• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.57-69
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• 2008

Objectives : To review the controlling methods used in RCTs (randomized controlled trials) of auricular acupuncture. Methods : To investigate the controlling methods used in clinical trials of auricular acupuncture, 46 articles were retrieved from PUBMED (from August 1976 to August 2007, with limits: english, clinical trial) using the key words of "ear acupuncture", "auricular acupuncture", "auriculo-medicine", and sorted out according to the types of control treatments. Among them, 10 articles were selected based on STRICTA (Standards for Reporting Intervention in Controlled Trials of Acupuncture), and the controlling methods used in those articles were reviewed. Results : In clinical trials of auricular acupuncture, 'sham acupoints (non-acupoints and non-treatment acupoints included)', 'minimal acupuncture', 'pseudo-intervention', and 'placebo devices' have been used as controlling methods, but their 'inactivity' have been in question. To compensate the disadvantages of 'minimal acupuncture', and 'pseudo-intervention' control, placebo auricular acupuncture needles have been developed, although these needles didn't satisfy the conditions of 'blinding' and 'physical inactivity' simultaneously. Conclusions : Further researches on 'sham acupoints' and new development of 'placebo auricular acupuncture needles' are needed.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.4
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• pp.77-86
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• 2011

Objectives: This study aims to evaluate domestic clinical studies related to the exercise program targeting farmers. Methods: Five Korean databases were seamed for prospective clinical trials of exercise program targeting farmers from 2001 to August, 2011. Only studies conducted in Korean language were searched. Results: Thirteen clinical studies were included among 3374 studies searched. Six were observational studies, four were non-randomized controlled trials, and three were randomized controlled trials. All of included studies reported favorable effects of exercise group compared to baseline of controlled group. Conclusions: We found various mistake in the applications of statistical methodologies in the studies of exercise program targeting farmers. It is necessary for more randomized controlled trials to evaluate effect of exercise program target farmers.

• 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.

• Journal of Biomedical Engineering Research
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• v.45 no.2
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• pp.81-89
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• 2024

Purpose : This study conducted a systematic review and meta-analysis to evaluate the clinical effectiveness of laser acupuncture for each condition using information from laser acupuncture trials registered on clinicaltrials.gov from January 2013 to June 2023. Methods : We quantitatively and qualitatively analysed the results of 16 clinical trials of laser acupuncture whose research results were confirmed. A risk of bias assessment was also carried out to assess the quality of each clinical trial. Results : A meta-analysis including three clinical trials was conducted to evaluate the comparative effectiveness of laser acupuncture and sham laser acupuncture in reducing pain and found that the laser acupuncture group had a statistically significant reduction in pain compared with the sham laser acupuncture group. In addition, 11 of the 13 trials not included in the meta-analysis showed a positive effect of laser acupuncture. Conclusion : Although laser acupuncture has a long history of clinical use and a lot of research, there is still some scepticism due to the lack of a clear mechanism of action and inconsistent reports of clinical effectiveness. In addition, there is a significant lack of systematic reviews of clinical evidence for major disease specific, and ongoing research is needed to establish an objective evidence base for the clinical effectiveness of laser acupuncture.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.25 no.2
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• pp.49-60
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• 2012

Objective : Acupuncture has been used for treating eye disease for thousands of years but there are few evidence based medicine (EBM) for its use. This study is a review of Clinical trials related to the treatment of eye disease by acupuncture therapy. Methods : We referred a Pubmed site by using searching word of "eye, acupuncture" (Limits: 10 Year, Clinical Trials, Humans, English). Results : Eight journals with twelve papers were searched. Eight of these studies were randomized and ten trials of acupuncture treatments reported significant effect. On the topic of these clinical trials, five of them were about dry eyes, four about disorder of refraction, two about intraocular pressure and one about visual function. The result of clinical studies represented the significant cure rate. Conclusion : We found that RCTs about the acupucnture for eye diseases were more and more published. But their average impact factor was 2.16 and average modified Jadad score was 3.89, so there needs more qualifying studies.

