• 제목/요약/키워드: Randomized Control Trials

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고혈압 환자를 대상으로 한 기공운동 임상연구 방법론 고찰 (Review of Clinical Trials Using Qigong Exercise on Patients with Hypertension)

  • 정희정;박지은;류연;최선미
    • Korean Journal of Acupuncture
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    • 제28권3호
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    • pp.177-186
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    • 2011
  • Objectives : The aim of this study is to review clinical trials using Qigong exercise on patients with hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of Qigong exercise were performed in 21 electronic databases (5 international databases and 16 Korean databases). English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of 11 studies met the inclusion criteria. Five randomized controlled trials, Four non-randomized trials and two before-after studies were included. Seven studies used self-developed Qigong exercise. Two studies used Guolin Qigong exercise and two studies used Qigong exercise with an anti-hypertension drug. Of the nine randomized trials or non-randomized trials, four studies used an anti-hypertension drug control and three studies used waiting list controls. Compared to baseline, a change in blood pressure after the Qigong exercise treatment was significant in all studies. However, the results effect of blood pressure between Qigong exercise and controlled trials were not consistent. Conclusions : There are low-quality clinical trials of Qigong exercise for hypertension. To evaluate the effects of Qigong exercise, more rigorous trials are warranted.

한약제제 무작위 대조군 연구에서 대조군 설계의 문제점과 대안 (Problems and Countermeasures of Control Group Design in Randomized Controlled Trials of Herbal Medicine)

  • 윤영희;최인화
    • 한방안이비인후피부과학회지
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    • 제21권2호
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    • pp.94-101
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    • 2008
  • Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

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임상연구에서 나타난 고혈압 뜸치료법에 대한 고찰 (Review of Moxibustion Treatment for Hypertension in Clinical Trials)

  • 류연;박지은;김애란;정희정;최선미
    • Journal of Acupuncture Research
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    • 제28권5호
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    • pp.87-96
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    • 2011
  • Objectives : The aim of this study is to review clinical trials using moxibustion on hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of moxibustion were performed in nine electronic databases (four international databases and five Korean databases) and handsearch. English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of twelve studies met the inclusion criteria. Seven randomized controlled trial, three non-randomized trials and two before-after studies were included. Seven studies used direct moxibustion(two are scarring one) and five used indirect one. Five of twelve studies used moxibustion treatment just one time, except for that most frequency was once daily or 2-3 times per week for 1-2 months. Of ten randomized or non-randomized studies, three used antihypertension drug control and another three used waiting list control. Compare to baseline, change of blood pressure after moxibustion treatment was significant in all studies. However, the results of effect in blood pressure between moxibustion and controlled were not consistent. Methodological quality of clinical trials included in this review was low and has risk of bias, especially in blinding of parcitipant. Conclusions : There are little high-quality clinical trials of moxibustion for hypertension. To evaluate the effect of moxibustion, more rigorous trials are warranted. Also, methodology of clinical trials have to be descripted in detail.

화상의 침 치료에 대한 체계적 문헌고찰 (Acupuncture for the Treatment of Burns: A Systematic Review of Randomized Controlled Trials and Case Controlled Trials)

  • 이지은;정서윤;최유민;정민정
    • 대한한방소아과학회지
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    • 제31권4호
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    • pp.19-30
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    • 2017
  • Objectives The study was conducted to evaluate the acupuncture treatment for burns by reviewing international randomized controlled studies and case controlled studies. Methods In the review, ten academic literature archives; NDSL, OASIS, PubMed, Cochrane library, CNKI, WANFANG, CINAHL, J-STAGE, CiNii, and EMBASE were used as the main databases to search for the randomized controlled trials or the case controlled trials about acupuncture treatment of burns using the keywords "burns AND acupuncture", "burn AND acupuncture", and "scald AND acupuncture". Results Initially, a total of 852 studies were founded except duplicate studies. 801 studies were excluded after screening of title and abstract. After reviewing 51 papers, a total of four randomized controlled trials and two case controlled trials were selected. These studies were analyzed by year, subjects, treatment intervention, evaluation criteria, treatment effect, adverse events, and 'Risk of Bias' assessment for randomized studies and non-randomized studies. From the six papers out of 51 papers those were reviewed, patients with burns were divided into two groups. The experimental group received acupuncture treatment, while the control group did not. The results of the completed studies have shown that the experimental group receiving acupuncture treatment demonstrated significant improvement compared to the control group, and there was no serious adverse events. Conclusions According to some of the studies, acupuncture in burn treatment is worth to try. However, additional well-designed randomized controlled studies will be required to justify the effectiveness of acupuncture treatment of burns.

만성 요로감염의 한약 치료에 관한 무작위 대조군 임상 연구 분석 (Review of Randomized Controlled Trials of Korean Medicine for Chronic Urinary Tract Infections)

  • 이지원;김동철
    • 대한한방부인과학회지
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    • 제33권4호
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    • pp.113-126
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    • 2020
  • Objectives: This study aimed to review randomized controlled trials on the effectiveness of korean medicine for chronic urinary tract infections. Methods: We analyzed the randomized controlled trials that intervented korean medicine treatment on chronic urinary tract infections retrieved using seven databases. Literature search was conducted on August 10, 2020. Results: Of the 188 studies searched, 8 studies were finally selected. In all studies, the treatment group was treated with korean medicine and the control group was treated with western medicine. Although the evaluation index was different for each study, all the indexes in the treatment group were significantly improved compared to the control group. Conclusions: Korean medicine treatment for chronic urinary tract infections had a significant effect compared to the western medicine treatment. Further high quality randomized controlled trials should be carried out to verify the strong evidence and safety of herbal medicine treatment.

