• Title/Summary/Keyword: RCT(Randomized Controlled Trial)

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Orally Administered Korean Herbal Medicine Medications of Randomized Controlled Trials Published in the Journal of Korean Medicine and Related Journals: A Narrative Analysis using CONSORT-CHM 2017 (CONSORT-CHM 2017 지침에 근거한 대한한의학회지 및 회원학회지에 투고된 경구투여 한약 중재를 활용한 무작위 배정 비교 임상 연구(RCT)의 양적, 질적 평가 연구)

  • Se-hun Moon;Jung-ho Jo;Seung-kwan Choi;Yun-hee Han;Hyeon-jun Woo;Byeong-hyeon Jeon;Won-bae Ha;Jung-han Lee
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1212-1242
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    • 2023
  • Objectives: This study aims to explore the current usage status of orally administered Korean herbal medicine in randomized controlled trials (RCTs) published in the Journal of Korean Medicine and member journals using the CONSORT-Chinese Herbal Medicine Formulas 2017 (CONSORT-CHM 2017) checklist. Methods: We searched the OASIS, RISS, and KMBASE archives as well as the websites of the Journal of Korean Medicine and 45 member journals to identify RCTs that used herbal interventions. Two independent researchers searched and categorized the RCTs and performed a quantitative evaluation by journal, study design, and target disease, as well as qualitative evaluation of the literature using CONSORT-CHM 2017. Results: After the search, 66 articles were selected. The quantitative evaluation resulted in 13 articles (19.6%) that were published in the Journal of Korean Medicine and 12 articles (18.1%) in the Journal of Internal Korean Medicine. In terms of study design, 62 articles (93.9%) were parallel, 4 articles (6%) were crossover, and 2-arm parallel study designs were the most common in 45 articles (68.2%). In terms of the study participants, physiological characteristics and mechanisms in healthy individuals were the most common in 21 studies (31.8%) and obesity in 9 studies (13.6%). In terms of assessing completeness in the CONSORT-CHM 2017 items, 29 articles were rated high, 31 were rated moderate, and 6 were rated low. Items 4a, 6a, and 7a had low reporting rates (≤ 30%), while items 2a, 2b, and 12a were completely reported in all studies. Conclusion: Future RCTs using orally administered Korean herbal medicine need to be reported completely, and the CONSORT-CHM 2017 checklist can be a helpful tool for this purpose.

A Randomized Controlled Clinical Trial of Topical Herbal Gel Treatment for Chronic Shoulder Pain (만성 어깨 통증의 한약 추출 외용 젤 치료에 대한 임상연구)

  • Jo, Su Jeong;Choi, Young Doo;Jang, Jin Taek;Kim, Kap Sung;Lee, Seung Deok
    • Journal of Acupuncture Research
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    • v.31 no.4
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    • pp.1-9
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    • 2014
  • Objectives : The aim of this study is to evaluate the efficacy of a topical herbal gel application for the treatment of chronic shoulder pain. Methods : We compared the effects of Dapureo gel, which contains several herbal medicines known to improve shoulder pain, with those of placebo gel by double-blind method. 30 participants were randomized - 15 were assigned to treatment group and the other 15 were assigned to control group. Either Dapureo gel(treatment group) or placebo gel(control group) was applied topically by themselves, once a day for 2 weeks. Primary outcome was daily visual analogue scale(VAS) changes for shoulder pain which was self-reported for 2 weeks. Secondary outcome was the difference in the total shoulder pain and disability index(SPADI) which was measured at a baseline and 2 weeks after the treatment. Results : Primary outcome: Subjects of treatment group showed statistically significant improvement in VAS compared to control subjects continuously from the second day(p <0.05) to the fifteenth day(p <0.001). The treatment group showed 31% of pain reduction on the fifteenth day, while the control group showed only 7%. Secondary outcome: In terms of SPADI changes, the treatment group showed improvement compared to the control group(p <0.01). Conclusions : These results suggest that the topical herbal gel treatment used in this study is effective in improving chronic shoulder pain.

