• The Journal of Korean Obstetrics and Gynecology
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• v.32 no.3
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• pp.214-226
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• 2019

Objectives: The purpose of this study is to review clinical studies of Traditional Chinese medicine (TCM) on Genito-Pelvic Pain/Penetration Disorder (GPPPD) in women. Methods: Key words "Dyspareunia", "Vaginismus" were searched on Chinese National Knowledge Infrastructure Database (CNKI) on April 21th 2019. Results: 2 case reports and 7 clinical trials were collected in accordance with the selection and exclusion criteria. Among the 7 trials, 4 were controlled trials, and 3 were single-arm trials. The types of intervention were herb medication in 8 studies, and compound TCM treatment including acupuncture, moxibustion, and cupping therapy in 1 study. All 4 controlled trials were about dyspareunia and conducted by herbal medicine of TCM. The study results and methods of intervention were analyzed. Conclusions: 2 case reports described the effectiveness of compound TCM treatments (acupuncture, moxibustion, cupping therapy) and herb medicine in dyspareunia. In 4 controlled trials, 2 trials described the effectiveness of herb medicine (oral or vaginal agent) compared to western treatment in dyspareunia, and other 2 trials described no effectiveness of herbal enema compared to danazol. In 3 single-arm trials, 1 trial of dyspareunia and 2 trials of vaginismus described the effectiveness of herb medicine. All the 9 selected studies reported improved or disappeared symptoms of GPPPD, or high effective rate after TCM treatment. There was limitation that the selected studies were retrieved from only one site of CNKI, and generalized results could not be derived, further studies should be carried out. Additional well-designed clinical studies on GPPPD in women are needed in Korea.

• Journal of Physiology & Pathology in Korean Medicine
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• v.26 no.2
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• pp.248-252
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• 2012

This study aimed to evaluate the perception of informed consent for subjects who are participated in oriental medicine clinical trials and over 60 years old. In this research, 215 subjects who were participated in clinical trials were surveyed between Apr. 13, 2011 and Jul. 20, 2011. And the collected data was analyzed with computer software of SPSS 17.0. In the case of objective perception, almost all of subjects answered that they have ever heard of the consent form. However, 50.7 points were collected for the question of "As I already signed the consent form, I have to participate in the clinical trials", which showed the subjects had misperception about quitting the clinical trials. In the case of subjective perception, subjects well knew that the purpose of clinical trial is research, not medical treatment. However, the perception about the purpose of clinical trials that they are participated in was low. In the both cases of objective and subjective perception with general characteristics, they showed differences (p<0.045) with the marital status of subjects, however other categories did not show any difference. In conclusion, researchers should provide sufficient explanation as well as adequate Information in order to protect the personality of subjects, so that the subjects can make a right decision.

• Journal of Korean Medicine for Obesity Research
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• v.11 no.1
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• pp.47-60
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• 2011

Objectives The objective of this study was to contribute to the development of pharmacupuncture for obesity treatment by reviewing the studies of pharmacupuncture experimentations and clinical trials. Methods We searched the papers with keywords of 'obesity' and 'pharmacupuncture' in the search site, RISS, Oriental medicine advanced searching integrated system(OASIS), Korean traditional knowledge portal, the society of Korean medicine for obesity research, Korean pharmacupuncture institute, the Korean academy of oriental rehabitation medicine and Korean acupuncture & moxibustion society. Results 1. We reviewed 37 articles searched. 27 articles(73.0%) were animal experimentations, 5 articles(13.5%) were cell experimentations, 4 articles(10.8%) were clinical trials and 1 article(2.7%) was study analysis. 2. The herbs, using for animal experimentations, were atratylodes japonica, coix lachrymajobi, ephedra sinica, crataegus pinnatifida, wild ginseng and etc. Acupucture points were joksamni(ST36), zhongwan(CV12), gansoo(BL18), pungnyung(ST40), umnungchon(SP9), bisu(BL20), gokji (LI11), cheun-chu(ST25) and etc. 3. For cell experimentations, preadipocytes and adipocytes performed on cell cultures with using rats, 3T3-L1 preadipocytes and porcine skin including fat tissue were treated with fel ursi, bovis calculus, ephedrae herba, spirodelae herba, wild ginseng. 4. For clinical trials, Sangsik no.1, Bigiheo, ephedra, green tea and sweet bee venom were injected at the region where a lot of fat like zhongwan(CV12), xiawan(CV10), kwanwon(CV4), cheun-chu(ST25) and thigh. Conclusion Through animal and cell experimentations and clinical trials, the treatment of obesity using local acupuncture therapy was effective. For clinical use, however, it is considered that animal and cell experimentation and clinical trial's connection using one kind of herb and studies about more clinical trials and associated side effects are needed.

