• Title/Summary/Keyword: randomized clinical trials

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Paulinia cupana (Guaraná) for the treatment of cancer related fatigue in patients undergoing radiation therapy or chemotherapy: a meta-analysis of three clinical trials

  • Giglio, Auro Del;Serpa, Ary;Cubero, Daniel;Riechelman, Rachel;Paschoin, Maira
    • CELLMED
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    • v.1 no.1
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    • pp.6.1-6.4
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    • 2011
  • For cancer patients undergoing radiation therapy (RT) or systemic chemotherapy (CHT), cancer-related fatigue (CRF) is a common problem that can negatively impact their quality of life. Guarana (Paullinia cupana) is a plant native to the Amazon basin that has been used as a stimulant since pre-Columbian times. PURPOSE: To evaluate the effectiveness of guarana extract on fatigue in BC patients undergoing either CHT or RT. A total of 137 cancer patients (85% with Breast Cancer) undergoing either CHT (101) or RT (36) were randomized to receive either a placebo or guarana. In all 3 studies, the guarana was given as an unmanipulated dry extract at a dose of 75 mg PO QD in the first two studies or 50 mg PO BID in the third study. Patients were crossed over to the other experimental arm, and we evaluated fatigue with the Chalder Scale in all three studies. Guarana significantly improved the The Chalder Scale Global Scores (- 0.85; 95% CI:-1.31 to -0.40; p = 0.0002); Physical Fatigue Scores (-0.44; 95% CI: - 0.74 to - 0.13; p = 0.005) and Mental Fatigue Scores (-0.93; 95% CI: - 1.14 to - 0.72; p < 0.00001). Guarana did not produce any CTCAE grades 3 or 4 toxicities in any of the studies. Guarana is an effective, cheap and non-toxic alternative for the treatment of fatigue in cancer patients undergoing treatment.

Effects of Exercise Type on Neck Disability, Pain, and Postural Changes in Subjects with Forward Head Posture: Systematic Review and Meta-Analysis

  • Na, Jeong-Gon;Lee, Han-Suk;Park, Sun-Wook
    • Journal of the Korean Society of Physical Medicine
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    • v.13 no.3
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    • pp.121-132
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    • 2018
  • PURPOSE: This study was conducted to investigate the effects of type of exercise on neck disability, pain, and postural changes in subjects with forward head posture. METHODS: Two independent researchers conducted a search using KISS, RISS, DBpia (domestic), PubMed, OVID, and Science Direct (overseas) databases. We selected randomized controlled clinical trials by searching using the terms "forward head posture", "exercise therapy", and "therapeutic exercise". Studies published from 2007 to December 2017 were included. PEDro Scale was used to evaluate the quality of the selected studies, and meta-analysis was conducted using the CMA program. This review was registered at PROSPERO (CRD42018068633). RESULTS: Of the total 13768 studies searched, 17 were selected. Positive effects on neck disability were achieved with the base and biomechanical elements (ES=1.63, 95% confidence interval [CI] .49 to 2.75) as well as base, modulator, and biomechanical elements (ES=1.50, 95% [CI] .69 to 2.30). Neck pain improved with the base, modulator, and biomechanical elements (ES=1.96, 95% [CI] 1.08 to 2.82), while postural changes improved with biomechanical elements (ES=1.45, 95% [CI] .64 to 2.25). Additionally, type of exercise had a positive effect. CONCLUSION: The most effective exercises for neck disability are of the base and biomechanical elements, while the most effective types for neck pain are of the base, modulator, and biomechanical elements and the most effective exercise for posture is of biomechanical elements. Combined exercises targeting biomechanical elements were effective at treating disability, pain, and postural changes.

