• 제목/요약/키워드: randomized controled clinical trial

검색결과 6건 처리시간 0.019초

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

  • 손창규
    • Korean Journal of Acupuncture
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    • 제26권1호
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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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대체의학 임상실험 현황에 대한 문헌고찰 (A Literature Review of Clinical Trials on Alternative Medicine)

  • 조현;유진영;박수희
    • 한국산학기술학회논문지
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    • 제11권11호
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    • pp.4395-4403
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    • 2010
  • 본 연구는 2000년 1월부터 2010년 3월까지 Pubmed에 게재된 논문 중, alternative medicine 으로 검색하여 근거중심 대체의학에 대한 연구 현황을 알아보고자 문헌고찰을 하였다. 682편의 연구 중 대체의학에 관한 임상연구는 19개였으며 연구전체 대상자는 2,573명이었다. 논문분석 결과 RCT(Randomized Controlled Trial) 실험 설계연구가 44%였으며 CCT(Controlled Clinical Trials)가 16%, OD(efficacy studies with either a controlled or an Other than controlled Design) 40%였다. 가장 많은 임상실험이 시행된 중재 방법은 Acupuncture과 Massage 였다. 대상 질병군 분포는 근골격계 및 결합조직의 질환과 관련된 '통증 완화'에 대한 임상연구가 20%, 다음으로 특정 감염성 및 기생충성 질환, 신생물이 각각 15% 순이었다. 근거중심 대체의학 현황을 파악하고자 문헌 고찰한 결과 대체의학을 통한 중재가 질병치료에 효과가 있는지에 대한 과학적 근거를 제시한 임상연구가 부족하다. 대체의학의 품질, 안정성, 유효성 확보를 위해 대체의학에 대한 질 높은 연구필요하며 근거중심 대체의학의 활성화가 필요할 것으로 생각된다.

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

  • 김석환;박보라;최금애;임현주;이상룡;정대규;김락형;김태헌;김경옥;정인철
    • 동의신경정신과학회지
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    • 제20권2호
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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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    • 제6권1호
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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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모니터기반 가상현실게임을 이용한 중재가 급성기 뇌졸중 환자의 인지 기능과 일상생활활동에 미치는 영향에 대한 사전연구: 이중 맹검 무작위 대조 시험 연구 (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)

  • 최봉근;권재성
    • 한국콘텐츠학회논문지
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    • 제20권9호
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    • pp.531-540
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    • 2020
  • 본 연구의 목적은 4주 동안 모니터기반 가상현실게임 중재가 급성기 뇌졸중 환자의 인지 기능과 일상생활활동에 미치는 영향에 대해 알아보기 위함이었다. 본 연구는 급성기 뇌졸중 환자 19명이 참여하였다. 모니터기반 가상현실 게임중재와 전산화 인지중재의 효과성을 비교하기 위하여, 두 집단에 1일 30분, 주 5회, 총 4주 중재하였고, 효과에 대한 측정은 TMT A & B, DST, RKMT, K-MBI를 중재 전과 후에 실시하였다. 실험군에서는 모든 변수에 대해 유의미한 향상을 보였으나, 대조군에서는 TMT A와 DST을 제외한 항목에서만 유의미한 향상을 보였다. 본 연구를 통하여, 가상현실게임 중재가 뇌졸중 환자의 인지 기능과 일상생활활동에 효과적인 치료로 적용될 가능성을 확인하였다. 또한 모니터기반 가상현실게임 중재가 인지중재를 필요로 하는 환자들에게 임상에 있는 작업치료사들이 유용하게 사용될 수 있을 것이라 사료된다.

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

  • 장민기;윤은혜;정찬영;변혁;김은정;김경호;김갑성;이승덕
    • Journal of Acupuncture Research
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    • 제27권1호
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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.