• Title/Summary/Keyword: Randomized Clinical Trials

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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.

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.

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.

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.

Effect of luteal phase support with vaginal progesterone on pregnancy outcomes in natural frozen embryo transfer cycles: A meta-analysis

  • Seol, Aeran;Shim, Yoo Jin;Kim, Sung Woo;Kim, Seul Ki;Lee, Jung Ryeol;Jee, Byung Chul;Suh, Chang Suk;Kim, Seok Hyun
    • Clinical and Experimental Reproductive Medicine
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    • v.47 no.2
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    • pp.147-152
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    • 2020
  • Objective: The purpose of this study was to determine the effect of vaginal progesterone for luteal phase support (LPS) on the clinical pregnancy rate (CPR) in natural frozen embryo transfer (FET) cycles via a meta-analysis. Methods: We performed a meta-analysis of randomized controlled trials (RCTs) and retrospective studies that met our selection criteria. Four online databases (PubMed, Embase, Medline, and the Cochrane Library) were searched between January 2017 and May 2017. Studies were selected according to predefined inclusion criteria and meta-analyzed using R software version 2.14.2. The main outcome measure was CPR. Results: A total of 18 studies were reviewed and assessed for eligibility. One RCT (n = 435) and three retrospective studies (n = 3,033) met the selection criteria. In a meta-analysis of the selected studies, we found no significant difference in the CPR (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.60-1.55) between the vaginal progesterone and control groups. An analysis of the two retrospective cohort studies that reported the live birth rate (LBR) following FET showed a significantly higher LBR in the vaginal progesterone group (OR, 1.72; 95% CI, 1.21-2.46). A subgroup meta-analysis of FET conducted 5 days after injection of human chorionic gonadotropin showed no significant differences between the two groups with regard to the CPR (OR, 1.18; 95% CI, 0.90-1.55) or miscarriage rate (OR, 0.73; 95% CI, 0.36-1.47). Conclusion: The results of this meta-analysis of the currently available literature suggest that LPS with vaginal progesterone in natural FET cycles does not improve the CPR.

The Effect of Dachaihu Decoction for Hyperlipidemic Acute Pancreatitis: A Systematic Review and Meta-Analysis (고지혈성 급성 췌장염에 대한 대시호탕의 효과 : 체계적 문헌고찰과 메타분석)

  • Kim, Yoon-jung;Jung, Yu-jin;Park, Dong-il
    • The Journal of Internal Korean Medicine
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    • v.41 no.3
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    • pp.306-325
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    • 2020
  • Objectives: The aim of this study is to investigate the effect of a Dachaihu decoction for hyperlipidemic acute pancreatitis (HLAP) by systematic review and meta-analysis of Chinese clinical studies. Methods: China National Knowledge Infrastructure (CNKI) was utilized as the major search engine. The date of the literature search was March 7, 2020. Randomized controlled trials (RCTs) about using a Dachaihu decoction for HLAP were included in this study. Meta-analysis was performed by synthesizing outcome data, including total effective rate, abdomen pain relief time, first bowel movement time, blood amylase recovery time, and triglyceride (TG) levels (mmol/L). The selected literature was assessed using Cochrane's risk of bias (RoB). Results: Twelve of 44 RCTs met the inclusion criteria. Most studies were evaluated with RoB as having unclear risk. The total effective rate of herbal medicine treatment based on the Dachaihu decoction was significantly higher than that of symptomatic supportive treatment in 10 articles (risk ratio=1.15, 95% CI: 1.08 to 1.21, p<0.00001, I2=0%). Herbal medicine treatment based on a Dachaihu decoction was significantly more effective than symptomatic supportive treatment in terms of reducing abdomen pain relief time (in all articles; mean difference=-1.70, 95% CI: -1.91 to -1.41, p<0.00001, I2=45%), first bowel movement time (in 7 articles; mean difference=-1.46, 95% CI: -1.86 to -1.05, p<0.00001, I2=73%), blood amylase recovery time (in 8 articles; mean difference=-1.48, 95% CI: -2.04 to -0.92, p<0.00001, I2=90%), and TG levels (in 8 articles; mean difference=-1.59, 95% CI: -2.28to -0.91, p<0.00001, I2=90%). Only one article reported side effects of treatment among the intervention group and control group, citing pancreatic ulcer and pancreatic pseudocyst formation. Conclusions: This study suggests that herbal medicine treatment based on a Dachaihu decoction could yield higher efficacy for HLAP than symptomatic supportive treatment alone. However, the results might be somewhat biased because of the poor quality and small sample size of the included RCTs. Well-qualified clinical studies are needed to prove the effectiveness of Dachaihu decoction therapy for HLAP.

