• The Journal of Korean Medicine
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• v.33 no.1
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• pp.12-23
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• 2012

Objectives: This study evaluated clinical trials of acupuncture treatment for hypertension and to assess their methodology and results. Methods: Eight Korean databases and four international databases were searched for clinical trials of acupuncture treatment for hypertension up to June 2011. Study quality was assessed using the risk of bias (ROB) tool. Results: Twenty-four trials of acupuncture for hypertension were included. There were 14 randomized and 1 non-randomized controlled trials and 9 before-after studies. The most frequently used acupuncture points were zsnli (ST36), qch (LI11), fngch (GB20), snynjio (SP06), snjin (LI03) and hgu (LI04). In more than half of the studies, needle retention time was 20~30 minutes. Compared to baseline, change of blood pressure after treatment was significant in all studies. However, the results of effect on blood pressure between acupuncture and control were not consistent. Conclusions: There is insufficient evidence to suggest that acupuncture is an effective treatment for hypertension. Further well-designed clinical trials will be required to evaluate the effects and safety of acupuncture treatment for hypertension.

• 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.

• Quality Improvement in Health Care
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• v.2 no.1
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• Journal of Acupuncture Research
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• v.28 no.5
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• pp.29-38
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• 2011

Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

• Journal of Korean Medicine Rehabilitation
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• v.19 no.3
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• pp.33-46
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• 2009

Objectives : The objective of the study was to summarize randomized clinical trials(RCTs) that have assessed the effectiveness of herbal medicine on treatment of obesity and to propose better process of study. Methods : NLM Medline(pubmed), EMBASE, the Cochrane library, Science Direct, EBSCO, 4 Korean medical databases were systematically searched and 4 Korean medical journals were manually searched for clinical trials investigating the efficacy of herbal medicines on treatment of overweight or obese people from 1998 to 2008. The methodological quality was assessed using a Jadad score and validity was assessed using Oxford Pain Validity Scale(OPVS). Results : 14 RCTs met all the inclusion criteria. The methodological and ethical quality of the trials was generally low. The mean score by Jadad was 2.6 and the mean score of validity was 11.2. Complex herbal medicine was used in 8 RCTs and single herbal medicine was used in 6 RCTs. Except 1 RCT, the other RCTs reported positive effects of herbal medicine on treatment of obesity. Herbal medicines didn't seem to affect toxicity. In general adverse events relevant with the therapy were minor, but more than half of RCTs did not report about the safety or adverse events of herbal medicine, questioning their reliability. Conclusions : Although most RCTs concluded the efficacy and safety of herbal medicines on treatment of obesity, the quality of trials was low in general. Further rigorous clinical trials using complex herbal medicine should be performed.

• 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.

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• Journal of Acupuncture Research
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• v.22 no.2
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• pp.163-170
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• 2005

Background : Over the last thirty years, majority of researches on clinical effectiveness of acupuncture have been explanatory (or experimental) randomized controlled trial. The benefits of acupuncture in clinical trials are still controversial and most studies concluded that further control studies were required. Standardized combinations of acupuncture points for all the experimental subjects in various past studies have been criticized because such treatments do not reflect current routine clinical treatment. Objective : This paper aims to review pragmatic clinical trials on the effect of acupuncture treatment and to develop the ideal clinical research methodology of acupuncture study. Method : Clinical studies of acupuncture relevant with pragmatic or individualized trials were searched mainly in Pubmed and Science direct databases. All articles were fully reviewed by researchers, and data were evaluated by usage of a standardized form. Results & Suggestion : Pragmatic acupuncture researches were tried for various symptoms (eg. low back pain, hypertension, depression during pregnancy, sleep quality in HIV disease, chronic poststroke leg spasticity, headache, etc). Individualized acupuncture treatments based on oriental disease pattern diagnosis reflexes practical treatments which is more effective than unified and fixed acupuncture treatments without any theoretical basis of oriental medical philosophy. Conclusion : To overcome the controversies and limitations of past explanatory acupuncture trials, more individualized and tailored acupuncture trials with the theoretical basis of oriental medical diagnosis is highly recommended. Also clear definition and categorization of pattern identification should be established for further active clinical researches and applications of acupuncture.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.11 no.11
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• pp.4395-4403
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• 2010

The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.

• 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.