• 제목/요약/키워드: double-blinding

검색결과 18건 처리시간 0.026초

무작위 대조 이중맹검 시험을 통한 봉약침(蜂藥鍼)의 경항통(頸項痛)에 미치는 영향(影響) (A Randomized Controlled Double Blinding Study of Bee Venom Acupuncture Therapy on Sprain of C-spine)

  • 김경태;송호섭
    • Journal of Acupuncture Research
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    • 제22권4호
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    • pp.189-195
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    • 2005
  • Objectives : This study was to evaluate the effectiveness of Bee Venom acupuncture therapy on sprain of C-spine by randomized controlled double blinding method. Methods : A randomized double blinding study of bee venom acupuncture therapy was conducted on sprain of C-spine. We divided sprain of C-spine patient into 2 groups: one group with both acupuncture and saline acupuncture therapy, and another group with both acupuncture and bee venom acupuncture therapy. To estimate the efficacy of treatment that applied for two groups, we used visual analog scale(VAS) and neck disability index(NDI). We compared the VAS and NDI score of two groups statistically. Results : STZ induced increase of serum creatinine, BUN and albumin secretion were lowered by AD-1 treatment.

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좌섬요통(挫閃腰痛)에 있어 봉약침(蜂藥鍼)의 효과(效果)에 대한 연구(硏究)(A Randomized Controlled Trial; Double Blinding) (The Effectiveness of Bee Venom Acupuncture Therapy on the Treatment of Sprain of L-spine(A Randomized Controlled Trial; Double Blinding))

  • 김경태;송호섭
    • Journal of Acupuncture Research
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    • 제22권4호
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    • pp.113-120
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    • 2005
  • objectives : This study was to evaluate the effectiveness of Bee Venom acupuncture therapy for sprain of L -spine. Methods : A randomized double blinding study of bee venom acupuncture therapy was conducted on sprain of L-spine. We divided sprain of L-spine patient into 2 groups: one group with both acupuncture and saline acupuncture therapy, and another group with both acupuncture and bee venom acupuncture therapy. To estimate the efficacy of treatment that applied for two groups, we used visual analog scale(VAS) and oswestry disability index(ODI). We compared the VAS and ODI score of two groups statistically. Results : 1. As a result of evaluation by using visual analog scale(VAS) and oswestry disability index(ODI), treatment score after 5 days was marked more higher than score before treatment and treatment score after 10 days treatment was more higher than treatment score after 5 days on each groups. 2. After 10 days treatment, acupuncture and bee venom acupuncture therapy group had significant result on visual analog scale(VAS) and oswestry disability index(ODI) compared with acupuncture and saline acupuncture therapy group. Conclusion : Bee Venom acupuncture therapy can be used with acupuncture therapy for highly effective treatment for sprain of L-spine.

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무작위 배정 비교 임상 시험을 통한 국내의 약침 연구에 대한 체계적 고찰 (Randomized Clinical Controlled Trials with Herbal Acupuncture (Pharmacopuncture) in Korea - A Systematic Review)

  • 박봉기;조정효;손창규
    • 대한한의학회지
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    • 제30권5호
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    • pp.115-126
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    • 2009
  • Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture. Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics. Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally. Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.

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성요한초제제 임상시험 고찰을 통한 한약기원 항우울제 임상시험 방법론 연구 (A Study on the Methodology for a Clinical Trial of an Antidepressive Korean Herb by Comparison with St. John's Wort Trials)

  • 정희;이지형;장보형;고성규
    • 대한한방내과학회지
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    • 제28권2호
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    • pp.363-376
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    • 2007
  • Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

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Assessment of Double-blindness at the Conclusion of the $\beta-Blocker$ Heart Attack Trial

  • Byington Robert P.;Curb J. David;Mattson Margaret E.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.293-296
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    • 1994
  • At the conclusion of a double-blinded, randomized clinical trial of propranolol hydrochloride, but before un blinding, the patients and clinic personnel were asked to guess the treatment group assignment of each patient. While 79.9% of the patients receiving propranolol correctly Identified their treatment group assignment, 57.2% of the patients receiving placebo incorrectly guessed that they were aiso in the propranolol group. No specific mechanism was identified to explain why more patients receiving propranolol were better able to guess' their group assignment. Clinic physicians correctly identified the group assignment of 69.9% of the patients receiving propranolol and 68.8% of the patients receiving placebo. Clinic coordinators correctly identified the group assignment of 67.1% of the patients receiving propranolol and 70.6% of the patients receiving placebo. For clinic personnel, heart rate level and heart rate change seem to be the mechanisms employed to Identify their patients' treatment assignment.

