• Title/Summary/Keyword: Randomized Clinical Trials

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Rview of Recent Clinical Research for Herbal Medicine Treatment on Vitiligo in Children - Focused on Chinese Randomized Controlled Trials - (소아 백반증의 한약 치료에 대한 최신 임상 연구 동향 - 중국 무작위 대조군 연구를 중심으로 -)

  • Jang, Jin Woo;Choi, Il Shin;Park, Beom Chan;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.141-155
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    • 2021
  • Objective The purpose of this study is to gather information from clinical studies conducted in China and analyze the effects of herbal medicine treatment for childhood vitiligo. Methods The randomized controlled trials (RCTs) with herbal medicine treatment for childhood vitiligo from the Chinese Academic Journal (CAJ) from China National Knowledge Infrastructure (CNKI) were searched. Then, each study was analyzed by demographics, disease durations, interventions, treatment periods, outcomes, adverse events, and compositions of the herbal medicine used. Result A total of 6 RCTs were included. All the trials except for one used a combination of Chinese herbal medicine with Western medicine as their treatment groups. The total efficacy rate was used to measure the effectiveness, and the treatment groups reported a significantly higher total efficacy rate compared to the control groups in all studies. In one study, a control group treated with compound glycyrrhizin capsule and topical compound kaliziran tincture combination treatment was compared with a treatment group which used the same treatment that the control group received in addition to oral herbal medicine. This study also showed higher total effectiveness in the treatment group than the control group. Conclusions In pediatric vitiligo, a combination of herbal medicine treatment rather than Western medical treatment alone can improve symptoms. In addition, it was suggested that the therapeutic effect can be enhanced when oral herbal medicine is used in combination with other herbal medicine treatments.

A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis: Focused on Comparative Studies with Manual Acupuncture Treatment during Recent Five Years (퇴행성 슬관절염의 화침 치료에 대한 체계적 문헌 고찰 및 메타분석: 최근 5년간의 호침 치료 비교 연구를 중심으로)

  • Ko, Hong-Je;Yoo, Jae-Hee;Shin, Jeong-Cheol
    • Korean Journal of Acupuncture
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    • v.36 no.2
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    • pp.104-114
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    • 2019
  • Objectives : The purpose of this study is to review the effectiveness of fire needling treatment for knee osteoarthritis in comparison with manual acupuncture treatment. Methods : Through four foreign online databases (PubMed, Cochrane library, EMBASE, and CNKI) and five domestic online databases (NDSL, RISS, KISS, OASIS, and KTKP), we searched for clinical studies that performed fire needling treatment for knee osteoarthritis until May 10, 2019. Only randomized controlled trials were selected and we assessed the risk of bias according to the Cochrane RoB criteria. This review examined the selected studies into first author, publication year, sample size, outcome measurements, results, acupoints, treatment time & period and so on. Results : A total of 7 RCTs were selected in this review and all were conducted in China. Treatment period of more than 4 weeks and treatment visits of 10 to 20 times were the most common. EX-LE4 and ST35 (=EX-LE5) acupoints were most frequently selected in treatment. Among the evaluation indexes, a total efficacy rate was used the most. Most of fire needling groups showed more significant results compared with the manual acupuncture groups statistically. Conclusions : All studies showed that fire needling treatments for knee osteoarthritis were more effective than manual acupuncture treatments statistically. Therefore, the results of this study could be utilized as a preliminary data for another clinical research on fire needling treatment for knee osteoarthritis. However, further well-designed randomized controlled trials will be needed to develop sufficient evidence about the effectiveness and safety of fire needling treatment for knee osteoarthritis in the future.

