• Title/Summary/Keyword: Randomized Clinical Trials

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A Systematic Review on clinical studies of Korean medicine for smoking cessation - Focusing on study design (한의약 금연 임상연구의 체계적 고찰 - 연구 설계를 중심으로)

  • Park, Yu Lee;Jang, Soobin;Sung, Hyun Kyung;Kweon, Seung Uk;Sung, Joo Won;Yang, Jaehyung;Park, Bongkyu;Ko, Seong-Gyu;Park, Sunju
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.3
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    • pp.115-129
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    • 2015
  • Objective : This study aims to review clinical studies evaluating effectiveness of Korean medicine for smoking cessation. It also aims to critically analyze study design of the studies and suggest strategies for future clinical studies on smoking cessation. Method : Only domestic databases such as RISS, KISS, DBPIA, NDSL, and OASIS were searched from August to November 2011 for clinical studies on smoking cessation. There was no limitation on study design, period, and language. The studies were qualitatively analyzed focusing on study design including participants, intervention, and outcome measurements. Results : Out of 537 studies searched, 27 studies were included in the analysis. 56% of the studies were observational studies, 33% were quasi-experimental studies, and 11% were randomized controlled studies. 44% and 32% of the studies were conducted at educational institutions and hospitals, respectively. The average number of the participants were 182, which ranged from 15 to 1,056. Most of the participants were male. Intervention used were mostly auricular acupuncture, and the most frequently used acupoints were Lung, Shinmun, Endocrine, Pharynx & Larynx, and Inner nose. The average length of treatment period was four weeks, and the treatment was provided twice per week. The outcomes were measured at the end of the treatment and only 26% of the studies conducted follow-up measurements. 26% of the studies utilized questionnaires of which validity was evaluated and only 15% used objective measurements such as exhaled Carbon monoxide and Cotinine test. Conclusion : Though many clinical studies on effectiveness of Korean medicine for smoking cessation were conducted, there are still debates on quality of evidence. Recently, guidelines have been developed for clinical trials evaluating effectiveness of smoking cessation program. Thus, in the future, clinical studies should be developed based on these guidelines and designed to improve validity and reliability.

The Clinical Interchange between Western Medicine and Oriental Medicine: with the Stroke Patient Outcomes Research (일부 한.양방병원 뇌혈관질환 환자의 진료결과 및 만족도의 비교연구 -한양방협진 진료프로토콜의 적용을 중심으로-)

  • Park, Jong-Ku;Kang, Myung-Guen;Lee, Seong-Soo;Kim, Dal-Rae;Choi, Seo-Young;Han, Chang-Ho;Yoo, Jun-Sang;Kim, Min-Gi;Kim, Chun-Bae
    • The Journal of Internal Korean Medicine
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    • v.22 no.4
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    • pp.691-702
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    • 2001
  • Objectives : This study was done to assess the effects of the clinical interchange between the Western Medicine and the Oriental Medicine for ischemic stroke patients. The patient outcomes include changes in neurologic function by modified NIH stoke scale, stroke pattern identification scale, and patient satisfaction, Methods : For the assessment of effects, this study was performed with 178 inpatients who had undergone the stroke care at three hospitals (W Hospital adopted western therapy, S Oriental Hospital adopted Sasang constitution medicine therapy, and H Oriental Hospital adopted mixed therapy according to a joint protocol on Western Oriental medical care) from November 1997 to December 1998. Patients were interviewed or written with self-entered questionnaire forms, and clinical data were obtained, Physicians or oriental doctors wrote clinical questionnaire forms according to the care process. Results : The patient outcomes within three hospitals at 2 stages (at admission and discharge in the modified NIH stroke scale. at admission and second weeks during admission in the stroke pattern identification scale) were found to be decreased, Especially in the results of hierarchical multiple regression analysis, the degree of improvement of modified NIH stroke scale of the stroke patients at W Hospital was significant large than it at S Oriental Hospital. Also, the degree of improvement of stroke pattern identification scale at W Hospital was significantly large than it at other two hospitals. However, the patient's satisfaction score at three hospitals wasn't significantly different. Conclusions : The result of this study suggested that the joint clinical research of Western & Oriental medical practitioners was possible even if there was a conflict between Western Medicine and Oriental Medicine. Therefore Western & Oriental medical practitioners share a mutual responsibility to apply evidence-based practice, to seek scientific empirical proof through randomized clinical trials between the multicenter.