A Review of Korean Medical Pathogenesis, Pattern Identification, Treatment Principle and Herbal Medicines for Allergic Conjunctivitis in Pediatric Patients (소아 알레르기 결막염의 한의학적 병인, 변증, 치법 및 한약재 선택에 대한 문헌적 고찰)

  • Kim, Ye Ji;Seo, Hae Sun;Park, Yong Seok;Park, Sul Gi;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.2
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    • pp.21-36
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    • 2021
  • Objectives We aimed to understand etiology, pattern differentiation, treatment principle, and the role of selected herbs in the treatment of Korean herbal medicine for allergic conjunctivitis (AC) in children. Methods We searched relevant literature published up to February 20, 2021 through CNKI, using search formula of (SU= '結膜炎'+'conjunctivitis') AND (SU='儿童'+'小儿'+'少儿'+'幼年') AND (SU='治療'+'中医治療'+'中藥'+'中医藥'+'顆粒'+'胶囊'+'自擬'+'湯'+'丸'+'散'+'方'). Results Among 81 searched studies, 9 randomized controlled trials and 1 case report were selected and analyzed. In all studies included, the efficacy of herbal treatment for AC was confirmed, and there was no evidence that herbal medicine treatment has higher risk of developing side effects compared to conventional eye drop treatment. As an etiology, wind (風邪) was observed the most frequently, and Saposhnikoviae Radix (防風) and Schizonepetae Spica (荊芥) were in frequent use to dispel wind (祛風). As visceral pattern identification, spleen (脾) and lung (肺) were two important keywords, and spleen deficiency (脾虛), dampness-heat in the spleen and stomach (脾胃濕熱), lung qi deficiency (肺氣虛) were main pathologic mechanisms. Else, treatments related to liver (肝) and removing dampness-heat (濕熱) were mentioned next. Conclusions This study is significant in that AC in children, which has a lack of research compared to other allergic diseases, has been studied in the contents of Korean medicine and laid foundation that can be used as basic data in the actual clinical field. Based on this study, it is hoped that clinical data of Korean herbal medicine treatment for childhood AC will be further accumulated.

Ki67 Index Is the Most Powerful Factor for Predicting the Recurrence in Atypical Meningioma : Retrospective Analysis of 99 Patients in Two Institutes

  • Lee, Sang Hyuk;Lee, Eun Hee;Sung, Kyoung Su;Kim, Dae Cheol;Kim, Young Zoon;Song, Young Jin
    • Journal of Korean Neurosurgical Society
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    • v.65 no.4
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    • pp.558-571
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    • 2022
  • Objective : The primary objective of this study was to identify predicting factors for local control (LC) of atypical meningioma, and we validated them with comparing the predicting factors for recurrence-free survival (RFS). We also examined the rate of LC after surgical resection with or without adjuvant treatment and RFS. Methods : Clinical and radiological records of patients with atypical meningiomas diagnosed at two institutes from January 2000 to December 2018 were reviewed retrospectively. Histopathological features were also reviewed using formalin-fixed paraffin embedded samples from pathological archives. Results : Of the 99 atypical meningiomas eligible for analysis, 36 (36.4%) recurred during the follow-up period (mean, 83.3 months; range, 12-232 months). The rate of 3-year LC and 5-year LC was 80.8% and 74.7%, respectively. The mean time-to-recurrence was 49.4 months (range, 12-150). The mean RFS was 149.3 months (95% confidence interval, 128.8-169.8 months) during the mean follow-up duration of 83.3 months (range, 12-232 months). Multivariate analysis using Cox proportional-hazard regression model showed that the extent of resection (hazard ratio [HR], 4.761; p=0.013), Ki67 index (HR, 8.541; p=0.004), mitotic index (HR, 3.275; p=0.044), and tumor size (HR, 3.228; p=0.041) were independently associated with LC. These factors were also statistically associated with RFS. In terms of radiotherapy after surgical resection, the recurrence was not prevented by immediate radiotherapy because of the strong effect of proliferative index on recurrence. Conclusion : The present study suggests that the extent of resection, proliferative index (according to Ki67 expression) and mitotic index, and tumor size are associated with recurrence of atypical meningiomas. However, our results should be further validated through prospective and randomized clinical trials to overcome the inborn bias of retrospective nature of the study design.

