• Title/Summary/Keyword: Randomized Clinical Trials

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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.

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

  • Kwon, Chan-Young;Lee, Hoon-Hui;Im, Yong-Seok
    • Korean Journal of Acupuncture
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    • v.34 no.3
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    • pp.179-184
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    • 2017
  • Objectives : Despite the applicability of Korean Medicine(KM) treatments for facial asymmetry, no relevant study has been reported. In this case report, we report the effect and safety of KM treatments on facial asymmetry by mandibular lateral displacement. Methods : Three patients suffering from facial asymmetry received twelve KM treatment sessions composed of Motion Style Treatment(MST), Yinyang Balance Appliance(YBA) of Functional Cerebrospinal Therapy(FCST), and Instrument Assisted Soft Tissue Mobilization(IASTM). The photos of each patient were taken before and after the treatment. And four primary reference lines were assessed before and after the treatment. Results : All subjects were improved after KM treatments on photos. However, no statistical significance was observed. Conclusions : This case report is the first to introduce the effect of KM treatments on facial asymmetry. Further well-designed, randomized, placebo-controlled trials are needed to verify these results.

A Before and After Study about the Effects of Korean Medical Treatment on Halitosis Patients: Using OralChroma$^{TM}$ (구취 환자의 한방 치료 효과에 대한 전.후 비교 연구: OralChroma$^{TM}$를 이용하여)

  • Choi, Jane;Kim, Jin-Sung;Jang, Seung-Won;Son, Ji-Yeong;Baek, Seung-Hwan;Han, Seong-Jun;Lee, Eom-Jee;Ryu, Bong-Ha
    • The Journal of Internal Korean Medicine
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    • v.35 no.4
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    • pp.532-545
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    • 2014
  • Objectives: The purpose of this study was to evaluate the clinical effect of Korean medical treatments such as herbal medicine, acupuncture, and electroacupuncture by using the portable gas chromatograph OralChroma$^{TM}$ (Abimedical, Japan) in halitosis patients. Methods: We surveyed 30 halitosis patients who had visited the Oral Diseases Clinic in the Korean Medical Hospital of Kyunghee University from October, 2013 to November, 2014. Before starting Korean medical treatment, the subjects were evaluated on sociodemographic characteristics, severity of discomfort using visual analogue scale (VAS), unstimulated salivary flow rate (USFR), and halitosis associated life-quality test (HALT) score. To evaluate the therapeutic effect, we measured the volatile sulfur compounds (VSCs) in breath by using OralChroma$^{TM}$ before and after 3 weeks treatment. Results: The concentration of total VSCs measured by OralChroma$^{TM}$ significantly decreased (p=0.001). Furthermore, the level of hydrogen sulfide and methyl mercaptan also significantly decreased (p<0.05). However, although the level of dimethyl sulfide decreased as well, there was no significance(p>0.05). Conclusions: Korean medical treatment was effective in treating halitosis by decreasing VSCs. Further study, with well-designed randomized controlled trials with larger number of cases will be needed in the future.

Trend of Pharmacopuncture Therapy for Treating Cervical Disease in Korea

  • Kim, Seok-Hee;Jung, Da-Jung;Choi, Yoo-Min;Kim, Jong-Uk;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.17 no.4
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    • pp.7-14
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    • 2014
  • Objectives: The purpose of this study is to analyze trends in domestic studies on pharmacopuncture therapy for treating cervical disease. Methods: This study was carried out on original copies and abstracts of theses listed in databases or published until July 2014. The search was made on the Oriental medicine Advanced Searching Integrated System (OASIS) the National Digital Science Library (NDSL), and the Korean traditional knowledge portal. Search words were 'pain on cervical spine', 'cervical pain', 'ruptured cervical disk', 'cervical disc disorder', 'stiffness of the neck', 'cervical disk', 'whiplash injury', 'cervicalgia', 'posterior cervical pain', 'neck disability', 'Herniated Nucleus Pulposus (HNP)', and 'Herniated Intervertebral Disc (HIVD)'. Results: Twenty-five clinical theses related to pharmacopuncture were selected and were analyzed by year according to the type of pharmacopuncture used, the academic journal in which the publication appeared, and the effect of pharmacopuncture therapy. Conclusion: The significant conclusions are as follows: (1) Pharmacopunctures used for cervical pain were Bee venom pharmacopuncture, Carthami-flos pharmacopuncture, Scolopendra pharmacopuncture, Ouhyul pharmacopuncturen, Hwangryun pharmacopuncture, Corpus pharmacopuncture, Soyeom pharmacopuncture, Hwangryunhaedoktang pharmacopuncture, Shinbaro phamacopuncture. (2) Randomized controlled trials showed that pharmacopuncture therapy combined with other methods was more effective. (3) In the past, studies oriented toward Bee venom pharmacopuncture were actively pursued, but the number of studies on various other types of pharmacopuncture gradually began to increase. (4) For treating a patient with cervical pain, the type of pharmacopuncture to be used should be selected based on the cause of the disease and the patient's condition.

Analysis of Research Papers Published in the Journal of the Korean Academy of Nursing-Focused on Research Trends, Intervention Studies, and Level of Evidence in the Research (최근 2년간 Journal of Korean Academy of Nursing 게재논문 분석-연구 동향, 실험중재, 연구의 근거등급을 중심으로)

  • Shin, Hyun-Sook;Hyun, Myung-Sun;Ku, Mi-Ok;Cho, Myung-Ok;Kim, Sook-Young;Jeong, Jea-Sim;Jeong, Geum-Hee;SeoMoon, Gyeong-Ae;Son, Youn-Jung
    • Journal of Korean Academy of Nursing
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    • v.40 no.1
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    • pp.139-149
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    • 2010
  • This study aimed was done to analyze recent trends in nursing research published in the Journal of Korean Academy of Nursing by focusing on the content of nursing interventions and their level of evidence. Methods: A total of 209 studies published between 2007 and 2008 were reviewed using analysis criteria developed by the researchers. Results: The number of quantitative studies was greater than that of qualitative studies. There was a slight increase in the number of qualitative studies and studies including elderly populations, which reflects the recent population trend in Korea. More randomized controlled trials with a low risk of bias were needed to support more evidence-based nursing practice. Concerning the low rate of ethical consideration, stricter application of research ethics needs to be encouraged. Conclusion: The findings of this study suggest the recent trends in nursing research and the direction of nursing research and review in the Journal.