• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.206-233
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• 1994

The Medical Research Council has for some years encouraged collaborative clinical trials in leukaemia and other cancers, reporting the results in the medical literature. One unreported result which deserves such publication is the development of the expertise to design and analyse such trials. This report was prepared by a group of British and American statisticians, but it is intended for people without any statistical expertise. Part!, which appears in this issue, discusses the design of such trials; Part II, which will appear separately in the January 1977 issue of the Journal, gives full instructions for the statistical analysis of such trials by means of life tables and the logrank test, including a worked example, and discusses the interpretation of trial results, including brief reports of particular trials. Both parts of this report are relevant to all clinical trials which study time to death, and would be equally relevant to clinical trials which study time to other particular classes of untoward event: first stroke, perhaps, or first relapse, metastasis, disease recurrence, thrombosis, transplant rejection, or death from a particular cause. Part I, in this issue, collects together ideas that have mostly already appeared in the medical literature, but Part II, next month, is the first simple account yet published for non-statistical physicians of how to analyse efficiently data from clinical trials of survival duration. Such trials include the majority of all clinical trials of cancer therapy; in cancer trials, however, it may be preferable to use these statistical methods to study time to local recurrence of tumour, or to study time to detectable metastatic spread, in addition to studying total survival. Solid tumours can be staged at diagnosis; if this, or any other available information in some other disease is an important determinant of outcome, it can be used to make the overall logrank test for the whole heterogeneous trial population more sensitive, and more intuitively satisfactory, for it will then only be necessary to compare like with like, and not, by chance, Stage I with Stage III.

• The Journal of Korean Academic Society of Nursing Education
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• v.22 no.4
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• pp.559-566
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• 2016

Purpose: This study aimed to examine the communication styles and nursing service satisfaction of clinical research nurses perceived by clinical subjects. Methods: The data were collected with self-administrated questionnaires after receiving consents from 200 clinical trial subjects. The data were analysed with descriptive statistics, t-test, ANOVA, Pearson's correlation coefficients and stepwise multiple regression analysis using SPSS 21.0 statistic program. Result: Clinical subjects perceived that clinical research nurses used the informative, affective, and non-authoritative communication styles. The study identified factors influencing the nursing service satisfaction, and they were the informative communication styles (${\beta}$=.34, p<.001) and affective communication styles (${\beta}$=.35, p<.001, $R^2$=37%) by multiple linear regression. Conclusion: If educational programs on communication are developed to help clinical research nurses use the informative and affective communication styles according to the characteristics of subjects and applied to the field of practice, they will be able to increase the nursing service satisfaction and contribute to the higher quality of clinical trials.

• Journal of Periodontal and Implant Science
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• v.45 no.6
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• pp.229-237
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• 2015

Purpose: The aim of this study was to determine the clinical feasibility of using dehydrothermally cross-linked collagen membrane (DCM) for bone regeneration around peri-implant dehiscence defects, and compare it with non-cross-linked native collagen membrane (NCM). Methods: Dehiscence defects were investigated in twenty-eight patients. Defect width and height were measured by periodontal probe immediately following implant placement (baseline) and 16 weeks afterward. Membrane manipulation and maintenance were clinically assessed by means of the visual analogue scale score at baseline. Changes in horizontal thickness at 1 mm, 2 mm, and 3 mm below the top of the implant platform and the average bone density were assessed by cone-beam computed tomography at 16 weeks. Degradation of membrane was histologically observed in the soft tissue around the implant prior to re-entry surgery. Results: Five defect sites (two sites in the NCM group and three sites in the DCM group) showed soft-tissue dehiscence defects and membrane exposure during the early healing period, but there were no symptoms or signs of severe complications during the experimental postoperative period. Significant clinical and radiological improvements were found in all parameters with both types of collagen membrane. Partially resorbed membrane leaflets were only observed histologically in the DCM group. Conclusions: These findings suggest that, compared with NCM, DCM has a similar clinical expediency and possesses more stable maintenance properties. Therefore, it could be used effectively in guided bone regeneration around dehiscence-type defects.