Acupuncture for Premenstrual Syndrome: A Systematic Review and Meta-analysis (월경전증후군에 대한 침 치료의 효과 : 체계적 문헌고찰과 메타분석)

  • An-Na Kim;Young-Eun Kim;Eun-Hee Lee;Mi-Ju Son
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.3
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    • pp.154-172
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    • 2023
  • Objectives: This study aimed to assess the clinical evidence supporting the use of acupuncture (AC) for premenstrual syndrome (PMS). Methods: We searched randomized controlled trials (RCTs) that used AC for PMS in 9 databases (PubMed, EMBASE, Cochrane Library, CINAHL, CNKI, CiNii, SCIENCE ON, KoreaMed, OASIS) from their inception to July 2022. Results: We identified 1,168 studies, of which 15 RCTs met the inclusion criteria. The risk of bias in the included studies was relatively unclear or high. Meta-analysis of 3 RCTs showed that the AC group had a significantly higher effective rate than the Medroxyprogesterone group (RR 1.48, 95% CI (1.23, 1.78), p<0.0001). Meta-analysis of 2 RCTs showed that there was no statistically significant difference between the AC group and the Sham AC group in the effective rate (RR 4.72, 95% CI (0.88, 25.36), p=0.07). In a review of individual studies, the AC group was more effective than the control group in terms of the effective rate, symptom scale, quality of life, adverse events, and recurrence rate. Conclusions: The AC group was more effective than general treatments groups such as sham AC, western medicine, and dietary supplements, and there were no serious adverse events. However, the evidence on the effectiveness and safety of acupuncture for PMS was inconclusive due to the small number of included studies and low quality. Therefore, systematic reviews based on more rigorously designed randomized clinical trials are needed in the future to properly evaluate the effect of AC on PMS.

A Systematic Review of Evidence for Education and Training Interventions in Microsurgery

  • Ghanem, Ali M.;Hachach-Haram, Nadine;Leung, Clement Chi Ming;Myers, Simon Richard
    • Archives of Plastic Surgery
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    • v.40 no.4
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    • pp.312-319
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    • 2013
  • Over the past decade, driven by advances in educational theory and pressures for efficiency in the clinical environment, there has been a shift in surgical education and training towards enhanced simulation training. Microsurgery is a technical skill with a steep competency learning curve on which the clinical outcome greatly depends. This paper investigates the evidence for educational and training interventions of traditional microsurgical skills courses in order to establish the best evidence practice in education and training and curriculum design. A systematic review of MEDLINE, EMBASE, and PubMed databases was performed to identify randomized control trials looking at educational and training interventions that objectively improved microsurgical skill acquisition, and these were critically appraised using the BestBETs group methodology. The databases search yielded 1,148, 1,460, and 2,277 citations respectively. These were then further limited to randomized controlled trials from which abstract reviews reduced the number to 5 relevant randomised controlled clinical trials. The best evidence supported a laboratory based low fidelity model microsurgical skills curriculum. There was strong evidence that technical skills acquired on low fidelity models transfers to improved performance on higher fidelity human cadaver models and that self directed practice leads to improved technical performance. Although there is significant paucity in the literature to support current microsurgical education and training practices, simulated training on low fidelity models in microsurgery is an effective intervention that leads to acquisition of transferable skills and improved technical performance. Further research to identify educational interventions associated with accelerated skill acquisition is required.

A Review of Recent Clinical Researches in Chinese Medical Journal for Efficacy and Safety of Pediatric Herbal Medicine Inhalation Therapy (소아 무화흡입요법의 효과 및 안전성에 대한 최신 중의학 임상 연구 고찰 - 2010년 이후 발표된 임상 연구 논문을 중심으로 -)

  • Park, Sul Gi;Park, So Hyun;Shin, Dong Gil;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.3
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    • pp.82-102
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    • 2019
  • Objectives The purpose of this study is to investigate clinical studies on the efficacy and safety of herbal medicine inhalation therapy in children by analyzing recent randomized controlled trials conducted in China. Methods We searched the clinical studies from the China Academic Journal (CAJ) in China National Knowledge Infrastructure (CNKI) using a by key word '霧化吸入' and specific criteria from 1st January 2010 to 2nd July 2019. Data regarding years of publication, demographic information, target diseases or symptoms, treatment methods, outcome measure, results and adverse events are collected for this study. Results Total of 44 randomized controlled trials were selected and analyzed. Respiratory diseases and symptoms (84.1%) were the most frequent target diseases that herbal medicine inhalation therapy was used. Acute stomatitis was another disease state that the therapy was used. In most of the studies, the herbal medicine inhalation in children showed significant efficacies. The most commonly used herbal medicines were Ephedrae Herba (麻黃), Lonicera Flos (金銀花), Armeniacae Semen (杏仁), Glycyrrhizae Radix et Rhizoma (甘草), Scutellaria Radix (黃芩), Forsythia Fructus (連翹) etc. Hardly any adverse effects were reported from the trials selected. Conclusions Based on the results of the clinical studies from China, herbal medicine inhalation therapy in children can be an effective and safe option for treatment and symptom improvement.

