• Title/Summary/Keyword: Randomized Clinical Trials

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Serum Pleiotrophin Could Be an Early Indicator for Diagnosis and Prognosis of Non-Small Cell Lung Cancer

  • Du, Zi-Yan;Shi, Min-Hua;Ji, Cheng-Hong;Yu, Yong
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.4
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    • pp.1421-1425
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    • 2015
  • Aims: Pleiotrophin (PTN), an angiogenic factor, is associated with various types of cancer, including lung cancer. Our aim was to investigate the possibility of using serum PTN as an early indicator regarding disease diagnosis, classification and prognosis, for patients with non-small cell lung cancer (NSCLC). Methods: Significant differences among PTN levels in patients with small cell lung cancer (SCLC, n=40), NSCLC (n=136), and control subjects with benign pulmonary lesions (n=21), as well as patients with different pathological subtypes of NSCLC were observed. Results: A serum level of PTN of 300.1 ng/ml, was determined as the cutoff value differentiating lung cancer patients and controls, with a sensitivity and specificity of 78.4% and 66.7%, respectively. Negative correlations between serum PTN level and pathological differentiation level, stage, and survival time were observed in our cohort of patients with NSCLC. In addition, specific elevation of PTN levels in pulmonary tissue in and around NSCLC lesions in comparison to normal pulmonary tissue obtained from the same subjects was also observed (n=2). Conclusion: This study suggests that the serum PTN level of patients with NSCLC could be an early indicator for diagnosis and prognosis. This conclusion should be further assessed in randomized clinical trials.

Gemcitabine And Cisplatin Followed by Chemo-Radiation for Advanced Nasopharyngeal Carcinoma

  • Jamshed, Arif;Hussain, Raza;Iqbal, Hassan
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.2
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    • pp.899-904
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    • 2014
  • Concurrent chemo-radiation (CRT) has been established as the standard of care for non-metastatic loco-regionally advanced nasopharyngeal carcinoma (NPC) but recently the addition of induction chemotherapy in the already established regimen has presented an attractive multidisciplinary approach. This retrospective study was carried out to evaluate the efficacy of induction chemotherapy (IC) followed by CRT for the management of loco-regionally advanced NPC. Between July 2005 and September 2010, 99 patients were treated with cisplatin based IC followed by CRT. Induction chemotherapy included a 2 drug combination; intravenous gemcitabine $1000mg/m^2$ on day 1 and 8 and cisplatin $75mg/m^2$ on day 1 only. Radiotherapy (RT) was given as a phase treatment to a total dose of 70 Gy in 35 fractions. Concurrent cisplatin ($75mg/m^2$) was administered to all patients on days 1, 22 and 43. All patients were evaluated for tumor response and adverse effects after IC and 6 weeks after the completion of the treatment protocol. Statistical analysis was performed using SPSS version 17 and Kaplan Meier estimates were applied to project survival. Median follow-up duration was 20 months. The 5-year overall survival (OS), loco regional control (LRC) and relapse free survival (RFS) rates were 71%, 73% and 50%respectively. Acute grade 4 toxicity related to induction chemotherapy and concurrent chemo-radiation was 4% and 2% respectively, with only 3 toxicity-related hospital admissions. We conclude that induction gemcitabine and cisplatin followed by chemo-radiation is a safe and effective regimen in management of nasopharyngeal carcinoma, meriting further investigation in randomized clinical trials.

