Search

Background: Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang(SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods: This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion: This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. Trial registration: This study is registered at ClinicalTrials.gov, ID: NCT03374345. Registered on (15 February 2018). Keywords: Herbal medicine, Cold Hypersensitivity, Sipjeondaebo-tang, Cold intolerance.

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents (PDF 39 kb)

Background Cold hypersensitivity in the hands and feet (CHHF) is a common complaint in Asian female population especially in Korea. Due to the symptoms of CHHF the quality of individual's daily life can be degraded. Ucha-Shinki-Hwan (UCHA) is widely used in the treatment of various diseases including CHHF by harmonizing Yin and Yang, and improving the vitality of whole body. However, the efficacy of UCHA as a treatment option of CHHF has not been assessed in trials. Thus, we aimed to investigate the efficacy and safety of UCHA in Korean women with CHHF through this trial. Methods This study will be an exploratory, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Korean women aged 19 to 59 years who complaint with CHHF will be enrolled from 5 university affiliated Korean medicine hospitals. A total of 164 subjects will be randomly assigned to a treatment group (UCHA) or a placebo group at a 1:1 ratio. The subjects will receive 2.5 g of either UCHA or placebo three times a day for 8 weeks. The primary outcome will be evaluated with the visual analog scale score of CHHF. The secondary outcome measures will be changes in skin temperature in extremities as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion This study will be the first trial to explore the efficacy and safety of UCHA for CHHF patient. This will provide meaningful clinical information on herbal medicine treatment of CHHF and a clinical evidence for planning a full randomized clinical trial. Disclosures and acknowledgments The authors report no competing interests. Trial registration This study is registered at ClinicalTrials.gov, ID: NCT03790033. Registered on (31 December 2018) PROTOCOL VERSION:: The final approved version of the trial protocol is V1.3. (25 January 2019).

Background This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet. Methods This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version. Discussion The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients. Trial registration ClinicalTrials.gov, ID: NCT03083522. Registered on 20 March 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-3013-9) contains supplementary material, which is available to authorized users.

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: recommended items to address in a clinical trial protocol and related documents*. (PDF 39 kb)

Objectives This study aims to analyze Heart Rate Variability (HRV) in women after missed abortion compared with healthy women Methods We studied 35 women who visited Kang-Nam Kyung-Hee Korean Hospital after missed abortion from 01 January 2012 to 28 February 2015 (missed abortion group) and 35 normal women visiting medical examination center from 1 January 2014 to 31 December 2014 (Normal Group). We measured HRV of each women and investigated the difference of HRV between two groups. Results The standard deviation of NN intervals (SDNN) in Missed abortion group is lower than normal group. The square root of the mean square difference of successive NNs (RMSSD) in Missed abortion group is lower than normal group. However there was no significant difference. Total Power (TP) and Low frequency power (LF) is significantly lower in Missed abortion group compared with normal group. High frequency power (HF), Very low frequency power (VLF) and LF/HF ratio in missed abortion group is lower than normal group. but There was no significant difference. Conclusions Missed abortion group is lower in function of overall autonomic nervous system, especially sympathetic nerve.

Objectives Chronic leukorrhea is troublesome symptom to many women. It is well known that Korean medicine is safe and effective on chronic leukorrhea. So this study aims to report the clinical effect of Korean medicine on chronic leukorrhea diagnosed with qi deficiency. Methods The patient received herbal medication, acupuncture, moxibustion, cupping therapy, and Gong-jin therapy during hospitalization (about 17 days). Ikkijeseup-tang (IJST) was applied. Results Chronic leukorrhea, lethargy and loss of appetite was effectively reduced after the treatment. Qi deficiency questionnaire score decreased from 90 to 33. Visual Analogue Scale for chronic leukorrhea decreased from 7 to 0. SF-36 score increased from 268 to 323. Conclusions This case shows that Korean medicine is effective on chronic leukorrhea diagnosed with qi deficiency. Further experimental studies and clinical studies are needed.

A Study on the Relationship between Body Composition and Menopause Rating Scale (MRS), The Menopause-specific Quality of Life Questionnaire (MENQOL) of Postmenopausal Women Kang-In Park, Yeon-Kyoung Pak, Kyoung-Sun Park, Deok-Sang Hwang Chang-Hoon Lee, Jun-Bok Jang, Jin-Moo Lee Dept. of Korean Medicine Obstetrics and Gynecology, College of Korean Medicine, Kyung-Hee University Objectives: Postmenopausal symptoms are subject to many factors. Recently, obesity has been suggested as a factor of hot flush. So this study aims to report the relationship between body composition and Menopause Rating Scale (MRS), The Menopause-specific Quality of Life Questionnaire (MENQOL) of postmenopausal women. Methods: We studied 42 climacteric women who had visited Kyung Hee University Hospital at Gangdong from April 2011 to July 2014. 42 women had filled out MRS, MENQOL, and they had taken body composition tests. Pearson correlation tests were conducted. (Correlation was statistically significant at the 0.05 level) Results: Correlation between psychological subscale of MENQOL and Waist-Hip Ratio (WHR) was statistically significant (pearson correlation coefficient=0.385; p-value=0.012). But other subscales of MRS and MENQOL were not statistically related with body composition. Conclusions: WHR could be an important factor of psychological health of menopausal women. So, abdominal fat reduction must be considered when curing menopausal symptoms. In connection with climacteric depression, well-designed studies would be necessary.

