• Title, Summary, Keyword: RCT

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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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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.

A Systematic Review on the Effects of Robot-Assisted Therapy for Stroke Patient (뇌졸중 환자에서 로봇보조치료 효과에 관한 체계적 고찰)

  • Park, Jin-Hyuk
    • Therapeutic Science for Rehabilitation
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    • v.2 no.2
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    • pp.21-36
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    • 2013
  • Objective : The purpose of this study was to look at a systematic review on the effects of robot-assisted therapy on stroke rehabilitation in upper limbs. Through this comprehensive study, we have to compare the studies. Methods : We systematically examined papers published in journal from June 2012 to September 2012, using EMBASE, MEDLINE, etc. 12 studies(randomized controlled trials) were included in the analyses. Results : Selected 12 studies were Pedro score 2 or more. The primary outcome measure tools including tools for upper extremity function and activities daily of living were used. Through various intervention, Robot-assisted therapy maximizes the effectiveness of intervention. The effects of upper extremity function and functional ability(ADL) by robot-assisted therapy showed significant effect, but no difference exists between the robot-assisted therapy and conventional therapy groups in terms of upper extremity function and functional ability. Conclusions : Robot-assisted therapy has been widely used clinically for stroke patients to maximize the effect had been applied to various interventions. Robot-assisted therapy depending on the methods of intervention showed that the effect of difference. In the future study, the use of robot-assisted therapy applied to a variety of interventions is needed on occupational therapy.

Complementary and Alternative Medicine for Oral Health : a Literature Review of Randomized Controlled Clinical Trials (구강건강에 이용되는 보완대체의학 치료: 무작위대조임상연구를 통한 문헌적 고찰)

  • Kim, Da-Hee;Choi, Gwang-Ho;Hwang, Eui-Hyoung;Heo, Kwang-Ho;Kim, Yong-Deok;Shin, Byung-Cheul
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.3
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    • pp.23-39
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    • 2014
  • Objective : This review aims at analyzing Complementary and Alternative Medicine (CAM) therapies, using for oral health to know current use of CAM in dental area by analyzing randomized controlled clinical trials (RCTs). Method : We searched the following 6 electronic databases until 1 July 2014. : Pubmed, Medline, Embase, Allied and Complementary Medicine Database(AMED), Cumulative Index to Nursing and Allied Health Literature(CINAHL), the Cochrane Library. We included parallel RCTs and cross-over RCTs that assessed the efficacy of CAM regardless of blinding and language. Results : A total of 154 RCT articles were included. There were 2-arm parallel study design(69.5%), 3-arm parallel study design(20.8%), 4-arm parallel study design(4.5%) and Cross-over design(5.2%). Complementary and alternative medicine RCTs in oral health tend to increase in the early-2000s and in the mid-2010s. In addition, 154 citations were classified according to diseases and interventions that categorized Natural Products studies(68.2%), Mind and Body Practices studies(31.8%). We classified in detail that vitamin and mineral therapies(29.9%), dietary supplements(24.7%), acupuncture(23.3%), Herbal medicine(13.6%), homeopathy (2.6%), energy therapies(2.6%), Massage(1.9%), biofeedback(0.6%), traditional medicine(0.6%). Conclusion : Increasing publications and diverse interventions regarding CAM for oral health is observed by analyzing RCTs from the literature review. Further studies are needed to be performed as systematic reviews to verify their effectiveness and the research to inquire into side effect.

Abiraterone for Treatment of Metastatic Castration-resistant Prostate Cancer: a Systematic Review and Meta-analysis