Gastric Cancer in Asian American Populations: a Neglected Health Disparity

  • Taylor, Victoria M.;Ko, Linda K.;Hwang, Joo Ha;Sin, Mo-Kyung;Inadomi, John M.
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.24
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    • pp.10565-10571
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    • 2015
  • Gastric cancer incidence rates vary dramatically by world region with East Asia having the highest rate. The Asian population of the United States (US) is growing rapidly and over 17 million Americans are of Asian descent. A majority of Chinese, Korean and Vietnamese Americans are immigrants. Americans of East and Southeast Asian descent experience marked gastric cancer disparities and the incidence rate among Korean men in the US is over five times higher than the incidence rate among non-Hispanic white men. Randomized controlled trials have provided evidence for the effectiveness of helicobacter pylori identification and eradication in preventing gastric cancer. Additionally, Japan and South Korea have both experienced improvements in gastric cancer mortality following the implementation of programs to detect early stage gastric cancers. There are currently no clear US guidelines regarding the primary and secondary prevention of gastric cancer in high-risk immigrant populations. However, it is likely that a proportion of US physicians are already recommending gastric cancer screening for Asian patients and some Asian immigrants to the US may be completing screening for gastric cancer in their native countries. Surveys of US primary care physicians and Asian American communities should be conducted to assess current provider practices and patient uptake with respect to gastric cancer prevention and control. In the absence of clinical guidelines, US health care providers who serve high-risk Asian groups could consider a shared decision-making approach to helicobacter pylori identification and eradication, as well as gastric endoscopy.

Clinical Study of Gamitaeeumjowi-tang for Obese Patients (가미태음조위탕(加味太陰調胃湯) 전탕액을 활용한 비만 환자에 대한 임상 연구)

  • Seo, Nam-Jun;Nam, Dong-Woo;Lee, Eun-Ok;Shim, Bum-Sang;Ahn, Kyoo-Seok;Kim, Sung-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.22 no.2
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    • pp.446-452
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    • 2008
  • To evaluate the anti-obesity efficacy of Gamitaeeumjowi-tang consisting of Taeeumjowitang and Daehwang. Eleven male(n=4) and female(n=7), obesity patients were recruited by Tenten Diet Network from November 2005 to February 2006. All the subjects were treated with Gamitaeeumjowi-tang 3 times a day for 12 weeks. Weight, BMI, body fat weight, Total cholesterol, LDL, HDL, Triglycerides, GOT, GPT, and CT results were evaluated before and after the 12 week treatment. Weight, BMI, body fat weight, total cholesterol, triglyceride, and subcutaneous fat in upper and lower abdomen all showed significant decrease after 12 weeks of administration. Also Gamitaeeumjowi-tang showed no toxic effects based on liver function test. Taken together, The potentials of Gamitaeeumjowi-tang as a safe and effective treatment for obesity has been recognized through this study. Further large sample sized and double blinded randomized control trials are needed to fully confirm the findings of this study.

Effect of Kegel Exercise to Prevent Urinary and Fecal Incontinence in Antenatal and Postnatal Women: Systematic Review (임신 및 출산 여성의 요실금 및 대변실금 예방을 위한 케겔운동의 효과: 체계적 문헌 고찰)

  • Park, Seong-Hi;Kang, Chang-Bum;Jang, Seon Young;Kim, Bo Yeon
    • Journal of Korean Academy of Nursing
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    • v.43 no.3
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    • pp.420-430
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    • 2013
  • Purpose: The aim of this study was to review the literature to determine whether intensive pelvic floor muscle training during pregnancy and after delivery could prevent urinary and fecal incontinence. Methods: Randomized controlled trials (RCT) of low-risk obstetric populations who had done Kegel exercise during pregnancy and after delivery met the inclusion criteria. Articles published between 1966 and 2012 from periodicals indexed in Ovid Medline, Embase, Scopus, KoreaMed, NDSL and other databases were selected, using the following keywords: 'Kegel, pelvic floor exercise'. The Cochrane's Risk of Bias was applied to assess the internal validity of the RCT. Fourteen selected studies were analyzed by meta-analysis using RevMan 5.1. Results: Fourteen RCTs with high methodological quality, involving 6,454 women were included. They indicated that Kegel exercise significantly reduced the development of urinary and fecal incontinence from pregnancy to postpartum. Also, there was low clinical heterogeneity. Conclusion: There is some evidence that for antenatal and postnatal women, Kegel exercise can prevent urinary and fecal incontinence. Therefore, a priority task is to develop standardized Kegel exercise programs for Korean pregnant and postpartum women and make efficient use of these programs.

