• Title/Summary/Keyword: Randomized Clinical Trials

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Analysis of Studies on Guibi-tang(Guipitang) for Fundamental Establishment of Evidence Based Medicine(EBM) (EBM 기반구축을 위한 귀비탕(歸脾湯) 연구 문헌 분석)

  • Kim, Jung-Hoon;Lee, Jun-Kyoung;Ha, Hye-Kyoung;Seo, Chang-Seob;Lee, Mi-Young;Lee, Ho-Young;Jung, Da-Young;Lee, Nam-Hun;Lee, Jin-Ah;Huang, Dae-Sun;Shin, Hyun-Kyoo
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.3
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    • pp.205-216
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    • 2009
  • Objectives : To establish the fundaments for EBM of Traditional Korean Medicine, the papers on Guibi-tang(Guipitang) which were frequently used in medical institutions of Traditional Korean Medicine were analyzed through researching domestic and international literatures. Methods : The papers were classified by the year of publishment, by experimental methods, by laboratory animals used in biological experiment and by the kinds of studies on biological efficacy. Results : Of total 39 papers were registered in domestic journals. Since 1980, publishments of papers have continuously increased. The papers on biological studies were 34 volumes, clinical studies were 5 volumes. Biological studies mainly showed the effects of anti-stress, anti-oxidant, hemostasis, anti-osteoporosis, gastroprotection, reproductive ability, brain cell activity, radioprotection. And clinical studies showed improvements of fearful throbbing, memory and orientation, insomnia, vericose vein, schizophrenia. Conclusions : Guibi-tang(Guipitang) could be used to fortify the spleen, nourish the heart and then control the blood. However biological studies need to be conducted in accordance with clinical study and further clinical studies on randomized controlled trials should be proceeded.

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The Utility and Benefits of External Lumbar CSF Drainage after Endovascular Coiling on Aneurysmal Subarachnoid Hemorrhage

  • Kwon, Ou-Young;Kim, Young-Joon;Kim, Young-Jin;Cho, Chun-Sung;Lee, Sang-Koo;Cho, Maeng-Ki
    • Journal of Korean Neurosurgical Society
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    • v.43 no.6
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    • pp.281-287
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    • 2008
  • Objective : Cerebral vasospasm still remains a major cause of the morbidity and mortality, despite the developments in treatment of aneurysmal subarachnoid hemorrhage. The authors measured the utility and benefits of external lumbar cerebrospinal fluid (CSF) drainage to prevent the clinical vasospasm and its sequelae after endovascular coiling on aneurysmal subarachnoid hemorrhage in this randomized study. Methods : Between January 2004 and March 2006, 280 patients with aneurysmal subarachnoid hemorrhage were treated at our institution. Among them, 107 patients met our study criteria. The treatment group consisted of 47 patients who underwent lumbar CSF drainage during vasospasm risk period (about for 14 days after SAH), whereas the control group consisted of 60 patients who received the management according to conventional protocol without lumbar CSF drainage. We created our new modified Fisher grade on the basis of initial brain computed tomography (CT) scan at admission. The authors established five outcome criteria as follows : 1) clinical vasospasm; 2) GOS score at 1-month to 6-month follow-up; 3) shunt procedures for hydrocephalus; 4) the duration of stay in the ICU and total hospital stay; 5) mortality rate. Results : The incidence of clinical vasospasm in the lumbar drain group showed 23.4% compared with 63.3% of individuals in the control group. Moreover, the risk of death in the lumbar drain group showed 2.1 % compared with 15% of individuals in the control group. Within individual modified Fisher grade, there were similar favorable results. Also, lumbar drain group had twice more patients than the control group in good GOS score of 5. However, there were no statistical significances in mean hospital stay and shunt procedures between the two groups. IVH was an important factor for delayed hydrocephalus regardless of lumbar drain. Conclusion : Lumbar CSF drainage remains to playa prominent role to prevent clinical vasospasm and its sequelae after endovascular coiling on aneurysmal subarachnoid hemorrhage. Also, this technique shows favorable effects on numerous neurological outcomes and prognosis. The results of this study warrant clinical trials after endovascular treatment in patients with aneurysmal SAH.

