• Title/Summary/Keyword: Randomized Clinical Trials

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Assessment of Appropriateness of Criteria for Insurance Coverage on Systemic Therapy used in Renal Cell Carcinoma (신세포암에 사용되는 전신 항암요법의 요양급여기준에 관한 고찰)

  • Kim, Jeong-Yeon;Park, Eun-Ji;Bae, Min-Kyung;Yoon, Jeong-Hyun
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.319-331
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    • 2011
  • Purpose: The purpose of this study is to evaluate current criteria for insurance coverage by Health Insurance Review & Assessment Service (HIRA) on the systemic therapy used in the treatment of advanced or metastatic renal cell carcinoma (RCC), by reviewing all available clinical evidences including a variety of clinical practice guidelines. Methods: We searched clinical databases and collected data from published phase 1 through 3 randomized clinical trials on all systemic therapies used in RCC, including novel targeted therapies. Additionally, current clinical practice guidelines on the management of kidney cancer or RCC were reviewed. Based on the collected data we evaluated the appropriateness of the HIRA criteria for insurance coverage on the systemic therapy of RCC whether they are evidence-based and up to date. Results: On the basis of the collected data we concluded that there was a need for a revision in HIRA criteria for systemic therapy of RCC. Despite recent emerging therapeutic advances and changes in therapeutic strategies of management of RCC, some of anticancer regimens were inappropriately listed even though they were not proven to provide efficacy or safety superior to those of other therapies. We thus proposed an updated recommendation based on current clinical evidences. Conclusion: Systemic therapy of RCC is being rapidly changed with the advancement of understanding of the molecular biology of cancer. Consequently newly developed targeted therapies are becoming the standard therapy in the management of medically or surgically unresectable advanced or metastatic RCC. To provide effective and safe therapy to patients with RCC, the criteria for insurance coverage should be made carefully taking into consideration of most up-to-date and high-quality clinical evidences, and should be continuously reviewed so as to reflect evidence-based clinical practice.

[ $\b{S}afety\;\b{A}nd\;\b{E}fficacy$ ] of $\b{K}orean$ red ginseng Intervention (SAEKI) Trial: Rationale, Design, and Expected Findings

  • Sievenpiper John L;Buono Marco Di;Stavro P. Mark;Jenkins Alexandra L;Nam Ki Yeul;Choi Melody;Naeem Asima;Leiter Lawrence A;Sung Mi-Kyung;Vuksan Vladimir
    • Proceedings of the Ginseng society Conference
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    • 2002.10a
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    • pp.424-455
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    • 2002
  • Diabetes mellitus is reaching epidemic proportions worldwide. The insufficiency of medication to cope with this burden has coincided with a dramatic rise in the prevalence of use of complementary and alternative therapies, especially herbal treatments. This surge in demand presents a challenge to prove the safety and efficacy of these treatments in diabetes. Korean red ginseng (steam treated Panax ginseng C.A. Meyer) is a strong candidate to succeed. It has been shown to possess a multitude of hypoglycemic effects and improve metabolic disturbances related to diabetes in in vitro and animal models. Data in humans is also emerging to support these benefits. Whether these results can be replicated in a rigorous clinical testing program is unclear. We therefore investigated the antidiabetic effects of Korean red ginseng in a series of 2 acute and 1 longterm randomized, double-blinded, placebo-controlled clinical trials. This paper provides the rationale for this program of study, expanding on the problem of diabetes, its management, and the possible role for Korean red ginseng. It then describes the design and expected findings.

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The Relationship between Oral Disease and Respiratory Disease in the Elderly (임상가를 위한 특집 1 - 노년의 구강 질환과 호흡기 질환의 관계)

  • Jeong, Jin-Seok;Heo, Seok-Mo
    • The Journal of the Korean dental association
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    • v.51 no.9
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    • pp.494-500
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    • 2013
  • Recently, several researches indicated the relationship between oral condition and respiratory disease such as pneumonia and chronic obstructive pulmonary disease (COPD). Respiratory disease is known as common chronic disease in the elderly increasing mortality and morbidity. In this study, we have reviewed the association between oral disease and respiratory disease in the elderly. The related data were searched and collected from abroad and domestic studies. The studies included the randomized controlled clinical trials (RCTs), longitudinal, cohort, case-control, and systematic review studies. With the data from the studies, we concluded that poor oral hygiene or periodontal disease can influence the pneumonia in the elderly. Further studies will be needed to investigate the association between oral disease and COPD.