Impact of GNB3, ADRB3, UCP2, and PPAR${\gamma}$-Pro12Ala polymorphisms on Boiogito response in obese subjects : A randomized, double-blind, placebo-controlled trial (방기황기탕의 유전자 다형성에 따른 비만 치료 효과 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Bose, Shambhunath;Lim, Chi-Yeon;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.12 no.2
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    • pp.28-43
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    • 2012
  • Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.

Effects of a Complex Exercise Program using Dynamic Taping on Patients with Tension-Type Headache and Chronic Neck Pain with Forward Head Posture (다이나믹 테이핑을 적용한 복합 운동프로그램이 긴장성 두통과 전방머리자세를 동반한 만성 목 통증 환자에게 미치는 효과)

  • Park, Sam-Ho;Jung, Seung-Hwa
    • Journal of The Korean Society of Integrative Medicine
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    • v.10 no.4
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    • pp.23-34
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    • 2022
  • Purpose : This study examined the effects of pain, neck dysfunction, psychosocial level, headache impact test (HIT), postural alignment, and trapezius muscle tone of the complex exercise program using dynamic taping in patients with tension headache and chronic neck pain with forward head posture. Methods : The design of this is a randomized controlled trial (RCT). Thirty-four patients with chronic neck pain were screened using a randomized assignment program and assigned to experimental group (n=17) and control group (n=17). Both groups underwent a complex exercise program. In addition, the experimental group dynamic taping was applied to the upper trapezius muscle. All interventions were applied three times per week for four weeks. The visual analogue scale (VAS), the neck disability index (NDI), short form-12 health survey questionnaire (SF-12), Headache impact test-6 (HIT-6), Craniovertebral angle (CVA), Cranial rotation angle (CRA), upper trapezius muscle tone were compared to evaluate the effect on intervention. Results : Both groups showed significant differences before and after the intervention in VAS, NDI, SF-12, HIT-6, and CVA, CRA (p<.05). In addition, significant differences in NDI and upper trapezius muscle tone were observed between the experimental group and control group (p<.05). Conclusion : A complex exercise program using dynamic taping for patients with tension headache and chronic neck pain with forward head posture are effective method with clinical significance in improving the function and reducing upper trapezius muscle tone.

Chuna Manual Therapy for Functional Dyspepsia : A Systematic Review and Meta-analysis (기능성 소화불량증에 대한 추나요법의 효과 : 체계적 문헌고찰과 메타분석)

  • Heo, In;Shin, Byung-Cheul;Hwang, Eui-Hyoung;Hwang, Man-Suk;Kim, Byung-Jun;Kim, So-Yeon;Heo, Kwang-Ho
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.10 no.1
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    • pp.1-14
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    • 2015
  • Objectives : To evaluate the evidence supporting the effectiveness of Chuna manual therapy for functional dyspepsia. Methods : We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for functional dyspepsia. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : Thirteen RCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy combined with medication treatments in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with medication plus specific electromagnetic therapy to medication treatments alone. Conclusions : Our systematic review found encouraging but limited evidence of Chuna manual therapy for functional dyspepsia. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend sham-controlled RCTs or comparative effectiveness research to test the effectiveness of Chuna manual therapy.

Effects of Laughter Therapy on Depression and Sleep Wake Disorders of the Elderly in Residential Facilities : A Systematic Review and Meta-analysis (웃음요법이 시설거주 노인의 우울과 수면 장애에 미치는 효과 : 체계적 고찰 및 메타분석)

  • Kim, Eun-Jung;Yang, Jin-Hyang
    • Journal of Korea Entertainment Industry Association
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    • v.15 no.8
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    • pp.291-303
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    • 2021
  • The purpose of this study is to identify the effects of laughter therapy on depression and sleep wake disorders among the elderly in residential facilities using a systemic review and meta-analysis. Twelve databases were searched. Two researchers independently performed the selection of the studies, data coding and assessment. The risk of bias was assessed using risk of bias (RoB) and risk of bias assessment tool for non-randomized studies (RoBANs). To estimate the effect size, meta-analysis of the studies was performed using R version 4.04. Out of the 1,122 retrieved articles, one randomized controlled trial (RCT) and eleven non-randomized controlled trials (non-RCTs) were selected for analysis. The overall effect size of eleven studies on depression was determined to be -1.04 (95% Cl: -1.53~-0.54, p<.001). There were statistically significant in the effect of below ten sessions and the effect of below 400 minutes'and 400 to 1000 minutes'interventions on depression. The overall effect size of five studies on sleep wake disorders was 0.83 (95% Cl: -0.26~1.93, p=.136), which was not statistically significant. There was statistically significant in the effect of below 300 minutes'interventions on sleep wake disorders. Laughter therapy was an effective non-pharmacological intervention to reduce depression among the elderly in residential facilities. The findings also suggest that guidelines for laughter therapy need to be developed considering the number of sessions and a duration of intervention to reduce depression and sleep wake disorders of the elderly in residential facilities.