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Evidence-Based Clinical Practice Guideline for Fluid Therapy to Prevent Contrast-induced Nephropathy (조영제 유발 신장병증 예방을 위한 수액요법에 관한 근거기반 임상실무지침 개발)

  • Lee, Kyung Hae;Shin, Kyung Min;Lee, Hyeon Jeong;Kim, So Young;Chae, Jung Won;Kim, Mi Ra;Han, Min Young;Ahn, Mi Sook;Park, Jin Kyung;Chung, Mi Ae;Chu, Sang Hui;Hwang, Jung Hwa
    • Journal of Korean Clinical Nursing Research
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    • v.23 no.1
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    • pp.83-90
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    • 2017
  • Purpose: This study was to develop evidence-based clinical practice guideline in order to prevent contrastinduced nephropathy (CIN) for patients undergoing percutaneous coronary intervention (PCI). Methods: The guideline was developed based on the "Scottish Intercollegiate Guidelines Network (SIGN)". The first draft of guideline was developed through 5 stages and evaluated by 10 experts.(1) Clinical questions were ensured in PICO format.(2) Two researchers conducted a systematic search through electronic database, identifying 170 studies. We selected 27 full text articles including 16 randomized clinical trials, 7 systematic reviews, and 4 guidelines. Quality of each studies were evaluated by the Cochran's Risk of Bias, AMSTAR, K-AGREEII. Among the studies, 11 studies were excluded.(3) The strength of recommendations were classified and quality of recommendations were ranked.(4) Guideline draft was finalized.(5) Content-validation was conducted by an expert group. All contents were ranked above 0.8 in CVI. Results: Evidence-based clinical practice guideline to prevent CIN was dveloped.(1) The guideline for preventing CIN recommends using 0.9% saline.(2) Standardized rate of fluid therapy is 1 to 1.5ml/kg/hr.(3) Execute hydration for 6~12hrs before PCI and after PCI. Conclusion: This study suggests evidence-based clinical practice guideline for preventing CIN which can be more efficiently used in clinical practice.

Effects of Korean Medicine on Pain in Patients with Parkinson's Disease: A Retrospective Study (파킨슨병 환자의 통증에 대한 한의치료의 효과 : 후향적 연구)

  • Jeong, Hye-seon;Kim, Ha-ri;Kim, Seo-young;Yim, Tae-bin;Jin, Chul;Kwon, Seungwon;Cho, Seung-yeon;Jung, Woo-sang;Moon, Sang-kwan;Park, Jung-mi;Ko, Chang-nam;Park, Seong-uk
    • The Journal of Internal Korean Medicine
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    • v.41 no.6
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    • pp.947-958
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    • 2020
  • Objectives: To investigate efficacy of Korean medicine for patients with Parkinson's Disease (PD) with pain. Methods: We performed a retrospective review of the medical records for patients diagnosed with PD between 2012 and 2019 at Gangdong Kyung Hee University Korean Medicine Hospital in South Korea. Results: Twenty-two patients with King's Parkinson's Disease Pain Scale(KPPS) scores at least twice were analyzed for evaluating the efficacy of Korean medicine for pain treatment in PD. The mean total scores before and after Korean medicine treatment were 15.23±1 .01 and 9.2±8.7, respectively, and the mean difference between the before/after total scores was 6.0±5.8 (P<0.001). Specifically, the score of radicular pain was significantly decreased (P=0.048). Conclusions: These findings suggest that Korean medicine could be beneficial for reducing pain associated with PD. Clinical efficacy should be confirmed by further studies, such as large-sample cohort studies and randomized controlled trials to clarify the pathological pain relief mechanism and the analgesic effect of Korean medicine.

Taegeuk Acupuncture for Patients with Chronic Musculoskeletal Pain: A Retrospective Analysis of Medical Records (만성 근골격계 통증환자에 대한 태극침법의 임상적 유효성: 후향적 의무기록 분석 연구)

  • Kim, Jae Kyu;Kim, Kun Hyung;Noh, Seung Hee;Kim, Yu Ri
    • Journal of Acupuncture Research
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    • v.31 no.2
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    • pp.145-152
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    • 2014
  • Objectives : This study aimed to assess the effectiveness and safety of Taegeuk acupuncture for patients with chronic musculoskeletal pain. Methods : A retrospective analysis of the electronic medical records of Pusan National University Korean Medicine Hospital from March 2012 to March 2013 was performed. Eligible cases were outpatients who had received at least six sessions of Taegeuk acupuncture for their pain and had agreed to the use of their medical records for research purposes. Pain levels, heart rate variability, and patients' perceptions of the safety of acupuncture were investigated through the medical records and follow-up telephone interviews. Results : Fifteen cases were selected for analysis. All had suffered from musculoskeletal pain for at least one year. After six sessions of Taegeuk acupuncture, the average score on the pain numeric rating scale decreased from $6.7{\pm}2.0$ to $2.9{\pm}2.2$(a 43 % reduction). Follow-up telephone interviews revealed that patients experienced no adverse event after Taegeuk acupuncture. Conclusions : Patients with chronic musculoskeletal pain showed a reduction of more than half of the baseline pain after six sessions of Taegeuk acupuncture. However, the beneficial effects observed in this retrospective analysis should be interpreted with caution due to selection and recall bias. Further randomized controlled trials of Taegeuk acupuncture for chronic musculoskeletal pain are warranted.

