• YAKHAK HOEJI
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• v.50 no.6
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• pp.386-392
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• 2006

Pramlintide, a synthetic analogue of human hormone amylin, is the first of a new class of amylinomimetic compounds. Present study was undertaken to compile and analyze the clinical trials of pramlintide, and thereby to facilitate the design of the bridging study for the earlier introduction of the drug, which might be needed by diabetes patients in Korea. Sixty-two articles from Pubmed and MEDLINE search were used to analyze the trials of pramlintide along with prescribing information and New Drug Application packet obtained form the manufacturer. The efficacy of the new drug was attributed to three mechanisms: delay of gastric emptying time, inhibition of post-prandial glucagon secretion, and reduction of food intake by enhanced satiety. Clinical trials consistently identified the effectiveness of the drug for the treatment of type 1and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase III clinical trials were peformed with mostly caucasian and some black and hispanic people. None of the trials documented the proportion of either Asian or Korean participants. Since Korean diabetes patients show different epidemiology and characteristics in their disease state, it appears that the bridging study of pramlintide should be designed in the level of full scale Phase III clinical trial along with pharmacokinetic and pbarmacodynamic studies.

• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.172-178
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• 2012

Data from clinical studies are needed for psychiatrists to make quick and scientific decisions based on the best available evidence in clinical settings. Various methods of clinical studies are useful for clinicians to have reliable answers to unmet clinical needs. Although randomized controlled trials may provide high-quality information about major issues, well-designed, naturalistic and observational studies often give us unbiased explanation for real-world phenomena. Adequate selection of clinical variables and appropriate number of participants are key factors of well-designed clinical studies. Statistical methods can add an extra dimension to initial design of clinical studies. Given ethical issues in clinical studies on psychiatric disorders, special regards should be paid to participants' ability to provide informed consents. New strategies of clinical studies need to be developed to meet clinical needs and protect the rights and welfare of study participants.

• The Journal of Pediatrics of Korean Medicine
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• v.26 no.2
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• pp.53-61
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• 2012

Objectives To make comprehensive feature of clinical trials using herbal medicine and their results by today, then help a strategy for herbal medication-derived clinical studies in the future. Methods Through medical website (Pubmed EBSCO Medline), foreign clinical literatures about atopic dermatitis and herbal medicine were searched. And domestic clinical literatures about atopic dermatitis using internet website (OASIS) and hand-searching. Analysis was performed according to distribution mainly by subject, study design, number by year and its efficacy. Results and Conclusions Seventy-nine (Domestic literatures: Fifty, Foreign literatures: Twenty-nine) literatures were selected according to inclusion criteria of clinical study. 80% of domestic clinical literatures were observational studies, 50% of foreign were intervention. There were six adverse effect case studies, two follow-ups, one case report, four translational and four uncontrolled clinical trials in foreign literatures. And nineteen case reports, eighteen case series, two follow-up and five uncontrolled clinical studies in domestic. Six RCTs have established by four external herb therapy and two decoctions in Korea, showed positive effects. Three out of four external applications RCTs, four out of seven decoctions showed positive results in foreign studies. This study revealed the current status of atopic dermatitis clinical research using herbal drugs. To put clinical trials to use of herbal medicine in the treatment atopic dermatitis, scientific and objective-based studies should be needed.

• The Journal of Korean Medicine
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• v.30 no.6
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• pp.80-85
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• 2009

Objective: This study aimed to build an overview of randomized clinical controlled trials (RCTs) for chronic fatigue-related symptoms to extract the useful data for management of patients and development of therapeutics using Korean traditional medicine in the future. Methods: All RCT-derived papers for chronic fatigue-related symptoms were collected via PubMed Database. We surveyed elementary information of RCTs such as clinical question, study design, and its quality and results. Results: A total of fifty-three RCTs met these review criteria. Most of the RCTs were performed in Western countries, particularly the UK and USA. The major portion of RCTs focused on chronic fatigue syndrome using immune modulators, psychotherapeutic and anti-depressants. Five RCTs using complementary and alternative medicine, including herbal remedies, showed positive results. Conclusions: Fatigue-related symptoms are a main target of Oriental medicine. This study provides helpful information for planning clinical study of chronic fatigue-related symptoms using traditional Korean medicine.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.39
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• pp.33.1-33.10
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• 2017

