• Title/Summary/Keyword: Randomized controled trial

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Overview for pattern and results of moxibustion-derived clinical trials (뜸을 이용한 RCT임상연구의 경향에 대한 개괄)

  • Son, Chang-Gue
    • Korean Journal of Acupuncture
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    • v.26 no.1
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    • pp.41-49
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    • 2009
  • Objective : To make comprehensive picture of clinical trials using moxibustion and their results by today, then help a strategy for moxibustion-derived clinical studies in the future. Methods : Surveyed literatures containing randomized controled clinical trial (RCT) from PubMed and Korean journals. Analysis was performed according to distribution mainly by study subject, target diseases, study design, and its efficacy. Results : Fifty two literatures were selected according to inclusion criteria of randomized controled clinical study. Moxibustion-derived RCT have been rapidly increased from 2003 since the first was published in China in 1992. The main subjects of RCT are associated with immunity, cancer, arthritis, chronic colitis and urogenital disorders, which are connected to cold-elated pathogenesis. The average number of subjects was 94, and direct-moxibustion was mainly applied. The control groups were set up by giving conventional therapy, herbal medicine, acupuncture or only observation. The most of RCTs showed positive results. Conclusions : This study would be helpful for designing or conducting RCTs to develop the scientific development of moxibustion.

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A Literature Review of Clinical Trials on Alternative Medicine (대체의학 임상실험 현황에 대한 문헌고찰)

  • Cho, Hyun;Yoo, Jin-Yeong;Park, Soo-Hee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.11 no.11
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    • pp.4395-4403
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    • 2010
  • The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.

The Systematic Review of Clincal Trial(s) Intervening Traditional Korean Herbal Medicine: Extension of Developing Clinical Guideline for Hwa-byung (화병 진료지침 개발을 위한 한약 임상시험 방법론 연구)

  • Kim, Seok-Hwan;Park, Bo-Ra;Choi, Keum-Ae;Lim, Hyun-Ju;Lee, Sang-Ryong;Jung, Dae-Gyu;Kim, Rak-Hyung;Kim, Tae-Hun;Kim, Kyung-Ok;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.2
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    • pp.163-176
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    • 2009
  • Objectives : To address most probable and suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on hwa-byung. Study Design : A systematic review of research studies of complementary and/or alternative medical(CAM) treatment of depression, and of domestic clinical trials of Traditional Korean Medicine, and of Chinese clinical trials of Traditional Chinese Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of depression intervening herbal medicine were searched through MEDLINE, Cochrane Library, and CNKI databases. Also, domestic RCTs intervening Traditional Korean Herbal Medicine were searched through Korean Traditional Knowledge Portal and Korean studies Information Service System(KISS). Studies were evaluated using Iadad scale and self-designed tool for this study. Results : Thirty four RCT studies( 10 from MEDLINE, 16 from CNKI, 8 domestic studies) of herbal medicine met inclusion criteria. Mean Jadad score of studies published in English was 2.8${\pm}$0.79, in Chinese 1.94${\pm}$0.77, and in Korean 2.75${\pm}$0.71. Twenty one percent of studies included pattern differentiation in their inclusion criteria. Twenty nine percent of studies used combined treatment of herbal and conventional medicine. Among studies on depression, 9% included Complementary Medical assessing tools. Conclusions : There is shortage of domestic clinical trial involving herbal medicine. In China, studies tend to focus on investigating effect of Combined treatment of herbal and conventional medicine on depression. Clinical trial(s) of hwa-byung should provide good internal validity by describing methodology for randomization, double-blinding, and attrition. Also, specific guideline for clinical trial, including Traditional Korean Medical aspects across inclusion criteria, and assessing tools is needed.

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Effects of Antioxidant Nutrient Supplementation on the Lipid Peroxidation and Antioxidative Enzyme Activities in Patients with Coronary Heart Disease

  • Joung, Hyojee;Chun, Byung Yeol;Choi, Young Sun;Kim, Sueun;Park, Wee Hyun;Jun, Jae Eun;Chae, Shung Chull;Song, Kyung Eun;Cho, Sung Hee;Oh, Hee Sook
    • Preventive Nutrition and Food Science
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    • v.6 no.1
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    • pp.51-56
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    • 2001
  • This study was carried out to evaluate whether antioxidant nutrient suppplementation with $\alpha$-tocopherol, vitamin C, $\beta$-carotene, and selenium reduces the lipid peroxide levels and increases the antioxidative enzyme activities in patients with coronary hart disease. Eighty nine patients participated in a randomized, double-blind, placebo-controlled trial. The antioxidant group (45 patients) was given daily doses of $\alpha$-tocopherol (400 IU), vitamin C (50 mg), $\beta$-carotene (15 mg), and selenium (50 $\mu\textrm{g}$) and forty four patients received a placebo. Thirty eight subjects (84.4%) of the antioxidant group and thirty nine subjects (88.6%) of the placebo group completed the three-month supplementation. Serum levels of tocopherol, vitamin C and $\beta$-carotene significantly increased in the antioxidant group compared with the baseline (p<0.05). Thiobarbituric acid-reactive substances(TBARS) decreased significantly (0.6 nmol MDA/mL) in the antioxidant group compared with that (0.09 nmol MDA/mL) in the placebo group (p=0.03). However, antioxidant supplementation did not affect the level of oxidized-LDL measured as autoantibodies against oxidized-LDL. The superoxide dimutase activity in red blood cells increased in the antioxidant group compared with the baseline (p<0.05). However, glutathione peroxidase activities did not change after supplementation in both groups, and catalase activity significantly decreased in the placebo group (p<0.05). These results suggest that antioxidant supplementation for 3 months with $\alpha$-tocopherol, vitamin C, $\beta$-carotene and selenium in patients with coronary heat disease may be partially protective against oxidative stress.