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전력분석 공격에 대응하는 타원곡선 상의 결합 난수 스칼라 곱셈 알고리즘 (A Combined Random Scalar Multiplication Algorithm Resistant to Power Analysis on Elliptic Curves)

  • 정석원
    • 사물인터넷융복합논문지
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    • 제6권2호
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    • pp.25-29
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    • 2020
  • 타원곡선 암호 알고리즘은 RSA 공개키 알고리즘에 비해 짧은 키의 길이와 적은 통신 부하 때문에 IoT 환경에서 인증용으로 많이 사용되고 있다. 타원곡선 암호 알고리즘의 핵심연산인 스칼라 곱셈이 안전하게 구현되지 않으면, 공격자가 단순 전력분석이나 차분 전력분석을 사용하여 비밀 키를 찾을 수 있다. 본 논문에서는 스칼라 난수화와 타원곡선점 가리기를 함께 적용하고, 연산의 효율성이 크게 떨어지지 않으며 전력분석 공격법에 대응하는 결합 난수 타원곡선 스칼라 알고리즘을 제안한다. 난수 r과 랜덤 타원곡선 점 R에 대해 변형된 Shamir의 두 배 사다리 알고리즘을 사용하여 타원곡선 스칼라 곱셈 kP = u(P+R)-vR을 계산한다. 여기에서 위수 n=2l±c일 때, 2lP=∓cP를 이용하여 l+20 비트 정도의 u≡rn+k(modn)과 ν≡rn-k(modn)를 구한다.

소아환자를 위한 음악: 무작위 임상연구의 체계적인 문헌고찰 (Music for Pediatric Patients in Medical Settings: A Systematic Review of Randomized Controlled Trials)

  • 이진형
    • 인간행동과 음악연구
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    • 제10권2호
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    • pp.1-33
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    • 2013
  • 본 연구는 소아환자대상 최근의 음악치료 및 음악을 사용한 임상연구들에 대한 체계적인 문헌고찰(Systematic Review)을 위해 실시되었다. 이를 위해 13개 데이터베이스를 이용하여 2000년부터 2012년 사이에 영어로 발표 된 무작위 임상 및 교차설계 연구들을 자료로 수집하였고, 최초 검색 되었던 1023개의 논문 중 선정 및 제외기준에 따라 영어문헌 15건을 선별하였다. 선별 결과 연구 대상자는 1개월에서 만 18세까지의 아동 및 청소년으로 11명에서 150명 까지 표본크기가 다양했으며 전체 연구 참여자는 987명으로 집계되었다. 선별된 연구들은 음악요법 및 음악치료 연구로 분류되어 전반적인 유형, 연구절차와 방법론, 임상접근법, 측정도구 및 연구결과에 대해 체계적으로 분석되었다. 총 7건의 음악요법과 8건의 음악치료로 분류된 연구들은 7개영역의 종속변수를 36종류의 측정도구를 사용하여 측정하였는데 음악의 임상적 사용에 있어 음악의 선택, 종류 및 임상접근방법에 큰 차이가 있음이 나타났다. 연구절차와 방법론의 분석 결과 다수의 연구들이 주요 연구절차에 대한 기술이 충분치 않고 특히 무작위배정(Randomization), 배정순서 은폐(Allocation Concealment), 이중 또는 부분은폐(double or partial blinding) 및 참여자 감소율(Attrition Rate)과 같은 방법론적 표준에 미치지 못함이 도출되었다. 전반적인 연구결과가 통계적으로 유의하거나 긍정적 결과가 보고된 바 있으나, 연구 방법론적 문제들과 임상접근법들의 이질성으로 인해 그 결과가 편향에 의해 오염되거나 신뢰성에 문제가 있음을 확인할 수 있다. 그 결과 음악이 소아 환자들의 신체 및 사회 심리적 필요를 다루는 도구로 임상적 가치가 있음을 제안할 수는 있지만 이에 대한 과학적인 근거로서는 절차와 접근법이 보다 엄격하고 균일하여 추후 재현이 가능한 연구들이 다수 요구됨을 알 수 있다.

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.

한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰 (Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients)

  • 박봉기;왕경화;조정효;손창규
    • 대한한의학회지
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    • 제31권5호
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

한약을 이용한 chemotherapy-induced peripheral neuropathy (CIPN) 치료 관련 무작위 배정 임상 시험에 대한 고찰 (A review of herbal medicines for chemotherapy induced peripheral neuropathy)

  • 박봉기
    • 대한암한의학회지
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    • 제21권2호
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    • pp.51-61
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    • 2016
  • Background : Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients who were exposed to chemotherapy. CIPN impacts on the quality of life and could delay chemotherapy. The aim of this review was to assess the therapeutic effectiveness of herbal medicine in CIPN patients. Methods : Randomized controlled trials (RCTs) were included in this review. We searched MEDLINE, Cochrane database, EMBASE, CNKI, Wanfang and four Korean databases without restrictions on time or language. The risk of bias was assessed using the Cochrane risk of bias tool. Results : Eleven RCTs involving 706 patients met the inclusion criteria. Eleven different herbal medicines were examined in the included trials. Almost RCTs showed insufficiency in the reporting randomization method and allocation concealment. One trial used allocation concealment and a double-blinding method. Five studies reported that participants dropped out of RCTs and conducted an 'as-treated analysis'. One trials reported adverse effects of herbal medicine. In ten of the eleven trials, the use of herbal medicine had shown significant differences in clinical symptoms or nerve conduction velocity. Conclusions : The use of herbal medicines for CIPN showed significant improvements in the management of CIPN. However, conclusions cannot be drawn because of the generally low quality of methodology and low quantity of data for each single herbal medicine. Further rigorous trials are needed.