• Title/Summary/Keyword: randomized controlled trial(RCT)

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A Review of Clinical Studies about Bojungikgi-tang Combined with Surgical Therapy on Rectal Prolapse - Focusing on Randomized Controlled Trial (직장 탈출증에 대한 보중익기탕과 수술 치료 병용요법의 임상 연구 고찰 - 무작위 대조군 연구를 중심으로)

  • Kyung-hwan Kong;Do-hyeon Kim
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.38 no.2
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    • pp.59-65
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    • 2024
  • Rectal prolapse is a condition where the rectal wall protrudes outside the anus. While it is a rare condition, it can cause discomfort for patients due to the protrusion of the rectal structure, discharge of mucus and blood, fecal incontinence, constipation, and other inconveniences. In this review, we analyzed a randomized controlled trial (RCT) study that used the herbal medicine Bojungikgi-tang(Buzhongyiqi-tang) as a complementary therapy to improve the weaknesses and side effects of the standard treatment, surgical therapy, for rectal prolapse. The analysis included 12 RCT studies, and in all studies, the prescription involved the use of Astragali Radix at the highest dosage. Among the 11 studies that evaluated efficacy, 7 studies showed a significant effect compared to the control group. In all 3 studies that evaluating recurrence rates and all 5 studies investigating complications after surgery, the experimental group showed significant effects. Based on these findings, this study could be considered as a foundational evidence for the application of bojungikgi-tang(Buzhongyiqi-tang) in clinical practice in Korean medicine for patients with rectal prolapse. It could also serve as foundational data for future research.

Relationship between Postural Balance Training and Fall Risks for Elderly: a Systematic Review of Randomized Controlled Trials

  • Kim, Heesuk;Hwang, Sujin
    • Physical Therapy Rehabilitation Science
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    • v.10 no.2
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    • pp.185-196
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    • 2021
  • Objective: Falling is one of main accident to facilitate the physical injuries in order adults. The purpose of the systematic review was to determine the effects of postural balance training whether the recovery of falls in elderly with normal physical function or not throughout summing the selected studies quantitatively. Design: A systematic review Methods: MEDLINE and other four databases were searched up to April 20, 2021 and randomized controlled trials (RCTs) evaluating postural balance approaches on fall risks in elderly. The researched studies excluded the double studies, titles and abstract, and finally full-reported study. The selected RCTs studies were extracted characteristics of the studies and summary of results based on PICOS-SD (population, intervention, comparison, outcomes, and setting- study design) model to synthesize the papers qualitatively. Results: The review involved 22 RCT reports with 4,847 community older adults aged 65 years or over. Nineteen of the selected RCT studies reported dual or multimodal exercises show the beneficial effect for older adults compared to one-type treatment or no intervention. All of selected showed low risk in the selection, attrition, and reporting bias. However, detection bias showed low risk at 75% records of the involved RCTs and performance bias was low risk at only three records. Conclusions: The results of the systematic review propose that a standardized therapeutic approach and the intensity are needed for improving risk of falls in older adults.

A Review of Randomized Controlled Trials of Traditional Chinese Medicine Treatment for Coronavirus Disease 2019 Patients (Coronavirus Disease-2019 환자 치료에 대한 중의 RCT 연구 동향)

  • Park, Ju-heon;Yoon, Seong-hoon;Lee, In
    • The Journal of Internal Korean Medicine
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    • v.43 no.1
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    • pp.41-52
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    • 2022
  • Objectives: The purpose of this study is to investigate recent trends in randomized controlled trials (RCTs) on the treatment of Coronavirus disease 2019 (COVID-19) patients with traditional Chinese medicine (TCM) and analyze the results for the activation of COVID-19 Korean medicine research. Methods: We searched for RCTs published from December 2019 to October 2021 in the Chinese National Knowledge Infrastructure Database (CNKI). The investigation focused on the type of study, the purpose of the study, and the treatment methods. Results: A total of 8 RCTs were selected and analyzed from the 447 searched studies. All studies attempted to observe the effects of herbal medicine. Herbal medicine included granules, decoctions, and intravenous injections. The most frequently used herb type was drugs for clearing away heat and detoxification and releasing the exterior syndrome. In most studies, the effectiveness of TCM treatment of COVID-19 was significantly high. Conclusions: Although more quality studies are needed to support these results, TCM treatment for COVID-19 has been effective. Therefore, we hope that Korean medicine studies on infectious diseases will be actively conducted like TCM and contribute to national health.

