• Journal of Korean Medicine Rehabilitation
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• v.28 no.4
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• pp.11-20
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• 2018

Objectives To systematically explore the effects of acupuncture treatment for rotator cuff disorders and review the clinical trials. Methods We searched 9 electronic databases (PubMed, Cochrane central, Embase, China National Knowledge Infrastructure [CNKI], Korea Institute of Science and Technology Information [KISTI], National Digital Science Library [NDSL], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]) to find randomized controlled trials that used acupunture treatment for rotator cuff disorders. We assessed the designs of the randomized controlled trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). The methodological quality of randomized controlled trials were assessed using the Cochrane Risk of Bias (RoB) tool. Results Total 5 trials were reviewed. 4 out of 5 randomized clinical trials reported meaningful effects of acupuncture treatments compared to control group. However risk of bias seemed high. Conclusions Although the results suggest that acupuncture treatment has favorable effects for rotator cuff disorders, most of the studies included methodologically high risk of bias. Thus, well designed randomized clinical trials which evaluate the effects of acupuncture treatment for rotator cuff disorders should be encouraged.

• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.164-171
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• 2012

The placebo effect, a response observed during the placebo arm of a clinical trial, is produced by the psychobiological action of the placebo as well as by other potential contributors to symptom amelioration such as spontaneous improvement, regression to the mean, biases, concurrent treatments, and study design. From a psychological viewpoint, there are many mechanisms that contribute to placebo effects, including expectations, conditioning, learning, and anxiety reduction. Placebo responses are also mediated by opioid and non-opioid mechanisms including dopamine, serotonin, cholecystokinin, and immune mediators. During recent years, a trend towards increased placebo effects in clinical trials of neuropsychiatric drugs has been noted. Indeed, the placebo effects observed in clinical trials constitute an increasing problem and interfere with signal-detection analyses of potential treatments. Several potential factors including protocol/study design and conduct related factors may account for the placebo effect observed in clinical trials. This paper reviews key issues related to this problem and aims to identify potential solutions.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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• pp.35-39
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• 1997

Recent development of human genetics and techniques of gene transfer and expression have opened the way for investigating novel approaches based on the genetic modification of cells to treat both inherited and acquired diseases. This approach is referred to as gene therapy. Over the past few years, gene therapy has moved from the laboratory to phase I clinical trials. Although the clinical performance of gene transfer experiments is still in an early phase of development, the NIH of Health Recombinant DNA Advisory Comittee (RAC) has approved more than 150 protocols that involve gene transfer or putative gene therapy procedures in clinical settings. Many sectors of society in United States have participated in the design and formulation of these clinical trials through local Institutional Review Boards, the National Institutes of Health (NIH) RAC, the Chemotherapy Evaluation Program of the National Cancer institute, and the FDA. Currently, clinical trials involving gene modification are under way at many medical centers throughout the United Slates. The goals of these trials are as follows. (1) The design should be directed to short-term achievable goals. (2) Each clinical trial is best considered as an intermediate step in a multistep process. (3) The design should identify evaluable proximate endpoints for toxicity and for efficacy, (4) The potential benefits and possible risks for patients participating in these trial should be defined.

• The Journal of Korean Medicine
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• v.28 no.3 s.71
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• pp.116-125
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• 2007

Objective : To overview the protocols of clinical acupuncture research on cancer in the USA. Methods : Using 'acupuncture' and 'cancer' as keyword search terms in Clinical Trials. gov, 28 clinical studies were found. Three studies by non-American institutions were excluded and 25 studies were analyzed. Analytic parameters were cancer condition, primary outcome, research institution, study design, and acupuncture intervention. Results : Breast cancer was the most frequent single condition in the searched protocols. Pain and quality of life were the primary outcomes in many studies. Memorial Sloan-Kettering Cancer Centerin New York has performed the largest number of acupuncture cancer studies. The majority of studies were randomized controlled trials with active controls or placebo/sham controls. Total enrollment varied between the range of 10 and 700 subjects and ages of these subjects were at least above 18 years old (except one protocol). Most protocols had strict exclusion criteria for acupuncture needling such as bleeding disorders, infection, heart disorder, and central nervous system disorder. Conclusions : Clinical acupuncture studies for cancer patients have focused on pain, quality of life, and side effects induced by anti-cancer therapies. Re-evaluation and cautions for strict exclusion criteria in foreign countries are required to perform multi-national acupuncture trials.

• Journal of Korean Medicine for Obesity Research
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• v.8 no.1
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• pp.23-32
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• 2008

Objectives We aimed at reviewing the clinical trials of the acupuncture application for obesity treatment, recently. Methods We searched the clinical trials papers with keywords of obesity, weight loss, overweight, obese and acupuncture and limited method to clinical trial since 2006 in the search site, Scopus. Results & Conclusion We reveiwed 13 articles searched. Recently, acupuncture application for obesity treatment were 3 types ; traditional acupuncture, auricular acupuncture and electroacupuncture. In the 13 articles, 6 articles were uncontrolled trials and 7 were controlled trials. Acupuncture application were effective method to decrease weight and to improve complication such as Polycystic ovarian syndrome, insulin resistance and psychological symptoms.

