• 제목/요약/키워드: Randomized allocation

검색결과 55건 처리시간 0.019초

털부처꽃과 돌단풍 에탄올 추출물의 한국 성인 체지방량 감소에 대한 유효성 및 안전성에 관한 인체적용시험 (Eficacy and Sfety Human Study of the Ethanol Extracts from Lythrum Salicaria L. and Aceriphyllum Rossii for Reducing Body Fat Percentage of Korean Adult)

  • 박원형;선승호;차윤엽
    • 동의생리병리학회지
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    • 제27권6호
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    • pp.832-841
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    • 2013
  • This research, as a basic preliminary study for development of functional health food, is aimed at assessing the body fat reduction effect and for application to human body for such reduction in actual clinical settings by preliminary extraction of 2 types of wild edible greens, Lythrum salicaria L. and Aceriphyllum rossii. Subjects over the age of 19 and less than 60 years old with BMI value range of $23.0kg/m^2{\sim}29.9kg/m^2$ were recruited through screening were divided into experimental group and control group, each with 25 subjects, through randomized allocation. With both patients and evaluators wearing blindfold, the experimental group was orally administered with 4 capsules of 500mg of composite preparation containing the extracts of Lythrum salicaria L. and Aceriphyllum rossii 3 times a day for a period of 8 weeks while the control group was orally administered with 4 capsules of 500mg of placebo (fake food) with the same appearance as the preparation administered to the experimental group 3 times a day for a period of 8 weeks. After having carried out evaluation on physical examinations (body weight, BMI and body fat ratio, etc.), laboratory tests (general blood test, biochemical test of blood and urine test), lipid test, the changes were analyzed. There was no significant change between the 2 groups and within the groups in BMI and body fat ratio, which are the primary effectiveness evaluation at each time. There was no significant difference between the 2 groups in serum lipid and WHR, obesity related KOQOL, KEAT-26 which are the secondary effectiveness evaluations. There was no change between the 2 groups and within the groups in vital sign, CBC, BC and urin test. These results suggest that Lythrum salicaria L. and Aceriphyllum rossii ext. showed no significant reduction in BMI, body fat ratio and serum lipid. Additional confirmative clinical application test is needed in the future.

갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈 (Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women)

  • 김건형;김동일;황덕상;이진무;김형준;윤현민;정희정;강경원;이명수;최선미
    • 대한한방부인과학회지
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    • 제23권1호
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    • pp.42-52
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    • 2010
  • Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

Effects of different space allowances on growth performance, blood profile and pork quality in a grow-to-finish production system

  • Jang, J.C.;Jin, X.H.;Hong, J.S.;Kim, Y.Y.
    • Asian-Australasian Journal of Animal Sciences
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    • 제30권12호
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    • pp.1796-1802
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    • 2017
  • Objective: This experiment was conducted to evaluate the optimal space allowance on growth performance, blood profile and pork quality of growing-finishing pigs. Methods: A total of ninety crossbred pigs [$(Yorkshire{\times}Landrace){\times}Duroc$, $30.25{\pm}1.13kg$] were allocated into three treatments (0.96: four pigs/pen, $0.96m^2/pig$; 0.80: five pigs/pen, $0.80m^2/pig$; 0.69: six pigs/pen, $0.69m^2/pig$) in a randomized complete block design. Pigs were housed in balanced sex and had free access to feed in all phases for 14 weeks (growing phase I, growing phase II, finishing phase I, and finishing phase II). Results: There was no statistical difference in growing phase, but a linear decrease was observed on average daily gain (ADG, p<0.01), average daily feed intake (ADFI, p<0.01), and body weight (BW, p<0.01) with decreasing space allowance in late finishing phase. On the other hand, a quadratic effect was observed on gain to feed ratio in early finishing phase (p<0.03). Consequently, overall ADG, ADFI, and final BW linearly declined in response to decreased space allowance (p<0.01). The pH of pork had no significant difference in 1 hour after slaughter, whereas there was a linear decrease in 24 h after slaughter with decreasing space allowance. Floor area allowance did not affect pork colors, but shear force linearly increased as floor space decreased (p<0.01). There was a linear increase in serum cortisol concentration on 14 week (p<0.05) with decreased space allocation. Serum IgG was linearly ameliorated as space allowance increased on 10 week (p<0.05) and 14 week (p<0.01). Conclusion: Data from current study indicated that stress derived from reduced space allowance deteriorates the immune system as well as growth performance of pigs, resulting in poor pork quality. Recommended adequate space allowance in a grow-to-finish production system is more than $0.80m^2/pig$ for maximizing growth performance and production efficiency.

이중맹검을 위한 Sham Acupuncture에 대한 임상연구 (The Study of the Sham Acupuncture for Double Blind)

  • 임정아;서정철;이은용;이향숙;문형철;최선미;황우준;조남근;김성철
    • Journal of Acupuncture Research
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    • 제23권5호
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    • pp.127-144
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    • 2006
  • Background and Purpose : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group. So we didn't say it was true acupuncture effect, though subjects in clinical study improved. To investigate the possibility of sham acupuncture application, we examined how well subjects distinguished real acupuncture from sham acupuncture. Methods : We investigate the possibility of sham acupuncture application as the following 3 kinds of methods. 1. The public (n=60) and Oriental Medicine Doctors (n=20) looked at the appearance of acupuncture and then were treated with randomly allocated acupuncture and judged it as real or sham. 2. The public (n=60) and Oriental Medicine doctors (n=20) were treated with randomly allocated acupuncture, then they looked at the appearance of acupuncture and judged it as real or sham. 3. The public (n=60) were treated with randomly allocated acupuncture (right-real-left-sham), (right-sham-left-real), (left-real-right-sham), (left-sham-right-real), then they judged it as real or sham. Results : 1. When the public (n=60) looked at the acupuncture appearance, the correct judgement ratio was 63.3%. After they were treated with acupuncture, the correct judgement ratio was 50.0%. 2. When Oriental Medicine doctors (n=20) looked at the acupuncture appearance, the correct judgement ratio was 25.0%. After they were treated with acupuncture, the correct judgement ratio was 45.0%. 3. When the public (n=60) were treated with acupuncture, the correct judgement ratio was 50.0%. After they looked at the acupuncture appearance, the correct judgement ratio was 63.3%. 4. When Oriental Medicine doctors (n=20) were treated with acupuncture, the correct judgement ratio was 65.5%. After they looked at the acupuncture appearance, the correct judgement ratio was 65.0%. 5. After the public (n=60) were treated with randomly allocated sham or real acupuncture as (right-real-left-sham), (right-sham-left-real), (left-real-right-sham), or (left-sham-right-real). the correct judgement ratio was 66.7% in looking at the acupuncture appearance group, and in not looking at 60.0%. Conclusion : These results indicated that Kim Sham Acupuncture could apply to the double blind clinical study of acupuncture effect. And more continuous studies are needed on Sham Acupuncture apparatus.

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손목터널증후군에 사용된 침 치료 보고의 질 평가 (A Systematic Review on the Reporting Quality of Acupuncture Treatment for Carpal Tunnel Syndrome)

  • 현지윤;신주은;임채정;박지연
    • Korean Journal of Acupuncture
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    • 제37권3호
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    • pp.131-144
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    • 2020
  • Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.