• Title/Summary/Keyword: Randomized clinical trial

Search Result 894, Processing Time 0.029 seconds

Overview of RCT for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis

  • Son, Chang-Gue
    • The Journal of Korean Medicine
    • /
    • v.32 no.3
    • /
    • pp.44-49
    • /
    • 2011
  • Objective: This study aimed to get information on the current status of therapies to date for non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH). Methods: All randomized clinical controlled trial (RCT)-derived papers for NAFLD or NASH were reviewed via PubMed Database. Results: 39 RCTs met the review criteria, of which 15 and 24 papers were for NAFLD and NASH, respectively. 83% of the papers were released since 2006, and 30 studies were conducted for western medicines, antioxidants and lifestyle intervention whereas nine trials were done using herbal medicine or acupuncture which showed positive outcome. Conclusions: NAFLD and NASH are new epidemic disorders which can be a target of traditional Oriental medicine. This study will be helpful for the Oriental medicine-based strategies or therapeutic development for them.

Clinical Trial Protocol Development of Acupuncture for Disaster Survivors: Results from an Expert Survey (전문가 설문조사에 기반한 재난 경험자에 대한 침치료 임상연구 프로토콜 개발)

  • Huiyong Kwak;Chanyoung Kwon;Jungtae Leem;Sang-Ho Kim
    • Journal of Oriental Neuropsychiatry
    • /
    • v.35 no.1
    • /
    • pp.15-26
    • /
    • 2024
  • Objectives: The objective of this study is to develop a specialized clinical research protocol for acupuncture treatment specifically designed for disaster survivors based on insights from an expert survey. Methods: An expert panel comprising specialists in neuropsychiatry, acupuncture, and clinical research methodology was assembled. Initial data to inform the clinical research protocol design was collected utilizing open-ended responses, multiple-choice questions, and a 5-point Likert scale to gauge agreement levels. Next, this data was disseminated to a panel of experts. A cohesive clinical research protocol was then formulated during a core panel meeting by integrating insights from a panel of 10 experts. Results: The protocol developed herein entails a non-randomized controlled study involving participants aged 19~64 years old who have been identified as high-risk or cautious according to the National Trauma Center screening test. The study design includes the establishment of an active control group, which allows for the assessment of an additional effect through comparison with conventional therapy. The selected acupuncture approach involves a combination of manual acupuncture and ear acupuncture. For clinical outcome assessment, the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 was proposed to gauge trauma symptoms. Representative scales for various domains such as depression, anxiety, anger, insomnia, pain, and quality of life were also provided for reference. Conclusions: The developed protocol is anticipated to streamline the swift design and initiation of clinical trials during disaster scenarios. It is also designed to be scalable, thereby enabling its application in both non-randomized control group studies and single-group before-and-after comparisons.

The Assessment of Risk of Bias on Clinical Trials of Korean Medicine for Alopecia (탈모증의 한약제제 임상연구에 대한 비뚤림 위험 평가)

  • Ryu, Deok-hyun;Roh, Seok-sun
    • Journal of Haehwa Medicine
    • /
    • v.24 no.1
    • /
    • pp.25-36
    • /
    • 2015
  • Objective : This study aims to evaluate a risk of bias by Risk of Bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of herbs to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methos : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmd, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medince assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trials, 13 non-randomized controlled trials and 3 case reports. This study evaluates the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusion : We must try to specify concretely methods of allocation concealment after planning and practicing it for reducing a selection bias in randomized controlled trials. Also report a reason of missing value and blinding outcome assessments. And we have to agonize and mention methods of blinding of researchers for reducing a detection bias in non-randomized controlled trials.

  • PDF

Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial

  • Zhang, Li;Chen, Xiaoyun;Cheng, Yanqi;Chen, Qilong;Tan, Hongsheng;Son, Dongwook;Chang, Dongpill;Bian, Zhaoxiang;Fang, Hong;Xu, Hongxi
    • Journal of Ginseng Research
    • /
    • v.43 no.4
    • /
    • pp.676-683
    • /
    • 2019
  • Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.

Current Clinical Evidence for Korean Red Ginseng in Management of Diabetes and Vascular Disease: A Toronto's Ginseng Clinical Testing Program

  • Vuksan, Vladimir;Sievenpipper, John;Jovanovski, Elena;Jenkins, Alexandra L.
    • Journal of Ginseng Research
    • /
    • v.34 no.4
    • /
    • pp.264-273
    • /
    • 2010
  • While ginseng is reported to have a wide array of applications, there is growing evidence for its indications in diabetes and vascular disease. A clear connection, however, has not been established between ginseng's composition, dose and its targeted efficacy in humans. We therefore developed and initiated the Korean Red Ginseng Clinical Testing Program for diabetes and vascular function which is an efficacy and safety-based clinical screening model for ginseng. The most efficacious sources, ginsenoside profiles, doses, and modes of administration were examined in sequential, acute, followed by long term, randomized-controlled trials to investigate the efficacy and safety profiles. This review discusses the current state of the clinical research of Korean red ginseng program conducted in Toronto, paving the way for the use of clinically selected ginseng and its ginsenoside fractions in the management of diabetes and vascular diseases.