• Neonatal Medicine
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• v.15 no.2
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• pp.119-122
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• 2008

Clinical research is a necessity, not an option, for developing better and new medicines and therapeutic modalities. But in the course of clinical research, there are rules and guidelines that should be followed to ensure the due respect for persons, beneficence, and justice for persons who voluntarily participate in the research as described in the Belmont Report. Good Clinical Practice (GCP) is an "international scientific and ethical quality standard for designing, conducting, recording, and reporting" clinical trials. The main purposes of GCP would be to protect rights, safety, and well-being of trial subjects, in compliance with the principles of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible. In order to achieve these, investigators must be fully aware of the meanings as well as actual procedures involved in the research and should make the best effort to comply with GCP. For those individuals who belong to vulnerable populations, such as neonates, in addition to the general principles of GCP, further measures to ensure added protection should be implemented. It is our duty to develop and provide better care through clinical research even for neonates. But in doing so, we have to make sure that the importance of protecting the rights, safety, and well-being of the subjects supersede the interests of science and society.

• Journal of East-West Nursing Research
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• v.17 no.1
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• pp.9-15
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• 2011

Purpose: The purpose of this study was to investigate recognition and knowledge regarding clinical trials, in particular, after a clinical trial education program (CTEP) among student nurses. Methods: A cross-sectional survey design of 215 student nurses at a university in Seoul was used with structured questionnaires. Results: Respondents had a high level of need for clinical trial and moderate levels in favorable image, safety, and need for education regarding clinical trial. The respondents who had participated in the CTEP felt the clinical trial more favorable and safer than those who did not. However, there were no significant differences in necessity of clinical trials and need for education regarding clinical trial between the CTEP participation and no participation groups. Respondents had a high level of knowledge about clinical trial, even though half of the respondents misunderstood that the physician can convince the subject to participate in clinical trial. There was no significant difference in knowledge level between groups. One third of the respondents had an intention to work in the area related to clinical trial because of aptitude or future prospect. Conclusion: The results of this study demonstrated that the CTEP might have an effect on student nurses' recognition rather than knowledge. The CTEP should be therefore developed targeting specific areas of misconceptions and recognition changes.

• The Journal of the Korean dental association
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• v.53 no.7
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• pp.476-484
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• 2015

Purpose: This study intended to analyze the validity of clinical effectiveness data of clinical trials testing systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent. Material and Methods: Among 5 clinical trials claimed as proof of clinical effectiveness on the Web site of the manufacturer of this chemotherapeutic agent, a review of 4 clinical trials, written in either Korean or English, was conducted. Data were extracted from studies for the following variables: year of publication, age, sample size, follow-up period, combination with contemporary periodontal treatments, randomization, randomization check, blinded measurement, and statistical test type. Results: The study subjects' age intervals were too diverse to decide a common target population to generalize the findings. No study stated clearly the rationale for the sample size determination. Follow-up period to observe the start of clinical effectiveness was inconsistent and decided without any rationale of pathophysiological latent period. Randomization to make the comparisons on the same start line was performed but failed in a study. Randomization effect was not checked in 4 studies. Performance of blinded measurement of clinical outcomes to prevent bias was unclear in 2 studies. Type of statistical test was inappropriate in 3 studies. Conclusions: Based on the analysis of the validity of data on clinical and demographic variables, the four available clinical trials have not demonstrated compelling evidence of therapeutic effectiveness of systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent to improve prognosis of periodontal disease either with the contemporary periodontal treatment or without it.

• Journal of Acupuncture Research
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• v.26 no.5
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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.

• The Journal of Pediatrics of Korean Medicine
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• v.26 no.2
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• pp.53-61
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• 2012

Objectives To make comprehensive feature of clinical trials using herbal medicine and their results by today, then help a strategy for herbal medication-derived clinical studies in the future. Methods Through medical website (Pubmed EBSCO Medline), foreign clinical literatures about atopic dermatitis and herbal medicine were searched. And domestic clinical literatures about atopic dermatitis using internet website (OASIS) and hand-searching. Analysis was performed according to distribution mainly by subject, study design, number by year and its efficacy. Results and Conclusions Seventy-nine (Domestic literatures: Fifty, Foreign literatures: Twenty-nine) literatures were selected according to inclusion criteria of clinical study. 80% of domestic clinical literatures were observational studies, 50% of foreign were intervention. There were six adverse effect case studies, two follow-ups, one case report, four translational and four uncontrolled clinical trials in foreign literatures. And nineteen case reports, eighteen case series, two follow-up and five uncontrolled clinical studies in domestic. Six RCTs have established by four external herb therapy and two decoctions in Korea, showed positive effects. Three out of four external applications RCTs, four out of seven decoctions showed positive results in foreign studies. This study revealed the current status of atopic dermatitis clinical research using herbal drugs. To put clinical trials to use of herbal medicine in the treatment atopic dermatitis, scientific and objective-based studies should be needed.