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Sample records for bypass grafting-a double-blind

  1. Low dose Colchicine in prevention of atrial fibrillation after coronary artery bypass graft: a double blind clinical trial

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    Mahmoodreza Sarzaeem

    2014-06-01

    Conclusion: Colchicine is an anti-inflammatory medication and has very few side effects at low doses. According to the 48% reduction in the incidence of atrial fibrillation in Colchicine patients undergoing coronary artery bypass grafting surgery, this drug can be prescribed as a prophylaxis for prevention of post-CABG atrial fibrillation.

  2. Preoperative carbohydrate load and intraoperatively infused omega-3 polyunsaturated fatty acids positively impact nosocomial morbidity after coronary artery bypass grafting: a double-blind controlled randomized trial.

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    Feguri, Gibran Roder; de Lima, Paulo Ruiz Lúcio; de Cerqueira Borges, Danilo; Toledo, Laura Ramos; Batista, Larissa Nadaf; E Silva, Thaís Carvalho; Segri, Neuber José; de Aguilar-Nascimento, José Eduardo

    2017-04-20

    A strategy of limited preoperative fasting, with carbohydrate (CHO) loading and intraoperative infusion of omega-3 polyunsaturated fatty acids (ω-3 PUFA), has seldom been tried in cardiovascular surgery. Brief fasting, followed by CHO intake 2 h before anesthesia, may improve recovery from CABG procedures and lower perioperative vasoactive drug requirements. Infusion of ω-3 PUFA may reduce occurrences of postoperative atrial fibrillation (POAF) and shorten hospital stays. The aim of this study was to assess morbidity (especially POAF) in ICU patients after coronary artery bypass grafting (CABG)/cardiopulmonary bypass (CPB) in combination, if preoperative fasts are curtailed in favor of CHO loading, and ω-3 PUFA are infused intraoperatively. Fifty-seven patients undergoing CABG were randomly assigned to receive 12.5% maltodextrin (200 ml, 2 h before anesthesia), without infusing ω-3 PUFA (CHO, n = 14); water (200 ml, 2 h before anesthesia), without infusing ω-3 PUFA (controls, n = 14); 12.5% maltodextrin (200 ml, 2 h before anesthesia) plus intraoperative ω-3 PUFA (0.2 mcg/kg) (CHO + W3, n = 15); or water (200 ml, 2 h before anesthesia) plus intraoperative ω-3 PUFA (0.2 mcg/kg) (W3, n = 14). Perioperative clinical variables and mortality were analyzed, examining the incidence of POAF, as well as the need for inotropic vasoactive drugs during surgery and in ICU. Two deaths occurred (3.5%), but there were no instances of bronchoaspiration and mediastinitis. Neither ICU stays nor total postoperative stays differed by group (P > 0.05). Patients given preoperative CHO loads (CHO and CHO + W3 groups) experienced fewer instances of hospital infection (RR = 0.29, 95%CI 0.09-0.94; P = 0.023) and were less reliant on vasoactive amines during surgery (RR = 0.60, 95% CI 0.38-0.94; P = 0.020). Similarly, the number of patients requiring vasoactive drugs while recovering in ICU differed significantly by group (P = 0

  3. Low-Level Laser and Light-Emitting Diode Therapy for Pain Control in Hyperglycemic and Normoglycemic Patients Who Underwent Coronary Bypass Surgery with Internal Mammary Artery Grafts: A Randomized, Double-Blind Study with Follow-Up.

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    Lima, Andréa Conceição Gomes; Fernandes, Gilderlene Alves; Gonzaga, Isabel Clarisse; de Barros Araújo, Raimundo; de Oliveira, Rauirys Alencar; Nicolau, Renata Amadei

    2016-06-01

    This study aimed to evaluate the efficacy of low-level laser therapy (LLLT) and light-emitting diodes (LEDs) for reducing pain in hyperglycemic and normoglycemic patients who underwent coronary artery bypass surgery with internal mammary artery grafts. This study was conducted on 120 volunteers who underwent elective coronary artery bypass graft (CABG) surgery. The volunteers were randomly allocated to four different groups of equal size (n = 30): control, placebo, LLLT [λ = 640 nm and spatial average energy fluence (SAEF) = 1.06 J/cm(2)], and LED (λ = 660 ± 20 nm and SAEF = 0.24 J/cm(2)). Participants were also divided into hyperglycemic and normoglycemic subgroups, according to their fasting blood glucose test result before surgery. The outcome assessed was pain during coughing by a visual analog scale (VAS) and the McGill Pain Questionnaire. The patients were followed for 1 month after the surgery. The LLLT and LED groups showed a greater decrease in pain, with similar results, as indicated by both the VAS and the McGill questionnaire (p ≤ 0.05), on the 6th and 8th postoperative day compared with the placebo and control groups. The outcomes were also similar between hyperglycemic and normoglycemic patients. One month after the surgery, almost no individual reported pain during coughing. LLLT and LED had similar analgesic effects in hyperglycemic and normoglycemic patients, better than placebo and control groups.

  4. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial.

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    Whitlock, Richard P; Devereaux, P J; Teoh, Kevin H; Lamy, Andre; Vincent, Jessica; Pogue, Janice; Paparella, Domenico; Sessler, Daniel I; Karthikeyan, Ganesan; Villar, Juan Carlos; Zuo, Yunxia; Avezum, Álvaro; Quantz, Mackenzie; Tagarakis, Georgios I; Shah, Pallav J; Abbasi, Seyed Hesameddin; Zheng, Hong; Pettit, Shirley; Chrolavicius, Susan; Yusuf, Salim

    2015-09-26

    Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared

  5. Gabapentin May Relieve Post-Coronary Artery Bypass Graft Pain: A Double Blind Randomized Clinical Trial

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    MSoltanzadeh

    2011-09-01

    Full Text Available Background: One of the most common complaints after coronary artery bypass graft (CABG is post-operative pain. Gabapentin is an anticonvulsant and antineuralgic agent. Objective: To evaluate the analgesic effect of preemptive gabapentin on post-operative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial was conducted on 60 male candidates for CABG. The patients were divided into two groups—the gabapentin (n=30 and the control group (n=30. The test group received 800 mg gabapentin orally two hours before the surgery followed by 400 mg of the drug two hours post-extubation. The control group received placebo instead. Then severity of pain was recorded according to an 11-point visual analog pain scale. The amount of morphine consumed, its side effects and hemodynamic changes were also recorded during and at 2, 6, 12, 18 and 24 hours after extubation. Results: The mean±SD cumulative morphine consumption at the first 24 hours after extubation in gabapentin group was 0.9±1.5 mg while it was 1.5±4 mg for the control group. Therefore, gabapentin group consumed 38% less than the control group (P=0.01. The pain scores during rest and coughing at 2, 6, and 12 hours after extubation were also significantly lower in the gabapentin group compared with the control group (P=0.02. The mean±SD mechanical ventilation time was 5.4±1.7 hours for gabapentin group and 1.6±4.4 hours for the control group (P=0.035. The other variables including hemodynamic changes (HR, SBP and DBP, and incidence of nausea, vomiting and respiratory depression showed no significant difference between the studied groups within 24 hours after extubation. Conclusion: Oral pre-medication with gabapentin before CABG significantly reduces post-operative pain and morphine consumption in adult cardiac surgery.

  6. Plasma-Lyte 148 vs. Hartmann's solution for cardiopulmonary bypass pump prime: a prospective double-blind randomized trial.

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    Weinberg, Laurence; Chiam, Elizabeth; Hooper, James; Liskaser, Frank; Hawkins, Angela Kim; Massie, Denise; Ellis, Andrew; Tan, Chong O; Story, David; Bellomo, Rinaldo

    2017-11-01

    The mechanisms of acid-base changes during cardiopulmonary bypass (CPB) remain unclear. We tested the hypothesis that, when used as CPB pump prime solutions, Plasma-Lyte 148 (PL) and Hartmann's solution (HS) have differential mechanisms of action in their contribution to acid-base changes. We performed a prospective, double-blind, randomized trial in adult patients undergoing elective cardiac surgery with CPB. Participants received a CPB prime solution of 2000 mL, with either PL or HS. The primary endpoint was the standard base excess (SBE) value measured at 60 minutes after full CPB flows (SBE60min). Secondary outcomes included changes in SBE, pH, chloride, sodium, lactate, gluconate, acetate, strong ion difference and strong ion gap at two (T2min), five (T5min), ten (T10min), thirty (T30min) and sixty (T60min) minutes on CPB. The primary outcome was measured using a two-tailed Welch's t-test. Repeated measures ANOVA was used to test for differences between time points. Twenty-five participants were randomized to PL and 25 to HS. Baseline characteristics, EURO and APACHE scores, biochemistry, hematology and volumes of cardioplegia were similar. Mean (SD) SBE at T60min was -1.3 (1.4) in the PL group and -0.1 (2.7) in the HS group; p=0.55. No significant differences in SBE between the groups was observed during the first 60 minutes (p=0.48). During CPB, there was hyperacetatemia and hypergluconatemia in the PL group and hyperlactatemia and hyperchloremia in the HS group. No significant difference between the groups in plasma bicarbonate levels and total weak acid levels were found. Complications and intensive care unit and hospital length of stays were similar. During CPB, PL and HS did not cause a significant metabolic acidosis. There was hyperacetatemia and hypergluconatemia with PL and hyperchloremia and hyperlactatemia with HS. These physiochemical effects appear clinically innocuous.

  7. A randomized, double-blind, placebo-controlled trial of a COX-2 inhibitor (Rofecoxib) in patients undergoing coronary artery bypass surgery.

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    Wong, Poo-Sing; Asmat, Atasha; Chan, Yiong-Huak; Lee, Chuen-Neng

    2006-04-01

    The endothelium of patients with coronary artery disease shows increased expression of cyclooxygenase-2 (COX-2) during coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass. This, together with serotonin, may lead to coronary microvessel spasm, which potentially, can contribute to myocardial ischemia and injury after surgery. We performed a randomized, double-blind, placebo-controlled trial in patients undergoing isolated CABG to determine whether short-term treatment with a selective COX-2 inhibitor, Rofecoxib (25 mg), given preoperatively and for 5 days after operation, can offer better myocardial protection in patients undergoing CABG by measuring serial cardiac troponin T (cTnT) levels. The study was powered to recruit 150 consecutive patients undergoing isolated CABG but the study was terminated prematurely by the worldwide withdrawal of rofecoxib. There were highly statistically significant (P<0.001) increases in cTnT in both groups at each time point (1, 6, 24 and 48 h after onset of cardiopulmonary bypass) compared to preoperative levels. cTnT levels were similar at all post-operative time points between the 2 groups. There is no evidence that short-term treatment with rofecoxib has a myocardial protective effect in patients undergoing CABG. There is also no evidence that its effect is deleterious to the myocardium in patients undergoing CABG.

  8. Vitamin C in prevention of atrial fibrillation after coronary artery bypass graft: double blind randomized clinical trial

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    Mahmoodreza Sarzaeem

    2014-03-01

    Conclusion: Vitamin C is relatively safe, inexpensive, well tolerated and has a low complication. According to the 44% reduction in the incidence of atrial fibrillation in vitamin C patients undergoing coronary artery bypass grafting surgery, this drug can be prescribed as a prophylaxis for prevention of post-CABG atrial fibrillation.

  9. Cardioprotective effect of sevoflurane and propofol during anaesthesia and the postoperative period in coronary bypass graft surgery: a double-blind randomised study.

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    Soro, Marina; Gallego, Lucía; Silva, Vanessa; Ballester, María T; Lloréns, Julio; Alvariño, Ana; García-Perez, María L; Pastor, Ernesto; Aguilar, Gerardo; Martí, Francisco J; Carratala, Arturo; Belda, F Javier

    2012-12-01

    Volatile anaesthetics may have direct cardioprotective properties due to effects similar to ischaemic preconditioning and postconditioning. Clinical results in cardiac surgery patients are controversial and may be related to the timing of administration of anaesthetics intraoperatively. We hypothesised that the cardioprotective effect of sevoflurane in coronary bypass graft surgical patients would be greater if administration during anaesthesia continued in the ICU for at least 4 h postoperatively until weaning from mechanical ventilation. Double-blind, double-dummy, prospective, randomised and controlled clinical trial. In a single centre between June 2006 and June 2007. Seventy-five adult patients were assigned randomly to receive anaesthesia and postoperative sedation either with propofol (control, n = 37) or sevoflurane (n = 36). Myocardial biomarkers were measured before surgery, at the time of admission to the intensive care unit and at 6, 24, 48 and 72 h. The need for inotropic support, and lengths of stay in the intensive care unit and hospital were also recorded. Elevation of myocardial biomarkers was the primary endpoint. The secondary endpoints were haemodynamic events and lengths of stay in the intensive care unit and hospital. Necrosis biomarkers increased significantly in the postoperative period in both groups with no significant differences at any time. Inotropic support was needed in 72.7 and 54.3% of patients in the propofol and sevoflurane groups, respectively (P = 0.086). There were no significant differences in haemodynamic variables, incidence of arrhythmias, myocardial ischaemia or and lengths of stay in the ICU and hospital between the two groups. In patients undergoing coronary bypass graft surgery, continuous administration of sevoflurane as a sedative in the ICU for at least 4 h postoperatively did not yield significant improvements in the extent and time course of myocardial damage biomarkers compared to propofol.

  10. Minimally invasive coronary artery bypass grafting: a systematic review.

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    Kikuchi, Keita; Mori, Makoto

    2017-06-01

    To minimize surgical morbidity in coronary artery bypass grafting, minimally invasive cardiac surgery has gained popularity. Minimally invasive coronary artery bypass grafting offers unique advantages compared to conventional off-pump coronary artery bypass or minimally invasive direct coronary artery bypass in that it enables the surgeon to harvest and graft bilateral internal thoracic arteries via a small thoracotomy while being conducted completely off-pump. This review focuses on current evidence behind off-pump coronary artery bypass, multi-arterial revascularization, patient populations that would most benefit from bilateral internal thoracic artery minimally invasive coronary artery bypass grafting, the surgical technique, and early outcomes. By overcoming the perceived inability to utilize bilateral internal thoracic arteries in minimally invasive coronary artery bypass grafting, the new technique further expands the armamentarium of surgeons and cardiologists. Hybrid coronary revascularization with bilateral internal thoracic artery minimally invasive coronary artery bypass grafting further augments the appeal of the next generation of minimally invasive cardiac surgery.

  11. Effect of metformin pretreatment on myocardial injury during coronary artery bypass surgery in patients without diabetes (MetCAB): a double-blind, randomised controlled trial

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    El Messaoudi, S.; Nederlof, R.; Zuurbier, C.J.; Swieten, H.A. van; Pickkers, P.; Noyez, L.; Dieker, H.J.; Coenen, M.J.H.; Donders, A.R.T.; Vos, A.; Rongen, G.A.P.J.M.; Riksen, N.P.

    2015-01-01

    BACKGROUND: During coronary artery bypass graft (CABG) surgery, ischaemia and reperfusion damage myocardial tissue, and increased postoperative plasma troponin concentration is associated with a worse outcome. We investigated whether metformin pretreatment limits cardiac injury, assessed by troponin

  12. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial.

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    Thielmann, Matthias; Kottenberg, Eva; Kleinbongard, Petra; Wendt, Daniel; Gedik, Nilgün; Pasa, Susanne; Price, Vivien; Tsagakis, Konstantinos; Neuhäuser, Markus; Peters, Jürgen; Jakob, Heinz; Heusch, Gerd

    2013-08-17

    Remote ischaemic preconditioning has been associated with reduced risk of myocardial injury after coronary artery bypass graft (CABG) surgery. We investigated the safety and efficacy of this procedure. Eligible patients were those scheduled to undergo elective isolated first-time CABG surgery under cold crystalloid cardioplegia and cardiopulmonary bypass at the West-German Heart Centre, Essen, Germany, between April, 2008, and October, 2012. Patients were prospectively randomised to receive remote ischaemic preconditioning (three cycles of 5 min ischaemia and 5 min reperfusion in the left upper arm after induction of anaesthesia) or no ischaemic preconditioning (control). The primary endpoint was myocardial injury, as reflected by the geometric mean area under the curve (AUC) for perioperative concentrations of cardiac troponin I (cTnI) in serum in the first 72 h after CABG. Mortality was the main safety endpoint. Analysis was done in intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT01406678. 329 patients were enrolled. Baseline characteristics and perioperative data did not differ between groups. cTnI AUC was 266 ng/mL over 72 h (95% CI 237-298) in the remote ischaemic preconditioning group and 321 ng/mL (287-360) in the control group. In the intention-to-treat population, the ratio of remote ischaemic preconditioning to control for cTnI AUC was 0·83 (95% CI 0·70-0·97, p=0·022). cTnI release remained lower in the per-protocol analysis (0·79, 0·66-0·94, p=0·001). All-cause mortality was assessed over 1·54 (SD 1·22) years and was lower with remote ischaemic preconditioning than without (ratio 0·27, 95% CI 0·08-0·98, p=0·046). Remote ischaemic preconditioning provided perioperative myocardial protection and improved the prognosis of patients undergoing elective CABG surgery. German Research Foundation. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. The effect of epsilon-aminocaproic acid and aprotinin on fibrinolysis and blood loss in patients undergoing primary, isolated coronary artery bypass surgery: a randomized, double-blind, placebo-controlled, noninferiority trial.

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    Greilich, Philip E; Jessen, Michael E; Satyanarayana, Neeraj; Whitten, Charles W; Nuttall, Gregory A; Beckham, Joseph M; Wall, Michael H; Butterworth, John F

    2009-07-01

    Until recently, aprotinin was the only antifibrinolytic drug with a licensed indication in cardiac surgery in the United States. The most popular alternative, epsilon-aminocaproic acid (EACA), has not been adequately compared with aprotinin. We undertook this study to test the hypothesis that EACA, when dosed appropriately, is not inferior to aprotinin at reducing fibrinolysis and blood loss. Seventy-eight patients scheduled for primary, isolated coronary artery bypass graft surgery were randomly assigned to receive "full Hammersmith" dose aprotinin, high dose EACA (100 mg/kg initial loading dose, 5 g in the pump prime solution, 30 mg x kg(-1) x h(-1) maintenance infusion) or equal volumes of a saline-placebo in a double-blind trial. Reductions in peak D-dimer formation (a measure of fibrinolysis) and 24-h chest tube drainage (CTD) were the primary end points by which noninferiority of EACA was tested. The noninferiority limit was set at a 30% increase in peak D-dimer formation (a difference of 250 microg/mL) and 24-h CTD (a difference of 350 mL) relative to aprotinin. The between-group differences (EACA versus aprotinin) in peak D-dimer formation (-3.58 microg/L, 95% CI -203 to 195 microg/L) and 24-h CTD (67 mL, 95% CI -90 to 230 mL) were within the predetermined noninferiority margins (250 microg/mL and 350 mL, respectively) and satisfied the criteria for noninferiority. Compared with saline, significant between-group reductions in peak D-dimer formation were observed using EACA (589 microg/L, 95% CI 399-788 microg/L; P < 0.0001) and aprotinin (585 microg/L, 95% CI 393-778 microg/L; P < 0.0001). Similar reductions in 24 h CTD were also seen using EACA (239 mL, 95% CI 50-415 mL; P < 0.05) and aprotinin (323 mL, 95% CI 105-485 mL; P < 0.05) compared with saline. Plasma EACA levels were maintained well above a target of 260 microg/mL. When dosed in a pharmacologically guided manner, EACA is not inferior to aprotinin in reducing fibrinolysis and blood loss in

  14. Concomitant aorto-right subclavian artery bypass with off-pump coronary artery bypass grafting: a case report.

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    Tazume, Hirokazu; Okamoto, Ken; Fukui, Toshihiro

    2017-10-11

    Atherosclerotic stenosis of the brachiocephalic artery sometimes occurs in patients with coronary artery disease, and can cause stroke during the perioperative period of coronary artery bypass grafting. We describe the case of a 77-year old male with severe stenosis of the brachiocephalic artery and severe coronary artery disease. He successfully underwent aorto-right subclavian artery bypass that was performed concomitantly with off-pump coronary artery bypass. Concomitant aorto-subclavian artery bypass with off-pump coronary artery bypass grafting is a therapeutic option that minimizes the risk of perioperative stroke in patients with brachiocephalic artery stenosis and coronary artery disease.

  15. Left Atrial Myxoma Following Coronary Artery Bypass Grafting with Patient Coronary Arterial Grafts: a Rarity.

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    Patel, Kartik; Rahul, Kumar; Tarsaria, Malkesh; Malhotra, Amber

    2017-01-01

    The development of left atrial myxoma after coronary artery bypass graft surgery is a rare entity. A 60-year-old man with previous off-pump coronary artery bypass grafting four years ago with patent coronary grafts was diagnosed with left atrial mass. The patient underwent successful resection of the same through minimally invasive right anterolateral thoracotomy. Histopathology of the atrial mass confirmed the diagnosis of atrial myxoma.

  16. Outcome of coronary endarterectomy with off-pump coronary artery bypass grafting: A retrospective study

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    Redoy Ranjan

    2017-09-01

    Full Text Available In this study, we assessed the outcome of surgical revascularization technique, coronary artery bypass grafting (CABG with or without coronary endarterectomy for patients with diffuse coronary artery disease in a single surgeon’s practice on 2,189 patients from January 2009 and December 2016. The variables like intubation time, ICU stay, postoperative myocardial infarction, arrhythmia, renal impairment, stroke and ICU mortality were compared. Among these patients, 1,000 patients required coronary endarterectomy in addition to off-pump coronary artery bypass grafting (OPCABG. Initially, the mortality and incidence of postoperative blood transfusion were higher in the group of patients who had coronary endarterectomy in addition to CABG. However, postoperative combined use of heparin, warfarin and double anti-platelet agent was associated with decreased mortality significantly in our study. In comparison to other group, the patients in the combined coronary endarterectomy with CABG group had a higher incidence of male sex, past myocardial infarction and poor left ventricular function. Total myocardial revascularization is attainable when coronary endarterectomy is performed in addition to off-pump coronary artery bypass graft surgery in diffuse coronary artery disease.

  17. Enterobacter cloacae infection of an expanded polytetrafluoroethylene femoral-popliteal bypass graft: a case report

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    Schilling Jolyon

    2010-05-01

    Full Text Available Abstract Introduction Enterobacter cloacae infections are common among burn victims, immunocompromised patients, and patients with malignancy. Most commonly these infections are manifested as nosocomial urinary tract or pulmonary infections. Nosocomial outbreaks have also been associated with colonization of certain surgical equipment and operative cleaning solutions. Infections of an aortobifemoral prosthesis, an aortic graft, and arteriovenous fistulae are noted in the literature. To our knowledge, this is the first isolated account of an E. cloacae infection of a femoral-popliteal expanded polytetrafluoroethylene bypass graft. Case presentation A 68-year-old Caucasian man presented with fever and rest pain in the right lower extremity five months after the placement of a vascular expanded polytetrafluoroethylene graft for femoral-popliteal bypass. Computed tomography angiography demonstrated peri-graft fluid that was aspirated percutaneously with image guidance and cultured to reveal E. cloacae. The graft was revised and then removed. The patient completed a six-week course of ceftazidime and is currently without signs of infection. There were no other reports of E. cloacae graft infections in any patients receiving treatment in the same surgical suite within a month of this report. Conclusion Isolated cases of E. cloacae infection of surgical bypass grafts are rare (unique in this setting. Clinicians should have a high index of suspicion for device contamination in such cases and should consider testing for possible microbial reservoirs. Graft removal is required due to the formation of biofilm and the recent emergence of Enterobacteriaceae producing extended-spectrum beta-lactamase in community acquired infections.

  18. Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial.

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    Weimar, Christian; Bilbilis, Konstantinos; Rekowski, Jan; Holst, Torulv; Beyersdorf, Friedhelm; Breuer, Martin; Dahm, Manfred; Diegeler, Anno; Kowalski, Arne; Martens, Sven; Mohr, Friedrich W; Ondrášek, Jiri; Reiter, Beate; Roth, Peter; Seipelt, Ralf; Siggelkow, Markus; Steinhoff, Gustav; Moritz, Anton; Wilhelmi, Mathias; Wimmer-Greinecker, Gerhard; Diener, Hans-Christoph; Jakob, Heinz; Ose, Claudia; Scherag, Andre; Knipp, Stephan C

    2017-10-01

    The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG. Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days. From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, -3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes. Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing. URL: https://www.controlled-trials.com. Unique identifier: ISRCTN13486906. Copyright © 2017 The Author(s).

  19. Towards Spirituality After Coronary Artery bypass grafting: A Hermeneutic Phenomenological Study

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    Mohammad Abbasi

    2017-03-01

    Full Text Available Abstract Background and Objectives: Patients are oriented towards spirituality after coronary artery bypass grafting (CABG. The aim of this study was to explore the patients’ spiritual experiences after CABG. Methods: This qualitative study was conducted using hermeneutic phenomenology. 11 participants (7 males and 4 females were interviewed in Tehran Heart Center Hospital in 2013 using maximum variation along with purposive sampling methods. The interviews were recorded and then converted to texts word for word. The texts were analyzed using van Manen six-step method. Results: The main theme of the contents which were experienced by the participants was spirituality and its sub contents were: trust in God, Supplicating to the Prophet and Imams, and accepting the will of God. Conclusion: The findings showed that the participants who had undergone surgery on coronary artery bypass grafting had a rise in spirituality. They took advantage of spirituality to handle their problems. Using the research findings, members of the treatment team, especially nurses, can use this study to advance care planning and to train patients and their families better.

  20. Postoperative neuralgia in the leg after saphenous vein coronary artery bypass graft: a prospective study.

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    Nair, U R; Griffiths, G; Lawson, R A

    1988-01-01

    The degree of cutaneous sensory deficit in the leg was assessed after removal of the long saphenous vein in 50 consecutive patients undergoing coronary artery bypass vein grafts randomly assigned subcutaneous sutures or a single layer of sutures. Removal of the vein and repair of the leg incision were done by the same team of surgeons. In group 1 (25 patients) the leg incision was repaired with "00" Dexon subcutaneous and "00" prolene subcuticular sutures while in group 2 (25 patients) closure was effected by a single layer of interrupted "00" nylon sutures. All had crepe pressure bandage from the base of the toes to the groin for the first 24 hours followed by TED stockings for six to eight weeks. Sutures were removed on the eighth postoperative day. Cutaneous sensation in the leg and ankle was assessed 48 hours, seven days, and six to eight weeks after surgery, and a final comparison of the cosmetic effects and sensory perception after one year or more was made in 37 patients. There were no major differences between the groups at 48 hours in sensory abnormalities (anaesthesia, hyperaesthesia, and pain) but sensory recovery was significantly better in group 2 at the second and third assessments. There was some reduction in sensory abnormalities at the final review in group 1. No appreciable difference was noted in the quality of the scar between the two groups. We conclude that cutaneous sensation is better preserved by repairing the leg incision in a single layer. Subcutaneous sutures may produce neuropraxia of the long saphenous nerve by direct pressure as healing progresses. PMID:3281308

  1. Return to the workforce following coronary artery bypass grafting: A Danish nationwide cohort study.

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    Butt, Jawad H; Rørth, Rasmus; Kragholm, Kristian; Kristensen, Søren L; Torp-Pedersen, Christian; Gislason, Gunnar H; Køber, Lars; Fosbøl, Emil L

    2018-01-15

    Returning to the workforce after coronary artery bypass grafting (CABG) holds important socioeconomic consequences not only for patients, but the society as well. Yet data on this issue are limited. We examined return to the workforce and associated factors in patients of working age undergoing CABG. Using Danish nationwide administrative registries, we identified 6031 patients of working age (18-60years) undergoing isolated CABG (1998-2011) who were part of the workforce 30days prior to admission and alive at discharge. One year after discharge for CABG, 4827 (80.0%) patients had returned to the workforce, 614 (10.2%) were on paid sick leave, 267 (4.4%) received disability pension, 250 (4.1%) were on early retirement, 57 (0.9%) had died, and 16 (0.3%) had emigrated. Factors associated with return to the workforce were identified using multivariable logistic regression. Younger age (18-45 versus 56-60years; odds ratio, 1.89; 95% confidence interval, 1.48-2.42), male sex (1.51, 1.24-1.84), and higher level of education (higher educational level versus basic school; 1.53, 1.05-2.23) and income (highest quartile versus lowest; 3.01, 2.42-3.75) were associated with return to the workforce. Urgency of surgery (emergency versus elective; 0.65, 0.49-0.88), cardiovascular comorbidity, a history of chronic kidney disease (0.49, 0.29-0.84) and liver disease (0.47, 0.28-0.80), as well as additional hospital admissions within the first year post-discharge (>2 versus none; 0.25, 0.19-0.32) were associated with a lower likelihood of returning to the workforce. One year after discharge for CABG, four out of five patients were part of the workforce and mortality was low. Younger age, male sex, higher socioeconomic status, and absence of major comorbidities were associated with return to the workforce. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Double blind placebo controlled exposure to molds

    DEFF Research Database (Denmark)

    Meyer, H W; Jensen, K A; Nielsen, K F

    2005-01-01

    The objective was to develop an experimental setup for human exposure to mold spores, and to study the clinical effect of this exposure in sensitive subjects who had previously experienced potentially building-related symptoms (BRS) at work. From three water-damaged schools eight employees....... In conclusion this is, to our knowledge, the first study to successfully conduct a human exposure to a highly controlled dose of fungal material aerosolized directly from wet building materials. This short-term exposure to high concentrations of two different molds induced no more reactions than exposure...... to placebo in eight sensitive school employees. However, a statistical type II error cannot be excluded because of the small sample size. PRACTICAL IMPLICATIONS: In this double blind, placebo controlled study of mold exposure changes in symptoms, objective measurements and blood samples were small and mostly...

  3. Acute Compartment Syndrome of the Lower Leg after Coronary Artery Bypass Grafting: A Silent but Dangerous Complication

    NARCIS (Netherlands)

    te Kolste, Henryk Jan; Balm, Ron; de Mol, Bas

    2015-01-01

    Acute compartment syndrome (ACoS) is a serious, limb-threatening condition, but ACoS after coronary artery bypass grafting (CABG) is rare. ACoS is diagnosed with the help of typical symptoms, but due to the use of analgesics in a postoperative setting, these symptoms may vary. Identifying risk

  4. Nuclear DNA as Predictor of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft: A Pilot Study.

    Science.gov (United States)

    Likhvantsev, Valery V; Landoni, Giovanni; Grebenchikov, Oleg A; Skripkin, Yuri V; Zabelina, Tatiana S; Zinovkina, Liudmila A; Prikhodko, Anastasia S; Lomivorotov, Vladimir V; Zinovkin, Roman A

    2017-12-01

    To measure the release of plasma nuclear deoxyribonucleic acid (DNA) and to assess the relationship between nuclear DNA level and acute kidney injury occurrence in patients undergoing cardiac surgery. Cardiovascular anesthesiology and intensive care unit of a large tertiary-care university hospital. Prospective observational study. Fifty adult patients undergoing cardiac surgery. Nuclear DNA concentration was measured in the plasma. The relationship between the level of nuclear DNA and the incidence of acute kidney injury after coronary artery bypass grafting was investigated. Cardiac surgery leads to significant increase in plasma nuclear DNA with peak levels 12 hours after surgery (median [interquartile range] 7.0 [9.6-22.5] µg/mL). No difference was observed between off-pump and on-pump surgical techniques. Nuclear DNA was the only predictor of acute kidney injury between baseline and early postoperative risk factors. The authors found an increase of nuclear DNA in the plasma of patients who had undergone coronary artery bypass grafting, with a peak after 12 hours and an association of nuclear DNA with postoperative acute kidney injury. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. The Effect of Music on Anxiety and Cardiovascular Indices in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Trial.

    Science.gov (United States)

    Heidari, Saeide; Babaii, Atye; Abbasinia, Mohammad; Shamali, Mahdi; Abbasi, Mohammad; Rezaei, Mahboobe

    2015-12-01

    The instability of cardiovascular indices and anxiety disorders are common among patients undergoing coronary artery bypass graft (CABG) and could interfere with their recovery. Therefore, improving the cardiovascular indices and anxiety is essential. This study aimed to investigate the effect of music therapy on anxiety and cardiovascular indices in patients undergoing CABG. In this randomized controlled trial, 60 patients hospitalized in the cardiovascular surgical intensive care unit of Shahid Beheshti Hospital in Qom city, Iran, in 2013 were selected using a consecutive sampling method and randomly allocated into the experimental and control groups. In the experimental group, patients received 30 minutes of light music, whereas in the control group, patients had 30 minutes of rest in bed. The cardiovascular indices and anxiety were measured immediately before, immediately after and half an hour after the study. Data were analyzed using the chi-square test and repeated measures analysis of variance. Compared to the immediately before intervention, the mean anxiety scores immediately after and 30 minutes after the intervention were significantly lower in the experimental group (P 0.05). Music therapy is effective in decreasing anxiety among patients undergoing CABG. However, the intervention was not effective on cardiovascular indices. Music can effectively be used as a non-pharmacological method to manage anxiety after CABG.

  6. Predictive Factors for Delayed Extubation in the Intensive Care Unit after Coronary Artery Bypass Grafting; A Southern Iranian Experience

    Directory of Open Access Journals (Sweden)

    Shahrbanoo Shahbazi

    2012-12-01

    Full Text Available Background: Early extubation is implemented in cardiothoracic units worldwide for its advantages such as decreased mortality, morbidity, and hospitalization costs. We conducted a retrospective study to evaluate potential factors which may affect extubation time. Methods: The records of 334 eligible patients who underwent elective coronary artery bypass grafting (CABG in 2008 in Kowsar Hospital in Shiraz, southern Iran were evaluated to find the factors that can affect the extubation time. The patients were divided to early (equal or less than 6 hours and late extubation groups. The patients’ demographic data and operative variables were extracted from the records. We excluded patients with difficult intubation, severe acid base disturbance, neurological problems, and cardiovascular instability; and those who used intra-aortic balloon pump, had underwent emergency operation, or had another concomitant surgery. Results: Multiple logistic regressions comparing age, sex, number of grafts, ejection fraction, pump time, hematocrit, number of risk factors, and number of inotropic drugs, identified only age as a predictor of delayed extubation (odds ratio=1.07, CI 95%=1.04-1.10, P<0.001. Also, in both studied groups the men to women ratio was higher (P<0.05.Conclusion: Although in our study age was the only predictive factor for delayed extubation, a comprehensive study including preoperative, perioperative, and postoperative factors is recommended in our area.

  7. The Predictive Value of Integrated Pulmonary Index after Off-Pump Coronary Artery Bypass Grafting: A Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Evgenia V. Fot

    2017-08-01

    Full Text Available BackgroundThe early warning scores may increase the safety of perioperative period. The objective of this study was to assess the diagnostic and predictive role of Integrated Pulmonary Index (IPI after off-pump coronary artery bypass grafting (OPCAB.Materials and MethodsForty adult patients undergoing elective OPCAB were enrolled into a single-center prospective observational study. We assessed respiratory function using IPI that includes oxygen saturation, end-tidal CO2, respiratory rate, and pulse rate. In addition, we evaluated blood gas analyses and hemodynamics, including ECG, invasive arterial pressure, and cardiac index. The measurements were performed after transfer to the intensive care unit, after spontaneous breathing trial and at 2, 6, 12, and 18 h after extubation.Results and DiscussionThe value of IPI registered during respiratory support correlated weakly with cardiac index (rho = 0.4; p = 0.04 and ScvO2 (rho = 0.4, p = 0.02. After extubation, IPI values decreased significantly, achieving a minimum by 18 h. The IPI value ≤9 at 6 h after extubation was a predictor of complicated early postoperative period (AUC = 0.71; p = 0.04 observed in 13 patients.ConclusionIn off-pump coronary surgery, the IPI decreases significantly after tracheal extubation and may predict postoperative complications.

  8. Efficacy of cardiac resynchronization with defibrillator insertion in patients undergone coronary artery bypass graft: A cohort study of cardiac function

    Directory of Open Access Journals (Sweden)

    Reza Karbasi Afshar

    2015-01-01

    Full Text Available Introduction: Cardiac resynchronization therapy (CRT is a proven therapeutic method in selected patients with heart failure and systolic dysfunction which increases left ventricular function and patient survival. We designed a study that included patients undergoing coronary artery bypass graft (CABG, with and without CRT-defibrillator (CRT-D inserting and then measured its effects on these two groups. Patients and Methods: Between 2010 and 2013, we conducted a prospective cohort study on 100 coronary artery disease patients where candidate for CABG. Then based on the receiving CRT-D, the patients were categorized in two groups; Group 1 ( n = 48, with CRT-D insertion before CABG and Group 2 ( n = 52 without receiving CRT-D. Thereafter both of these groups were followed-up at 1-3 months after CABG for mortality, hospitalization, atrial fibrillation (AF, echocardiographic assessment, and New York Heart Association (NYHA class level. Results: The mean age of participants in Group 1 (48 male and in Group 2 (52 male was 58 ± 13 and 57 ± 12 respectively. Difference between Groups 1 and 2 in cases of mean left ventricular ejection fraction (LVEF changes and NYHA class level was significant ( P > 0.05. Hospitalization ( P = 0.008, mortality rate ( P = 0.007, and AF were significantly different between these two groups. Conclusions: The results showed that the increase in LVEF and patient′s improvement according to NYHA-class was significant in the first group, and readmission, mortality rate and AF was increased significantly in the second group.

  9. Preoperative brain magnetic resonance imaging and postoperative delirium after off-pump coronary artery bypass grafting: a prospective cohort study.

    Science.gov (United States)

    Omiya, Hiroki; Yoshitani, Kenji; Yamada, Naoaki; Yamada, Naoki; Kubota, Yosuke; Takahashi, Kanae; Kobayashi, Junjiro; Ohnishi, Yoshihiko

    2015-06-01

    Delirium after cardiac surgery is a serious complication, increasing morbidity and mortality. Despite its high expectations, off-pump coronary artery bypass grafting (OPCAB) has largely failed to reduce the incidence of postoperative neurological complications. To further investigate the reasons for this failure, we used perioperative brain magnetic resonance imaging (MRI) to determine the relation between MRI findings and postoperative delirium. Altogether, 98 patients undergoing elective OPCAB were enrolled in this prospective observational study. Patients underwent brain MRI and magnetic resonance angiography (MRA) before and after surgery to identify cerebral infarction, white matter lesions, and intracranial artery stenosis. Postoperative delirium in the intensive care unit was measured using the delirium rating scale. The relation between postoperative delirium and MRI findings was examined using logistic regression. Magnetic resonance imaging and MRA was completed in 88 (90%) of the patients. New ischemic lesions were present in seven (7.9%) patients. Delirium rating scale scores of 0, 1-7, and ≥ 8 were found in 25 (31%), 48 (60%), and seven (9%) patients, respectively. Multivariate logistic regression analysis revealed that new ischemic lesions (odds ratio [OR] 11.07, 95% confidence interval [CI]: 1.53 to 80.03; P = 0.017), carotid artery stenosis (OR 7.06, 95% CI: 1.59 to 31.13; P = 0.010), history of myocardial infarction (OR 3.78, 95% CI: 1.05 to 13.65; P = 0.043), and deep subcortical white matter hyperintensity (OR 3.04, 95% CI: 1.14 to 8.12; P = 0.027) were significantly associated with postoperative delirium. Magnetic resonance imaging findings of new cerebral ischemic lesions, carotid stenosis, and deep subcortical white matter hyperintensity correlated significantly with postoperative delirium in patients who had undergone OPCAB surgery.

  10. Does sleep quality affects the immediate clinical outcome in patients undergoing coronary artery bypass grafting: A clinico-biochemical correlation

    Directory of Open Access Journals (Sweden)

    Minati Choudhury

    2017-01-01

    Full Text Available Objective: Poor sleep quality is emerging as high prevalence among the patients suffering from cardiometabolic disturbances. The vascular polypeptide endothelin 1 (ET-1 is involved in many of the health disorders. However, its potential involvement in patients having poor sleep quality along with cardiovascular problem is limited. The present study was formulated to conduct a prospective analysis of the relationship between ET-1 and in hospital outcome in sleep disorder patients undergoing routine coronary artery bypass grafting (CABG. Methods: A total of 156 patients were enrolled and divided into two groups based on the Pittsburg Sleep Quality Index (PSQI of ≤5 (Group I, n = 101 or >5 (Group II, n = 55. Blood sample was collected before anesthesia induction (ET-1a and at 48 h (ET-1b to analyze the plasma ET-1 and blood sugar level. The patients were monitored for any intraoperative adverse events and postoperative complications during their hospital stay. Results: Both groups were comparable in relation to age, sex, incidence of smoking and alcohol consumption. The distribution of comorbid conditions was also similar in both groups. The ET-1 level was higher in Group II than Group I before anesthesia induction as well as 48 h postoperatively (4.5 ± 1.75 vs. 10.61 ± 9.3, P = 0.001; 2.08 ± 1.3 vs. 8.3 ± 9.86, P = 0.0001, respectively. The Group II patients had a longer duration of mechanical ventilation (14.6 ± 12.05 vs. 10.1 ± 8.19, P = 0.001, Intensive Care Unit stay (2.08 ± 0.95 vs. 2.7 ± 1.45, P = 0016 and hospital stay (5.98 ± 1.73 vs. 7.8 ± 3.66, P = 0.0001, respectively. The high number of patients from Group II required inotrope and intra-aortic balloon pump support while compared with Group I (P ≤ 0.05 in each. The overall postoperative complication rate was significantly higher among patients with PSQI of >5 (Group II except the rate of infection and neurological complications which was similar among both group of

  11. Does sleep quality affects the immediate clinical outcome in patients undergoing coronary artery bypass grafting: A clinico-biochemical correlation.

