• Journal of Nutrition and Health
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• v.41 no.2
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• pp.147-155
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• 2008

Medical nutrition therapy (MNT) is considered a keystone of medical treatment of chronic diseases. However, only few studies have evaluated medical and economical outcome of MNT. The study was performed on the patient with type 2 diabetes mellitus to evaluate the effect of clinical and cost-effective outcomes of MNT. Subjects from two general hospitals were randomly assigned to two different groups; One receiving basic nutritional education (BE) (n = 35), and the other receiving intensive nutritional education (IE) (n = 32) for a 6-month clinical trial. The group which received BE had a single visit with a dietitian, while the other group which received IE had an initial visit with a dietitian addition to two visits during the first 4 weeks of the study periods. Anthropometric parameters, blood components, and dietary intake were measures at the beginning of study period and after 6 month. Cost-effective analysis included direct labor costs, educational materials and medication cost difference during 6 months. After 6 month, subjects from IE group showed significant reduction of body weight (p <0.05) and systolic blood pressure (p <0.05), whereas BE group did not show any significant changes. Result from biochemical indices showed glycated hemoglobin concentration was significantly reduced by 0.7% (p <0.05) only in the IE group. The ratio of energy intake to prescribed energy intake decreased significantly in both groups (p <0.05). Mean time taken for a dietitian to educate the subject was 67.9 ${\pm}$ 9.3 min/person for BE group, while 96.4 ${\pm}$ 12.2 min/person for IE group. Mean number of educational materials was 1.9 ${\pm}$ 0.7/person for BE group and 2.5 ${\pm}$ 0.7/person for IE group. Change in glycated hemoglobin level along the 6 month period of study can be achieved with an investment of \88,510/% by implementing BE and \53,691/% by implementing IE. Considering the net cost-effect of blood glucose control and HbA Ic, IE which provides MNT by dietitian had a cost efficiency advantage than that of BE. According to this study, MNT provided by dietitian had a significant improvements in medical and clinical outcomes compared to that of BE intervention. Therefore, MNT protocol should be performed by systemic intensive nutrition care by dietitian in clinical setting to achieve good therapeutic results of DM with lower cost.

• Journal of Acupuncture Research
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• v.24 no.3
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• pp.215-229
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• 2007

Objectives : Placebo phenomena have been considered as a confounding factor of clinical trial. Expectancy and belief of acupuncture have not been evaluated quantitatively. The present study was performed to analyze the emotional and cognitive factor .of acupuncture and investigate whether the expectancy of acupuncture treatment is associated with the cognition of acupuncture. Methods : The expectancy and the perception of bodily sensation (PBS) of 22 participants were assessed using self-reported questionnaire. The subjects used the self assessment manikin (SAM) to rate each of the standard affective image of the international affective picture system (lAPS) and other acupuncture-related image. Based on the degree of expectancy, the high expectant (HE) and the low expectant (LE) group were classified. The thermal and pressure pain threshold was objectively evaluated using radiant-heat device and algometer. The degree of expected pain of acupuncture and the actual pain of painful stimulation was subjectively evaluated using facial pain scales (FPS). Results : Using SAlVI analysis, we identified the negative correlation between hedonic valence and arousal dimension on acupuncture-related visual cue. The degree of the PBS and general pain threshold did not show any significant difference between the HE and the LE group. The HE group rated the acupuncture images as more pleasant, more arousing, than the LE group. In addition, we also found that the higher expectancy marked the lower FPS of the expected pain of acupuncture, but not of the actual pain of painful stimulation. Conclusions : Our preliminary study identified the psychological dimensions of acupuncture-related visual cue. These findings indicate that the expectancy of acupuncture could affect the cognition of acupuncture.

• The Journal of the Society of Stroke on Korean Medicine
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• v.6 no.1
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• pp.25-32
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• 2005

Background and purpose: Arterial stiffness is an important, independent determinant of cardiovascular risk. Pulse wave velocity (PWV) has been used as a valuable index of arterial stiffness and as a surrogate marker for atherosclerosis. The Framingham risk score was developed using categorized risk factors to predict the 10 year absolute risk of developing coronary heart disease (CHD). This algorithm is established using recommended guidelines for blood pressure, total cholesterol, and high density lipoprotein cholesterol in addition to age, smoking history and history of diabetes. Tongxinluo(TXL) has been shown to have anti hyperlipidemic activity and anti atherogenic effects. To determine its efficacy and safety, we examined whether TXL improves PWV, ABI, Framingham score, blood pressure, and lipid profile in high risk group of cardiovascular diseases. Subjects and methods: 49 subjects with the high risk of cardiovascular diseases were recruited. Subjects were administered TXL with the dose of 1110mg three times a day for 8 weeks. baPWV, ABI, Framingham risk score, Blood pressure and serum lipid profile were assessed at baseline and after 4 and 8weeks. Results: Total cholesterol, LDL cholesterol, triglyceride, total lipid and phospolipid significantly decreased after 4 weeks of medication. Total cholesterol, total lipid and phospolipid significantly decreased after 8 weeks of medication. There were no significant changes in Framingham risk scores, ABI, PWV and blood pressure. On safety assessment, there were no adverse effects, hepatic or renal toxicity. Conclusion: We suggest that TXL is a safe and useful herbal medicine for hyperlipidemia and as for anti-atherognic effects, further research would be necessary.

