• Title/Summary/Keyword: Acupuncture randomized trial

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Research Trends in Evidence Based Medicine on Acupuncture -Randomized Controlled Trial- (침 관련 근거중심의학의 연구 동향 - Randomized Controlled Trial을 중심으로 -)

  • Lee, Ro-Min;Nam, Sang-Su;Lee, Sang-Hoon;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.26 no.2
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    • pp.147-158
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    • 2009
  • Objectives : The purpose of this study is to review the recent research trends of evidence based medicine, especially human randomized controlled trials on acupuncture. Methods : The articles were collected by retrieving the database of Pubmed and Journal of Korean Acupuncture & Moxibustion Society. The retrieving period was from October 2003 to September 2008, and the search term was 'acupuncture'. The articles were classified according to their publication journals, countries, publication years, targeted diseases, types of acupuncture and types of control. Results : In total, 558 articles in Pubmed and 35 articles in Journal of Korean Acupuncture & Moxibustion Society were searched. The number of articles on acupuncture research has increased with higher rate since 2000, but the Qualitative development has not achieved the same amplitude. Studies in Korea were insufficient both in Qualitative and Quantitative aspects. In countries, China had the most papers, and in targeted diseases, pain diseases were most dominant. In the types of acupuncture, classical acupuncture, and in the types of control, conventional western treatment showed the highest frequency. Conclusions: We need to do many-sided and more high Quality researches on acupuncture. For that, well-designed randornized trials are absolutely necessary.

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

  • Liu, Yan;Park, Ji-Eun;Kim, Ae-Ran;Jung, Hee-Jung;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.28 no.5
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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.

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

  • Lee, Jieun;Jeong, Seoyoon;Choi, Yoomin;Jeong, Minjeong
    • The Journal of Pediatrics of Korean Medicine
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    • v.31 no.4
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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.

Individualized Traditional Korean Acupuncture for Knee Osteoarthritis : a Protocol for a Randomized Controlled Trial

  • Byun, Hyuk;Baek, Seung-Tae;Park, In-Shik;Kim, Kap-Sung;Kim, Sun-Woong;Choi, Sun-Mi;Lee, Seung-Deok
    • The Journal of Korean Medicine
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    • v.27 no.4
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    • pp.225-232
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    • 2006
  • Objective : To test the hypotheses that individualized traditional Korean acupuncture improves pain and disability in patients with osteoarthritis of the knee and that benefits remain after stopping treatment more so than is the case for standardized minimal acupuncture. Design : Randomized single blind controlled trial with two intervention arms (individualized traditional Korean acupuncture, standardized minimal acupuncture) of six weeks' duration and three months follow-up. Setting : Acupuncture interventions were applied by two training doctors in the Department of Acupuncture and Moxibustion in a 1000-bed hospital. Assessment of the result was performed in a university-based laboratory. Participants : 50 patients with symptoms of knee osteoarthritis as diagnosed by an orthopedist. Intervention : Individualized traditional Korean acupuncture or standardized minimal acupuncture for six weeks. Main outcome measures: Primary outcome measure was pain as measured by the visual analogue scale. Secondary measures of pain and disability included the Western Ontario and McMaster Universities (WOMAC) index, Short Form-36 (SF-36), Lequesne Functional Index (LFI) score and Korean version of Health Assessment Questionnaire (KHAQ). Discussion : This paper presents detail on the rationale, design, methods and operational aspects of the trial.

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Safety and Effectiveness of Fluoroscopy-Guided Acupotomy for Carpal Tunnel Syndrome: Protocol for a Pilot Randomized, Patient-Assessor Blind, Parallel Clinical Trial

  • Yang, Muhack;Kim, Jae Kyoun;Park, Gun Woo;Cha, Eunhye;Jang, Jongwon;Seo, Jihye;Lee, Sangkwan;Kim, Sungchul
    • Journal of Acupuncture Research
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    • v.36 no.2
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    • pp.100-106
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    • 2019
  • Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.

