty-two patients were treated twice a week for 8 weeks, and follow up was done after 4 weeks from the last treatment. Patients were checked hot flash VAS (visual analog scale), frequency and duration every time they visited. Results : Hot flash relief efficacy by 100mm hot flash VAS was obvious in both groups. Hot flash VAS scores of study group were smaller than the scores of control group at the early stage (3rd, $4^{th}$ and $8^{th}$ visit), but there wasn't a remarkable difference between study and control group at the end of the trial. Besides, diminution of hot flash VAS was faster and more even in the study group than control group by visualization using 'Box plot'. We compared frequency and duration of hot flash, 100mm sweating, palpitation, sleep disturbance VAS, and Kupperman Index, MENQOL, Patient's global assessment score. Both groups showed definite decrease from the baseline, but the difference was not statistically significant. There wasn't any adverse event. Hot flash relief efficacy was kept in most patients after 4 weeks' follow-up. Conclusion : Acupoint combination by Traditional Korean medical theory is effective on hot flashes and hot flash relief efficacy was faster and more even in optimal stimulation than minimal stimulation.

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The Enhancing Effect of Atopic Dermatitis by cosmetics containing estern medical herbs (한방소재 화장품의 아토피 피부염 개선 효과)

  • Kang, Shin-Jyung;Kim, Ae-Jung;Lee, Yeon-Hee;Lee, Myoung-Sook;Joung, Kyung-Hee;Cho, Nam-Ji
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.10 no.11
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    • pp.3500-3505
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    • 2009
  • Sixteen moderate atopic dermatitis patients were treated with applying toner and cream using estern medical herbs[Estern medical complex(Radix Glycyrrhizae, Radix Angelicae Dahuricae, Rhizoma Ligustici Chuanxiong, Fructus ponciri Seu Aurantii Immaturus, Radix Rehmanniae Praeparata, Radix Puerariae, Rhizoma Corydalis), Cypress, Green tea, Radix Astragali, Red ginseng, Syrup ferment, Apple ferment filtrate] on the atopic area 2-3 times per day for 6 weeks. After 6 weeks of study, the result was a decrease in SCORAD index($26.9{\pm}11.8$ to $14.9{\pm}9.7$(p<0.05)), IgE($641.9{\pm}1294.6$ to $565.8{\pm}1076.8$), Eosinophil count($246.7{\pm}203.5$ to $203.3{\pm}130.7$(p<0.05)) and TEWL($16.7{\pm}5.1$ to $15.4{\pm}8.7$(p<0.05)). And skin hydration was increased($36.6{\pm}10.0$ to $44.0{\pm}10.3$(p<0.01)) maintaining skin pH level. The patient;s and physician's global assessment also improved. Therefore, estern medical herbs may play a role in treatment of atopic dermatitis.

Moxibustion for Knee Osteoarthritis : A Protocol for a Pilot Randomized Controlled Trial (슬관절염에 대한 뜸 치료의 유효성 및 안전성 연구 : 무작위 대조 예비 임상연구 프로토콜)

  • Lee, Seung-Hoon;Kim, Kun-Hyung;Kim, Tae-Hun;Kim, Jung-Eun;Kim, Joo-Hee;Kang, Kyung-Won;Jung, So-Young;Kim, Ae-Ran;Park, Hyo-Ju;Shin, Mi-Suk;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.1-15
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    • 2011
  • Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

Clinical Use of Thromboelastography as Monitor of Coagulopathy at the Pre and Post-Cardiopulmonary Bypass (개심술 환자의 체외순환 전후 혈전 탄성 묘사도의 임상적 이용)

  • 강경훈;김경훈
    • Journal of Chest Surgery
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    • v.30 no.11
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    • pp.1092-1096
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    • 1997
  • Thromboelastography(TEG) enables a global assessment of hemostatic function to be made from a single blood sample, documenting the interaction of platelets with protein coagulation cascade from the time of the initial platelet-fibrin interaction, through platelet aggregation, clot strengthening and fibrin cross linking to eventual clot Iysis. Thirty-five patients(mean age 34$\pm$ 12) undergoing open heart surgery from April 1st, 1996 to August 31th, 1996 were investigated at preoperatively and immediate, one hour, and 24 hours after cessation of cardiopulmonary bypass using TEG. Comparisons were made between classic hematological indices and TEG data. There were statistically significant correlation between maximal amplitude(MA) and platelet count before CPB, activating clotting time(ACT) and TEG date(R time, K time and a angle) at 24-hour after CPB. The data on the predictive accuracy for postoperative bleeding at 24-hour after CPB, the TEG was significantly better than ACT(57%) or the coagulation profiles(43%) as a predictor of postoperative bleeding, with an accuracy rate of 100% (P=0.0043). In conclusion, TEG seems to be easy to use, clinically accurate, cost effective and provides data which can effectively manage a patient's hemostasis.