Recent Progress in Research on Anticancer Activities of Ginsenoside-Rg3 (Ginsenoside Rg3의 항암효능 연구의 진보)

  • Nam, Ki Yeul;Choi, Jae Eul;Hong, Se Chul;Pyo, Mi Kyung;Park, Jong Dae
    • Korean Journal of Pharmacognosy
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    • v.45 no.1
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    • pp.1-10
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    • 2014
  • Ginsenoside Rg3 (G-Rg3) is one of protopanaxadiol ginsenosides characteristic of red ginseng, steamed and dried ginseng (Panax ginseng), which has recently attracted much attention for its antitumor properties in vitro and in vivo animal models. Experimental studies have demonstrated that it could promote cancer cell apoptosis, inhibit cancer cell growth, the apoptosis of cancer cells, adhesion, invasion and metastasis, and also prevent an angiogenetic formation in prostate, breast, ovarian, colorectal, gastric, liver and lung cancer etc. It has shown the antitumor activities by modulation of diverse signaling pathways, including regulation of cell proliferation mediators (CDKs and cyclins), growth factors (vascular endothelial growth factor), tumor suppressors (p53 and p21), cell death mediators (caspases, Bcl-2, Bax), inflammatory response molecules ($NF-{\kappa}B$ and COX-2), protein kinases (JNK, Akt, and AMP-activated protein kinase) and Wnt/${\beta}$-catenin signaling. In addition, the combination of Rg3 and chemotherapeutic agents have synergistically enhanced therapeutic efficacy and reduced antagonistically side effects. Furthermore, it can reverse the multidrug resistance of cancer cells, prolong the survival duration and improve life quality of cancer patients. Taken together, accumulating evidences could provide the potential of G-Rg3 in the treatment of cancers and the feasibility of further randomized placebo controlled clinical trials.

Research Trends of Pattern Identification of Korean Medicine Using the Network Analysis (네트워크 분석을 통한 국내 변증 연구의 동향)

  • Jin, Hee-Jeong;Lee, JaeChul;Jang, Eunsu
    • The Journal of the Korea Contents Association
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    • v.14 no.12
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    • pp.1037-1046
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    • 2014
  • This study aims to analyze Korea's trend of 'pattern identification(PI)' research using network analysis. We selected 368 papers from OASIS (Oriental Medicine Advanced Searching Integrated System) by review of two Korean medicine experts. Network analysis between keyword of PI studies were performed. As a result, number of PI studies has increased over the last 10 years. 'Korean journal of oriental physiology and pathology' and 'Journal of Korean oriental internal medicine' have published most papers related to PI. As research category, there are 144 papers in the cross-sectional study, and 71 papers in case report study. In the case of randomized clinical trials, there are only 3 papers. In studies for PI, stroke, pattern analysis, and blood stasis were the keywords make up the main network.

Higher dextrose delivety via TPN related to the development of hyperglycemia in non-diabetic critically ill patients

  • Lee, Ho-Sun;Koh, Shin-Ok;Park, Moo-Suk
    • Nutrition Research and Practice
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    • v.5 no.5
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    • pp.450-454
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    • 2011
  • The beneficial effects of total parenteral nutrition (TPN) in improving the nutritional status of malnourished patients during hospital stays have been well established. However, recent randomized trials and meta-analyses have reported an increased rate of TPN-associated complications and mortality in critically ill patients. The increased risk of complications during TPN therapy has been linked to the development of hyperglycemia, especially during the first few days of TPN therapy. This retrospective study was conducted to determine whether the amount of dextrose from TPN in the 1st week in the intensive care unit (ICU) was related to the development of hyperglycemia and the clinical outcome. We included 88 non-diabetic critically ill patients who stayed in the medical ICU for more than two days. The subjects were 65 ${\pm}$ 16 years old, and the mean APACHE (Acute Physiology and Chronic Health Evaluation) II score upon admission was 20.9${\pm}$7.1. The subjects received 2.3${\pm}$1.4 g/kg/day of dextrose intravenously. We divided the subjects into two groups according to the mean blood glucose (BG) level during the 1st week of ICU stay: <140 mg/dl vs ${\geq}$ 140 mg/dl. Baseline BG and the amount of dextrose delivered via TPN were significantly higher in the hyperglycemia group than those in the normoglycemia group. Mortality was higher in the hyperglycemia group than in the normoglycemia group (42.4% vs 12.8%, P=0.008). The amount of dextrose from TPN was the only significant variable in the multiple linear regression analysis, which included age, APACHE II score, baseline blood glucose concentration and dextrose delivery via TPN as independent variables. We concluded that the amount of dextrose delivered via TPN might be associated with the development of hyperglycemia in critically ill patients without a history of diabetes mellitus. The amount of dextrose in TPN should be decided and adapted carefully to maintain blood glucose within the target range.

