• Journal of Physiology & Pathology in Korean Medicine
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• v.20 no.6
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• pp.1678-1727
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• 2006

This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

• Mood & Emotion
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• v.16 no.3
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• pp.140-151
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• 2018

Objectives : The purpose of this study was to examine effects of adjunctive aripiprazole versus bupropion, on depressive symptoms of female depression. Methods : Sixty six female patients with major depressive disorders were enrolled from a six-week, randomized prospective open-label multi-center study. Participants were randomized to receive aripiprazole (2.5-10 mg/day) or bupropion (150-300 mg/day). Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale (HAM-D17), Iowa Fatigue Scale, Drug-Induced Extrapyramidal Symptoms Scale, Psychotropic-Related Sexual Dysfunction Questionnaire scores, and Clinical Global Impression-Severity (CGI-S) were obtained at baseline and after one, two, four, and six weeks. Changes on individual items of HAM-D17 were assessed as well as on composite scales (anxiety, insomnia and drive), and on four core subscales that capture core depression symptoms. Results : Overall, both treatments improved depressive symptoms, without causing serious adverse events. There were significant differences in the HAM-D17 total score (p=0.046) and CGI-S (p=0.004), between aripiprazole and bupropion augmentation, favoring aripiprazole over bupropion. Aripiprazole revealed significantly greater effect size in depressed mood (p=0.006), retardation (p=0.005), anxiety psychic (p=0.032), and general somatic symptom (p=0.01). Conclusion : While both treatments were effective, results of this study suggested that aripiprazole may be preferable, in treating general and core symptoms of female depression.

• Sleep Medicine and Psychophysiology
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• v.19 no.2
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• pp.77-83
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• 2012

Objectives: Recent studies have reported a correlation between obstructive sleep apnea syndrome (OSA) and depression. In attempt to verify the suggestion that eveningness is related to depression, we examined the effect of morningness-eveningness on their depressive mood in patinets with OSA. Methods: The examination was based on the medical records and polysomnography reports of 211 OSA patients. Information was gathered from the patients who filled out the H$\ddot{o}$rne and Ostberg questionnaire (HOQ), profile of mood states-Korean version (K-POMS), and Epworth sleepiness scale (ESS). We compared mean values of K-POMS total, subscales of K-POMS, ESS, and OSA severity variables among the 3 morningness-eveningness groups (morningness, eveningness, and neither groups). Partial correlation analysis was performed between variables and ANCOVA was performed among the 3 groups after adjustment with age and weight. Results: There were significant negative correlations between HOQ and the followings : K-POMS total, POMS-T (tension-anxiety), POMS-D (depression-dejection), POMS-A (anger-hostility), POMS-F (fatigue-inertia), POMS-C (confusion-bewilderment), spontaneous arousal index, average O2 saturation. There were significant positive correlations between HOQ and the followings : POMS-V (vigor-activity), apnea-hypopnea index, respiratory arousal index, snore time. There were significant negative correlations between POMS-D and the followings : HOQ, POMS-V, stage 1 sleep (%), AHI, TAI (total arousal index), oxygen desaturation index, respiratory arousal index, neck circumference, average O2 desaturation, snore time (%). There were significant positive correlations between POMS-D and K-POMS total, POMS-T, POMS-A, POMS-F, POMS-C, sleep latency, stage 2 sleep (%), heart rate, spontaneous arousal index. There were significant differences in K-POMS total, POMS-T, POMS-D, POMS-F, POMS-C, spontaneous arousal index among the three HOQ groups in ANCOVA. Conclusion: The depressive correlates of OSA patients might be affected, not by excessive daytime sleepiness or OSA severity indexes, but by eveningness circadian characteristics. It would be important to take into account the morningness-eveningness tendency when we manage the depressive mood of OSA patients.