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[Retracted]Assessing Nutritional Status in Outpatients after Gastric Cancer Surgery: A Comparative Study of Five Nutritional Screening Tools ([논문철회]위암 수술 후 외래환자의 영양상태 평가: 5가지 영양검색도구의 비교연구)

  • Cho, Jae Won;Youn, Jiyoung;Choi, Min-Gew;Rha, Mi Young;Lee, Jung Eun
    • Korean Journal of Community Nutrition
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    • v.26 no.4
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    • pp.280-295
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    • 2021
  • Objectives: This study aimed to examine the characteristics of patients according to their nutritional status as assessed by five nutritional screening tools: Patient-Generated Subjective Global Assessment (PG-SGA), NUTRISCORE, Nutritional Risk Index (NRI), Prognostic Nutritional Index (PNI), and Controlling Nutritional Status (CONUT) and to compare the agreement, sensitivity, and specificity of these tools. Methods: A total of 952 gastric cancer patients who underwent gastrectomy and chemotherapy from January 2009 to December 2012 at the Samsung Medical Center were included. We categorized patients into malnourished and normal according to the five nutritional screening tools 1 month after surgery and compared their characteristics. We also calculated the Spearman partial correlation, Cohen's Kappa coefficient, the area under the curve (AUC), sensitivity, and specificity of each pair of screening tools. Results: We observed 86.24% malnutrition based on the PG-SGA and 85.82% based on the NUTRISCORE among gastric cancer patients in our study. When we applied NRI or CONUT, however, the malnutrition levels were less than 30%. Patients with malnutrition as assessed by the PG-SGA, NUTRISCORE, or NRI had lower intakes of energy and protein compared to normal patients. When NRI, PNI, or CONUT were used to identify malnutrition, lower levels of albumin, hemoglobin, total lymphocyte count, total cholesterol, and longer postoperative hospital stays were observed among patients with malnutrition compared to those without malnutrition. We found relatively high agreement between PG-SGA and NUTRISCORE; sensitivity was 90.86% and AUC was 0.78. When we compared NRI and PNI, sensitivity was 99.64% and AUC was 0.97. AUC ranged from 0.50 to 0.67 for comparisons between CONUT and each of the other nutritional screening tools. Conclusions: Our study suggests that PG-SGA and NRI have a relatively high agreement with the NUTRISCORE and PNI, respectively. Further cohort studies are needed to examine whether the nutritional status assessed by PG-SGA, NUTRISCORE, NRI, PNI, and CONUT predicts the gastric cancer prognosis.

[Republished study] Assessing Nutritional Status in Outpatients after Gastric Cancer Surgery: A Comparative Study of Five Nutritional Screening Tools ([재출판] 위암 수술 후 외래환자의 영양상태 평가: 5가지 영양검색도구의 비교연구)

  • Cho, Jae Won;Youn, Jiyoung;Choi, Min-Gew;Rha, Mi Young;Lee, Jung Eun
    • Korean Journal of Community Nutrition
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    • v.27 no.3
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    • pp.205-222
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    • 2022
  • Objectives: This study examined the characteristics of patients according to nutritional status assessed by five nutritional screening tools: Patient-Generated Subjective Global Assessment (PG-SGA), NUTRISCORE, Nutritional Risk Index (NRI), Prognostic Nutritional Index (PNI), and Controlling Nutritional Status (CONUT) and to compare the agreement, sensitivity, and specificity of these tools. Methods: A total of 952 gastric cancer patients who underwent gastrectomy and chemotherapy from January 2009 to December 2012 were included. The patients were categorized into malnutrition and normal status according to five nutritional screening tools one month after surgery. The Spearman partial correlation, Cohen's Kappa coefficient, the area under the curve (AUC), sensitivity, and specificity of each two screening tools were calculated. Results: Malnutrition was observed in 86.24% of patients based on the PG-SGA and 85.82% based on the NUTRISCORE. When NRI or CONUT were applied, the proportions of malnutrition were < 30%. Patients with malnutrition had lower intakes of energy and protein than normal patients when assessed using the PG-SGA, NUTRISCORE, or NRI. Lower levels of albumin, hemoglobin, total lymphocyte count, and total cholesterol and longer postoperative hospital stays were observed among patients with malnutrition compared to normal patients when NRI, PNI, or CONUT were applied. Relatively high agreement for NUTRISCORE relative to PG-SGA was found; the sensitivity was 90.86%, and the AUC was 0.78. When NRI, PNI, and CONUT were compared, the sensitivities were 23.72% for PNI relative to NRI, 44.53% for CONUT relative to NRI, and 90.91% for CONUT relative to PNI. The AUCs were 0.95 for NRI relative to PNI and 0.91 for CONUT relative to PNI. Conclusions: NUTRISCORE had a high sensitivity compared to PG-SGA, and CONUT had a high sensitivity compared to PNI. NRI had a high specificity compared to PNI. This relatively high sensitivity and specificity resulted in 77.00% agreement between PNI and CONUT and 77.94% agreement between NRI and PNI. Further cohort studies will be needed to determine if the nutritional status assessed by PG-SGA, NUTRISCORE, NRI, PNI, and CONUT predicts the gastric cancer prognosis.