The Effects of Diabetes Management Programs using Mobile App: A Systematic Review and a Meta-Analysis (모바일 앱을 이용한 당뇨환자관리의 효과: 체계적 문헌고찰과 메타분석)

  • Kim, Hee Eon;Kim, EunJa;Kim, Gaeun
    • The Journal of the Korea Contents Association
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    • v.15 no.1
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    • pp.300-307
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    • 2015
  • The purpose of this review was to evaluate the effects of diabetes management program using mobile appllication. A systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA Statement was conducted. Studies published between 2004 and 2014 were reviewed using the following databases: Ovid, CINAHL and Cochrane library. The keywords used were (app*OR mobile) AND (nurs* OR health* OR medic*) AND (diabet*). Selected studies were assessed for methodological quality using Scottish Intercollegiate Guidelines Network (SIGN)' Checklist. Three hundred seventy five studies were identified, All the 3 studies found mobile application as a valid strategy on clinical usefulness in diabetes management. This review provides updated evidence for app-based management program in diabetes management. Further studies are needed to increase generalizability using randomized controlled trials, enough sample size. In addition, valid measurements are needed to assess the main outcomes.

Phase II Study on Safety and Efficacy of Yadanzi® (Javanica oil emulsion injection) Combined with Chemotherapy for Patients with Gastric Cancer

  • Liu, Jin;Huang, Xin-En;Tian, Guang-Yu;Cao, Jie;Lu, Yan-Yan;Wu, Xue-Yan;Xiang, Jin
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.3
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    • pp.2009-2012
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    • 2013
  • Objective: To investigate the efficacy and safety of Yadanzi$^{(R)}$ (Javanica oil emulsion injection) combined with chemotherapy for treatment of patients with advanced gastric cancer. Methods: From January 2011 to December 2012, we recruited 75 patients with advanced gastric cancer, who received javanica oil emulsion injection together with chemotherapy. After two cycles of treatment, efficacy and safety of the combined therapies were evaluated. Results: Overall response rate of 75 patients after treatment was 85.3% (CR+PR+SD). Treatment related side effects were recorded. No treatment related death occurred. Conclusions: Javanica oil emulsion injection combined with chemotherapy could be considered as a safe and effective regimen in treating patients with advanced gastric cancer. Further randomized clinical trials should be conducted to confirm whether the addition of Yadanzi$^{(R)}$ to chemotheraphy could be associated with reduced toxicity, enhanced tolerability and improved quality of life for patients with advanced gastric cancer.

Lung Cancer Screening with Low-dose Computed Tomography (저선량 CT를 이용한 폐암의 선별 검사)

  • Hwang, Jung Hwa
    • Tuberculosis and Respiratory Diseases
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    • v.57 no.2
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    • pp.118-124
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    • 2004
  • Lung cancer is the leading cause of cancer death for men and women in the industrialized world. It is desirable to detect disease at a stage when it is not causing symptoms and when control or cure is possible. If the screening test detects patients with the disease at an early stage, they can be examined to confirm the diagnosis and intervention can alter the natural history of the disease. The results of screening programs designed to detect early lung cancer using either conventional chest radiograph or sputum cytology are disappointing for a diagnostic screening test. Because of advances in helical CT imaging techniques, screening for lung cancer has been suggested as a possible method of improving outcome. Findings in recent publications suggest that substantial dose reduction is possible in chest CT. The advantages of low-dose CT are more sensitive than chest radiograph for detecting small pulmonary nodules that may be lung cancers, shorter scanning time than conventional chest CT scan without intravenous contrast injection, cheaper cost than standard CT, low radiation dose. However, the true clinical significance of the small tumors found by screening is still unknown, and their effect on mortality awaits future investigation. Furthermore, in addition to detecting an increased number of lung cancers, low-dose CT found at least one indeterminate nodule in many of all screened patients. The majority should be benign but evaluation of all these indeterminate nodules is not a trivial problem in routine practice. In conclusion, lung cancer screening with low-dose CT is a complex subject. The true effectiveness of lung cancer screening (a reduction in mortality from lung cancer) with low-dose CT can be determined through well-designed randomized control trials with enrolment of appropriate subjects.