• 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.

• The Journal of Korean Medicine
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• v.26 no.2 s.62
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• pp.85-94
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• 2005

Objectives: This study was carried out to estimate the demand for clinical trials and contribute to the consolidation of function and role in the clinical trial centers of oriental medicine. Methods: A survey of the demand was made of 379 faculties of oriental medicine in 11 oriental medical colleges throughout the country using two?part investigations by e-mail questionnaire over 1 month. The final data from 56 faculties were analyzed. Results: Clinical trials of oriental medicine have been continuously increasing. Furthermore, the demand and necessity for clinical trials of oriental medicine have also been continuously enhanced. Although there were arguments for and against the establishment of a clinical trial center for oriental medicine, the demand and necessity for the establishment was the overall consensus. Concerning objections, a high intention of use was observed. Conclusions: These results imply that the demand for clinical trials will increase remarkably through the establishment of a clinical trial center for oriental medicine. Further study is needed about the demand for such a center.

• The Journal of Korean Medicine
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• v.38 no.1
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• pp.93-111
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• 2017

Objectives: The aim of this study is to make evidence-based data for developing a traditional Korean medicine clinical practice guideline for acute bronchitis. Methods: We searched 3 international databases(PubMed, EMBASE, CENTRAL) and 7 domestic databases (KoreaMed, Kmbase, NDSL, KISS, KISTI, OASIS, KoreaTK) to identify randomized controlled trials (RCTs) of acute bronchitis using medicine in recent 10 years. The chosen trials were analyzed by their study design, age range, intervention group, control group, primary and second outcome measure, inclusion and exclusion of participants and adverse events. Results: 15 RCTs are finally included in this study and most of their medications are herbal medicine. For diagnosis and outcome measure of acute bronchitis, Bronchitis Severity Score(BSS) was mostly used. Other measurements eligible are coughing fits, quality of life scale, sputum viscosity, change of individual symptoms and patient's satisfaction. Test duration was for average 7days and safety assessment was held by recording adverse events. Except for anti-inflammatory and antibiotic trials, all medications are found to be effective and well-tolerated. General risk of bias of chosen trials is evaluated low. Conclusions: A well designed clinical trials for traditional Korean medicine of acute bronchitis is needed and this study is expected to make it available.

• Journal of Korean Medicine Rehabilitation
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• v.28 no.2
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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.

• Journal of Korean society of Dental Hygiene
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• v.14 no.6
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• pp.839-847
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• 2014

Objectives: The purpose of the study was to investigate the perception of clinical trials of dental hygienist. Methods: A self-reported questionnaire was filled out by 126 dental hygienists in Seoul, Kyonggi and other area from October 1 to November 15, 2012. The instrument of the study was adapted from Jung and reconstructed. The questionnaire consisted of general characteristics of the subjects(9 questions) and recognition for clinical trials(10 questions). Recognition for clinical trials instrument included recognition for clinical trial conception(2 questions), objective recognition(5 questions), and subjective recognition for clinical trial(3 questions). The instrument was score by Likert 5 scale and Cronbach alpha was 0.936 in the study. Data were analyzed by SPSS 20.0 program and set at p<0.05. Independent t-test, chi-square test, one way ANOVA, and post-hoc Duncan test were done. Results: Those who had higher ages and higher education tended to have longer clinical careers(p<0.05). There was a significant difference in clinical trials between the level of education, clinical dental hygienists and professors. The differences in problem perception for activation of clinical trial according to workplace appeared to lack of publicity and inadequacy of facilities(p<0.05). Conclusions: To improve the perception of the clinical trials in dental hygienists, it is necessary to prepare the human resources programs, the additional curricula, continuing education courses and active publicity.

• 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.