• Title/Summary/Keyword: clinical effect

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Placebo Effects and Clinical Trials of Neuropsychiatric Drugs (위약효과와 신경정신약물의 임상시험)

  • Kim, Sung-Wan;Jang, Ji-Eun;Yoon, Jin-Sang
    • 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.

A clinical literature review and research-trends analysis of bee venom pharmacopuncture for cancer patients (암 환자에 대한 봉독 약침요법의 임상문헌 고찰 및 연구동향 분석)

  • Kim, Joo-Hee
    • The Journal of Korean Medicine
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    • v.41 no.3
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    • pp.247-259
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    • 2020
  • Objectives: This review aims to investigate clinical studies related to bee venom pharmacopuncture for cancer patients and to analyze the research trend for further study. Methods: We searched for clinical studies using bee venom pharmacopuncture therapy on patients with cancer through the electronic databases including Pubmed, Cochrane library, OASIS, KISS, NDSL, and KMBASE. There was no restriction on language and publication date, and after selection/exclusion process, the study design, target disease, intervention details including acupoints, treatment frequency and period, outcomes, study results and adverse events were extracted. Results: Thirteen clinical studies were finally selected. There were a randomized controlled trial RCT about the effect of sweet bee venom pharmacopuncture on cancer-related pain, and three case series about chemotherapy-induced peripheral neuropathy. In case reports, there were nine studies about oligodendroglioma, plexiform neurofibroma, breast cancer, prostate cancer, lung cancer, urachal adenocarcinoma, malignant melanoma, and atypical squamous cells of undetermined significance. The bee venom therapy affected the improvement of outcomes such as symptoms, quality of life, tumor response, and lab findings. Conclusions: The present study found that bee venom therapy is applicable to the treatment of cancer patients, and showed some effect on various symptoms. However, due to insufficient number and quality of studies, well designed and high-quality clinical trials are necessary to confirm the effectiveness and safety of bee venom pharmacopuncture therapy in patients with cancer.

The Mediating Effect of Emotional Intelligence on the Relationship between Emotional Labor and Psychological Well-being of Clinical Nurses (임상간호사의 감정노동과 심리적 안녕감의 관계에서 감성지능의 매개효과)

  • Kang, Su-Mi;Bae, Sun Hyoung
    • Journal of muscle and joint health
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    • v.22 no.3
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    • pp.185-194
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    • 2015
  • Purpose: The purpose of this study is to determine the mediator or moderator effect of clinical nurses' emotional intelligence on the relationship between the emotional labor and psychological well-being. Methods: Data was collected from 240 nurses in tertiary hospitals located in B city using structured questionnaires. Data was analyzed with descriptive statistics, Pearson's correlation coefficient and hierarchical multiple regression using the SPSS program. Results: Clinical nurses' emotional intelligence had a significant correlation with emotional labor (r=-.13, p=.039) and psychological well-being (r=.52, p<.001). Also, clinical nurses' emotional intelligence showed mediating effects between the emotional labor and psychological well-being. However, emotional intelligence did not show moderating effects. Conclusion: The results of this study show that the clinical nurses' emotional intelligence has an important influence on nurses' emotional labor and psychological well-being. This finding points to the importance of emotional intelligence to increase psychological well-being and suggests that the hospital should develop education and training programs to enhance nurses' emotional intelligence and promote clinical nurses' psychological well-being.

Recent Clinical Research on the Effect of External Therapy for Infantile Anorexia - Based on the Recent Traditional Chinese Medical Journal - (소아 식욕부진의 외치법에 대한 연구 동향 - 최근 중의잡지를 중심으로 -)

  • Lee, Ji Young;Lee, Seung Yeon;Yu, Sun Ae
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.97-107
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    • 2016
  • Objectives The purpose of this study is to investigate recent clinical studies on the effect of external therapy for infantile anorexia. Methods We searched for the study at CNKI by a keyword 'xiaoaryanshizheng' after 2010. 40 clinical studies which were using one external therapy method were selected. Result Selected 40 clinical studies were divided into six types of external therapy. The subjects for these clinical studies were between three months and 14 years old children. The number of the subjects was between 20 and 260. The period of treatment was between three days and three months. Only using one external therapy for infantile anorexia had 84.62%-100% cure rate. Conclusions Based on these clinical studies, external therapy has been shown as an effective treatment on infantile anorexia.

