• Title/Summary/Keyword: Clinical Trials

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Selection of Adequate Indicators for the Development of a Questionnaire to Evaluate the Effects of Ojeock-san (오적산의 치료 효과 평가에 활용될 변증 설문지 개발을 위한 타당성 문항 추출 연구)

  • Lee, Seung-Deok;Kim, Eun-Jung;Jung, Chan-Yung;Shin, Kyung-Min;Jang, Min-Ki;Yoon, Eun-Hye;Hwuang, Ji-Hoo;Kim, Sun-Woong;Kim, Kap-Sung
    • The Journal of Korean Medicine
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    • v.31 no.4
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    • pp.101-114
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    • 2010
  • Background: Currently, evidence-based medicine is widely propagated as a reference for proper clinical practice. As a result, there is an increasing need for more clinical trials based on Oriental diagnostic methods to evaluate the efficacy of Oriental medicine, including acupuncture and herbal medicine. The purpose of this study was to confirm which symptoms are adequate indicators of effects of Ojeock-san for lower back pain and develop a questionnaire to evaluate its effects. Methods: We interviewed 102 Oriental medical doctors working in Seoul with a preformed questionnaire which included questions about symptoms of lower back pain and indicators for Ojeock-san. We sampled respondents who answered that they trust the effectiveness of Ojeock-san in telephone survey carried out using multistage stratified random sampling technique from March to April, 2009. We categorized the respondents into two groups, differentiating them by gender, career, workplace, and trust level of Ojeock-san effect. Results: About half of the respondents selected 13 questions as the adequate indicators of Ojeock-san for low back pain. There were no differences in the top 11 selected indicators in total selection and top 3 ranking selection. The comparison of frequency of top 13 questions in total selections between the two groups showed no difference. Conclusions: There were 13 symptoms which were considered adequate indicators of effects of Ojeock-san for lower back pain found by many Oriental medical doctors. This questionnaire can be utilized as a diagnostic adjunctive tool, tested for validity and reliability of questionnaires through further studies.

Evaluation of Pregnancy and Thyroid Function (임신과 갑상선 기능의 평가)

  • Park, Chang-Eun
    • Korean Journal of Clinical Laboratory Science
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    • v.50 no.1
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    • pp.1-10
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    • 2018
  • During early pregnancy, before the development of a functioning thyroid gland, thyroid stimulating hormone (TSH) is a very sensitive marker of thyroid dysfunction during pregnancy. Normal values have been modified during gestation with a downward shift. The fetus is influenced by the TSH supplied by the mother. TSH and free thyroxine (FT4) concentrations vary during pregnancy and conventional units can vary between laboratories. A downward shift of the TSH reference range occurs during pregnancy, with a decrease in both the lower and upper limits of maternal TSH, relative to the typical non-pregnant TSH reference range. Each laboratory produces its own reference TSH and FT4 concentrations because there are many different assays that yield different results in pregnancy. Therefore, automated immunoassays used for serum FT4 analysis are still used widely, but the important considerations discussed above must be noted. The use of population-based, trimester-specific reference ranges remains the best way to handle this issue The slight downward shift in the upper reference range of TSH occurring in the latter first trimester (7~12 weeks) of pregnancy, typically not observed prior to 7 weeks. Their use indicates high or low levels in a quantitative manner independent of the reference ranges. These data highlight the importance of calculating population-based pregnancy-specific thyroid parameter reference intervals. A precision medicine initiative in this area will require the collection and analysis of a large number of genetic, biological, psychosocial, and environmental variables in large cohorts of individuals. Large prospective randomized controlled trials will be needed to resolve these controversies.

Antispastic Effect of Electroacupuncture on Upper Extremity in Stroke Patients by T-reflex Study : A Single-Blind, Randomized Controlled, Preliminary Study