    Science.gov (United States)

    Choudhury, Minati; Gupta, Anushree; Hote, Milind P; Kapoor, Poonam Malhotra; Khanna, Sandeep; Kalaivani, M V; Kiran, Usha

    2017-01-01

    Poor sleep quality is emerging as high prevalence among the patients suffering from cardiometabolic disturbances. The vascular polypeptide endothelin 1 (ET-1) is involved in many of the health disorders. However, its potential involvement in patients having poor sleep quality along with cardiovascular problem is limited. The present study was formulated to conduct a prospective analysis of the relationship between ET-1 and in hospital outcome in sleep disorder patients undergoing routine coronary artery bypass grafting (CABG). A total of 156 patients were enrolled and divided into two groups based on the Pittsburg Sleep Quality Index (PSQI) of ≤5 (Group I, n = 101) or >5 (Group II, n = 55). Blood sample was collected before anesthesia induction (ET-1a) and at 48 h (ET-1b) to analyze the plasma ET-1 and blood sugar level. The patients were monitored for any intraoperative adverse events and postoperative complications during their hospital stay. Both groups were comparable in relation to age, sex, incidence of smoking and alcohol consumption. The distribution of comorbid conditions was also similar in both groups. The ET-1 level was higher in Group II than Group I before anesthesia induction as well as 48 h postoperatively (4.5 ± 1.75 vs. 10.61 ± 9.3, P = 0.001; 2.08 ± 1.3 vs. 8.3 ± 9.86, P = 0.0001, respectively). The Group II patients had a longer duration of mechanical ventilation (14.6 ± 12.05 vs. 10.1 ± 8.19, P = 0.001), Intensive Care Unit stay (2.08 ± 0.95 vs. 2.7 ± 1.45, P = 0016) and hospital stay (5.98 ± 1.73 vs. 7.8 ± 3.66, P = 0.0001, respectively). The high number of patients from Group II required inotrope and intra-aortic balloon pump support while compared with Group I (P ≤ 0.05 in each). The overall postoperative complication rate was significantly higher among patients with PSQI of >5 (Group II) except the rate of infection and neurological complications which was similar among both group of patients. The postoperative in hospital

  12. A randomized, double blind trial of prophylactic fibrinogen to reduce bleeding in cardiac surgery

    Directory of Open Access Journals (Sweden)

    Mostafa Sadeghi

    2014-07-01

    Full Text Available BACKGROUND AND OBJECTIVES: Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery. In this prospective, randomized, double-blind study, we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding. METHODS: A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1 g of fibrinogen concentrate 30 min prior to the operation, while patients in the control group received placebo. Post-operative bleeding volumes, prothrombin time, partial thromboplastin time, INR, hemoglobin and transfused blood products in both groups were recorded. A strict red blood cell transfusion protocol was used in all patients. RESULTS: There were no significant differences between intra-operative packed red blood cells infusion in the studied groups (1.0 ± 1.4 in fibrinogen group, and 1.3 ± 1.1 in control group. Less postoperative bleeding was observed in the fibrinogen group (477 ± 143 versus 703 ± 179, p = 0.0001. Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion (p = 0.094. No thrombotic event was observed through 72 h after surgery. CONCLUSION: Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft.

  13. A placebo-controlled double-blind study

    African Journals Online (AJOL)

    This report covers a review of the literature and a description of a double-blind placebo-controlled trial, of 200 mg of amantadine hydrochloride daily in the treatment of 23 parkinsonian patients. Statistical analysis of clinical results showed a significant improvement in rigidity and tremor at rest and a fair improvement in ...

  14. A double-blind randomized control trial of diazepam

    OpenAIRE

    1983-01-01

    A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo.

  15. randomised double blind study to compare effectiveness of honey

    African Journals Online (AJOL)

    2014-02-02

    Feb 2, 2014 ... the side effects of salbutamol include tachycardia, palpitations, headache and tremor. MATERIALS AND METHODS. We conducted a hospital based randomised double- blinded clinical trial evaluating effectiveness of honey and salbutamol against that of placebo at the paediatric casualty of the Aga Khan ...

  16. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Background: Osteoarthritis of the hip or knees is a very disabling condition in both Caucasians and Africans. A lot of medical drugs have been in use with their corresponding side effects, hence the search for newer drugs with fewer side effects. Study design: A double blind clinical trial comparing the safety and efficacy of ...

  17. Ozone treatment of recurrent aphthous stomatitis: a double blinded study

    OpenAIRE

    AL-Omiri, Mahmoud K.; Mohannad Alhijawi; AlZarea, Bader K.; Ra’ed S. Abul Hassan; Edward Lynch

    2016-01-01

    This study aimed to evaluate the use of ozone to treat recurrent aphthous stomatitis (RAS). Consecutive sixty-nine participants with RAS were recruited into this non-randomized double blind, controlled cohort observational study (test group). A control group of 69 RAS patients who matched test group with age and gender was recruited. RAS lesions in test group were exposed to ozone in air for 60?seconds while controls received only air. Ulcer size and pain were recorded for each participant at...

  18. Dexamethasone : Benefit and prejudice for patients undergoing on-pump coronary artery bypass grafting - A study on myocardial, pulmonary, renal, intestinal, and hepatic injury

    NARCIS (Netherlands)

    Morariu, AM; Loef, BG; Aarts, LPHJ; Rietman, GW; Rakhorst, G; van Oeveren, W; Epema, AH

    2005-01-01

    Study objectives: Cardiac surgery with cardiopulmonary bypass (CPB) results in perioperative organ damage caused by the systemic inflammatory response syndrome (SIRS) and ischemia/ reperfusion injury. Administration of corticosteroids before CPB has been demonstrated to inhibit the activation of the

  19. Ondansetron treatment reduces rotavirus symptoms—A randomized double-blinded placebo-controlled trial

    National Research Council Canada - National Science Library

    Marie Hagbom; Daniel Novak; Malin Ekström; Younis Khalid; Maria Andersson; Magnus Lindh; Johan Nordgren; Lennart Svensson

    2017-01-01

    .... The objective of this randomized double-blinded placebo-controlled study was to investigate whether ondansetron, a serotonin receptor antagonist could attenuate rotavirus- and norovirus-induced...

  20. Superior Two-year Results of Externally Unsupported Polyester Compared to Supported Grafts in Above-knee Bypass Grafting : A Multicenter Randomised Trial

    NARCIS (Netherlands)

    Vriens, B. H. R.; van Det, R. J.; Meerwaldt, R.; van der Palen, J.; Gerrits, D. G.; Zeebregts, C. J.; Geelkerken, R. H.

    Objectives: The aim of this study was to compare externally supported thin wall knitted polyester (P-EXS) and externally unsupported thin wall knitted polyester (P-non-EXS) for above-knee (AK) femoro-popliteal bypass grafting. Design: A prospective multicenter randomised clinical trial. Material and

  1. Effects of perioperative statin treatment on postoperative atrial fibrillation and cardiac mortality in patients undergoing coronary artery bypass grafting: a propensity score analysis

    Directory of Open Access Journals (Sweden)

    Ayşegül Kunt

    2015-08-01

    Full Text Available Aim To evaluate the effect of perioperative statin treatment on postoperative atrial fibrillation and cardiac mortality in patients undergoing coronary artery bypass grafting. Methods A total of 1890 patients who underwent isolated coronary artery bypass were analyzed retrospectively, of which 425 patients (22.4% older than 70 were included in the study. The demographic properties, preoperative, operative and postoperative data and other medications of these patients were recorded. Continuous preoperative and postoperative atorvastatin therapy were received by 124 (29.17% patients; 301 (70.82% patients were matched to a control group (no-statin group. The two groups were matched by propensity score analysis in terms of atrial fibrillation development and cardiac mortality. Results Medical history, medical treatment, cardiovascular history, and operative characteristics demonstrated significant heterogeneity in both groups. Postoperative atrial fibrillation was similar in both groups. Before propensity score matching, the percentages of patients in postoperative atrial fibrillation with respect to Atorvastain-group and No-statin-group were 13.71 and 10.3 respectively; however, those were 13.71 and 14.51 after matching. In a multivariate regression analysis, five-vessel bypass (odds ratio OR, 2.354; 95% confidence interval CI, 0.99 to 5.57 was an independent predictor of postoperative atrial fibrillation in patients undergoing coronary artery bypass grafting. In-hospital mortality was higher in the Atorvastatin-group compared with the No-statingroup: 124 (8.9% versus 301 (3.7%, respectively; p=0.027. Conclusion Perioperative atorvastatin treatment is not found to be associated with reduced postoperative atrial fibrillation and cardiac mortality in patients undergoing isolated coronary artery bypass grafting above the age of seventy years.

  2. Double-blind, placebo-controlled food challenge with apple

    DEFF Research Database (Denmark)

    Skamstrup Hansen, K; Vestergaard, H; Stahl Skov, P

    2001-01-01

    the pollen season and took place from 1997 to 1999. The freeze-dried apple material was characterized by means of leukocyte histamine release (HR), skin prick test (SPT), and immunoblotting experiments. The study population consisted of birch pollen-allergic patients with a history of rhinitis in the birch......The aim of the study was to develop and evaluate different methods of double-blind, placebo-controlled food challenge (DBPCFC) with apple. Three different DBPCFC models were evaluated: fresh apple juice, freshly grated apple, and freeze-dried apple powder. All challenges were performed outside......-pollen season and positive specific IgE to birch. For comparison of the DBPCFC models, 65 patients with a positive open oral challenge with apple were selected. In the characterization of the freeze-dried apple material, 46 birch pollen-allergic patients were included. The IgE reactivity to apple was evaluated...

  3. Effect of L-Carnitine Supplementation on Reverse Remodeling in Patients with Ischemic Heart Disease Undergoing Coronary Artery Bypass Grafting: A Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    da Silva Guimarães, Sheila; de Souza Cruz, Wanise; da Silva, Licinio; Maciel, Gabrielle; Huguenin, Ana Beatriz; de Carvalho, Monicque; Costa, Bárbara; da Silva, Geisiane; da Costa, Carlos; D'Ippolito, João Alvaro; Colafranceschi, Alexandre; Scalco, Fernanda; Boaventura, Gilson

    2017-01-01

    During cardiac failure, cardiomyocytes have difficulty in using the substrates to produce energy. L-carnitine is a necessary nutrient for the transport of fatty acids that are required for generating energy. Coronary artery graft surgery reduces the plasma levels of L-carnitine and increases the oxidative stress. This study demonstrates the effect of L-carnitine supplementation on the reverse remodeling of patients undergoing coronary artery bypass graft. Patients with ischemic heart failure who underwent coronary graft surgery were randomized to group A - supplemented with L-carnitine or group B controls. Left ventricular ejection fraction, left ventricular systolic and diastolic diameters were assessed preoperatively, 60 and 180 days after surgery. Our study included 28 patients (26 [93.0%] males) with a mean age ± SD of 58.1 ± 10.5 years. The parameters for the evaluation of reverse remodeling did not improve after 60 and 180 days of coronary artery bypass grafting in comparison between groups (p > 0.05). Evaluation within the L-carnitine group showed a 37.1% increase in left ventricle ejection fraction (p = 0.002) and 14.3% (p = 0.006) and 3.3% (p > 0.05) reduction in systolic and diastolic diameters, respectively. L-carnitine supplementation at a dose of 50 mg/kg combined with artery bypass surgery did not demonstrate any additional benefit in reverse remodeling. However, evaluation within the L-carnitine group may indicate a clinical benefit of L-carnitine supplementation. © 2017 S. Karger AG, Basel.

  4. Ozone treatment of recurrent aphthous stomatitis: a double blinded study.

    Science.gov (United States)

    Al-Omiri, Mahmoud K; Alhijawi, Mohannad; AlZarea, Bader K; Abul Hassan, Ra'ed S; Lynch, Edward

    2016-06-15

    This study aimed to evaluate the use of ozone to treat recurrent aphthous stomatitis (RAS). Consecutive sixty-nine participants with RAS were recruited into this non-randomized double blind, controlled cohort observational study (test group). A control group of 69 RAS patients who matched test group with age and gender was recruited. RAS lesions in test group were exposed to ozone in air for 60 seconds while controls received only air. Ulcer size and pain were recorded for each participant at baseline and daily for 15 days. Ulcer duration was determined by recording the time taken for ulcers to disappear. The main outcome measures were pain due to the ulcer, ulcer size and ulcer duration. 138 RAS participants (69 participants and 69 controls) were analyzed. Ulcer size was reduced starting from the second day in test group and from the fourth day in controls (p ≤ 0.004). Pain levels were reduced starting from the first day in the test group and from the third day in controls (p ≤ 0.001). Ulcer duration, ulcer size after day 2 and pain levels were more reduced in the test group. In conclusion, application of ozone on RAS lesions for 60 seconds reduced pain levels and enhanced ulcers' healing by reducing ulcers' size and duration.

  5. Double-blind comparative trial with 2 antiregurgitation formulae.

    Science.gov (United States)

    Vandenplas, Y; Leluyer, B; Cazaubiel, M; Housez, B; Bocquet, A

    2013-09-01

    Many mothers consult physicians because of frequent infant regurgitation. Guidelines recommend reassurance and dietary treatment as first approaches. The aim of the present study was to test and compare the efficacy of 2 antiregurgitation formulae (ARF). A prospective, double-blind, randomized cross-over trial was performed for a 1-month period in 115 formula-fed infants (ages 2 weeks-5 months) comparing 2 ARF (ARF-1: nonhydrolyzed protein, locust bean gum; ARF-2: specific whey hydrolysate, locust bean gum, specially treated starch). The primary endpoint was the incidence of regurgitation. At inclusion, mean age was 9.1 weeks; anthropometric parameters did not differ between the groups. According to the intention-to-treat analysis, the mean number of episodes of regurgitation decreased from 8.25 to 2.32 with ARF-1 and to 1.89 with ARF-2 (statistically significant difference between both ARF, P = 0.0091). The mean score of regurgitated volume decreased significantly more with ARF-2 than with ARF-1 (P = 0.0265). There was no significant difference in stool frequency and consistency between both groups. The efficacy of both ARF was demonstrated by the decreased number and volume of regurgitations. ARF-2 was statistically more effective than ARF-1. Comparative trials enable the selection of the best therapeutic option.

  6. Iopamidol vs Metrizamide: a double blind study for cervical myelography

    Energy Technology Data Exchange (ETDEWEB)

    Drayer, P.; Warner, M.A.; Allen, S.; Bates, M.; Sudilovsky, A.; Luther, J.; Wilkins, R.

    1982-11-01

    A double-blind study was performed on 20 patients comparing the safety and efficacy of Iopamidol and Metrizamide in cervical myelography. The radiographic qualities of the Iopamidol and Metrizamide examinations were equivalent when using the same volume (12 to 13 ml), concentration (200 mg I/ml) and a C1-2 route of administration. The performance of a CT scan on selected patients in specified areas of interest provided additional diagnostic information in some patients (e.g. syringomyelia, degenerative spondylosis). The adverse reactions were mild in the Iopamidol group with 4 of the 10 patients experiencing no adverse reactions. The more severe reactions, including disorientation, agitation, dysarthria, asterixis, hyperreflexia and EEG abnormalities were limited to the Metrizamide group with one or more occurring in 2 of the 10 patients studies. Only one Metrizamide patient experienced no adverse reactions. In this study containing a limited number of patients, Iopamidol was shown to be a diagnostically effective and safer contrast medium for performing cervical myelography.

  7. The role of neutrophil gelatinase-associated lipocalin in predicting acute kidney injury in patients undergoing off-pump coronary artery bypass graft: A pilot study

    Directory of Open Access Journals (Sweden)

    Vishal Jain

    2016-01-01

    Full Text Available Objective: Acute kidney injury (AKI is a commonly encountered postoperative complication after cardiac surgery especially in high risk patients. AKI though seen more commonly after conventional on pump coronary artery bypass surgery (CCABG, is not uncommon after off pump coronary bypass surgery (OPCAB. Various biomarkers have shown promise over last one decade as an early marker for predicting AKI postoperatively. NGAL is one such biomarker whose concentration is increased in urine after any nephrotoxic and ischemic insult. The objective of this study was to assess the role of urine NGAL in predicting AKI after OPCAB in patients with increased risk of developing AKI. Design: A prospective cohort study. Setting: A clinical study in a multi specialty hospital. Participants: Eighty patients. Materials and Methods: study was approved by the hospital research ethics committee. 80 patients posted for OPCAB with an increased risk of developing AKI defined as having a Cleveland Clinic Foundation Acute renal failure scoring System score of ≥6 were included in the study. Patients with coronary angiography (CAG within 48 hrs prior to surgery, pre-existing AKI, preoperative renal replacement therapy (RRT and CKD stage 5 were excluded. Urine NGAL level before the start of surgery baseline and at 4 hrs post surgery were done. Renal function tests were assessed on the day of surgery (4 hrs post surgery and on the next three days. Result: Seven patients developed AKI as defined by acute kidney infection network (AKIN and risk injury failure loss end stage (RIFLE criteria for AKI. NGAL value at 4 hrs in patients who developed AKI was significantly higher than in those patients who did not develop AKI (P < 0.05. Conclusion: urine NGAL is an early biomarker of acute kidney injury in patients undergoing OPCAB surgeries. However, large multicentre studies may be needed to confirm it.

  8. Inhalation versus intravenous anaesthesia for adults undergoing on-pump or off-pump coronary artery bypass grafting: A systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    El Dib, Regina; Guimarães Pereira, José E; Agarwal, Arnav; Gomaa, Huda; Ayala, Ana Patricia; Botan, Andresa Graciutti; Braz, Leandro Gobbo; de Oliveira, Luciane Dias; Lopes, Luciane Cruz; Mathew, Preethy J

    2017-08-01

    To compare the use of inhalation versus intravenous anaesthesia for adults undergoing on-pump or off-pump coronary artery bypass grafting. A systematic review. A hospital-affiliated university. The following databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 10), MEDLINE, EMBASE, and LILACS (from inception to October 2016). We used the GRADE approach to rate overall certainty of the evidence. In total we included 58 studies with a total of 6105 participants. The methodological quality was difficult to assess as it was poorly reported in 35 included studies (three or more domains were rated as unclear risk of bias). Two trials of sevoflurane showed a statistically significant reduction in death within 180 to 365days of surgery (on-pump) (RR 4.10, 95% CI 1.42 to 11.79; p=0.009; I 2 =not applicable; high quality of evidence). There was also a statistically significant difference favouring sevoflurane compared to propofol on both inotropic (RR 2.11, 95% CI 1.53 to 2.90; ppump. Two trials of sevoflurane (MD -0.22, 95% CI -0.41 to -0.03; p=0.02; I 2 =0%) and two further trials of desflurane (MD -0.33, 95% CI -0.45 to -0.20; ppump, respectively. There is high quality evidence that sevoflurane reduces death within 180 to 365days of surgery and, inotropic and vasoconstrictor support compared to propofol for patients undergoing coronary artery bypass grafting. There is also some evidence showing that the cardiac index is minimally influenced by administration of sevoflurane and desflurane compared to propofol. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Double blind randomized phase II study with radiation + 5-fluorouracil ± celecoxib for resectable rectal cancer

    National Research Council Canada - National Science Library

    Debucquoy, Annelies; Roels, Sarah; Goethals, Laurence; Libbrecht, Louis; Cutsem, Eric Van; Geboes, Karel; Penninckx, Freddy; D’Hoore, André; McBride, William H; Haustermans, Karin

    2009-01-01

    To assess the feasibility and efficacy of the COX-2 inhibitor celecoxib in conjunction with preoperative chemoradiation for patients with locally advanced rectal cancer in a double blind randomized phase II study...

  10. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder

    NARCIS (Netherlands)

    Chouinard, G; Saxena, B; Belanger, MC; Ravindran, A; Bakish, D; Beauclair, L; Morris, P; Nair, NPV; Manchanda, R; Reesal, R; Remick, R; O'Neill, MC

    Background: Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors. In a 12-week randomized, multicenter, double-blind trial, the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in

  11. Is Double-Blinded Peer Review Necessary? The Effect of Blinding on Review Quality.

    Science.gov (United States)

    Chung, Kevin C; Shauver, Melissa J; Malay, Sunitha; Zhong, Lin; Weinstein, Aaron; Rohrich, Rod J

    2015-12-01

    The review process can be completely open, double-blinded, or somewhere in between. Double-blinded peer review, where neither the authors' nor peer reviewers' identities are shared with each other, is thought to be the fairest system, but there is evidence that it does not affect reviewer behavior or influence decisions. Furthermore, even without presenting author names, authorship is often apparent to reviewers, especially in small specialties. In conjunction with Plastic and Reconstructive Surgery (PRS), the authors examined the effect of double-blinded review on review quality, reviewer publishing recommendation, and reviewer manuscript rating. The authors hypothesized that double-blinded review will not improve review quality and will not affect recommendation or rating. Traditionally, PRS peer review has been conducted in a single-blinded fashion. During a 3-month period of standard operation of the Journal, the authors examined reviews, recommendations, and manuscript ratings. Beginning October 1, 2014, PRS started conducting reviews in a double-blinded manner. The authors examined the additional reviews submitted during a 3-month period after the change. Review quality was assessed using the validated Review Quality Instrument. Double-blinding had no effect on reviewer publishing recommendation or manuscript ranking. Review quality did not improve after the implementation of double-blinded review. Blinding was successful 66 percent of the time. The most common reasons for blinding failure were reviewer familiarity with authors' work and author self-citation. Double-blinding adds considerable work for authors and editorial staff and has no positive effect on review quality. Furthermore, the authors' results revealed no publication bias based on author identity at PRS.

  12. Short-term effects of preoperative beta-blocker use for isolated coronary artery bypass grafting: A systematic review and meta-analysis.

    Science.gov (United States)

    Wang, Liangshan; Wang, Hong; Hou, Xiaotong

    2018-02-01

    The use of preoperative beta-blockers has been used as a quality standard for patients undergoing coronary artery bypass grafting (CABG). However, the benefits of beta-blockers use before CABG remain controversial. We performed a systematic review and meta-analysis to investigate the short-term effects of preoperative beta-blocker use for patients undergoing isolated CABG. We searched PubMed, Embase, and the Cochrane Library for English articles published from inception to August 16, 2016. Observational studies comparing preoperative beta-blockers therapy or non-beta-blockers therapy were considered eligible for the current study. Six observational studies with 1,231,850 patients were included. The pooled analyses of unadjusted outcome (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.71-0.95; P = .007) or risk-adjusted outcome (OR, 0.95; 95% CI, 0.92-0.97; P = .000) showed slight reduction in operative mortality, whereas an insignificant difference in mortality rate was observed in pooling postoperative data from propensity score analysis (OR, 0.97; 95% CI, 0.94-1.00; P = .088). Removing one study that used propensity-score covariate adjustment, subgroup analysis of propensity-matched patients (313,417 in each group) still generated a statistically nonsignificant benefit for preoperative beta-blocker use (OR, 0.97; 95% CI, 0.94-1.00; P = .093). Furthermore, the preoperative use of beta-blockers did not reduce the incidence of major postoperative complications, such as postoperative myocardial infarction, stroke, atrial fibrillation, reoperation, renal failure, prolonged ventilation, and sternal wound infection. Our study suggests that the use of preoperative beta-blockers did not reduce either operative mortality or the incidence of postoperative complications in patients undergoing CABG. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  13. Prognostic value of strain and strain rate in the prediction of postoperative atrial fibrillation in patients undergoing coronary artery bypass grafting: a systematic literature review

    Directory of Open Access Journals (Sweden)

    Leila Bigdelu

    2016-03-01

    Full Text Available Introduction: Atrial fibrillation (AF is a common dysrhythmia postoperatively after coronary artery bypass grafting (CABG. Myocardial strain and strain-rate imaging is used for the assessment of postoperative atrial fibrillation (POAF as a new echocardiographic method. Methods: PubMed and Scopus were searched thoroughly using the following search terms: (strain and strain rate AND (atrial fibrillation OR AF on March 2015 to find English articles in which the strain and strain-rate echocardiographic imaging had been used for the evaluation of AF in patients undergone CABG. Full text of the relevant papers was fully reviewed for data extraction.Result: Of overall 6 articles found in PubMed, 10 records found in Scopus and 4 articles found through reference list search, only 6 papers fully met the inclusion criteria for further assessment and data extraction. The results of strain and strain-rate assessment showed that in total of 542 patients undergoing CABG, POAF occurred in 106 patients. Studies showed that the reduction of left atrial (LA strain rate is correlated with AF. Consistently, the results of present review showed that LA strain and strain-rate in patients who developed AF postoperatively after CABG are significantly reduced, suggesting that strain and strain-rate could be a predictor of POAF.Conclusion: Based on the obtained results, strain and strain-rate is a suitable and accurate echocardiographic technique in the assessment of left atrial function , and it might be helpful to detect the patients who are at high risk of POAF.

  14. Effect of milrinone on cardiac functions in patients undergoing coronary artery bypass graft: a meta-analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    You Z

    2015-12-01

    Full Text Available Zhigang You,* Lin Huang,* Xiaoshu Cheng, Qinghua Wu, Xinghua Jiang, Yanqing WuDepartment of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, People’s Republic of China *These authors contributed equally to this work Background and aim: Inotropes are commonly used to treat myocardial dysfunction, which is the major complication after coronary artery bypass graft (CABG. Milrinone, a phosphodiesterase 3 inhibitor, is one of these inotropes. Recently, a number of clinical studies have been carried out to evaluate the effects of milrinone on cardiac function in patients with low ventricular ejection fraction undergoing CABG. However, it has been inconclusive because of the inconsistent results. In addition, some studies found that milrinone increased the incidence of postoperative atrial arrhythmias and did not show any long-term beneficial effects on survival. Therefore, it is very important to perform a meta-analysis to summarize the results so as to determine the clinical efficacy and safety of milrinone.Method: Several databases and websites for clinical trials were searched until October 2015 for prospective clinical studies comparing milrinone versus placebo on cardiac functions in patients undergoing CAGB.Results: Four articles were identified by our search strategy. 1 Milrinone decreased incidence of myocardial ischemia and myocardial infarction (15.6% versus 44.4%; 4.7% versus 18% in milrinone and control group respectively. 2 Milrinone decreased duration of inotropic support (95% confidence interval [CI]: -6.52 to -1.68; P=0.0009 and mechanical ventilation (h support (95% CI -5.00 to -0.69; P=0.010, but did not decrease the requirement for intra-aortic balloon pump or inotropic support (P>0.05. 3 Milrinone did not decrease the overall mortality or morbidity, intensive care unit stay (P>0.05.Conclusion: Perioperative continuous infusion of milrinone is effective to lower incidence of myocardial

  15. Efficacy and effectiveness of on- versus off-pump coronary artery bypass grafting: A meta-analysis of mortality and survival.

    Science.gov (United States)

    Filardo, Giovanni; Hamman, Baron L; da Graca, Briget; Sass, Danielle M; Machala, Natalie J; Ismail, Safiyah; Pollock, Benjamin D; Collinsworth, Ashley W; Grayburn, Paul A

    2018-01-01

    Despite many studies comparing on- versus off-pump coronary artery bypass graft (CABG), there is no consensus as to whether one of these techniques offers patients better outcomes. We searched PubMed from inception to June 30, 2015, and identified additional studies from bibliographies of meta-analyses and reviews. We identified 42 randomized controlled trials (RCTs) and 31 rigorously adjusted observational studies (controlling for the Society of Thoracic Surgeons-recognized risk factors for mortality) reporting mortality for off-pump versus on-pump CABG at specified time points. Trial data were extracted independently by 2 researchers using a standardized form. Differences in probability of mortality (DPM) were estimated for the RCTs and observational studies separately and combined, for time points ranging from 30 days to 10 years. RCT-only data showed no significant differences at any time point, whereas observational-only data and the combined analysis showed short-term mortality favored off-pump CABG (n = 1.2 million patients; 36 RCTs, 26 observational studies; DPM [95% confidence interval (CI)], -44.8% [-45.4%, -43.8%]) but that at 5 years it was associated with significantly greater mortality (n = 60,405 patients; 3 RCTs, 5 observational studies; DPM [95% CI], 10.0% [5.0%, 15.0%]). At 10 years, only observational data were available, and off-pump CABG showed significantly greater mortality (DPM [95% CI], 14.0% [11.0%, 17.0%]). Evidence from RCTs showed no differences between the techniques, whereas rigorously adjusted observational studies (with >1.1 million patients) and the combined analysis indicated that off-pump CABG offers lower short-term mortality but poorer long-term survival. These results suggest that, in real-world settings, greater operative safety with off-pump CABG comes at the expense of lasting survival gains. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  16. Aspartame sensitivity? A double blind randomised crossover study.

    Directory of Open Access Journals (Sweden)

    Thozhukat Sathyapalan

    Full Text Available Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008 and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04, reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that

  17. Eyewitness Science and the Call for Double-Blind Lineup Administration

    Directory of Open Access Journals (Sweden)

    Dario N. Rodriguez

    2013-01-01

    Full Text Available For several decades, social scientists have investigated variables that can influence the accuracy of eyewitnesses’ identifications. This research has been fruitful and led to many recommendations to improve lineup procedures. Arguably, the most crucial reform social scientists advocate is double-blind lineup administration: lineups should be administered by a person who does not know the identity of the suspect. In this paper, we briefly review the classic research on expectancy effects that underlies this procedural recommendation. Then, we discuss the eyewitness research, illustrating three routes by which lineup administrators’ expectations can bias eyewitness identification evidence: effects on eyewitnesses’ identification decisions, effects on eyewitnesses’ identification confidence, and effects on administrator records of the lineup procedure. Finally, we discuss the extent to which double-blind lineup administration has been adopted among police jurisdictions in the United States and address common concerns about implementing a double-blind standard.

  18. Impact of balanced tetrastarch raw material on perioperative blood loss: a randomized double blind controlled trial.

    Science.gov (United States)

    Joosten, A; Tircoveanu, R; Arend, S; Wauthy, P; Gottignies, P; Van der Linden, P

    2016-10-01

    As 6% hydroxyethyl starch (HES) 130/0.40 or 130/0.42 can originate from different vegetable sources, they might have different clinical effects. The purpose of this prospective, randomized, double-blind controlled trial was to compare two balanced tetrastarch solutions, one maize-derived and one potato-derived, on perioperative blood loss in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). We randomly assigned 118 patients undergoing elective cardiac surgery into two groups, to receive either a maize- or a potato-derived HES solution. Study fluids were administered perioperatively (including priming of CPB) until the second postoperative day (POD#2) using a goal directed algorithm. The primary outcome was calculated postoperative blood loss up to POD#2. Secondary outcomes included short-term incidence of acute kidney injury (AKI), and long-term effect (up to one yr) on renal function. Preoperative and intraoperative characteristics of the subjects were similar between groups. Similar volumes of HES were administered (1950 ml [1250-2325] for maize-HES and 2000 ml [1500-2700] for potato-HES; P=0.204). Calculated blood loss (504 ml [413-672] for maize-HES vs 530 ml [468-705] for potato-HES; P=0.107) and the need for blood components were not different between groups. The incidence of AKI was similar in both groups (P=0.111). Plasma creatinine concentration and glomerular filtration rates did vary over time, although changes were minimal. Under our study conditions, HES 130/0.4 or 130/0.42 raw material did not have a significant influence on perioperative blood loss. Moreover, we did not find any effect of tetrastarch raw material composition on short and long-term renal function. EudraCT number: 2011-005920-16. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  20. Placebo reactions in double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; van der Heide, S.; Bijleveld, C. M. A.; Kukler, J.; Duiverman, E. J.; Dubois, A. E. J.

    Background: A cardinal feature of the double-blind, placebo-controlled food challenge (DBPCFC) is that placebo administration is included as a control. To date, the occurrence and diagnostic significance of placebo events have not extensively been documented. Objective: To analyse the occurrence and

  1. Placebo reactions in double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; van der Heide, S.; Bijleveld, C. M. A.; Kukler, J.; Duiverman, E. J.; Dubois, A. E. J.

    2007-01-01

    A cardinal feature of the double-blind, placebo-controlled food challenge (DBPCFC) is that placebo administration is included as a control. To date, the occurrence and diagnostic significance of placebo events have not extensively been documented. To analyse the occurrence and features of placebo

  2. A double-blind, placebo-controlled study of sertraline with naltrexone for alcohol dependence.

    LENUS (Irish Health Repository)

    Farren, Conor K

    2009-01-01

    Significant preclinical evidence exists for a synergistic interaction between the opioid and the serotonin systems in determining alcohol consumption. Naltrexone, an opiate receptor antagonist, is approved for the treatment of alcohol dependence. This double-blind placebo-controlled study examined whether the efficacy of naltrexone would be augmented by concurrent treatment with sertraline, a selective serotonin receptor uptake inhibitor (SSRI).

  3. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R

    2002-01-01

    BACKGROUND: Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy. METHODS: In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic...

  4. Effects of methylphenidate on fatigue and depression: a randomized, double-blind, placebo-controlled trial

    National Research Council Canada - National Science Library

    Kerr, Christopher W; Drake, Julie; Milch, Robert A; Brazeau, Daniel A; Skretny, Judith A; Brazeau, Gayle A; Donnelly, James P

    2012-01-01

    ...) as compared with placebo. In a randomized, double-blind, placebo-controlled trial, 30 hospice patients, both inpatients and outpatients, who had fatigue scores of at least four on a scale of zero to 10 (0=no fatigue and 10=worst fatigue...

  5. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  6. ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study

    NARCIS (Netherlands)

    Lansbergen, M.M.; Dongen-Boomsma, M. van; Buitelaar, J.K.; Slaats-Willemse, D.I.E.

    2011-01-01

    Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo

  7. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  8. No matrix effect in double-blind, placebo-controlled egg challenges in egg allergic children

    NARCIS (Netherlands)

    Libbers, L.; Flokstra-de Blok, B. M. J.; Vlieg-Boerstra, B. J.; van der Heide, S.; van der Meulen, G. N.; Kukler, J.; Kerkhof, M.; Dubois, A. E. J.

    Background Diagnostic and accidental food allergic reactions may be modified by the matrix containing the allergenic food. Previous studies of double-blind, placebo-controlled food challenges (DBPCFCs) with peanut found an effect of the fat content of the challenge matrix on the severity of the

  9. Oral S-adenosylmethionine in primary fibromyalgia. Double-blind clinical evaluation

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Danneskiold-Samsøe, B; Andersen, R B

    1991-01-01

    S-adenosylmethionine is a relatively new anti-inflammatory drug with analgesic and anti-depressant effects. Efficacy of 800 mg orally administered s-adenosylmethionine daily versus placebo for six weeks was investigated in 44 patients with primary fibromyalgia in double-blind settings. Tender point...... effects on primary fibromyalgia and could be an important option in the treatment hereof....

  10. Clinical effects of buspirone in social phobia : A double-blind placebo-controlled study

    NARCIS (Netherlands)

    denBoer, JA; Westenberg, HGM; Pian, KLH

    Background: The results of open pilot studies suggest that the serotonin-1A (5-HT1A) receptor agonist buspirone might be effective in social phobia. Method: In the present study, the efficacy of buspirone was investigated in patients with social phobia using a 12-week double-blind placebo-controlled

  11. A double-blind placebo controlled trial of paroxetine in the ...

    African Journals Online (AJOL)

    A double-blind placebo controlled trial of paroxetine in the management of social phobia (social anxiety disorder) in South Africa. Dan J. Stein, Michael Berk, Charl Els, Robin A. Emsley, Leon Gittelson, Don Wilson, Rosemary Oakes, Brian Hunter ...

  12. Effect of decaffeinated versus regular coffee on blood pressure: A 12-week, double-blind trial.

    NARCIS (Netherlands)

    Dusseldorp, van M.; Smits, P.; Thien, T.; Katan, M.B.

    1989-01-01

    The effect of decaffeinated versus regular coffee on blood pressure and heart rate was investigated. In a randomized double-blind, crossover trial, 45 healthy volunteers (23 women and 22 men, 25-45 years old) with a habitual intake of 4-6 cups coffee/day received 5 cups of regular coffee each day

  13. Double blind clinical trial comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Summary. Background: Osteoarthritis of the hip or knees is a very disabling condition in both Caucasians and Africans. A lot of medical drugs have been in use with their corresponding side effects, hence the search for newer drugs with fewer side effects. Study design: A double blind clinical trial comparing the safety and ...

  14. Randomized, double-blind, controlled trial of acetylcysteine in amyotrophic lateral sclerosis

    NARCIS (Netherlands)

    Louwerse, E. S.; Weverling, G. J.; Bossuyt, P. M.; Meyjes, F. E.; de Jong, J. M.

    1995-01-01

    BACKGROUND: Free radicals may play a role in the pathogenesis of amyotrophic lateral sclerosis. OBJECTIVE: To investigate the efficacy of the free radical scavenging agent acetylcysteine in patients with amyotrophic lateral sclerosis. DESIGN: Randomized, double-blind, placebo-controlled clinical

  15. A Randomized Double-Blind Crossover Study of Phase-Shift Sound Therapy for Tinnitus

    NARCIS (Netherlands)

    Heijneman, Karin M.; de Kleine, Emile; van Dijk, Pim

    Objective. The purpose of this study was to compare the efficacy of the treatment of tinnitus with a phase-shifting pure tone to that of the same tone treatment without phase shifting. Study Design. A double-blind crossover randomized controlled trial. Setting. This study was conducted at the

  16. A randomized, double-blind, placebo-controlled crossover study of ...

    African Journals Online (AJOL)

    Erectile dysfunction (ED) is one of the major health concerns affects the quality of life among Thai male. The treatment of ED by the first-line drugs is limited to a certain group of patients due to their side effects and costs. Alternative medicine can be beneficial for the treatment of ED. This is a randomized, double-blind, ...

  17. Label-Free, Single Molecule Resonant Cavity Detection: A Double-Blind Experimental Study

    Directory of Open Access Journals (Sweden)

    Maria V. Chistiakova

    2015-03-01

    Full Text Available Optical resonant cavity sensors are gaining increasing interest as a potential diagnostic method for a range of applications, including medical prognostics and environmental monitoring. However, the majority of detection demonstrations to date have involved identifying a “known” analyte, and the more rigorous double-blind experiment, in which the experimenter must identify unknown solutions, has yet to be performed. This scenario is more representative of a real-world situation. Therefore, before these devices can truly transition, it is necessary to demonstrate this level of robustness. By combining a recently developed surface chemistry with integrated silica optical sensors, we have performed a double-blind experiment to identify four unknown solutions. The four unknown solutions represented a subset or complete set of four known solutions; as such, there were 256 possible combinations. Based on the single molecule detection signal, we correctly identified all solutions. In addition, as part of this work, we developed noise reduction algorithms.

  18. Randomised double blind trial of morphine versus diamorphine for sedation of preterm neonates

    OpenAIRE

    Wood, C; Rushforth, J; Hartley, R.; Dean, H; Wild, J.; Levene, M.

    1998-01-01

    AIMS—To compare the safety and effectiveness of morphine and diamorphine for the sedation of ventilated preterm neonates in a double blind, randomised trial.
METHODS—Eighty eight babies were allocated to receive either morphine (n = 44) or diamorphine (n = 44) by bolus infusion (200 or 120mcg/kg, respectively, over two hours), followed by maintenance infusion (25 or 15 mcg/kg/h, respectively) during the initial phase of their respiratory disease. Serial monitoring of phys...

  19. ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study

    OpenAIRE

    Lansbergen, M. M.; van Dongen-Boomsma, M.; Buitelaar, J K; Slaats-Willemse, D.

    2010-01-01

    Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo feedback-controlled design and to explore the initial efficacy of individualized EEG-neurofeedback training in children with ADHD. Fourteen children (8–15 years) with ADHD defined according to the DSM-IV-TR ...

  20. A double-blind clinical trial of griseofulvin in patients with Raynaud's phenomenon

    Science.gov (United States)

    Sabri, S.; Roberts, V. C.; Higgins, R. F.; Cotton, L. T.; Williams, D. I.; Wilson, L. C.

    1973-01-01

    Twenty-four patients with Raynaud's phenomenon were treated with griseofulvin and a placebo in a double-blind cross-over clinical trial. The results were assessed subjectively and plotted sequentially. The number of patients able to distinguish the active from the placebo treatment was statistically significant (P=0·05). There were indications that the response was dose dependent. Further studies are needed to establish whether griseofulvin offers useful clinical improvement in this condition. PMID:4596620

  1. Luteal Phase Support in the Intrauterine Insemination (IUI) Cycles: A Randomized Double Blind, Placebo Controlled Study.

    OpenAIRE

    Batool Hossein Rashidi; Fatemeh Davari Tanha; Haleh Rahmanpour; Mahya Ghazizadeh

    2014-01-01

    Objective: To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI) cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG), in sub fertile couples. Materials and methods: This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They und...

  2. Double-Blind Comparison of Iodamide and Diatrizoate for Excretory Urography 1

    Science.gov (United States)

    Rosenfield, Arthur T.; Putman, Charles E.; Ulreich, Sidney; Koss, Neal

    1977-01-01

    A double-blind comparison of meglumine iodamide and Renografin 60 (52% meglumine diatrizoate and 8% sodium diatrizoate) for bolus excretory urography was performed. Doses of 0.8 cc/kg. to a maximum of 55 cc were administered to fifty patients, twenty-five receiving each drug. There is a suggestion that iodamide may be superior to diatrizoate in pyelocalyceal opacification while being equal to diatrizoate in parenchymal opacification and in types and severity of side-effects. PMID:345632

  3. Double-blind trial of naproxen and phenylbutazone in ankylosing spondylitis.

    Science.gov (United States)

    Van Gerwen, F; Van der Korst, J K; Gribnau, F W

    1978-02-01

    In a double-blind double-placebo crossover study naproxen (500-750 mg daily) was found to be equivalent to phenylbutazone (400-600 mg daily) in the control of disease activity in 20 patients suffering from ankylosing spondylitis during a two times 5-week trial period. No serious side effects were observed during the trial period. Gastric complaints occurred twice as often under phenylbutazone as under naproxen.