Efficacy of Acupuncture for Parkinson's Disease over the Last Decade: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Yeonju Kim;Yigun Lim;Subin Ahn;Junyeop Oh;Yoonbyeong Chae;Yoomin Choi;Jong Uk Kim
    • Journal of Acupuncture Research
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    • v.41 no.1
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    • pp.29-52
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    • 2024
  • The aim of this review is to consolidate findings from clinical investigations spanning the past decade regarding the impact of acupuncture on Parkinson's disease (PD). The objective is to assess the efficacy of acupuncture as a therapeutic approach to PD, with the intention of informing future clinical practices and advancing the foundation for subsequent research endeavors in this area. A comprehensive literature search was conducted to identify clinical trials exploring the effects of acupuncture on PD between January 2014 and August 2023. Databases search included PubMed, EMBASE, CNKI, OASIS, KISS, KMBASE, RISS, and ScienceON. Quantitative evidence from randomized controlled trials (RCTs) was systematically reviewed, and the methodological quality of the included studies was assessed using Cochrane's risk of bias tool. Meta-analysis was performed using Review Manager (RevMan) 5.4.1 software. The systematic review encompassed a total of 38 RCTs involving 2,786 participants. Meta-analysis of 12 studies revealed that individuals treated with a combination of acupuncture and Western medicine exhibited notable improvements compared to those receiving Western medicine alone or sham acupuncture alongside Western medicine. However, the overall quality of the RCTs was deemed low, and no serious adverse events were reported. Across clinical investigations conducted in the past decade, acupuncture appears to hold promise as a complementary treatment for PD patients when administered alongside Western medicine. Nevertheless, this study identifies certain limitations that warrant consideration in future research endeavors. Enhanced emphasis on conducting high-quality RCTs is imperative to comprehensively evaluate the efficacy of acupuncture in managing PD.

Review of Clinical Studies for Herbal Medicine Treatment on Childhood Obesity - Focusing on Studies from the China Academic Journal (CAJ) - (중의학 데이터베이스 (CAJ)를 이용한 소아 비만의 한약치료에 대한 임상 연구 동향)

  • Kim, Seo Hyeong;Ryu, Hyang;Kim, Kibong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.32 no.3
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    • pp.26-43
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    • 2018
  • Objectives The purpose of this study was to analyze recent traditional Chinese medicine clinical studies for treatment of childhood obesity. Methods We analyzed 11 clinical studies from January, 2000 to March, 2018 about childhood obesity from the China Academic Journal (CAJ) and China National Knowledge Infrastructure (CNKI). All selected studies were Randomized Controlled Trials and analyzed in order of publication year, demographic information, treatment method, evaluation methods, results, adverse reactions and relapse after treatment discontinuation. Results The main Traditional Chinese Medicine (TCM) treatment was the herbal decoctions, granules and pills. In most studies, the total efficacy of the treatment group was reported to be higher than that of the control group. Adverse reactions were found in small number of studies. Frequently used medical herbs were Crataegi Fructus (山?), Atractylodis Rhizoma (蒼朮), Citri Pericarpium (陳皮), Poria (茯?), and Nelumbinis Folium (荷葉). Also, Water-draining and swelling-dispersing medicinal (利水退腫藥), Qi-regulating medicinal (理氣藥), Resolving dampness with aroma medicinal (芳香化濕藥), Blood-activating and stasis-dispelling medicinal (活血祛瘀藥), Qi-tonifying medicinal (補氣藥), and Digestant medicinal (消食藥) were commonly used. Conclusions This study showed that traditional Chinese medicine, especially herbal medicine treatment can be effective and safe option for treating childhood obesity. These research results can be utilized in other clinical studies as well as in treatment of childhood obesity. Additional well-designed randomized controlled trials and systematic reviews are need to confirm the conclusion.