  • Cho, Min Kyoung;Lee, In;Kwon, Jung Nam;Shin, Byung Cheul;Ko, Sung Hwa;Ko, Hyun Yoon;Shin, Yong Il;Hong, Jin Woo
    • The Journal of Korean Medicine
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    • v.36 no.4
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    • pp.8-18
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    • 2015
  • Objectives: There have been several studies evaluated effect of electroacupuncture (EA) on spasticity but most studies could not assess spasticity quantitatively because they used clinical rating scales for assessment spasticity. The objective of this study is to evaluate effect of EA on poststroke spasticity quantitatively using tendon reflex (T-reflex). Methods: 29 stroke patients with upper extremity spasticity were randomized to EA group and control group. The EA group received combined EA and rehabilitation therapy 5 times a week for 3 weeks. Acupuncture treatment was given at Jian Yu (LI 15), Qu Chi (LI 11), Shao Hai (HT 3), Wai Guan (TE 5), He Gu (LI 4), Lie Que (LU 7), Hou Xi (SI 3) of the affected side, 30 minutes of electrical stimulation with a frequency of 40/13 Hz was applied at Qu Chi (LI 11), He Gu (LI 4). The control group received only rehabilitation therapy. The efficacy of treatment was assessed using T-reflex latency and amplitude, modified Ashworth scale (MAS) of biceps brachii, brachioradialis and triceps brachii. Fugl-Meyer motor function assessment (FMA) and functional independence measure (FIM) were also measured to assess motor function and functional independence. All outcomes were measured before treatment, immediately after 3 weeks of treatment and 1 week after 3 weeks of treatment. Results: No statistically significant differences were found in outcomes including T-reflex between the study groups except for FIM values immediately after 3 weeks of treatment (p=0.037). Conclusions: These results suggest that 3 weeks of EA does not reduce poststroke upper extremity spasticity electrophysiologically and clinically. However, small sample sizes and contradictory tendency between results from T-reflex and those from MAS require cautious judgement on interpretation of the results. A larger, well-designed clinical trials for quantitative evaluation of effect of EA on poststroke spasticity will be needed.

Early gonadotropin-releasing hormone antagonist start improves follicular synchronization and pregnancy outcome as compared to the conventional antagonist protocol

  • Park, Chan Woo;Hwang, Yu Im;Koo, Hwa Seon;Kang, Inn Soo;Yang, Kwang Moon;Song, In Ok
    • Clinical and Experimental Reproductive Medicine
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    • v.41 no.4
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    • pp.158-164
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    • 2014
  • Objective: To assess whether an early GnRH antagonist start leads to better follicular synchronization and an improved clinical pregnancy rate (CPR). Methods: A retrospective cohort study. A total of 218 infertile women who underwent IVF between January 2011 and February 2013. The initial cohort (Cohort I) that underwent IVF between January 2011 and March 2012 included a total of 68 attempted IVF cycles. Thirty-four cycles were treated with the conventional GnRH antagonist protocol, and 34 cycles with an early GnRH antagonist start protocol. The second cohort (Cohort II) that underwent IVF between June 2012 and February 2013 included a total of 150 embryo-transfer (ET) cycles. Forty-three cycles were treated with the conventional GnRH antagonist protocol, 34 cycles with the modified early GnRH antagonist start protocol using highly purified human menopause gonadotropin and an addition of GnRH agonist to the luteal phase support, and 73 cycles with the GnRH agonist long protocol. Results: The analysis of Cohort I showed that the number of mature oocytes retrieved was significantly higher in the early GnRH antagonist start cycles than in the conventional antagonist cycles (11.9 vs. 8.2, p=0.04). The analysis of Cohort II revealed higher but non-significant CPR/ET in the modified early GnRH antagonist start cycles (41.2%) than in the conventional antagonist cycles (30.2%), which was comparable to that of the GnRH agonist long protocol cycles (39.7%). Conclusion: The modified early antagonist start protocol may improve the mature oocyte yield, possibly via enhanced follicular synchronization, while resulting in superior CPR as compared to the conventional antagonist protocol, which needs to be studied further in prospective randomized controlled trials.

Surgical Treatment of Gastric Cancer

  • Kim, Sang-Woon
    • Journal of Yeungnam Medical Science
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    • v.20 no.2
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    • pp.105-116
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    • 2003
  • Definitely, treatment for gastric cancer is primarily surgical. Detection in early stage of disease and complete surgical resection is the best way to cure gastric cancer. If surgery is planned, careful preoperative evaluation and corrections of physiologic and psychologic abnormalities are essential to reduce perioperative morbidity or mortality. Basic principle of gastrectomy for gastric cancer is an en bloc resection of tumor with adequate margins of normal tissue and with regional lymph nodes and omental tissues. To complete these principles, regional lymph nodes and all omental tissues should be removed altogether during performing various types of gastric resection. The lymph node dissection is one of the most effective procedures for gastric cancer to achieve curative resection. The basic types of gastric resection are distal subtotal gastrectomy and total gastrectomy according to the condition of primary lesions and the status of lymph node metastases. When the primary lesion is located near the esophagogastric junction, it is sometimes hard for a surgeon to select adequate surgical method. Postoperative quality of life in a patient has become a very important factor to be considered in every step of surgical therapy. With increasing incidence of early gastric cancer, a number of surgical trials for limited surgery or endoscopic procedures have been performed, but the long-term clinical results should be carefully analyzed to define the clinical relevance of these new techniques. For patients with disseminated gastric cancer, a palliative procedure can be performed to improve quality of life of patients and to avoid immediate death due to the cancer-related complications.