Recent Clinical Research of Acupuncture for the Treatment of Tinnitus (이명의 침 치료에 관한 최근 임상 연구 동향)

  • Lee, Kyou-Young;Hong, Chul-Hee
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
    • /
    • v.28 no.3
    • /
    • pp.48-65
    • /
    • 2015
  • Objectives : The aim of this study is to analyze recent clinical research of the acupuncture for the treatment of tinnitus.Methods : We searched pubmed for foreign journals with the title/abstract 'tinnitus, acupuncture' published in the last 10 years, and for domestic journals we searched NDSL, RISS, KISS, The National Assembly Library, The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology with the same conditions as foreign journals.Results : We selected total 10 papers: 7 RCTs, 1 RCT protocol, 1 clinical trial, 1 Systematic Review. In RCT, all studies showed positive effect, however in comparison with the control groups, only 2 studies showed meaningful effects.Conclusions : Positive effect of the acupuncture on tinnitus is expected, but because of several limits observed in many papers, we can't draw defined conclusions. Further well-designed researches are needed.

Effect of high-dose ginsenoside complex (UG0712) supplementation on physical performance of healthy adults during a 12-week supervised exercise program: A randomized placebo-controlled clinical trial

  • Lee, Eon Sook;Yang, Yun Jun;Lee, Jun Hyung;Yoon, Yeong Sook
    • Journal of Ginseng Research
    • /
    • v.42 no.2
    • /
    • pp.192-198
    • /
    • 2018
  • Background: Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance. Methods: Sedentary individuals (n = 117) were randomly assigned into one of three groups: low-dose ginsenoside supplementation (100 mg/d, n = 39), high-dose ginsenoside supplementation (500 mg/d, n = 39), or a placebo group (500 mg/d, n = 39). All participants underwent a supervised 12-wk aerobic and resistance exercise training course. To assess the effects of supplementation on physical performance, maximal oxygen consumption ($VO_2max$), anaerobic threshold (AT), lactic acid, and muscle strength of the dominant knee were measured at baseline, every visit, and after the training program. Results: Both ginsenoside groups showed significant increases in $VO_2max$ and muscular strength during exercise training. There were no definite changes in AT and lactic acid levels over time. After exercise training, there were definite differences in the $VO_2max$ (28.64.9 to $33.7{\pm}4.9ml/kg/min$ in high-dose group vs. $30.4{\pm}6.7$ to $32.8{\pm}6.6ml/kg/min$ in placebo, p = 0.029) and AT ($19.3{\pm}4.2$ to $20.9{\pm}3.5ml/kg/min$ in high-dose group vs. $20.0{\pm}5.1$ to $20.0{\pm}4.9ml/kg/min$ in placebo, p = 0.038) between the high-dose ginsenoside and placebo groups. However, there was no difference in $VO_2max$ between the low-dose ginsenoside and placebo groups (p = 0.254). There were no differences in muscular strength during exercise training among the three groups. Conclusion: High-dose ginsenoside supplementation (UG0712) augmented the improvement of aerobic capacity by exercise training.

Recent Clinical Research on Effect of Acupuncture for Rhinitis - Within RCT, Review - (비염의 침 치료에 대한 최근 임상 연구 동향 - RCT, Review 중심으로 -)

  • Shin, Ji-Hye;Lee, Jang-Cheon;Kim, Ki-Bong
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.26 no.1
    • /
    • pp.46-59
    • /
    • 2012
  • Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for rhinitis in other countries. We have analyzed the studies on effect of acupuncture for rhinitis within randomized controlled trial(RCT), reviewed for 11 years (from 2001 to 2011). Methods The search database includes PubMed. To narrow the search, the following key search terms were used: 'rhinitis, acupuncture'. The search was limited to the publication date from 2001 to 2011. Results Total 20 studies were selected: RCT(13), review(5), case report(1), and cost effectiveness study(1). In RCT, 9 studies used acupuncture only, and 8 studies of them have revealed that acupuncture is effective on rhinitis. In review, 3 studies are systematic review, 2 studies are no systematic review. Among systematic review, 2 studies have revealed partial effectiveness of acupuncture for rhinitis, but they suggested the necessity of further studies. Conclusions Domestic studies on effect of acupuncture for rhinitis are necessary. For more accurate results, controlled, large scale and well designed studies are recommended.

Recent Clinical Research Trends on Acupuncture Treatment of Meniere's Disease (메니에르 병의 침 치료에 관한 최근 임상 연구 동향)

  • Lee, Kyou-Young;Hong, Chul-Hee
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
    • /
    • v.31 no.3
    • /
    • pp.26-38
    • /
    • 2018
  • Objectives : The purpose of this study is to investigate the possibility of applying acupuncture to the treatment of meniere's disease, which has no definite treatment methods, by analyzing the latest clinical researches about acupuncture treatment of meniere's disease. Methods : A case study and Randomized Controlled Trial (RCT) related to the acupuncture treatment of meniere's disease were searched using domestic and international thesis search engines including OASIS, CNKI, J-STAGE, PubMed. This study include acupuncture treatment and acupuncture combined with other treatments such as herbal medicine. The search was limitied to the publication date from 2000 to 2018 with free full text. Results : 17 cases were selected. There were 7 case studies in Korea, 5 case studies in China, and 5 RCT papers in China. All 12 cases reported improvement in meniere's disease and all RCT studies showed significantly higher treatment effects in the experimental group than in the control group. Conclusions : Acupuncture treatment showed significant effects for meniere's disease when applied alone or in combination with other treatments. In the future, various systematic studies should be conducted only for acupuncture treatment.