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.

Effects of Self-Care Intervention Study on Chronic Obstructive Pulmonary Disease: Focusing on a Systematic Review of a Randomized Controlled Trials (만성폐쇄성폐질환의 자가간호 중재연구(RCT) 효과에 관한 체계적 문헌고찰)

  • Kyoung Mi Moon;Inhee Park;Hyun Joo Kim
    • Journal of Industrial Convergence
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    • v.21 no.8
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    • pp.97-110
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    • 2023
  • This study presents a systematic literature review aimed at integrating and analyzing the research findings regarding the components of various self-care intervention programs conducted for individuals with chronic obstructive pulmonary disease (COPD) both domestically and internationally. The paper selection criteria were established based on materials from PubMed, CINAHL, EMBASE, /MEDLINE, RISS, DBpia, KISS, and KMbase databases, covering the period from January 1, 2000, to September 30, 2022. The inclusion criteria included controlled pre-post experimental study designs. A total of 23 studies were included in this systematic review. The intervention-related factors examined included the sample size, type of intervention mediator, intervention frequency, and duration. Additionally, factors associated with intervention effects, such as measurement tools and variables, were analyzed. The findings of the analysis support the notion that self-care intervention programs for COPD can contribute to the prevention of symptom exacerbation and hospital readmissions among patients. Consequently, the development of a tailored self-care intervention program specifically designed for COPD patients in South Korea is warranted, considering aspects such as patient accessibility, convenience, and motivation for long-term sustainability.

A Review of Clinical Studies for Chinese Medicine Treatment of Idiopathic Thrombocytopenic Purpura Using the CNKI Database (특발성 혈소판 감소성 자반증의 중의치료에 대한 임상연구 동향 - CNKI검색을 중심으로)

  • Ji-eun Bae;Jae-won Park;Jun-kyu Lim;Mi-so Park;Jeong-su Hong;Dong-jin Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1045-1062
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    • 2022
  • Objectives: The aim of this study was to analyze the latest clinical studies on Korean medicine treatment of idiopathic thrombocytopenic purpura (ITP) in the Chinese National Knowledge Infrastructure (CNKI) database. Methods: We searched the last 6 years of clinical studies discussing Oriental medicine-based treatments for ITP in the CNKI database. A meta-analysis of 13 RCTs was performed by synthesizing the outcomes, including the measured platelet count and total effective rate. The quality of the studies was assessed using Cochrane's risk of bias (RoB) tool. RevMan 5.4.1 software was used for data analysis. Results: Of the 15 selected studies, 1 was a non-randomized controlled trial (nRCT), 2 were case series, and 12 were randomized controlled trials (RCTs). Treatments in all studies included oral herbal medicine. The most frequently used herbal decoction was the Liangxue Jiedu prescription (凉血解毒方), and the most commonly used herb was Agrimonia pilosa (仙鶴草), Astragali Radix (黃芪), Fossilia Glycyrrhizae Radix et Rhizoma (甘草), and Rehmannia glutinosa Liboschitz ex Steudel (地黃). The meta-analysis showed significantly better improvement in platelet counts and total effective rate for ITP in the treatment group than in the control group. Conclusion: Treatment with herbal medicine was effective in treating ITP. However, the significance of this conclusion is somewhat limited due to the low quality of the available studies. Multifaceted and scientifically designed clinical studies are required to develop treatments for ITP based on Korean medicine. The results of this study could be used as basic data for further ITP studies.

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.