Role of Balloon Guide Catheter in Modern Endovascular Thrombectomy

  • Chueh, Ju-Yu;Kang, Dong-Hun;Kim, Byung Moon;Gounis, Matthew J.
    • Journal of Korean Neurosurgical Society
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    • v.63 no.1
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    • pp.14-25
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    • 2020
  • Proximal flow control achieved with a balloon guide catheter (BGC) during endovascular treatment of acute ischemic stroke is reviewed in this article. In clinical practice, BGCs offer a multi-faceted approach for clot retrieval by creating proximal flow arrest, reducing embolic burden, and shortening procedure time. Evaluation of frontline thrombectomy procedures with BGCs revealed advantages of combined use over the conventional guide catheter (CGC), notably in the significant reduction of distal emboli to both the affected and previously unaffected territories. Recently, new measures of early and complete reperfusion at first thrombectomy pass have been identified as independent predictors of improved outcomes, which were consistently demonstrated with use of BGC as a safe and effective option to minimize number of passes during intervention. Prior randomized controlled trials reported the positive correlation between BGC-treated patients and a lower risk of mortality as well as shortened procedure time. While BGC use is more common in stent retriever-mediated mechanical thrombectomy, preliminary data has shown the potential benefit of device application during contact aspiration thrombectomy to achieve successful recanalization. However, the question of which major endovascular strategy reigns superior as a frontline remains to be answered. Along with clinical case assessments, BGC performance during in-vitro simulation was analyzed to further understand mechanisms for optimization of thrombectomy technique.

Review on Laser or LED Therapy for the Photobiomodulation of Diseases of the Cerebral Nervous System (뇌신경질환에 사용된 레이저 및 광선치료에 대한 임상 연구 고찰)

  • Lee, Kyung-Goo;Shin, Jong-Hun;Lee, Kyung-Jin;Sun, Seung-Ho;Han, Chang-Ho;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.35 no.4
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    • pp.546-555
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    • 2014
  • Objectives: Recently, many studies have reported beneficial effects from the application of laser and light-emitting diode (LED) therapy for cerebral nervous disease. Transcranial laser therapy and LED therapy may be an effective method to treat diseases of the cerebral nervous system. This study aims to discuss the possibility of laser and LED therapy for cerebral nervous disease by reviewing literature about its effectiveness. Methods: We searched papers using PubMed, Science Direct, CINAHL, KTKP, Oasis and NDSL, using the keywords "Laser therapy, low-level", "Transcranial laser", "Transcranial light emitting diode" and "stroke", "traumatic brain injury", "dementia", "anxiety", "cognitive", "emotional effects", "psychiatric disorder", "multiple sclerosis", "Parkinson's disease". The search range included randomized controlled trials (RCTs) and clinical case series. Reviews and animal experiments were not included. Studies not matched with inclusion criteria were excluded. Results: A total 1,119 studies were found. 1,100 were excluded from scanning titles and abstracts and finally 9 articles were selected. Among the 9 articles, 5 were RCTs, one was a controlled study, and the other 3 were case reports. They reported that transcranial laser therapy and LED treatment had beneficial effects from photobiomodulation to the cerebral nervous system. Clinical evaluation factors showed favorable trends. Conclusions: Transcranial laser therapy and LED therapy seem to be effective to the cerebral nervous system and they may be a favorable choice for cerebral nervous disease.