  4. New validated recipes for double-blind placebo-controlled low-dose food challenges.

    Science.gov (United States)

    Winberg, Anna; Nordström, Lisbeth; Strinnholm, Åsa; Nylander, Annica; Jonsäll, Anette; Rönmark, Eva; West, Christina E

    2013-05-01

    Double-blind placebo-controlled food challenges are considered the most reliable method to diagnose or rule out food allergy. Despite this, there are few validated challenge recipes available. The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by investigating whether there were any sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials. The challenge materials contained the same hypoallergenic amino acid-based product, with or without added food allergens. The test panels consisted of 275 school children, aged 8-10 and 14-15 yr, respectively, from five Swedish schools. Each participant tested at least one recipe. Standardized blinded triangle tests were performed to investigate whether any sensory differences could be detected between the active and placebo materials. In our final recipes, no significant differences could be detected between the active and placebo materials for any challenge food (p > 0.05). These results remained after stratification for age and gender. The taste of challenge materials was acceptable, and no unfavourable side effects related to test materials were observed. In summary, these new validated recipes for low-dose double-blinded food challenges contain common allergenic foods in childhood; cow's milk, hen's egg, soy, wheat and cod. All test materials contain the same liquid vehicle, which facilitates preparation and dosing. Our validated recipes increase the range of available recipes, and as they are easily prepared and dosed, they may facilitate the use of double-blind placebo-controlled food challenges in daily clinical practice. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  5. Centbutindole vs trifluoperazine : a double-blind controlled clinical study in acute schizophrenia.

    Directory of Open Access Journals (Sweden)

    Doongaji D

    1989-01-01

    Full Text Available Twenty-nine acute schizophrenic patients were treated under double-blind conditions for six weeks with either centbutindole in a dose range of 3 mg/day to 4.5 mg/day or trifluoperazine in the dose range of 15 mg/day to 22.5 mg/day. Both drugs produced a significant improvement in initial psychopathology. No significant differences were demonstrated between the two treatment conditions.

  6. Pain after microlaparoscopic cholecystectomy. A randomized double-blind controlled study

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R

    2000-01-01

    BACKGROUND: Laparoscopic cholecystectomy (LC) is traditionally performed with two 10-mm and two 5-mm trocars. The effect of smaller port incisions on pain has not been established in controlled studies. METHODS: In a double-blind controlled study, patients were randomized to LC or cholecystectomy...... to LC (38%). The micro-LC instruments therefore need further technical development before this surgical technique can be used on a routine basis for laparoscopic cholecystectomy....

  7. Double-blind trial of naproxen and phenylbutazone in ankylosing spondylitis.

    Science.gov (United States)

    Van Gerwen, F; Van der Korst, J K; Gribnau, F W

    1978-01-01

    In a double-blind double-placebo crossover study naproxen (500-750 mg daily) was found to be equivalent to phenylbutazone (400-600 mg daily) in the control of disease activity in 20 patients suffering from ankylosing spondylitis during a two times 5-week trial period. No serious side effects were observed during the trial period. Gastric complaints occurred twice as often under phenylbutazone as under naproxen. PMID:343727

  8. Double-blind trial of flurbiprofen and phenylbutazone in acute gouty arthritis.

    Science.gov (United States)

    Butler, R C; Goddard, D H; Higgens, C S; Hollingworth, P; Pease, C T; Stodell, M A; Scott, J T

    1985-01-01

    Flurbiprofen has been compared with phenylbutazone in a double-blind study involving 33 patients with acute gout. Patients received either flurbiprofen 400 mg daily for 48 h followed by 200 mg daily, or phenylbutazone 800 mg daily for 48 h followed by 400 mg daily. The drugs were of comparable efficacy, while side-effects were uncommon and relatively mild. Flurbiprofen appears to be a satisfactory alternative to phenylbutazone in the management of acute gouty arthritis. PMID:3907678

  9. Reintroduction failure is common among adolescents after double-blind placebo-controlled food challenges.

    Science.gov (United States)

    Strinnholm, Å; Winberg, A; Hedman, L; Rönmark, E; Lindh, V

    2017-02-01

    There has been a lack of research on adolescents who undergo double-blind placebo-controlled food challenges. The aim of this study was to investigate food allergic adolescents' experiences and consequences of double-blind placebo-controlled food challenges. This qualitative, descriptive interview study included 17 adolescents aged 14-15 years with total elimination of cows' milk, hens' eggs or cod due to food allergies. The participants, who were initially identified from a large population-based cohort study, were interviewed 18 months after completing their challenges. The double-blind placebo-controlled food challenge proved to be a complex experience for the adolescents, involving fear of potential reactions and the hope that the food could be reintroduced. Experiences during the challenge were described in three themes: facing fears in a secure environment, being hesitant but curious about unknown tastes and waiting for unknown food reactions. Experiences after the challenge were described in two themes: gaining control and freedom and continuing old habits. A negative challenge was not consistently associated with the reintroduction of the challenged food. This study highlighted the importance of considering the adolescents' expectations and experiences of the challenge and the reintroduction process to ensure desirable changes in their dietary habits. Follow-ups should be performed regardless of the outcome of challenges. ©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  10. A randomised, double-blinded study comparing giving etoricoxib vs. placebo to female patients with fibromyalgia.

    Science.gov (United States)

    Mahagna, H; Amital, D; Amital, H

    2016-02-01

    Current therapeutic approaches to fibromyalgia syndrome (FMS) do not provide satisfactory pain control to a high percentage of patients. This unmet need constantly fuels the pursuit for new modalities for pain relief. This randomised, double-blind, controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS. In this double-blind, placebo-controlled study, female patients were randomised to receive either 90 mg etoricoxib once daily or placebo for 6 weeks. Several physical and mental parameters were assessed throughout the study. The primary end-point was the response to treatment, defined as ≥ 30% reduction in the average Brief Pain Inventory score. Secondary outcomes were changes in the Fibromyalgia Impact Questionnaire, SF-36 Quality of Life assessment questionnaire and Hamilton rating scales for anxiety and depression. Overall, 73 patients were recruited. Although many outcome measures improved throughout the study, no difference was recorded between the etoricoxib- and placebo-treated groups. The Brief Pain Inventory, Fibromyalgia Impact Questionnaire, The Hamilton Anxiety and Depression scores did not differ between the two groups. This is the first randomised, double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS. Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects. © 2016 John Wiley & Sons Ltd.

  11. Treatment Assignment Guesses by Study Participants in a Double-Blind Dose Escalation Clinical Trial of Saw Palmetto

    OpenAIRE

    Lee, Jeannette Y.; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    Objectives: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM).

  12. Topical Calcipotriol for Preventive Treatment of Hypertrophic Scars A Randomized, Double-blind, Placebo-Controlled Trial

    NARCIS (Netherlands)

    van der Veer, Willem M.; Jacobs, Xander E.; Waardenburg, Ingmar E.; Ulrich, Magda M.; Niessen, Frank B.

    2009-01-01

    Objectives: To evaluate the efficacy of topical application of calcipotriol to healing wounds in preventing or reducing hypertrophic scar formation and to investigate the biochemical properties of the epidermis associated with hypertrophic scar formation. Design: Randomized, double-blind,

  13. [Probiotic prophylaxis in patients with predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Besselink, M.G.; Santvoort, H.C. van; Buskens, E.; Boermeester, M.A.; Goor, H. van; Timmerman, H.M.; Nieuwenhuijs, V.B.; Bollen, T.L.; Ramshorst, B. van; Witteman, B.J.M.; Rosman, C.; Ploeg, R.J.; Brink, M.; Schaapherder, A.F.; Dejong, C.H.; Wahab, P.J.; Laarhoven, C.J.H.M. van; Harst, E. van der; Eijck, C.H. van; Cuesta, M.A.; Akkermans, L.M.; Gooszen, H.G.

    2008-01-01

    OBJECTIVE: To evaluate whether enteral prophylaxis with probiotics in patients with predicted severe acute pancreatitis prevents infectious complications. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. METHOD: A total of 296 patients with predicted severe acute pancreatitis

  14. Topical Calcipotriol for Preventive Treatment of Hypertrophic Scars A Randomized, Double-blind, Placebo-Controlled Trial

    NARCIS (Netherlands)

    van der Veer, Willem M.; Jacobs, Xander E.; Waardenburg, Ingmar E.; Ulrich, Magda M.; Niessen, Frank B.

    2009-01-01

    Objectives: To evaluate the efficacy of topical application of calcipotriol to healing wounds in preventing or reducing hypertrophic scar formation and to investigate the biochemical properties of the epidermis associated with hypertrophic scar formation. Design: Randomized, double-blind,

  15. Iodine supplementation improves cognition in iodine-deficient schoolchildren in Albania: a randomized, controlled, double-blind study

    National Research Council Canada - National Science Library

    Zimmermann, Michael B; Connolly, Kevin; Bozo, Maksim; Bridson, John; Rohner, Fabian; Grimci, Lindita

    2006-01-01

    .... In a double-blind intervention trial, 10-12-y-old children (n = 310) in primary schools in rural southeastern Albania were randomly assigned to receive 400 mg I (as oral iodized oil) or placebo...

  16. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease

    National Research Council Canada - National Science Library

    Catassi, Carlo; Fabiani, Elisabetta; Iacono, Giuseppe; D'Agate, Cinzia; Francavilla, Ruggiero; Biagi, Federico; Volta, Umberto; Accomando, Salvatore; Picarelli, Antonio; De Vitis, Italo; Pianelli, Giovanna; Gesuita, Rosaria; Carle, Flavia; Mandolesi, Alessandra; Bearzi, Italo; Fasano, Alessio

    2007-01-01

    ... (ie, contaminating gluten). This was a multicenter, double-blind, placebo-controlled, randomized trial in 49 adults with biopsy-proven CD who were being treated with a gluten-free diet (GFD) for > or =2 y...

  17. Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study

    National Research Council Canada - National Science Library

    Hoving, Marjanke A; van Raak, Elisabeth P M; Spincemaille, Geert H J J; Palmans, Liesbeth J; Sleypen, Frans A M; Vles, Johan S H

    2007-01-01

    ...). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate...

  18. Randomised double blind placebo controlled trial of prednisolone in children admitted to hospital with respiratory syncytial virus bronchiolitis

    NARCIS (Netherlands)

    van Woensel, JBM; Wolfs, TFW; vanAalderen, WMC; Brand, PLP; Kimpen, JLL

    Background - Experimental and clinical evidence suggests that respiratory syncytial virus (RSV) bronchiolitis is an immune mediated disease. Corticosteroids might therefore be effective in the treatment of RSV bronchiolitis. Methods - A randomised double blind trial was conducted in children up to

  19. Citalopram, Methylphenidate, or Their Combination in Geriatric Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

    National Research Council Canada - National Science Library

    Lavretsky, Helen; Reinlieb, Michelle; St. Cyr, Natalie; Siddarth, Prabha; Ercoli, Linda M; Senturk, Damla

    2015-01-01

    ... patients.Method:The authors conducted a 16-week randomized double-blind placebo-controlled trial for geriatric depression in 143 older outpatients diagnosed with major depression comparing treatment response in three treatment groups...

  20. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy : efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L F; Lindeboom, J; Kasteleijn-Nolst Trenité, D G; Heimans, J J; Snoek, F J; Touw, D J; Adèr, H J; van Alphen, H A

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  1. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L. F.; Lindeboom, J.; Kasteleijn-Nolst Trenité, D. G.; Heimans, J. J.; Snoek, F. J.; Touw, D. J.; Adèr, H. J.; van Alphen, H. A.

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  2. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    OpenAIRE

    amrutesh, sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hyg...

  3. Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial.

    Science.gov (United States)

    Welter, Marie-Laure; Houeto, Jean-Luc; Thobois, Stéphane; Bataille, Benoit; Guenot, Marc; Worbe, Yulia; Hartmann, Andreas; Czernecki, Virginie; Bardinet, Eric; Yelnik, Jerome; du Montcel, Sophie Tezenas; Agid, Yves; Vidailhet, Marie; Cornu, Philippe; Tanguy, Audrey; Ansquer, Solène; Jaafari, Nematollah; Poulet, Emmanuel; Serra, Giulia; Burbaud, Pierre; Cuny, Emmanuel; Aouizerate, Bruno; Pollak, Pierre; Chabardes, Stephan; Polosan, Mircea; Borg, Michel; Fontaine, Denys; Giordana, Bruno; Raoul, Sylvie; Rouaud, Tiphaine; Sauvaget, Anne; Jalenques, Isabelle; Karachi, Carine; Mallet, Luc

    2017-08-01

    Deep brain stimulation (DBS) has been proposed to treat patients with severe Tourette's syndrome, and open-label trials and two small double-blind trials have tested DBS of the posterior and the anterior internal globus pallidus (aGPi). We aimed to specifically assess the efficacy of aGPi DBS for severe Tourette's syndrome. In this randomised, double-blind, controlled trial, we recruited patients aged 18-60 years with severe and medically refractory Tourette's syndrome from eight hospitals specialised in movement disorders in France. Enrolled patients received surgery to implant bilateral electrodes for aGPi DBS; 3 months later they were randomly assigned (1:1 ratio with a block size of eight; computer-generated pairwise randomisation according to order of enrolment) to receive either active or sham stimulation for the subsequent 3 months in a double-blind fashion. All patients then received open-label active stimulation for the subsequent 6 months. Patients and clinicians assessing outcomes were masked to treatment allocation; an unmasked clinician was responsible for stimulation parameter programming, with intensity set below the side-effect threshold. The primary endpoint was difference in Yale Global Tic Severity Scale (YGTSS) score between the beginning and end of the 3 month double-blind period, as assessed with a Mann-Whitney-Wilcoxon test in all randomly allocated patients who received active or sham stimulation during the double-blind period. We assessed safety in all patients who were enrolled and received surgery for aGPi DBS. This trial is registered with ClinicalTrials.gov, number NCT00478842. Between Dec 6, 2007, and Dec 13, 2012, we enrolled 19 patients. We randomly assigned 17 (89%) patients, with 16 completing blinded assessments (seven [44%] in the active stimulation group and nine [56%] in the sham stimulation group). We noted no significant difference in YGTSS score change between the beginning and the end of the 3 month double-blind period

  4. Multicentre Double-Blind Placebo-Controlled Food Challenge Study in Children Sensitised to Cashew Nut.

    Directory of Open Access Journals (Sweden)

    Johanna P M van der Valk

    Full Text Available Few studies with a limited number of patients have provided indications that cashew-allergic patients may experience severe allergic reactions to minimal amounts of cashew nut. The objectives of this multicentre study were to assess the clinical relevance of cashew nut sensitisation, to study the clinical reaction patterns in double-blind placebo-controlled food challenge tests and to establish the amount of cashew nuts that can elicit an allergic reaction.A total of 179 children were included (median age 9.0 years; range 2-17 years with cashew nut sensitisation and a clinical history of reactions to cashew nuts or unknown exposure. Sensitised children who could tolerate cashew nuts were excluded. The study included three clinical visits and a telephone consultation. During the first visit, the medical history was evaluated, physical examinations were conducted, blood samples were drawn and skin prick tests were performed. The children underwent a double-blind placebo-controlled food challenge test with cashew nut during the second and third visits. The study showed that 137 (76.5% of the sensitised children suspected of allergy to cashew nut had a positive double-blind placebo-controlled food challenge test, with 46% (63 manifesting subjective symptoms to the lowest dose of 1 mg cashew nut protein and 11% (15 developing objective symptoms to the lowest dose. Children most frequently had gastro-intestinal symptoms, followed by oral allergy and skin symptoms. A total of 36% (49/137 of the children experienced an anaphylactic reaction and 6% (8/137 of the children were treated with epinephrine.This prospective study demonstrated a strikingly high percentage of clinical reactions to cashew nut in this third line population. Severe allergic reactions, including anaphylaxis requiring epinephrine, were observed. These reactions were to minimal amounts of cashew nut, demonstrated the high potency of this allergens.www.ncbi.nlm.nih.gov/pubmed NTR3572.

  5. Doxycycline in early CJD: a double-blinded randomised phase II and observational study.

    Science.gov (United States)

    Varges, Daniela; Manthey, Henrike; Heinemann, Uta; Ponto, Claudia; Schmitz, Matthias; Schulz-Schaeffer, Walter J; Krasnianski, Anna; Breithaupt, Maren; Fincke, Fabian; Kramer, Katharina; Friede, Tim; Zerr, Inga

    2017-02-01

    The main objective of the present study is to study the therapeutic efficiency of doxycycline in a double-blinded randomised phase II study in a cohort of patients with sporadic Creutzfeldt-Jakob disease (sCJD). From the National Reference Center of TSE Surveillance in Germany, patients with probable or definite sCJD were recruited for a double-blinded randomised study with oral doxycycline (EudraCT 2006-003934-14). In addition, we analysed the data from patients with CJD who received compassionate treatment with doxycycline in a separate group. Potential factors which influence survival such as age at onset, gender, codon 129 polymorphism and cognitive functions were evaluated. The primary outcome measure was survival. Group 1: in the double-blinded randomised phase II study, 7 patients in the treatment group were compared with 5 controls. Group 2: 55 patients with sCJD treated with oral doxycycline were analysed and compared with 33 controls by a stratified propensity score applied to a Cox proportional hazard analysis. The results of both studies were combined by means of a random-effects meta-analysis. A slight increase in survival time in the doxycycline treatment group was observed (p=0.049, HR=0.63 (95% CI 0.402 to 0.999)). On the basis of our studies, a larger trial of doxycycline should be performed in persons in the earliest stages of CJD. EudraCT 2006-003934-14; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  6. Response of pain to static magnetic fields in postpolio patients: a double-blind pilot study.

    Science.gov (United States)

    Vallbona, C; Hazlewood, C F; Jurida, G

    1997-11-01

    To determine if the chronic pain frequently presented by postpolio patients can be relieved by application of magnetic fields applied directly over an identified pain trigger point. Double-blind randomized clinical trial. The postpolio clinic of a large rehabilitation hospital. Fifty patients with diagnosed postpolio syndrome who reported muscular or arthritic-like pain. Application of active or placebo 300 to 500 Gauss magnetic devices to the affected area for 45 minutes. Score on the McGill Pain Questionnaire. Patients who received the active device experienced an average pain score decrease of 4.4 +/- 3.1 (p postpolio subjects.

  7. Double-blind controlled trial comparing carbamazepine to oxazepam treatment of alcohol withdrawal.

    Science.gov (United States)

    Malcolm, R; Ballenger, J C; Sturgis, E T; Anton, R

    1989-05-01

    Of 86 alcoholic men with severe alcohol withdrawal who began a double-blind controlled study comparing carbamazepine, 800 mg/day, to oxazepam, 120 mg/day, 66 (carbamazepine, N = 32; oxazepam, N = 34) completed the 7-day trial. In general, the drugs were found to be equally efficacious in treating the withdrawal syndrome and not significantly different with respect to side effects. The subjects taking oxazepam had an increase in global psychological distress from day 3 to day 7, and those taking carbamazepine exhibited a decline. The study suggests that carbamazepine is as effective and safe as benzodiazepine treatment for alcohol withdrawal.

  8. A double-blind comparison of phenylbutazone and suxibuzone, a prodrug of phenylbutazone, in rheumatoid arthritis.

    Science.gov (United States)

    Mizushima, Y; Shiokawa, Y; Honma, M; Kageyama, T

    1983-01-01

    One hundred and fifty patients with rheumatoid arthritis received suxibuzone (426 mg/day, equivalent to 300 mg of phenylbutazone), a prodrug of phenylbutazone, or phenylbutazone (300 mg/day) in a six-week double-blind comparison study. After six weeks of treatment, morning stiffness, joint symptoms, and grip strength all improved almost equally in both groups. On the other hand, the frequency and severity of side-effects, particularly of gastro-intestinal (GI) disturbances, were markedly and significantly lower in the suxibuzone group. This study indicates that some prodrugs of non-steroid anti-inflammatory drugs are useful because they have fewer side-effects.

  9. Azathioprine in rheumatoid arthritis: double-blind study of full versus half doses versus placebo.

    OpenAIRE

    Woodland, J; Chaput de Saintonge, D M; Evans, S J; Sharman, V L; Currey, H L

    1981-01-01

    To test whether azathioprine in effective in rheumatoid arthritis in doses smaller than those normally used the drug was tested at 2 dosage levels, 2.5 and 1.25 mg/kg/day (2.5 AZ and 1.25 AZ), against placebo under double-blind conditions over 24 weeks. Dropouts were 7 out of 15 in the 2.5 AZ group, 4 out of 14 in the 1.25 AZ group, and 2 out of 13 in the placebo group. Some significant improvement occurred in all 3 groups, including those on placebo. However, the 2.5 AZ group fared significa...

  10. A randomized double-blind study evaluating Anandron associated with orchiectomy in stage D prostate cancer.

    Science.gov (United States)

    Namer, M; Toubol, J; Caty, A; Couette, J E; Douchez, J; Kerbrat, P; Droz, J P

    1990-12-20

    A randomized double-blind study with a 3-yr follow-up comparing the two arms "orchiectomy + Anandron (300 mg)" vs "orchiectomy + placebo" in 125 patients with stage D prostate cancer has confirmed the beneficial effects of the combined Anandron therapy on subjective parameters and on the best objective response (NPCP criteria), although these effects were not statistically significant, but failed to detect any improvement in time-to-disease progression or survival. Comparison with the results of other trials emphasizes the urgent need to establish suitable prognostic factors by further clinical research before evaluating the benefits of individual drugs.

  11. Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial

    DEFF Research Database (Denmark)

    Wejse, Christian; Gomes, Victor F; Rabna, Paulo

    2009-01-01

    RATIONALE: Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. OBJECTIVES: To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. METHODS: We conducted a randomized, double-blind......, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months...

  12. "Live high-train low" using normobaric hypoxia: a double-blinded, placebo-controlled study

    DEFF Research Database (Denmark)

    Siebenmann, Christoph; Robach, Paul; Jacobs, Robert A

    2012-01-01

    The combination of living at altitude and training near sea level [live high-train low (LHTL)] may improve performance of endurance athletes. However, to date, no study can rule out a potential placebo effect as at least part of the explanation, especially for performance measures. With the use o...... of a placebo-controlled, double-blinded design, we tested the hypothesis that LHTL-related improvements in endurance performance are mediated through physiological mechanisms and not through a placebo effect. Sixteen endurance cyclists trained for 8 wk at low altitude (...

  13. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted in ...... with focal dystonia (torticollis) by examining the video recordings. Results On average for all patients, DBS improved the BFMDRS movement scores (p...... ratings were assessed by using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and video recordings. Quality of life was evaluated by using questionnaires (36-item Short Form Health Survey). Supplemental Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores were assessed for patients...

  14. Double-blind Cross-over Trial of Flurbiprofen and Phenylbutazone in Ankylosing Spondylitis

    Science.gov (United States)

    Calin, A.; Grahame, R.

    1974-01-01

    A double-blind cross-over study in 35 patients with ankylosing spondylitis was carried out comparing flurbiprofen (150 mg daily)—a new non-steroidal anti-inflammatory agent—with phenylbutazone (300 mg daily) over a four-week period. Flurbiprofen was well tolerated and shown to have therapeutic efficacy approaching that of phenylbutazone. The results suggest that flurbiprofen may prove a valuable alternative in the treatment of ankylosing spondylitis, and longterm efficacy and tolerance studies are clearly indicated. PMID:4611579

  15. Carbamazepine versus oxazepam in the treatment of alcohol withdrawal: a double-blind study.

    Science.gov (United States)

    Stuppaeck, C H; Pycha, R; Miller, C; Whitworth, A B; Oberbauer, H; Fleischhacker, W W

    1992-03-01

    The use of more than 130 drugs and drug combinations against the alcohol withdrawal syndrome reflects the fact that views on its treatment are far from being unequivocal. Benzodiazepines are the first choice treatment but it should not be disregarded that they have side effects and, above all, a varying risk of dependency themselves. In recent years many trials have focused on carbamazepine in this respect. Its efficacy was proven in various open and double-blind studies, most of them using concomitant sedative drugs, thereby diminishing the reliability of the results. In a double-blind study we compared the efficacy of carbamazepine with that of oxazepam, in 60 in-patients suffering from alcohol withdrawal syndrome. The main rating instrument was the Clinical Institute Withdrawal Scale--Alcohol (CIWA-A). The 7-day trial showed equal efficacy of carbamazepine and oxazepam during the first 5 days and a statistically significant superiority of carbamazepine on days 6 and 7. Four patients in each group had to be dropped from the study due to side effects or after having withdrawn informed consent. There was no decrease in white blood counts under carbamazepine. The experiences with carbamazepine up to now suggest a more widespread use, especially in non-delirious withdrawal states.

  16. Biphasic versus monophasic shock waveform for conversion of atrial fibrillation: the results of an international randomized, double-blind multicenter trial

    National Research Council Canada - National Science Library

    Page, Richard L; Kerber, Richard E; Russell, James K; Trouton, Tom; Waktare, Johan; Gallik, Donna; Olgin, Jeff E; Ricard, Philippe; Dalzell, Gavin W; Reddy, Ramakota; Lazzara, Ralph; Lee, Kerry; Carlson, Mark; Halperin, Blair; Bardy, Gust H

    2002-01-01

    .... In an international, multicenter, randomized, double-blind clinical trial, we compared the effectiveness of damped sine wave monophasic versus impedance-compensated truncated exponential biphasic...

  17. Intravenous Dexmedetomidine Promotes Spinal Bupivacaine Anesthesia and Postoperative Analgesia in Lower Limb Surgery: A Double-Blind, Randomized Clinical CONSORT Study

    National Research Council Canada - National Science Library

    Zhang, Hao; Li, Ming; Zhang, Sai-Yu; Fu, Min; Zhang, Si-Yan

    2016-01-01

    .... This prospective, randomized, double-blind clinical study was designed to observe the efficacy of intravenous DEX without loading dose on spinal blockade duration, postoperative sedation, patient...

  18. Pregabalin for anxiety in patients with schizophrenia - A randomized, double-blind placebo-controlled study

    DEFF Research Database (Denmark)

    Schjerning, Ole; Damkier, Per; Lykkegaard, Signe Engelhardt

    2017-01-01

    INTRODUCTION: Anxiety is frequent in patients with schizophrenia and poses a major impact on patients perceived quality of life, daily functioning and risk of suicide. Pregabalin has shown effective in the treatment of generalized anxiety disorder and has been suggested for the treatment of anxiety...... in patients with schizophrenia. As evidence is sparse regarding treatment of anxiety in this patient group, we aimed to investigate the use of pregabalin for anxiety in patients with schizophrenia. METHODS: A randomized, double-blind placebo controlled study was used. Patients were randomized to either...... placebo or pregabalin (≤600mg/d) as add-on treatment. Primary analyses were intention-to-treat based with change in Hamilton Anxiety Scale after 4 and 8weeks of treatment as primary outcome. Secondary outcomes were change in psychopathology, quality-of-life, cognitive functioning and sleep. The study used...

  19. Lisuride versus bromocriptine treatment in Parkinson disease: a double-blind study.

    Science.gov (United States)

    LeWitt, P A; Gopinathan, G; Ward, C D; Sanes, J N; Dambrosia, J M; Durso, R; Calne, D B

    1982-01-01

    Twenty-eight parkinsonian patients were studied in a double-blind, crossover comparison of lisuride and bromocriptine. All but two patients completed the study, with each drug adjusted to an optimal dose (mean daily intake of 4.5 mg for lisuride and 56.5 mg for bromocriptine). Treatment with each drug was given for 7 to 10 weeks; three assessments were made at biweekly intervals with optimal dose levels. Conventional antiparkinsonian medications, including levodopa, were not changed. Efficacy and adverse effects were assessed by objective and subjective techniques. The only significant difference was slightly better control of akinesia with bromocriptine. There was considerable variability in the optimal dose of each drug, though the clinical profile of lisuride was quite similar to that of bromocriptine.

  20. Oral S-adenosylmethionine in primary fibromyalgia. Double-blind clinical evaluation

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Danneskiold-Samsøe, B; Andersen, R B

    1991-01-01

    = 0.03) and mood evaluated by Face Scale (P = 0.006) in the actively treated group compared to placebo. The tender point score, isokinetic muscle strength, mood evaluated by Beck Depression Inventory and side effects did not differ in the two treatment groups. S-adenosylmethionine has some beneficial......S-adenosylmethionine is a relatively new anti-inflammatory drug with analgesic and anti-depressant effects. Efficacy of 800 mg orally administered s-adenosylmethionine daily versus placebo for six weeks was investigated in 44 patients with primary fibromyalgia in double-blind settings. Tender point...... score, isokinetic muscle strength, disease activity, subjective symptoms (visual analog scale), mood parameters and side effects were evaluated. Improvements were seen for clinical disease activity (P = 0.04), pain experienced during the last week (P = 0.002), fatigue (P = 0.02), morning stiffness (P...

  1. Effectiveness of expectant management versus methotrexate in tubal ectopic pregnancy: a double-blind randomized trial.

    Science.gov (United States)

    Silva, Priscila Matthiesen; Araujo Júnior, Edward; Cecchino, Gustavo Nardini; Elito Júnior, Julio; Camano, Luiz

    2015-04-01

    To compare the effectiveness of expectant management versus methotrexate in selected cases of tubal ectopic pregnancy. A double-blind randomized trial included 23 selected patients with a confirmed diagnosis of tubal pregnancy who met the inclusion criteria (hemodynamic stability, initial serum β-hCG concentration 0.999). The β-hCG values became undetectable at 22 ± 15.4 days in the methotrexate group and 20.6 ± 8.4 days in the placebo group (p = 0.80). This study showed no statistically significant difference between the treatment with methotrexate and placebo, with similar success rates and similar time interval for β-hCG to become undetectable.

  2. Double blind comparison of three hearing aid circuits with new hearing aid users.

    Science.gov (United States)

    Hayes, D E; Cormier, K L

    2000-01-01

    This study was a double blind comparison of three types of hearing aid circuits: Class A linear peak clipping, Class D compression limiting and K-Amp wide dynamic range compression. Subjective ratings, speech perception tests, real ear measurements and questionnaire data were obtained from a group of 17 new hearing aid users with mild to moderate sensorineural hearing loss. The results indicate a similar performance for all three circuits. We saw no evidence of performance degradation due to saturation distortion, even in the presence of high levels of speech and noise. Our primary conclusions include recommending K-Amps to new hearing aid users with mild to moderate hearing loss, mostly on the basis of battery life, while cautioning about the use of compression knee-point controls and recognizing that Class A and Class D amplifiers are virtually equivalent in every performance measurement.

  3. Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study.

    Science.gov (United States)

    Rogel, Ainat; Guez, Jonathan; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Todder, Doron

    2015-09-01

    The benefits of clinical neurofeedback training are well known, however, its adverse side-effects are less studied. This research focuses on the transient adverse side effects of neurofeedback training via a double-blind, sham/controlled methodology. Thirty healthy undergraduate students volunteers were randomly divided into three treatment groups: increasing a modified Sensory Motor Rhythm, increasing Upper Alpha, and Sham/control group who receive a random reward. The training sessions were administered for a total of ten sessions. Questionnaires of transient adverse side effects were completed by all volunteers before each session. The results suggest that similar to most medical treatments, neurofeedback can cause transient adverse side effects. Moreover, most participants reported experiencing some side effects. The side effects can be divided into non-specific side effect, associated with the neurofeedback training in general and specific ones associated with the particular protocol. Sensory Motor Rhythm protocol seems to be the most sensitive to side effects.

  4. Effect of Anodal Transcranial Direct Current Stimulation on Autism: A Randomized Double-Blind Crossover Trial

    Directory of Open Access Journals (Sweden)

    Anuwat Amatachaya

    2014-01-01

    Full Text Available The aim of this study was to evaluate the Childhood Autism Rating Scale (CARS, Autism Treatment Evaluation Checklist (ATEC, and Children’s Global Assessment Scale (CGAS after anodal transcranial direct current stimulation (tDCS in individuals with autism. Twenty patients with autism received 5 consecutive days of both sham and active tDCS stimulation (1 mA in a randomized double-blind crossover trial over the left dorsolateral prefrontal cortex (F3 for 20 minutes in different orders. Measures of CARS, ATEC, and CGAS were administered before treatment and at 7 days posttreatment. The result showed statistical decrease in CARS score (P<0.001. ATEC total was decreased from 67.25 to 58 (P<0.001. CGAS was increased at 7 days posttreatment (P=0.042. Our study suggests that anodal tDCS over the F3 may be a useful clinical tool in autism.

  5. EVALUTION OF UNILATERAL ELECTRO-CONVULSIVE THERAPY (A double blind study).

    Science.gov (United States)

    Chatterjee, S B; Mohammed, E

    1980-04-01

    A double blind study of one hundred twenty patients ( ninety schizophrenics and thirty depressives )-who were divided equally into three groups, who received either (a) bilateral ECT or (b) unilateral application of electrodes on non-dominant hemisphere or (c) unilateral on dominant hemisphere was conducted. The three groups were compared regarding efficacy of the therapy, effects on memory, speed of recovery from each shock session and lastly changes in the electro-encephalogram.It was found that all the three techniques were more or less equal in therapeutic efficacy. There was no significant difference between them in the speed of recovery, nor in the EEG changes. Only difference was that in the field of memory, unilateral non-dominant group showed significant improvement in the 'immediate verbal recall' component of memory in particular. Results have been discussed in view of the current literature on the subject.

  6. Efficacy of nebulized L-epinephrine for treatment of croup: a randomized, double-blind study.

    Science.gov (United States)

    Eghbali, Aziz; Sabbagh, Ali; Bagheri, Bahador; Taherahmadi, Hassan; Kahbazi, Manijeh

    2016-02-01

    The objective of this study was to compare the effect of L-epinephrine plus dexamethasone vs. dexamethasone for treatment of croup in children. A randomized, double-blind clinical trial was implemented on 174 patients with croup, aged from 6 months to 6 years, and admitted to the Amir Kabir Pediatric Hospital (Arak, Iran). After randomized allocation, patients were administered dexamethasone, and then, they received either saline or L-epinephrine. Westley croup scores, heart rate, respiratory rate, and blood pressure were recorded every half an hour for a total of 120 min. There was a significant difference in mean of croup scores between two groups (P nebulized L-epinephrine compared to patients who received placebo. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  7. Pterygium excision with or without postoperative irradiation, a double-blind study

    Energy Technology Data Exchange (ETDEWEB)

    de Keizer, R.J.W. (Amsterdam Univ. (Netherlands). Academisch Ziekenhuis)

    1982-01-29

    A double-blind study (covering 40 months) of 40 eyes with a pterygium which had not previously been operated on, was carried out to study the effect of post-operative irradiation. Nineteen eyes were treated by the 'bare sclera' operation technique only and in 13 cases (68%) a recurrence occurred within 4 months. In 18 eyes from the group of patients treated with Sr 90 irradiation on the 1st, 7th and 14th postoperative day (maximum 3 x 1000 rad) no recurrences were seen. Patients with a recurrent pterygium and diplopia, symblepharon, visual disturbances (growth over the pupil or severe astigmatism) or many previous operations, were treated by lamellar keratoplasty (Dake, 1980). The recurrences without these complications were treated with success by the 'bare sclera' technique and postoperative irradiation. Complications did not occur in any of the series.

  8. Phlebitis induced by parenteral treatment with flucloxacillin and cloxacillin: a double-blind study.

    Science.gov (United States)

    Svedhem, A; Alestig, K; Jertborn, M

    1980-01-01

    Two studies were performed on a total of 54 patients with staphylococcal infections. Study I compares with phlebitogenic properties of flucloxacillin after intravenous infusions when either saline or sterile water was used as a solvent. No difference was observed between the two solvents, and the frequency of phlebitis for the total material without respect to solvents was 5% after 1 day of treatment and 13% after 2 days. Study II was a double-blind comparison of phlebitis caused by intravenous infusions of either flucloxacillin or cloxacillin. The frequencies of phlebitis were found to be 18 and 13%, respectively. After 2 days of treatment the frequency of phlebitis increased dramatically for both drugs. All infusions were given through a plastic cannula of 5-cm length and 1.2-mm diameter. PMID:7447412

  9. Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication

    DEFF Research Database (Denmark)

    Tönnesen, K H; Albuquerque, P; Baitsch, G

    1993-01-01

    . Adverse events of any type were reported by 18 patients (12.2%) in the indobufen group and by 11 patients (7.2%) in the placebo group. The mechanism whereby the drug is effective in this clinical condition could be related to both its antiplatelet and hemorheologic effects.......The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-blind, placebo-controlled run-in phase, followed by a six-month double-blind randomized...... treatment period. A total of 302 patients were allocated to treatment with either placebo (154 patients) or indobufen (148) 200 mg twice daily. The results of the overall intention-to-treat analysis of the study population showed statistically significant superiority of indobufen over placebo after six...

  10. Pacemaker current inhibition in experimental human cardiac sympathetic activation: a double-blind, randomized, crossover study.

    Science.gov (United States)

    Schroeder, C; Heusser, K; Zoerner, A A; Großhennig, A; Wenzel, D; May, M; Sweep, F C G J; Mehling, H; Luft, F C; Tank, J; Jordan, J

    2014-06-01

    Hyperpolarization-activated, cyclic nucleotide-gated 4 (HCN4) channels comprise the final pathway for autonomic heart rate (HR) regulation. We hypothesized that HCN4 inhibition could reverse autonomic imbalance in a human model of cardiac sympathetic activation. Nineteen healthy men ingested oral metoprolol+reboxetine, ivabradine+reboxetine, or placebo+reboxetine in a double-blind, randomized, crossover fashion. We assessed HR, blood pressure (BP), stroke volume, and cardiac output during rest and profound orthostatic stress. HR variability, BP variability, and baroreflex sensitivity were analyzed. Metoprolol, but not ivabradine, decreased resting HR and BP. Ivabradine attenuated the HR increase to orthostatic stress, albeit to a lesser extent than metoprolol. Stroke volume and cardiac output at a given HR were significantly lower with metoprolol. Unlike metoprolol, ivabradine did not affect HR variability, BP variability, or baroreflex sensitivity. Ivabradine attenuates sympathetic influences on HR at the sinus node level, leaving myocardial sympathetic activation unopposed. Reversal of parasympathetic dysfunction by ivabradine appears limited.

  11. Levetiracetam in primary orthostatic tremor: a double-blind placebo-controlled crossover study.

    Science.gov (United States)

    Hellriegel, Helge; Raethjen, Jan; Deuschl, G; Volkmann, Jens

    2011-11-01

    In a double-blind crossover study we evaluated the antitremor effect of a 4-week treatment with either escalating dosages of levetiracetam or placebo in orthostatic tremor. Twelve patients with orthostatic tremor participated in the study. Primary end point was improvement in stance duration. Secondary end points were total track length of the sway path and tremor total power. The patients' impression of impairment was assessed by a visual analog scale and quality of life by the SF-36. We found no significant effect of dosage or treatment on stance duration (P = .175), total track length (P = .690), total power (P = .280), or visual analog scale (P =.735). Neither was SF-36 differentially changed by levetiracetam or placebo (SF-36, Physical Component Summary: P = .079; SF-36, Mental Component Summary: P = .073). Side effects like dizziness, fatigue, or nausea were only mild to moderate. Levetiracetam is ineffective in the treatment of orthostatic tremor. Copyright © 2011 Movement Disorder Society.

  12. Lamotrigine monotherapy in newly diagnosed untreated epilepsy: a double-blind comparison with phenytoin.

    Science.gov (United States)

    Steiner, T J; Dellaportas, C I; Findley, L J; Gross, M; Gibberd, F B; Perkin, G D; Park, D M; Abbott, R

    1999-05-01

    Lamotrigine is an effective add-on therapy against a range of epileptic seizure types. Comparative studies with carbamazepine (CBZ) as monotherapy in newly diagnosed epilepsy suggest similar efficacy. In this study, lamotrigine (LTG) and phenytoin (PHT) are compared. In a double-blind parallel-groups study, 181 patients with newly diagnosed untreated partial seizures or secondarily or primary generalised tonic-clonic seizures were randomised to two treatment groups. One group (n = 86) received LTG titrated over 6 weeks from a starting dose of 100 mg/day. The other (n = 95) received PHT titrated from 200 mg/day. Treatment continued for epilepsy. LTG was better tolerated, more frequently causing rash, but with a lower incidence of central nervous system side effects.

  13. A Double-Blind, Placebo-Controlled Trial of Modafinil for Cocaine Dependence

    Science.gov (United States)

    Dackis, Charles A.; Kampman, Kyle M.; Lynch, Kevin G.; Plebani, Jennifer G.; Pettinati, Helen M.; Sparkman, Thorne; O’Brien, Charles P.

    2012-01-01

    This is a randomized, double blind, placebo-controlled study of modafinil treatment for cocaine dependence. Patients (n=210), who were actively using cocaine at baseline, were randomized to 8-weeks of modafinil (0 mg/day, 200 mg/day or 400 mg/day) combined with once-weekly cognitive behavioral therapy (CBT). Our primary efficacy measure was cocaine abstinence, based on urine benzoylecgonine (BE) levels, with secondary measures of craving, cocaine withdrawal, retention and tolerability. We found no significant differences between modafinil and placebo patients on any of these measures. However, there was a significant gender difference in that male patients treated with 400 mg/day tended to be more abstinent than their placebo-treated counterparts (p=0.06). Our negative findings might be explained by gender differences and/or inadequate psychosocial treatment intensity in patients with severe cocaine dependence. PMID:22377391

  14. Terbutaline depot tablets in childhood asthma. A double-blind controlled study

    DEFF Research Database (Denmark)

    Foged, N; Høst, A; Ljungholm, K

    1985-01-01

    Thirty children 8-13 years old, with perennial asthma and with a reversibility of greater than or equal to 20% in lung function (FEV1) were given a sustained-release preparation of terbutaline sulphate 5 mg twice a day and ordinary tablets 2.5 mg three times a day; each treatment lasted 1 week....... The design of the study was double-blind, cross-over, with a randomized allocation of the drugs. Both drugs improved the lung function significantly. The children had significantly less coughing during the night when they took depot tablets than when they took ordinary tablets. The side effects were few...... with both treatments. Most of the patients preferred the depot tablets....

