• Journal of Acupuncture Research
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• 제26권5호
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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.

• Journal of Acupuncture Research
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• 제22권2호
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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.

• Korean Journal of Acupuncture
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• 제31권4호
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• pp.158-167
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• 2014

Objectives : The results from randomized controlled trials on traditional medicine have been negative or ambiguous. The appropriateness of the research methodology started to be questioned. However, the research methodology appropriate for studying traditional medicine has not been well-established. This study aims to explore the appropriate research methodologies for clinical studies on acupuncture. Methods : Clinical researches evaluating the efficacy and effectiveness of acupuncture for back pain were systematically searched and evaluated focusing on research methodology. The acupuncture treatment protocol is evaluated by 9 items which is individual treatment based on diagnosis, combining proximal and distal acupoints, exact location of acupoint, De Qi, adequate stimulation, duration of acupuncture, treatment sessions, treatment interval, and establishing relationship between patients and doctors. Results : Systematic review of acupuncture researches on low back pain suggested that observational studies and pragmatic trials rather than explanatory studies could incorporate these elements. Qualitative studies also could help understanding complex characteristics of acupuncture treatment which could not be evaluated by quantitative studies. Conclusions : In designing clinical researches on acupuncture, various study designs, especially observational study and pragmatic study, should be considered according to research objectives and subjects. The efforts to incorporate the core characteristics of acupuncture practiced in everyday clinical setting are also essential.

• Journal of Acupuncture Research
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• 제41권2호
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• pp.107-114
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• 2024

Background: Low back pain (LBP) is a common musculoskeletal disorder worldwide, with a lifetime prevalence of up to 80%. Among nonsurgical treatments for chronic LBP, Korean medicine treatments are highly preferred, and pharmacopuncture therapy combining acupuncture and herbal medicine is widely used. However, no evidence-based study has focused on the use of various types of pharmacopuncture. Methods: The pragmatic randomized controlled clinical trial will include 44 participants; recruitment will start in July 2023. All participants will receive integrated Korean medicine treatment including acupuncture, cupping, and infrared therapy, and the intervention group will also receive pharmacopuncture. After 16 treatment sessions, twice a week for 8 weeks, follow-up assessments will be performed at week 9. As a pragmatic randomized controlled clinical protocol, the type, dose, and acupoints of acupuncture and pharmacopuncture are not determined in advance but are selected and recorded according to the clinical judgment of the Korean medicine doctor. Results: The primary outcome will be measured using a visual analog scale score, and the secondary outcomes include the Oswestry disability index, patient global impression of change, no worse than mild pain, and range of motion. Safety will be assessed by examining participants' self-reported adverse events and vital signs and conducting blood tests before and after the test. Conclusion: This study aims to provide clinical evidence of the effectiveness and safety of pharmacopuncture for chronic LBP.

• Journal of Acupuncture Research
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• 제23권1호
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• pp.187-215
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• 2006

Objectives : To determine whether the pragmatic acupuncture treatment provides more effective pain relief than treatment using the same acupuncture point to the all patients. Methods : We randomly allocated participants to treatment group 1 and 2. The group 1 is the pragmatic treatment group and the group 2 is using the same acupuncture point to the all patients. Primary outcomes were measured by the Western Ontario and McMaster Universities Osteoarthritis index(WOMAC) pain and function scores at 4, 8, and 14 weeks. Secondary outcomes were measured by 100mm VAS(Visual Analog Scale), ROM(Range of Motion) using Goniometer, and pain threshold using pressure algometer. Results : When patients were extension of the knee, they were statistically significant in improvement of the ROM in 14 weeks. Whole body condition and pain rate through VAS measurement were improved significantly in 14 weeks. Also pain score and function score of WOMAC were improved significantly in 14 weeks. We could get difference in pain score of two acupuncture groups significantly in 14 weeks. But we could not get difference in whole score of two acupuncture groups significantly. Local temperature using T.C thermometer was changed significantly in 14 weeks. But we could not get difference in whole score of two acupuncture groups significantly. Excluding above item, DITI, pain threshold, and ROM of the knee flexion were no difference in before and after treatment.