Review of Randomized Controlled Clinical Trials Targeting Treatment of Diabetic Peripheral Neuropathy (당뇨병성 말초 신경병증에 대한 RCT 분석 연구)

  • Kim, Jin-Mi;Son, Chang-Gue;Cho, Chung-Sik;Kim, Chul-Jung
    • The Journal of Korean Medicine
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    • v.31 no.4
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    • pp.164-170
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    • 2010
  • Objective: This study aimed to produce an overview of RCT for treatments of diabetic peripheral neuropathy. Method: All RCT studies for treatments of diabetic peripheral neuropathy were selected via PubMed. The general trend of RCT number, subject and result, including Oriental medicine, were analyzed. Result: A total 147 RCT studies were found. The number of RCT has rapidly increased since 2003. 114 RCTs were conducted with western drugs, while RCTs with electrical stimulation and Oriental medicine were eight and ten respectively. All RCTs with acupuncture, moxibustion and herbal drugs showed positive results. Conclusion: Oriental medicine-derived RCTs for diabetic peripheral neuropathy are very rare, even their potential was sufficient. This study may provide valuable information for development of Oriental medicine against diabetic peripheral neuropathy in the future.

Mechanisms of Action of Probiotics (Probiotics의 작용기전)

  • Ko, Jae-Sung
    • Clinical and Experimental Pediatrics
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    • v.48 no.7
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    • pp.691-695
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    • 2005
  • There is scientific evidence that administration of probiotics is effective in the treatment of acute infectious diarrhea in children and the prevention of antibiotic associated diarrhea and nosocomial/community acquired diarrhea. Probiotics prevent relapse of recurrent pouchitis and decrease the initial onset of pouchitis in ulcerative colitis. Probiotic organisms suppress growth of pathogens as well as their epithelial attachment and/or invasion either directly by secreting antimicrobial substances or by stimulating host expression of protective molecules. Additionally, probiotics enhance mucosal barrier function and can stimulate host production of immunosuppressive molecules that downregulate inflammatory responses or allergic immune response. Mechanisms of action explain therapeutic effects and randomized controlled trials are warranted before recommendations for therapeutic or preventive use can be given.

Nutritional strategy of early amino acid administration in very low birth weight infants

  • Lee, Byong Sop
    • Clinical and Experimental Pediatrics
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    • v.58 no.3
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    • pp.77-83
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    • 2015
  • Relative to a fetus of the same gestational age, very low birth weight (VLBW) infants are more likely to be underfed and to undergo growth restriction during their early hospital stay. The current trend towards "early and aggressive" nutritional strategies in VLBW infants aims to overcome the early nutritional deficiency and thereby boost postnatal catch-up growth, simultaneously improving long-term neurodevelopmental outcomes. Although the minimum starting amino acid (AA) dose to prevent negative nitrogen balance is well established, the upper limit and the rate of increase of early AA doses are controversial. Most randomized controlled trials show that early and high-dose (target, 3.5 to 4.9 g/kg/day) AA regimens, with or without high nonprotein calories, do not improve long-term growth and neurodevelopment. High-dose AA supplementation may lead to early metabolic disturbances and excessive or disproportionate plasma AA levels, particularly in infants of very low gestational age. Further large studies are needed to clarify the optimal strategy for early administration of parenteral AA doses in VLBW infants.