Review of Clinical Research on Effect of Traditional Chinese Medicine for Febrile Seizure (열성 경련에 대한 중의학 임상 연구 동향 - RCT를 중심으로 -)

  • Lee, Bo Ram;Lee, Eun Ju;Lee, Ji Hong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.78-96
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    • 2016
  • Objectives The purpose of this study is to provide clinical evidence of Korean medicine for febrile seizure by review of randomized controlled trials on the effect of TCM (traditional Chinese medicine) for febrile seizure. Methods We searched randomized controlled trials about TCM treatment of febrile seizure from the China National Knowledge Infrastructure (CNKI) (January 2008 to June 2016). The selected literatures were assessed by Jadad scale. Results 40 papers were selected from 160 studies. Analyses of selected studies indicated that the TCM treatment group has significantly higher cure rate for febrile seizure than first aid or western medicine group. The most commonly used herbs were Gardeniae Fructus (梔子), Uncariae Ramulus cum Uncis (鉤藤), Cornus Gazeliae (羚羊角), Margarita (珍珠), Scutellariae Radix (黃芩), Glycyrrhizae Radix (甘草). The most commonly used acupoints were GV26 (人中), LI4 (合谷), KI1 (湧泉), GV20 (百會). There were no serious adverse events reported from the TCM treatment group during the treatment period. Conclusions TCM has been shown as not only effective but also safe treatment on febrile seizure. This finding can be widely utilized in clinical practice and can form the basis for development of clinical practice guidelines in future.

Recruitment for Phase I of the Trials of Hypertension Prevention

  • Satterfield Suzanne;Borhani Nemat O.;Whelton Paul;Goodwin Laretha;Brinkmann Connie;Charleston Jeanne;Corkery Beth Walker;Dolan Lee;Hataway Heidi;Hertert Stephanie;Lakatos Ed;Milas N. Carole;Morris Martha Clare
    • 대한예방의학회:학술대회논문집
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    • 1994.02b
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    • pp.313-319
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    • 1994
  • Phase I of the Trials of Hypertension Prevention was a multicenter, randomized, controlled trial designed to determine the efficacy of seven nonpharmacologic interventions in reducing blood pressure among persons with high-normal diastolic blood pressure. the initial goal for recruitment was to enroll 2,100 participants over a nine-month period. The yield from the first screening visit to randomization was 13% overall, with clinic-specific yields ranging from 4.5% to 31.7%. After five months of recruitment, approximately 60% of the goal for that point in the recruitment timetable had been randomized. Clinical centers falling short of their goals at that time altered their recruitment strategies and intensified their efforts, and centers that had exceeded their goals recruited additional participants. As a result, 2,182 participants, or 104\% of the goal for recruitment, were randomized over a 13-month period. Those clinics using a cohort, or wave, type of enrollment were most successful in achieving their recruitment goals within the prescribed timetable.

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근거 중심 치의학 - 2. 근거 수준과 비판적 평가

  • Hong, Soon-Min
    • The Journal of the Korean dental association
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    • v.45 no.3 s.454
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    • pp.169-181
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    • 2007
  • In this second part of series report on evidence-based dentistry, the level of evidence and the methods for critical appraisal are discussed. The epidemiologic studies, namely clinical studies have some bias per se, and the degree of bias is somewhat predetermined by the study design. The level of evidence can be defined as the reliability of the clinical study and it is dependent on the degree of bias. Thus, it is important to determine the type of the study and to understand its structure before critically appraising them. Systematic reviews of primary studies, randomized controlled trials, nonrandomized clinical trials, cohort studies, case-control studies, and case reports / series constitute the clinical studies and the level of evidence follows the order of the studies listed above. Critical appraisal is the most important procedure in evidence-based dentistry. It is done to determine the credibility of research papers and their usefulness in the clinician s own practice. Critical appraisal is consisted of multiple questions that are helpful for evaluating validity and usefulness of the studies concerning therapy, diagnosis, prognosis, and causation.

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