Dental implants are a common treatment for the loss of teeth. This paper summarizes current knowledge on implant surfaces, immediate loading versus conventional loading, short implants, sinus lifting, and custom implants using three-dimensional printing. Most of the implant surface modifications showed good osseointegration results. Regarding biomolecular coatings, which have been recently developed and studied, good results were observed in animal experiments. Immediate loading had similar clinical outcomes compared to conventional loading and can be used as a successful treatment because it has the advantage of reducing treatment times and providing early function and aesthetics. Short implants showed similar clinical outcomes compared to standard implants. A variety of sinus augmentation techniques, grafting materials, and alternative techniques, such as tilted implants, zygomatic implants, and short implants, can be used. With the development of new technologies in three-dimension and computer-aided design/computer-aided manufacturing (CAD/CAM) customized implants can be used as an alternative to conventional implant designs. However, there are limitations due to the lack of long-term studies or clinical studies. A long-term clinical trial and a more predictive study are needed.

• Journal of Acupuncture Research
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• v.33 no.2
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• pp.77-87
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• 2016

Objectives : This is a pilot study for a large randomized controlled trial to investigate the efficacy and safety of a newly developed contrast therapy device-- alternating topical heat and cold -- for patients with chronic low back pain. The main objective of this study is to confirm the feasibility of the study design. Methods : The design was a randomized, 2-arm, parallel-group, single-blind, placebo controlled trial. Patients in each group received real or sham contrast therapy in an acupuncture point 10 times over four weeks. The primary outcome measure was pain intensity on a 100-mm visual analogue scale (VAS). The secondary outcomes were back-related dysfunction based on the Oswestry Disability Index (ODI), the Roland-Morris disability questionnaire (RMDQ), and range of motion of lumbar spine based on the modified Schober test (mSchober test), Finger-to-Floor distance (FTF distance), and Finger-to-Thigh distraction (FTT distraction). Results : A total of 30 subjects with chronic low back pain were randomly assigned to a contrast therapy group (n＝15) or a sham group (n＝15). A repeated-measures analysis of variance showed statistically significant group time interaction for VAS, RMDQ, mSchober test and FTF distance (p<0.05). The treatment group showed significant improvement in pain intensity and functional disability as compared to the sham group. Conclusion : Contrast therapy may be an effective and safe treatment for chronic low back pain.

• The Journal of Advanced Prosthodontics
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• v.11 no.3
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• pp.147-154
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• 2019

PURPOSE. This study aimed to evaluate the effect of two different implant-abutment connection structures with identical implant design on peri-implant bone level. MATERIALS AND METHODS. This clinical study was a patient-blind randomized controlled trial following the CONSORT 2010 checklists. This trial was conducted in 24 patients recruited between March 2013 and July 2015. Implants with internal friction connection were compared to those with external hex connection. One implant for each patient was installed, replacing the second molar. Implant-supported crowns were delivered at four months after implant insertion. Standardized periapical radiographs were taken at prosthesis delivery (baseline), and one year after delivery. On the radiographs, distance from implant shoulder to first bone-to-implant contact (DIB) and peri-implant area were measured, which were the primary and secondary outcome, respectively. RESULTS. Eleven external and eleven internal implants were analyzed. Mean changes of DIB from baseline to 1-year postloading were 0.59 (0.95) mm for the external and 0.01 (0.68) mm for the internal connection. Although no significant differences were found between the two groups, medium effect size was found in DIB between the connections (Cohen's d = 0.67). CONCLUSION. Considering the effect size in DIB, this study suggested the possibility of the internal friction connection structure for more effective preservation of marginal bone.