• Korean Journal of Psychosomatic Medicine
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• v.21 no.1
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• pp.44-54
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• 2013

Objectives : To investigate the frequency and clinical characteristics of premenstrual syndrome(PMS)/premenstrual dysphoric disorder(PMDD) in high school students, and determine the correlates of PMS/PMDD in association with comorbid depression and anxiety. Methods : A total of 1688 students were recruited from 5 high schools in Seoul, Korea. Subjects completed the questionnaire composed of scales to measure premenstrual symptoms, depression, and anxiety, as well as sociodemographic and reproductive variables. Subjects were categorized into 3 groups by using the Premenstrual Symptom Screening Tool(PSST) to determine the frequency and clinical characteristics of PMS/PMDD. Multivariate logistic regression was used to identify the correlates of PMS/PMDD. Results : The frequency of moderate to severe PMS and PMDD was 20.1% and 6.4%, respectively. Irritability(78.8%), fatigue(76.4%), and emotional sensitivity(69.8%) were common premenstrual symptoms, and functional impairment in academic performance(67.1%) was dominant. Dysmenorrhea[odd ratio(OR)=3.68, 95% confidence interval(CI) 2.45-5.55], family history of PMS(OR=1.91, 95% CI 1.35-2.71), and use of oral contraceptive (OR=1.85, 95% CI 1.16-2.94) were associated with the increased risk of PMS/PMDD after adjustment for depression and anxiety. Negative attitude to menses(OR=15.60, 95% CI 3.61-67.42) was associated with the increased risk of PMS/PMDD, particularly in subjects without depression and anxiety. Conclusions : PMS was common, as the frequency of PMS more than moderate severity including PMDD exceeded 25%, and disrupted daily functioning in adolescents. PMS is associated with various sociodemographic and menstrual characteristics, and these associations are affected by comorbid depression and anxiety.

• Tuberculosis and Respiratory Diseases
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• v.42 no.4
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• pp.465-473
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• 1995

Background: The prevalence of pulmonary tuberculosis has decreased progressively after the control of the tuberculosis began as national control. But as diabetes, malignancy, immunodeficiency disease recently tend to be increased, the tuberculosis become to the important national health problem. So, this study was designed to observe the state and the change of the prevalence and the clinical status of pulmonary tuberculosis for recent 10 years at one women's university. Method: We retrospectively investigated the epidemiology and the clinical status of 612 patients who were registered at the Ewha Womans University Health Center by analyzing records from 1983 to 1992. Results: 1) The prevalence rate had been steadily decreased from 0.63% in 1983 to 0.11 % in 1992. The prevalence of freshman and the incidence rate according to the entrance year while in the university significantly decreased since 1989. 2) In classifying by registered source, 45.6% of students were detected by annual periodical health examination, 34.5% by entrance physical examination, 12.0% by hospital, 5.4% by health center clinic, 2.5% by reentrance physical examination, sequentially. 3) The students with past history of tuberculosis were 70(11.4%) and 61(10%) suffered from pulmonary tuberculosis. The patients with family history of tuberculosis were 142(23.3%). 4) There were 530(86.6%) with minimal disease, 79(12.9%) with moderate and only 3(0.5%) with far advanced, when classified by the severity of disease. 5) The initial symptoms were mild breathing difficulty in 30.1%, sweating in 14.9%, fatigue in 14.3%, febrile sense in 11.7%, hemoptysis in 8.2%, sequentially. 6) The duration of treatment was $10.6{\pm}3.6$ months in mild group, $14.9{\pm}5.2$ months in the moderate group(P<0.05). 7) The side reactions of the drug were GI trouble in 7.2%, hepatitis in 1.8%, skin rash in 0.8% and streptomycin side in used patients in 9.1%. Conclusion: The prevalence of pulmonary tuberculosis among the students in one women's university was significantly lower than that of university students and 20-24 year-old age group announced in tuberculosis survey on a national scale, and significantly decreased since 1989. The treatment effect was desirable in student's group managed by university health center.