Kidney-sparing Management Versus Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Systematic Review and Meta-analysis

  • Luo, You;She, Dong-Li;Xiong, Hu;Fu, Sheng-Jun;Yang, Li
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5907-5912
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    • 2015
  • Purpose: To evaluate and update evidence for prognostic effects of kidney-sparing (KS) management and nephroureterectomy (NU) for upper tract urothelial carcinomas. Materials and Methods: Pubmed, Embase and the Cochrane Library were retrieved for the identification of comparative studies of kidney-sparing procedure and nephroureterectomy for upper tract urothelial carcinoma prior to December 2014. The data were extracted independently by 2 reviewers and the quality of the included studies was assessed. Review Manager 5.3 and STATA 13 were used to perform the meta-analysis. Results: Twenty-three observational studies including 1,587 KS and 3,996 NU were evaluated. The results of the meta-analysis showed that nephroureterectomy had no significant benefit with regard to intravesical recurrence (IRFS), metastasis (MFS), cancer specific survival (CSS) and overall survival (OS) except the total tumor recurrence (RFS) when compared with kidney sparing management. The respectively pooled outcomes were HR 1.36 (0.69-2.68, P=0.38) for IRFS, 1.09 (0.59-2.01, P=0.78) for MFS, 1.17 (0.77-1.79, P=0.47) for CSS, 1.50 (0.90-2.48, P=0.12) for OS and 1.61 (1.03-2.51, P=0.04) for RFS. Conclusions: On the whole, kidney-sparing management had equivalent prognostic effect on upper tract urothelial carcinoma as the standard nephroureterectomy except in tumor recurrence. However, the results should be interpreted with caution for lack of stage and grade stratification and multi-center randomized controlled trials are still needed to verify our results.

Clinical Practice Guideline on Acupuncture for Post-stroke Spasticity (뇌졸중후 경직에 대한 침치료 임상진료지침)

  • Kim, Je-Shin;Shin, Seung-Won;Lee, Eui-Ju;Shin, Byung-Cheul;Lee, Myeong-Soo;Lim, Sung-Min;Nam, Dong-Woo;Moon, Sang-Kwan
    • The Journal of Korean Medicine
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    • v.36 no.1
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    • pp.1-8
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    • 2015
  • Objectives: This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the patients with post-stroke spasticity. 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 post-stroke spasticity, 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: One systematic review and 7 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of electroacupuncture treatment for post-stroke spasticity. However, it did not show any sufficient evidence to treat the patients with post-stroke spasticity with the sole acupuncture. The moderate evidence was presented that over 3 times of the electroacupuncture treatments with 1-100 Hz frequency should be performed every week on the acupoints, such as LI11, LI10, TE5, LI4, ST36, GB34, ST40, or LR3, for 20-30 minutes. 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 post-stroke spasticity.

Clinical Practice Guideline for acupuncture in Post-stroke urinary incontinence (뇌졸중 후 요실금에 대한 침치료 임상진료지침)

  • Lee, Ji-Won;Shin, Byung-Cheul;Lee, Myeong-Soo;Lim, Sung-Min;Yoo, Jung-Hee;Cho, Chung-Sik;Moon, Sang-Kwan;Yook, Tae-Han;Joo, Jong-Cheon;Lee, Eui-Ju
    • Journal of Sasang Constitutional Medicine
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    • v.29 no.4
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    • pp.317-325
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    • 2017
  • Objectives This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the stroke patients with Post-stroke Urinary Incontinence(PSUI). 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 PSUI, 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 8 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of acupuncture treatment for PSUI. 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 BL23, CV3, SP6, CV4, CV6, ST28, BL28, BL32, GV20, BL22, GV4 or ST36, for 15-30 minutes. 1-150 Hz frequency is suggested if electro-acupuncture treatments 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. There was a moderate evidence to support safety of acupuncture treatment for PSUI. We recommend acu-points of constitutional acupuncture for Sasangin on the healthy side.

