• Korean Journal of Acupuncture
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• 제26권4호
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• pp.53-66
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• 2009

Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.

• 대한기관윤리심의기구협의회지
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• 제4권2호
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1994년도 교수 연수회(역학)
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• pp.74-83
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• 1994

• 응용통계연구
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• 제27권1호
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• pp.13-20
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• 2014

제 1상 임상시험의 목적은 피험자가 견딜 수 있는 최대의 용량인 최대허용용량(Maimum Tolerated Dose; MTD)을 추정하는 것이다. 최대허용용량을 추정하는 방법으로는 SM방법, ATD방법, CRM방법 등이 있다. 본 연구에서는 제 1상 임상시험에서 멈춤규칙을 이용한 최대허용용량 추정법을 제안하였다. 제안한 최대허용용량 추정법은 연속재평가방법(Continual Reassessment Method; CRM)과 모의실험을 통해 비교하였다.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 2001년도 제53차 추계 학술대회 연제집
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• pp.302-304
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• 2001

• 동의신경정신과학회지
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• 제23권4호
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• pp.37-48
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• 2012

Objectives : The purpose of this study is to investigate the frequently used herbal materials among herbal prescription for vascular dementia. Methods : Every article relevant to vascular dementia was initially obtained from a Korean database and PubMed. Keywords searched were 'vascular dementia', 'herbal medicine' and 'human'. Results : Clinical study, which vascular dementia were treated with herbal medicine, were 12. Among these 12 articles, 6 were case study, 1 was Controlled Clinical Trial and 5 were Ramdomized Controlled Trial (RCT). High frequently used herbal materials were Ginseng Radix (9 times), Cnidii Rhizoma (8 times), Glycyrrhizae Radix, Citri Pericarpium, Astragali Radix and Angelicae Gigantis Radix (6 times). Conclusions : We could know frequent-used herbal medicine for vascular dementia. To be aware of the frequently used herbal medicine for vascular dementia can be helpful in adding herbal materials to prescription in a clinical treatment and development of new drugs.

• Asian Pacific Journal of Cancer Prevention
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• 제14권4호
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• pp.2643-2647
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• 2013

Background: Despite anti-smoking campaigns, smoking prevalence among Thai males aged 30 or older is high, at around 50%. The purpose of this study was to determine the relationship between smoking and mortality in a rural Thai community. Materials and Methods: Subjects enrolled into the Khon Kaen cohort study between 1990 and 2001 were followed up for their vital status until $16^{th}$ March 2012. The death resource was from the Bureau of Policy and Strategy, Ministry of Interior, Thailand. A Cox proportional hazards model was used to analyse the association between smoking and death, controlling for age, education level and alcohol drinking, and confidence intervals were calculated using the floating risk method. Results: The study recruited 5,962 male subjects, of whom 1,396 died during a median 13.5 years of follow-up. Current smokers were more likely to die than never smokers after controlling for age, education level and alcohol drinking (HR, 95%CI: 1.41, 1.32-1.51), and the excess mortality was greatest for lung cancer (HR, 95%CI: 3.51, 2.65-4.66). However, there was no increased risk with increasing dose of tobacco, and no difference in risk between smokers of yamuan (hand-rolled cigarettes) and manufactured tobacco. Conclusion: Mortality from cancer, particularly lung cancer, and from all causes combined is dependent on smoking status among men in rural Thailand, but the relative risks are lower than have been reported from studies in high income countries, where the tobacco epidemic is more established.

• 대한한방부인과학회지
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• 제19권4호
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• pp.205-215
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• 2006

Purpose : To identify factors related to the severity and frequency of hot flush of postmenopausal women who participated in a clinical trial. Methods : A cross-section study of 34 postmenopausal women between 40 and 60 years of age was done. VAS(visual analog scale) was used to evaluate the hot flush degree. Statistical analysis was performed with multiple linear regression analysis. Results : Hot flush VAS was proportional to the percent body fat with 1.467 regression coefficient (p-value= 0.010). It implies that the symptom of hot flush becomes worse as the percent body fat increases. Some hormones also have effects on hot flush. We found that LH might cause increment of hot flush VAS(i.e., the corresponding regression coefficient is 0.912). Sasang constitution was not relevant to the hot flush degree. Hot flush VAS seemed to increase as the vascular aging degree by SA-2000 getting worse, but it was not statistically significant (p-value= 0.594). Conclusion : This study is a part of a prospective clinical trial. For more accurate result, larger-scale cross-section study or clinical trial are necessary.

• 한국약용작물학회지
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• 제19권5호
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• pp.373-379
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• 2011

Paeoniae Radix Rubra is a preparation consisting of desiccated roots of Paeonia lactiflora PALL (belonging to Ranunculaceae). Paeoniae Radix Rubra is used as a medicinal herb in Asian countries to treat many diseases. Ethanol- or water-based extracts of Paeoniae Radix Rubra were prepared and tested on RAW 264.7 cells, a murine macrophage cell line. The expression of some pro-inflammatory proteins, including inducible nitric oxide synthase (iNOS), cyclooxygenase-2 (COX-2), extracellular signal-regulated kinase 1/2 (ERK1/2) and phosphorylated ERK1/2 was detected by Western blot analyses, while PGE2 expression was quantified by ELISA. Both the water and ethanol extracts of Paeoniae Radix Rubra suppressed LPS-induced nitric oxide (NO) production and exhibited cell toxicity in accordance with increased NO production. Also, both extracts reduced the expression of COX-2 and iNOS, and inhibited phosphorylation of ERK1/2 in LPS-stimulated RAW 264.7 cells. Extracts prepared from Paeoniae Radix Rubra contain anti-inflammatory agents that inhibit the iNOS and MAPK pathways.

• 대한한방부인과학회지
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• 제33권4호
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• pp.75-92
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• 2020

Objectives: This clinical trial is performed to investigate the effect of improving the menopausal symptoms and the safety of extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. in menopausal women Methods: This study was randomized, double blinded, placebo-controlled clinical trial. 110 women with menopausal symptoms were assigned to treatment group (n=55) and control group (n=55). The results of this study were evaluated through changes in Kupperman Index score, Menopause-specific Quality of Life Questionnaire (MENQOL) score, degree of hot flashes and sweating, Body Mass Index(BMI), laboratory test results including female hormones. Results: In the treatment group compared to before baseline, there was significant difference in the Kupperman Index total score, score of each item in the Kupperman Index, MENQOL total score, hot flush and sweating visual analogue scale (VAS), hot flush score, and hot flush duration at one time. However, there was also a significant change compared to baseline in the control group, there was no significant difference between the treatment group and the control group. There was no significant change in female hormone levels in both group, and there were no adverse events associated with the clinical trial product. Conclusions: This clinical trial showed that extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. was helpful in improving menopausal symptoms in menopausal women without significant side effects.