• 제목/요약/키워드: Placebo-controlled

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만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험 (Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease)

  • 이상도;서광원;이정연;허진원;최익수;박재선;심태선;오연목;박인원;류왕성;최병휘
    • Tuberculosis and Respiratory Diseases
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    • 제57권4호
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    • pp.320-328
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    • 2004
  • 연구배경 : 만성폐쇄성폐질환의 경과 중 조기에 나타나는 폐혈관의 변화는 이후 만성폐쇄성폐질환의 불량한 예후 인자인 폐고혈압증의 원인이 된다. Beraprost sodium (BPS)은 경구투여가 가능한 prostacyclin 유사 약제이며, 원발성폐고혈압 환자에서 생존율을 향상시킨다고 알려져 있다. 본 연구는 만성폐쇄성폐질환 환자에 대한 BPS의 효과에 대해 알아보고자 하였다. 연구방법 : 본 연구는 이중맹검, 무작위, 무효약대조, 2기관 임상시험이다. 2003년 6월부터 2004년 6월까지 만성폐쇄성폐질환 환자 21명이 선정되었다(이중 BPS를 3개월간 복용한 BPS군은 11명, 무효약을 복용한 무효약군은 10명). 기초평가, 폐기능검사, 혈역학적 지표에서 두 군간 통계적 차이는 없었다. 연구결과 : 심장초음파검사에서 Trans Tricuspid valve Pressure Gradient(TTPG) 측정값이 BPS군에서 BPS 복용 전보다 복용 3개월 후 현저한 감소를 보였다[17.7(${\pm}11.4$)에서 8.2(${\pm}8.9$) mm Hg, p-value<0.05]. 한편 무효약군 에서는 통계학적 차이가 없었다. 6분 도보거리는 무효약군에서는 감소를 보였고 BPS군에서는 증가된 결과를 보였으나 통계적 유의성은 없었다. 결 론 : 만성폐쇄성폐질환 환자에서 BPS의 경구복용은 폐동맥압을 감소하게 하였다. 이런 결과의 임상적 중요 성인 증상 및 질병의 자연경과의 개선을 조사하기 위한 추가연구가 필요할 것으로 사료된다.

패 추출물이 제2형 당뇨병 환자의 혈당 및 항산화 체계에 미치는 영향 (Effects of Ishige okamurae Extract Supplement on Blood Glucose and Antioxidant Systems in Type 2 Diabetic Patients)

  • 강연주;김학주;한지숙
    • 한국식품영양과학회지
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    • 제40권12호
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    • pp.1726-1733
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    • 2011
  • 본 연구는 패추출물 섭취를 통해 제 2형 당뇨병 환자의 혈당, 혈중지질 및 항산화 체계 개선에 있어서 패추출물의 효능을 규명하고자 하였다. 동결건조 한 패추출물을 200 mg 캡슐로 만들어 제 2형 당뇨환자에게 아침과 저녁 식전에 4캡슐씩 하루 8캡슐(1600 mg)을 10주간 섭취하도록 하였다. 위약군은 동량의 corn starch를 실험군과 동일하게 제조한 후 같은 방법으로 섭취하게 하였고, 이중맹검법을 사용하였다. 실험대상자는 총 46명이며 실험군 24명, 위약군 22명으로 구성되었으며, 두 군의 일반적 특성 및 생활습관은 유의적 차이가 없었다. 패추출물 섭취군에서 공복혈당은 10주간 섭취 후 $136.50{\pm}31.96$ mg/dL에서 $130.90{\pm}29.88$ mg/dL로 감소하였으나 유의적인 차이를 보이지 않았다. 당화혈색소는 $7.34{\pm}0.78%$에서 $6.82{\pm}0.98%$로 유의적(p<0.01)으로 감소하였다. 특히 당화혈색소가 8% 미만인 저당화혈색소 군에서 유의적으로(p<0.05) 감소하는 것으로 나타났다. 인슐린저 항성은 패추출물군의 경우 $2.77{\pm}0.49$ mmol/L에서 $2.19{\pm}0.62$ mmol/L로 감소하였으나 유의성이 없었으며 위약군도 유의한 변화가 없었다. 패추출물의 섭취가 10주간 이루어지면서 혈청지질의 변화는 유의하지 않았으나 HDL-콜레스테롤 경우 위약군에서 감소한 반면 패추출물군에서는 $41.14{\pm}7.86$ mg/dL에서 $46.82{\pm}5.69$ mg/dL로 증가하였다. LDL-콜레스테롤은 $115.43{\pm}27.47$ mg/dL에서 $108.73{\pm}22.36$ mg/dL로 감소하였으나 유의한 변화는 없었다. 지질과산화물 농도는 패추출물 섭취군에서 $6.83{\pm}1.05$ nmol/MDA에서 $5.72{\pm}1.28$ nmol/MDA로 그 함량이 감소되었고, superoxide dismutase, glutathione peroxidase, catalase와 같은 항산화 효소계의 활성은 위약군에 비하여 패추출물 섭취군에서 증가하였으나 유의적인 차이를 보이지 않았다. 간기능 지표인 AST, ALT, ${\gamma}$-GTP와 신장 기능 지표인 BUN, creatinine에서 유의적인 차이 없이 정상범위를 나타내었다. 이상의 연구 결과 한국인 제2형 당뇨병 환자에서 패추출물의 섭취는 지난 2~3개월간의 평균 혈당관리 상태를 파악할 수 있는 지표인 당화혈색소 감소에 효과적인 것으로 나타났으며, 패추출물 복용 후에도 간 및 신장기능이 정상으로 확인되었으므로 패추출물은 당뇨병 환자들의 평균 혈당관리에 도움을 줄 수 있을 것으로 사료된다.