The Effect of Relaxation Technique on Reduction of Anxiety of Nursing Students in the First Clinical Practice (이완술사용이 간호학생들의 첫 임상실습 직전 불안감소에 미치는 영향)

  • 박정숙
    • Journal of Korean Academy of Nursing
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    • v.16 no.3
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    • pp.123-130
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    • 1986
  • This Study is aimed at showing the effect of relaxation technique on reduction of anxiety of nursing students in the first clinical practice. The samples of this research were eighty fresh-man students of Dong San Junior College of Nursing. Of them thirty-eight were experimental group and remaining forty-two were control group. This study has been conducted from October 14 to 22, 1985. Subjects in all two groups had measured their trait anxiety, after then, the researcher carried out Byun's relaxation technique with experimental group every other day After the experimental period, subjects in all two groups had measured their state anxiety. The tools of this study were two kinds: Spielberg, Gorsuch & Lushene's STAI, and Byun's relaxation technique. To test the statistical difference in the subjects' trait anxiety, score of lecture in pre-clinical practice and score of practice pre-clinical practice, t-test was performed. To verify the hypotheses, ANCOVA was performed. Results of this study were as follows: The main hypothesis that the nursing students who use relaxation technique will have less degree of anxiety in the first clinical practice than the nursing students who don't use relaxation technique was accepted (P<.005). Conclusively, the researcher thinks that it is necessary that nursing students were prepared with relaxation technique to reduce anxiety in their first clinical practice.

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Recent Clinical Research on Effect of Acupuncture for Urticaria (두드러기의 침치료에 대한 최근 임상 연구 동향)

  • Han, Ye ji;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.1
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    • pp.22-31
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    • 2016
  • Objectives The purpose of this study is to investigate recent clinical studies on the effect of acupuncture for urticaria worldwide. Methods Based on the PubMed search with the key search terms of 'urticaria, acupuncture', dated between 2002 to 2015, a total of 9 randomized controlled trials (RCTs), 3 case series, and 2 case reports have been found, and were analyzed. Results and conclusions 1. The most commonly used acupoints were Quchi (LI 11), Xuehai (SP 10), Zusanli (ST 36), Sanyinjiao (SP 6), Dazhui (GV 14). 2. The most commonly used meridians were The Ren Channel, The Du Channel and The Gall Bladder Meridian of Foot-Shaoyang. 3. The treatment period varied from 12 days to 3 months. 4. Acupuncture treatment found to be significantly more or equally effective than the western medicine. 5. More clinical studies are needed to prove a true effectiveness of the acupuncture for urticaria. In case of laboratory tests, serum immunoglobulin E (IgE), interleukin 4 (IL-4) and Helicobacter pylori negative rate might be helpful.

Recent Clinical Research on Effect of Acupuncture on Sore Throat (인후통의 침치료에 대한 국외 임상 연구 동향)

  • Han, Ye ji;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.2
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    • pp.47-55
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    • 2016
  • Objectives The purpose of this study is to investigate recent clinical studies on the effect of acupuncture on sore throat. Methods Based on the PubMed search with the key search terms of 'sore throat, acupuncture', dated from 1992 to 2015, 7 controlled trials and 8 case series was found, and were analyzed for this study. Results 1. The most commonly used acupoints were Quchi (LI11), and Hegu (LI4). 2. The most commonly used meridians were The Lung Meridian of Hand-Taiyin and The Large Intestine Meridian of Hand-Yangming. 3. Acupuncture treatment was effective for both acute and chronic sore throat. 4. More clinical studies are needed to prove the effectiveness of the acupuncture on sore throat. To be more objective on the study results, we can measure temperature drops on or amount of analgesic consumption for sore throat after acupuncture treatment.