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Effect of Cognitive Behavioral Therapy (CBT) for Perinatal Depression: A Systematic Review and Meta-Analysis (산전우울 임부를 위한 인지행동치료 프로그램의 효과: 체계적 문헌고찰 및 메타분석)

  • Shin, Hyeon-Hee;Shin, Yeong-Hee;Kim, Ga-Eun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.11
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    • pp.271-284
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    • 2016
  • This study was carried out to evaluate the efficacy of CBT for perinatal depression through systematic literature review and meta-analysis. The following databases were used to search the literature: CINAHL, PubMed, EMBASE, Koreamed, Library of Korean Congress, KISS, and Korean Academic Publication Database. Keywords included 'perinatal depression,' 'pregnant women,' and 'cognitive behavioral therapy,' and the evaluated articles were published up to May 2016. Using the R program, the effect size of perinatal depression and anxiety were calculated by random-effects model. The heterogeneity of the effect size was analyzed by data moderator analysis using the meta-ANOVA. Furthermore, the funnel plot, Egger's regression test, fail-safe N, trim-and-fill test, and publication bias analysis were conducted and used to verify the results. Out of the 180 selected articles, 16 clinical trial studies were meta-analyzed. Each articles were evaluated for the risk of bias by the checklist of SIGN; the overall risk of bias was low. The effect size of CBT for perinatal depression was Hedges' g=-0.55 (95% CI: -0.76~-0.33), which was a moderate level, while for anxiety reduction, Hedges' g=-0.20 (95% CI: -0.48~-0.08) and it was not statistically significant. Heterogeneity or risk of publication bias were low. This meta-analytic study found that CBT is moderately effective in reducing perinatal depression in pregnant women.

Enhanced Transdermal Delivery of Vitamin C Derivative using lontophoretic Gel Patch with Flexible Thin Layer Battery (Flexible Thin Layer Battery가 부착된 lontophoretic Gel Patch를 이용한 Vitamin C 유도체의 경피 흡수 증진)

  • Cho, Wan-Goo;Rang, Mun-Jeong;Song, Young-Sook;Lim, Young-Ho;Park, Hyeon-Woo
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.33 no.1 s.60
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    • pp.23-28
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    • 2007
  • Ascorbic acid (vitamin C, AsA) has been known as a strong reducing agent and is supposed to retard the synthesis of melanin pigment. A main problem that arose in using vitamin C in cosmetic formulation was its poor stability and low skin permeability, which result in low lightening efficacy in clinical trials. In this study, iontophoretic gel patch with flexible thin layer battery was employed in order to enhance skin permeation of vitamin c derivative (ascorbyl glucoside, AsAG) and to increase its lightening efficacy. in vitro iontophoretic skin permeation and stability of AsAG, safety and clinical lightening efficacy of iontophoretic patch containing 2% AsAG solution were examined. A optimun current of ionthophoretic patch for korean women was 0.1 mA, considering the skin permeability and skin irritation of consumers. We suggest that iontophoretic gel patch could be a safe system for enhancing the skin permeation of AsAG and lightning efficacy.

Systematic Review of Hominis Placenta Pharmacopuncture in English and Korean Literature

  • Ryoo, Dek-Woo;Kim, Hong-Guk;Kim, Sung-Jin;Baek, Seung-Won;Jeong, Seong-Mok;Yoon, Jin-Young;Lee, Chang-Hee;Goo, Bon-Hyuk;Kim, Min-Jeong;Park, Yeon-Cheol;Baek, Yong-Hyeon;Nam, Sang-Soo;Seo, Byung-Kwan
    • Journal of Acupuncture Research
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    • v.34 no.4
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    • pp.153-158
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    • 2017
  • Background: Hominis placenta (HP) is used in Korean medicine to tonify qi and blood, and enrich yin and tonify yang. HP has been reported to have therapeutic effects. Methods: A survey of international and Korean electronic databases was conducted using the search terms "hominis placenta pharmacopuncture" and "hominis placenta extract". The search was limited to material published up to May 31, 2017. Results: A total of 83 studies were included in this systematic review: 50 were clinical studies, 25 were basic studies, and 8 were other types of study. Among clinical studies, the most frequently treated disease groups were musculoskeletal diseases and nervous system diseases. In vitro studies were conducted mainly on anti-inflammatory, analgesic, and anti-cell necrosis models. Most of the in vivo studies were performed in rheumatoid arthritis or diabetic complications models. Conclusion: HP pharmacopuncture has effects in the treatment of various diseases. Further large-scale randomized controlled trials are needed to improve the level of evidence for HP pharmacopuncture. It would be helpful if future in vitro and in vivo studies could identify the mechanism of action of HP pharmacopuncture.