Background In recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea. It can lead to gynecological problems such as irregular menstruation, miscarriage, and infertility. Traditionally, Korean herbal medicine has been the primary treatment method used to balance thermoregulation in the human body; however, its effectiveness has not been confirmed through systematic study. Thus, in this trial, we will investigate the feasibility of a full randomized clinical trial, Danggui-Sayuk-Ga-Osuyu-Saenggang-tang (DSGOST) in Korean women with CHH. Methods This study will be a pilot, multicenter, double-blind, randomized, parallel-group, two-arm, placebo-controlled clinical trial. A total of 66 participants will be randomly divided into two groups, a DSGOST treatment group and a placebo control group, in a 1:1 ratio using a web-based randomization system. Each group will take DSGOST or placebo three times daily for 6 weeks. The primary outcome will be measured using Visual Analogue Scale (VAS) scores of CHH. Secondary outcomes will include changes in skin temperature of the hands, Clinical Global Impressions (CGI) scale scores, recovery rate of skin temperature of the hands after the cold stress test, and the Korean version of the WHO Quality of Life Scale, abbreviated version (WHOQOL-BREF). Discussion This trial will be the first trial to reflect the newly defined disease range of CHH which was compiled by Korean medicine expert consensus. This study will provide considerable evidence for further large-scale trials and general clinical guidelines for CHH in the Korean medical field. Trial registration This study is registered at ClinicalTrials.gov, ID: NCT02645916. Registered on 30 December 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2002-8) contains supplementary material, which is available to authorized users.

SPIRIT Checklist. Recommendations for scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol. (PDF 39 kb)

Anti-metastatic Effect on Cancer cell and Immune System Activation by Orally Administered Boyanghwano-tangJin-Hwan Kim, Deok-Sang Hwang, Jin-Moo LeeChang-Hoon Lee, Kyung-Sub Lee, Jun-Bok JangDept. of Gynecology, College of Korean Medicine, Kyung-Hee UniversityObjectives: This study was designed to investigate intestinal immune system activation and anti-metastatic effect on cancer cells by orally administered extracts of Boyanghwano-tang.Methods: To observe immunomodulating effects of Boyanghwano-tang on Peyer's patch cells, we measured cytokines GM-CSF, IL-4. In addition to observing effects of Boyanghwano-tang on hematopoiesis, we measured proliferation of bone marrow cells mediated by Peyer's patch cells in vitro.IgA induction activated in intestinal content and serum was measured to observe the effect of orally administered Boyanghwano-tang on mucosal immune system.After administering ovalbumin (OVA) with Boyanghwano-tang, Proliferation of Peyer's patch cell was measured to investigate gut immunostimulatory effect. Anti-metastatic experiments were conducted in vivo mouse model by using colon 26-M3.1 carcinoma cell.Results: The amounts of GM-CSF and IL-4 in the culture supernatant of P eyer's patch cells were significantly increased compared to the contro l group. The proliferation of bone marrow cell was significantly up-regualted with Boyanghwano-tang. These results indicate that oral administration of Boyanghwano-tang enhances the secretion of hematopoietic growth factors such as GM-CSF and IL-4 from Pe yer's patch cells, and these cytokines also act on modulator of bone marrow cell proliferation.After orally administering OVA with Boyanghwano-tang, IgA induction and Proliferation of peyer's patch cell was up-regulated with Boyanghwano-tang. These results means orally administered Boyanghwano-tang activates intestinal immune system and has an inhibitory effect on tumor metastasis.In addition, We found that orally administered Boyanghwano-tang significantly inhibited tumor metastasis in vivo.Conclusions: Orally administered Boyanghwano-tang appears to have considerable activity on the anti-metastasis by activation of immune system.Key Words: Boyanghwano-tang, Cancer, Anti-metastasis, Complementary Therapies, Immune System

Results: PCR decreased the number of TRAP positive cells and TRAP activities in BMMs stimulated with RANKL and M-CSF. PCR restrained the formation of actin ring. PCR down regulated the induction of NFATc1, c-Fos, TRAP and OSCAR by RANKL. PCR inhibited NF-κB activity by inducing degradation of IκBα. Conclusions: We suggest that PCR Extracts can be an effective therapeutic agent on osteoclast differentiation caused by diseases such as osteoporosis.

Purpose: The purpose of this study is to examine acupuncture and moxibustion treatment suggested on the papers of urinary incontinence(UI) in medicine journals and to establish the future direction. Methods: The papers which were associated with acupuncture and HG published between 1992 and 2012 in Medline and Scopus were searched. Results: 14 studies met the condition. They were 3 randomized controlled trials(RCTs) and 5 clinical studies. 8 studies revealed that acupuncture and moxibustion have efficacies in UI. Conclusions: From the paper research, acupuncture and moxibustion treatment seem to be effective on UI. However, due to the lack sufficient research of UI, it would be necessary to fulfill further study about the period of acupuncture and moxibustion treatment on UI and the selection of acupoint through well-designed study and establish standard of evidence of them.

The purpose of this study is to identify the priorities with respect to the characteristics of tourism resources development plan between the South and the North Korea. Through a preliminary investigation 287 lists of questions were distributed from May 14, 2012 to December 5, 2012 and from among them 252 lists were used. Expert Choice 11.5 was used to do pairwise comparisons and priorities assessment. Based upon the results of empirical analysis, the priority order sets of the domain of tourism resources development plan should be related to the development contents, the development objects, the development patterns, and the development subjects in the South Korea. Those should be related to the development subjects, the development objects, the development contents, and the development patterns in the North Korea.