• Journal of Nutrition and Health
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• v.44 no.5
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• pp.428-442
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• 2011

This study investigated the actual status of constipation. In total, 978 female students in Korea participated. We identified the relationship among constipation and life style, clothing patterns, housing patterns, dietary habits, and dietary intake in a constipation symptom group and a normal group. The actual constipation rate based on the Rome II criteria was 27.0% (n = 264). Body weight (p < 0.05) and body mass index (p < 0.05) in the constipation group were significantly higher than those in the normal group. The incidence of functional bowel disease and irritable bowel syndrome in the constipation group were significantly higher than those in the normal group. The discomfort of wearing underwear was significantly higher in the constipation group than that in the normal group. The constipation group revealed a significantly higher rate of irregular dietary habits than those in the normal group. The dietary diversity score of the normal group was 4.22 (p < 0.05), which was significantly higher than that of constipation group (4.12). No significant difference in life style factors was observed. It is necessary for university female students to correct their dietary habits, maintain food intake of three times per day, and select diverse foods. Furthermore, it is necessary for university female students to wear comfortable clothing to lessen symptoms and improve constipation rates.

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.6
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• pp.1611-1620
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• 2008

This clinical research was conducted to test patients with Atopic Dermatitis by external application with Hwangryeonhaedok-Tang in cosmetics. We gave scores to 31 patients who visited the Dept. of Oriental Medical Opthalmology & Otolaryngology & Dermatology of Semyung University Jecheon Oriental Medical Hospital from May 15th, 2008 to June 26th. Fifteen patients were treated with the ointment that contain Hwangryeonhaedok-Tang (experimental group) and sixteen patients were treated with normal ointment that doesn't have Hwangryeonhaedok-Tang (control group) for 4 weeks. We observed change of total IgE, eosinophil count, Skin Temperature, Transepidermal Water Loss(TEWL), Skin Hydration and Skin pH. Also Clinical Index of Atopic Dermatitis(SCORAD Index) and global assesment of efficacy were used to evaluate the effects of Hwangryeonhaedok-Tang. Statistical analysis was performed by using frequency analysis and descriptive analysis. Statistical significance was achieved if the probability was less than 5%(p<0.05). After 4 weeks of external application treatment, SCORAD Index in experimental group was significant statistically decreased compared with control group. After 4 weeks of external application treatment, total IgE of both groups were decreased and eosinophil count in control group was decreased but experimental group was unstatistically decreased. Unstatistically, both groups didn't showed significant effect on Skin Temperature. Transepidermal Water Loss(TEWL) in both groups were increased but experimental group was significant decreased compared with control group. Skin Hydration in experimental group was significant statistically increased compared with control group. Statistically, both groups didn't showed significant effect on Skin pH. Only experimental group showed little increase. After 4 weeks of external application treatment, experimental group showed significant effect on global assesment of efficacy. Considering the above results, we can speculate that cosmetics with Hwangryeonhaedok-Tang has some therapeutical effects in mitigating the symptoms of Atopic Dermatitis.

• Journal of The Korean Society of Clinical Toxicology
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• v.11 no.1
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• pp.9-18
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• 2013

Purpose: Antidotes for toxicological emergencies can be life-saving. However, there is no nationwide stocking and delivery system for emergency antidotes in Korea. We report on a two-year experience of a nationwide stocking and delivery trial for emergency antidotes at emergency departments in Korea. Methods: An expert panel of clinical toxicologists reviewed and made a list of 15 stocked antidote. These antidotes were purchased or imported from other countries and delivered from 14 antidote stocking hospitals nationwide 24 hours per day, seven days per week. Results: From August 1, 2011 to April 30, 2013, 177 patients with acute poisoning, with a median age of 48.5 years, were administered emergency antidotes. The causes of poisoning were intentional in 52.0% and 88.0% were intentional as a suicide attempt. Regarding clinical severity, using the poisoning severity score, 40.7% of patients had severe to fatal poisoning and 39.0% had moderate poisoning according to clinical severity. The most frequent presenting symptom was neurologic deficit, such as altered mentality (62.7%). alerted mentality (62.7%). Emergency antidotes were administered as follows: methylene blue (49 cases), flumazenil (31), N-acetylcysteine (25), glucagon (17), 100% ethanol (15), cyanide antidote kit (12), anti-venin immunoglobulin (5), pyridoxine (4), hydroxocobalamine (2), and deferoxamine (1). The median time interval from antidote request to delivery at the patient's bedside was 95 minutes (interquartile range 58.8-125.8). Conclusion: Findings of this study demonstrated the possibility of successful operation of the nationwide system of emergency antidotes stocking and delivery in Korea.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.16 no.2
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• pp.279-285
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• 2005