A Pilot Study to Assess the Effect of Gami-Jiwhang-Tang on Cognitive Effects in Healthy Children

  • Bahn Geon-Ho;Kim Chang-Ju;Chung Joo-Ho;Kim Yong-Hee;Paik Eun-Kyung;Park Jae-Hyung
    • 대한한의학회지
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    • 제25권4호
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    • pp.129-138
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    • 2004
  • Objective : Treatments for patients with mental retardation and pervasive developmental disorders are not curative, and are designed to help those with disabilities adjust to their environments and daily demands. As clinicians, the present authors tried to find agents with potentially curative properties. Among the numerous herbal formulations available, we chose and assessed Gami-jiwhang-tang (GJT) in the hope that it would improve cognitive development of children. Methods : Subjects were typically-developing healthy, 7- to 8-year-old boys and girls living in Seoul, Korea. The experimental group took GJT for six weeks and was followed up six weeks after discontinuation of GJT. The control group was assessed at the same intervals but did not receive placebos. To measure the effects of GJT, neuropsychological tests and intelligence test were taken before commencing GJT and twelve weeks later. Resulets and Conclusion : For all of the ANOVAs, the treatment by time interaction terms was not significant. However, the experimental group showed the tendency to be progressed in most subscales compared with the control group, especially on performance intelligence, visual organization, and verbal fluency. Conclusion : Although GJT failed to reveal significant improvement in cognition, we remain hopeful about the compound and believe that it should be evaluated by a double-blind, placebo-controlled trial in the future.

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안면 비대칭에 대한 한의학적 치료의 효과: 증례보고 (The Effect of Korean Medicine Treatments on Facial Asymmetry: A Case Report)

  • 권찬영;이훈희;임용석
    • Korean Journal of Acupuncture
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    • 제34권3호
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    • pp.179-184
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    • 2017
  • 목적 : 안면 비대칭에 대한 한의학적 치료의 적용가능성에도 불구하고, 아직까지 관련 연구는 보고되지 않고 있다. 이 증례보고에서 저자들은 하악골 측방변위로 인한 안면 비대칭에 대하여 한의학적 치료의 효과와 안전성을 보고하였다. 방법 : 3명의 안면 비대칭 환자가 동작침법, 기능적 뇌척주요법의 음양균형장치, 연부조직이완술로 구성된 한의학적 치료를 12회 받았다. 치료 전후에 환자의 사진이 촬영되었다. 치료 전후의 4개의 주요 기준선의 변화가 평가되었다. 결과: 모든 환자들은 사진상의 호전을 보였다. 하지만 통계적으로 유의한 차이는 없었다. 결론 : 이 증례보고는 안면 비대칭에 대해 한의학적 치료의 효과를 보고하는 첫 번째 보고이다. 추후 이러한 결과를 확인하기 위한 더 잘 설계된, 무작위화, 플라세보 대조 연구가 필요하다.