  15. The antimyotonic effect of lamotrigine in non-dystrophic myotonias: a double-blind randomized study

    DEFF Research Database (Denmark)

    Andersen, Grete; Hedermann, Gitte; Witting, Nanna

    2017-01-01

    , and randomized patients in blocks of 10. Participants and investigators were all blinded to treatment until the end of the trial. In two 8-week periods, oral lamotrigine or placebo capsules were provided once daily, with increasing doses (from 25 mg, 50 mg, 150 mg to 300 mg) every second week. The primary....... Like mexiletine, lamotrigine is a sodium channel blocker, but unlike mexiletine, lamotrigine is available, inexpensive, and well tolerated. We investigated the potential of using lamotrigine for treatment of myotonia in patients with non-dystrophic myotonias. In this, randomized double-blind, placebo...... was registered at ClinicalTrials.gov (NCT02159963) and EudraCT (2013-003309-24). We included 26 patients (10 females, 16 males, age: 19-74 years) from 13 November 2013 to 6 July 2015. Twenty-two completed the entire study. One patient withdrew due to an allergic reaction to lamotrigine. Three patients withdrew...

  16. Minocycline versus co-trimoxazole in chancroid : A double-blind randomised study

    Directory of Open Access Journals (Sweden)

    Oberoi C

    1994-01-01

    Full Text Available This double-blind randomised parallel-group study comparing the efficacy and side effects of minocycline with that of cotrimoxazole in chancroid, had 56 analysable cases, 28 in each group. All admissible cases were assessed clinically on a scale of 0 to 3 for number and size of ulcers, pain, discharge, surrounding erythema and bubo. Each drug individually showed significant improvement in all clinical parameters. Minocycline showed significantly better improvement than cotrimoxazole in all parameters. Minocycline had 43% cure rate, and no failures, against 36% cure and 25% failure for cotrimoxazole. Both the drug were well tolerated. We conclude that minocycline is a superior alternative to cotrimoxazole in the therapy of chancroid.

  17. Rizatriptan in migraineurs with unilateral cranial autonomic symptoms: a double-blind trial.

    Science.gov (United States)

    Barbanti, Piero; Fofi, Luisa; Dall'Armi, Valentina; Aurilia, Cinzia; Egeo, Gabriella; Vanacore, Nicola; Bonassi, Stefano

    2012-07-01

    The objective and background is to confirm in a double-blind, placebo-controlled study the high triptan response rates we had previously reported in an open study in migraine patients with unilateral cranial autonomic symptoms. In this randomized, double-blind, placebo-controlled study 80 migraineurs with unilateral cranial autonomic symptoms were assigned to receive rizatriptan 10 mg wafer or placebo (ratio 1:1) and treated for a single moderate or severe migraine attack. The primary endpoints were pain freedom at 2 h and total migraine freedom at 2 h. Secondary endpoints included pain relief, no associated symptoms and sustained pain freedom or relief. Significantly more patients reported pain freedom at 2 h after taking rizatriptan (54 %) than after placebo (8 %) (therapeutic gain 46 % [28 %; 64 %]; P < 0.001). Similarly, significantly more patients reported total migraine freedom at 2 h after rizatriptan (51 %) than after placebo (8 %) (therapeutic gain 43 % [26 %; 61 %]; P < 0.001). Rizatriptan was also more effective than placebo on most secondary endpoints. We confirm in a placebo-controlled study our previous data suggesting that the presence of unilateral cranial autonomic symptoms in migraineurs predicts a positive response to triptans, probably owing to intense trigeminal peripheral afferent activation which strongly recruits peripheral neurovascular 5-HT1B/1D receptors. Acute and preventive pharmacological trials in migraine should focus also on this subset of migraine patients.

  18. ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study.

    Science.gov (United States)

    Lansbergen, M M; van Dongen-Boomsma, M; Buitelaar, J K; Slaats-Willemse, D

    2011-02-01

    Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo feedback-controlled design and to explore the initial efficacy of individualized EEG-neurofeedback training in children with ADHD. Fourteen children (8-15 years) with ADHD defined according to the DSM-IV-TR criteria were randomly allocated to 30 sessions of EEG-neurofeedback (n = 8) or placebo feedback (n = 6). Safety measures (adverse events and sleep problems), ADHD symptoms and global improvement were monitored. With respect to feasibility, all children completed the study and attended all study visits and training sessions. No significant adverse effects or sleep problems were reported. Regarding the expectancy, 75% of children and their parent(s) in the active neurofeedback group and 50% of children and their parent(s) in the placebo feedback group thought they received placebo feedback training. Analyses revealed significant improvements of ADHD symptoms over time, but changes were similar for both groups. This pilot study shows that it is feasible to conduct a rigorous placebo-controlled trial to investigate the efficacy of neurofeedback training in children with ADHD. However, a double-blind design may not be feasible since using automatic adjusted reward thresholds may not work as effective as manually adjusted reward thresholds. Additionally, implementation of active learning strategies may be an important factor for the efficacy of EEG-neurofeedback training. Based on the results of this pilot study, changes are made in the design of the ongoing study.

  19. Ciguatera fish poisoning: a double-blind randomized trial of mannitol therapy.

    Science.gov (United States)

    Schnorf, Hans; Taurarii, M; Cundy, T

    2002-03-26

    Ciguatera poisoning (CP) is worldwide the most common fish-borne illness and one of the most common forms of nonbacterial food poisoning. IV mannitol is considered the treatment of choice for CP but has not been evaluated in a double-blind randomized trial. A prospective clinical study of 50 patients with CP on Rarotonga, Cook Islands, was conducted to better define the neurologic picture of CP and to study the effect of mannitol or normal saline under double-blind randomized conditions over a 24-hour period. The neurologic presentation of CP was that of a predominantly sensory, length-dependent polyneuropathy, with preferential small-fiber involvement. Motor paresis, cranial nerve dysfunction, and CNS abnormalities were absent but for a rare mild transitory cerebellar syndrome. At 24 hours, 96% of mannitol-treated patients and 92% of normal saline-treated patients had some improvement of symptoms (p = 1.0), whereas 12% and 24% of patients in each group were asymptomatic (p = 0.46). By 24 hours, the prevalence of the various polyneuropathic symptoms and signs was reduced roughly by half in both groups. Discomfort or pain along the vein used for infusion was more frequent in the mannitol group (84%) than in the normal saline group (36%) (p = 0.0015). Mannitol was not superior to normal saline in relieving symptoms and signs of CP at 24 hours in this study population but had more side effects. These results do not support single-dose mannitol as standard treatment for CP.

  20. A randomised, double-blind, placebo-controlled trial of tropisetron in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Shiraishi Tetsuya

    2010-06-01

    Full Text Available Abstract Background Cognitive deficits in schizophrenia are associated with psychosocial deficits that are primarily responsible for the poor long-term outcome of this disease. Auditory sensory gating P50 deficits are correlated with neuropsychological deficits in attention, one of the principal cognitive disturbances in schizophrenia. Our studies suggest that the α7 nicotinic acetylcholine receptor (α7 nAChR agonist tropisetron might be a potential therapeutic drug for cognitive deficits in schizophrenia. Therefore, it is of particular interest to investigate the effects of tropisetron on the cognitive deficits in patients with schizophrenia. Methods A randomised, placebo-controlled trial of tropisetron in patients with schizophrenia was performed. A total of 40 patients with chronic schizophrenia who had taken risperidone (2 to 6 mg/day were enrolled. Subjects were randomly assigned to a fixed titration of tropisetron (n = 20, 10 mg/day or placebo (n = 20 in an 8-week double-blind trial. Auditory sensory gating P50 deficits and Quality of Life Scale (QLS, Cambridge Neuropsychological Test Automated Battery (CANTAB, and Positive and Negative Syndrome Scale (PANSS scores were measured. Results In all, 33 patients completed the trial. Tropisetron was well tolerated. Administration of tropisetron, but not placebo, significantly improved auditory sensory gating P50 deficits in non-smoking patients with schizophrenia. The score on the rapid visual information processing (sustained visual attention task of CANTAB was significantly improved by tropisetron treatment. Total and subscale scores of PANSS were not changed by this trial. QLS scores in the all patients, but not non-smoking patients, were significantly improved by tropisetron trial. Conclusions This first randomised, double-blind, placebo-controlled trial supports the safety and efficacy of adjunctive tropisetron for treatment of cognitive deficits in schizophrenia.

  1. Safety and efficacy of rivastigmine in children with Down syndrome: A double blind placebo controlled trial.

    Science.gov (United States)

    Spiridigliozzi, Gail A; Hart, Sarah J; Heller, James H; Schneider, Heather E; Baker, Jane Ann; Weadon, Cathleen; Capone, George T; Kishnani, Priya S

    2016-06-01

    Individuals with Down syndrome (DS) have decreased cholinergic function and an uneven profile of cognitive abilities, with more pronounced deficits in learning, memory, and expressive language. Cholinesterase inhibitors may improve cognitive function in adults and adolescents with DS, but studies in children with DS have been limited. This study aimed to: (i) investigate the safety and efficacy of rivastigmine treatment; (ii) build upon our open-label studies in children with DS in a double-blind, placebo-controlled clinical trial; and (iii) investigate specific cognitive domains that may respond to rivastigmine treatment. We conducted a 20-week double-blind, placebo-controlled trial to investigate the safety and efficacy of rivastigmine in 22 children and adolescents with DS aged 10-17 years. Safety measures included reports of adverse events, laboratory parameters, and electrocardiograms. Efficacy measures included parental assessments of adaptive behavior and executive function, and direct measures of language and memory. No group differences were found on safety measures and 22 of 24 participants that passed study screening completed the study. The results did not demonstrate evidence for significant improvement in aspects of cognition, language, or overall function in the children receiving rivastigmine. Our results suggest that rivastigmine is safe and well-tolerated for children and adolescents with DS, but may not be effective for improving performance on the selected measures in this study. However, larger samples and/or alternate measures could possibly reveal improvements in cognitive function with rivastigmine treatment. Further research is needed to define a battery of cognitive measures that is sensitive to treatment effects in DS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  2. Double-blind placebo-controlled trial of dapsone in antihistamine refractory chronic idiopathic urticaria.

    Science.gov (United States)

    Morgan, Matt; Cooke, Andrew; Rogers, Laura; Adams-Huet, Beverley; Khan, David A

    2014-01-01

    Management of antihistamine refractory chronic idiopathic urticaria (CIU) has poorly defined therapeutic options. To evaluate the efficacy of dapsone (4,4'-diaminodiphenylsulfone) in antihistamine refractory CIU compared with placebo. Twenty-two patients with antihistamine refractory CIU were randomly assigned to 100 mg of dapsone daily or placebo for 6 weeks in a 14-week double-blind, placebo-controlled crossover trial. End points were measured from a daily diary that reflected the weekly hive score, the weekly itch score, and a visual analog scale (VAS) score. Secondary to a carryover effect, the first period results were analyzed as a parallel design that compared placebo with dapsone directly by using repeated-measures analysis. After 6 weeks, the patients in the dapsone arm showed mean improvement over baseline in VAS (2.3 [95% CI, 0.6-4.1], P = .01), urticaria score (-3.5 [95% CI, -6.2 to -0.9], P = .01), and itch score (-4.8 [95% CI, -7.6 to -2.1], P = .001), whereas the placebo arm showed no improvement over baseline for VAS, urticaria, or itch scores. Dapsone showed greater improvement compared with placebo for itch (P = .047) and VAS (P = .04). Of the 22 patients, 3 showed complete resolution of hives and itch with dapsone, whereas 31% and 41% had ≥ 50% resolution of hives and itch, respectively. No serious adverse effects were observed with dapsone. To our knowledge, this is the first double-blind, placebo controlled study of dapsone in CIU and indicates that dapsone has efficacy in patients with antihistamine refractory CIU. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  3. Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine

    Science.gov (United States)

    Jankovic, J.; Gilden, J. L.; Hiner, B. C.; Kaufmann, H.; Brown, D. C.; Coghlan, C. H.; Rubin, M.; Fouad-Tarazi, F. M.

    1993-01-01

    PURPOSE: To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure. PATIENTS: Ninety-seven patients with orthostatic hypotension were randomized in a 4-week, double-blinded, placebo-controlled study with a 1-week placebo run-in period. Patients ranged in age from 22 to 86 years (mean: 61 years). METHODS: After a 1-week run-in phase, either placebo or midodrine at a dose of 2.5 mg, 5 mg, or 10 mg was administered three times a day for 4 weeks. Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase. The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached. Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension (syncope, dizziness/lightheadedness, weakness/fatigue, and low energy level). RESULTS: Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p hypotension compared to placebo: dizziness/lightheadedness, weakness/fatigue, syncope, low energy level, impaired ability to stand, and feelings of depression. The overall side effects were mainly mild to moderate. One or more side effects were reported by 22% of the placebo group compared with 27% of the midodrine-treated group. Scalp pruritus/tingling, which was reported by 10 of 74 (13.5%) of the midodrine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%). CONCLUSION: We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure.

  4. Coenzyme Q10 effect in prevention of atrial fibrillation after Coronary Artery Bypass Graft: double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Jalal Moludi

    2015-05-01

    Results: Thirty-eight women and forty-two men with a mean age of 58.37±7.98 years were enrolled in the study in two CoQ10 and placebo groups (each consisting of 40 patients. The incidence of postoperative AF was 45% in the control group to 20% in the intervention group decreased after supplementation (P=0.030. ICU stay and length of in-hospital stay did not significant. The incidence of arrhythmias ventricular tachycardia (VT and VF in this period was not significant (P=0.865. Conclusion: Q10 supplements have low side effects. Due to the reduction in the incidence of AF in patients after, CABG, these supplements can be recommended for the prevention of AF.

  5. Remote ischaemic preconditioning for heart surgery. The study design for a multi-center randomized double-blinded controlled clinical trial--the RIPHeart-Study.

    Science.gov (United States)

    Meybohm, Patrick; Zacharowski, Kai; Cremer, Jochen; Roesner, Jan; Kletzin, Frank; Schaelte, Gereon; Felzen, Marc; Strouhal, Ulrich; Reyher, Christian; Heringlake, Matthias; Schön, Julika; Brandes, Ivo; Bauer, Martin; Knuefermann, Pascal; Wittmann, Maria; Hachenberg, Thomas; Schilling, Thomas; Smul, Thorsten; Maisch, Sonja; Sander, Michael; Moormann, Tobias; Boening, Andreas; Weigand, Markus A; Laufenberg, Rita; Werner, Christian; Winterhalter, Michael; Treschan, Tanja; Stehr, Sebastian N; Reinhart, Konrad; Hasenclever, Dirk; Brosteanu, Oana; Bein, Berthold

    2012-06-01

    Transient ischaemia of non-vital tissue has been shown to enhance the tolerance of remote organs to cope with a subsequent prolonged ischaemic event in a number of clinical conditions, a phenomenon known as remote ischaemic preconditioning (RIPC). However, there remains uncertainty about the efficacy of RIPC in patients undergoing cardiac surgery. The purpose of this report is to describe the design and methods used in the "Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart)-Study". We are conducting a prospective, randomized, double-blind, multicentre, controlled trial including 2070 adult cardiac surgical patients. All types of surgery in which cardiopulmonary bypass is used will be included. Patients will be randomized either to the RIPC group receiving four 5 min cycles of transient upper limb ischaemia/reperfusion or to the control group receiving four cycles of blood pressure cuff inflation/deflation at a dummy arm. The primary endpoint is a composite outcome (all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure) until hospital discharge. The RIPHeart-Study is a multicentre trial to determine whether RIPC may improve clinical outcome in cardiac surgical patients.

  6. Long-Term Neurodevelopmental Outcome of Children Treated with Tri-Iodothyronine after Cardiac Surgery: Follow-Up of a Double-Blind, Randomized, Placebo-Controlled Study.

    Science.gov (United States)

    Mittnacht, Janna; Choukair, Daniela; Kneppo, Carolin; Brunner, Romuald; Parzer, Peter; Gorenflo, Matthias; Bettendorf, Markus

    2015-01-01

    Transient thyroid dysfunction occurs in children after cardiopulmonary bypass (CPB). We demonstrated significant benefits of acute postoperative tri-iodothyronine (T3) treatment for recovery and myocardial function. Now we report the long-term neurodevelopment of these children. Twenty-eight children (70% of the original study population) could be recruited for a follow-up examination (median age 10.7 years, range 10-19.6 years) retaining the double-blind, randomized, placebo-controlled protocol. Cognitive function and motor development were tested, as were growth and thyroid and cardiac functions. The median full-scale intelligence quotient of all children was within the reference range and similar in the placebo and T3 groups. Tests for motor and cognitive functions, growth, and thyroid and cardiac functions revealed concurrent results. Overall intellectual development is preserved in adolescents treated with CPB in infancy irrespectively of low postoperative thyroid hormone concentrations. While acute postoperative T3 treatment in children after CPB improves recovery, no significant long-term effects on neurodevelopment could be detected. We therefore speculate that transient postoperative thyroid dysfunction by means of nonthyroidal illness syndrome is predominantly mediated by extranuclear, nongenomic mechanisms and thus acutely affects the cardiovascular system but not the development of the central nervous system mediated by genomic mechanisms. © 2015 S. Karger AG, Basel.

  7. Efficacy of treatment in older depressed patients : A systematic review and meta-analysis of double-blind randomized controlled trials with antidepressants

    NARCIS (Netherlands)

    Kok, Rob M.; Nolen, Willem A.; Heeren, Thea J.

    2012-01-01

    Background: This systematic review evaluated all published double-blind, randomized controlled antidepressant trials (RCTs) of acute phase treatment of older depressed patients. Methods: Meta-analyses were conducted in 51 double-blind RCTs of antidepressants in older patients. The results were also

  8. Intrathecal Baclofen in Children with Spastic Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study

    Science.gov (United States)

    Hoving, Marjanke A.; van Raak, Elisabeth P. M.; Spincemaille, Geert H. J. J.; Palmans, Liesbeth J.; Sleypen, Frans A. M.; Vles, Johan S. H.

    2007-01-01

    Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB…

  9. Behavioral Responses and the Impact of New Agricultural Technologies: Evidence from a Double-blind Field Experiment in Tanzania

    NARCIS (Netherlands)

    Bulte, E.H.; Beekman, G.; Falco, Di S.; Hella, J.P.; Pan, L.

    2014-01-01

    Randomized controlled trials (RCTs) in the social sciences are typically not double-blind, so participants know they are “treated” and will adjust their behavior accordingly. Such effort responses complicate the assessment of impact. To gauge the potential magnitude of effort responses we implement

  10. The effect of ultrasound on osteogenesis in the vertically distracted edentulous mandible. A double-blind trial

    NARCIS (Netherlands)

    Schortinghuis, J.; Bronckers, A. L. J. J.; Gravendeel, J.; Stegenga, B.; Raghoebar, G. M.

    2008-01-01

    Whether low intensity pulsed ultrasound therapy stimulates osteogenesis in mandibular distraction was investigated in a double-blind trial. Nine patients underwent a vertical mandibular distraction over a distance of 5.1 +/- 1.2 mm. Ultrasound or placebo therapy was started daily from the first day

  11. Amoxicillin plus metronidazole in the treatment of adult periodontitis patients : A double-blind placebo-controlled study

    NARCIS (Netherlands)

    Winkel, EG; Van Winkelhoff, AJ; Timmerman, MF; Van der Velden, U; Van der Weijden, GA

    Background, aims: The aim of this double-blind, parallel study was to evaluate the adjunctive effects of systemically administered amoxicillin and metronidazole in a group of adult periodontitis patients who also received supra- and subgingival debridement. Methods: 49 patients with a diagnosis of

  12. A Randomized, Double-Blind, Crossover Comparison of MK-0929 and Placebo in the Treatment of Adults with ADHD

    Science.gov (United States)

    Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.

    2012-01-01

    Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…

  13. Raloxifene and body composition and muscle strength in postmenopausal women: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Jacobsen, D.E.; Samson, M.M.; Emmelot-Vonk, M.H.; Verhaar, H.J.

    2010-01-01

    OBJECTIVE: To compare the effects of raloxifene and placebo on body composition and muscle strength. DESIGN: Randomized, double-blind, placebo-controlled trial involving 198 healthy women aged 70 years or older conducted between July 2003 and January 2008 at the University Medical Centre, Utrecht,

  14. Effects of fluoxetine on disease activity in relapsing multiple sclerosis : a double-blind, placebo-controlled, exploratory study

    NARCIS (Netherlands)

    Mostert, J. P.; Admiraal-Behloul, F.; Hoogduin, J. M.; Luyendijk, J.; Heersema, D. J.; van Buchem, M. A.; De Keyser, J.

    Background: Suppressing the antigen-presenting capacity of glial cells could represent a novel way of reducing inflammatory activity in multiple sclerosis (MS). Aims: To evaluate the effects of fluoxetine on new lesion formation in patients with relapsing MS. Methods: In a double-blind,

  15. Penicillin for acute sore throat : randomised double blind trial of seven days versus three days treatment or placebo in adults

    NARCIS (Netherlands)

    Zwart, S; Sachs, APE; Ruijs, GJHM; Gubbels, JW; Hoes, AW; de Melker, RA

    2000-01-01

    Objective To assess whether treatment with penicillin for three days and the traditional treatment for seven days were equally as effective at accelerating resolution of symptoms in patients with sore throat compared with placebo. Design Randomised double blind placebo controlled trial. Setting 43

  16. Implant decontamination during surgical peri-implantitis treatment : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    de Waal, Yvonne C. M.; Raghoebar, Gerry M.; Huddleston Slater, James J. R.; Meijer, Henny J. A.; Winkel, Edwin G.; van Winkelhoff, Arie Jan

    Aim The objective of this randomized, double-blind, placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride (CPC) on microbiological and clinical parameters. Material & Methods Thirty patients (79 implants) with

  17. Sensory testing of recipes masking peanut or hazelnut for double-blind placebo-controlled food challenges

    NARCIS (Netherlands)

    Ronteltap, A.; Schaik, van J.; Wensing, M.; Rynja, F.J.; Knulst, A.C.; Vries, de J.H.M.

    2004-01-01

    Background: In a double-blind placebo-controlled food challenge (DBPCFC), it is necessary that recipes comprising the allergen cannot be distinguished from placebo. Aims of the study: We investigated whether the method of paired comparisons, a sensory difference test, could be used to test the

  18. Efficacy of heat-inactivated hepatitis B vaccine in haemodialysis patients and staff. Double-blind placebo-controlled trial

    NARCIS (Netherlands)

    Desmyter, J.; Colaert, J.; de Groote, G.; Reynders, M.; Reerink-Brongers, E. E.; Lelie, P. N.; Dees, P. J.; Reesink, H. W.

    1983-01-01

    The efficacy of a heat-inactivated hepatitis B vaccine, 3 micrograms of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in

  19. Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial

    NARCIS (Netherlands)

    Coutinho, R. A.; Lelie, N.; Albrecht-van Lent, P.; Reerink-Brongers, E. E.; Stoutjesdijk, L.; Dees, P.; Nivard, J.; Huisman, J.; Reesink, H. W.

    1983-01-01

    The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised placebo controlled double blind trial. At the trial end point (21.5 months), 17 hepatitis B

  20. Liberal versus restrictive fluid administration to improve recovery after laparoscopic cholecystectomy: a randomized, double-blind study

    DEFF Research Database (Denmark)

    Holte, Kathrine; Klarskov, Birthe; Christensen, Dorte Stig

    2004-01-01

    knowledge of physiological and clinical effects of different fluid substitution regimens. METHODS: In a double-blind study, 48 ASA I-II patients undergoing laparoscopic cholecystectomy were randomized to 15 mL/kg (group 1) or 40 mL/kg (group 2) intraoperative administration of lactated Ringer's solution (LR...

  1. Iron supplementation in HIV-infected Malawian children with anemia: a double-blind, randomized, controlled trial

    NARCIS (Netherlands)

    Esan, Michael O.; van Hensbroek, Michael Boele; Nkhoma, Ernest; Musicha, Crispin; White, Sarah A.; ter Kuile, Feiko O.; Phiri, Kamija S.

    2013-01-01

    It is unknown whether iron supplementation in human immunodeficiency virus (HIV)-infected children living in regions with high infection pressure is safe or beneficial. A 2-arm, double-blind, randomized, controlled trial was conducted to examine the effects of iron supplementation on hemoglobin, HIV

  2. Late reactions in food-allergic children and adolescents after double-blind placebo-controlled food challenges

    NARCIS (Netherlands)

    Saleh-Langenberg, J.; Flokstra-de Blok, B. M. J.; AlAgla, N.; Kollen, B. J.; Dubois, A. E. J.

    The time during which children are observed following a double-blind, placebo-controlled food challenge (DBPCFC) varies in clinical practice. There are little data on late reactions (LRs) following DBPCFCs. Therefore, we determined the prevalence, severity and clinical characteristics of late

  3. Effects of magnetic stray fields from a 7 Tesla MRI scanner on neurocognition: a double-blind randomised crossover study

    NARCIS (Netherlands)

    van Nierop, L.E.; Slottje, P.; van Zandvoort, M.J.; de Vocht, F.; Kromhout, H.

    2012-01-01

    OBJECTIVE This study characterises neurocognitive domains that are affected by movement-induced time-varying magnetic fields (TVMF) within a static magnetic stray field (SMF) of a 7 Tesla (T) MRI scanner. METHODS Using a double-blind randomised crossover design, 31 healthy volunteers were tested in

  4. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical...

  5. Implant decontamination during surgical peri-implantitis treatment : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    de Waal, Yvonne C.M.; Raghoebar, Gerry M; Huddleston Slater, James J R; Meijer, Hendrikus; Winkel, Edwin G; van Winkelhoff, Arie Jan

    AIM: The objective of this randomized, double-blind, placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride (CPC) on microbiological and clinical parameters. MATERIAL & METHODS: Thirty patients (79 implants) with

  6. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment : a randomized, double-blind, controlled trial

    NARCIS (Netherlands)

    de Waal, Y. C. M.; Raghoebar, G. M.; Meijer, H. J. A.; Winkel, E. G.; van Winkelhoff, A. J.

    ObjectiveThe objective of this randomized, double-blind, controlled trial was to evaluate the clinical, radiographic, and microbiological effects of implant surface decontamination with a 2% chlorhexidine (CHX) solution in comparison with a 0.12% chlorhexidine+0.05% cetylpyridinium chloride (CPC)

  7. Validation of novel recipes for double-blind, placebo-controlled food challenges in children and adults

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; Herpertz, I.; Pasker, L.; van der Heide, S.; Kukler, J.; Jansink, C.; Vaessen, W.; Beusekamp, B. J.; Dubois, A. E. J.

    2011-01-01

    In double-blind, placebo-controlled food challenges (DBPCFCs), the use of challenge materials in which blinding is validated is a prerequisite for obtaining true blinded conditions during the test procedure. Therefore, the aim of this study was to enlarge the available range of validated recipes for

  8. Validation of novel recipes for double-blind, placebo-controlled food challenges in children and adults

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; Herpertz, I.; Pasker, L.; van der Heide, S.; Kukler, J.; Jansink, C.; Vaessen, W.; Beusekamp, B. J.; Dubois, A. E. J.

    P>Background: In double-blind, placebo-controlled food challenges (DBPCFCs), the use of challenge materials in which blinding is validated is a prerequisite for obtaining true blinded conditions during the test procedure. Therefore, the aim of this study was to enlarge the available range of

  9. Adverse reactions to simultaneous influenza and pneumococcal conjugate vaccinations in children : randomized double-blind controlled trial

    NARCIS (Netherlands)

    Jansen, Angelique G S C; Sanders, Elisabeth A M; Smulders, Sara; Hoes, Arno W; Hak, Eelko

    In a randomized double-blind controlled trial, the safety was assessed of simultaneous administration of influenza and pneumococcal conjugate vaccines in children with previous physician-diagnosed respiratory tract infections. In total, 579 children aged 18-72 months were assigned to receive

  10. A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder

    NARCIS (Netherlands)

    Westenberg, HGM; Stein, DJ; Yang, HC; Li, D; Barbato, LM

    This was a randomized double-blind placebo-controlled multicenter study to assess the efficacy, safety, and tolerability of fluvoxamine in a controlled release (CR) formulation for treatment of generalized social anxiety disorder (GSAD). A total of 300 subjects with GSAD were randomly assigned to

  11. The effect of cetirizine in dogs with chronic atopic dermatitis: a randomized, double blind, placebo-controlled trial

    NARCIS (Netherlands)

    Hsiao, Yun-Hsia; Chen, Charles; Willemse, Ton

    2016-01-01

    It was the aim of this study to evaluate the effect of cetirizine in dogs with atopic dermatitis (AD), fulfilling Favrot's diagnostic clinical criteria. In a randomized, double blind, placebo-controlled study, the dogs received either 3 mg/kg cetirizine orally once daily (n=27), or a placebo (n=23)

  12. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  13. Development and validation of challenge materials for double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, BJ; Bijleveld, CMA; van der Heide, S; Beusekamp, BJ; Wolt-Plompen, SAA; Kukler, J; Brinkman, J; Duiverman, EJ; Dubois, AEJ

    Background: The use of double-blind, placebo-controlled food challenges (DBPCFCs) is considered the gold standard for the diagnosis of food allergy. Despite this, materials and methods used in DBPCFCs have not been standardized. Objective: The purpose of this study was to develop and validate

  14. Raloxifene improves verbal memory in late postmenopausal women: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Jacobsen, D.E.; Samson, M.M.; Emmelot-Vonk, M.H.; Verhaar, H.J.

    2010-01-01

    OBJECTIVE: The aim of this study was to examine the effects of raloxifene compared with those of placebo on verbal memory, mental processing speed, depression, anxiety, and quality of life. METHODS: A randomized, double-blind, placebo-controlled trial of 213 healthy women 70 years or older was

  15. Effects of folic acid and zinc sulfate on male factor subfertility: a double-blind, randomized, placebo-controlled trial.

    NARCIS (Netherlands)

    Wong, W.Y.; Merkus, J.M.W.M.; Thomas, C.M.G.; Menkveld, R.; Zielhuis, G.A.; Steegers-Theunissen, R.P.M.

    2002-01-01

    OBJECTIVE: To study the effects of folic acid and zinc sulfate treatment on semen variables in fertile and subfertile men. DESIGN: Double-blind, placebo-controlled interventional study. SETTING: Two outpatient fertility clinics and nine midwifery practices in The Netherlands. PARTICIPANT(S): One

  16. Development and validation of challenge materials for double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, Berber J.; Bijleveld, Charles M. A.; van der Heide, Sicco; Beusekamp, Berta J.; Wolt-Plompen, Saskia A. A.; Kukler, Jeanet; Brinkman, Joep; Duiverman, Eric J.; Dubois, Anthony E. J.

    2004-01-01

    The use of double-blind, placebo-controlled food challenges (DBPCFCs) is considered the gold standard for the diagnosis of food allergy. Despite this, materials and methods used in DBPCFCs have not been standardized. The purpose of this study was to develop and validate recipes for use in DBPCFCs in

  17. A randomized multicenter double-blind comparison of urapidil and ketanserin in hypertensive patients after coronary artery surgery

    NARCIS (Netherlands)

    van der Stroom, J. G.; van Wezel, H. B.; Langemeijer, J. J.; Korsten, H. H.; Kooyman, J.; van der Starre, P. J.; Kal, J. E.; Porsius, M.; van den Ende, R.; van Zwieten, P. A.

    1997-01-01

    To compare the hemodynamic responses, safety, and efficacy of urapidil and ketanserin in hypertensive patients after coronary artery surgery. Randomized double-blind study. Multi-institutional. One hundred twenty-two patients undergoing elective coronary artery surgery. When hypertension (defined as

  18. Identification of hazelnut major allergens in sensitive patients with positive double-blind, placebo-controlled food challenge results

    DEFF Research Database (Denmark)

    Pastorello, Elide A; Vieths, Stefan; Pravettoni, Valerio

    2002-01-01

    The hazelnut major allergens identified to date are an 18-kd protein homologous to Bet v 1 and a 14-kd allergen homologous to Bet v 2. No studies have reported hazelnut allergens recognized in patients with positive double-blind, placebo-controlled food challenge (DBPCFC) results or in patients...

  19. A DOUBLE BLIND TRIAL OF GABAPENTIN VS. LORAZEPAM IN THE TREATMENT OF ALCOHOL WITHDRAWAL

    Science.gov (United States)

    Myrick, Hugh; Malcolm, Robert; Randall, Patrick K.; Boyle, Elizabeth; Anton, Raymond F.; Becker, Howard C.; Randall, Carrie L.

    2009-01-01

    Introduction Some anticonvulsants ameliorate signs and symptoms of alcohol withdrawal, but have an unacceptable side effect burden. Among the advantages of using anticonvulsant agents in this capacity is their purported lack of interaction with alcohol that could increase psychomotor deficits, increase cognitive impairment, or increase intoxication. The aim of the current study was to evaluate alcohol use and symptom reduction of gabapentin as compared to lorazepam in the treatment of alcohol withdrawal in a double-blinded randomized clinical trial. Methods One hundred individuals seeking outpatient treatment of alcohol withdrawal with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) ratings ≥10 were randomized to double-blind treatment with two doses of gabapentin (900 mg tapering to 600 mg or 1200 tapering to 800 mg) or lorazepam (6 mg tapering to 4 mg) for four days. Severity of alcohol withdrawal was measured by the CIWA-Ar on days 1-4 of treatment and on days 5, 7 and 12 post-treatment and alcohol use monitored by verbal report and breath alcohol levels Results CIWA-Ar scores decreased over time in all groups; high-dose gabapentin was statistically superior but clinically similar to lorazepam (p=0.009). During treatment, lorazepam-treated participants had higher probabilities of drinking on the first day of dose decrease (day 2) and the second day off medication (day 6) as compared to gabapentin-treated participants (p=.0002). Post-treatment, gabapentin-treated participants had less probability of drinking during the follow-up post-treatment period (probability=.2 for 900 mg and probability=.3 for 1200mg) compared to the lorazepam-treated participants (probability=.55). The gabapentin groups also had less craving, anxiety, and sedation compared to lorazepam. Conclusions Gabapentin was well tolerated and effectively diminished the symptoms of alcohol withdrawal in our population especially at the higher target dose (1200mg) used in this

  20. A double-blind trial of gabapentin versus lorazepam in the treatment of alcohol withdrawal.

    Science.gov (United States)

    Myrick, Hugh; Malcolm, Robert; Randall, Patrick K; Boyle, Elizabeth; Anton, Raymond F; Becker, Howard C; Randall, Carrie L

    2009-09-01

    Some anticonvulsants ameliorate signs and symptoms of alcohol withdrawal, but have an unacceptable side effect burden. Among the advantages of using anticonvulsant agents in this capacity is their purported lack of interaction with alcohol that could increase psychomotor deficits, increase cognitive impairment, or increase intoxication. The aim of this study was to evaluate alcohol use and symptom reduction of gabapentin when compared with lorazepam in the treatment of alcohol withdrawal in a double-blinded randomized clinical trial. One hundred individuals seeking outpatient treatment of alcohol withdrawal with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) ratings > or =10 were randomized to double-blind treatment with 2 doses of gabapentin (900 mg tapering to 600 mg or 1200 tapering to 800 mg) or lorazepam (6 mg tapering to 4 mg) for 4 days. Severity of alcohol withdrawal was measured by the CIWA-Ar on days 1 to 4 of treatment and on days 5, 7, and 12 post-treatment and alcohol use monitored by verbal report and breath alcohol levels. CIWA-Ar scores decreased over time in all groups; high-dose gabapentin was statistically superior but clinically similar to lorazepam (p = 0.009). During treatment, lorazepam-treated participants had higher probabilities of drinking on the first day of dose decrease (day 2) and the second day off medication (day 6) compared to gabapentin-treated participants (p = 0.0002). Post-treatment, gabapentin-treated participants had less probability of drinking during the follow-up post-treatment period (p = 0.2 for 900 mg and p = 0.3 for 1200 mg) compared to the lorazepam-treated participants (p = 0.55). The gabapentin groups also had less craving, anxiety, and sedation compared to lorazepam. Gabapentin was well tolerated and effectively diminished the symptoms of alcohol withdrawal in our population especially at the higher target dose (1200 mg) used in this study. Gabapentin reduced the probability of drinking

  1. Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia.

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    Schabus, Manuel; Griessenberger, Hermann; Gnjezda, Maria-Teresa; Heib, Dominik P J; Wislowska, Malgorzata; Hoedlmoser, Kerstin

    2017-04-01

    See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article.Neurofeedback training builds upon the simple concept of instrumental conditioning, i.e. behaviour that is rewarded is more likely to reoccur, an effect Thorndike referred to as the 'law of effect'. In the case of neurofeedback, information about specific electroencephalographic activity is fed back to the participant who is rewarded whenever the desired electroencephalography pattern is generated. If some kind of hyperarousal needs to be addressed, the neurofeedback community considers sensorimotor rhythm neurofeedback as the gold standard. Earlier treatment approaches using sensorimotor-rhythm neurofeedback indicated that training to increase 12-15 Hz sensorimotor rhythm over the sensorimotor cortex during wakefulness could reduce attention-deficit/hyperactivity disorder and epilepsy symptoms and even improve sleep quality by enhancing sleep spindle activity (lying in the same frequency range). In the present study we sought to critically test whether earlier findings on the positive effect of sensorimotor rhythm neurofeedback on sleep quality and memory could also be replicated in a double-blind placebo-controlled study on 25 patients with insomnia. Patients spent nine polysomnography nights and 12 sessions of neurofeedback and 12 sessions of placebo-feedback training (sham) in our laboratory. Crucially, we found both neurofeedback and placebo feedback to be equally effective as reflected in subjective measures of sleep complaints suggesting that the observed improvements were due to unspecific factors such as experiencing trust and receiving care and empathy from experimenters. In addition, these improvements were not reflected in objective electroencephalographic-derived measures of sleep quality. Furthermore, objective electroencephalographic measures that potentially reflected mechanisms underlying the efficacy of neurofeedback such as spectral electroencephalographic

  2. ROPIVACAINE VERSUS LIDOCAINE FOR EPISIOTOMY-A RANDOMISED DOUBLE BLIND STUDY

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    Pushpalatha Nagaraj

    2017-04-01

    Full Text Available BACKGROUND Episiotomy is a most common surgical procedure for parturients during vaginal delivery. The problem encountered with episiotomy is pain, which is maximum during first 24 hours and may be severe enough to disturb the puerperium. This study aims to compare analgesic efficacy of analgesics, ropivacaine and lidocaine for perineal infiltration during episiotomy. MATERIALS AND METHODS We conducted a randomised double blind study for a period one year from August 2013 in a tertiary hospital. 100 parturients were included. RESULTS Ropivacaine 0.75% compared to lidocaine 2% did not show any statistical significant changes at suturing and after 4 hours; however, there were great statistically significant changes in VAS scores after 8 hours, 12 hours, 24 hours of episiotomy suturing. Ropivacaine group did not require systemic analgesics for 24 hours, but lidocaine group required systemic analgesics after 4 hours of suturing. Both groups (Ropivacaine and Lidocaine did not have any adverse effects. CONCLUSION Ropivacaine can be used safely for episiotomy wound infiltration thereby reducing the need for systemic analgesia.

  3. Clarithromycin in the treatment of RSV bronchiolitis: a double-blind, randomised, placebo-controlled trial.

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    Tahan, F; Ozcan, A; Koc, N

    2007-01-01

    Respiratory syncytial virus (RSV) bronchiolitis is the most common lower respiratory tract infection in infancy. To date, there is no effective therapy for RSV bronchiolitis. In order to investigate the efficacy of clarithromycin in the treatment of RSV bronchiolitis, the present authors conducted a randomised, double-blind, placebo-controlled trial comparing clarithromycin with placebo in 21 infants with a diagnosis of RSV bronchiolitis. The infants were randomised to receive clarithromycin or placebo daily for 3 weeks. Levels of interleukin (IL)-4, IL-8, eotaxin, and interferon-gamma were determined in plasma, before and after treatment, using ELISA. Six months after treatment, parents were surveyed as to whether their child had experienced wheezing within the previous 6 months. Treatment with clarithromycin was associated with a statistically significant reduction in the length of hospital stay, the duration of need for supplemental oxygen and the need for beta(2)-agonist treatment. There were significant decreases in plasma IL-4, IL-8 and eotaxin levels after 3 weeks of treatment with clarithromycin. Readmission to the hospital within 6 months after discharge was significantly lower in the clarithromycin group. In conclusion, clarithromycin has statistically significant effects on the clinical and laboratory findings in respiratory syncytial virus bronchiolitis. Therefore, clarithromycin treatment may be helpful in reducing the short-term effects of respiratory syncytial virus bronchiolitis.

  4. Oral immunotherapy of recurrent urinary tract infections: a double-blind placebo-controlled multicenter study.

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    Schulman, C C; Corbusier, A; Michiels, H; Taenzer, H J

    1993-09-01

    We treated 166 patients suffering from recurrent urinary tract infections under double-blind conditions for 3 months with 1 capsule daily of either the immunostimulating bacterial extract (85) or a placebo (81), followed by a 3-month observation period without the test drugs. The bacterial extract exerted a significant beneficial curative action and long-term consolidative effect on the frequency of recurrent urinary tract infections with marked improvements in the characteristic signs and symptoms. It was significantly superior to placebo for the majority of the assessed parameters: number of recurrent urinary tract infections, bacteriuria, leukocyturia, erythrocyturia, nitrituria, albuminuria and casts in urine. Consumption of antibiotics, chemotherapeutics, urinary antiseptics or disinfectants was significantly less under active drug therapy compared to placebo. Tolerance was good with only 2 side effects reported in 2 patients (2%) in the active group compared to 11 among 5 (6%) in the placebo group. Therefore, the bacterial extract can be considered an efficient and well tolerated drug for the treatment of urinary tract infections, and their accompanying signs and symptoms, as well as for decreasing the risk of recurrences and the need for antibiotics and other antibacterial drugs.