Review of Clinical Researches about Korean Medicine Treatment on Language Disorder of Cerebral Palsy (뇌성마비 언어장애에 대한 한의 치료 연구 동향)

  • Kim, Lakhyung;Yu, Gyung
    • The Journal of Pediatrics of Korean Medicine
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    • v.26 no.4
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    • pp.32-37
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    • 2012
  • Objectives: The purpose of this study was to obtain some understanding about Korean medicine treatment on language disorder in cerebral palsy for future practice and the research, from the clinical studies. Methods: The literature was searched using the database-China Academic Journals (CAJ). Clinical studies of Korean medicine treatment for language disorder in cerebral palsy, including Randomized controlled trial (RCT), case control study, case series, case report were analyzed. Results: Fifteen Clinical studies met our inclusion criteria; One case study and six case series, one non-randomized controlled trial and seven RCTs. Acupuncture treatment, especially Head acupuncture, was the major treatment for language disorder of cerebral palsy in clinical studies, as it was used in fourteen studies. Acupoint massage, tuina, and acupoint injection were employed as treatment methods in the studies. Acupuncture treatment was used for language disorder of cerebral palsy combined with language therapy and other rehabilitation treatment in many studies. The effectiveness in the treatment groups, regardless of treatment methods, was higher than that of control group in all RCT studies. Conclusions: The results of this study could be used in the practice and the future study about language disorder of cerebral palsy.

Electroacupuncture Treatment for Women with Primary Obesity: A Review of Randomized Controlled Trials

  • Lee, Soo Jin;Oh, Da Yoon;Park, Jae Eun;Lee, Min Cheol;Jeon, Myung Kyu;Jang, Yeong Suk;Kim, Hyeon Jin;Ahn, Jae Young;Hong, Noo ri;Kim, Woo Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.79-87
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    • 2020
  • The purpose of this review was to evaluate the effectiveness of electroacupuncture treatment for women with "primary obesity." Primary obesity is caused by an imbalance in energy intake and consumption due to abnormal eating and living habits in the absence of specific diseases causing the obesity. A literature review (up to December 2019) of randomized controlled trials (RCT) of electroacupuncture treatment for women with "primary obesity" was performed. Relevant clinical studies were retrieved from several databases, and interventions and results were analyzed. There were 6 RCT that fitted the inclusion criteria for this review. The intervention for the treatment group of the selected 6 RCT was electrical stimulation applied to acupoints. Interventions for the control groups included non-treatment, general acupuncture, and so on. Indicators for assessing treatment effects varied from study to study. Four out of 5 studies used body mass index (BMI) as an assessment tool and showed a significant decrease in BMI following electroacupuncture treatment. There were 4 studies using waist circumference as an indicator of abdominal obesity and these studies showed a significant decrease in waist circumference following electroacupuncture treatment. Electroacupuncture treatment used in primary obese women had a clinically significant effect, however, further RCT are needed.

The Recent Trends of Clinical Research on General Anxiety Disorder in Chinese Herbal Medicine (범불안장애의 중의학 약물 임상시험 최신 동향)

  • No, Dong-Jin;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.4
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    • pp.79-89
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    • 2009
  • Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

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Innovative customized CAD/CAM nickel-titanium lingual retainer versus standard stainless-steel lingual retainer: A randomized controlled trial

  • Gelin, Emilie;Seidel, Laurence;Bruwier, Annick;Albert, Adelin;Charavet, Carole
    • The korean journal of orthodontics
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    • v.50 no.6
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    • pp.373-382
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    • 2020
  • Objective: To compare computer-aided design and computer-aided manufacturing (CAD/CAM) customized nitinol retainers with standard stainless-steel fixed retainers over a 12-month study period. Methods: This randomized controlled trial (RCT) was conducted on 62 patients randomly allocated to a control group that received stainless-steel retainers or a test group that received customized CAD/CAM nickel-titanium retainers. Four time points were defined: retainer placement (T0) and 1-month (T1), 6-month (T2), and 12-month (T3) follow-up appointments. At each time point, Little's irregularity index (LII) (primary endpoint) and dental stability measurements such as intercanine width were recorded in addition to assessment of periodontal parameters. Radiological measurements such as the incisor mandibular plane angle (IMPA) were recorded at T0 and T3. Failure events (wire integrity or debonding) were assessed at each time point. Results: From T0 to T3, LII and other dental measurements showed no significant differences between the two groups. The data for periodontal parameters remained stable over the study period, except for the gingival index, which was slightly, but significantly, higher in the test group at T3 (p = 0.039). The IMPA angle showed no intergroup difference. The two groups showed no significant difference in debonding events. Conclusions: This RCT conducted over a 12-month period demonstrated no significant difference between customized CAD/CAM nickel-titanium lingual retainers and standard stainless-steel lingual retainers in terms of dental anterior stability and retainer survival. Both retainers eventually appeared to be equally effective in maintaining periodontal health.