Review of the Acupuncture Randomized Trials(ART) and the Acupuncture in Routine Care(ARC): the Acupuncture Trials in Germany (독일에서 수행된 대규모의 침 치료 임상연구 Acupuncture Randomized Trials와 the Acupuncture in Routine Care에 대한 고찰)

  • Han, Kuk In;Yoon, Ju Yeon;Jeong, Jin Su;Lee, Seung Ho;Jang, In Soo
    • Journal of Acupuncture Research
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    • v.30 no.5
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    • pp.117-123
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    • 2013
  • Objectives : The purpose is to review large-scale clinical researches, the acupuncture randomized trials(ART) and the acupuncture in routine care(ARC), concerning efficacy and effectiveness of acupuncture performed in Germany. Methods and Results : We have reviewed the studies that were searched by keyword 'acupuncture' as the title and'Witt CM' as one of the main authors in PubMed. Sixteen clinical reports focused on the ART and ARC studies were analyzed among all thirty six were searched. Six studies were related with the ART and eight were focused on the ARC, and other two were on both. Finally, across all researches except osteoarthritis of knee trials in the ART, compared the acupuncture group with the control were significantly improved. On the other hand, ARC showed that additional acupuncture plus routine care was more effective than routine care alone and the response to treatment of the non-randomized group did not differ the one of the randomized acupuncture group. Conclusions : The results may suggest that acupuncture treatment has obvious clinical effectiveness. These results are expected to inspire domestic research and clinical applications in Korea, and more rigorous research on the efficacy of acupuncture should be guaranteed.

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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Alternation of Topical Heat and Cold for Chronic Low Back Pain : A Randomized Controlled Pilot Trial

  • Choi, Young Doo;Jo, Su Jeong;Jung, Chan Yung;Kim, Kap Sung;Lee, Seung Deok
    • Journal of Acupuncture Research
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    • v.33 no.2
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    • pp.77-87
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    • 2016
  • Objectives : This is a pilot study for a large randomized controlled trial to investigate the efficacy and safety of a newly developed contrast therapy device-- alternating topical heat and cold -- for patients with chronic low back pain. The main objective of this study is to confirm the feasibility of the study design. Methods : The design was a randomized, 2-arm, parallel-group, single-blind, placebo controlled trial. Patients in each group received real or sham contrast therapy in an acupuncture point 10 times over four weeks. The primary outcome measure was pain intensity on a 100-mm visual analogue scale (VAS). The secondary outcomes were back-related dysfunction based on the Oswestry Disability Index (ODI), the Roland-Morris disability questionnaire (RMDQ), and range of motion of lumbar spine based on the modified Schober test (mSchober test), Finger-to-Floor distance (FTF distance), and Finger-to-Thigh distraction (FTT distraction). Results : A total of 30 subjects with chronic low back pain were randomly assigned to a contrast therapy group (n=15) or a sham group (n=15). A repeated-measures analysis of variance showed statistically significant group time interaction for VAS, RMDQ, mSchober test and FTF distance (p<0.05). The treatment group showed significant improvement in pain intensity and functional disability as compared to the sham group. Conclusion : Contrast therapy may be an effective and safe treatment for chronic low back pain.

Acupuncture Experience in Patients with Chronic Low Back Pain(2): A Qualitative Study - Focused on Participants in Randomized Controlled Trial (만성 요통 환자의 침 치료 경험(2): 질적 연구 - 무작위 대조군 연구 피험자를 대상으로)

  • Kim, Song-Yi;Lee, Kee-Byoung;Lee, Hyangsook;Son, Haeng-Mi;Song, Mi-Yeon;Lee, Hyejung;Park, Hi-Joon
    • Korean Journal of Acupuncture
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    • v.29 no.4
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    • pp.581-597
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    • 2012
  • Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

An Analysis of Clinical Trials for Understanding and Application of Pragmatic Clinical Trial (실용적 임상연구에 대한 이해와 적용을 위한 연구 사례 분석)

  • Yun, Young-Ju;Kang, Kyung-Won;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.26 no.5
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    • pp.105-116
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    • 2009
  • The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

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