  5. Acetazolamide improves central sleep apnea in heart failure: a double-blind, prospective study.

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    Javaheri, Shahrokh

    2006-01-15

    Acetazolamide is a mild diuretic and a respiratory stimulant. It is used to treat periodic breathing at high altitude. To determine the therapeutic efficacy of acetazolamide on central sleep apnea associated with heart failure. Twelve male patients with stable systolic heart failure whose initial polysomnograms showed more than 15 episodes per hour of apnea and hypopnea participated in the study. The patients were randomized to a double-blind cross-over protocol with acetazolamide or placebo, taken 1 h before bedtime for six nights with 2 wk of washout. Polysomnography, pulmonary function tests, arterial blood gases, and left ventricular ejection fraction were obtained initially along with a sleep questionnaire, history, and physical examination. Baseline measurements were repeated at the end of each arm. There were no significant differences between parameters at baseline and placebo. In comparing placebo with acetazolamide, the hourly number of episodes of central apnea (49 +/- 28 vs. 23 +/- 21 [mean +/- SD]; p = 0.004) and the percentage of total sleep time spent below an arterial oxyhemoglobin saturation of 90% (19 +/- 32 vs. 6 +/- 13%; p = 0.01) decreased significantly. Acetazolamide improved subjective perception of overall sleep quality (p = 0.003), feeling rested on awakening (p = 0.007), daytime fatigue (p = 0.02), and falling asleep unintentionally during daytime (p = 0.002). In patients with heart failure, administration of a single dose of acetazolamide before sleep improves central sleep apnea and related daytime symptoms.

  6. A randomized double-blind crossover study of phase-shift sound therapy for tinnitus.

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    Heijneman, Karin M; de Kleine, Emile; van Dijk, Pim

    2012-08-01

    The purpose of this study was to compare the efficacy of the treatment of tinnitus with a phase-shifting pure tone to that of the same tone treatment without phase shifting. A double-blind crossover randomized controlled trial. This study was conducted at the University Medical Center Groningen. Twenty-two patients with predominantly tonal tinnitus underwent both intervention and control treatments. Each treatment consisted of three 30-minute sessions in 1 week. The control treatment was identical to the intervention treatment, except that the stimulus was a pure tone without phase shifting. Questionnaires, tinnitus loudness match, and annoyance and loudness ratings were used to measure treatment effects. Pure-tone treatment and phase-shift treatment had no significant effect on tinnitus according to questionnaires (Tinnitus Handicap Index, Tinnitus Reaction Questionnaire, Hospital Anxiety and Depression Scale, and Maastricht Questionnaire), audiological matching procedures, and loudness and annoyance ratings of tinnitus. Furthermore, phase-shift treatment showed no additional significant improvement in comparison with pure-tone treatment. Changes in questionnaire scores due to pure-tone and the phase-shift treatment were correlated. On average across the group, both treatments failed to demonstrate a significant effect. Both treatments were beneficial for some patients. However, a positive effect was not demonstrated that could be attributed to the periodic shifting of the phase of the stimulus tone.

  7. Tramadol versus codeine/acetaminophen after pediatric tonsillectomy: A prospective, double-blinded, randomized controlled trial.

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    Friedrichsdorf, Stefan J; Postier, Andrea C; Foster, Laurie Pane; Lander, Timothy A; Tibesar, Robert J; Lu, Yi; Sidman, James D

    2015-01-01

    Tonsillectomy is one of the most common pediatric surgical procedures performed in the United States. The postoperative period can be particularly painful, and there is currently no consensus on an optimal analgesic regimen. The objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy. Prospective, double-blinded, randomized controlled trial. Large, Midwestern US pediatric hospital. Eighty-four children aged 4-15 years who underwent a tonsillectomy (with or without adenoidectomy) procedure were randomized and 74 were included in the analysis. Group 1 received liquid codeine/acetaminophen for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed). Group 2 received liquid tramadol for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed). Efficacy and side effects were evaluated using a 10-day take-home diary that was completed by parents. Children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores. Oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group, and itching was experienced by significantly more children in the tramadol group during the postoperative period. As part of multimodal analgesia, scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties, low potential for side effects, and good safety profile.

  8. Transdermal rotigotine in advanced Parkinson's disease: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Nomoto, Masahiro; Mizuno, Yoshikuni; Kondo, Tomoyoshi; Hasegawa, Kazuko; Murata, Miho; Takeuchi, Masahiro; Ikeda, Junji; Tomida, Takayuki; Hattori, Nobutaka

    2014-10-01

    Rotigotine, a non-ergot dopamine receptor agonist, offers potential for continuous dopaminergic stimulation that could avoid the fluctuations observed with traditional treatments. We conducted a randomized, double-blind, placebo-controlled trial in Japanese patients with advanced Parkinson's disease (PD) to investigate the efficacy and safety of rotigotine. Inclusion criteria included the presence of motor complications, such as wearing off, on-off, delayed-on/no-on, any circumstances that could interfere with levodopa dose escalation because of side effects, or declining levodopa efficacy. The enrolled patients received once-daily applications of rotigotine transdermal patches or matched placebo patches. A total of 174 patients were randomly assigned to rotigotine (87 patients) or placebo (87 patients). The full analysis set included 172 patients (86 for the rotigotine group and 86 for the placebo group). The maximum maintenance dose of rotigotine was set at 16 mg/24 h. The changes in unified PD rating scale Part III scores from baseline to the end of the trial were -10.1 ± 9.0 (mean ± standard deviation) in the rotigotine group and -4.4 ± 7.4 in the placebo group (p patients in each group. Rotigotine at doses of up to 16 mg/24 h is efficacious and safe in Japanese patients with advanced PD.

  9. The efficacy of azithromycin in pityriasis rosea: A randomized, double-blind, placebo-controlled trial

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    Deepika Pandhi

    2014-01-01

    Full Text Available Background: Macrolides are prescribed in the treatment of pityriasis rosea despite conflicting results of the limited number of studies evaluating their role in its treatment. Aim: A randomized double-blind placebo-controlled trial was conducted to evaluate the effect of azithromycin on the clinical course of pityriasis rosea. Methods: Seventy patients of pityriasis rosea were given either azithromycin (n = 35 or placebo (n = 35 and were followed-up at 2, 4 and 6 weeks. Pruritus was assessed in both groups using the visual analogue scale (VAS . Change in the pityriasis rosea severity score (PRSS and in the VAS were recorded as outcome measures and were compared statistically. Results: The decrease in PRSS from baseline through 2, 4 and 6 weeks within both treatment (P < 0.001 and placebo (P < 0.001 arms was found to be statistically significant; however, this change was not significantly different in the two groups (P = 0.179. Similarly, the decrease in VAS was found to be statistically significant within both groups (P < 0.001; however, the change was comparable between the two groups (P < 0.937. Analysis by Fisher′s exact test did not find a significant difference between the two groups for PRSS and VAS. Conclusion: Azithromycin is not effective in pityriasis rosea and the use of macrolides for this disease should not be encouraged in clinical practice.

  10. The effect of Breezy candy on halitosis: a double-blind, controlled, and randomized study.

    Science.gov (United States)

    Barak, Shlomo; Katz, Joseph

    2012-04-01

    Halitosis (bad breath) is a common condition that is socially crippling for vast parts of the population and results from malodorous volatile sulfur compounds, which are by-products of oral bacteria. In this doubled-blind, randomized study, 75 subjects with halitosis were evaluated. The participants were treated with or without abrasive microcapsules (candy) containing zinc gluconate 0.5%, propolis 2%, and a combination of both (zinc 0.25% and propolis 1%). The halitosis was assessed by a Halimeter, a portable instrument that measures the emission of volatile sulfur compounds at different time exposures to the treatments. Breezy candy (which is sugar-free) was found effective in the treatment of halitosis for up to 4 hours. While treatment with regular candy (group 1, traditional candy without abrasive particles) showed reduction in malodor of 10%, Breezy candy showed reduction of up to 60% in malodor (P halitosis. The combined effect of abrasion by microcapsules with zinc supplement represents a novel and successful approach for the treatment of halitosis.

  11. Pidotimod in the management of vulvar papillomatosis: double-blind clinical trial versus placebo.

    Science.gov (United States)

    Guerra, B; Perino, A; Polatti, F; Scala, M

    1998-05-01

    To investigate whether the immune system improvement induced by pidotimod increases the rate of spontaneous disappearance of vulvar papillomatous lesions, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Forty-nine patients (23 in the pidotimod group and 26 in the placebo group) with first diagnosis of vulvar papillomatosis as shown by clinical and histological findings underwent 90-day treatment with oral 800-mg pidotimod once a day or identical placebo. The main outcome measure was the difference between vulvar papillomatous infected area before and after treatment judged by the following: complete regression (complete disappearance of all papillomatous lesions); partial regression (a decrease of at least 75% of the infected area); no response (a decrease of less than 75% of the infected area or new viral lesions not present at baseline). Forty patients completed the trial according to the study protocol and were entered in the "per protocol" analysis of efficacy. Complete regression was observed in 12 of 18 patients (66.7%) receiving pidotimod compared with 7 of 22 patients (31.8%) receiving placebo. The total infected surface area at the end of treatment was 10.1 +/- 18.5 mm2 (mean +/- SD) in the pidotimod arm and 198.3 +/- 399.2 mm2 in the placebo arm (p pidotimod group, more data are needed to confirm our encouraging results.

  12. Citicoline Combination Therapy for Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Roohi-Azizi, Mahtab; Arabzadeh, Somaye; Amidfar, Meysam; Salimi, Samrand; Zarindast, Mohammad Reza; Talaei, Ali; Akhondzadeh, Shahin

    Residual symptoms of major depressive disorder are a source of long-term morbidity. New therapeutic strategies are required to alleviate this morbidity and enhance patient quality of life. Citicoline has been used for vascular accidents and has been effective in cognitive rehabilitation. It has been used successfully to reduce craving in patients with substance abuse disorder and for mood management of bipolar disorder. Here, we test citicoline effectiveness as an adjuvant therapy in major depression. A double-blind randomized trial was designed on 50 patients with major depressive disorder who were under treatment with citalopram. Patients were allocated to 2 groups and received citicoline (100 mg twice a day) or placebo as an adjuvant treatment for 6 weeks. Depressive symptoms were assessed by the Hamilton Depression Rating Scale (HDRS) at baseline and at weeks 2, 4, and 6. Significantly greater improvement was observed in the HDRS scores of the citicoline group compared with the placebo group from baseline to weeks 2, 4, and 6 (Ps = 0.030, 0.032, and 0.021, respectively). Repeated-measures general linear model demonstrated a significant effect for time × treatment interaction on the HDRS score (F2.10,101.22 = 3.12, P = 0.04). Remission rate was significantly higher in the citicoline group compared with the placebo group (P = 0.045). Citicoline was an effective adjuvant to citalopram in the therapy of major depressive disorder.

  13. A randomized, double-blind, placebo-controlled trial of coenzyme Q10 in Huntington disease.

    Science.gov (United States)

    McGarry, Andrew; McDermott, Michael; Kieburtz, Karl; de Blieck, Elisabeth A; Beal, Flint; Marder, Karen; Ross, Christopher; Shoulson, Ira; Gilbert, Peter; Mallonee, William M; Guttman, Mark; Wojcieszek, Joanne; Kumar, Rajeev; LeDoux, Mark S; Jenkins, Mary; Rosas, H Diana; Nance, Martha; Biglan, Kevin; Como, Peter; Dubinsky, Richard M; Shannon, Kathleen M; O'Suilleabhain, Padraig; Chou, Kelvin; Walker, Francis; Martin, Wayne; Wheelock, Vicki L; McCusker, Elizabeth; Jankovic, Joseph; Singer, Carlos; Sanchez-Ramos, Juan; Scott, Burton; Suchowersky, Oksana; Factor, Stewart A; Higgins, Donald S; Molho, Eric; Revilla, Fredy; Caviness, John N; Friedman, Joseph H; Perlmutter, Joel S; Feigin, Andrew; Anderson, Karen; Rodriguez, Ramon; McFarland, Nikolaus R; Margolis, Russell L; Farbman, Eric S; Raymond, Lynn A; Suski, Valerie; Kostyk, Sandra; Colcher, Amy; Seeberger, Lauren; Epping, Eric; Esmail, Sherali; Diaz, Nancy; Fung, Wai Lun Alan; Diamond, Alan; Frank, Samuel; Hanna, Philip; Hermanowicz, Neal; Dure, Leon S; Cudkowicz, Merit

    2017-01-10

    To test the hypothesis that chronic treatment of early-stage Huntington disease (HD) with high-dose coenzyme Q10 (CoQ) will slow the progressive functional decline of HD. We performed a multicenter randomized, double-blind, placebo-controlled trial. Patients with early-stage HD (n = 609) were enrolled at 48 sites in the United States, Canada, and Australia from 2008 to 2012. Patients were randomized to receive either CoQ 2,400 mg/d or matching placebo, then followed for 60 months. The primary outcome variable was the change from baseline to month 60 in Total Functional Capacity score (for patients who survived) combined with time to death (for patients who died) analyzed using a joint-rank analysis approach. An interim analysis for futility revealed a conditional power of <5% for the primary analysis, prompting premature conclusion in July 2014. No statistically significant differences were seen between treatment groups for the primary or secondary outcome measures. CoQ was generally safe and well-tolerated throughout the study. These data do not justify use of CoQ as a treatment to slow functional decline in HD. NCT00608881. This article provides Class I evidence that CoQ does not slow the progressive functional decline of patients with HD. © 2016 American Academy of Neurology.

  14. Randomised, Double Blind, Placebo-Controlled Trial of Echinacea Supplementation in Air Travellers

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    E. Tiralongo

    2012-01-01

    Full Text Available Objective. To identify whether a standardised Echinacea formulation is effective in the prevention of respiratory and other symptoms associated with long-haul flights. Methods. 175 adults participated in a randomised, double-blind placebo-controlled trial travelling back from Australia to America, Europe, or Africa for a period of 1–5 weeks on commercial flights via economy class. Participants took Echinacea (root extract, standardised to 4.4 mg alkylamides or placebo tablets. Participants were surveyed before, immediately after travel, and at 4 weeks after travel regarding upper respiratory symptoms and travel-related quality of life. Results. Respiratory symptoms for both groups increased significantly during travel (P<0.0005. However, the Echinacea group had borderline significantly lower respiratory symptom scores compared to placebo (P=0.05 during travel. Conclusions. Supplementation with standardised Echinacea tablets, if taken before and during travel, may have preventive effects against the development of respiratory symptoms during travel involving long-haul flights.

  15. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  16. A double blind randomised comparison of chlordiazepoxide and lorazepam in alcohol withdrawal.

    Science.gov (United States)

    Rajmohan, V; Sushil, K; Mohandas, E

    2013-10-01

    To compare the efficacy of lorazepam and chlordiazepoxide in alcohol withdrawal in a double blind design. The study sample consisted of 108 consecutive admissions to the de addiction ward, which after informed consent and selection based on inclusion criteria, were randomised to two groups. A comparison of the efficacy of chlordiazepoxide and lorazepam was done post randomisation. The initial withdrawal assessment and subsequent progress of withdrawal were assessed using Clinical Institute Assessment for Alcohol-revised (CIWA-Ar). The rate of withdrawal and total duration of withdrawal were compared among the two groups. Lorazepam treated group showed a significant difference in the rate of improvement over 48 h compared to chlordiazepoxide group (70.4% vs. 54.8%; p=0.000). The total duration of withdrawal was also significantly lesser with lorazepam (5.6 days vs. 6.7 days; p=0.001). Lorazepam is more effective than chlordiazepoxide in alcohol withdrawal in both a faster rate in the drop of withdrawal severity and lessening the total duration of withdrawal. Copyright © 2013 Elsevier B.V. All rights reserved.

  17. Effects of piracetam on pediatric breath holding spells: a randomized double blind controlled trial.

    Science.gov (United States)

    Abbaskhanian, Ali; Ehteshami, Sara; Sajjadi, Sadegh; Rezai, Mohammad Sadegh

    2012-01-01

    Breath holding spells (BHS) are common paroxysmal non-epileptic events in the pediatric population which are very stressfull despite their harmless nature. There has been no specific treatment found for the spells yet. The aim of this study was to evaluate the efficacy of piracetam (2-oxo-l-pyrrolidine) on these children. In this randomized double blind clinical trial study, 150 children with severe BHS referred to our pediatric outpatient service were enrolled from August 2011 to July 2012. The patients were randomized into two equal groups. One received 40mg/kg/day piracetam and the other group received placebo, twice daily. Patients were followed monthly for three months. The number of attacks/month before and after treatment were documented. Of the enrolled patients, 86 were boys. The mean age of the patients was 17 months (range, 6 to 24 months). In the piracetam group, 1 month after treatment an 81% response to treatment was found. In the placebo group, none of the patients had complete remission and 7% of the cases had partial remission. Overall, control of breath-holding spells was observed in 91% of the patients in the group taking piracetam as compared with 16% in the group taking placebo at the end of the study. There was no significant difference detected between the groups regarding the prevalence of drug side effects. A significant difference was detected between piracetam and placebo in prevention and controlling BHS. Piracetam (40mg/kg/day) had a good effect on our patients.

  18. Albendazole versus metronidazole in the treatment of adult giardiasis: a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Cañete, Roberto; Rodríguez, Pablo; Mesa, Lumey; Brito, Katia; Prior, Ada; Guilhem, Dirce; Novaes, M R C G

    2012-01-01

    Albendazole (ABZ) is a benzimidazole carbamate compound currently in use for human medical practice against enterobiasis and soil-transmitted helminthiasis (STH); However, its spectrum of activity is broad and goes beyond these infections. This study compares the efficacy and safety of ABZ versus metronidazole (MTZ) in human giardiasis. A randomized, double-blind, clinical trial was carried out at the Centre of Hygiene, Epidemiology and Microbiology in Matanzas City, Cuba. Adult patients with confirmed symptomatic G. duodenalis mono-infection were randomly assigned to receive either ABZ [400 mg daily (n = 75)] or MTZ [250 mg t.i.d. (n = 75)], both for 5 days. Follow-up fecal samples were obtained at 3, 5, 7 days after treatment end. The efficacy was similar for both treatment groups: ABZ (82.6%) and MTZ (85.3%); p > 0.05. Side-effects including bitter taste, headache, vomiting and dizziness were significantly higher in the MTZ group. Abdominal pain was significantly higher in ABZ group. ABZ was found as effective as MTZ in the treatment of G. duodenalis infections in adult patients from Cuba and could be a useful drug in areas where co-infection with STH infections is common.

  19. 5-HT3 antagonist for cognition improvement in schizophrenia: a double blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Neyousha Mohammadi

    2010-01-01

    Full Text Available   Abstract   Introduction: Patients with schizophrenia characteristically exhibit cognitive deficits. The level of cognitive impairment is found to predict the functional outcome of the illness more strongly than the severity of positive or negative symptoms. The purpose of this study was to assess the efficacy of ondansetron, a 5-HT3 receptor antagonist as an adjuvant agent in the treatment of chronic schizophrenia in particular for cognitive impairments.   Methods: This investigation was a 12-week, double blind study of parallel groups of patients with stable chronic schizophrenia. Thirty patients were recruited from inpatient and outpatient departments. All participants met Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR criteria for schizophrenia. To be eligible, patients were required to have been treated with a stable dose of risperidone as their primary antipsychotic treatment for a minimum period of 8 weeks. The subjects were randomized to receive ondansetron (8 mg/day or the placebo in addition to risperidone. Cognition was measured by a cognitive battery. Patients were assessed at baseline and after 8, and 12 weeks after the medication started.   Results: Administration of ondansetron significantly improved visual memory based on improvement on visual reproduction, visual paired associate and figural memory sub tests of Wechsler Memory Scale Revised.  Discussion: The present study indicates ondansetron as potential adjunctive treatment strategy for chronic schizophrenia particularly for cognitive impairments.

  20. A new acupuncture method for management of irritable bowel syndrome: A randomized double blind clinical trial

    Science.gov (United States)

    Rafiei, Rahmatollah; Ataie, Mehdi; Ramezani, Mohammad Arash; Etemadi, Ali; Ataei, Behrooz; Nikyar, Hamidreza; Abdoli, Saman

    2014-01-01

    Background: Irritable bowel syndrome (IBS) is gastrointestinal functional disorder which is multifactorial with unknown etiology. There are several modalities for treatment of it. Acupuncture is increasingly used in numerous diseases, also in gastrointestinal disorders like IBS. The purpose of the study was to assess the effects of catgut embedding acupuncture in improving of IBS. Materials and Methods: A randomized double blind sham control clinical trial was designed. A total of 60 IBS patients assigned to three separated groups. The first group received clofac as drug only group (DO). The second one received catgut embedding acupuncture in special point (AP) and the last group received sham acupuncture (SA). Symptoms, pain, depression and anxiety assessed before and after two weeks at the end of study. Results: There was statistically significant difference between AP and SA and DO in constipation and bloating. Differences that were statistically significant favored acupuncture on pain (F = 6.409, P = 0.003), and depression (F = 6.735, P = 0.002) as the other outcomes. The average (standard deviation (SD)) of weight loss was 2 kg (0.88) in acupuncture group. Conclusion: Our finding showed a significant positive associated between acupuncture and IBS. Catgut embedding acupuncture is a new method which can eliminated IBS symptoms and can use as alternative therapeutic method for improvement of IBS. PMID:25538771

  1. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial.

    Science.gov (United States)

    Thelen, Mark D; Dauber, James A; Stoneman, Paul D

    2008-07-01

    Prospective, randomized, double-blinded, clinical trial using a repeated-measures design. To determine the short-term clinical efficacy of Kinesio Tape (KT) when applied to college students with shoulder pain, as compared to a sham tape application. Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries. A majority of tape applications that are reported in the literature involve nonstretch tape. The KT method has gained significant popularity in recent years, but there is a paucity of evidence on its use. Forty-two subjects clinically diagnosed with rotator cuff tendonitis/impingement were randomly assigned to 1 of 2 groups: therapeutic KT group or sham KT group. Subjects wore the tape for 2 consecutive 3-day intervals. Self-reported pain and disability and pain-free active ranges of motion (ROM) were measured at multiple intervals to assess for differences between groups. The therapeutic KT group showed immediate improvement in pain-free shoulder abduction (mean +/- SD increase, 16.9 degrees +/- 23.2 degrees ; P = .005) after tape application. No other differences between groups regarding ROM, pain, or disability scores at any time interval were found. KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain. Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported. Therapy, level 1b-.

  2. Double-blind, multiple-dose comparison of buprenorphine and morphine in postoperative pain.

    Science.gov (United States)

    Tigerstedt, I; Tammisto, T

    1980-12-01

    The analgesic profile and side-effects of buprenorphine 0.3 mg and morphine 10 mg intramuscularly were compared postoperatively in a double-blind, non-crossover, multiple-dose study. When the patient complained of moderate to severe postoperative pain after halothane-relaxant anesthesia for upper abdominal surgery, the first test dose of either drug was given. Subsequent similar doses of buprenorphine 0.3 mg or morphine 10 mg were given when required (maximum ten doses). The first dose of both drugs gave an equal decrease in pain intensity, suggesting a relative potency of 33:1 for both buprenorphine/morphine. A mean of 0.51 mg buprenorphine or 17 mg morphine had to be administered for satisfactory initial analgesia. Thereafter, the next analgesic dose was required a mean of 10.3 h after buprenorphine compared to 5.9 h after morphine (P less than 0.01). Significantly (P less than 0.01) fewer analgesic doses (mean 5.6) were needed in the buprenorphine group within the first 48 h postoperatively as compared to the morphine group (mean 7.3). A more pronounced mean decrease in the respiratory rate was observed after buprenorphine, but the mean minimum respiratory rates did not differ significantly from each other. Other effects of the two drugs on vital signs were similar. The incidence of other side-effects was fairly similar after both analgesics. The patients' subjective appraisal favoured buprenorphine.

  3. Curcuminoid treatment for knee osteoarthritis: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Panahi, Yunes; Rahimnia, Ali-Reza; Sharafi, Mojtaba; Alishiri, Gholamhossein; Saburi, Amin; Sahebkar, Amirhossein

    2014-11-01

    Treatment of osteoarthritis (OA) is challenging owing to the inefficacy and long-term adverse events of currently available medications including non-steroidal anti-inflammatory drugs. Curcuminoids are polyphenolic phytochemicals with established anti-inflammatory properties and protective effects on chondrocytes. The aim of this study is to investigate the clinical efficacy of curcuminoids in patients suffering from knee OA. A pilot randomized double-blind placebo-control parallel-group clinical trial was conducted among patients with mild-to-moderate knee OA. Patients were assigned to curcuminoids (1500 mg/day in 3 divided doses; n = 19) or matched placebo (n = 21) for 6 weeks. Efficacy measures were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS) and Lequesne's pain functional index (LPFI) scores during the study. There was no significant difference in age, gender, body mass index, and VAS, WOMAC and LPFI scores between the study groups at baseline (p > 0.05). Treatment with curcuminoids was associated with significantly greater reductions in WOMAC (p = 0.001), VAS (p  0.05). There was no considerable adverse effect in both groups. To conclude, curcuminoids represent an effective and safe alternative treatment for OA. Copyright © 2014 John Wiley & Sons, Ltd.

  4. The effect of buffered lidocaine in local anesthesia: a prospective, randomized, double-blind study.

    Science.gov (United States)

    Lee, Hyuk Jin; Cho, Young Jae; Gong, Hyun Sik; Rhee, Seung Hwan; Park, Hyun Soo; Baek, Goo Hyun

    2013-05-01

    Open carpal tunnel decompression under local anesthesia is routinely done by many surgeons. However, patients complain of pain during the injection of local anesthesia. This prospective, double-blind, randomized study was to compare the pain visual analog scale (VAS) scores of local anesthesia using lidocaine with and without sodium bicarbonate in patients with bilateral carpal tunnel syndrome. Twenty-five patients underwent bilateral simultaneous carpal tunnel decompression. All had topical anesthetic cream applied on the palm and wrist before the lidocaine block. In a randomized manner, half of the hands were blocked with nonbuffered lidocaine and half were blocked with buffered lidocaine. Pain was evaluated on a VAS score. The mean pain VAS score in the hand with buffered lidocaine was 4.6 ± 1.5 and 6.5 ± 1.5 for the hand with nonbuffered lidocaine. After adjustment for individual threshold of the pain, the mean pain VAS score changed into 4.6 ± 1.3 with buffered lidocaine and 6.6 ± 1.7 without buffered lidocaine. In open carpal tunnel surgery, the use of buffered lidocaine for local anesthesia reduces the anesthetic pain effectively. Therapeutic I. Copyright © 2013 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  5. Azathioprine in rheumatoid arthritis: double-blind study of full versus half doses versus placebo.

    Science.gov (United States)

    Woodland, J; Chaput de Saintonge, D M; Evans, S J; Sharman, V L; Currey, H L

    1981-08-01

    To test whether azathioprine in effective in rheumatoid arthritis in doses smaller than those normally used the drug was tested at 2 dosage levels, 2.5 and 1.25 mg/kg/day (2.5 AZ and 1.25 AZ), against placebo under double-blind conditions over 24 weeks. Dropouts were 7 out of 15 in the 2.5 AZ group, 4 out of 14 in the 1.25 AZ group, and 2 out of 13 in the placebo group. Some significant improvement occurred in all 3 groups, including those on placebo. However, the 2.5 AZ group fared significantly better than the placebo group, while the 1.25 AZ group results tended to fall between the other 2 groups. We conclude that, in order to obtain the reported effectiveness of azathioprine in rheumatoid arthritis, it is necessary to start treatment with 2.5 mg/kg/day. Halving this dosage reduces the effectiveness of the drug.

  6. A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation.

    Science.gov (United States)

    Zubairi, Ali Bin Sarwar; Salahuddin, Nawal; Khawaja, Ali; Awan, Safia; Shah, Adil Aijaz; Haque, Ahmed Suleman; Husain, Shahid Javed; Rao, Nisar; Khan, Javaid Ahmad

    2013-03-28

    Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. However, there is very little information as to their role in acute asthma exacerbations. We hypothesized that LTRAs may accelerate lung function recovery when given in an acute exacerbation. A randomized, double blind, placebo-controlled trial was conducted at the Aga Khan University Hospital to assess the efficacy of oral montelukast on patients of 16 years of age and above who were hospitalized with acute asthma exacerbation. The patients were given either montelukast or placebo along with standard therapy throughout the hospital stay for acute asthma. Improvements in lung function and duration of hospital stay were monitored. 100 patients were randomized; their mean age was 52 years (SD +/- 18.50). The majority were females (79%) and non-smokers (89%). The mean hospital stay was 3.70 ± 1.93 days with 80% of patients discharged in 3 days. There was no significant difference in clinical symptoms, PEF over the course of hospital stay (p = 0.20 at day 2 and p = 0.47 at day 3) and discharge (p = 0.15), FEV1 at discharge (p = 0.29) or length of hospital stay (p = 0.90) between the two groups. No serious adverse effects were noted during the course of the study. Our study suggests that there is no benefit of addition of oral montelukast over conventional treatment in the management of acute asthma attack. 375-Med/ERC-04.

  7. Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial.

    Science.gov (United States)

    Gottschling, Sven; Meyer, Sascha; Gribova, Inessa; Distler, Ludwig; Berrang, Jens; Gortner, Ludwig; Graf, Norbert; Shamdeen, M Ghiath

    2008-07-15

    To investigate whether laser acupuncture is efficacious in children with headache and if active laser treatment is superior to placebo laser treatment in a prospective, randomized, double-blind, placebo-controlled trial of low level laser acupuncture in 43 children (mean age (SD) 12.3 (+/-2.6) years) with headache (either migraine (22 patients) or tension type headache (21 patients)). Patients were randomized to receive a course of 4 treatments over 4 weeks with either active or placebo laser. The treatment was highly individualised based on criteria of Traditional Chinese medicine (TCM). The primary outcome measure was a difference in numbers of headache days between baseline and the 4 months after randomization. Secondary outcome measures included a change in headache severity using a 10 cm Visual Analogue Scale (VAS) for pain and a change in monthly hours with headache. Measurements were taken during 4 weeks before randomization (baseline), at weeks 1-4, 5-8, 9-12 and 13-16 from baseline. The mean number of headaches per month decreased significantly by 6.4 days in the treated group (pmeasures headache severity and monthly hours with headache decreased as well significantly at all time points compared to baseline (pchildren with headache with active laser treatment being clearly more effective than placebo laser treatment.

  8. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy.

    Science.gov (United States)

    Homan, Matjaž; Mahkovic, Dora; Orel, Rok; Mamula, Petar

    2016-05-01

    Studies in adults have shown that postprocedural abdominal pain is reduced with the use of carbon dioxide (CO(2)) instead of air for insufflation during colonoscopy. The aim of our study was to compare postprocedural abdominal pain and girth in children undergoing colonoscopy using CO(2) or air for insufflation. This was a prospective, randomized, double-blind study that included 76 consecutive pediatric patients undergoing colonoscopy for various indications. Patients were randomly assigned to either CO(2) or air insufflation. At 2, 4, and 24 hours after the examination, the patients' pain was assessed by using the 11-point numerical rating scale. The waist circumference was measured 10 minutes and 2 and 4 hours after colonoscopy. A significantly higher proportion of patients had no pain after colonoscopy in the CO(2) group compared with the air group (82 vs 37% at 2 hours and 95% vs. 63% at 4 hours, P < .001). Mean abdominal pain scores 2 and 4 hours after the procedure were statistically significantly lower in the CO(2) group compared with the control air group (0.5 vs 2.6 at 2 hours and 0.1 vs 1.2 at 4 hours, P < .001). There was no difference in waist circumference between the 2 groups at all time intervals. The results of this randomized trial show clear benefits of CO(2) insufflation for colonoscopy in reducing postprocedural discomfort. ( NCT02407639.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  9. Ibuprofen and paracetamol for pain relief during medical abortion: a double-blind randomized controlled study.

    Science.gov (United States)

    Livshits, Anna; Machtinger, Ronit; David, Liat Ben; Spira, Maya; Moshe-Zahav, Aliza; Seidman, Daniel S

    2009-05-01

    To determine the efficacy of a nonsteroidal anti-inflammatory drug vs. paracetamol in pain relief during medical abortion and to evaluate whether nonsteroidal anti-inflammatory drugs interfere with the action of misoprostol. A prospective double-blind controlled study. University-affiliated tertiary hospital. One hundred twenty women who underwent first-trimester termination of pregnancy. Patients received 600 mg mifepristone orally, followed by 400 microg of oral misoprostol 2 days later. They were randomized to receive ibuprofen or paracetamol when pain relief was necessary. Patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after medical abortion. Success rates, as defined by no surgical intervention, and pain scores were assessed. Ibuprofen was found to be statistically significantly more effective for pain relief after medical abortion compared with paracetamol. There was no difference in the failure rate of medical abortion, and the frequency of surgical intervention was slightly higher in the group that received paracetamol (16.3% vs. 8.5%). Ibuprofen was found to be more effective than paracetamol for pain reduction during medical abortion. A history of surgical or medical abortion was predictive for high pain scores. Despite its anti-prostaglandin effects, ibuprofen use did not interfere with the action of misoprostol.

  10. Acetylcysteine in the treatment of subacute sinusitis: A double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Bahtouee, Mehrzad; Monavarsadegh, Gholamhosein; Ahmadipour, Mohammadjavad; Motieilangroodi, Mazyar; Motamed, Niloofar; Saberifard, Jamshid; Eghbali, Seyyedsajjad; Adibi, Hooman; Maneshi, Hesam; Malekizadeh, Hasan

    2017-01-01

    Sinusitis is a common disease with harmful effects on the health and finances of patients and the economy of the community. It is easily treated in most of its acute stages but is associated with some management difficulties as it goes toward chronicity. Therefore, we tried to improve the treatment of subacute sinusitis by using acetylcysteine, which is a safe mucolytic and antioxidant agent. Thirty-nine adult patients with subacute sinusitis proved by computed tomography (CT) were enrolled in a double-blind, placebo-controlled trial. They received oral amoxicillin-clavulanic acid and normal saline nasal drops for 10 days and oral pseudoephedrine for 7 days. In addition, the patients received acetylcysteine (600 mg orally, once daily) in the intervention group or placebo in the control group for 10 days. A paranasal CT scan was taken at baseline and 30 days after patients finished the treatment and was evaluated quantitatively by Lund-Mackay (LM) score. Symptoms and some aspects of quality of life also were assessed at baseline and 14 days after initiation and 30 days after termination of the treatment via the Sino-Nasal Outcome Test questionnaire. The groups showed no significant difference in LM score after treatment. A positive correlation was observed between the LM and SNOT-20 scores. We concluded that adding oral acetylcysteine to amoxicillin-clavulanic acid, pseudoephedrine, and intranasal normal saline has no benefit for the treatment of subacute sinusitis.

  11. VITAMINE E IN THE MANAGEMENT OF DRUG INDUCED TARDIVE DYSKINESIA: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    M KAR AHMADI

    2002-12-01

    Full Text Available Introduction. Expresssion of tardive dyskinesia as one of the side effects of antipsychotic drugs causes various problems in psychotic patients. It is the main cause of patient"s drug incompliance.Vitamine E with it"s antioxidants properties might be an effective treatment for tardive dyskinesia. Methods. In a randomized double blind clinical trial, thirty inpatients of the psychiatric hospital in Isfahan were studied. Patients were stratified according to their age, psychiatric disorder and duration, intensity of tardive dyskinesia and antipsychotic dosage. Then they were asssigned randomly into two groups. Vitamine E (600 mg/day was administered to interventional group (15 patients. Another group received placebo (15 patients. Treatment durated for 6 weeks. Abnormal Involuntary Movment Scale (AIMS was used to measure tardive dyskinesia intensity. Results. Average of disorder intensity in those who received vit. E, dropped down from 8.33/10 (befor treatment to 6.13/10 (after treatment. It means 26.3 percent reduction of tardive dyskinesia intensity. This difference was only 7.3 percent in control group. There were no statistical diffrence between two groups after treatment (P>0.05. Discussion. There is no statistical efficacy for vitamine E in the management of tardive dyskinesia. But it is recommended to make another study with more samples.

  12. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  13. Sedation with midazolam for voiding cystourethrography in children: a randomised double-blind study

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    Stokland, E.; Jacobsson, B.; Ljung, B. [Dept. of Paediatric Radiology and Clinical Physiology, The Queen Silvia Children' s Hospital, Gothenburg (Sweden); Andreasson, S. [Dept. of Paediatric Anaesthesiology, The Queen Silvia Children' s Hospital, Gothenburg (Sweden); Jodal, U. [Dept. of Paediatrics, The Queen Silvia Children' s Hospital, Gothenburg (Sweden)

    2003-04-01

    Background: Sedation with midazolam facilitates the performance of diagnostic procedures in children, including voiding cystourethrography (VCUG). However, the influence of sedation on voiding and imaging results have not been adequately evaluated. Objective: Midazolam and placebo were compared to assess discomfort during VCUG and to evaluate if sedation influenced the outcome of the examination. Materials and methods: The study was prospective, randomized and double-blind, and included 95 children, 48 in the midazolam group (median age 2.2 years) and 47 in the placebo group (median age 3.2 years). The evaluation included the child's/parent's experience of the VCUG, as well as the examination results. Results: The children/parents in the midazolam group experienced the VCUG as less distressing compared to those in the placebo group (P < 0.001). Forty-six of 48 children sedated with midazolam could void during the imaging procedure compared to 38 of 47 children given placebo (NS). There was no difference in frequency or grade of vesicoureteric reflux or bladder emptying between the groups. Conclusions: When sedation is required to perform VCUG in children, midazolam can be used without negative effect on the outcome of the examination. (orig.)

  14. Clinical study of Tribulus terrestris Linn. in Oligozoospermia: A double blind study.

    Science.gov (United States)

    Sellandi, Thirunavukkarasu M; Thakar, Anup B; Baghel, Madhav Singh

    2012-07-01

    Infertility is a problem of global proportions, affecting on an average 8-12% of couples worldwide. Low sperm count (Oligozoospermia) is one of the main causes of male infertility and it is correlated with Kshina Shukra. The fruits of Gokshura (Tribulus terrestris. Linn) are considered to act as a diuretic and aphrodisiac; they used for urolithiasis, sexual dysfunctions, and infertility. Hence, it was planned to study the effect of Gokshura in the management of Kshina Shukra (Oligozoospermia), and to evade the preconception, a double-blind, randomized, placebo-controlled study was designed. In this study, eligible subjects between the age of 21 and 50 years, with a complaint of Kshina Shukra (Oligozoospermia), were randomized to receive either Gokshura granules or placebo granules for 60 days. The primary outcome measures were percentage changes in the Pratyatmaka Lakshanas (cardinal symptoms) of Kshina Shukra, Agni bala, Deha bala, Satva bala, the semenogram, and in the Quality of the Sexual Health Questionnaire. The placebo granules showed 70.95% improvement, whereas, the Gokshura granules showed 78.11% improvement in Rogi bala (Agni bala, Deha bala, Satva bala, and the Quality of Sexual Health) and Rogabala (Semen Analysis and Pratyatmaka Lakshanas). The Gokshura granules have shown superior results in the management of Kshina Shukra, as compared to the placebo granules.

  15. Temperament and character in couples with fertility disorders: a double-blind, controlled study.

    Science.gov (United States)

    Fassino, Secondo; Garzaro, Lorenzo; Peris, Clementina; Amianto, Federico; Pierò, Andrea; Abbate Daga, Giovanni

    2002-06-01

    To evaluate the personality features of infertile patients. A double-blind, controlled study. An outpatient facility for diagnosis and care of infertility. We assessed 142 infertile couples with obstetric-gynecologic clinical and instrumental examinations. The couples were divided into three groups: organic infertility, functional infertility, and infertility of uncertain origin. The third group was excluded. Organic infertility and functional infertility were ascertained with gynecologic and andrologic clinical examinations, seminal liquid examination, postcoital testing, progesterone assay, hysterosalpingography, biopsy of endometrium, and laparoscopy. Personality traits were assessed with the Temperament and Character Inventory (TCI). Results of the Temperament and Character Inventory. Infertile women showed lower Cooperativeness than control women. Women with functional infertility had lower scores in Cooperativeness and Self-Directedness than women with organic infertility. Men belonging to the functional infertility group had a lower Novelty Seeking score than did those of the organic infertility group. Men and women in the functional infertility group showed higher Harm Avoidance than those in the organic infertility and control groups. The results emphasize that the study of personality in the diagnostic and therapeutic assessment of infertility might provide useful predictive elements for functional infertility.

  16. Luteal Phase Support in the Intrauterine Insemination (IUI Cycles: A Randomized Double Blind, Placebo Controlled Study.

    Directory of Open Access Journals (Sweden)

    Batool Hossein Rashidi

    2014-12-01

    Full Text Available To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG, in sub fertile couples.This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They underwent ovarian stimulation with clomiphene citrate (100 mg and hMG (75 IU in preparation for the IUI cycle. Study group (n = 127 received luteal phase support in the form of vaginal progesterone (400 mg twice a day, and control group (n = 126 received placebo. Clinical pregnancy and abortion rates were assessed and compared between the two groups.The clinical pregnancy rate was not significantly higher for supported cycles than that for the unsupported ones (15.75% vs. 12.69%, p = 0.3. The abortion rate in the patients with progesterone luteal support compared to placebo group was not statistically different (10% vs. 18.75%, p = 0.45.It seems that luteal phase support with vaginal progesterone was not enhanced the success of IUI cycles outcomes, when clomiphene citrate and hMG were used for ovulation stimulation.

  17. Luteal Phase Support in the Intrauterine Insemination (IUI) Cycles: A Randomized Double Blind, Placebo Controlled Study.

    Science.gov (United States)

    Hossein Rashidi, Batool; Davari Tanha, Fatemeh; Rahmanpour, Haleh; Ghazizadeh, Mahya

    2014-12-01

    To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI) cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG), in sub fertile couples. This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They underwent ovarian stimulation with clomiphene citrate (100 mg) and hMG (75 IU) in preparation for the IUI cycle. Study group (n = 127) received luteal phase support in the form of vaginal progesterone (400 mg twice a day), and control group (n = 126) received placebo. Clinical pregnancy and abortion rates were assessed and compared between the two groups. The clinical pregnancy rate was not significantly higher for supported cycles than that for the unsupported ones (15.75% vs. 12.69%, p = 0.3). The abortion rate in the patients with progesterone luteal support compared to placebo group was not statistically different (10% vs. 18.75%, p = 0.45). It seems that luteal phase support with vaginal progesterone was not enhanced the success of IUI cycles outcomes, when clomiphene citrate and hMG were used for ovulation stimulation.