Sample size calculation for comparing time-averaged responses in K-group repeated binary outcomes

  • Wang, Jijia;Zhang, Song;Ahn, Chul
    • Communications for Statistical Applications and Methods
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    • v.25 no.3
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    • pp.321-328
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    • 2018
  • In clinical trials with repeated measurements, the time-averaged difference (TAD) may provide a more powerful evaluation of treatment efficacy than the rate of changes over time when the treatment effect has rapid onset and repeated measurements continue across an extended period after a maximum effect is achieved (Overall and Doyle, Controlled Clinical Trials, 15, 100-123, 1994). The sample size formula has been investigated by many researchers for the evaluation of TAD in two treatment groups. For the evaluation of TAD in multi-arm trials, Zhang and Ahn (Computational Statistics & Data Analysis, 58, 283-291, 2013) and Lou et al. (Communications in Statistics-Theory and Methods, 46, 11204-11213, 2017b) developed the sample size formulas for continuous outcomes and count outcomes, respectively. In this paper, we derive a sample size formula to evaluate the TAD of the repeated binary outcomes in multi-arm trials using the generalized estimating equation approach. This proposed sample size formula accounts for various correlation structures and missing patterns (including a mixture of independent missing and monotone missing patterns) that are frequently encountered by practitioners in clinical trials. We conduct simulation studies to assess the performance of the proposed sample size formula under a wide range of design parameters. The results show that the empirical powers and the empirical Type I errors are close to nominal levels. We illustrate our proposed method using a clinical trial example.

Effect of a Mentoring Program as a Strategy for Retention of Clinical Nurses (임상간호사 유지 전략으로서 멘토링 프로그램의 효과)

  • Lee, Byoung-Sook;Park, Jeong-Sook;Lee, Jeong-Hee;Hong, Sun-Nam
    • Journal of Korean Academy of Nursing Administration
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    • v.16 no.1
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    • pp.48-58
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    • 2010
  • Purpose: The purpose of this study was to identify the effect of a mentoring program as a strategy for the retention of clinical nurses. Method: Research subjects were 20 mentors, 20 mentees and 22 clinical nurses for a control group of mentees. A mentoring program was developed by an expert committee and applied to the experimental group for six months. Data were collected at three and six months after the application of the program from September, 2008 to March, 2009. Data were analyzed using $x^$-test, t-test, Repeated Measures ANOVA, One-way ANOVA in SPSS/Win 15.0 Program. Results: Job satisfaction, organizational commitment, empowerment, and carrier commitment in the mentees of the experimental group were significantly higher than the nurses of the control group. Intention of resignation in mentees of the experimental group were significantly lower than the nurses of the control group. Also, there were significant interaction between the groups and the times of measurements in all variables. Conclusion: The mentoring program showed positive impact on the variables for maintenance of clinical nurses. Recommendation: Based on these findings, retention strategies using mentoring programs were recommended to reduce clinical nurses' resignation and improve the competency of clinical nurses that leads to the productivity of nursing organizations.

A Study for Indication and Adopted Techniques of Chuna Treatment-Focusing on Domestic Clinical Studies (추나치료의 적응증별 적용 기법에 관한 연구 - 국내 임상 논문을 중심으로-)

  • Park, Sang-Hun;Ko, Youn-Seok;Lee, Jung-Han
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.8 no.2
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    • pp.57-66
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    • 2013
  • Objectives : The present study examines indications and treatment techniques of Chuna manual therapy. Methods : We searched the clinical studies on Chuna manual therapy through 5 korean web databases, 2 journals.(key word 'chuna') After selecting appropriate clinical studies(Bongchuna, massage, side effect, contraindication are excepted), we analyzed them according to diseases, Chuna techniques, type of clinical trials. Results : 101 studies are selected and analyzed. They studied about cervical(26%), thoracic(12%), lumbar (29%)spinal disorders, temporomandibular joint disorders(4%), pelvic region disorders(4%), upper(6%), lower extremity(5%) disorders and other diseases(15%). Spinal disorders are studied frequently. Mild techniques like supine position both hand cervical spine flexion distraction, JS supine position cervical spine distraction, flexion distraction technique are used more frequently than adjustment by thrust. Conclusions : We have to enhance education and training about techniques that are frequently used and studied. Research and improvement of infrequently used techniques are needed. In-depth research about side effects and contraindication is needed. Highquality clinical research and systematic review should be needed to prove the therapeutic effect of Chuna treatment.

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