A Literature Study of Topical Application of Chinese Herbal Medicine for Allergic Rhinitis (국소한약외용제의 알레르기성 비염 치료 효과에 대한 문헌 고찰)

  • Bang, Mi Ran;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.52-60
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    • 2016
  • Objectives The purpose of this study is to analyze studies about the effects of topical application of Chinese herbal medicine for allergic rhinitis within randomized controlled trials (RCT). Methods The search database includes KJTK (Korean Traditional Knowledge Portal), OASIS (Oriental Medicine Advanced Searching Integrated system), CNKI (China National Knowledge Infrastructure), PubMed, and EMBASE. We used the following key search terms: "allergic rhinitis", "traditional Chinese medicine", "traditional Korean medicine", "Chinese herbal medicine", "randomized controlled trial", "clinical study", "nasal spray", and "nasal drop" Results Five studies were selected for analysis. Three studies used nasal spray of Chinese herbal medicine and two studies used nasal drops of Chinese herbal medicine for the intervention. Frequently used herbs were Magnoliae Flos (辛夷), Scutellariae Radix (黃芩), Coptidis Rhizoma (黃連), and Astragali Radix (黃芪). For the outcome measures, studies used symptom score, questionnaire of Quality of Life, nasal airway resistance, or laboratory studies. From all 5 studies, it has been shown that topical application of Chinese herbal medicine was effective for improving symptoms of allergic rhinitis. Two out of five studies showed statistical difference between study group and control group. Conclusions This study shows that topical application of Chinese herbal medicine can improve symptoms of allergic rhinitis. Well-designed RCT studies with low risk of bias and studies with outcome measures for assessing the immunomodulatory effects are necessary to confirm these findings.

Review on RCT Research Papers Related Nausea and Vomiting in Pregnancy - Focusing on Acupoint Treatment - (임신오조(姙娠惡阻) 관련 무작위대조군연구(RCT)에 관한 고찰 - 경혈을 이용한 치료를 중심으로 -)

  • Jang, Suk-Woo;Ahn, In-Suk;Choi, Min-Sun;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.26 no.2
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    • pp.138-150
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    • 2013
  • Objectives: To observe randomized controlled trials(RCTs) related to investigating the effects of acupoint treatments on nausea and vomiting in pregnancy to establish the basis of korean medical treatments, and suggest the problems of future clinical research. Methods: After searching for national and international papers published after 2000 and restricting the parameters to 'clinical trial', 'controlled clinical trial', 'randomized controlled trial', then comparing the subjects, methods, research tools, and results to understand the effects and re-comparing the conflicting results to assume the cause. Results: Of the 9 research papers that applied acupressure, four of them used control and experimental groups, and three(75%) research papers indicated significant reduction in vomiting and nausea, and of the seven research papers that utilized the experimental and placebo groups, five(71.4%) reported significant reducing effects. Of the four research papers the used acupuncture treatments, four research papers using control and placebo groups, two showed improvements in symptoms but did not have significant results compared to sham acupuncture groups, and two showed significant reduction of symptoms compared to the control groups. The one research paper that used electrical stimulation showed significant results in the reduction of vomiting and nausea compared to the control group. Conclusions: Acupressure and electrical stimulation showed efficacy reducing the symptoms. Acupuncture treatments did not indicate efficacy some experiments. Therefore it is thought that future acupuncture treatments should use methods that resemble actual clinical medicine to establish efficacy to produce significant results.

Benefit of chuna for managing symptoms in chronic fatigue syndrome patients: A systematic review and meta-analysis (만성피로증후군의 증상관리를 위한 추나요법의 유용성: 체계적인 문헌고찰과 메타분석)

  • Song, Jeongyun;Kim, Junyeol;Nam, Donghyun
    • The Journal of Korean Medicine
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    • v.41 no.3
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    • pp.205-220
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    • 2020
  • Objectives: The aim of this review is to assess the clinical benefit of chuna for managing symptoms in chronic fatigue syndrome (CFS) Methods: We searched eligible studies from the following 11 databases with no language restriction: Pubmed, CENTRAL, Embase, CNKI, CQVIP, Wanfang, CiNii, OASIS, RISS and Koreamed. We selected randomized controlled trial (RCT), quasi-randomized controlled trial (Quasi-RCT) and controlled clinical trial (CCT) in which patients with chronic fatigue syndrome were treated with chuna. The results of the included studies were synthesized through meta-analysis, and their risk of bias were also assessed. Results: We searched 914 potentially relevant studies, and only 20 studies were selected for this systematic review. Meta-analysis showed that chuna was more effective in improving general symptoms (n=291, RR 0.19 [95% CI 0.11 to 0.32], Z=6.08, p<0.00001, I2=0%), fatigue (n=487, SMD -0.95 [95% CI -1.19 to -0.71], Z=7.76, p<0.00001, I2=37%) and sleep disorder (n=139, SMD -0.58 [95% CI -0.92 to -0.24], Z=3.36, p=0.0008, I2=0%) compared to health supplements or usual care. When chuna was used as an added intervention, it was more effective in improving general symptoms(n=729, RR 0.25 [95% CI 0.15 to 0.42], Z=5.19, p<0.00001, I2=0%) and fatigue severity alone(n=217, SMD -1.21 [95% CI -1.53 to -0.89], Z=7.45, p<0.00001, I2=15%) compared to control. Conclusion: We found that chuna was beneficial for improving severity of general symptoms and fatigue at post treatment in CFS patients.