Effect of Cardiotonic Pills$^{(R)}$ on Chest Pain and Discomfort: A Multi-center Double-blind Randomized Controlled Trial. (심적환$^{(R)}$이 흉통 흉민에 대하여 미치는 영향에 대한 다기관 무작위배정 이중맹검 임상연구)

  • Jang Insoo;Ko Changnam;Lee In;Park Jung-mi;Kim Sehyun;Kim Sangwoo
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.95-104
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    • 2005
  • Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

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The Effects of High Fidelity Simulation-Based Education on Clinical Competence and Confidence in Nursing Students: A Systematic Review (고충실도 시뮬레이션 기반 교육이 간호학생의 임상수행능력과 간호수행 자신감에 미치는 효과: 체계적 문헌 고찰)

  • Lee, Chong-Mi;So, Hyang-Sook;Kim, Younkyoung;Kim, Jeong-Ee;An, Minjeong
    • The Journal of the Korea Contents Association
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    • v.14 no.10
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    • pp.850-861
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    • 2014
  • The purpose of this review was to evaluate the effects of simulation-based education on clinical competence and confidence in nursing students and summarize the available evidence on the simulation-based intervention. A systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA Statement was conducted. Studies published between 2005 and 2014 were reviewed using the following databases: RISS, KISS, and Google Scholar. The keywords used were nursing and either simulation or simulator. Selected studies were assessed for methodological quality using Quality Assessment Tool for Quantitative Studies. Seventeen studies were identified, including a total of 1,912 nursing students. All the 16 studies found simulation as a valid strategy on clinical competence and confidence in nursing education. This review provides updated evidence for simulation-based learning in nursing education. Further studies are needed to increase generalizability using randomized controlled trials, enough sample size, and longitudinal study design. In addition, valid measurements are needed to assess the main outcomes.

Systematic Review on Presbycusis Treated by Herbal Medicine Focusing on Kidney Deficiency (노인성 난청의 한약 치료에 대한 체계적 문헌고찰: 신허(腎虛)을 중점으로)

  • Lim, Hui-yeong;Jin, Han-Sol;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.34 no.4
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    • pp.49-70
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    • 2021
  • Objectives : This study was conducted to approve the effectiveness and safety of herbal medicine on presbycusis with kidney deficiency. Methods : We searched randomized controlled trials(RCTs) on presbycusis patients diagnosed with kidney deficiency through 10 electronic databases from the start to Sep 7, 2021. Study collection and data extraction, and evaluation of risk of bias were conducted by two independent collaborator. The evaluation of the risk of bias in included RCTs was carried out by using Cochrane risk-of-bias tool. And the data synthesis was conducted by using Review Manager(RevMan, ver.5.4). Results : 1. The treatment group which used herbal medicine(HM) alone was more effective than the control group which used only western medicine(WM) on effective rate of hearing loss. 2. In 3 studies comparing the HM-WM combination treatment group with the control groups using the same WM treatment, the effective rate was statistically significantly higher in the HM-WM combination treatment group. 3. Of the 5 studies that reported adverse reactions, one study reported mild nausea and dizziness, but the difference between the HM treatment group and the WM control group was not statistically significant, and no side effects occurred in other 3 studies. 4. In studies comparing HM and WM, the HM treatment group improved hearing loss, whole blood viscosity, serum TNF-𝛼, IL-1𝛽, IL-6, and oxidative stress indicators better than the WM control group, and there was no significant difference. 5. In studies comparing the HM-WM treatment group with the WM control group, the severity of tinnitus, quality of life, and feelings of anxiety and depression were better in the treatment group than the control group. Conclusions : This study shows that the herbal medicine can improve symptoms of presbycusis with kidney deficiency.