• Journal of Acupuncture Research
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• 제28권3호
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• pp.55-71
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• 2011

Objectives : The purposes of this preliminary study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture in treating urinary incontinence (UI) in premenopausal women with delivery history and the feasibility of performing the study procedures. We also tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving disease-specific quality of life. Methods : This study was a pragmatic randomized clinical trial. Subjects between the ages of 20 and 49 years were randomly assigned to a treatment(n=11) or control group(n=11) and analyzed. Both groups were supposed to do Kegel exercise at home during 4 weeks and acupuncture was applied to the treatment group twice a week(8 sessions) additionally. Subjects performed 1 hour pad test and completed a 3-day urination diary, international consultation on incontinence modular questionnaire(ICIQ), and incontinence - quality of life(I-QOL) at base line and 5 weeks. Results : Both group showed improvement in 1 hour pad test and the reducing amount of UI was significantly larger in treatment group(p=0.0182). The significant improvements in ICIQ and I-QOL were also observed in treatment group and sustained until the follow-up measurement at 16 weeks. Any adverse reaction related to acupuncture did not happen. Conclusions : It was feasible to recruit subjects and perform the study procedures. The positive results of this study support the requirement for additional research investigating the efficacy of acupuncture in the treatment of UI in women.

• 식품보건융합연구
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• 제4권2호
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• pp.13-16
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• 2018

Acupuncture has been clinically used to treat patients suffering from eye disease. It has been used in efforts to help preserve vision for those with a wide range of eye conditions including glaucoma and intraocular hypertension. High intraocular pressure (IOP) is usually associated with glaucoma and conventional treatment is focused on lowering IOP. Controlling this risk factor should help hasten the onset of glaucoma for those patents that are suspect or borderline candidates for glaucoma. In review of the limited scientific research there are not many studies that support conclusive evidence for the use of acupuncture on eye diseases and particularly glaucoma and ocular hypertension. For the information that does exist, diverse results from various interventions make it difficult to draw clear conclusions. The existing studies use different acupoints, techniques, frequencies, and durations. Individual treatment strategies according to the practitioner's subjective experience, patient condition, and the use of other complimentary and natural strategies is ideal for taking a more dynamic and wholistic approach to getting results. Until more pragmatic research models are funded and implemented, case reports can offer good examples of experiential and objective outcomes. This case report presents a 61 year old healthy female patient diagnosed with open-angle borderline glaucoma with elevated IOP. The patients IOP was successfully reduced with 12 treatments over three months using scalp electro-acupuncture and distal Master Tung points.

• 대한한방소아과학회지
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• 제25권3호
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• pp.1-11
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• 2011

Objectives: The purpose of this study is to investigate various treatments in other countries for nocturnal enuresis. We analyze the treatments on enuresis (within acupuncture, moxibustion, psychotherapy and chiropractic) and herb for 12 years (from 2000 to 2011). Methods: Databases include PubMed and Web of Science. To narrow the search, the following key search terms were used: 'enuresis, acupuncture', 'enuresis, moxibustion', 'enuresis, psychotherapy', 'enuresis, chiropractic' and 'enuresis, herb'. The search was limited to the publication date from 2000 to 2011. Results: There are 31 studies on enuresis treatment by using acupuncture, 3 on moxibustion, 91 on psychotherapy, and 8 on chiropractic. Among them, 27 studies on acupuncture, 3 on moxibustion, 86 on psychotherapy and 5 on chiropractic reveal that patients with enuresis benefit from the each treatment. Conclusions: In the future, various researches on acupoint are necessary. Especially, studies on enuresis by using psychotherapy and chiropractic are needed. With those efforts, treatments on enuresis will become more pragmatic and beneficial.

• Korean Journal of Acupuncture
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• 제35권4호
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• pp.174-186
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• 2018

Objectives : The aim of this survey was to investigate the general characteristics of sports injury patients in Korean medical institutions by Korean Medicine Doctors (KMDs) and the treatment patterns of Korean medicine for ankle sprain which is one of the common sports injuries. Methods : An online survey was conducted on KMDs interested in sports injuries to assess their experience and perception of sports injuries including diagnosis, intervention, and treatment plan for ankle sprain. Results : A total of 276 KMDs participated in the survey. They answered that 12% (median, range 0~80%) of patients visiting a Korean medical institution had sports injuries. Sports injuries frequently occur in the ankle, back, shoulder, knee, and elbow and the most common sports injury was sprain/strain. Many participants were aware that sports injuries should be treated differently from other musculoskeletal diseases in general. They reported that confirmation of fracture, swelling, and tenderness was essential to diagnose ankle sprains. Acupuncture was the most commonly used treatment and reported to need 2 to 6 weeks of treatment period, depending on the severity. Conclusions : Based on the findings regarding treatment of sports injury patients by KMDs, this study would be utilized as basic information for pragmatic clinical research design related to sports medicine in the future.

• Korean Journal of Acupuncture
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• 제30권1호
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• pp.21-26
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• 2013

Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.