• Title/Summary/Keyword: double-blinding

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

  • Kim, Kyung-Tae;Song, Ho-Sueb
    • Journal of Acupuncture Research
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    • v.22 no.4
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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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The Effectiveness of Bee Venom Acupuncture Therapy on the Treatment of Sprain of L-spine(A Randomized Controlled Trial; Double Blinding) (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))

  • Kim, Kyung-Tae;Song, Ho-Sueb
    • Journal of Acupuncture Research
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    • v.22 no.4
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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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Randomized Clinical Controlled Trials with Herbal Acupuncture (Pharmacopuncture) in Korea - A Systematic Review (무작위 배정 비교 임상 시험을 통한 국내의 약침 연구에 대한 체계적 고찰)

  • Park, Bong-Ky;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.30 no.5
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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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A Study on the Methodology for a Clinical Trial of an Antidepressive Korean Herb by Comparison with St. John's Wort Trials (성요한초제제 임상시험 고찰을 통한 한약기원 항우울제 임상시험 방법론 연구)

  • Jung, Hee;Lee, Ji-Hyung;Jang, Bo-Hyoung;Ko, Seong-Gyu
    • The Journal of Internal Korean Medicine
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    • v.28 no.2
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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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    • 1994.02b
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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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A Combined Random Scalar Multiplication Algorithm Resistant to Power Analysis on Elliptic Curves (전력분석 공격에 대응하는 타원곡선 상의 결합 난수 스칼라 곱셈 알고리즘)

  • Jung, Seok Won
    • Journal of Internet of Things and Convergence
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    • v.6 no.2
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    • pp.25-29
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    • 2020
  • The elliptic curve crypto-algorithm is widely used in authentication for IoT environment, since it has small key size and low communication overhead compare to the RSA public key algorithm. If the scalar multiplication, a core operation of the elliptic curve crypto-algorithm, is not implemented securely, attackers can find the secret key to use simple power analysis or differential power analysis. In this paper, an elliptic curve scalar multiplication algorithm using a randomized scalar and an elliptic curve point blinding is suggested. It is resistant to power analysis but does not significantly reduce efficiency. Given a random r and an elliptic curve random point R, the elliptic scalar multiplication kP = u(P+R)-vR is calculated by using the regular variant Shamir's double ladder algorithm, where l+20-bit u≡rn+k(modn) and v≡rn-k(modn) using 2lP=∓cP for the case of the order n=2l±c.

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

  • Lee, Jin Hyung
    • Journal of Music and Human Behavior
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    • v.10 no.2
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    • pp.1-33
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    • 2013
  • The aim of this study was to systematically review the latest clinical trials in music medicine and medical music therapy for pediatric patients. Thirteen databases were searched to obtain randomized controlled/crossover design studies published between the year 2000 and 2012 in English language. Out of 1012 articles retrieved in the initial search, fifteen studies were identified based on an exclusion criteria. Overall, selected articles involved children 1 month to 18 years, sample size of 11 to 150, and total participants of 987. Studies were classified and compared as music medicine or music therapy studies through a systematic synthesis assessing general characteristics, methodological quality, measured outcomes, types of interventions and the study results. Seven music medicine and eight music therapy studies measured seven dependent variables using thirty-six different measurement tools with a large heterogeneity in the selection, type, and method of music interventions. Evaluation of the methodological quality revealed that many studies did not provide a full report of the research method, and did not meet some or most methodological standards, such as randomization, allocation concealment, double or partial blinding, and intention to treat analysis. Although overall research results were positive if not significant, poor methodological quality and heterogeneity in design and intervention strategies raise the question of research bias and trustworthiness issues. The systematic review concluded that music may have a valuable clinical effect in addressing the physical and psychosocial needs of hospitalized children, although more rigorous, homogeneous and replicable studies are greatly needed.

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.

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

  • Park, Bong-Ky;Wang, Jing-Hua;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.5
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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.

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

  • Park, Bongki
    • Journal of Korean Traditional Oncology
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    • v.21 no.2
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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.