A Systematic Review of effect on Heat-sensitive Moxibustion for Benign Prostatic Hyperplasia (전립선비대증에 대한 열민구(熱敏灸)의 효과에 관한 체계적 문헌 고찰)

  • Kim, MinSeok;Ju, HongMin;Kim, MinHwa;Park, SunYoung;Yun, YoungJu;Park, SeongHa
    • The Journal of Korean Medicine
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    • v.42 no.3
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    • pp.153-164
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    • 2021
  • Objectives: The aim of this study is to investigate the effect of Heat-sensitive Moxibustion on Benign Prostatic Hyperplasia Methods: We searched articles from Academic Journals(CAJ) online databases, Oriental Medicine Advanced Searching Integrated System (OASIS), Searching key words were '前列腺增生', '熱敏灸' and '열민구', '전립선비대'. The search range included randomized controlled trials (RCTs). Among the articles published to 2020, 10 articles were found. After review the title, abstract and original, 3 articles were selected finally to rule out treatment combined with completely different treatments. Result: The Heat-sensitive moxibustion at acupoints in the treatment of Benign prostatic hyperplasia were significantly superior to control group after treatment in the symptoms of patients, IPSS, QOL, PVR and Qmax(P<0.05). The Heat-sensitive moxibustion can significantly reduce the incidence of temporary urinary incontinence after Transurethral resection of the prostate(TURP) and improve life quality and satisfaction of patients(P<0.05). The individualized desensitization saturated time and amount of Heat-sensitive moxibustion is superior effective to general amount and time of traditional moxibustion in the total effective rate, IPSS, Ru and Qmax(P<0.01) for Benign prostatic hyperplasia. Conclusion: Heat sensitive moxibustion directly transfer heat to the source of a disease. So it can be considered as a good treatment for Benign prostate hypertrophy. It was also shown a better effect on BPH compared to traditional moxibustion, According to the thermo principles of tumor, if the tumor cell's death temperature of 43℃ is reached, that can cause tumor degeneration. Therefore I think Heat sensitive moxibustion can be applied to various tumor disease. The results of this study could be applied to clinical treatment of BPH. However, additional large-scale clinical researches should be conducted.

A Narrative Review of the Korean Medicine Treatments for Achilles Tendinopathy (아킬레스 건병증의 한의학적 치료에 대한 국내외 연구 동향 분석)

  • Yoon, Kyung-Young;Hwang, Dong-Wook;Bae, In-Su;Youn, Jun-Heum;Lee, Yu-Jin;Jang, Won-Suk;Yoo, Sang-Joon;Lee, Do-Hoon;Kang, Dong-Hyeob;Son, Ja-Yean;Yang, Seok-Gyu;Cho, Hyun-Woo
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.4
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    • pp.33-45
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    • 2022
  • Objectives The purpose of this review was to investigate clinical treatment trends of Achilles tendinopathy. Methods Clinical studies about Korean medicine treatments on Achilles tendinopathy were searched in 5 databases. The included studies were classified according to the authors, published years, study designs, purposes of study, methods, interventions outcome measures and adverse event. Results In 23 studies, total number of patients were 1,135. The included studies consist of 14 randomized controlled trials (RCT), 5 non-RCT, 2 retrospective study and 2 case reports. Patients were conducted with 9 kinds of treatment, which is acupuncture, electro-acupuncture, pharmacopuncture, acupotomy, moxibustion, cupping, Chuna, herbal medicine, physiotherapy. Most studies used visual analogue scale as primary outcome. Conclusions Based on the results of the collected studies, the use of Korean medicine treatment on Achilles tendinopathy seem to be effective. Despite the large number of RCTs, the level of research cannot be guaranteed, so it is considered that more rigorous researches are needed in future studies.