Efficacy of Single-Dose Antimicrobial Prophylaxis for Preventing Surgical Site Infection in Radical Gastrectomy for Gastric Carcin

  • Han, Ji Hoon;Jeong, Oh;Ryu, Seong Yeop;Jung, Mi Ran;Park, Young Kyu
    • Journal of Gastric Cancer
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    • v.14 no.3
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    • pp.156-163
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    • 2014
  • Purpose: Information regarding antimicrobial prophylaxis (AMP) for gastric cancer surgery is limited. The present study investigated the efficacy of single-dose AMP for the prevention of surgical site infection (SSI) in patients undergoing gastrectomy for gastric carcinoma. Materials and Methods: Between 2011 and 2013, 1,330 gastric carcinoma surgery patients were divided into two AMP administration groups depending on the duration of treatment. Postoperative outcomes including morbidity and SSI were compared between the two groups overall and in matched patients. Risk factors for SSI were analyzed. Results: The extended group (n=1,129) received AMP until postoperative day 1 and the single-dose group (n=201) received single-dose AMP only during an operation. Postoperatively, there were no significant differences between the two groups with respect to overall morbidity, mortality, or length of hospital stay. The SSI rate of the single-dose group was not significantly different from that of the extended group overall (4.5% vs. 5.5%, respectively, P=0.556) or in matched patients (4.5% vs. 4.0%, respectively, P=0.801). There was no increase in the SSI rate of the single-dose group compared to the extended group in subgroups based on different clinicopathological and operative factors. Univariate and multivariate analyses revealed male gender, open surgery, and operating time (${\geq}180$ minutes) as independent risk factors for SSI. Conclusions: Single-dose AMP showed no increase in the postoperative SSI rate compared to postoperative extended use in patients undergoing gastrectomy for gastric carcinoma. The efficacy of single-dose AMP requires further investigation in randomized clinical trials specific to gastric cancer surgery.

Research Trends in Complementary Medical Therapy for the Common Cold (감기에 대한 보완 의학적 연구 동향 - Pubmed를 중심으로 -)

  • Lim, Do-Hee;Hwang, Ji-Ho;Yang, Soo-Young;Shim, Jae-Chul;Chae, Eun-Young;Park, Yang-Chun
    • The Journal of Korean Medicine
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    • v.27 no.3 s.67
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    • pp.151-168
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    • 2006
  • Objectives: To help the Oriental medicine clinical studies for the common cold treatment, this study analyzed the tendency of research into complementary medicine on the common cold recently published in PubMed. Methods: This study analyzed 26 research papers on complementary medicine on the common cold published in PubMed Over the past 10 years. It measured annually and for each country the number of papers published, the number of subjects, the period of research, the area of trial, the method of study, the objective of study, and intervention, respectively and intervention, the objective of study, and the result of trials overall. Results: There were research papers concerning treatment, prevention, safety of herbal medicine, inducement, and improvement of symptoms of the common cold in the study objective the most among them concerned treatment of the common cold. There were more positive results compared to negative results for treatment and prevention. The results for safety and symptom improvement were positive, while the results for the inducement were indeterminate. There were research papers about using food and medicine, acupuncture, hydrotherapy, and cold exposure in intervention the most among them were about using food and medicine. The food and medicine interventions were Echinacea preparations, vitamins, zinc preparations, Baptisia, Thuja, the root of North American ginseng, probiotic bacteria, troxerutin, garlic, Andrographis paniculata, and caffeine. The use of Echinacea preparations was the most frequent among them. Conclusions: Recent research results of complementary medicine on the common cold were more positive than negative.

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