상지말초신경손상에 대한 침술치료의 효과: 체계적 문헌고찰 (Acupuncture for Upper Extremity Peripheral Nerve Injury: A Systematic Review)

  • 김영준;김태령;우창훈;신병철
    • 한방재활의학과학회지
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    • 제28권2호
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    • pp.73-82
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    • 2018
  • Objectives The purpose of this study is to systematically explore the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury and to review the methodology of clinical trials. Methods We searched 9 electronic databases(3 international, 1 Chinese, 5 Korean) including English, Korean and Chinese, up to December 2017 for randomized controlled trials which evaluated the effects of the acupuncture in patients with upper extremity peripheral nerve injury. We abstracted the designs of the randomized clinical trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). Results A total of 8 papers were reviewed. All randomized clinical trials were conducted in China. Of them, five studies(62.5%) were electro-acupuncture as intervention. All randomized clinical trials reported favorable effects of acupuncture treatments compared to baseline or control group with outcomes of efficacy rate. However risk of bias seemed high. LI4, LI11, SI3, PC3, PC6 were most frequently used for acupoints to treat upper extremity peripheral nerve injury. Conclusions These results suggest that it is recommended to develop more detailed reporting standards for acupuncture treatment method. In the future, well designed randomized clinical trials which evaluate the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury is highly needed.

회전근개 질환에 대한 침술 치료의 효과: 체계적 문헌 고찰 (Acupuncture Treatment for Rotator Cuff Disorder: A Systematic Review)

  • 최현민;한수연;황두리;강준혁
    • 한방재활의학과학회지
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    • 제28권4호
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    • pp.11-20
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    • 2018
  • Objectives To systematically explore the effects of acupuncture treatment for rotator cuff disorders and review the clinical trials. Methods We searched 9 electronic databases (PubMed, Cochrane central, Embase, China National Knowledge Infrastructure [CNKI], Korea Institute of Science and Technology Information [KISTI], National Digital Science Library [NDSL], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]) to find randomized controlled trials that used acupunture treatment for rotator cuff disorders. We assessed the designs of the randomized controlled trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). The methodological quality of randomized controlled trials were assessed using the Cochrane Risk of Bias (RoB) tool. Results Total 5 trials were reviewed. 4 out of 5 randomized clinical trials reported meaningful effects of acupuncture treatments compared to control group. However risk of bias seemed high. Conclusions Although the results suggest that acupuncture treatment has favorable effects for rotator cuff disorders, most of the studies included methodologically high risk of bias. Thus, well designed randomized clinical trials which evaluate the effects of acupuncture treatment for rotator cuff disorders should be encouraged.

지적장애의 침 치료에 대한 최신 임상연구 동향 - 중국 무작위 배정 임상연구를 중심으로 - (Recent Trends in Clinical Research of Acupuncture Treatment for Intellectual Disability - Focused on Chinese Randomized Controlled Trials -)

  • 김재현;박용석;이지홍;장규태
    • 대한한방소아과학회지
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    • 제35권4호
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    • pp.34-47
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    • 2021
  • Objectives The purpose of this study is to analyze the trend of recent randomized controlled trials (RCTs) which used acupuncture for the treatment of intellectual disability in China, and to evaluate the efficacy of the treatment. Methods The RCTs published from January 2017 to July 2021 were searched using China National Knowledge Infrastructure (CNKI). Then, those were analyzed by acupuncture treatment methods used and their results. Results A total of 18 randomized controlled trials were selected and analyzed. Most studies showed significantly higher Intelligence Quotient, Development Quotient, and a total effective rate in an acupuncture treatment group than those of the control group. The most used acupoints were EX-HN1 followed by Niesanzhen, Naosanzhen, Zhisanzhen, Shouzhizhen, GV20. Conclusions Based on the results of the analyzed randomized controlled trials, an acupuncture treatment has shown to be effective in the treatment of intellectual disability. However, additional well designed clinical trials are needed to solidify these findings.

산후신통의 한방 치료에 대한 무작위대조군연구에 관한 고찰 (Review of Randomized Controlled Trials on Korean Traditional Medicine Treatment for Postpartum Pain)

  • 노은지;최수지;김동일
    • 대한한방부인과학회지
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    • 제33권2호
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    • pp.90-111
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    • 2020
  • Objectives: The purpose of this study was to analyze randomized controlled trials (RCTs) related to the effect and safety of Korean Traditional Medicine treatment for postpartum pain, and to suggest desirable future clinical research trend. Methods: Randomized controlled trials (RCTs) on postpartum pain were searched using domestic and foreign search engines to investigate the effect and safety of Korean Traditional Medicine on postpartum pain, and 12 studies were selected as a result. Results: There were 4 studies using Acupoint Therapy, 3 studies using Herbal Medicine, 3 studies using Using Acupoint Therapy and Herbal Medicine together, and 2 studies using Manipulative Therapy for postpartum pain. As control interventions, non-treatment, other Korean Traditional Medicine treatment, or Western medicine were used. All the studies reported a significant effect in experimental group compared to the control group, with no or minor side effects. Conclusions: Korean Traditional Medicine treatment showed effectiveness and safety for postpartum pain. In the future, it is necessary to eliminate the ambiguity of recruiting subjects and to study the most effective application method of Korean Traditional Medicine treatment for postpartum pain.