  • Zhou, Zhi-Rui;Liu, Shi-Xin;Zhang, Tian-Song;Xia, Jun;Li, Bo
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.3
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    • pp.1313-1320
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    • 2014
  • Introduction: Although most prostate cancers initially respond to castration with luteinizing hormonereleasing analogues or bilateral orchiectomy, progression eventually occurs. Based on the exciting results of several randomized controlled trials (RCTs), it seems that patients with metastatic castration-resistant prostate cancer (mCRPC) might benefit more from treatment withabiraterone. Therefore we conducted a systematic review to evaluate the efficacy and toxicity of abiraterone in the treatment of mCRPC. Methods: Literature was searched from Embase, PubMed, Web of Science, and Cochrane Library up to July, 2013. Quality of the study was evaluated according to the Cochrane's risk of bias of randomized controlled trial (RCT) tool, then the Grading of Recommendations Assessment, Development and Evaluation (GRADE) System was used to rate the level of evidence. Stata 12.0 was used for statistical analysis. Summary data from RCTs comparing abiraterone plus prednisone versus placebo plus prednisone for mCRPC were meta-analyzed. Pooled hazard ratios (HRs) for overall survival (OS), radiographic progression-free survival (RPFS) and time to PSA progression (TTPP); Pooled risk ratios (RR) for PSA response rate, objective response rate and adverse event were calculated. Results: Ten trials were included in the systematic review; Data of 2,283 patients (1,343 abiraterone; 940 placebo) from two phase 3 trials: COU-AA-301 and COU-AA-302 were meta-analyzed. Compared with placebo, abiraterone significantly prolonged OS (HR, 0.74; 95% confidence interval [CI], 0.66 to 0.84), RPFS (HR, 0.59; 95% CI, 0.48 to 0.74) and time to PSA progression (HR, 0.55; 95% CI, 0.43 to 0.70); it also significantly increased PSA response rate (RR, 3.63; 95% CI, 1.72 to 7.65) and objective response rate (RR, 3.05; 95% CI, 1.51 to 6.15). This meta-analysis suggested that the adverse events caused by abiraterone are acceptable and can be controlled. Conclutios: Abiraterone significantly prolonged OS, RPFS and time to progression patients with mCRPC, regardless of prior chemotherapy or whether chemotherapy-na$\ddot{i}$ve, and no unexpected toxicity was evident. Abiraterone can serve as a new standard therapy for mCRPC.

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.

The Clinical Trial of Terminal Cancer Patients and The Nature of Self-Determination of The Subject (말기 암 환자에 대한 임상시험과 피험자의 자기결정권의 본질)

  • Song, Young-Min
    • The Korean Society of Law and Medicine
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    • v.15 no.1
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    • pp.211-237
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    • 2014
  • Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

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Evaluation on the Quality of Research Field with Traditional Herbal Prescriptions for Dementia Therapy (치매 치료용 한약 처방의 연구성과에 대한 정성평가)

  • Heo, Eun-Jung;Kang, Jong-Seok;Kang, Hyung-Won;Jeon, Won-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.1
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    • pp.93-114
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    • 2012
  • Objective : This study aimed to review the performance of traditional herbal prescriptions for treating dementia and present a strategy for research on dementia therapy utilizing herbal medicine. Methods : A definition was made to clarify the technology regarding the development of herbal prescriptions for treating dementia. The queries were compounded based on the initial keywords provided by experts in the field, then applied to the Web of Science database search engines from January 1986 to September 2011 to search related scientific articles. Before performing the analysis, papers were extracted from the initial search reviewed by experts and 80 articles were selected. Then, the selected papers were analyzed in terms of publish year, country, and type of herbal prescriptions. Furthermore, the research performance evaluation for treating dementia by herbal prescriptions was also created in terms of country and organization based on forward citation analysis. In addition to, for the evaluation regarding research quality, we classified and reviewed papers into two types: clinical studies and experimental studies. Results : According to the quantitative information analysis of 80 articles, the number of papers has increased by 21.9% per the yearly mean from 1995, and Japan had the largest portion within this research field. There were 34 kinds of traditional herbal prescriptions, among them Ukgansan had the highest number of studies followed by Jodeungsan, Dangkisoosan and so on. In addition, quality index as calculated by cites per paper is higher than average in Switzerland, Turkey and Japan. In the view of the evaluation on quality there were 12 clinical studies, 8 RCT reported that herbal prescriptions had efficacy at cognition, behavioral & psychological symptoms (BPSD) and activity of daily life (ADL) in various type of dementia. In experimental studies most of the studies were performed using animal models. The studies using Ukgansan were aimed at improving BPSD. The papers studied with Jodeungsan and Dangkisoosan targeted vascular dementia. Conclusions : In this study, research to develop traditional herbal prescriptions for treating dementia has the potential to improve symptoms since herbal medicines work as both multi-function and multi-target in dementia with multiple pathological or neurotoxic pathways. Therefore, the results of the research should be used in order to establish strategies to develop technology for treating dementia with traditional herbal prescriptions in the future.