• Communications for Statistical Applications and Methods
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• v.19 no.6
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• pp.877-884
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• 2012

Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

• Journal of Acupuncture Research
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• v.26 no.4
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• pp.11-18
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• 2009

Objectives : The objective of this review was to evaluate clinical trials of warming acupuncture for musculoskeletal pain diseases, to assess the methodologic quality of the trials and determine whether low-quality trials are associated with positive outcomes, to document adverse effects and to identify the effectiveness of the warming acupuncture. Methods : Seven databases and the Journal ZHONGGUO ZHENJIU(中國鍼灸) published between 2004－2008 were searched. Korean and Chinese randomized trials were evaluated for methodologic quality using the modified Jadad scale. Outcome measurements were pain, function and global improvement. The best-evidence synthesis was performed to determine the strength of evidence by control group. Results : Six clinical trials representing 564 patients with musculoskeletal pain diseases were identified. For pain and function, there was moderate evidence that warming acupuncture is more effective than manual acupuncture. For patient global assesment, there was limited evidence that warming acupuncture is more effective than manual acupuncture. However, for function, there was inconclusive evidence that warming acupuncture is more effective than acupuncture with TDP or western medicine or acupoint-injection treatment. Conclusions : The evidence suggests that warming acupuncture is more effective for musculoskeletal pain diseases than manual acupuncture, acupuncture with TDP, western medicine and acupoint-injection treatment. But the evidence is moderate to inclusive due to the low methodologic quality of the trials. Further clinical trials with high methodologic quality is required to investigate the effectiveness of warming acupuncture.

• Journal of the Korean Data and Information Science Society
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• v.19 no.4
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• pp.1429-1440
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• 2008

In a meta-analysis combining the results from different clinical trials, it is important to consider the possible heterogeneity in outcomes between trials. Such variations can be regarded as random effects. Thus, random-effect models such as HGLMs (hierarchical generalized linear models) are very useful. In this paper, we propose a HGLM framework for analyzing the binominal response data which may have variations in the odds-ratios between clinical trials. We also present the prediction intervals for random effects which are in practice useful to investigate the heterogeneity of the trial effects. The proposed method is illustrated with a real-data set on 22 trials about respiratory tract infections. We further demonstrate that an appropriate HGLM can be confirmed via model-selection criteria.

• Korean Journal of Acupuncture
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• v.30 no.4
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• pp.201-211
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• 2013

Objectives : The aim of this study is to summarize and compare acupuncture points used for dental disorder in the classics with those used in recent clinical trials. Methods : We searched the data for acupuncture points used and rationale of acupuncture in dentistry. Following two sources were searched: 1) seven Classics of traditional medicine and 2) clinical trials through Pubmed from January 2000 to March 2013 with no language restriction. Results : Dental pain was the most common disorder in the dentistry section of the Classics of traditional medicine. We found many similarities of acupuncture points used between literatures and clinical trials. From the meridian perspective, large intestine meridian(LI), stomach meridian(ST), triple energizer meridian(TE), and gallbladder meridian(GB) were frequently used in the Classics of traditional medicine and the clinical trials. From the acupuncture point perspective, acupuncture points were selected according to syndrome. The specific points such as five transport points, source points, and connecting points were also used. In the clinical trials, combination of acupuncture points usually consisted adjacent points and distant points. Among them, LI4 was used in all of the studies included in this review. Conclusions : For well-designed clinical trial, appropriate intervention is essential. To establish appropriate acupuncture treatment, we have to suggest reasoning for treatment based on literature and/or expert consensus. Our review only focused on pain relief in dentistry and had many limitations. Further studies based on the literatures such as the Classics of traditional medicine are required to ensure the rationale of acupuncture treatments in various dental disorders.

• Korean Journal of Acupuncture
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• v.38 no.4
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• pp.222-234
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• 2021

Objectives : The purpose of this study is to examine the efficacy of fire needling and warm needling for De Quervain Syndrome by reviewing clinical studies for recent 10 years. Methods : Randomized controlled trials, non-randomized controlled trials, and case series containing more than 20 cases about fire needling and warm needling for De Quervain Syndrome published since 2011 were searched through four foreign online databases (CNKI, Pubmed, EMBASE, Cochrane Library) and five Korean online databases (OASIS, Science ON, DBPIA, KISS, RISS). The number and characteristics of participants, treatment points and main treatment methods involving other combination treatments, treatment cycle or total periods of treatments, evaluation indices, efficacy, and adverse events were analyzed. Risk of bias of included randomized clinical trials was assessed using a revised tool for assessing risk of bias in randomized trials (RoB 2). Results : A total of 6 randomized clinical trials and 2 case series involving 471 participants were included. Tender point or 'Ashi point' was the most commonly used treatment point, followed by LU4. Treatment frequency ranged from once a day to once a week. One to three outcome measures were used to evaluate the results of the studies, with the efficacy rate the most frequently used, followed by visual analogue scale. Overall risk of bias of all included randomized clinical trials was judged to have some concerns. Conclusions : All selected studies showed that fire needling and warm needling treatments for De Quervain syndrome were more effective than other clinical methods or acupuncture treatments. However, as the number of clinical studies is still too small and the risk of bias of the studies is not low, it is believed that more systematic and objective studies should be conducted.