• Journal of Korean Academy of Nursing
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• v.34 no.1
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• pp.53-62
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• 2004

Purpose This study was designed to verify the effect of aromatherapy on a postpartum mother's perineal healing. Method The research design was a clinical trial. The methods of aromatherapy were applied sitz bath or soap application using essential oils with Lavender, Myrrh, Neroli, Rose, Grapefruit, Mandarin, Orange, and Roman Chamomile. The subjects of this experiment were postpartum mothers who delivered vaginally with an episiotomy. They were allocated to one of three groups; the aroma-sitz bath group, aroma-soap application group or control group. To evaluate the effect of aromatherapy, the perineal healing status was measured using the REEDA scale and smears of episiotomy wound were obtained. The data were analyzed by repeated measures of ANOVA, ANCOV A, x$^2$- test, and multiple response analysis via SPSS program. Results The REEDA scale was significantly low in the experimental group at postpartum 5th and 7th days (P=.009, P=.003), respectively. Most were observed ‘few’(5-10 bacteria per field) bacteria in the smears of episiotomy wound. The one bacteria was identified in the 50.8% of subjects in pretest and two bacteria in the 60.3% in posttest. Most frequently identified bacteria were Escherichia coli and Enterococcus faecalis. Conclusion In conclusion, these findings indicate that postpartum aromatherapy for perineal care could be effective in healing the perineum perineal care could be effective in healing the perineum.

• The Journal of Korean Obstetrics and Gynecology
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• v.31 no.1
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• pp.99-121
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• 2018

Objectives: Genital herpes is common disease in gynecological field. Although various treatment options such as herbal medicine, acupuncture, moxibustion are used in genital herpes, there is not enough evidence about the treatment options. This study is to prove the efficacy of oriental medicine on genital herpes by investigating papers and suggest direction of future research. Method: We searched for papers which had both genital herpes and oriental medicine from Cochrane, Pubmed, Scopus, CNKI, Oasis, Korean traditional knowledge portal, Journal of Korean Obstetrics & Gynecology up to November 2017. After searching papers, we classified according to the study design and analyzed selected studies. Results: Sixteen papers were finally selected. Four papers are laboratory studies with Hartley guinea pig with recurrent genital herpes. Twelve papers are clinical trials which includes one single group trial, one controlled trial, ten randomized controlled trials. All of the studies have shown that herbal medicine is effective in improving the symptom of genital herpes and decreasing the recurrent rate of genital herpes and also has immunoregulatory effect. Conclusions: This study shows that herbal medicine could be a good treatment option for genital herpes. However, more well-designed clinical studies and laboratory studies will be needed.

• Biomedical Science Letters
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• v.28 no.1
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• pp.34-41
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• 2022

In this study, conditions for extraction of functional component from Nypa fruticans wurmb was optimized. The yield by extraction with 30% ethanol (LE30, 42.12%) was higher than those hot water extraction (LDW 33.32%), 50% ethanol (LE50, 40.12%) and 70% ethanol (LE70, 34.5%). The extract was purified and analyzed by GC MS. The prevailing compounds found in extract were Cyclodecasiloxane-, pentadecanoic acid, -eicosane, undecanal and tridecanoic acid. The presence of saturated and unsaturated fatty acids in ethanolic extract vindicate the use of this plant to treat many diseases in traditional medicine. The total phenolic contents in the LDW, LE30, LE50, LE70 extract were 128±1.65 mg/g, 205±2.3 mg/g, 210±4.23 mg/g and 180±5.6 mg/g, respectively. The DPPH was highest in LE70 extract (1,000 ㎍/mL, 81.14%), ABTS was highest in LE50 extract (1,000 ㎍/mL, 84.14%). The protective effects against oxidative stress in raw 264.7 cell imparted by the LE50 extract was better than those imparted by the other extracts. The findings of the present study suggest that 50% ethanol is best solvent for extraction of Nypa fruticans Wurmb, considering yield, polyphenol content, and antioxidant activities with extraction cost.