Analysis of Food Intake and Physical Activity in Randomized Controlled Trials on Herbal Medicine for Treatment of Human Obesity (비만 치료 한약 무작위 대조 임상시험에서의 음식 섭취량과 운동량 실태분석)

  • Kim, Doo-Hee;Shin, Woo-Suk;Park, Won-Hyung;Cha, Yun-Yeop;Song, Yun-Kyung;Ahn, Min-Youn;Ko, Seong-Gyu
    • Journal of Korean Medicine for Obesity Research
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    • v.13 no.2
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    • pp.58-65
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    • 2013
  • Objectives: The objective of this study was to analyse the methods being used to control food intake and physical activity in RCTs of human obesity. Methods: A total of 21 randomized controlled trials (RCTs) were investigated. Nine of which were domestic studies from "http://oasis.kiom.re.kr" and the other of which were foreign studies from systematic reviews of RCTs on herbal medicine for treatment of human obesity. Results: According to domestic studies, "low calorie diet" were recommended in five cases of the domestic studies, "maintain current dietary habit" were recommended in two and no information on diet was two. Considering the seven cases where the information on diet was available, patients' food intake were checked at every visit in six cases. Only two cases among the six had been dropped owing to the violation of dietary habit by patients. Exercises were prohibited in two cases, "maintain current level of phisical activity" were recommended in three cases and, from the rest, no information was available. The level of physical activity were not strictly controlled by any means hence no drop out. According to foreign studies, "low calorie diet" were recommended in two cases, "very low calorie diet (less than 700 kcal/day)" in one case, "maintain current dietary habit" in two cases, "do not eat fat" in two cases and no information was available in the rest five cases. Exercises which concerns spending about 300 kcal/day was recommended in one case, "moderate exercise" were recommended in three cases, "maintain current level of physical activity" were recommended in three cases and no information available in the rest five cases. Conclusions: In order to improve the accuracy of RCT, for the dietary side, researchers should record patient food intake at every visit by means of 24-hour dietary recall methods. This can be supplemented by multiple choice survey that are designed to help patients to diagnose themselves more accurately leading to less bias. For the exercise side, it is highly recommended to confine the exercises to walking only so as to quantify the amount of physical activity more easily by using pedometer.

Treatment packages of persistent allergic rhinitis for developing PRCT protocols : An expert survey (통년성 알레르기 비염의 표준 치료 모델 개발 : 실용임상연구 프로토콜 개발을 위한 기초 연구)

  • Kim, Nam-Kwen;Lee, Dong-Hyo;Seo, Eun-Sung;Choi, Eun-Ji;Jang, Bo-Hyeong;Choi, In-Hwa;Ko, Seong-Gyu
    • Journal of Society of Preventive Korean Medicine
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    • v.17 no.3
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    • pp.143-153
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    • 2013
  • Objective : This study was done to define the treatment protocol of Traditional Korean Medicine for persistent allergic rhinitis, which might be necessary for conducting PRCT study. Methods : Data were collected by questionnaire from Korean Medicine doctors participated in the Conference of The Korean Oriental Medical Ophthalmology & Otolaryngology & Dermatology Society in October 2012. We investigated their treatment procedures for persistent allergic rhinitis in ordinary clinical settings. Their treatment patterns including annual treatment period, frequencies and treatment times were also investigated. Finally, we combined the national insurance covered or out-of-pocket treatments as treatment packages according to the response rates of each contents, and displayed them as treatment protocols for PRCT study. Results : 50 Korean medicine doctors described the informed consent and questionnaire. Response rates of each treatment procedure were listed in Table 2 to Table 5. Treatment periods, frequencies and treatment time of each visit were listed in Table 6. Finally, treatment packages which would be defined for PRCT were listed in Table 7 as treatment package 1(response rates were over 50%), package 2(response rates were over 25%), package 3(response rates were over10%). Conclusion : These results provide the rational background and preliminary sources of defining treatment packages for developing PRCT protocols.