• 제목/요약/키워드: double-blinding

검색결과 18건 처리시간 0.026초

급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검 (The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study)

  • 송호섭
    • 대한약침학회지
    • /
    • 제8권2호
    • /
    • pp.11-16
    • /
    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

범불안장애의 중의학 약물 임상시험 최신 동향 (The Recent Trends of Clinical Research on General Anxiety Disorder in Chinese Herbal Medicine)

  • 노동진;이상룡;정인철
    • 동의신경정신과학회지
    • /
    • 제20권4호
    • /
    • pp.79-89
    • /
    • 2009
  • Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

  • PDF

국내 한약 처방을 이용한 무작위 배정 임상연구논문의 질 평가 (Quality Assessment of Randomized Controlled Trials using Herbal Remedies in Korea)

  • 김윤영;유종향;이수경;이시우
    • 동의생리병리학회지
    • /
    • 제25권5호
    • /
    • pp.927-933
    • /
    • 2011
  • This study aimed to evaluate the quality of herbal medicine-related RCT (Randomized controlled clinical trial) papers. 79 papers were searched from the domestic Hakjin paper list, and 16 papers of them were evaluated in terms of the Jadad Quality Assessment Scale and the adequacy of allocation concealment, and ethical validity. The evaluation results from Jadad Quality Assessment Scale showed that 15 papers showed high quality with the Jadad score of 3 points or higher, and none of the papers had a problem with randomization and double-blinding. The evaluation results from adequacy of allocation concealment showed that 3 of the papers were executed proper allocation concealment, and all of them had 5 points of Jadad score. IRB (Institutional Review Board) approval and written consent was investigated for the evaluation of ethical validity, and 12 papers had the IRB approval, and 14 papers had written consent. The papers published before 2005 were absent of IRB approval and written consent, and none of the papers had IRB approval number. From the above results, it is concluded that rigorous clinical research led high quality of research papers, and the ethical aspect of clinical researches are getting more important to protect the rights of research participants.

요각통 환자에 대한 Bee Venom과 Sweet Bee Venom의 효능 비교 연구 (The Comparison of Effectiveness between Bee Venom and Sweet Bee Venom Therapy on Low back pain with Radiating pain.)

  • 이태호;황희상;장소영;차정호;정기훈;노정두;이은용
    • 대한약침학회지
    • /
    • 제10권3호
    • /
    • pp.85-89
    • /
    • 2007
  • Objective The aim of this study is to investigate if Sweet Bee Venom therapy has the equal effect in comparison with Bee Venom Therapy on Low back pain with Radiation pain. Methods Clinical studies were done 24 patients who were treated low back pain with radiation pain to Dept. of Acupuncture & Moxibusition, of Oriental Medicine Se-Myung University from April 1, 2007 to September 30, 2007. Subjects were randomly divided into two groups ; Bee Venom treated group(Group A, n=10), Sweet Bee Venom treatred group(Group B, n=14). In Bee Venom treated group(Group A), we treated patients with dry needle acupuncture and Bee Venom therapy. In Sweet Bee Venom treatred group(Group B), we treated patients with dry needle acupuncture and Sweet Bee Venom therapy. All process of treatment were performed by double blinding method. To estimate the efficacy of controlling pain. we checked Visual Analog Scale(VAS). For evaluating functional change of patients, Straight Leg Raising Test(S.L.R.T) was measured. Results 1. In controlling pain, Sweet Bee Venom treatred group(Group B) had similar ability in comparison with Bee Venom treated group(Group A). 2. In promoting function, Sweet Bee Venom treatred group(Group B) had similar ability in comparison with Bee Venom treated group(Group A). Conclusions It may be equal effects as compared with using Bee Venom to treat low back pain with radiation pain using Sweet Bee Venom. We can try to treat other disease known to have effect with Bee Venom.

말초성 안면신경마비에 대한 약침병행치료 효능의 임상적 고찰 - 자하거 약침과 Sweet Bee Venom을 중심으로 - (The Clinical Research of the Effectiveness of Pharmacopuncture Complex Therapy on Peripheral Facial Paralysis - Hominis Placenta Pharmacopuncture Therapy and Sweet Bee Venom Therapy -)