A Literature Review of the Microneedle Therapy System for Hair Loss

  • Kim, Jeong-Hyon;Shim, Sung-Eun;Kim, Jun-Yeon;Kim, Ha-Na;Hwang, Ji-Min;Park, Kyeong-Ju;Jo, Min-Gi;Jang, Jun-Yeong;Kim, Jung-Hyun;Goo, Bonhyuk;Park, Yeon-Cheol;Seo, Byung-Kwan;Baek, Yong-Hyeon;Nam, Sang-Soo
    • Journal of Acupuncture Research
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    • v.37 no.4
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    • pp.203-208
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    • 2020
  • This literature review was designed to investigate the effects of the microneedle therapy system (MTS) on alopecia in experimental, and clinical studies. The MTS is acupuncture needling therapy delivered by a roller. A literature review of studies published before May 2020 was conducted using 9 online databases, and a total of 13 studies (4 in vivo studies and 9 clinical trials) were included. Most studies showed that the MTS was effective when used in combination with other treatments. In vivo studies reported an increased level of hair growth factors following treatment. Typically, 1.5 mm needles were used in the MTS treatment and photographic evaluation (by either camera or microscope) was reported in most studies. Oriental medicine research included 2 in vivo studies, which reported positive effects when combined with the MTS. There were no reported severe side effects. the MTS might be safe and has a drug delivery effect. Further studies need to be conducted regarding the frequency and needle length depending on the type of alopecia using Oriental and Western medicine.

Aromatase Inhibition and Capecitabine Combination as 1st or 2nd Line Treatment for Metastatic Breast Cancer - a Retrospective Analysis

  • Shankar, Abhishek;Roy, Shubham;Rath, Goura Kishor;Julka, Pramod Kumar;Kamal, Vineet Kumar;Malik, Abhidha;Patil, Jaineet;Jeyaraj, Pamela Alice;Mahajan, Manmohan K
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.15
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    • pp.6359-6364
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    • 2015
  • Background: Preclinical studies have shown that the combination of an aromatase inhibitor (AI) and capecitabine in estrogen receptor (ER)- positive cell lines enhance antitumor efficacy. This retrospective analysis of a group of patients with metastatic breast cancer (MBC) evaluated the efficacy and safety of combined AI with capecitabine. Materials and Methods: Patients with hormone receptor-positive metastatic breast cancer treated between 1st January 2005 and 31st December 2010 with a combination of capecitabine and AI were evaluated and outcomes were compared with those of women treated with capecitabine in conventional dose or AI as a monotherapy. Results: Of 72 patients evaluated, 31 received the combination treatment, 22 AI and 19 capecitabine. The combination was used in 20 patients as first-line and 11 as second-line treatment. Mean age was 46.2 years with a range of 28-72 years. At the time of progression, 97% had a performance status of <2 and 55% had visceral disease. No significant difference was observed between the three groups according to clinical and pathological features. Mean follow up was 38 months with a range of 16-66 months. The median PFS of first-line treatment was significantly better for the combination (PFS 21 months vs 8.0 months for capecitabine and 15.0 months for AI). For second-line treatment, the PFS was longer in the combination compared with capecitabine and Al groups (18 months vs. 5.0 months vs. 11.0 months, respectively). Median 2 year and 5 year survival did not show any significant differences among combination and monotherapy groups. The most common adverse events for the combination group were grade 1 and 2 hand-for syndrome (69%), grade 1 fatigue (64%) and grade 1 diarrhoea (29%). Three grade 3 hand-foot syndrome events were reported. Conclusions: Combination treatment with capecitabine and AI used as a first line or second line treatment was safe with much lowered toxicity. Prospective randomized clinical trials should evaluate the use of combination therapy in advanced breast cancer to confirm these findings.