  18. Rupatadine improves quality of life in mastocytosis: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Siebenhaar, F; Förtsch, A; Krause, K; Weller, K; Metz, M; Magerl, M; Martus, P; Church, M K; Maurer, M

    2013-07-01

    Mastocytosis is frequently associated with mast cell-mediated symptoms which require relieving medication. While second generation antihistamines (sgAHs) are the first line therapeutic strategy to treat mast cell mediator-related symptoms, controlled clinical trials on how they improve quality of life have not been performed. This randomized, double-blind, placebo-controlled, cross-over trial assessed rupatadine 20 mg daily in the treatment of mastocytosis symptoms in 30 adult patients. Symptoms were assessed by a visual analogue scale (VAS) and symptom specific quality of life questionnaire (ItchyQoL). The mean ItchyQoL total score and VAS symptom score were significantly improved in the rupatadine treatment phase compared with placebo. There were also significant reductions from placebo in the severity of itch, wheal and flare, flushing, tachycardia and headache but not gastrointestinal symptoms. In this first comprehensive trial of a sgAH in mastocytosis, rupatadine 20 mg daily for 4 weeks significantly controlled symptoms and improved patients' quality of life. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. A multicentre double-blind comparison of oxaprozin aspirin therapy on rheumatoid arthritis.

    Science.gov (United States)

    Hubsher, J A; Ballard, I M; Walker, B R; Gold, J A

    1979-01-01

    Preliminary clinical studies showed that oxaprozin (4,5 Diphenyl-2-oxazolepropionic acid) has anti-inflammatory and analgesic properties with a plasma half-life of about 40 hours. Consequently, a multicentre, double-blind parallel trial was conducted for 12 weeks at thirteen investigator sites, utilizing 212 patients with classic rheumatoid arthritis and comparing oxaprozin 600 mg/day, oxaprozin 1200 mg/day and aspirin 3900 mg/day. Both the oxaprozin and aspirin-treated patients had statistically significant improvement from baseline periods, in most key categories evaluated. Oxaprozin administered twice a day (b.i.d.) was as effective as aspirin administered four times a day (q.i.d.) and caused significantly less tinnitus (p less than 0.001). Fewer patients receiving high dose oxaprozin (2%) dropped out of the study because of unsatisfactory response than did those receiving aspirin (10%). There were no clinically significant laboratory abnormalities in the gastro-intestinal, renal, hepatic or haematological parameters monitored. This study suggests that oxaprozin is effective and well tolerated in the treatment of rheumatoid arthritis.

  20. Does oral alprazolam affect ventilation? A randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Carraro, G E; Russi, E W; Buechi, S; Bloch, Konrad E

    2009-05-01

    The respiratory effects of benzodiazepines have been controversial. This investigation aimed to study the effects of oral alprazolam on ventilation. In a randomised, double-blind cross-over protocol, 20 healthy men ingested 1 mg of alprazolam or placebo in random order, 1 week apart. Ventilation was unobtrusively monitored by inductance plethysmography along with end-tidal PCO(2) and pulse oximetry 60-160 min after drug intake. Subjects were encouraged to keep their eyes open. Mean +/- SD minute ventilation 120 min after alprazolam and placebo was similar (6.21 +/- 0.71 vs 6.41 +/- 1.12 L/min, P = NS). End-tidal PCO(2) and oxygen saturation did also not differ between treatments. However, coefficients of variation of minute ventilation after alprazolam exceeded those after placebo (43 +/- 23% vs 31 +/- 13%, P alprazolam than after placebo (5.2 +/- 5.7 vs 1.3 +/- 2.3 calls, P alprazolam were related to a greater number of calls. Oral alprazolam in a mildly sedative dose has no clinically relevant effect on ventilation in healthy, awake men. The increased variability of ventilation on alprazolam seems related to vigilance fluctuations rather than to a direct drug effect on ventilation.

  1. Polypodium leucotomos extract in atopic dermatitis: a randomized, double-blind, placebo-controlled, multicenter trial.

    Science.gov (United States)

    Ramírez-Bosca, A; Zapater, P; Betlloch, I; Albero, F; Martínez, A; Díaz-Alperi, J; Horga, J F

    2012-09-01

    Topical corticosteroids are used to treat inflammation and relieve itching in atopic dermatitis, but their use is limited by adverse reactions. The main aim of this study was to investigate whether daily treatment with Polypodium leucotomos extract would reduce the use of topical corticosteroids in children and adolescents with atopic dermatitis. We also analyzed oral antihistamine use and changes in disease severity. We performed a phase IV randomized, double-blind, placebo-controlled, multicenter trial involving 105 patients aged between 2 and 17 years who were receiving topical corticosteroids to treat moderate atopic dermatitis. The patients were randomized to receive, in addition to their standard treatment, Polypodium leucotomos extract or placebo (both in capsule form) for 6 months. The percentage of days on which topical corticosteroids and other atopic dermatitis treatments were used was calculated. Use of Polypodium leucotomos extract did not significantly reduce the mean (SD) percentage of days on which topical corticosteroids were used (11% [12%] vs 12% [11%] for placebo). A significant reduction was, however, observed for oral histamine use (median percentage of days, 4.5% in the Polypodium leucotomos group and 13.6% in the placebo group [P= .038]). The percentage of patients who used oral antihistamines was also lower in the Polypodium leucotomos group. Long-term treatment with Polypodium leucotomos extract has benefits for children and adolescents with atopic dermatitis who require pharmacologic treatment to reduce inflammation and relieve itching. Copyright © 2011 Elsevier España, S.L. and AEDV. All rights reserved.

  2. Lactose and fructose malabsorption in children with recurrent abdominal pain: results of double-blinded testing.

    Science.gov (United States)

    Gijsbers, C F M; Kneepkens, C M F; Büller, H A

    2012-09-01

    To investigate malabsorption of lactose and fructose as causes of recurrent abdominal pain (RAP). In 220 children (128 girls, mean age 8,8 [4.1-16.0] years) with RAP, hydrogen breath tests (H(2) BT; abnormal if ΔH(2) > 30 ppm) were performed with lactose and fructose. Disappearance of RAP with elimination, recurrence with provocation and disappearance with re-elimination, followed by a 6-month pain-free follow-up, were considered indicative of a causal relation with RAP. For definite proof, a double-blinded placebo-controlled (DBPC) provocation was performed. Malabsorption of lactose was found in 57 of 210, of fructose in 79 of 121 patients. Pain disappeared upon elimination in 24/38 patients with lactose malabsorption, and in 32/49 with fructose malabsorption. Open provocation with lactose and fructose was positive in 7/23 and 13/31 patients. DBPC provocation in 6/7 and 8/13 patients was negative in all. However, several children continued to report abdominal symptoms upon intake of milk or fructose. Lactose intolerance nor fructose intolerance could be established as causes of RAP, according to preset criteria including elimination, open provocation and DBPC provocation. However, in clinical practice, persistent feeling of intolerance in some patients should be taken seriously and could warrant extended elimination with repeated challenges. © 2012 The Author(s)/Acta Paediatrica © 2012 Foundation Acta Paediatrica.

  3. A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis.

    Science.gov (United States)

    Krause, David S; Simjee, A E; van Rensburg, Christo; Viljoen, Johann; Walsh, Thomas J; Goldstein, Beth P; Wible, Michele; Henkel, Timothy

    2004-09-15

    Anidulafungin is a novel antifungal agent of the echinocandin class. This randomized, double-blind, double-dummy study compared the efficacy and safety of intravenous anidulafungin to that of oral fluconazole in 601 patients with endoscopically and microbiologically documented esophageal candidiasis. Patients received intravenous anidulafungin (100 mg on day 1, followed by 50 mg per day) or oral fluconazole (200 mg on day 1, followed by 100 mg per day) for 7 days beyond resolution of symptoms (range, 14-21 days). At the end of therapy, the rate of endoscopic success for anidulafungin (242 [97.2%] of 249 treated patients) was found to be statistically noninferior to that for fluconazole (252 [98.8%] of 255 treated patients; treatment difference, -1.6%; 95% confidence interval, -4.1 to 0.8). The safety profile of anidulafungin was similar to that of fluconazole; treatment-related adverse events occurred in 9.3% and 12.0% of patients, respectively. Laboratory parameters were similar between treatment arms. Anidulafungin is as safe and effective as oral fluconazole for the treatment of esophageal candidiasis, when assessed at the completion of therapy.

  4. Homoeopathic pathogenetic trial of Withania somnifera: A multicentric, double-blind, randomised, placebo-controlled trial

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    Pritha Mehra

    2017-01-01

    Full Text Available Background: Homoeopathic drug proving being the first step in finding the pathogenetic powers of a drug is an integral part of Homoeopathic system of medicine. Objective: To elicit the pathogenetic response of Withania somnifera in homoeopathic potencies on healthy human provers. Materials and Methods: A multicentre, randomised, double-blind, placebo-controlled trial was conducted at four centres under Central Council for Research in Homoeopathy. Proving was conducted on 63 relatively healthy provers. All the provers were given 12 doses of placebo divided into 4 doses/day for 3 days during the first phase of the trial. After randomisation, 43 provers in the intervention group were given W. somnifera in 6C and 30C potencies in two phases. In the placebo group, 20 provers were administered unmedicated globules. The symptoms and signs manifested during the trial were noted down by the provers, elaborated by the proving masters and the data compilation on W. somnifera was done at proving-cum-data processing cell. Results: Out of 43 provers who were on actual drug trial, only 15 provers manifested 39 symptoms. The symptoms have been manifested predominantly in 30C potency. Among the objective findings, the drug has shown its effect on kidney, ovaries and helminthic infestation. Conclusion: The pathogenetic response elicited during this trial expands the scope of the use of W. somnifera and needs to be further validated by clinical verification study.

  5. SSRIs and ejaculation: a double-blind, randomized, fixed-dose study with paroxetine and citalopram.

    Science.gov (United States)

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-12-01

    Selective serotonin reuptake inhibitors (SSRIs) are known to induce delayed orgasm and ejaculation. However, different SSRIs may differentially delay ejaculation. A double-blind, fixed-dose study in healthy men with lifelong rapid ejaculation was performed to evaluate potential differences between clinically relevant doses of two selective serotonin reuptake inhibitors, paroxetine and citalopram, in their effects on ejaculation. Thirty men with an intravaginal ejaculation latency time (IELT) less than 1 minute were randomly assigned to receive paroxetine (20 mg/day) and citalopram (20 mg/day) for 5 weeks, after taking half the dosage in the first week. During the 1-month baseline and 6-week treatment period, IELTs were measured at home by using a stopwatch procedure. The trial was completed by 23 men. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.0004); the IELT after paroxetine and citalopram gradually increased from 18 and 21 seconds to approximately 170 and 44 seconds, respectively. Paroxetine 20 mg/day exerted a strong delay (8.9-fold increase), whereas citalopram 20 mg/day mildly delayed ejaculation (1.8-fold increase). These results indicate that paroxetine leads to a significant delay in orgasm and ejaculation, whereas citalopram seems to have less of an effect on it.

  6. Single dose oral ranitidine improves MRCP image quality: a double-blind study

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    Bowes, M.T. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Martin, D.F. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom)]. E-mail: derrick.martin@smtr.nhs.uk; Melling, A. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Roberts, D. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Laasch, H.-U. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Sukumar, S. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Morris, J. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom)

    2007-01-15

    Aim: To investigate the possibility of whether a single 300 mg dose of ranitidine given orally 2-3 h before magnetic resonance cholangiopancreatography (MRCP) could reduce the signal from the stomach and duodenum, and thus increase the conspicuousness of the biliary tree. Materials and methods: Thirty-five volunteers (22 female, 13 male), (age range 21-50) were underwent MRCP in a double-blind, placebo-controlled, randomized, crossover trial on a Philips Intera 1.5 T machine using a phased array surface coil. Imaging was carried out in the coronal oblique plane. Six 40 mm sections were acquired at varying angles to delineate the biliary tree and pancreatic duct. The 70 examinations were blindly scored by three consultants experienced in cholangiography. Results: After ranitidine administration there was a significant decrease in signal from the stomach (mean = 17.7, p = 0.0005, CI 10, 25.3) and duodenum (mean = 18.4, p = 0.0005, 95%CI 9.6, 27.1) with a significant increase in conspicuousness of the distal common duct (mean = 7.7, p = 0.033, 95%CI 0.7, 14.7) and proximal common duct (mean = 8.7, p = 0.010 CI 2.2, 15.2). There were no adverse effects. Conclusion: Oral ranitidine is a cheap and effective agent to decrease signal from the upper gastrointestinal tract and to improve visibility of the biliary tree.

  7. Kinesio Taping in patients with lumbar disc herniation: A randomised, controlled, double-blind study.

    Science.gov (United States)

    Keles, Betul Yavuz; Yalcinkaya, Ebru Yilmaz; Gunduz, Berrin; Bardak, Ayşe Nur; Erhan, Belgin

    2017-01-01

    Lumbar disc herniation (LDH) causes pain and working day loss when activated. Patients spend most of their time in the hospital. And also it may limit patients' daily living activities. Kinesio Taping (KT) is a method that can be easily applied to the patients and does not interfere with their daily activities or movements of body. This study investigated the effects of KT in patients with low back pain due to LDH. Randomised-placebo controlled double blind clinical trial. Sixty Patients with low back pain due to LDH were randomised as KT group or placebo taping group. Taping was performed once a week for three weeks. Patients were followed up during twelve weeks. Numeric rating scale (NRS), lumbar flexion, Health Assessment Questionnaire (HAQ), Oswestry Disability Index (ODI) and paracetamol tablets taken were used for outcome measurements. Demographic and clinical features of the groups were similar. There were significant improvements in all parameters during intervention period in groups. Improvements in NRS-activity, HAQ and ODI continued to twelfth weeks only in KT group. In KT group, analgesic need was significantly less at follow-up. KT reduced analgesic need of patients with LDH when compared with placebo taping.

  8. Dapsone Gel in the Treatment of Papulopustular Rosacea: A Double-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Faghihi, Gita; Khosravani, Parastoo; Nilforoushzadeh, Mohammad Ali; Hosseini, Sayyed Mohsen; Assaf, Fatemeh; Zeinali, Naser; Smiley, Abbas

    2015-06-01

    We aimed to evaluate the effects of 5% dapsone gel compared with 0.75% metronidazole gel in the treatment of papulopustular rosacea. In a double-blind randomized clinical trial, 56 adult patients with papulopustular rosacea were enrolled. The severity of disorder was determined by the patient according to visual analogue score (VAS). Investigator's global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. Follow-up assessments were done at 4, 8, and 12 weeks. Changes in VAS, IGA scores and number of lesions were evaluated. Intention to treat analysis was carried out using SPSS version 17 (Chicago, IL). There was no significant difference in sex and age distribution between the two groups. Mean (SD) IGA score before and after intervention in group D was 3.9 (0.9) and 3.3 (0.9), respectively (PDapsone gel was as effective as metronidazole gel in the treatment of papulopustular rosacea.

  9. Randomized Double-blind Clinical Trial of Bleaching Products in Patients Wearing Orthodontic Devices.

    Science.gov (United States)

    Montenegro-Arana, A; Arana-Gordillo, L A; Farana, D; Davila-Sanchez, A; Jadad, E; Coelho, U; Gomes, Omm; Loguercio, A D

    2016-01-01

    This double-blind randomized clinical trial evaluated tooth sensitivity (TS) and the effectiveness (EF) of two types of bleaching agents (Trèswhite Ortho [TWO] and Trèswhite Supreme [TWS]) when used in patients wearing orthodontic appliances. Forty patients between the ages of 18 and 40 years were randomly stratified, with an equal allocation rate, into two groups (n=20), according to the bleaching agent applied. Tooth color of the six maxillary anterior teeth was measured before and after the treatment with a spectrophotometer. The TS was recorded on three scales before and during the bleaching treatment. With regard to EF, a significant reduction was found (ranging from 7.3-9.6 and 5.3-9.5 Vita scale units for TWO and TWS, respectively, p0.63). The number of patients with sensitivity was 58.8% and 73.3% for TWO and TWS groups, respectively (p=0.53); however, with each of the three scales used, the intensity of sensitivity was low and there was no statistical difference between TWO and TWS (p>0.05). In spite of producing a side effect of low TS, the two bleaching treatments tested were effective for dental bleaching in patients with fixed orthodontic appliances.

  10. Prevalence of lactose intolerance in Chile: a double-blind placebo study.

    Science.gov (United States)

    Latorre, Gonzalo; Besa, Pablo; Parodi, Carmen G; Ferrer, Verónica; Azocar, Lorena; Quirola, Marife; Villarroel, Luis; Miquel, Juan F; Agosin, Eduardo; Chianale, José

    2014-01-01

    Lactase non-persistence (LNP), or primary hypolactasia, is a genetic condition that mediates lactose malabsorption and can cause lactose intolerance. Here we report the prevalence of lactose intolerance in a double-blind placebo study. The LCT C>T-13910 variant was genotyped by RT-PCR in 121 volunteers and lactose malabsorption was assessed using the hydrogen breath test (HBT) after consuming 25 g of lactose. Lactose intolerance was assessed by scoring symptoms (SS) using a standardized questionnaire following challenge with a lactose solution or saccharose placebo. The LNP genotype was observed in 57% of the volunteers, among whom 87% were HBT⁺. In the HBT⁺ group the median SS was 9 and in the HBT⁻ group the median SS was 3 (p meteorism. In the ROC curve analysis, an SS ≥ 6 demonstrated 72% sensitivity and 81% specificity for predicting a positive HBT. To estimate prevalence, lactose intolerance was defined as the presence of an SS ≥ 6 points after subtracting the placebo effect and 34% of the study population met this definition. The LNP genotype was present in more than half of subjects evaluated and the observed prevalence of lactose intolerance was 34%. © 2014 S. Karger AG, Basel.

  11. Bupropion in adults with Attention-Deficit/Hyperactivity Disorder: a randomized, double-blind study.

    Directory of Open Access Journals (Sweden)

    Mehdi Hamedi

    2014-09-01

    Full Text Available Attention-Deficit/Hyperactivity Disorder is one of the most common mental disorders in childhood, and it continues to adulthood without proper treatment. Stimulants have been used in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD for many years, and the efficacy of methylphenidate in the treatment of adults with ADHD has been proven to be acceptable according to meta-analysis studies. However, there are some concerns about stimulants. Finding other effective medications for the treatment of adult ADHD seems necessary. We hypothesized bupropion could be effective in the treatment of adult ADHD because some theoretical and experimental evidence exists to support efficacy of this medication. Forty-two patients with a diagnosis of ADHD, according to the revised fourth edition of the Diagnostic and Statistical Manual of Mental Disorders, were randomized to receive 150 mg/day bupropion or placebo for a 6-week double-blind, placebo-controlled clinical trial. Each patient filled the Conners' Adult ADHD Rating Scales-Self-Report-Screening version (CAARS before starting to take medication and in weeks 3 and 6 of the study. The mean score of the two groups receiving bupropion or placebo decreased over the 6 weeks. There was a significant difference between the two groups in CAARS score after 6 weeks. Bupropion is more effective than placebo in the treatment of adults with ADHD. Bupropion can be an alternative medication for the treatment of Adults with ADHD as its clinical efficacy was proven by other studies.

  12. A preliminary double-blind, placebo-controlled trial of divalproex sodium in borderline personality disorder.

    Science.gov (United States)

    Hollander, E; Allen, A; Lopez, R P; Bienstock, C A; Grossman, R; Siever, L J; Merkatz, L; Stein, D J

    2001-03-01

    Borderline personality disorder is characterized by affective instability, impulsivity, and aggression and is associated with considerable morbidity and mortality. Since anticonvulsant agents may be helpful in such symptomatology, we compared divalproex sodium with placebo in patients with borderline personality disorder. A 10-week, parallel, double-blind design was conducted. Sixteen outpatients meeting Structured Clinical Interview for DSM-IV Axis II Personality Disorders criteria for borderline personality disorder were randomly assigned to receive placebo (N = 4) or divalproex sodium (N = 12). Change was assessed in global symptom severity (Clinical Global Impressions-Improvement Scale [CGI-I]) and functioning (Global Assessment Scale [GAS]) as well as in specific core symptoms (depression, aggression, irritability, and suicidality). There was significant improvement from baseline in both global measures (CGI-I and GAS) following divalproex sodium treatment. A high dropout rate precluded finding significant differences between the treatment groups in the intent-to-treat analyses, although all results were in the predicted direction. Treatment with divalproex sodium may be more effective than placebo for global symptomatology, level of functioning, aggression, and depression. Controlled trials with larger sample sizes are warranted to confirm these preliminary results.

  13. Treatment of restless legs syndrome with pregabalin: a double-blind, placebo-controlled study.

    Science.gov (United States)

    Garcia-Borreguero, D; Larrosa, O; Williams, A-M; Albares, J; Pascual, M; Palacios, J C; Fernandez, C

    2010-06-08

    To assess the therapeutic efficacy, required dose, and tolerability of pregabalin in patients with idiopathic restless legs syndrome (RLS). This was a double-blind, placebo-controlled trial with polysomnographic control, providing Class II evidence. Ninety-eight patients underwent a 2-week single-blind period with placebo; 58 were randomized to receive pregabalin or placebo for 12 weeks under a flexible-dose schedule. Endpoints were mean change from baseline in the International Restless Legs Scale (IRLS) total score, Clinical Global Impression (CGI), and RLS-6 scales, as well as changes in periodic limb movements (PLMs) and sleep architecture. Patients under treatment with pregabalin had a greater improvement in IRLS score than under placebo (63% vs 38.2%; p architecture with an increase in slow wave sleep (p architecture and periodic limb movements. Adverse events included unsteadiness and sleepiness and should be screened carefully in the working population, particularly when pregabalin is administered in the afternoon. This study provides Class II evidence that pregabalin is effective for the treatment of restless legs syndrome and improves sleep architecture and periodic limb movements in placebo-unresponsive patients.

  14. Double-blind, placebo-controlled trial of rehabilitation for bilateral vestibular hypofunction: preliminary report.

    Science.gov (United States)

    Krebs, D E; Gill-Body, K M; Riley, P O; Parker, S W

    1993-10-01

    Vestibular rehabilitation (VR) is increasingly popular, but few data exist to support enthusiasts' claims of efficacy in improving functional abilities of patients with bilateral vestibular hypofunction (BVH). A double-blind, controlled study of eight subjects (mean, 64 +/- 12 years; seven females, one male) with bilateral vestibular hypofunction was conducted. Subjects in group A received 8 weeks of VR followed by 8 weeks of home VR exercises, whereas those in group B received 8 weeks of control treatment (isometric strengthening exercises) followed by 8 weeks of VR. At the end of 8 weeks, group A walked 8% faster and, during paced gait and stair-climbing, with greater stability, evidenced by a 10% larger maximum moment arm and a 17% decreased double-support duration during gait and stair stance. Group B improved less than 1% during the control treatment. Self-reported Dizziness Handicap Inventory scores did not differ significantly between control and active VR. All subjects improved compared with baseline tests at the 16-week post-test on both functional testing and on the Self-reported Dizziness Handicap Inventory scale. We conclude that in this small sample, VR effectively improved functional, dynamic stability during locomotion, but even strengthening exercises result in self-reported symptomatic improvement.

  15. A double blind randomized trial of ketofol versus propofol for endodontic treatment of anxious pediatric patients.

    Science.gov (United States)

    Mittal, N; Goyal, A; Gauba, K; Kapur, A; Jain, K

    2013-01-01

    To find out the safe and efficient sedative agent for primary molar pulpectomy in uncooperative pediatric patients. This double blind randomized trial enrolled 40 anxious and healthy 2-6 year olds. All subjects received IV propofol (1-1.5 mg/kg) or ketofol (1-1.5 mg/kg propofol with 0.25 mg/kg ketamine) as per group assignment after oral midazolam premedication (0.5 mg/kg). Sedation maintenance was done with propofol infusion at 25-75 microg/kg/min titrated to a predefined Worse level as per Houpt's sedation rating scale. Additional bolus/es was/were administered in the dosage similar to induction dose in case of inadequate sedation. Primary outcomes were intraoperative and postoperative adverse events. Secondary outcomes were vital signs, success of procedure, operator satisfaction, sedation quality, treatment time, recovery time and total propofol dose. Significantly greater incidence of respiratory depression was reported for ketofol group (11/20; 55%) when compared to propofol group (3/20; 15%) (p = 0.008). Desaturation was the most common adverse respiratory event with significantly greater incidence in ketofol group (9/20; 45%) when compared to propofol only group (3/20; 15%) (p = 0.033). No significant differences regarding secondary outcomes were reported in two groups. Both the regimen exhibited similar sedation profile while propofol alone emerged as a safer option.

  16. Effect of Saccharomyces boulardii in dog with chronic enteropathies: double-blinded, placebo-controlled study.

    Science.gov (United States)

    D'Angelo, Simona; Fracassi, Federico; Bresciani, Francesca; Galuppi, Roberta; Diana, Alessia; Linta, Nikolina; Bettini, Giuliano; Morini, Maria; Pietra, Marco

    2017-12-06

    Saccharomyces boulardii is used to treat acute and chronic enteropathies in humans, but to date, no studies have evaluated the use of this yeast in dogs. The current study, a prospective non-randomised, double-blinded, placebo-controlled study, evaluated the effects of S boulardii in healthy dogs and dogs with chronic enteropathies (CE). Four healthy dogs and 20 dogs with CE were included. In healthy dogs, S boulardii was administered for 10 days. Possible short-term adverse effects were recorded, and quantitative stool cultures for yeasts were performed. In dogs with CE, S boulardii or a placebo was administered in addition to standard treatment protocols. Canine Chronic Enteropathy Clinical Activity Index, abdominal ultrasonography, gastroenteroscopy and histology were performed at the time of diagnosis and after 60 days of treatment. In healthy dogs, S boulardii reached a steady state in five days and was completely eliminated on day 4 after administration. No short-term side effects were seen. Clinical activity index, stool frequency, stool consistency and body condition score improved significantly in dogs with CE receiving S boulardii versus the placebo. In conclusion, S boulardii can be safely used in dogs with CE and seems to achieve better control of clinical signs than standard therapy alone. © British Veterinary Association (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Chengappa, K N Roy; Perkins, Kenneth A; Brar, Jaspreet S; Schlicht, Patricia J; Turkin, Scott R; Hetrick, Michelle L; Levine, Michele D; George, Tony P

    2014-07-01

    Virtually no clinical trials for smoking cessation have been undertaken in bipolar disorder. Varenicline has shown efficacy for smoking cessation, but warnings about neuropsychiatric adverse events have been issued. We assessed the efficacy and safety of varenicline in euthymic bipolar subjects motivated to quit smoking. Clinically stable adult patients with DSM-IV bipolar disorder (n = 60) who smoked ≥ 10 cigarettes per day were randomized to a 3-month, double-blind, placebo-controlled varenicline trial and a 3-month follow-up. Study enrollment was completed from February 2010 through March 2013. Varenicline was dosed using standard titration, and smoking cessation counseling was provided to all patients. The primary outcome was defined as a 7-day point prevalence of self-reported no smoking verified by expired carbon monoxide level initiating smoking cessation in bipolar patients, but medication trials of longer duration are warranted for maintaining abstinence. Vigilance for neuropsychiatric adverse events is prudent when initiating varenicline for smoking cessation in this patient population. ClinicalTrials.gov identifier: NCT01010204. © Copyright 2014 Physicians Postgraduate Press, Inc.

  18. Hormone therapy in menopausal women with cognitive complaints: a randomized, double-blind trial.

    Science.gov (United States)

    Maki, P M; Gast, M J; Vieweg, A J; Burriss, S W; Yaffe, K

    2007-09-25

    To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints. Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4. The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women's Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p or=0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women.

  19. Estrogen for Alzheimer's disease in women: randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Henderson, V W; Paganini-Hill, A; Miller, B L; Elble, R J; Reyes, P F; Shoupe, D; McCleary, C A; Klein, R A; Hake, A M; Farlow, M R

    2000-01-25

    AD, the most prevalent cause of dementia, affects twice as many women as men. Therapeutic options are limited, but results of prior studies support the hypothesis that estrogen treatment may improve symptoms of women with this disorder. Forty-two women with mild-to-moderate dementia due to AD were enrolled into a randomized, double-blind, placebo-controlled, parallel-group trial of unopposed conjugated equine estrogens (1.25 mg/day) for 16 weeks. Outcome data were available for 40 women at 4 weeks and 36 women at 16 weeks. At both 4 and 16 weeks, there were no significant differences or statistical trends between treatment groups on the primary outcome measure (the cognitive subscale of the Alzheimer's Disease Assessment Scale), clinician-rated global impression of change, or caregiver-rated functional status. Exploratory analyses of mood and specific aspects of cognitive performance also failed to demonstrate substantial group differences. Although conclusions are limited by small sample size and the possibility of a type II error, results suggest that short-term estrogen therapy does not improve symptoms of most women with AD. These findings do not address possible long-term effects of estrogen in AD, possible interactions between estrogen and other treatment modalities, or putative effects of estrogen in preventing or delaying onset of this disorder.

  20. Probiotics for fibromyalgia: study design for a pilot double-blind, randomized controlled trial.

    Science.gov (United States)

    Roman, Pablo; Estévez, Ángeles F; Sánchez-Labraca, Nuria; Cañadas, Fernando; Miras, Alonso; Cardona, Diana

    2017-10-24

    Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by other symptoms such as emotional and cognitive deficits. The FMS patients show a high prevalence of gastrointestinal symptoms. Recently it has been found that microbes in the gut may regulate brain processes through the gut-microbiota-brain axis, modulating thus affection, motivation and higher cognitive functions. Therefore, the use of probiotics might be a new treatment that could improve the physical, psychological and cognitive state in FMS; however, no evidence about this issue is available. This paper describes the design and protocol of a double-blind, placebo-controlled and randomized pilot study. We use validated questionnaires, cognitive task through E-Prime and biological measures like urine cortisol and stool fecal samples. The trial aim is to explore the effects of eight weeks of probiotics therapy in physical (pain, impact of the FMS and quality of life), emotional (depression, and anxiety) and cognitive symptoms (attention, memory, and impulsivity) in FMS patients as compared to placebo. This pilot study is the first, to our knowledge, to evaluate the effects of probiotics in FMS. The primary hypothesis was that FMS patients will show a better performance on cognitive tasks, and an improvement in emotional and physical symptoms. These results will contribute to a better understanding in the gut-brain axis. Here we present the design and protocol of the study.

  1. Double-blind, placebo-controlled, crossover study of lamotrigine in treatment-resistant generalised epilepsy.

    Science.gov (United States)

    Beran, R G; Berkovic, S F; Dunagan, F M; Vajda, F J; Danta, G; Black, A B; Mackenzie, R

    1998-12-01

    Lamotrigine (LTG) is recognised as effective add-on therapy for focal epilepsies, but this is the first double-blind, placebo-controlled, crossover study in treatment-resistant generalised epilepsy. The study consisted of 2 x 8-week treatment periods followed by a 4-week washout period. Patients received doses of either 75 or 150 mg daily, depending on their concomitant antiepileptic drugs (AEDs). Long-term continuation was offered at the end of the study with open-label LTG. Five centres in Australia recruited 26 patients who were having absence, myoclonic, or generalized tonic-clonic seizures or a combination of these. Twenty-two patients completed the study. There was a significant reduction in frequency of both tonic-clonic and absence seizure types with LTG. A 350% decrease in seizures was observed for tonic-clonic seizures in 50% of cases and for absence seizures in 33% of evaluable cases. Rash was the only adverse effect causing discontinuation. Twenty-three of 26 opted for open-label LTG, with 20 still receiving LTG for a mean of 26 months. In these 20, 80% had > or =50% seizure reduction and five (25%) were seizure free. This study shows that LTG is effective add-on therapy in patients with refractory generalised epilepsies. Statistically significant reduction in seizures in both absence and tonic-clonic seizure types was seen even with low doses of LTG.

  2. A new acupuncture method for management of irritable bowel syndrome: A randomized double blind clinical trial

    Directory of Open Access Journals (Sweden)

    Rahmatollah Rafiei

    2014-01-01

    Full Text Available Background: Irritable bowel syndrome (IBS is gastrointestinal functional disorder which is multifactorial with unknown etiology. There are several modalities for treatment of it. Acupuncture is increasingly used in numerous diseases, also in gastrointestinal disorders like IBS. The purpose of the study was to assess the effects of catgut embedding acupuncture in improving of IBS. Materials and Methods: A randomized double blind sham control clinical trial was designed. A total of 60 IBS patients assigned to three separated groups. The first group received clofac as drug only group (DO. The second one received catgut embedding acupuncture in special point (AP and the last group received sham acupuncture (SA. Symptoms, pain, depression and anxiety assessed before and after two weeks at the end of study. Results: There was statistically significant difference between AP and SA and DO in constipation and bloating. Differences that were statistically significant favored acupuncture on pain (F = 6.409, P = 0.003, and depression (F = 6.735, P = 0.002 as the other outcomes. The average (standard deviation (SD of weight loss was 2 kg (0.88 in acupuncture group. Conclusion: Our finding showed a significant positive associated between acupuncture and IBS. Catgut embedding acupuncture is a new method which can eliminated IBS symptoms and can use as alternative therapeutic method for improvement of IBS.

  3. Assessment of tetanus immunity status by tetanus quick stick and anamnesis: a prospective double blind study.

    Science.gov (United States)

    Orsi, G B; Modini, C; Principe, M A; Di Muzio, M; Moriconi, A; Amato, M G; Calderale, S M

    2015-01-01

    In patients with wounds admitted to Emergency Departments (ED) acquiring tetanus vaccination history by interview is very unreliable. Protected patients may receive unnecessary prophylaxis and unprotected nothing. Aim of the study was to evaluate tetanus immunity status comparing the traditional anamnestic method with the Tetanus Quick Stick (TQS), a rapid immunochromatographic test. A double-blind prospective study was carried out in the ED of the 1,000 bed teaching hospital Umberto I in Rome. Adult patients (≥18) with wounds attending at the ED were randomly included. Tetanus immunity status was evaluated by healthcare workers (HCWs) comparing the TQS test with the anamnesis. TQS test was performed by a trained HCW and afterwards the anamnesis about tetanus immunity status was collected by another HCW unaware of the TQS result. Also cost analysis was carried out. Overall 400 patients (242 males and 158 females) were included, mean age was 46.7 ± 20.2 years (median 44 range 18 - 109), 304 (76.0%) were italians and 96 foreigners (24.0%). Overall, 209 (52.2%) resulted TQS +, and protective immunity level was associated to lower mean age (40.1 ± 16.8 vs 53.8 ± 21,1; pimmunity is inversely related to age, for immunity prevalence among adult patients attending our ED is about 50% and is mainly influenced by class age. TQS use allowed to reduce drastically inappropriate tetanus vaccine and immunoglobulins booster treatment. Also TQS use reduced costs.

  4. Hormone Replacement Therapy and Menopause: A Review of Randomized, Double-Blind, Placebo-Controlled Trials

    Directory of Open Access Journals (Sweden)

    Chueh Chang

    2003-06-01

    Full Text Available Hormone replacement therapy (HRT is frequently prescribed to healthy women to ameliorate menopausal symptoms. HRT is used long term (≥ 1 year to prevent chronic disease in older women. The objective of this study was to review the benefits and risks of HRT and studies of menopause or HRT in Taiwan via a MEDLINE search. Recommendations are provided for future HRT research in Taiwan. Randomized, double-blind, placebo-controlled clinical trials are considered the gold standard of scientific evidence. A MEDLINE literature search (January 1966-July 2002 identified 23 papers on trials (≥ 1 year that met the inclusion criteria. The results showed that various HRT regimens used for more than 1 year caused more harm than good in healthy menopausal women and that there was no benefit for women with coronary artery disease, Alzheimer's disease, hysterectomy, hysterosalpingooophorectomy, and ischemic stroke. None of this research was conducted in Taiwan. A MEDLINE search using the key words “estrogen replacement therapy and menopause in Taiwan” identified 16 studies. There was only one, short-term, HRT trial. No evidence suggested benefits from long-term HRT in menopausal women in Taiwan.

  5. Double-blind crossover trial of lamotrigine (Lamictal) as add-on therapy in intractable epilepsy.

    Science.gov (United States)

    Binnie, C D; Debets, R M; Engelsman, M; Meijer, J W; Meinardi, H; Overweg, J; Peck, A W; Van Wieringen, A; Yuen, W C

    1989-01-01

    A double-blind, placebo-controlled trial is reported of lamotrigine as add-on treatment in therapy-resistant epilepsy. A within-patients serial design was used, with two 3-month treatment periods and an intervening 6-week washout/crossover period. An unblinded investigator adjusted lamotrigine dosage to achieve a plasma concentration within a previously predicted therapeutic range. All patients had therapy-resistant partial seizures, some in combination with other seizure types and were without serious neurological or intellectual deficit. Of 34 patients recruited only one was withdrawn because of an adverse experience (maculo-papular rash) probably related to the experimental drug and 30 completed the trial. The other 3 withdrawals were due to default during baseline, dispensing error and cholecystectomy. There was a modest statistically significant reduction in total and partial seizures on lamotrigine compared to placebo treatment. There was no difference in adverse experiences or abnormal biochemical or haematological findings between the lamotrigine and placebo periods. The plasma concentrations of concomitantly administered antiepileptic drugs were not affected by lamotrigine treatment. It is concluded that lamotrigine shows promise as an antiepileptic drug with low toxicity.

  6. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial.

    Science.gov (United States)

    Zakrzewska, J M; Chaudhry, Z; Nurmikko, T J; Patton, D W; Mullens, E L

    1997-11-01

    Lamotrigine is a chemically novel antiepileptic drug which has not been adequately assessed for its antineuralgic properties. It was used in a double-blind placebo controlled crossover trial in 14 patients with refractory trigeminal neuralgia. Patients continued to take a steady dose of carbamazepine or phenytoin throughout the trial over a 31-day period. Each arm of the trial lasted 2 weeks with an intervening 3-day washout period. The maintenance dose of lamotrigine was 400 mg. Lamotrigine was superior to placebo (P = 0.011) based on analysis of a composite efficacy index which compared the numbers of patients assigned greater efficacy on lamotrigine with those assigned greater efficacy on placebo. Efficacy for one treatment over another was determined according to a hierarchy of: (i) use of escape medication; (ii) total pain scores; or (iii) global evaluations. Eleven of the 13 patients eligible for inclusion in the composite efficacy index showed better efficacy on lamotrigine compared with placebo. Global evaluations further suggested that patients did better on lamotrigine than placebo (P = 0.025). The adverse reactions with both lamotrigine and placebo were predominantly dose-dependent effects on the central nervous system. A 14th patient withdrew from the study due to severe pain during the placebo arm of the trial. It would appear that lamotrigine has antineuralgic properties.

  7. Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence.

    Science.gov (United States)

    Ling, Walter; Shoptaw, Steven; Hillhouse, Maureen; Bholat, Michelle A; Charuvastra, Charles; Heinzerling, Keith; Chim, David; Annon, Jeffrey; Dowling, Patrick T; Doraimani, Geetha

    2012-02-01

    To evaluate the efficacy and safety of the PROMETA™ Protocol for treating methamphetamine dependence. A double-blind, placebo-controlled 108-day study with random assignment to one of two study conditions: active medication with flumazenil (2 mg infusions on days 1, 2, 3, 22, 23), gabapentin (1200 mg to day 40) and hydroxazine (50 mg to day 10) versus placebo medication (with active hydroxazine only). Three substance abuse treatment clinics: two in-patient, one out-patient. Treatment-seeking, methamphetamine-dependent adults (n = 120). Primary outcome was percentage of urine samples testing negative for methamphetamine during the trial. No statistically significant between-group differences were detected in urine drug test results, craving, treatment retention or adverse events. The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  8. [Ergometric double-blind study, Isoket-spray versus placebo-spray, in patients with coronary heart disease (author's transl)].

    Science.gov (United States)

    Böhm, H; Ludwig, B; Torabizadeh, A

    1980-08-31

    In a double-blind study 40 patients with coronary heart disease, who all complained of typical exertion-dependent angina pectoris symptoms and showed ECG changes after work in conformity with a myocardiac hypoxia, were examined in ergometric exertion tests before as well as immediately and 60 minutes after a single dose of 3.75 mg of Isoket-spray or Placebo-spray respectively. The Isoket-spray group was compared with the placebo group, furthermore, within the Isoket-spray group, the original ergometry (without medication) and the subsequent ergometries. The ST-depression, the time until reattainment of the original electrocardiographical situation after cessation of exertion and the subjective complaints showed highly significant improvements after use of the Isoket-spray in both repeated ergometries. Rapid and long-term relief after application of Isoket-spray were thus impressively shown in this double-blind study.

  9. BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study

    OpenAIRE

    Franciska Gyulai; Katalin Rába; Ildikó Baranyai; Enikő Berkes; Tamás Bender

    2015-01-01

    Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the compari...

  10. Intravenous chlorpromazine in the acute treatment of episodic tension-type headache: a randomized, placebo controlled, double-blind study

    OpenAIRE

    Marcelo Eduardo Bigal; Carlos Alberto Bordini; José Geraldo Speciali

    2002-01-01

    Acute headache is a very frequent symptom, responsible for a significant percentage of caseload at primary care units and emergency rooms. Chlorpromazine is easily available in such settings. The aim of this study is to conduct a randomized, placebo-controlled, double-blind study to assess the efficacy of chlorpromazine on the acute treatment of episodic tension-type headache. We randomized 30 patients to receive placebo (10 ml of saline intravenous injections) and 30 patients to receive 0.1 ...

  11. STIMULATION OF ARITHMETIC SKILLS AND HEMODYNAMIC EFFECTS BY COFFEE-DRINKING : DOUBLE-BLIND ANALYSIS WITH DIFFERENT CONCENTRATIONS OF CAFFEINE

    OpenAIRE

    Satoh, Hiroyasu

    1994-01-01

    Effects of caffeine on arithmetic performance were investigated with 217 university students. A double-blind study for arithmetic skill test and hemodynamic effects was carried out after drinking caffeine-free or caffeine-containing (100, 180 and 250 mg) coffee. Eleven rounds of the arithmetic tests were performed ; first four rounds before, and subsequently seven rounds after coffee break. Each round consisted of three 1-min arithmetic tests. The arithmetic skill for each round was averaged....