급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검 (The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study)

  • 송호섭
    • 대한약침학회지
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    • 제8권2호
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    • pp.11-16
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    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

마황천오약침이 비만에 미치는 영향 (The Effect of Mahuang(Ephedra sinica Stapf)-Chuanwu(Aconitum carmichaeli Debx) Pharmacopuncture Treatment in Obese Patients)

  • 김진혁;신민섭;최석우;송범용;육태한
    • Journal of Acupuncture Research
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    • 제26권5호
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    • pp.77-83
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    • 2009
  • Objectives : We investigated the effects of Mahuang-Chuanwu Pharmacopuncture Treatment in Obese Patients by analysing Body mass index(BMI), waist measurement and weight. Methods : We investigated on 52 volunteers consisted of 24 subjects in experiment(Mahuang-Chuanwu Pharmacopuncture) group and 28 subjects in control(Normal Saline) group. The Study form was a single-blind and placebo-controlled clinical trial. 24 subjects in experiment group were injected Mahuang-Chuanwu Pharmacopuncture with additional common treatment and 28 subjects in control group were injected Normal Saline with additional common treatment with Dietic Theraphy and Exercise. We measured BMI, waist measurement and weight on 3 times : before 1st session, after first 5 sessions, and after 10 sessions. The SPSS 13.0 for Windows was used to analyze the data and the wilcoxon signed ranks test (in group), mann Whitney u t-test(between two groups) and ${\chi}^2$-test(description of number) were used to verify the result. Results : In experiment group. BMI, waist measurement and weight were significantly low at the period of after first 5 sessions and after 10 sessions. In control group, BMI, waist measurement and weight were significantly low at the period of after 10 sessions but weren't significantly low at the period of after first 5 sessions. The changes of BMI, waist measurement and weight in experiment group were significantly more than that in control group. Conclusions : The Results suggest that Mahuang(Ephedra sinica Stapf)-Chuanwu(Aconitum carmichaeli Debx) Pharmacopuncture is effective on the treatment of obesity, compared to Normal Saline.

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퇴행성 슬관절염에 대한 제통단의 안전성과 효능 임상연구 (Clinical Study of the Efficacy and. Safety of Jetongdan on Patients with Osteoarthritis of the Knee)

  • 서병관;류성룡;강중원;안경애;이상훈;최도영;김건식;이두익;이윤호;이재동
    • 대한한의학회지
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    • 제26권2호
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    • pp.231-240
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    • 2005
  • Objectives: In order to investigate the efficacy and safety of the newly developed herbal medicine Jetongdan, a placebo­controlled, randomized clinical trial of patients with osteoarthritis of the knee was undertaken. Methods: Data were obtained from 80 patients with OA of the knee. After enrollment, they were asked to answer a disease-specific questionnaire (Western Ontario and McMaster Universities (WOMAC) OA index) and analyzed with the erythrocyte sedimentation rate (ESR) in order to evaluate the efficacy of Jetongdan, and analyzed for aspartate transaminase (AST) level, alanine transaminase (ALT) level, blood mea nitrogen (BUN) level, and creatinine (Cr) level in order to evaluate the safety of Jetongdan. Results: The liver function and renal function did not deteriorate after treatment with Jetongdan. Composite WOMAC score and physical function subscale was improved, but pain subscale, stiffness subscale, and ESR were not improved by. This was possibly because the baseline characteristics of the two groups were not homogenized after randomization. Conclusions: Jetongdan could be a promising treatment option for osteoarthritis of the knee. Further study in a larger population with appropriate severity grades is recommended.