• Journal of Physiology & Pathology in Korean Medicine
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• v.31 no.1
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• pp.25-35
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• 2017

About 60% to 90% of a total population experience low back pain at least once of life, and about 35% to 79% among them experience a recurrent and chronic low back pain. thread-embedding therapy is mainly used to improve appearance or treat obesity in early stage, but recently it is also used to treat musculoskeletal pain. This study aimed to search Chinese study using thread-embedding therapy on low back pain and to analyse their methodology. Three Chinese database(CNKI(www.cnki.net), WANFANG(www.wanfangdata.com), WEIPU(www.cqvip.com)) were searched for clinical study of thread-embedding therapy up to March 2016. The characteristics of included studies and regimen of thread-embedding in those studies were analyzed. The total 21 studies (4 case studies, 16 non-randomized controlled trials, 1 randomized controlled trial) were included. All studies on thread embedding treatment of low back pain reported that its effectiveness was very good. The most frequently used acupoints was Ashi acupoints and acupoints on bladder meridian(BL) or governor vessel(GV). Thread-embedding therapy is considered very useful for low back pain in Traditional Chinese medicine. Further studies are needed to investigate the effect of thread-embedding therapy and to expand its application. This study is limited in that the literature search in the Chinese database were restricted.

• The Journal of Internal Korean Medicine
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• v.29 no.3
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• pp.800-809
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• 2008

Objective : Although chronic prostatitis/chronic pelvic pain syndrcme(CP/CPPS) is a common disease, there is no consensus on the etiology or pathology and treatment. This was a double-blinded, placebo-controlled, randomized clinical trial, investigating the therapeutic effects of the traditional Korean medicine, Bosingunyang-tang(BSGYT). Method : Participants who met US National Institutes of Health (NIH) consensus criteria for CP/CPPS were entered after applying inclusion/exclusion criteria. They were randomized to the BSGYT or placebo group. and treated three times a day for 6 weeks. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was used to estimate the clinical symptoms of CP/CPPS. Prostaglandin E2 and ${\beta}$-endorphin in prostatic fluid, collected by 2-glass pre-massage and post-massage test, were analyzed as factors associated with pain and inflammation. Result : The mean decrease in NIH-CPSI total score of the BSGYT group was 11.0 points, which is 5.7 points more than the placebo group. (Mann Whitney test P=0.038) Also the BSGYT group showed three times higher response rate than the placebo group in NIH-CPSI pain subscale score. (Fisher's exact test P=0.027) In those responders, prostaglandin E2 decreased significantly. (Wilcoxon's signed-ranks test P=0.037). No specific side effects were observed. Conclusion : After a 6-week treatment period, BSGYT improved clinical symptoms of CP/CPPS patients by decreasing PGE2 level in prostatic fluid.

• Korean Journal of Acupuncture
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• v.30 no.1
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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.

• 대한임상약리학회:학술대회논문집
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• 2003.12a
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• pp.20-21
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• 2003

• Journal of Oriental Neuropsychiatry
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• v.22 no.2
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• pp.1-13
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• 2011

Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

• Annals of Clinical Neurophysiology
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• v.12 no.1
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• pp.1-2
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• 2010

Chronic non-specific low back pain (CLBP) is one of the major health problems casting substantial amount of economic expenses and negative impact on quality of life onto an individual as well as society. On contrary to public familiarity, the ways of management of CLBP are diverse and there is yet no general consensus about which approach is better than others or to whom the specific management should be applied. Some hold the negative point of view on the efficacy of the invasive maneuver such as epidural injection because there is no controlled clinical trial (RCT) yielding better long term outcome of those invasive managements over conservative ones. But the experts of interventional or surgical treatment stress the methodological difficulty in performing RCT and assert that those invasive treatments can bring the prompt and complete resolution of low back pain and restoration of function in appropriately selected cases. These seemingly opposite views on the invasive management on CLBP are rather complimentary each other than to be contradictory.

• Journal of Haehwa Medicine
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• v.15 no.1
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• pp.41-45
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• 2006

Aims: This overview summarizes the existing evidence on acupuncture for cancer-related pain. Methods: Literature searches were conducted in 7 databases. All clinical studies of acupuncture, electroacupuncture, ear acupuncture and transcutaneous electrical nerve stimulation (TENS) in cancer patients with the main outcome measure of pain were included. Results: Of the 8 studies included, one high quality randomized clinical trial (RCT) of ear acupuncture showed statistically significant pain relief in comparison with placebo ear acupuncture. All the other studies were either non-blinded (n = 2) or uncontrolled clinical trials (n = 5). Most investigations suffered from methodological flaws such as inadequate study design, poor reporting of results, small sample size and overestimation of the results. Conclusions: The current evidence does not support the use of acupuncture as an adjunctive analgesic method for cancer patients. Only one high quality RCT showed promising results thus warranting further investigation into this under-researched area.