Objectives : This study was performed to evaluate the efficacy and safety of MPH-OROS and parental satisfaction for treatment of children with ADHD Method : The 569 participants were clinically diagnosed for ADHD using DSM-IV criteria. We switched current medication to MPH-OROS or introduced MPH-OROS for treatment of ADHD. We assessed the clinical global impression severity of illness (CGI-S), the clinical global impression severity of improvement(CGI-I). And the parents of participants measured the Korean version of Conners rating scale at baseline, the 1 st week and the 3rd week after MPH-OROS trial. At the 3rd week, the parents measured the parent satisfaction questionnaire. Results : $13\%$ of participants dropped out because of several causes including side effects. The change of CGI-S was significantly decreased. Using CGI-I, the improvement was $72.3\%$ at the 1st week and $87.4\%$ at the 3rd week. The total score of the Korean version of Conners parent rating scale was significantly decreased. The participants complaining one or more of side effects were 119$(20.7\%)$, and the most common side effect was anorexia. The $94\%$ of parents replied that they were overall satisfied with MPH-OROS trial. Also the advantages of MPH-OROS of parental report were the long duration of the drug, the improvement of schoolwork and attitude, the improvement of home behavior and homework and the improvement of overactivity. Conclusion : MPH-OROS is effective and well-tolerated in actual clinical use for ADHD.

• The Journal of KAIRB
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• v.2 no.2
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• Clinical and Experimental Reproductive Medicine
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• v.19 no.2
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• pp.169-174
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• 1992

Previous studies have indicated that immunological factor is responsible for the infertility. We have detected sperm antibodies in ZIFT patients which grouped as fertilization failure (A; n=18) and low fertilization rate (${\leq}50%$)(B; n=20). Patients, however, had normal oocytes and sperms. We collected serum from wives and semen from husbands and donors (fertile sperm), if it was needed. We examined class, binding patterns and amounts of antisperm antibodies(ASA) by direct and indirect immunobead binding assay. In group A, 11 husbands were ASA positive showing 62.2% and 61.1% binding with IgA and IgG, respectively, and two wives were ASA positive showing 70.0% and 71.0% binding with IgA and IgG, respectively. Binding sites were mainly at the head of sperms (84%). In group B, 8 husbands were ASA positive showing 37.5% and 40.0% binding with IgA and IgG, respectively, and two wives were ASA positive showing 41.3% and 42.0% binding with IgA and IgG, respectively. Binding sites were also mainly at the head of sperms (78%). For the treatment of ZIFT patients who had fertilization failure at the first trial, we used albumin fractionation method and dilution method with 30% fetal cord serum (FCS) to reduce the titer of ASA. We used partial zona dissection (P.Z.D.) method for wives who have antisperm antibodies in their serum. According to represented method, we could inhance the fertilization rate to 60.0% by albumin fractionation and 20.0% by P.Z.D., respectively. We concluded that the use of micromanipulation like P.Z.D. or the other sperm processing methods is required to increase a chance of fertilization. This result suggested that it should be a prerequisite to test antisperm antibodies prior to entering assisted reproductive technologies (ART) programs.

• Korean Journal of Psychosomatic Medicine
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• v.13 no.2
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• pp.85-94
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• 2005

Objectives: This prospective and open-label study was conducted to evaluate the efficacy and safety of quetiapine and haloperidol in patients with delirium. Methods : Fourty patients(19 patients in a quetiapine group : 21 patients in a haloperidol group) with delirium by DSM-IV were treated with flexible doses of open-label qvetiapine and haloperidol. To evaluate the primary efficacy of the medication, scores from the Korean version of Delirium Rating Scale(K-DRS) were assessed every seven days and to evaluate the secondary efficacy and safety, scores from the Clinical Global Impression-Severity, Korean Version of Mini-Mental State Examination, and the Drug-Induced Extrapyramidal Symptoms Scale were assessed at the baseline and the seventh day. Data were gathered from November 2004 to June 2005. Results : K-DRS scores for each group decreased significantly over the study period; however, no significant differences between groups were found. The group-by-time effect was not significant. In addition, there was no significant difference in the frequency of response to drugs between the two groups. No patients reported clinically significant side effects. Conclusion : These data show no significant difference in the efficacy and safety between quetiapine and haloperidol in the treatment of delirium. Since haloperidol has a great possibility of causing a extrapyramidal side effect resulted by previous studies, it is expected that quetiapine, a renowned medication with low side effects, may be a useful alternative agent to haloperidol, the classical antipsy-chotics, in the treatment of delirium.