Development of Evaluation Method of Regional Contractility of Left Ventricle Using Gated Myocardial SPECT and Assessment of Reproducibility (게이트 심근 SPECT를 이용한 좌심실의 국소탄성률 평가방법 개발 및 재현성 평가)

  • Lee, Byeong-Il;Lee, Dong-Soo;Lee, Jae-Sung;Kang, Won-Jun;Chung, June-Key;Lee, Myung-Chul;Choi, Heung-Kook
    • The Korean Journal of Nuclear Medicine
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    • v.37 no.6
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    • pp.355-363
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    • 2003
  • Purpose: Regional contractility can be calculated using the regional volume change of left ventricle measured by gated myocardial SPECT image and curve of central artery pressure obtained from radial artery pressure data. In this study, a program to obtain the regional contractility was developed, and reproducibility of regional contractility measurement was assessed. Materials and Methods: Seven patients(male:female=5:2, $58{\pm}11.9$ years) with coronary artery diseases underwent gated Tc-99m MIBI myocardial SPECT twice without delay between two scans. Regional volume change of left ventricle was estimated using CSA (Cardiac SPECT Analyzer) software developed in this study. Regional contractility was iteratively estimated from the time-elastance curve obtained using the time-pressure curve and regional time-volume curve. Reproducibility of regional contractility measurement assessed by comparing the contractility values measured twice from the same SPECT data and by comparing those measured from the pair of SPECT data obtained from a same patient. Results: Measured regional contractility was $3.36{\pm}3.38{mm}Hg/mL$ using 15-segment model, $3.16{\pm}2.25{mm}Hg/mL$ using 7-segment model, and $3.11{\pm}2.57{mm}Hg/mL$ using 5-segment model. The harmonic average of regional contractility value was almost identical to the global contractility. Correlation coefficient of regional contractility values measured twice from the same data was greater than 0.97 for all models, and two standard deviations of contractility difference on Bland Altman plot were 1.5%, 1.0%, and 0.9% for 15-, 7-, and 5-segment models, respectively. Correlation coefficient of regional contractility values measured from the pair of SPECT data obtained from a same patient was greater than 0.95 for all models, and two standard deviations on Bland Altman plot were 2.2%, 1.0%, and 1.2%. Conclusion: Regional contractility of left ventricle measured using developed software in this study was reproducible. Regional contractility of left ventricle will be a new useful index for myocardial function after analysis of the clinical data.

Validation of the Developed Nutritional Screening Tool for Hospital Patients (입원환자를 위해 개발된 영양검색 도구의 타당성 검증)

  • Lee, Jeong-Sook;Cho, Mi-Ran;Lee, Geum-Ju
    • Journal of Nutrition and Health
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    • v.43 no.2
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    • pp.189-196
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    • 2010
  • Malnutrition has been associated with higher hospital costs, mortality, rates of complications and longer length of hospital stay. Several nutritional screening tools have been developed to identify patients with malnutrition risk. However, many of those require much time and labor to administer and may not be applicable to a Korean population. Therefore, the aim of this study was to develop nutritional screening tool for Korean inpatients. Then we compare nutritional screening tools that developed and previously described. Seven hundred sixty-four patients at hospital admission were screened nutritional status and classified as well nourished, malnutrition stage 1 or stage 2 by the KNNRS (Kyunghee Neo Nutrition Risk Screening), PG-SGA (Patient-Generated Subjective Global Assessment) and NRS-2002 (Nutritional Risk Screening-2002). The KNNRS, PG-SGA and NRS-2002 respectively classified 28.7%, 51.3%, 48.5% of patients as malnourished status. Compared to the PG-SGA, the KNNRS had sensitivity 60.7% (95% CI 54.2-67.0) and specificity 81.2% (95% CI 75.3-85.2). Agreement was fair between KNNRS and PG-SGA (k = 0.34). Compared to the NRS-2002, the KNNRS had sensitivity 57.8% (95% CI 53.4-60.9) and specificity 64.4% (95% CI 60.2-69.8). Agreement was poor between KNNRS and NRS-2002 (k = 0.18). These result should include that the KNNRS and PGSGA have clinical relevance and fair concordance. However the rate of malnourished patients by KNNRS were less than by PG-SGA. For more effectivity of nutritional screening and management, the criteria of KNNRS would be better revised.