  12. Report on a double-blind trial comparing small and large doses of gold in the treatment of rheumatoid disease.

    Science.gov (United States)

    McKenzie, J M

    1981-11-01

    A double-blind trial was carried out for one year on 60 patients suffering from rheumatoid disease. A dosage of 10 mg of sodium aurothiomalate weekly was compared to 50 my weekly. The method and regime of the trial are described. Analysis of the results showed no statistical difference in response between the two groups. There was no appreciable difference in the toxic effects between the two groups and those reported were not serious.

  13. Oxytocin infusion during second stage of labour in primiparous women using epidural analgesia: a randomised double blind placebo controlled trial.

    OpenAIRE

    Saunders, N. J.; Spiby, H.; Gilbert, L.; Fraser, R. B.; Hall, J. M.; Mutton, P. M.; Jackson, A.; Edmonds, D. K.

    1989-01-01

    OBJECTIVE--To determine whether the high rate of forceps delivery associated with the use of epidural analgesia could be reduced through giving an intravenous infusion of oxytocin during the second stage of labour. DESIGN--A randomised, double blind, placebo controlled trial. SETTING--Delivery suites in three hospitals. SUBJECTS--226 Primiparous women with adequate epidural analgesia in whom full dilatation of the cervix had been achieved without prior stimulation with oxytocin. INTERVENTION-...

  14. The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism

    Science.gov (United States)

    Hyman, Susan L.; Stewart, Patricia A.; Foley, Jennifer; Cain, Usa; Peck, Robin; Morris, Danielle D.; Wang, Hongyue; Smith, Tristram

    2016-01-01

    To obtain information on the safety and efficacy of the gluten-free/casein-free (GFCF) diet, we placed 14 children with autism, age 3-5 years, on the diet for 4-6 weeks and then conducted a double-blind, placebo-controlled challenge study for 12 weeks while continuing the diet, with a 12-week follow-up. Dietary challenges were delivered via weekly…

  15. Efficacy and Safety of Pueraria lobata Extract in Gray Hair Prevention: A Randomized, Double-Blind, Placebo-Controlled Study

    OpenAIRE

    Jo, Seong Jin; Shin, Hyoseung; Paik, Seung Hwan; Na, Sun Jae; Jin, Yingji; Park, Won Seok; Kim, Su Na; Kwon, Oh Sang

    2013-01-01

    Background Graying of hair-a sign of aging-raises cosmetic concerns. Individuals with gray hair often look older than others their age; therefore, some dye their hair for aesthetic purposes. However, hair colorants can induce many problems including skin irritation, allergic reaction and hair-breakage. Objective This randomized, double-blind clinical trial was performed in order to examine the effects of APHG-1001, a compound including an extract from Pueraria lobata, on graying hair. Methods...

  16. Acyclovir given as prophylaxis against oral ulcers in acute myeloid leukaemia: randomised, double blind, placebo controlled trial.

    OpenAIRE

    Bergmann, O.J.; Ellermann-Eriksen, S; Mogensen, S C; Ellegaard, J.

    1995-01-01

    OBJECTIVES--To evaluate (a) the prophylactic effect of the antiherpetic drug acyclovir on oral ulcers in patients with acute myeloid leukaemia receiving remission induction chemotherapy and thus (b), indirectly, the role of herpes simplex virus in the aetiology of these ulcers. DESIGN--Randomised, double blind, placebo controlled trial. SUBJECTS--74 herpes simplex virus seropositive patients aged 18-84. Thirty seven patients received acyclovir (800 mg by mouth daily) and 37 placebo. The patie...

  17. Nests of red wood ants (Formica rufa-group are positively associated with tectonic faults: a double-blind test

    Directory of Open Access Journals (Sweden)

    Israel Del Toro

    2017-10-01

    Full Text Available Ecological studies often are subjected to unintentional biases, suggesting that improved research designs for hypothesis testing should be used. Double-blind ecological studies are rare but necessary to minimize sampling biases and omission errors, and improve the reliability of research. We used a double-blind design to evaluate associations between nests of red wood ants (Formica rufa, RWA and the distribution of tectonic faults. We randomly sampled two regions in western Denmark to map the spatial distribution of RWA nests. We then calculated nest proximity to the nearest active tectonic faults. Red wood ant nests were eight times more likely to be found within 60 m of known tectonic faults than were random points in the same region but without nests. This pattern paralleled the directionality of the fault system, with NNE–SSW faults having the strongest associations with RWA nests. The nest locations were collected without knowledge of the spatial distribution of active faults thus we are confident that the results are neither biased nor artefactual. This example highlights the benefits of double-blind designs in reducing sampling biases, testing controversial hypotheses, and increasing the reliability of the conclusions of research.

  18. Nests of red wood ants (Formica rufa-group) are positively associated with tectonic faults: a double-blind test.

    Science.gov (United States)

    Del Toro, Israel; Berberich, Gabriele M; Ribbons, Relena R; Berberich, Martin B; Sanders, Nathan J; Ellison, Aaron M

    2017-01-01

    Ecological studies often are subjected to unintentional biases, suggesting that improved research designs for hypothesis testing should be used. Double-blind ecological studies are rare but necessary to minimize sampling biases and omission errors, and improve the reliability of research. We used a double-blind design to evaluate associations between nests of red wood ants (Formica rufa, RWA) and the distribution of tectonic faults. We randomly sampled two regions in western Denmark to map the spatial distribution of RWA nests. We then calculated nest proximity to the nearest active tectonic faults. Red wood ant nests were eight times more likely to be found within 60 m of known tectonic faults than were random points in the same region but without nests. This pattern paralleled the directionality of the fault system, with NNE-SSW faults having the strongest associations with RWA nests. The nest locations were collected without knowledge of the spatial distribution of active faults thus we are confident that the results are neither biased nor artefactual. This example highlights the benefits of double-blind designs in reducing sampling biases, testing controversial hypotheses, and increasing the reliability of the conclusions of research.

  19. Double-Blind, Placebo-Controlled, Randomized Trial of Selenium in Graves Hyperthyroidism.

    Science.gov (United States)

    Kahaly, George J; Riedl, Michaela; König, Jochem; Diana, Tanja; Schomburg, Lutz

    2017-11-01

    Supplemental selenium (Se) may affect the clinical course of Graves disease (GD). Evaluate efficacy of add-on Se on medical treatment in GD. Double-blind, placebo-controlled, randomized supplementation trial. Academic endocrine outpatient clinic. Seventy untreated hyperthyroid patients with GD. Additionally to methimazole (MMI), patients received for 24 weeks either sodium selenite 300 µg/d po or placebo. MMI was discontinued at 24 weeks in euthyroid patients. Response rate (week 24), recurrence rate (week 36), and safety. A response was registered in 25 of 31 patients (80%) and in 27 of 33 (82%) at week 24 [odds ratio (OR) 0.93; 95% confidence interval (CI), 0.26 to 3.25; P = 0.904] in the Se (+MMI) and placebo (+MMI) groups, respectively. During a 12-week follow-up, 11 of 23 (48%) and 12 of 27 (44%) relapsed (OR 1.13; 95% CI, 0.29 to 2.66; P = 0.81) in the Se and placebo groups, respectively. Serum concentrations of Se and selenoprotein P were unrelated to response or recurrence rates. At week 36, 12 of 29 (41%) and 15 of 33 (45%) were responders and still in remission in the Se and placebo groups, respectively (OR 0.85; 95% CI, 0.31 to 2.32; P = 0.80). Serum levels of free triiodothyronine/free tetraiodothyronine, thyroid-stimulating hormone receptor antibody, prevalence of moderate to severe Graves orbitopathy, thyroid volume, and MMI starting dose were significantly lower in responders than in nonresponders. A total of 56 and 63 adverse events occurred in the Se and placebo groups, respectively (P = 0.164), whereas only one drug-related side effect (2.9%) was noted in 35 patients on placebo + MMI. Supplemental Se did not affect response or recurrence rates in GD.

  20. Immediate Pain Relief in Adhesive Capsulitis by Acupuncture-A Randomized Controlled Double-Blinded Study.

    Science.gov (United States)

    Schröder, Sven; Meyer-Hamme, Gesa; Friedemann, Thomas; Kirch, Sebastian; Hauck, Michael; Plaetke, Rosemarie; Friedrichs, Sunja; Gulati, Amit; Briem, Daniel

    2017-11-01

    Primary adhesive capsulitis (AC), or frozen shoulder, is an insidious and idiopathic disease. Severe pain is predominant in the first two of the three stages of the condition, which can last up to 21 months. Sixty volunteers with primary AC were randomly assigned to acupuncture with press tack needles compared with press tack placebos in a patient- and observer-blinded placebo-controlled study. The participants were subsequently offered classical needle acupuncture in an open follow-up clinical application. Thirty-four volunteers received conservative therapy, including 10 classical needle acupuncture treatments over 10 weeks, 13 volunteers received conservative therapy without classical needle acupuncture. All subjects agreed to follow-up after one year. Acupuncture treatment was performed using a specific distal needling concept, using reflex areas on distant extremities avoiding local treatment. An immediate improvement of 3.3 ± 3.2 points in Constant-Murley Shoulder Score (CMS) pain subscore was seen in the press tack needles group and of 1.6 ± 2.8 points in the press tack placebos group (P acupuncture significantly improved the pain subscore within 14.9 ± 15.9 weeks compared with 30.9 ± 15.8 weeks with only conservative therapy (P efficiency of distal needling acupuncture on immediate pain reduction was demonstrated in patients with AC and confirmed the applicability of press tack needles and press tack placebos for double-blind studies in acupuncture. Subsequent clinical application observation proved that results obtained with press tack needles/press tack placebos can be transferred to classical needle acupuncture. Integrating acupuncture with conservative therapy showed superior effectiveness with respect to the time course of the recovery process in AC compared with conservative therapy alone.

  1. Acupuncture improves sleep in postmenopause in a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Hachul, H; Garcia, T K P; Maciel, A L; Yagihara, F; Tufik, S; Bittencourt, L

    2013-02-01

    Insomnia increases in frequency as women approach and pass through menopause. Studies have not shown acupuncture efficacy for insomnia in postmenopausal women. The aim of this study was to evaluate the effectiveness of acupuncture therapy on sleep parameters, depression symptoms and quality of life in postmenopausal women with insomnia. This study included 18 postmenopausal women aged 50-67 years old. Participants had a body mass index ≤ 30 kg/m(2), presented a diagnosis of insomnia according to the DSM-IV criteria, had experienced at least 1 year of amenorrhea and had a follicle stimulating hormone level ≥ 30 mIU/ml. Participants were not using antidepressants, hypnotics or hormonal therapy. This study was randomized, double-blind and placebo-controlled. The sample was divided into two groups: acupuncture and 'sham' acupuncture. We performed ten sessions of acupuncture and 'sham' acupuncture during a period of 5 weeks. A polysomnography exam (PSG) and questionnaires (WHOQOL-BREF, Beck Depression Inventory and Pittsburgh Sleep Quality Index) were completed by all patients before and after the treatment period. Anthropometric, polysomnographic, and questionnaire data were similar among the groups at baseline. Comparison of baseline and post-treatment data of the acupuncture group showed that treatment resulted in significantly lower scores on the Pittsburgh Questionnaire and an improvement in psychological WHOQOL. The acupuncture group had a higher percentage of the N3 + 4 stage than the sham group in PSG findings. Acupuncture was effective in improving reported sleep quality and quality of life in postmenopausal women with insomnia.

  2. [Chest physiotherapy and bronchiolitis in the hospitalised infant. Double-blind clinical trial].

    Science.gov (United States)

    Sánchez Bayle, M; Martín Martín, R; Cano Fernández, J; Martínez Sánchez, G; Gómez Martín, J; Yep Chullen, G; García García, M C

    2012-07-01

    [corrected] To study the utility of chest physiotherapy by increased exhalation technique with assisted cough in the acute bronchiolite of the hospitalized new-born babys. Double-blind clinical trial accomplished on 236 patients of age lower than 7 months and hospitalizad with diagnosis of acute bronchiolitis, first episode, in a pediatric department in Madrid.The patients were randomized in two groups: those who have received maneuvers of chest physiotherapy and those who have received maneuvers placebo. Only physiotherapist were aware of the allocation group of the infants. The days of hospitalization and the hours of oxygentherapy were used like result measurement. From the totality of the studied children 57,6% received maneuvers of chest physiotherapy and 42,4% remaining received maneuvers placebo. In the group that received chest physiotherapy the average stay in the hospital was 4,56 days (95% confidence interval [CI] 4,36-6,06) and the average time of oxygentherapy was 49,98 (95% CI 43,64-67,13) hours opposite to 4,54 days (95%CI 3,81-5,73) and 53,53 hours (95% CI 48,03-81,40) respectively in the group that did not receive chest physiotherapy. In the patients with analytical print for VRS and that received chest physiotherapy less hours of oxygen therapy were needed 48,80 hours (95% CI 42,94-55,29) opposite to 56,68 hours (95% CI 55,46-65,52) respectively, being the only one turned out as per statistics significantly (P=.042). Results show that chest physiotherapy has not been effective in reducing hospital stay or length of oxygentherapy in patients with acute bronchiolitis, but in the positive study of children with respiratory syncytial virus in nasopharyngeal aspirate showed a reduced need hours of oxygen. hours (P=.042). Copyright © 2011 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  3. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis.

    Science.gov (United States)

    Amirav, Israel; Luder, Anthony S; Kruger, Natalie; Borovitch, Yael; Babai, Ilan; Miron, Dan; Zuker, Miriam; Tal, Gay; Mandelberg, Avigdor

    2008-12-01

    Cysteinyl leukotrienes are implicated in the inflammation of bronchiolitis. Recently, a specific cysteinyl leukotriene receptor antagonist, montelukast (Singulair [MSD, Haarlem, Netherlands]), has been approved for infants in granule sachets. Our goal was to evaluate the effect of montelukast on clinical progress and on cytokines in acute bronchiolitis. This was a randomized, placebo-controlled, double-blind, parallel-group study in 2 medical centers. Fifty-three infants (mean age: 3.8+/-3.5 months) with a first episode of acute bronchiolitis were randomly assigned to receive either 4-mg montelukast sachets or placebo, every day, from hospital admission until discharge. The primary outcome was length of stay, and secondary outcomes included clinical severity score (maximum of 12) and changes in type 1 and 2 cytokine levels (including interleukin4/IFN-gamma ratio as a surrogate for the T-helper 2/T-helper 1 ratio) in nasal lavage. Both groups were comparable at baseline, and cytokine levels correlated positively with disease severity. There were neither differences in length of stay (4.63+/-1.88 [placebo group] vs 4.65+/-1.97 days [montelukast group]) nor in clinical severity score and cytokine levels between the 2 groups. No differences in interleukin 4/IFN-gamma ratio between the 2 groups were seen. There was a slight tendency for infants in the montelukast group to recover more slowly than those in the placebo group (clinical severity score at discharge: 6.1+/-2.4 vs 4.8+/-2.2, respectively). Montelukast did not improve the clinical course in acute bronchiolitis. No significant effect of montelukast on the T-helper 2/T-helper 1 cytokine ratio when given in the early acute phase could be demonstrated.

  4. Pimpinella anisum in the treatment of functional dyspepsia: A double-blind, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    S Ashraffodin Ghoshegir

    2015-01-01

    Full Text Available Background: We aimed to evaluate the effects of Pimpinella anisum (anise from Apiaceae family on relieving the symptoms of postprandial distress syndrome (PDS in this double-blind randomized clinical trial. Materials and Methods: Totally, 107 patients attending the gastroenterology clinic, aged 18-65 years, diagnosed with PDS according to ROME III criteria and signed a written consent form were enrolled. They were randomized to receive either anise or placebo, blindly, for 4 weeks. Anise group included 47 patients and received anise powders, 3 g after each meal (3 times/day. Control group involved 60 patients and received placebo powders (corn starch, 3 gafter each meal (3 times/day. The severity of Functional dyspepsia (FD symptoms was assessed by FD severity scale. Assessments were done at baseline and by the end of weeks 2, 4 and 12. Mean scores of severity of FD symptoms and the frequency distribution of patients across the study period were compared. Results: The age, sex, body mass index, smoking history, and coffee drinking pattern of the intervention and control groups were not significantly different. Mean (standard deviation total scores of FD severity scale before intervention in the anise and control groups were 10.6 (4.1 and 10.96 (4.1, respectively (P = 0.6. They were 7.04 (4.1 and 12.30 (4.3 by week 2, respectively (P = 0.0001, 2.44 (4.2 and 13.05 (5.2 by week 4, respectively (P = 0.0001, and 1.08 (3.8 and 13.30 (6.2 by week 12, respectively (P = 0.0001. Conclusion: This study showed the effectiveness of anise in relieving the symptoms of postpartum depression. The findings were consistent across the study period at weeks 2, 4 and 12.

  5. High dose antithrombin supplementation in early preeclampsia: A randomized, double blind, placebo-controlled study.

    Science.gov (United States)

    D'Angelo, Armando; Valsecchi, Luca

    2016-04-01

    Antithrombin levels are often reduced in preeclampsia and infusion of antithrombin concentrates has been reported to prolong gestation in severe preeclampsia. We aimed to evaluate efficacy and safety of high-dose antithrombin (ATIII) supplementation in patients with single pregnancies and preeclampsia occurring before 30 weeks of gestation. In November 2004 a double-blind, placebo-controlled trial (code KB033) was started in 13 Italian centers. The planned sample size was of 240 patients (intention-to-treat, ITT population) to detect a 30% relative risk reduction of the primary endpoint, composite perinatal morbidity. Eligible patients were randomized to high dose AT (3000 IU/daily, ATIII Kedrion S.p.A., Italy), or placebo (1% glycine) for 7 days or less until delivery, whichever came first. The per-protocol (PP) population was restricted to patients receiving at least two days of treatment. The study was terminated by the sponsor in October 2007 after the enrolment of 38 evaluable patients - 20 randomized to high dose AT and 18 to placebo, 27 treated for 2 days or more - out of 164 screened patients. Enrolment failures were mainly represented by requirement for immediate delivery and consent refusal (91 patients). The primary endpoint occurred in 15 of 38 patients (39.5%), with a relative risk in the AT arm of 0.85 (95% CI 0.42-1.75) and 0.79 (95% CI 0.30-2.11) in the ITT and PP populations, respectively. Living neonates in the two arms had similar weight at birth, Apgar scores, and duration of hospitalization in neonatal ICU. In mothers, AT supplementation was associated with reduced blood loss at delivery and with surrogate laboratory markers (LDH, d-dimer). The results of this markedly underpowered trial, albeit suggestive of a potential maternal benefit, cannot support high-dose AT supplementation to improve fetal/neonatal outcomes in early preeclampsia. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial.

    Science.gov (United States)

    Oluwalana, Claire; Camara, Bully; Bottomley, Christian; Goodier, Sean; Bojang, Abdoulie; Kampmann, Beate; Ceesay, Samba; D'Alessandro, Umberto; Roca, Anna

    2017-02-01

    We have recently completed a proof-of-concept trial showing that bacterial colonization decreased in women and newborns after the administration of azithromycin during labor. Here, we aim to assess the effect of the intervention on maternal and neonatal clinical infections. This was a double-blind, placebo-controlled randomized trial. Gambian women in labor were given either an oral dose of azithromycin (2 g) or placebo. Follow-up was conducted for 8 weeks after delivery. From April 2013 to April 2014, we recruited 829 mothers and their 830 newborns. Sixteen infants died during the follow-up period (8 per arm). No maternal deaths or serious adverse events related to the intervention were reported. Maternal infections were lower in the azithromycin group (3.6% vs 9.2%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.22-0.71; P = .002), as was the prevalence of mastitis (1.4% vs 5.1%; RR, 0.29; 95% CI, 0.12-0.70; P = .005) and fever (1.9% vs 5.8%; RR, 0.33; 95% CI, 0.15-0.74; P = .006). Among newborns, the overall prevalence of infections was also lower in the azithromycin group (18.1% vs 23.8%; RR, 0.76; 95% CI, 0.58-0.99; P = .052) and there was a marked difference in prevalence of skin infections (3.1% vs 6.4%; RR, 0.49; 95% CI, 0.25-0.93; P = .034). Azithromycin given to women in labor decreases infections in both women and newborns during the puerperal period. Larger studies designed to evaluate the effect of the intervention on severe morbidity and mortality are warranted. Copyright © 2017 by the American Academy of Pediatrics.

  7. Double-blind, placebo-controlled study of HGF gene therapy in diabetic neuropathy.

    Science.gov (United States)

    Kessler, John A; Smith, A Gordon; Cha, Bong-Soo; Choi, Sung Hee; Wymer, James; Shaibani, Aziz; Ajroud-Driss, Senda; Vinik, Aaron

    2015-05-01

    To evaluate the safety and efficacy of a plasmid (VM202) containing two human hepatocyte growth factor isoforms given by intramuscular injections in patients with painful diabetic neuropathy. In a double-blind, placebo-controlled study, patients were randomized to receive injections of 8 or 16 mg VM202 per leg or placebo. Divided doses were administered on Day 0 and Day 14. The prospective primary outcome was change in the mean pain score measured by a 7 day pain diary. Secondary outcomes included a responder analysis, quality of life and pain measures, and intraepidermal nerve fiber density. There were no significant adverse events attributable to VM202. Eighty-four patients completed the study. Patients receiving 8 mg VM202 per leg improved the most in all efficacy measures including a significant (P = 0.03) reduction at 3 months in the mean pain score and continued but not statistically significant reductions in pain at 6 and 9 months. Of these patients, 48.4% experienced a ≥50% reduction in pain compared to 17.6% of placebo patients. There were also significant improvements in the brief pain inventory for patients with diabetic peripheral neuropathy and the questionnaire portion of the Michigan Neuropathy Screening Instrument. Patients not on pregabalin or gabapentin had the largest reductions in pain. VM202 was safe, well tolerated and effective indicating the feasibility of a nonviral gene therapy approach to painful diabetic neuropathy. Two days of treatment were sufficient to provide symptomatic relief with improvement in quality of life for 3 months. VM202 may be particularly beneficial for patients not taking gabapentin or pregabalin.

  8. A multicenter, randomized, double-blinded trial of pyridostigmine in postpolio syndrome.

    Science.gov (United States)

    Trojan, D A; Collet, J P; Shapiro, S; Jubelt, B; Miller, R G; Agre, J C; Munsat, T L; Hollander, D; Tandan, R; Granger, C; Robinson, A; Finch, L; Ducruet, T; Cashman, N R

    1999-10-12

    Postpoliomyelitis syndrome (PPS) is likely due to degeneration and dysfunction of terminal axons of enlarged postpolio motor units. Age-related decline in growth hormone and insulin-like growth factor (IGF-I) may be a contributing factor. Neuromuscular junction abnormalities and decreased IGF-I levels may respond to the anticholinesterase pyridostigmine, with consequent improvement in strength, fatigue, and quality of life. To determine the effect of pyridostigmine in PPS on health-related quality of life, isometric muscle strength, fatigue, and serum IGF-I levels; and to assess the safety of pyridostigmine in PPS. The study was a multicenter, randomized, double-blinded, placebo-controlled trial of a 6-month course of pyridostigmine 60 mg three times per day in 126 PPS patients. The primary data analysis compared mean changes of outcomes between treatment and control groups at 6 months using an intention to treat approach. Secondary analyses included a comparison of outcomes at 6 and 10 weeks, and in compliant patients. The study showed no significant differences in pyridostigmine and placebo-treated patients with regard to changes in quality of life, isometric strength, fatigue, and IGF-I serum levels at 6 months in the primary analysis and in compliant patients. There were no differences in outcomes at 6 and 10 weeks between groups. However, very weak muscles (1 to 25% predicted normal at baseline) were somewhat stronger (p = 0.10, 95% CI of difference -9.5 to 73.3%), and in compliant patients IGF-I was somewhat increased (p = 0.15, 95% CI of difference -6.4 to 44.8 ng/mL) at 6 months with the medication. Pyridostigmine was generally well tolerated. This study showed no significant differences between pyridostigmine and placebo-treated PPS patients on measures of quality of life, isometric strength, fatigue, and serum IGF-I.

  9. A Double-Blind, Placebo-Controlled Study of Atomoxetine in Young Children With ADHD

    Science.gov (United States)

    Vaughan, Brigette S.; Stoner, Julie A.; Daughton, Joan M.; Lubberstedt, Brian D.; Murray, Desiree W.; Chrisman, Allan K.; Faircloth, Melissa A.; Itchon-Ramos, Nilda B.; Kollins, Scott H.; Maayan, Lawrence A.; Greenhill, Laurence L.; Kotler, Lisa A.; Fried, Jane; March, John S.

    2011-01-01

    OBJECTIVE: To evaluate the efficacy and tolerability of atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in 5- and 6-year-old children. METHODS: This was an 8-week, double-blind, placebo-controlled randomized clinical trial of atomoxetine in 101 children with ADHD. Atomoxetine or placebo was flexibly titrated to a maximum dose of 1.8 mg/kg per day. The pharmacotherapist reviewed psychoeducational material on ADHD and behavioral-management strategies with parents during each study visit. RESULTS: Significant mean decreases in parent (P = .009) and teacher (P = .02) ADHD–IV Rating Scale scores were demonstrated with atomoxetine compared with placebo. A total of 40% of children treated with atomoxetine met response criteria (Clinical Global Impression–Improvement Scale indicating much or very much improved) compared with 22% of children on placebo, which was not significant (P = .1). Decreased appetite, gastrointestinal upset, and sedation were significantly more common with atomoxetine than placebo. Although some children demonstrated a robust response to atomoxetine, for others the response was more attenuated. Sixty-two percent of subjects who received atomoxetine were moderately, markedly, or severely ill according to the Clinical Global Impression–Severity Scale at study completion. CONCLUSIONS: To our knowledge, this is the first randomized controlled trial of atomoxetine in children as young as 5 years. Atomoxetine generally was well tolerated and reduced core ADHD symptoms in the children on the basis of parent and teacher reports. Reductions in the ADHD-IV Rating Scale scores, however, did not necessarily translate to overall clinical and functional improvement, as demonstrated on the Clinical Global Impression–Severity Scale and the Clinical Global Impression–Improvement Scale. Despite benefits, the children in the atomoxetine group remained, on average, significantly impaired at the end of the study. PMID:21422081

  10. Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication.

    Science.gov (United States)

    Markman, John D; Frazer, Maria E; Rast, Shirley A; McDermott, Michael P; Gewandter, Jennifer S; Chowdhry, Amit K; Czerniecka, Kate; Pilcher, Webster H; Simon, Lee S; Dworkin, Robert H

    2015-01-20

    To test the effects of pregabalin on the induction of neurogenic claudication. This study was a randomized, double-blind, active placebo-controlled, 2-period, crossover trial. Twenty-nine subjects were randomized to receive pregabalin followed by active placebo (i.e., diphenhydramine) or active placebo followed by pregabalin. Each treatment period lasted 10 days, including a 2-step titration. Periods were separated by a 10-day washout period, including a 3-day taper phase after the first period. The primary outcome variable was the time to first moderate pain symptom (Numeric Rating Scale score ≥4) during a 15-minute treadmill test (Tfirst). Secondary outcome measures included pain intensity at rest, pain intensity at the end of the treadmill test, distance walked, and validated self-report measures of pain and functional limitation including the Roland-Morris Disability Questionnaire, modified Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire. No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom (difference in median Tfirst = -1.08 [95% confidence interval -2.25 to 0.08], p = 0.61). In addition, none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo. Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis. This study provides Class I evidence that for patients with neurogenic claudication, compared with diphenhydramine, pregabalin does not increase the time to moderate pain during a treadmill test. © 2014 American Academy of Neurology.

  11. Randomised, double-blind, placebo-controlled trial of EPs 7630 in adults with COPD.

    Science.gov (United States)

    Matthys, Heinrich; Pliskevich, Dina A; Bondarchuk, Oleksandr M; Malek, Fathi A; Tribanek, Michael; Kieser, Meinhard

    2013-05-01

    Preventing and managing exacerbations is one major component in COPD treatment. We investigated whether EPs 7630, a herbal drug preparation from the roots of Pelargonium sidoides, could prolong time to acute exacerbation in patients with COPD stage II/III. In this randomised, double-blind, placebo-controlled clinical trial, patients were randomly allocated to oral 24-week add-on therapy with 3 × 30 drops/day EPs 7630 (n = 99) or placebo (n = 101) to a standardised baseline-treatment. Primary endpoint was time to first exacerbation of COPD. Secondary endpoints were number of exacerbations, consumption of antibiotics, quality of life, patient satisfaction, inability to work, and tolerability. Median time to exacerbation was significantly prolonged with EPs 7630 compared to placebo (57 versus 43 days, Kaplan-Maier-estimate; p = 0.005, one-sided centre-stratified log-rank test). The superiority of EPs 7630 was also confirmed in secondary endpoints, e.g., fewer exacerbations, less patients with antibiotic use, improved quality of life, higher patient satisfaction, and less days of inability to work. The incidence of minor gastrointestinal adverse events was higher in the EPs 7630 group. The results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use. Trial Registration No.: ISRCTN01681733. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Lyon, Jeffrey E; Khan, Raza A; Gessert, Charles E; Larson, Pamela M; Renier, Colleen M

    2011-10-01

    Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS). To determine the effect of the gamma-aminobutyric acid (GABA)-B agonist baclofen on the course of acute symptomatic AWS. Prospective, randomized, double-blind, placebo-controlled clinical study. Two tertiary-care hospitals in Duluth, Minnesota. Inpatient adults admitted for any reason (including AWS) judged to be at high risk for AWS. Inpatients who developed symptoms of AWS received symptom-triggered benzodiazepine treatment using lorazepam by standard protocol, and were randomized to receive baclofen 10 mg or placebo, 3 times per day, orally. AWS severity was assessed using the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar); lorazepam dose was monitored. Seventy-nine subjects were enrolled. The 44 subjects who developed symptoms of AWS were randomized to baclofen or placebo. Thirty-one subjects (18 baclofen, 13 placebo) completed 72 hours of assessments, either entirely as inpatients or with outpatient follow-up. The need for high doses of benzodiazepines (20 mg or more of lorazepam over 72 hours) to control AWS was less likely in the baclofen treatment group (1 of 18) than in the placebo-treated group (7 of 13) (P = 0.004). We found that the use of baclofen was associated with a significant reduction in the use of high doses of benzodiazepine (lorazepam) in the management of symptomatic AWS. The use of low-dose baclofen in the management of AWS deserves further study, as reduced dependence on high-dose benzodiazepines in AWS management could improve patient safety. Copyright © 2011 Society of Hospital Medicine.

  13. Double-blind, placebo-controlled study of immunotherapy with Parietaria judaica: clinical efficacy and tolerance.

    Science.gov (United States)

    Ferrer, M; Burches, E; Peláez, A; Muñoz, A; Hernández, D; Basomba, A; Enrique, E; Alonso, R; Cisteró-Bahima, A; Martín, S; Rico, P; Gandarias, B

    2005-01-01

    Allergy to Parietaria causes significant morbidity in most Mediterranean areas. The aim of this study is to investigate the efficacy and tolerance of Parietaria depot extract at 25 BU/mL (1.5 microg/mL Par j 1). We performed a multicenter double-blind, placebo-controlled study in rhinitic patients with/without asthma, sensitized to Parietaria. 42 patients followed 20-month immunotherapy. Clinical efficacy was based on symptom and medication scores and the percentage of healthy days (days without symptoms or medication). Severity of asthma/rhinitis scales, visual analogue scale, evaluation of the treatment by doctors and patients, immediate and delayed cutaneous response and quality of life questionnaires were also studied. The active group showed a sustained decrease in symptoms (p = 0.008), medication (p = 0.009) and both (p = 0.001), and an increase in healthy days (p = 0.001) throughout the study, with a threefold increase of healthy days and almost a three time reduction in medication only after one year of treatment. Asthma and rhinitis severity scales also decreased after immunotherapy, and blinded clinical evaluation by physicians confirmed efficacy in 85% and 77% of the active patients. Patient's self-evaluation returned similar results. None of these changes were observed with placebo. Immediate cutaneous response was significantly reduced at the maintenance phase in the active group and remained reduced throughout the study. Late-phase response after intradermal testing also showed a statistical decrease in actively treated patients. Immunotherapy was well tolerated and every systemic reaction reported was mild. In conclusion, immunotherapy with Parietaria 25 BU/mL is an effective and safe treatment for patients with respiratory allergies.

  14. A randomized, double-blind comparison of lorazepam and chlordiazepoxide in patients with uncomplicated alcohol withdrawal.

    Science.gov (United States)

    Kumar, Channaveerachari Naveen; Andrade, Chittaranjan; Murthy, Pratima

    2009-05-01

    For important reasons, lorazepam (Ativan) and chlordiazepoxide (Librium) are both popular treatments for alcohol-withdrawal syndrome. Nevertheless, there is little literature directly comparing the two drugs. A formal comparison is desirable because of pharmacokinetic and other differences that could affect safety and efficacy considerations relevant to practice in developing countries. One hundred consecutive consenting male inpatients in a state of moderately severe, uncomplicated alcohol withdrawal at screening were randomized to receive either lorazepam (8 mg/day) or chlordiazepoxide (80 mg/day) with dosing down-titrated to zero in a fixed-dose schedule across 8 treatment days. Double-blind assessments of withdrawal-symptom severity and impairing adverse events were obtained during treatment and for 4 days afterward. One chlordiazepoxide patient developed withdrawal delirium. Lorazepam and chlordiazepoxide showed similar efficacy in reducing symptoms of alcohol withdrawal as assessed using the revised Clinical Institute Withdrawal Assessment for Alcohol scale. During withdrawal, irritability and dizziness were more common with lorazepam, and palpitations were more common with chlordiazepoxide. No difficulties in drug discontinuation or differences in impairing adverse events were observed with either drug. With the treatment schedule used in this study, lorazepam is as effective as the more traditional drug chlordiazepoxide in attenuating uncomplicated alcohol withdrawal. Lorazepam, therefore, could be used with confidence when liver disease or the inability to determine liver function status renders chlordiazepoxide therapy problematic. The absence of clinically significant withdrawal complications with lorazepam in this large study contrasts with findings from previously published studies and suggests that higher doses of lorazepam than those formerly used may be necessary during alcohol withdrawal.

  15. A Randomized, Placebo-Controlled, Double-Blind Efficacy Study of Nefiracetam to Treat Poststroke Apathy.

    Science.gov (United States)

    Starkstein, Sergio E; Brockman, Simone; Hatch, Katherine K; Bruce, David G; Almeida, Osvaldo P; Davis, Wendy A; Robinson, Robert G

    2016-05-01

    To evaluate the efficacy of treatment with nefiracetam compared to placebo in poststroke apathy. A parallel group, randomized, placebo-controlled, double-blind two-center trial in patients with recent stroke and apathy was conducted in 2 tertiary teaching hospitals in Perth, Western Australia, between March 2010 and October 2014. Consenting patients hospitalized with stroke were screened for participation at the time of hospitalization and, if diagnosed with apathy 8-36 weeks later, they were randomized to 12 weeks of 900 mg/day nefiracetam or placebo. The primary efficacy parameter was change in apathy at 12 weeks defined by the 14-item Apathy Scale (AS). Of 2514 patients screened, only 377 (15%) were eligible for the study after the first screening, 233 declined further participation, and 144 were assessed for apathy at 8-36 weeks post stroke to confirm eligibility. Twenty patients out of 106 with a complete psychiatric assessment had apathy (19%). Of this sample, 13 patients were randomized. Overall, the AS score decreased by a mean of 7.0 points (95% CI = -14.6 to .6), but there was no significant between-group difference at week 12 (mean paired t-tests, P > .14). Treatment with nefiracetam did not prove to be more efficacious than placebo in ameliorating apathy in stroke. The main limitation was the very small sample randomized, highlighting the limitations of conducting drug trials for behavioral problems among stroke patients. Pharmacological studies of apathy in stroke will require a large multicenter study and a massive sample of patients. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  16. Omega-3 fatty acids modify human cortical visual processing--a double-blind, crossover study.

    Directory of Open Access Journals (Sweden)

    Isabelle Bauer

    Full Text Available While cardiovascular and mood benefits of dietary omega-3 fatty acids such as docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA are manifest, direct neurophysiological evidence of their effects on cortical activity is still limited. Hence we chose to examine the effects of two proprietary fish oil products with different EPA:DHA ratios (EPA-rich, high EPA:DHA; DHA-rich on mental processing speed and visual evoked brain activity. We proposed that nonlinear multifocal visual evoked potentials (mfVEP would be sensitive to any alteration of the neural function induced by omega-3 fatty acid supplementation, because the higher order kernel responses directly measure the degree of recovery of the neural system as a function of time following stimulation. Twenty-two healthy participants aged 18-34, with no known neurological or psychiatric disorder and not currently taking any nutritional supplementation, were recruited. A double-blind, crossover design was utilized, including a 30-day washout period, between two 30-day supplementation periods of the EPA-rich and DHA-rich diets (with order of diet randomized. Psychophysical choice reaction times and multi-focal nonlinear visual evoked potential (VEP testing were performed at baseline (No Diet, and after each supplementation period. Following the EPA-rich supplementation, for stimulation at high luminance contrast, a significant reduction in the amplitude of the first slice of the second order VEP kernel response, previously related to activation in the magnocellular pathway, was observed. The correlations between the amplitude changes of short latency second and first order components were significantly different for the two supplementations. Significantly faster choice reaction times were observed psychophysically (compared with baseline performance under the EPA-rich (but not DHA-rich supplementation, while simple reaction times were not affected. The reduced nonlinearities observed under the

  17. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits. Copyright © 2016, American Association for the Advancement of Science.

  18. Clozapine and risperidone in moderately refractory schizophrenia: a 6-month randomized double-blind comparison.

    Science.gov (United States)

    Schooler, Nina R; Marder, Stephen R; Chengappa, K N R; Petrides, Georgios; Ames, Donna; Wirshing, William C; McMeniman, Marjorie; Baker, Robert W; Parepally, Haranath; Umbricht, Daniel; Kane, John M

    2016-05-01

    Clozapine remains the only medication indicated for refractory schizophrenia. As new antipsychotic drugs become available, their efficacy compared to clozapine, particularly in moderately ill patients, is of great clinical interest. We compared risperidone, the first of these, to clozapine in partially responsive patients. Further, since participation of patients usually excluded from clinical trials is increasingly important, we broadened inclusion to a wider patient population. We compared clozapine (n = 53) to risperidone (n = 54) in a randomized, double-blind, 29-week trial in schizophrenia patients (diagnosed using DSM-IV) at 3 research outpatient clinics. Randomization was stratified by "narrow" or "broad" inclusion criteria. The study was conducted between December 1995 and October 1999. Time to treatment discontinuation for lack of efficacy and time to 20% improvement in the Brief Psychiatric Rating Scale psychotic symptom cluster were the primary outcome measures. There were no differences in all-cause discontinuation; clozapine-treated participants were significantly less likely to discontinue for lack of efficacy (15%) than risperidone-treated participants (38%) (Wilcoxon χ(2)1 = 6.10, P = .01). Clozapine resulted in significantly more global improvement (F2,839 = 6.07, P risperidone. There was no difference in proportions meeting an a priori criterion of psychosis improvement (risperidone: 57%; clozapine: 71%). Significant adverse effect differences in salivation (F1 = 4.05, P risperidone. Clozapine-treated partially responsive patients were less likely to discontinue treatment for lack of efficacy and improved more globally than those treated with risperidone, although psychotic symptoms did not differ. These findings suggest that clozapine should not be restricted to the most severely ill, treatment-refractory patients; it should be considered as an alternative for patients who have some response to other antipsychotics, but still experience

  19. Pirfenidone Accelerates Wound Healing in Chronic Diabetic Foot Ulcers: A Randomized, Double-Blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Luz E. Gasca-Lozano

    2017-01-01

    Full Text Available Background. Diabetic foot ulcers are one disabling complication of diabetes mellitus. Pirfenidone (PFD is a potent modulator of extracellular matrix. Modified diallyl disulfide oxide (M-DDO is an antimicrobial and antiseptic agent. Aim. To evaluate efficacy of topical PFD + M-DDO in a randomized, double-blind trial versus ketanserin in the treatment of noninfected chronic DFU. Methods. Patients received PFD + M-DDO or ketanserin for 6 months. Relative ulcer volume (RUV was measured every month; biopsies were taken at baseline and months 1 and 2 for histopathology and gene expression analysis for COL-1α, COL-4, KGF, VEGF, ACTA2 (α-SMA, elastin, fibronectin, TGF-β1, TGF-β3, HIF-1α, and HIF-1β. Results. Reduction of median RUV in the PFD + M-DDO group was 62%, 89.8%, and 99.7% at months 1–3 and 100% from months 4 to 6. Ketanserin reduced RUV in 38.4%, 56%, 60.8%, 94%, 94.8%, and 100% from the first to the sixth month, respectively. Healing score improved 4.5 points with PFD + M-DDO and 1.5 points with ketanserin compared to basal value. Histology analysis revealed few inflammatory cells and organized/ordered collagen fiber bundles in PFD + M-DDO. Expression of most genes was increased with PFD + M-DDO; 43.8% of ulcers were resolved using PFD + M-DDO and 23.5% with ketanserin. Conclusion. PFD + M-DDO was more effective than ketanserin in RUV reduction.