Virtual Reality-based Training Program Using Computer-human Interface for Recovery of Upper Extremity Use in Stroke Patients (뇌졸중 환자에서 상지 회복을 위해 컴퓨터-인간 연동을 이용한 가상현실 기반 훈련 프로그램)

  • Lee, Kyoung-Hee;Hwang, Ki-Chul
    • Journal of Digital Convergence
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    • v.14 no.1
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    • pp.285-290
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    • 2016
  • To identify virtual reality (VR) interventions used for upper extremity rehabilitation in stroke patients. The Medline database was searched up to February 11, 2015. Randomized controlled and clinical trials that included a VR intervention for upper extremity rehabilitation in stroke patients were included. The Physiotherapy Evidence Database (PEDro) scale was used to assess the quality of the included studies. In total, 8 studies were included. PEDro scores varied from 5 to 8/10. All studies showed significant improvement in outcomes in favor of the VR group. This review suggests that VR applications used for upper extremity rehabilitation in stroke patients predominantly mediate learning through providing task-oriented and graduated learning with variable and unpredictable practice.

Effects of Korean Red Ginseng on Dry Mouth: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Park, Jae-Woo;Lee, Beom-Joon;Bu, Young-Min;Yeo, In-Kwon;Kim, Jin-Sung;Ryu, Bong-Ha
    • Journal of Ginseng Research
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    • v.34 no.3
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    • pp.183-191
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    • 2010
  • Dry mouth is easily neglected if not associated with oral diseases. Consequently, xerostomatic patients often use unconventional therapies. In traditional Korean medicine, Korean red ginseng (KRG) has long been used to relieve dry mouth. However, no clinical trials have investigated whether KRG actually has an effect on dry mouth. This study was performed to evaluate the efficacy of KRG for dry mouth. We enrolled 100 volunteers with no obvious oral or salivary gland diseases and divided them into KRG and placebo groups. Each group was divided into six subgroups according to age and gender. The subjects received 6 g/day of KRG or placebo for 8 weeks. The dry mouth visual analog scale (VAS), salivary flow rate, and a dry mouth-related symptom questionnaire were evaluated at baseline and at 4 and 8 weeks. KRG treatment did not show any significant differences for any of the variables. However, KRG improved the dry mouth VAS at 4 weeks and dry mouthrelated symptoms at 8 weeks in women, but not in men. Subgroup analyses revealed that KRG markedly improved the dry mouth VAS in women of menopausal age (40 to 59 years) at 4 and 8 weeks. KRG may have beneficial effects for dry mouth in women, especially those of menopausal age, but not in men. Further investigation in post- and perimenopausal women is required to elaborate on these findings.

The Effects of Sciatic Nerve Mobilization on Hamstring Flexibility, Lower Limb Strength and Gait Performance in Patients With Chronic Stroke

  • Shin, Yun-hyeok;Chon, Seung-chul
    • Physical Therapy Korea
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    • v.22 no.4
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    • pp.8-16
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    • 2015
  • The purpose of this study was to evaluate the effects of mobilization of the sciatic nerve on hamstring flexibility, lower limb strength, and gait performance in patients with chronic stroke. This study was a randomized clinical trial with a crossover design. Sixteen subjects were recruited for this study. The subjects were randomly divided into two intervention groups and underwent either of the following two interventions: sciatic nerve mobilization or static stretching of the hamstring. We assessed hamstring flexibility, lower limb strength, and gait performance using a digital inclinometer, a hand-held dynamometer, and the 10-meter walk test, respectively. Subjects had a 24-hour rest period between each session in order to minimize carryover effects. Measurements for each test were assessed prior to and immediately after the intervention sessions. Using a two-way analysis of variance test with repeated measures, data from the two trials were analyzed by comparing the differences between both techniques. The level of statistical significance was set at .05. Sciatic nerve mobilization resulted in significantly better knee extensor strength (p=.023, from $15.32{\pm}5.98$ to $18.16{\pm}6.95kg$) and knee flexor strength (p=.011, from $7.80{\pm}4.80$ to $8.15{\pm}4.24kg$) in the experimental group than in the control group. However, no significant effects of static stretching of the hamstring were observed on hamstring flexibility from the ankle plantar flexion (p=.966) and ankle neutral positions (p=.210) and on gait performance (p=.396). This study indicated that the sciatic nerve mobilization technique may be more effective in muscle activation of the knee extensor muscle and knee flexor muscle than hamstring static stretching technique in patients with chronic stroke.