Randomized Clinical Trials of Herbal Acupuncture for Placebo Control (플라세보 약침에 대한 무작위배정 임상시험)

  • Seo, Jung-Chul;Xue, Charlie
    • Journal of Acupuncture Research
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    • v.25 no.6
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    • pp.153-161
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    • 2008
  • Objectives : This study was designed to find out whether normal saline(NS) acupuncture is able to be constituted as an appropriate control group for Cervi Cornu Parvum herbal acupuncture(CC). Methods : NS and CC were injected into Quchi($LI_{11}$) of the subjects. The subjects completed a questionnaire rating the intensity of 21 kinds of acupuncture sensation(hurting, penetrating, sharp, aching, intense, spreading, radiating, tingling, pricking, stinging, pulling, heavy, dull, numb, electric, shocking, hot, burning, cool, pulsing, and throbbing) and side effects. We compared subjective evaluations of acupuncture sensation and side effects between two groups. Results : As for CC most of the acupuncture sensation items were not significantly different from NS especially in less acupuncture-experienced subjects(average 2, below 10 time experiences) rather than more acupuncture-experienced subjects(above 10 time experiences). Conclusions : We found that NS might be an appropriate placebo herbal acupuncture for CC in small amount of acupuncture-experienced subjects. Further study is needed for new placebo herbal acupuncture for CC in more acupuncture-experienced subjects.

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Commonly used herbal medicines in the treatment for female reproductive dysfunction

  • Imai, Atsushi
    • Advances in Traditional Medicine
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    • v.6 no.1
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    • pp.1-11
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    • 2006
  • Herbal medicines are widely used for centuries to treat illness and improve health in Asia and the use of these remedies has become a worldwide form of alternative therapy. However, there is very limited evidence from randomized controlled trials to support the efficacy of the vast majority of herbal products. Of the commonly used herbal medicines, systemic clinical experiences and promising experiments in animals have found potential evidence of efficacy for six herbal medicines (Unkei-to, Hachimijio-gan, Keishi-bukuryo-gan, Toki-shakuyaku-san, Shakuyaku-kanzo-to, Sairei-to) in the treatment for female reproductive dysfunction. Because herbs may contain potent bioactive substances, the physician should have an opportunity to outline more stringent regulation, similar to over-the counter drug.

Effects of Pioglitazone and Rosiglitazone on Glucose and the Cardiovascular Risk Factors in Patients with Type 2 Diabetes: A Meta-analysis (Pioglitazone과 Rosiglitazone이 제2형 당뇨환자의 혈당조절 및 심혈관계 위험인자에 미치는 효과에 대한 메타분석)

  • Lee, Jae-Kyoung;Lee, Eui-Kyung
    • YAKHAK HOEJI
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    • v.53 no.6
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    • pp.357-367
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    • 2009
  • A meta-analysis of 63 randomized controlled trials of Pioglitazone and Rosiglitazone in patients with type 2 diabetes was conducted. Pioglitazone significantly lowered fasting plasma glucose and triglyceride (TG) level and increased high-density lipoprotein cholesterol (HDL) level. Rosiglitazone significantly lowered hemoglobin A1C level and fasting plasma glucose, whereas it increased all kinds of lipids (HDL, LDL (low-density lipoprotein cholesterol), TG, total cholesterol). In comparison, glucose lowering effect was higher in Rosiglitazone, and Pioglitazone produced a more favorable lipid profile.

Merkel cell carcinoma in the community setting: a case report

  • Callaghan, Cameron M.;Amornmarn, Rumpa
    • Radiation Oncology Journal
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    • v.36 no.2
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    • pp.163-170
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    • 2018
  • Merkel cell carcinoma (MCC) is a rare neuroendocrine tumor of the skin initially believed to arise from the Merkel cells. In the community setting a general radiation oncologist may only encounter this pathology in a handful of cases over the course of their career. Due to the low incidence of this malignancy, few prospective randomized controlled trials have ever been conducted and therefore guidelines are based on relatively lower levels of evidence upon which the clinical recommendations are made. We discuss the case of a female in her 90s presenting with a classic MCC primary lesion, as well as satellite lesions proximal to both the primary and the draining regional lymph nodes with no evidence of nodal involvement. Here we discuss the presentation, management, treatment planning, underlying pathology, results and sequelae of treatment. We also review new treatment modalities, and the most current staging systems and guidelines.