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Comparison of rhythmic and non-rhythmic aerobic exercises on depression and balance in the elderly

  • Kwon, Il-Ho;Song, Jun-Young;Kim, Do-Ye;Son, Je-Yeong;Shim, Yu-Jin;Shin, Won-Seob
    • Physical Therapy Rehabilitation Science
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    • v.6 no.3
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    • pp.146-151
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    • 2017
  • Objective: The purpose of this study was to investigate the effects rhythmic and non-rhythmic aerobic exercises on depression and balance of healthy elderly people. Design: Randomized controled trial. Methods: Nineteen older subjects were randomly divided into 2 groups for rhythmic and non-rhythmic aerobic exercises. Both aerobic exercises consisted of functional movements such as turning in opposite directions, and running in place, the exercise consisted of movements that could activate balance. The rhythmic training group initially used music with 8 beats, and then later progressed to 16 beats. Additionally, we adjusted the pace of the music using songs from 125 beats per minute (bpm) to 160 bpm. Both groups were exercised for 50 minutes a day, twice a week, for a total of 8 weeks. We measured the condition of the patients before the intervention, and after 8 weeks of intervention. The Beck depression inventory (BDI) was used to measure the degree of depression. The Berg balance scale (BBS) was used to measure static and dynamic balance ability. We measured the subject's subjective balance confidence using the fall efficacy scale (FES). Results: Both groups showed significant improvement in BDI, BBS, and FES (p<0.05). The rhythmic aerobic exercise group showed a significant improvement only in the BBS change values compared to the non-rhythmic group (p<0.05). Conclusions: According to this study, both rhythmic and non-rhythmic aerobic exercises resulted in significant improvement in the degree of depression and balance ability of the elderly. The rhythmic aerobic exercise was more effective for dynamic balance ability.

A Preliminary Study of the Effects of Monitor-Based Virtual Reality Games on the Cognition & Activities of Daily Living for Acute Stroke : A Double-blind Randomized Controled Trial (모니터기반 가상현실게임을 이용한 중재가 급성기 뇌졸중 환자의 인지 기능과 일상생활활동에 미치는 영향에 대한 사전연구: 이중 맹검 무작위 대조 시험 연구)

  • Choi, Bong-Geun;Kwon, Jae-Sung
    • The Journal of the Korea Contents Association
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    • v.20 no.9
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    • pp.531-540
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    • 2020
  • Objectives: This study aimed to investigate the effects of a 4-weeks intervention using a monitor-based virtual reality game intervention(VRI) on the cognitive function and activities of daily living of individuals with acute stroke. Methods: For this study, 19 individuals with acute stroke were recruited. To compare the effectiveness of the VRI and the computer based cognitive intervention(CBCI), Each of the two groups were provided different interventions a 30 minutes a day, 5 times per week for 4 weeks, and to measure the effects of the intervention, the TMT A&B, DST, RKMT and K-MBI were performed before and after interventions. Results: Both the VRI and the CBCI were found to have significantly improved the cognitive function and activities of daily living, and the difference in change compared between groups showed that the effectiveness of the VRI was significantly higher. Conclusion: Based on the findings of this study, the monitor-based VRI is anticipated to prove useful as an effective intervention for the cognitive function and activities of daily living of stroke patients. Furthermore, the utility of monitor-based VRI is likely to be high in clinical occupational therapy.

Credibility of a Newly Developed Sham Moxibustion (피부 열전도 온도에 근거를 둔 거짓 뜸 개발 및 평가 연구)

  • Jang, Min-Ki;Yoon, Eun-Hye;Jung, Chan-Yung;Byun, Hyuk;Kim, Eun-Jung;Kim, Kyung-Ho;Kim, Kap-Sung;Lee, Seung-Deok
    • Journal of Acupuncture Research
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    • v.27 no.1
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    • pp.117-127
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    • 2010
  • Background : To demonstrate the efficacy of moxibustion therapy, randomized controled trials are required. But, clinical trials of moxibustion had limitations due to the absence of a sham moxibustion model for an appropriate placebo. Objectives : To develop a new sham moxibustion model based on the thermal characteristics of commercial indirect moxibustion, especially temperature, and to evaluate whether it could be applied in clinical trials. Methods : By applying heat insulation, we created a sham moxibustion device that was indistinguishable from a real one with the naked eye. It also stimulated heat but had inert remedial value. A clinical trial was performed on subjects to test double blinding. The subjects were randomly assigned into two groups, a treatment group and a sham group. Acupoint Zusanli($ST_{36}$) was used in each group for 3 times. A sham acupuncture credibility questionnaire was modified into a moxibustion credibility questionnaire and was filled out after treatment. Results : No major difference was detected in the subjects' baseline data. Most subjects and practitioners could not distinguish the sham moxibustion device from the real one. But, subjects who had experience of moxibustion therapy more likely to distinguish the sham moxibustion device from the real one than subjects who didn't have experience of moxibustion therapy. The treatment group showed a significant difference in the VAS(Visual Analog Scale) for intensity of sensation during treatment than that of the sham group. Conclusions : The sham moxibustion device in this study is proved sufficient and credible to be applied in investigations of the effect of moxibustion. But it is more appropriate for the people who don't have experience of moxibustion therapy.