• 한방재활의학과학회지
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• 제33권2호
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• pp.49-55
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• 2023

Objectives The purpose of this study is to analyze randomized controlled trials about neuromuscular electrical stimulation for muscle wasting with cancer patient and evaluate it's motor functionality effect. Methods Studies will be searched from 7 online databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure [CNKI], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]). Participants will be cancer patients with muscle loss, regardless of cause, gender, race or age, interventions will be neuromuscular electrical stimulation. Other treatments than interventions will be the control group and the main outcome will be reviewed by motor functionality effect. Results Randomized controlled trials about neuromuscular electrical stimulation for muscle wasting should be included in the study. Primary outcomes include motor functionality effect. Secondary outcomes evaluate adverse event. The data uses Review Manager Software 5.4. Conclusions The conclusion of this study will provide a basis for determining whether neuromuscular electrical stimulation treatment for muscle wasting with cancer patient treatment is an effective and safe treatment method in clinical practice.

• 대한한의학회지
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• 제31권1호
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• pp.122-129
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• 2010

Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

• Korean Journal of Acupuncture
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• 제28권3호
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• pp.177-186
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• 2011

Objectives : The aim of this study is to review clinical trials using Qigong exercise on patients with hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of Qigong exercise were performed in 21 electronic databases (5 international databases and 16 Korean databases). English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of 11 studies met the inclusion criteria. Five randomized controlled trials, Four non-randomized trials and two before-after studies were included. Seven studies used self-developed Qigong exercise. Two studies used Guolin Qigong exercise and two studies used Qigong exercise with an anti-hypertension drug. Of the nine randomized trials or non-randomized trials, four studies used an anti-hypertension drug control and three studies used waiting list controls. Compared to baseline, a change in blood pressure after the Qigong exercise treatment was significant in all studies. However, the results effect of blood pressure between Qigong exercise and controlled trials were not consistent. Conclusions : There are low-quality clinical trials of Qigong exercise for hypertension. To evaluate the effects of Qigong exercise, more rigorous trials are warranted.

• Journal of Gastric Cancer
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• 제12권1호
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• pp.7-12
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• 2012

More than ten years have passed since the sentinel node (SN) concept for gastric cancer surgery was first discussed. Less invasive modified surgical approaches based on the SN concept have already been put into practice for malignant melanoma and breast cancer, however the SN concept is not yet placed in a standard position in gastric cancer surgery even after two multi-institutional prospective clinical trials, the Japan Clinical Oncology Group trial (JCOG0302) and the Japanese Society for Sentinel Node Navigation Surgery (SNNS) trial. What is the problem in the clinical application of the SN concept to gastric cancer surgery? There is no doubt that we need reliable indicator(s) to determine with certainty the absence of metastasis in the lymph nodes in order to avoid unnecessary lymphadenectomy. There are several matters of debate in performing the actual procedure, such as the type of tracer, the site of injection, how to detect and harvest, how to detect metastases of SNs, and learning period. These issues have to be addressed further to establish the most suitable procedure. Novel technologies such as indocyanine green (ICG) fluorescence imaging and one-step nucleic acid amplification (OSNA) may overcome the current difficulties. Once we know what the problems are and how to tackle them, we can pursue the goal.

• 동의생리병리학회지
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• 제24권4호
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• pp.566-570
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• 2010

This review was conducted to investigate clinical trial trend, clinical effect, and study methods of forest healing. Literature search was performed using the search engines of eight electronic databases from inception to march 2010 without language limitation. The search terms were "forest healing", "forest experience", "forest therapy", "forest treatment", "clinical trial", and "clinical study". Inclusion criteria were randomized controlled trials (RCTs) among all kinds of study searched about forest healing. Selection literature and data extraction was performed by authors(SH Sun and SG Lee) independently. Total three studies were selected finally. The methodological quality in all study was low because of poor reporting. Study indications were metal health, depression, self-esteem, and stress. The scale of studies was very small, which was the level of pilot study. There were no description for obtaining informed consent and being reviewed by Institutional Review Board (IRB), and could be any problems for statistical method in any studies. It is difficult to accept the fact that each studies had the significant effect for study indications in the results of studies. It is concluded that the evidence that health healing have a significant effect is insufficient. Further systematic and methodological study and well-designed clinical trial will be needed.

• 동의생리병리학회지
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• 제31권4호
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• pp.233-237
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• 2017

In this study, we report on the procedure of developing a guideline for clinical research protocol using moxibustion. Systematic review of the literature about moxibustion was conducted as a preliminary study to make basic content. Review and consulting by experts from each field was conducted to improve the quality. And we made checklist by arranging keypoint of this guideline. This guideline, Moxibustion Randomized Controlled Clinical Trial Guideline(MOXRATE), aims to be a guide for future researchers in planning clinical study using moxibustion as an intervention. MOXRATE also reports on an ethical issues.

• Korean Journal of Acupuncture
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• 제24권3호
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• 동의신경정신과학회지
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• 제22권4호
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• pp.31-39
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• 2011

Objectives : This study aimed to investigate frequently used herbal materials among herbal prescription for depression focusing on randomized controlled trial. Methods : Every article relevant to depression was initially obtained from China National Infrastructure(CNKI), Korean database and book hand-searching. Searching keywords were 'depression', 'herbal medicine' and 'randomized controllled trial(RCT)'. Results : Among comorbidity with depression, the most accompanied disease was that of circulatory system. Among sixty-five articles, depression with cerebral vascular disease was twenty-eight. Article about mood disorder was twenty-four. High frequently used herbal materials were Bupleuri Radix(41times), Curcumae Radix(34 times), Acori Graminei Rhizoma and Cnidii Rhizoma(24 times). Conclusions : According to this study, we could know select frequent-used herbal medicine. In a clinical treatment, herbal materials can be added herbal prescription related to depression. As these results, it can be helpful to develop new drugs.

• 한국의료질향상학회지
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• 제2권1호
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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.

• 한방안이비인후피부과학회지
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• 제31권2호
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• pp.40-59
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• 2018

Objectives : We report on the contents and reviews of the guidelines for clinical trials of herbal medicine for psoriasis. Methods : After reviewing the existing reports, the guidelines were drafted by the writing committee on guidelines for Korean medicine clinical trial center in Kyung Hee university Korean medicine hospital. Since then, the guidelines have been consulted by the experts in diseases, clinical trials and pharmaceuticals. In addition, the guidelines have been certified by the Korean medicine clinical trial center association and Korean Medicine Ophthalmology & Otolaryngology & Dermatology Society. Results : The guidelines for clinical trials are divided into 8 categories: (1) general contents, (2) evaluation standards of effectiveness, (3) outcome valuables, (4) selection of study participants, (5) designs of clinical trials, (6) safety evaluations, (7) combination therapies in psoriasis treatment and (8) Korean medical considerations. Conclusions : There are 3 major contents for discussion: (1) obscurity of Korean medical considerations to differentiate from existing guidelines, (2) the absence of Korean version of PASI and DLQI, which are validity parameters and (3) realistic institutional problem using the herbal medicine.