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뇌졸중후 요저류에 대한 침치료 임상진료지침 (Clinical Practice Guideline for acupuncture in Post-stroke urinary retention)

  • 이지원;이의주;신병철;이명수;임성민;조충식;문상관
    • 대한한의학회지
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    • 제37권1호
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    • pp.1-9
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    • 2016
  • Objectives: Objectives : This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the patients with Post-stroke Urinary Retention; PSUR. Methods: Experts committee, consisting of stroke or methodology specialists, searched Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and 19 Korean medicine journals. The search terms were selected to screen the randomized controlled trials (RCTs) or systematic reviews for the effectiveness of acupuncture on PSUR compared with placebo or conventional group. Levels of evidence and grades of recommendations were appraised based on Recommendations for Development of Clinical Practice Guideline in Korean Medicine. Results & Conclusions: 4 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of acupuncture treatment for PSUR. The moderate evidence was presented that over 3 times a week of the acupuncture should be performed over 4 weeks on the acupoints, such as SP6, CV3, CV6, CV4, SP9, BL28, BL23, BL22, KI3 or BL67, for 15-30 minutes. 20-140Hz frequency and 10-20 minutes of treatment is suggested if electro-acupuncture treatment is performed with. It was also suggested that the procedure should begin at the acute stage just after the vital signs of the patients are stabilized. Finally, there was a moderate evidence to support safety of acupuncture treatment for PSUR.

Clinical Efficacy and Safety of Yukgunja-tang for Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis

  • Park, SongWon;Lim, Seong-Woo
    • 대한한의학회지
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    • 제40권4호
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    • pp.16-28
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    • 2019
  • Objectives: The purpose of this meta-analysis was to evaluate the effects of Yukgunja-tang(YGJT, Rikkunshito, Liujunzi) on Gastroesophageal Reflux Disease(GERD). Methods: Sixteen electronic databases were used to search for studies published through March 2019, and a randomized controlled study was conducted to study the effects of YGJT or modified YGJT on GERD. Study quality was assessed using the risk bias tool provided by Cochran, and data analysis was performed using Review Manager 5.3.0 software Results: Two-hundred and forty articles were initially searched, and 13 studies that satisfied the study criteria were evaluated qualitatively; 11 of the 13 were included in the meta-analysis. In the two studies, the effects of YGJT and a placebo were compared. Meta-analysis showed that YGJT significantly improved FSSG (Frequency Scale for the Symptoms of GERD) scores, but not GSRS (Gastrointestinal Symptom Rating Scale) scores (FSSG: MD -2.40, 95% CI [-5.31, 0.51], p=0.11, GSRS: MD 0.05, 95% CI [-0.12, 0.22], p=0.55). Meta-analysis of nine studies comparing the efficacies of YGJT and conventional medicine showed that YGJT had a significant clinical effect (OR 5.72; 95% CI [3.41, 9.61]; I2 p<0.00001). Conclusion: This study suggests that YGJT effectively relieves the symptoms of GERD. Unfortunately, owing to the small sample sizes, limitations of several methodological qualities, we believe large-scale clinical studies with less bias will provide evidence of qualitative improvement.

Ginsenoside Rg3의 항암효능 연구의 진보 (Recent Progress in Research on Anticancer Activities of Ginsenoside-Rg3)

  • 남기열;최재을;홍세철;표미경;박종대
    • 생약학회지
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    • 제45권1호
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    • pp.1-10
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    • 2014
  • Ginsenoside Rg3 (G-Rg3) is one of protopanaxadiol ginsenosides characteristic of red ginseng, steamed and dried ginseng (Panax ginseng), which has recently attracted much attention for its antitumor properties in vitro and in vivo animal models. Experimental studies have demonstrated that it could promote cancer cell apoptosis, inhibit cancer cell growth, the apoptosis of cancer cells, adhesion, invasion and metastasis, and also prevent an angiogenetic formation in prostate, breast, ovarian, colorectal, gastric, liver and lung cancer etc. It has shown the antitumor activities by modulation of diverse signaling pathways, including regulation of cell proliferation mediators (CDKs and cyclins), growth factors (vascular endothelial growth factor), tumor suppressors (p53 and p21), cell death mediators (caspases, Bcl-2, Bax), inflammatory response molecules ($NF-{\kappa}B$ and COX-2), protein kinases (JNK, Akt, and AMP-activated protein kinase) and Wnt/${\beta}$-catenin signaling. In addition, the combination of Rg3 and chemotherapeutic agents have synergistically enhanced therapeutic efficacy and reduced antagonistically side effects. Furthermore, it can reverse the multidrug resistance of cancer cells, prolong the survival duration and improve life quality of cancer patients. Taken together, accumulating evidences could provide the potential of G-Rg3 in the treatment of cancers and the feasibility of further randomized placebo controlled clinical trials.