  • 박재흥;장선희;이창환;구지영;전대성;안창범;김철홍;송춘호;윤현민
    • Journal of Acupuncture Research
    • /
    • 제27권2호
    • /
    • pp.79-87
    • /
    • 2010
  • Objectives : The aim of this study is to investigate the effect of Hominis Placenta pharmacopuncture therapy and sweet bee venom therapy on peripheral facial paralysis. Methods : Clinical studies were done 36 patients who were treated peripheral facial paralysis to Dept. of Acupuncture and Moxibusition, of Oriental Medicine Dong-Eui University from June 15, 2009 to January 5, 2010. Subjects were randomly divided into 2 groups. : Hominis Placenta Pharmacopuncture treated group (group A, n=18), sweet bee venom treated group (group B, n=18). In group A, we treated patients with dry needle acupuncture and Hominis Placenta pharmacopuncture therapy. In group B, we treated patients with dry needle acupuncture and sweet bee venom therapy. All process of treatment were performed by double blinding method. To investigate the effectiveness of treatment applied for two groups, we used Yanagihara's unweighed grading system at before treatment, after 1week, 2weeks, 3weeks and 4weeks of treatment. Results : The Yanagihara's scores of group B were higher than those of group A, but not statistically significant. The improvement indexs of group A and group B were different, but not statistically significant. Conclusions : There were no significant differences statistically between Hominis Placenta pharmacopuncture therapy and sweet bee venom therapy on peripheral facial paralysis.

초기 말초성 안면신경마비에 대한 단무지 안추 신전법 병행 치료 효능의 임상적 고찰 (The Clinical Research of the Effectiveness of "Danmuji Anchu Traction technique" on Acute Peripheral Facial Paralysis)

  • 박재흥;이창환;이유환;권기순;윤현민;전대성;한민석
    • 척추신경추나의학회지
    • /
    • 제6권1호
    • /
    • pp.43-52
    • /
    • 2011
  • Objectives : The aim of this study is to investigate the effectiveness of combining "Danmuji Anchu Traction technique" on acute peripheral facial paralysis. Methods : Clinical studies were done 36 patients who were treated acute peripheral facial paralysis to Dept. of Acupuncture and Moxibustion, of Oriental Medicine Hospital Dongeui University from July 10, 2009 to September 15, 2010. subjects were randomly divided into 2 groups. : Complex oriental medical treatment without "Danmuji Anchu Traction technique" treated group (Group A, n=18), Complex oriental medical treatment with "Danmuji Anchu Traction technique" treated group (Group B, n=18). All process of treatment were performed by double blinding method. To compare the effectiveness of treatment applied for two groups, we used Yanagihara's unweighed grading system at before treatment, after 1week and 2weeks of treatment. Results: The Yanagihara's Scores of Group B and Improvement Indexes of Group B were higher than those of Group A, and showed significant difference statistically. "Danmuji Anchu Traction technique" can be available for relieving symptoms related with Acute Peripheral Facial Paralysis. And there were significant differences statistically between Complex oriental medical treatment without "Danmuji Anchu Traction technique" and Complex oriental medical treatment with "Danmuji Anchu Traction technique" on Acute Peripheral Facial Paralysis. Conclusions: These results suggested that "Danmuji Anchu Traction technique" effected for Acute Peripheral Facial Paralysis.

  • PDF

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
    • /
    • 제20권2호
    • /
    • pp.163-176
    • /
    • 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.

  • PDF

만성요통환자에 대한 Bee Venom과 Sweet Bee Venom의 치료효능 비교 연구 (The comparison of Effectiveness between Bee Venom and Sweet Bee Venom Therapy on Chronic Lower Back Pain.)

  • 김재홍;장선희;윤현민;안창범;장경전;김철홍;송춘호;최하나
    • 대한약침학회지
    • /
    • 제11권4호
    • /
    • pp.15-24
    • /
    • 2008
  • Objective The aim of this study is to investigate if Sweet Bee Venom(SBV) Therapy has the equal effect in comparison with Bee Venom (BV) Therapy on Chronic Lower Back Pain. Methods Clinical studies were conducted to 39 patients who were treated Chronic Lower Back Pain in Dept. of Acupuncture and Moxibustion, Dongeui University from March 1 to June 30, 2008. Subjects were randomly devided into 2 groups : BV treated group(Group A, n=19), SBV treated group(Group B, n=20) In BV treated group(Group A), we treated patients with dry needle acupuncture and BV Therapy. In SBV treated group(Group B), we treated patients with dry needle acupuncture and SBV Therapy. All process of treatment were performed by double blinding method. 1. To estimate the efficacy of venom in controlling pain, we have checked Visual Analog Scale(VAS). 2. For evaluating functional changes of patients, we have checked Oswestry Lower Back Disability Questionnaire(ODI). 3. To estimate Itching which is the most prominent symptom of allergic reaction, we have checked Visual Analog Scale(VAS). Results 1. In controlling pain, the results of BV treated group(Group A) is more effective than that of SBV treated group(Group B). 2. In promoting function, the results of BV treated group (Group A) is more effective than that of SBV treated group(Group B). 3. In controlling itching, the results of SBV treated group(Group B) is more effective than that of BV treated group(Group A). Conclusions According to the study, SBV Therapy shows more effective result than BV Therapy in controlling itching. But BV Therapy is more effective than SBV Therapy in controlling pain and promoting function.