Current Pharmacogenetic Approach for Oxaliplatin-induced Peripheral Neuropathy among Patients with Colorectal Cancer: A Systematic Review (대장암 환자의 옥살리플라틴(oxaliplatin) 유도 말초신경병증에 대한 약물유전학적 접근: 체계적 문헌고찰)

  • Ahn, Soojung;Choi, Soyoung;Jung, Hye Jeong;Chu, Sang Hui
    • Journal of Korean Biological Nursing Science
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    • v.20 no.2
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    • pp.55-66
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    • 2018
  • Purpose: Peripheral neuropathy is common among colorectal cancer (CRC) patients who undergo oxaliplatin-based (OXL) chemotherapy. A pharmacogenetic approach can be used to identify patients at high-risk of developing severe neuropathy. This type of approach can also help clinicians determine the best treatment option and prevent severe neurotoxicity. The purpose of this study is to investigate the evidence of pharmacogenetic markers for OXL-induced peripheral neuropathy (OXIPN) in patients with CRC. Methods: A systematic literature search was conducted using the following databases up to December 2017: Pubmed, EMBASE, and CINAHL. We reviewed the genetic risk factors for OXIPN in observational studies and randomized controlled clinical trials (RCTs). All processes were performed independently by two reviewers. Results: Sixteen studies published in English between 2006 and 2017 were included in this review. A genome-wide association approach was used in one study and various candidate genes were tested, based on their functions (e.g., DNA damage or repair, ion channels, anti-oxidants, and nerve growth etc.). The genes associated with incidence or severity of OXIPN were ABCG2, GSTP1, XRCC1, TAC1, and ERCC1. Conclusion: This study highlighted the need and the importance of conducting pharmacogenetic studies to generate evidence of personalized OXIPN symptoms management. Additional studies are warranted to accelerate the tailored interventions used for OXIPN in patients with CRC (NRF-2014R1A1A3054386).

A Systematic Review Focused on Health Behavior and Physiological Indicators of Diabetic Patients in Interventional Studies Based on Health Belief Model (건강신념모델 기반 중재연구가 당뇨환자의 건강행위와 생리적지표에 미치는 효과를 중심으로 한 체계적 문헌고찰)

  • Noh, Eun-Young;Cho, Yoonjeong;Lee, Yewon;Yun, Sunyoung
    • Journal of Korean Biological Nursing Science
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    • v.22 no.1
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    • pp.1-10
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    • 2020
  • Purpose: Diabetes Mellitus (DM) is a leading cause of death with a prevalence rate of 12.4% in South Korea. Self-management is crucial for patients with DM, because many studies have reported that self-management intervention based on the Health Belief Model (HBM) is effective. The purpose of this study was to investigate the current state of HBM based intervention studies and the components and effects of the theories used in the study for diabetes patients. Methods: A systematic review was conducted using the Pubmed, Cochrane Library and Embase databases from January 2009 to May 2019. We reviewed characteristics of intervention based on the HBM in randomized controlled clinical trials (RCTs), quasi-experimental study intervention. Results: Eight studies published in English between 2009 and 2019 were included in this review. The key components of the health behavior promotion program applied to the DM patients were perceived susceptibility, perceived severity, perceived benefits, perceived barriers and self-efficacy. The intervention based on these components has reported to significantly increase the health behavior change, likelihood of taking health action and improve physiological indicators (HbA1c, and fasting blood sugar etc.). Conclusion: This study highlighted the importance of intervention programs based on the HBM for DM patients.