Review of Clinical Research on Herbal Medicine Treatment of Migraine (편두통 환자의 한약치료 임상연구에 대한 고찰)

  • Lee, Su-yeong;Yun, Jong-min;Moon, Byung-soon
    • The Journal of Internal Korean Medicine
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    • v.39 no.4
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    • pp.550-569
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    • 2018
  • Objectives: The purpose of this study was to investigate the effects of herbal medicine treatment for patients with migraine and to suggest research methods for herbal medicine treatment on migraine. Methods: In this study, a search was conducted through several academic sites using a combination of terms '편두통', 'Migraine', '한약', '한약치료', 'Herbal medicine', 'Herbal medicines', 'Herb', 'Traditional Chinese Medicine', and 'TCM'. Randomized controlled trials using herbal medicine treatments for adult patients with migraine were selected. Results: Ultimately, 46 papers were selected and analyzed. A statistically significant improvement was noted in the treatment group in terms of clinical migraine symptoms and other migraine evaluation tools before and after the herbal medicine treatment. Herbal medicines were administered in decoction, pill, and granule formulations. Many kinds of medicinal herbs, such as 解表藥類, 補益藥類, 淸熱藥類, 活血祛瘀藥類, and 平肝藥類, have been used for migraine. Among them, 川芎, belonging to 活血祛瘀藥類, is mentioned 36 times and is the most frequently used medicine. Herbal medicine was used safely for migraine treatment, without major adverse reactions, and the recurrence rate was significantly lower in the treatment group than in the control group. Conclusions: In conclusion, the herbal medicine treatment for patients with migraine showed a statistically significant improvement in 46 papers. Future studies should utilize standardized and objective evaluation tools, along with appropriate experimental design. The relevant articles should be increased to a significant level to verify the effect of herbal medicine treatments on migraine.

High Intensity Laser for Laser Acupuncture Application (침구치료에 사용되는 고출력 레이저에 대한 고찰)

  • Yang, Chang-Sop;Sun, Seung-Ho;Jang, In-Soo
    • Korean Journal of Acupuncture
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    • v.28 no.3
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    • pp.1-12
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    • 2011
  • Objectives : The purpose of this study is to review laser acupuncture studies to find possibility for applying high intensity laser to acupuncture and moxibustion treatment. Methods : Searching papers was performed using search engines of five electronic databases, including Pubmed, Thomson ISI, EMBASE, Sciencedirect, and EBSCO, from inception to May 2011 without language limitation. Inclusion criteria were clinical studies with human, randomized controlled trials (RCTs), case-control studies, and case reports. Selecting papers was performed with titles and abstracts in first step, scrutinize full text in second step, and then the extrated data was analyzed by two authors independently. The methodological quality for RCTs was evaluated using Jadad's scale. Results : Total 8 papers, (3 RCTs, 5 controlld studies, and 1 case reports), were finally selected. The study dealt with surgical laser, argon and $CO_2$ laser was one for each, with GaAs laser was two, and with new semiconductor laser, GaN, were four. The output range was from 110 mW to 15 W. The study diseases were alcohol addiction, knee osteoarthritis, bronchopneumonia and asthma for children, and circulation. All studies reported positive effect. The methodological quality in all RCTs was low because of below 3 points and all studies had few subject numbers. Conclusions : We suggest that high intensity laser can be applied to acupuncture and moxibustion. Further rigorous and well-designed study will be needed for various disease. The oriental medical society needs to take active measures to study and clinical application of acupuncture and moxibustion treatment with high intensity laser.

Preemptive Use of Ketamine on Post Operative Pain of Appendectomy

  • Behdad, Akbar;Hosseinpour, Mehrdad;Khorasani, Parastoo
    • The Korean Journal of Pain
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    • v.24 no.3
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    • pp.137-140
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    • 2011
  • Background: Although early reviews of clinical findings were mostly negative, there is still a widespread belief for the efficacy of preemptive analgesia among clinicians. In this study, we evaluated whether the preemptive use of ketamine decreases post operative pain in patients undergoing appendectomy. Methods: In double-blind, randomized clinical trials, 80 adult male patients undergoing an operation for acute appendicitis were studied. Patients were randomly assigned to two groups. In the operating room, patients in the ketamine group received 0.5 mg/kg of ketamine IV 10 minutes before the surgical incision. In the control group, 0.5 mg/kg of normal saline was injected. The pain intensity was assessed at time 0 (immediately after arousal) and 4, 12, and 24 hours postoperatively using the 10 points visual analogue scale (VAS). Results: Eighty patients (40 for both groups) were enrolled in this study. For all of the evaluated times, the VAS score was significantly lower in the ketamine group compared to the control. The interval time for the first analgesic request was $23.1{\pm}6.7$ minutes for the case group and $18.1{\pm}7.3$ minutes for the control (P = 0.02). The total number of pethidine injections in the first 24 hours postoperatively was $0.6{\pm}0.6$ for the case group and $2.0{\pm}0.8$ for the controls (P = 0.032). There were no drug side effects for the case group. Conclusions: A low dose of intravenously administered ketamine had a preemptive effect in reducing pain after appendectomy.