Comparison of the Effectiveness of Herbal Medicine Eye Drops on Conjunctivitis : A Systematic Literature Review and Meta-Analysis (결막염에 대한 한방 점안액의 효과 비교 : 체계적 문헌 고찰과 메타 분석)

  • Lim, Hui-Yeong;Kim, Jee-Hee;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.35 no.3
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    • pp.48-65
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    • 2022
  • Objectives : This study was conducted to find out the effectiveness and safety of herbal medicine eye drops on conjunctivitis. Methods : We searched randomized controlled trials on conjunctivitis through 10 DBs from the start to April 27, 2022. Study collection and data extraction, and evaluation of risk of bias were conducted by two independent researchers. The evaluation of the risk of bias in included RCTs was carried out by using Cochrane risk-of-bias tool. And the data synthesis was conducted by using Review Manager(RevMan, ver.5.4). Results : Total of 106 studies are researched and 7 studies of them are finally included. 1. The herbal medicine eye drops are more effective on than the western medicine eye drops, but the heterogeneity was very high. So we conducted sensitivity analysis and compared to the herbal medicine eye drops and the western medicine eye drops, the total effective rate was higher in the herbal medicine eye drops and the heterogeneity was somewhat reduced. 2. In the subgroup analysis, Fufang Xiongdan eye drops and Houttuynia cordata Thunb eye drops are more effective than the western medicine. It may represent substantial heterogeneity. 3. In the subgroup analysis, the herbal medicine eye drops are more effective than antibiotic and antiviral eye drops on acute bacterial conjunctivitis, but showed high heterogeneity. On the other hand, the herbal medicine eye drops are more effective than antibiotic and antiviral eyed drops on acute viral conjuctivitis and showed low heterogeneity. 4. In the subgroup analysis, we compared the effectiveness of herbal and western medicine eye drops according to total effectiveness rate evaluation methods. When comparing the studies calculating the total effective rate by the sum of 'Cured', 'Significantly Impaired', and 'Improved', the effective rate of the herbal medicine eye drops was higher than that of the western medicine eye drops, and the heterogeneity was very low. 5. In most studies, side effects of herbal medicine eye drops were absent or mild. Conclusions : This study shows that herbal medicine eye drops may be more effective than western medicine eye drops and have safety. But further researches are needed to resolve the heterogeneity of this study.

Current situation of Translational research on Acupuncture, Moxibustion and Pharmacopuncture (침구와 약침에 대한 중개연구 현황)

  • Sin, Dae Chul;Song, Ho Sueb
    • Journal of Acupuncture Research
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    • v.33 no.2
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    • pp.109-116
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    • 2016
  • Objectives : Our primary objective lies in understanding the current landscape of translational research on acupuncture, moxibustion and pharmacopuncture. Methods : We searched our own selection of keywords of acupuncture, moxibustion and pharmacopuncture and translational research from three overseas databases (Pubmed, Scopus, Medicine) and four domestic databases (DBpia, KISS, Riss4u, Korea Med). Results : We have chosen 41 articles in total-40 articles on acupunture, 6 article on moxibustion(5 articles were duplicated in use in each category). Origin-wise, 48.8 %/24.8 %/17.0 % of our articles pool came from USA/China/Korea, respectively. UK, Austria, Thailand and Italy contributed the rest of our article pool. For those articles written in USA and China, review articles were the most common type. For the US articles, all 10 review articles were non-systematic reviews, while, for China's contribution, one out of 4 review articles were systematic review. Type-wise, our research pool's breakdown is as follows ; 17 review articles, 11 experimental research, 2 randomized controlled trials(RCT), 1 clinical trial, 4 conference reports, 1 letter, 1 study protocol and 4 uncategorized. Topic-wise, brain-neurology was most frequently referred with 8 articles, followed by parkinson's disease (3 articles) and epilepsy (2 articles). Conclusion : 1. In terms of research submission articles, Korea appears to be lacking translational research on acupuncture, moxibustion and pharmacopuncture, compared to USA and China, in our view. 2. Unlike the cases of USA and China, most of Korean translational research is limited to doing a T1 level of translational research. In order to bring bench-to-bedside to light. we believe, there should be more studies, and thereby a certain level of activation, to the T2 level of translational research in Korea. 3. Further, in our view there should be more efforts to improve article quality at the T1 level of translational research, which eventually becomes the fundamentals of the next level of research (i.e. T2 research), as well as to increase the number of research submissions, going forward.