  20. Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

    Science.gov (United States)

    Forray, Ariadna; Gilstad-Hayden, Kathryn; Suppies, Cristine; Bogen, Debra; Sofuoglu, Mehmet; Yonkers, Kimberly A

    2017-12-01

    Close to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking. This was an 8-week, double-blind, parallel, randomized, placebo-controlled pilot trial of 41 women with a history of pre-pregnancy smoking who achieved abstinence by 32 weeks of gestation. Immediately following delivery women were randomized to oral micronized progesterone (200mg twice daily) or placebo via computerized urn randomization program. The main outcome measures were descriptions of study feasibility: recruitment and retention. Secondary outcomes were 7-day point prevalence of abstinence at week 8, time to relapse and smoking cravings. The trial was feasible with adequate randomization, 64% (41/64) of eligible women, and trial retention, 78% (32/41) completed the trial. Women taking progesterone were 1.8 times more likely to be abstinent during week 8 and took longer to relapse (10 vs. 4 weeks) compared to the placebo group, although these differences did not reach statistical significance. After adjusting for age and pre-quit smoking level, the number needed to treat was 7. There was a 10% greater decline per week in craving ratings in the progesterone group compared to placebo (β=-0.10, 95% CI: -0.15, -0.04, p<0.01). No serious adverse events occurred during the trial. These preliminary findings support the promise of progesterone treatment in postpartum smokers and could constitute a therapeutic breakthrough.If these preliminary findings can be evaluated and replicated in a larger study with sufficient power, this may constitute an acceptable and safe smoking relapse prevention strategy for use

  1. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients.

    Science.gov (United States)

    Salonen, Bradley R; Bonnes, Sara L; Vallumsetla, Nishanth; Varayil, Jithinraj Edakkanambeth; Mundi, Manpreet S; Hurt, Ryan T

    2017-05-17

    Ethanol lock therapy (ELT) has been shown to reduce the rate of catheter-related bloodstream infection (CRBSI) in high-risk home parenteral nutrition (HPN) patients. The aim of this study was to determine whether ELT therapy for all patients newly started on HPN would reduce the incidence of CRBSI. This study was a prospective, double-blind, randomized controlled trial that was carried out from July 2014 to April 2016. The study participants were patients newly started on HPN, and they were randomly assigned to either treatment with ELT or our current standard of care with saline heparin locks. The primary outcome was occurrence of CRBSI. Thirty eight patients that were newly started on HPN were randomized to either treatment with ELT (n = 18) or to our current standard of care with heparin locks (n = 20). Four patients in the ELT group and one patient in the control arm had a CRBSI (p = 0.17). No significant adverse side effects were noted during the study. This study did not show improvement in the rate of CRBSI with ELT in all patients started on HPN. ELT therapy may be most helpful to reduce in CRBSI in high-risk HPN patients, but further studies with a randomized control trial design of high-risk patients are needed to further clarify this important issue in HPN patients. The study was registered at clinicaltrials.gov prior to patient enrollment (NCT02227329). Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  2. EXTRADURAL ANESTHESIA WITH AND WITHOUT KETAMIN: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    R TALA KOUB

    2001-09-01

    Full Text Available Introduction. Extradural anesthesia is a successfull procedure in many operations.This is also a suitable and elective anesthetic procedure in many operations have particular hemodynamic conditions. Hence the onset time on this of anesthesia is slow and the degree of sensory and motor block is relatively variable in many cases, this procedure is not accepted by anesthesiologists and surgeons. So, inspite of its priority in many cases, it is less used. Thegoal of this study is to achieve a practical and effective solution to shorten the onset of analgesia and increasing analgesic duration which studies adding ketamin to bupivacain in extradural anesthesia. Methods. This study is a double blinded randomized clinical trial. Forty adult patients in class 1 and 2 of ASA who have been candidate for elective lower limb or lower abdominal surgery in Al-zahra and Kashani medical center in 1998 were selected. Without receiving any premedications, all of the patients received 500 CC ringer lactated solution before onset of anesthesia and they were divided into 2 groups. Group 1 received 20 cc of 0.5 percent bupivacain+0.5cc of 0.9 percent normal saline. Group 2 (interventional received 20 cc of 0.5 percent bupivacain + 0.5 cc of Ketamin (25mg. The onset of sensory block and the duration of sensory and motor block were measured and compared in both groups. Results. The onset of sensory block in interventional group was shorter than in controlled group. The duration of sensory block in interventional group was longer than in controlled group. The duration of the motor block was longer in controlled group than interventional group (P < 0.05. Discussion. Adding ketamin to bupivacain results in earlier onset and longer duration of analgesia in extradural anesthesia. This effect may be due to the inhibitory effect of the ketamin on posterior nerve root activity in spinal cord which can be an effective mechanism of ketamin in making analgesia.

  3. Double-blind, placebo-controlled trial of risperidone plus topiramate in children with autistic disorder.

    Science.gov (United States)

    Rezaei, Vala; Mohammadi, Mohammad-Reza; Ghanizadeh, Ahmad; Sahraian, Ali; Tabrizi, Mina; Rezazadeh, Shams-Ali; Akhondzadeh, Shahin

    2010-10-01

    Autism is a complex neurodevelopmental disorder that forms part of a spectrum of related disorders referred to as Autism Spectrum Disorders. The present study assessed the effects of topiramate plus risperidone in the treatment of autistic disorder. Forty children between the ages of 4 and 12 years with a DSM IV clinical diagnosis of autism who were outpatients from a specialty clinic for children were recruited. The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients were randomly allocated to topiramate+risperidone (Group A) or placebo+risperidone (Group B) for an 8-week, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for children weighting above 40 kg. The dose of topiramate was titrated up to 200 mg/day depending on weight (100 mg/day for 30 kg). Patients were assessed at baseline and after 2, 4, 6 and 8 weeks after starting medication. Measure of outcome was the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale. Difference between the two protocols was significant as the group that received topiramate had a greater reduction in ABC-C subscale scores for irritability, stereotypic behavior and hyperactivity/noncompliance. The results suggest that the combination of topiramate with risperidone may be superior to risperidone monotherapy for children with autistic disorder. However the results need to be further confirmed by a larger randomized controlled trial. Copyright © 2010 Elsevier Inc. All rights reserved.

  4. Intraperitoneal local anesthetics have predominant local analgesic effect: a randomized, double-blind study.

    Science.gov (United States)

    Perniola, Andrea; Magnuson, Anders; Axelsson, Kjell; Gupta, Anil

    2014-08-01

    It remains unclear whether analgesia from intraperitoneal local anesthetics is via local or central mechanisms. This double-blind clinical trial tests the hypothesis that intraperitoneal local anesthetic is superior to continuous IV infusion for pain management. Primary outcome was morphine consumption during 0 to 24 h. Informed consent was obtained from 60 patients, age 30 to 75 yr, American Society of Anesthesiologists physical status I to II, undergoing abdominal hysterectomy. A computer-generated program randomized patients in parallel arms to group IV: continuous infusion of lidocaine 50 mg/h (10 ml) IV and saline 10 ml/h intermittently intraperitoneal; group IP: injection of lidocaine 50 mg/h (10 ml) once every hour intraperitoneally and continuous infusion of saline 10 ml/h intravenously; and group P (placebo): saline 10 ml/h both intravenously and intermittent intraperitoneal injection. Postoperative morphine consumption, pain intensity, recovery, home discharge, and lidocaine concentrations were measured. Morphine consumption during 0 to 24 h was lower in group IP versus group IV, mean difference -22.6 mg (95% CI, 11.4 to 33.8; P lidocaine in group IP was significantly lower than group IV, 0 to 4.5 h postoperatively (P = 0.03) with no evidence of systemic toxicity. Pain intensity and other recovery parameters were similar between the groups. The lower supplemental morphine consumption and plasma lidocaine concentration in group IP would confirm that the effects of local anesthetics are likely to be predominant via local intraperitoneal receptors or anti-inflammatory effects and not via central mechanisms alone.

  5. (Ab)normal saline and physiological Hartmann's solution: a randomized double-blind crossover study.

    Science.gov (United States)

    Reid, Fiona; Lobo, Dileep N; Williams, Robert N; Rowlands, Brian J; Allison, Simon P

    2003-01-01

    In this double-blind crossover study, the effects of bolus infusions of 0.9% saline (NaCl) and Hartmann's solution on serum albumin, haematocrit and serum and urinary biochemistry were compared in healthy subjects. Nine young adult male volunteers received 2-litre intravenous infusions of 0.9% saline and Hartmann's solution on separate occasions, in random order, each over 1 h. Body weight, haematocrit and serum biochemistry were measured pre-infusion and at 1 h intervals for 6 h. Biochemical analysis was performed on pooled post-infusion urine. Blood and plasma volume expansion, estimated by dilutional effects on haematocrit and serum albumin, were greater and more sustained after saline than after Hartmann's solution (P Hartmann's solution. Subjects voided more urine (median: 1,000 compared with 450 ml) of higher sodium content (median: 122 compared with 73 mmol) after Hartmann's than after saline (both P =0.049), despite the greater sodium content of the latter. The time to first micturition was less after Hartmann's than after saline (median: 70 compared with 185 min; P =0.008). There were no significant differences between the effects of the two solutions on serum sodium, potassium, urea or osmolality. After saline, all subjects developed hyperchloraemia (>105 mmol/l), which was sustained for >6 h, while serum chloride concentrations remained normal after Hartmann's (P Hartmann's solution, due possibly to the more physiological [Na(+)]/[Cl(-)] ratio in Hartmann's solution (1.18:1) than in saline (1:1) and to the hyperchloraemia caused by saline.

  6. Probiotics for the Treatment of Pediatric Helicobacter Pylori Infection: A Randomized Double Blind Clinical Trial

    Science.gov (United States)

    Khodadad, Ahmad; Farahmand, Fatemeh; Najafi, Mehri; Shoaran, Maryam

    2013-01-01

    Objective Helicobacter pylori is recognized as a major etiological factor in the pathogenesis of gastritis and peptic ulcer disease. H. Pylori eradication has a failure rate of more than 30% in pediatric patients, particularly because of poor compliance, antibiotic resistance and occurrence of side-effects. This study was aimed to determine whether adding the probiotics to a standard anti-H. pylori regimen could minimize the gastrointestinal side-effect prevalence and improve the eradication rate. Methods Double-blind randomized placebo controlled study conducted at Children's Medical Center in Tehran, Iran. Sixty six H. pylori positive children were treated with a triple drug treatment protocol (omeprazole+amoxycillin+furazolidon) and randomly allocated to receive either probiotic or placebo. All patients underwent esophagogastroduodendoscopy. H. pylori infection was diagnosed by either rapid urease test (RUT) or histology. H. pylori status was assessed after 4-8 weeks of the completion of treatment with stool H. pylori antigen test. The side effects of the treatment were determined in each group. Findings Mean age of patients was 9.09 (range 3-14) years, 44 (65.7%) patients were boys (sex ratio 2:1). All 66 patients completed the course of treatment and follow-up. The rate of H. pylori eradication was significantly higher in probiotic group (P=0.04). In probiotic supplemented children there was a lower rate of nausea/vomiting (P=0.02) and diarrhea (P=0.039) during treatment. Conclusion This study showed that probiotics have positive effect on the eradication of H. pylori infection. Adjuvant therapy with probiotic is recommended in order to reduce the frequency of antibiotic induced side-effects during treatment with antibiotics. PMID:23446685

  7. Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial.

    Science.gov (United States)

    Butchart, Joseph; Brook, Laura; Hopkins, Vivienne; Teeling, Jessica; Püntener, Ursula; Culliford, David; Sharples, Richard; Sharif, Saif; McFarlane, Brady; Raybould, Rachel; Thomas, Rhodri; Passmore, Peter; Perry, V Hugh; Holmes, Clive

    2015-05-26

    To determine whether the tumor necrosis factor α inhibitor etanercept is well tolerated and obtain preliminary data on its safety in Alzheimer disease dementia. In a double-blind study, patients with mild to moderate Alzheimer disease dementia were randomized (1:1) to subcutaneous etanercept (50 mg) once weekly or identical placebo over a 24-week period. Tolerability and safety of this medication was recorded including secondary outcomes of cognition, global function, behavior, and systemic cytokine levels at baseline, 12 weeks, 24 weeks, and following a 4-week washout period. This trial is registered with EudraCT (2009-013400-31) and ClinicalTrials.gov (NCT01068353). Forty-one participants (mean age 72.4 years; 61% men) were randomized to etanercept (n = 20) or placebo (n = 21). Etanercept was well tolerated; 90% of participants (18/20) completed the study compared with 71% (15/21) in the placebo group. Although infections were more common in the etanercept group, there were no serious adverse events or new safety concerns. While there were some interesting trends that favored etanercept, there were no statistically significant changes in cognition, behavior, or global function. This study showed that subcutaneous etanercept (50 mg/wk) was well tolerated in this small group of patients with Alzheimer disease dementia, but a larger more heterogeneous group needs to be tested before recommending its use for broader groups of patients. This study shows Class I evidence that weekly subcutaneous etanercept is well tolerated in Alzheimer disease dementia. © 2015 American Academy of Neurology.

  8. Topical clindamycin in post-adenotonsillectomy analgesia in children: a double-blind, randomized clinical trial.

    Science.gov (United States)

    Miura, Mauricio Schreiner; Saleh, Catia; de Andrade, Marina; Assmann, Melina; Lima, Lucélia Hernandes; Lubianca Neto, José Faibes

    2009-10-01

    Tonsillectomy, with or without adenoidectomy, is one of the most common surgical procedures in pediatric otolaryngology. Pain is the main cause of morbidity in the postoperative period, where it is serious in some cases, leading to odynophagia and resultant complications such as dehydration. We evaluated the effect of topical clindamycin in the reduction of oropharyngeal pain in children who underwent adenotonsillectomy. Secondary outcomes were otalgia, analgesic use, oral bacterial count, type of diet, secondary bleeding, vomiting, fever, and weight loss. Double-blind, randomized clinical trial. Tertiary hospital. Eighty-two children of both sexes between four and 12 years of age who underwent adenotonsillectomy were allocated to receive topical clindamycin or placebo in the immediate preoperative, intraoperative, and eight-to-12-hours postoperative periods. Pain was measured using a faces pain scale for five days. Reduction of oropharyngeal pain was significant with the use of clindamycin only on the first postoperative day (95% confidence interval, 2.22 to 4.41 [clindamycin] vs 4.53 to 6.3 [placebo]; P = .002). No difference was observed in the aerobic and anaerobic counts by tongue swab between premedication and third-postoperative-day samplings. There were no differences with respect to reduction in otalgia, paracetamol use, return to normal diet, variation in weight, secondary hemorrhage, vomiting, and fever. The use of topical clindamycin was beneficial in reducing pain on the first postoperative day, without effect on subsequent days. Future investigations could examine the use of topical clindamycin not only in the first 12 hours but also during five days of follow-up.

  9. Topical sucralfate in post-adenotonsillectomy analgesia in children: a double-blind randomized clinical trial.

    Science.gov (United States)

    Miura, Mauricio Schreiner; Saleh, Catia; de Andrade, Marina; Assmann, Melina; Ayres, Marcio; Lubianca Neto, José Faibes

    2009-09-01

    Tonsillectomy, with or without adenoidectomy, is one of the most common surgical procedures in pediatric otolaryngology. Despite its relative simplicity, pain is the main cause of morbidity in the postoperative period. We determined the effect of topical sucralfate on reduction of oropharyngeal pain in children submitted to adenotonsillectomy. Secondary outcomes were otalgia, analgesic use, type of diet, secondary bleeding, vomiting, fever, and weight loss. Double-blind, randomized clinical trial. Tertiary hospital. Eighty-two children of both sexes between four and 12 years old submitted to adenotonsillectomy were evaluated. They were allocated to receive topical sucralfate or placebo in intraoperative and postoperative periods four times a day for five days. Pain was measured through faces pain scale. Reduction in oropharyngeal pain was significant with use of sucralfate during five days of evaluation (mean, 95% confidence interval, and P value); day 1: 2.05, 1.53-2.58, P = 0.000; day 2: 2.1, 1.51-2.70, P = 0.001; day 3: 1.44, 0.88-1.99, P = 0.003; day 4: 1.13, 0.58-1.55, P = 0.027; day 5: 0.67, 0.26-1.04, P = 0.021). There was no difference in secondary outcomes. We found beneficial effect of use of sucralfate in reduction of oropharyngeal pain in the postoperative period of adenotonsillectomy. However, topical sucralfate does not have a potent effect to the point of being utilized as a single analgesic treatment. Because it is simple, safe, tolerated, and low-cost, it is an important tool as adjuvant treatment of post-tonsillectomy pain.

  10. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation

    Directory of Open Access Journals (Sweden)

    Nilsson Robert

    2011-09-01

    Full Text Available Abstract Background Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials. Methods We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enrolled 319 healthy smokers aged 20-65 years at two occupational health centers in Belgrade, Serbia. Most of them (81% expressed an interest to quit rather than just reduce their smoking. Study products were used ad libitum throughout the 48-week study period. The main study objective during the first 24 weeks was smoking reduction. The primary end-point was defined as a biologically verified reduction of ≥ 50% in the average number of smoked cigarettes per day during week 21-24 compared to baseline. During week 25-48 participants were actively instructed to stop smoking completely. Outcome measures of biologically verified, complete smoking cessation included 1-week point prevalence rates at clinical visits after 12, 24, 36, and 48 weeks, as well as 4-, 12- and 24-week continued cessation rates at the week 36 and 48 visits. Results At the week 24 visit, the proportion of participants who achieved the protocol definition of a ≥ 50% smoking reduction was similar in the two treatment groups. However, the proportion that reported more extreme reductions (≥ 75% was statistically significantly higher in the snus group than in the placebo group (p Conclusions Swedish snus could promote smoking cessation among smokers in Serbia, that is, in a cultural setting without traditional use of oral, smokeless tobacco. Trial registration www.clinicaltrials.gov, identifier: NCT00601042

  11. Does a mineral wristband affect balance? A randomized, controlled, double-blind study.

    Science.gov (United States)

    Hansson, Eva Ekvall; Beckman, Anders; Persson, Liselott

    2015-06-26

    Having good balance is a facilitating factor in the performance of everyday activities. Good balance is also essential in various sport activities in order to both get results and prevent injury. A common measure of balance is postural sway, which can be measured both antero-posteriorly and medio-laterally. There are several companies marketing wristbands whose intended function is to improve balance, strength and flexibility. Randomized controlled trials have shown that wristbands with holograms have no effect on balance but studies on wristbands with minerals seem to be lacking. The aim of this study was to investigate if the mineral wristband had any effect on postural sway in a group of healthy individuals. Randomized, controlled, double-blind study. The study group consisted of 40 healthy persons. Postural sway was measured antero-posteriorly and medio-laterally on a force plate, to compare: the mineral wristband, a placebo wristband, and without any wristband. The measurements were performed for 30 s, in four situations: with open eyes and closed eyes, standing on a firm surface and on foam. Analyses were made with multilevel technique. The use of wristband with or without minerals did not alter postural sway. Closed eyes and standing on foam both prolonged the dependent measurement, irrespective if it was medio-lateral or antero-posterior. Wearing any wristband (mineral or placebo) gave a small (0.22-0.36 mm/s) but not statistically significant reduction of postural sway compared to not wearing wristband. This study showed no effect on postural sway by using the mineral wristband, compared with a placebo wristband or no wristband. Wearing any wristband at all (mineral or placebo) gave a small but not statistically significant reduction in postural sway, probably caused by sensory input.

  12. Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial.

    Science.gov (United States)

    Verhoeven, Veronique; Lopez Hartmann, Maja; Remmen, Roy; Wens, Johan; Apers, Sandra; Van Royen, Paul

    2013-07-18

    In recent years, red yeast rice (RYR) supplements have been marketed aggressively as a natural way to lower cholesterol; however, the large majority of commercially available products have not been studied according to current research standards. In a double blind placebo controlled randomized trial, 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL were randomly allocated to receive a RYR extract or placebo for 8 weeks. As a primary outcome measure, we compared the before-after difference in lipid levels between both groups. As secondary outcome measures we looked at side-effects, CK elevation and a change in cardiovascular risk. LDL (low density lipoprotein) cholesterol was lowered with 36 mg/dL (22%) and total cholesterol with 37 mg/dL (15%) in the intervention group. This result was statistically significant as compared to the control group, in which no reduction in total cholesterol and LDL was observed (p < 0.001). There was no marked difference in CK (creatine kinase)-elevation or reported side-effects between study groups. In 5/31 participants in the intervention group, the lipid lowering effect resulted in lower cardiovascular risk as measured with SCORE (Systematic COronary Risk Evaluation). The RYR formulation under study was effective in lowering cholesterol and LDL cholesterol in this study population. RYR therapy may be an attractive and relatively well studied alternative in patients who are intolerant for statins or who have objections against pharmacological lipid lowering. However, consumers need to be warned that the actual content of commercially available preparations is not assured by governmental regulations, which raises effectiveness and safety issues. Clinicaltrials.gov, nr: NCT01558050.

  13. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial.

    Science.gov (United States)

    Sit, Dorothy K; McGowan, James; Wiltrout, Christopher; Diler, Rasim Somer; Dills, John Jesse; Luther, James; Yang, Amy; Ciolino, Jody D; Seltman, Howard; Wisniewski, Stephen R; Terman, Michael; Wisner, Katherine L

    2018-02-01

    Patients with bipolar disorder have recurrent major depression, residual mood symptoms, and limited treatment options. Building on promising pilot data, the authors conducted a 6-week randomized double-blind placebo-controlled trial to investigate the efficacy of adjunctive bright light therapy at midday for bipolar depression. The aims were to determine remission rate, depression symptom level, and rate of mood polarity switch, as well as to explore sleep quality. The study enrolled depressed adults with bipolar I or II disorder who were receiving stable dosages of antimanic medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). Patients were randomly assigned to treatment with either 7,000-lux bright white light or 50-lux dim red placebo light (N=23 for each group). Symptoms were assessed weekly with the Structured Interview Guide for the Hamilton Depression Scale With Atypical Depression Supplement (SIGH-ADS), the Mania Rating Scale, and the Pittsburgh Sleep Quality Index. Remission was defined as having a SIGH-ADS score of 8 or less. At baseline, both groups had moderate depression and no hypomanic or manic symptoms. Compared with the placebo light group, the group treated with bright white light experienced a significantly higher remission rate (68.2% compared with 22.2%; adjusted odds ratio=12.6) at weeks 4-6 and significantly lower depression scores (9.2 [SD=6.6] compared with 14.9 [SD=9.2]; adjusted β=-5.91) at the endpoint visit. No mood polarity switches were observed. Sleep quality improved in both groups and did not differ significantly between them. The data from this study provide robust evidence that supports the efficacy of midday bright light therapy for bipolar depression.

  14. A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation

    Science.gov (United States)

    2013-01-01

    Background Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. However, there is very little information as to their role in acute asthma exacerbations. We hypothesized that LTRAs may accelerate lung function recovery when given in an acute exacerbation. Methods A randomized, double blind, placebo-controlled trial was conducted at the Aga Khan University Hospital to assess the efficacy of oral montelukast on patients of 16 years of age and above who were hospitalized with acute asthma exacerbation. The patients were given either montelukast or placebo along with standard therapy throughout the hospital stay for acute asthma. Improvements in lung function and duration of hospital stay were monitored. Results 100 patients were randomized; their mean age was 52 years (SD +/− 18.50). The majority were females (79%) and non-smokers (89%). The mean hospital stay was 3.70 ± 1.93 days with 80% of patients discharged in 3 days. There was no significant difference in clinical symptoms, PEF over the course of hospital stay (p = 0.20 at day 2 and p = 0.47 at day 3) and discharge (p = 0.15), FEV1 at discharge (p = 0.29) or length of hospital stay (p = 0.90) between the two groups. No serious adverse effects were noted during the course of the study. Conclusion Our study suggests that there is no benefit of addition of oral montelukast over conventional treatment in the management of acute asthma attack. Trial registration Trial registration number: 375-Med/ERC-04 PMID:23537391

  15. A double-blind, placebo-controlled evaluation of the erectile response to transurethral alprostadil.

    Science.gov (United States)

    Hellstrom, W J; Bennett, A H; Gesundheit, N; Kaiser, F E; Lue, T F; Padma-Nathan, H; Peterson, C A; Tam, P Y; Todd, L K; Varady, J C; Place, V A

    1996-12-01

    Previous studies have indicated that the urethra may provide an effective route for administering vasoactive medication for the treatment of erectile dysfunction. We evaluated the safety and efficacy of alprostadil administered intraurethrally at home for the treatment of this disorder. This prospective, multicenter, double-blind, placebo-controlled study evaluated the erectile response to randomly assigned doses of transurethral alprostadil at home in 68 men with long-standing (mean 41 months) erectile dysfunction of primarily organic etiology. Patients completing the study each administered a random sequence of four different doses (125, 250, 500, and 1000 micrograms) and placebo over a 2 to 4-week period. Assessments included the couples' ability to have intercourse, patient ratings of erectile response by both categorical and visual analogue scales, penile volume measurements, and overall assessments of comfort and ease of administration. Overall, 75.4% (49 of 65) of study patients achieved full enlargement of the penis and 49.2% (32 of 65) achieved an erection judged by the patient to be sufficient for intercourse. In addition, 63.6% (42 of 66) of patients reported intercourse. Efficacy was similar across etiologies. The most common side effect was penile pain, which occurred in association with 9.1% to 18.3% of alprostadil administrations, depending on dose. Mean comfort ratings ranged from 79 to 87, depending on dose, where 0 = severe discomfort and 100 = comfortable; ease of administration scores were above 90 for each dose, where 0 = difficult and 100 = easy. There were no episodes of priapism in this study. Short-term treatment with transurethral alprostadil produced erections resulting in sexual intercourse in most patients with chronic erectile dysfunction. This therapy may be a useful treatment option for patients with erectile dysfunction.

  16. A double-blind crossover trial of clomipramine for rapid ejaculation in 15 couples.

    Science.gov (United States)

    Althof, S E; Levine, S B; Corty, E W; Risen, C B; Stern, E B; Kurit, D M

    1995-09-01

    The purpose of this study was to assess the sexual and psychosocial efficacy of clomipramine for rapid ejaculation. Fifteen physically healthy, self-selected couples (men had a mean age of 38 years) who met six eligibility criteria and did not meet five exclusion criteria participated in a variable-length, repeated measures, randomized, double-blind, placebo-controlled crossover study with a 2-month follow-up period. Sexual and psychosocial assessments were conducted at baseline, after placebo, after 25 mg/day of clomipramine, after 50 mg/day of clomipramine, and at the 2-month follow-up point. The major outcome measures included stopwatch timing of ejaculation latencies, modified Case Western Reserve University Sexual Function Questionnaire, Symptom Checklist-90-R, Dyadic Adjustment Scale, State-Trait Anxiety Inventory, and the Harder Self-Esteem Inventory. Baseline mean ejaculatory latency was 81 seconds; 25 mg/day of clomipramine increased it to 202 seconds and 50 mg/day of clomipramine to 419 seconds. This resulted in significantly greater sexual satisfaction scores for men and their partners (men, p < .001; women, p < .05), improvements in partner coital orgasmic attainment, and greater relationship and emotional satisfaction for the men. Withdrawal of the drug caused ejaculatory latencies to return to baseline. Clomipramine appears to be effective in significantly lengthening ejaculatory latencies and increasing sexual and relationship satisfaction. It can be a cost-effective chronic therapy for selected patients. These impressive results should not be expected in a less carefully screened population of men concerned about the timing of their orgasm during intercourse.

  17. Pentoxifylline as a rescue treatment for DMD: a randomized double-blind clinical trial.

    Science.gov (United States)

    Escolar, D M; Zimmerman, A; Bertorini, T; Clemens, P R; Connolly, A M; Mesa, L; Gorni, K; Kornberg, A; Kolski, H; Kuntz, N; Nevo, Y; Tesi-Rocha, C; Nagaraju, K; Rayavarapu, S; Hache, L P; Mayhew, J E; Florence, J; Hu, F; Arrieta, A; Henricson, E; Leshner, R T; Mah, J K

    2012-03-20

    To determine whether pentoxifylline (PTX) slows the decline of muscle strength and function in ambulatory boys with Duchenne muscular dystrophy (DMD). This was a multicenter, randomized, double-blinded, controlled trial comparing 12 months of daily treatment with PTX or placebo in corticosteroid-treated boys with DMD using a slow-release PTX formulation (~20 mg/kg/day). The primary outcome was the change in mean total quantitative muscle testing (QMT) score. Secondary outcomes included changes in QMT subscales, manual muscle strength, pulmonary function, and timed function tests. Outcomes were compared using Student t tests and a linear mixed-effects model. Adverse events (AEs) were compared using the Fisher exact test. A total of 64 boys with DMD with a mean age of 9.9 ± 2.9 years were randomly assigned to PTX or placebo in 11 participating Cooperative International Neuromuscular Research Group centers. There was no significant difference between PTX and the placebo group in total QMT scores (p = 0.14) or in most of the secondary outcomes after a 12-month treatment. The use of PTX was associated with mild to moderate gastrointestinal or hematologic AEs. The addition of PTX to corticosteroid-treated boys with DMD at a moderate to late ambulatory stage of disease did not improve or halt the deterioration of muscle strength and function over a 12-month study period. This study provides Class I evidence that treatment with PTX does not prevent deterioration in muscle function or strength in corticosteroid-treated boys with DMD.

  18. [Antacids--gel or tablet. A randomized, double-blind, placebo-controlled study].

    Science.gov (United States)

    Schulthess, H K; Häcki, W H

    1985-07-20

    A double blind placebo controlled trial was conducted to compare the effect of two antacid brands (liquid and tablet form) on fasting and postprandial intragastric pH. In 9 healthy volunteers intragastric pH was continuously recorded by solid state memory on 6 occasions. 40 mmol of each antacid was given one hour before and after a standardized meal. The time during which pH was below 3.5 during the first hour following each medication was, in the fasting state, 56.7 +/- 2.1 min. with placebo tablets, 30.7 +/- 8.0 min. (p 0.05) with magaldrate tablets, 26.6 +/- 8.0 min. (p less than 0.01) with Al-Mg-hydroxide tablets, 46.1 +/- 6.1 min. with placebo liquid, 18.4 +/- 5.2 min. (p less than 0.01) with magaldrate liquid, and 21.5 +/- 6.2 min. (p less than 0.01) with Al-Mg-hydroxide liquid. Postprandially the respective periods of time were 48.3 +/- 4.9 min. with placebo tablets, 45.4 +/- 4.6 min. (n.s.) with magaldrate tablets, 48.9 +/- 5.6 min. (n.s.) with Al-Mg-hydroxide tablets, 46.7 +/- 7.9 min. with placebo liquid, 26.6 +/- 9.3 min. (p less than 0.05) with magaldrate liquid, and 28.0 +/- 7.1 min. (p less than 0.05) with Al-Mg-hydroxide liquid. Both tested brands were equally effective. With regard to pH activity, both tested forms were more effective in fasting state than postprandially; tablets showed no measureable activity postprandially and were less effective than the liquid form. The usefulness of the usual medication of low-dosed antacids, one hour postprandially, is open to doubt.

  19. Calling the patient's own name facilitates recovery from general anaesthesia: a randomised double-blind trial.

    Science.gov (United States)

    Jung, Y S; Paik, H; Min, S-H; Choo, H; Seo, M; Bahk, J-H; Seo, J-H

    2017-02-01

    People can hear and pay attention to familiar terms such as their own name better than general terms, referred to as the cocktail party effect. We performed a prospective, randomised, double-blind trial to investigate whether calling the patient's name compared with a general term facilitated a patient's response and recovery from general anaesthesia. We enrolled women having breast cancer surgery with general anaesthesia using propofol and remifentanil. Patients were randomly allocated into two groups depending on whether the patient's name or a general term was called, followed by the verbal command - 'open your eyes!' - during emergence from anaesthesia; this pre-recorded sentence was played to the patient using headphones. Fifty patients were allocated to the name group and 51 to the control group. Our primary outcome was the time from discontinuation of anaesthesia until eye opening. The mean (SD) time was 337 (154) s in the name group and 404 (170) s in the control group (p = 0.041). The time to i-gel® removal was 385 (152) vs. 454 (173) s (p = 0.036), the time until achieving a bispectral index of 60 was 174 (133) vs. 205 (160) s (p = 0.3), and the length of stay in the postanaesthesia care unit was 43.8 (3.4) vs. 47.3 (7.1) min (p = 0.005), respectively. In conclusion, using the patient's name may be an easy and effective method to facilitate recovery from general anaesthesia. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

  20. The effect of gabapentin on muscle cramps during hemodialysis: A double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Seyed Seifollah Beladi Mousavi

    2015-01-01

    Full Text Available Hemodialysis‐associated muscle cramps (HAMC are a common complication during hemodialysis (HD sessions. A number of pharmacologic agents have been evaluated to prevent and or diminish HAMC; however, none of them has an established role. To the best of our knowledge, this is the first study to evaluate the possible effect of gabapentin on HAMC. In a double-blinded clinical trial, we compared the possible effect of gabapentin with a placebo in prevention and or diminishing episodes of HAMC in HD patients who had experienced frequent intradialytic muscle cramps. At first, placebo was given before each dialysis session for four weeks and then, after a two-week washout period, 300 mg of gabapentin was given before each dialysis session for four weeks to verify the effect of gabapentin on HAMC. Overall, 15 patients (seven men and eight women; mean age, 52.02 years with frequent intradialytic muscle cramps were enrolled in the study. The incidence of symptomatic muscle cramp decreased in the gabapentin group compared with the placebo group, with a significant difference between them (P = 0.001. The intensity of muscle cramps also decreased in the gabapentin group (P = 0.001. There was no significant association between HAMC in male and female patients (P = 0. 397, mean age of HD patients (P = 0.226 and cause of end-stage renal disease (P = 0.551. According to the results of our study, gabapentin prescription before each HD session significantly reduced the frequency and the intensity of muscle cramps during HD without any major side-effects.

  1. Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Phillips, Katharine A; Keshaviah, Aparna; Dougherty, Darin D; Stout, Robert L; Menard, William; Wilhelm, Sabine

    2016-09-01

    Body dysmorphic disorder is common, distressing, and often severely impairing. Serotonin reuptake inhibitors appear efficacious, but the few existing pharmacotherapy studies were short term (≤4 months), and no relapse prevention studies or continuation phase studies have been conducted to the authors' knowledge. The authors report results from the first relapse prevention study in body dysmorphic disorder. Adults (N=100) with DSM-IV body dysmorphic disorder received open-label escitalopram for 14 weeks (phase 1); 58 responders were then randomized to double-blind continuation treatment with escitalopram versus switch to placebo for 6 months (phase 2). Reliable and valid outcome measures were utilized. In phase 1, 67.0% of treated subjects and 81.1% of subjects who completed phase 1 responded to escitalopram. Body dysmorphic disorder severity (in both the intent-to-treat and the completer groups) and insight, depressive symptoms, psychosocial functioning, and quality of life significantly improved from baseline to end of phase 1. In phase 2, time to relapse was significantly longer with escitalopram than with placebo treatment (hazard ratio=2.72, 95% CI=1.01-8.57). Phase 2 relapse proportions were 18% for escitalopram and 40% for placebo. Among escitalopram-treated subjects, body dysmorphic disorder severity significantly decreased over time during the continuation phase, with 35.7% of subjects showing further improvement. There were no significant group differences in body dysmorphic disorder severity or insight, depressive symptoms, psychosocial functioning, or quality of life. Continuation-phase escitalopram delayed time to relapse, and fewer escitalopram-treated subjects relapsed than did placebo-treated subjects. Body dysmorphic disorder severity significantly improved during 6 additional months of escitalopram treatment following acute response; more than one-third of escitalopram-treated subjects experienced further improvement.

  2. A multicenter, randomized, double-blind, controlled trial of nebulized epinephrine in infants with acute bronchiolitis.

    Science.gov (United States)

    Wainwright, Claire; Altamirano, Luis; Cheney, Marise; Cheney, Joyce; Barber, Scott; Price, Darrell; Moloney, Sue; Kimberley, Ann; Woolfield, Nick; Cadzow, Susan; Fiumara, Frank; Wilson, Peter; Mego, Steve; VandeVelde, Dianne; Sanders, Sharon; O'Rourke, Peter; Francis, Paul

    2003-07-03

    The treatment of infants with bronchiolitis is largely supportive. The role of bronchodilators is controversial. Most studies of the use of bronchodilators have enrolled small numbers of subjects and have examined only short-term outcomes, such as clinical scores. We conducted a randomized, double-blind, controlled trial comparing nebulized single-isomer epinephrine with placebo in 194 infants admitted to four hospitals in Queens-land, Australia, with a clinical diagnosis of bronchiolitis. Three 4-ml doses of 1 percent nebulized epinephrine or three 4-ml doses of normal saline were administered at four-hour intervals after hospital admission. Observations were made at admission and just before, 30 minutes after, and 60 minutes after each dose. The primary outcome measures were the length of the hospital stay and the time until the infant was ready for discharge. The secondary outcome measures were the degree of change in the respiratory rate, the heart rate, and the respiratory-effort score and the time that supplemental oxygen was required. There were no significant overall differences between the groups in the length of the hospital stay (P=0.16) or the time until the infant was ready for discharge (P=0.86). Among infants who required supplemental oxygen and intravenous fluids, the time until the infant was ready for discharge was significantly longer in the epinephrine group than in the placebo group (P=0.02). The need for supplemental oxygen at admission had the greatest influence on the score for severity of illness and strongly predicted the length of the hospital stay and the time until the infant was ready for discharge (Pepinephrine (P=0.02 to Pnebulized epinephrine did not significantly reduce the length of the hospital stay or the time until the infant was ready for discharge among infants admitted to the hospital with bronchiolitis. Copyright 2003 Massachusetts Medical Society

  3. A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease

    Science.gov (United States)

    Bell, K.L.; Galasko, D.; Galvin, J.E.; Thomas, R.G.; van Dyck, C.H.; Aisen, P.S.

    2011-01-01

    Background: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. Objective: To determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD. Methods: This randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were randomly assigned to receive simvastatin, 20 mg/day, for 6 weeks then 40 mg per day for the remainder of 18 months or identical placebo. The primary outcome was the rate of change in the Alzheimer's Disease Assessment Scale–cognitive portion (ADAS-Cog). Secondary outcomes measured clinical global change, cognition, function, and behavior. Results: A total of 406 individuals were randomized: 204 to simvastatin and 202 to placebo. Simvastatin lowered lipid levels but had no effect on change in ADAS-Cog score or the secondary outcome measures. There was no evidence of increased adverse events with simvastatin treatment. Conclusion: Simvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. Classification of evidence: This study provides Class I evidence that simvastatin 40 mg/day does not slow decline on the ADAS-Cog. PMID:21795660

  4. Double-Blind Placebo Controlled Trial of Dapsone in Antihistamine Refractory Chronic Idiopathic Urticaria

    Science.gov (United States)

    Morgan, Matt; Cooke, Andrew; Rogers, Laura; Adams-Huet, Beverley; Khan, David A.

    2014-01-01

    Background Management of antihistamine refractory CIU has poorly defined therapeutic options. Objective To evaluate the efficacy of dapsone in antihistamine refractory CIU compared to placebo. Methods Twenty-two patients with antihistamine refractory CIU were randomly assigned to 100 mg of dapsone daily or placebo for 6 weeks in a 14 week double-blind, placebo-controlled crossover trial. Endpoints were measured from a daily diary reflecting weekly hive score (WHS) and weekly itch score (WIS) and a visual analog score. Secondary to a carryover effect, the first period results were analyzed as a parallel design comparing placebo to dapsone directly using repeated measures analysis. Results After 6 weeks patients in the dapsone arm showed mean improvement over baseline in VAS (+2.3 [0.6,4.1], p=0.01), urticaria score (-3.5 [-6.2, -0.9], p=0.01), and itch score (-4.8 [-7.6, -2.1], p=0.001), whereas the placebo arm showed no improvement over baseline for VAS, urticaria or itch scores. Dapsone showed greater improvement compared to placebo for itch (p=0.047) and VAS (p=0.04). Of the 22 patients, 3 showed complete resolution of hives and itch with dapsone, while 31% and 41% had ≥ 50% resolution of hives and itch respectively. No serious adverse effects were observed from dapsone. Conclusion To our knowledge, this is the first DBPC study of dapsone in CIU and suggests dapsone has efficacy in antihistamine refractory CIU patients. PMID:25213055

  5. Double-blind, placebo-controlled, randomized trial of octreotide in malignant bowel obstruction.

    Science.gov (United States)

    Currow, David C; Quinn, Stephen; Agar, Meera; Fazekas, Belinda; Hardy, Janet; McCaffrey, Nikki; Eckermann, Simon; Abernethy, Amy P; Clark, Katherine

    2015-05-01

    Does octreotide reduce vomiting in cancer-associated bowel obstruction? To evaluate the net effect of adding octreotide or placebo to standardized therapies on the number of days free of vomiting for populations presenting with vomiting and inoperable bowel obstruction secondary to cancer or its treatment. Twelve services enrolled people with advanced cancer presenting with vomiting secondary to bowel obstruction where surgery or anti-cancer therapies were not indicated immediately. In a double-blind study, participants were randomized to placebo or octreotide (600 μg/24 hours by infusion). Both arms received standardized supportive therapy (infusion of ranitidine [200 mg/24 hours], dexamethasone [8 mg/24 hours], and parenteral hydration [10-20 mL/kg/24 hours]). The primary outcome was patient-reported days free of vomiting at 72 hours. In a study that recruited to the numbers identified in its power calculation, 87 participants provided data at 72 hours (45, octreotide arm). Seventeen people (octreotide) and 14 (placebo) were free of vomiting for 72 hours (P = 0.67). Mean days free of vomiting were 1.87 (SD 1.10; octreotide) and 1.69 (SD 1.15; placebo; P = 0.47). An adjusted multivariate regression of the incidence of vomiting over the study showed a reduced number of episodes of vomiting in the octreotide group (incidence rate ratio = 0.40; 95% CI: 0.19-0.86; P = 0.019); however, people in the octreotide arm were 2.02 times more likely to be administered hyoscine butylbromide (P = 0.004), potentially reflecting increased colicky pain. Although there was no reduction in the number of days free of vomiting, the multivariate analysis suggests that further study of somatostatin analogues in this setting is warranted. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  6. Biologic vs synthetic inguinal hernia repair: 1-year results of a randomized double-blinded trial.

    Science.gov (United States)

    Bochicchio, Grant V; Jain, Ajay; McGonigal, Kelly; Turner, Douglas; Ilahi, Obeid; Reese, Stacey; Bochicchio, Kelly

    2014-04-01

    Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications. Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique. A prospective, randomized, double-blinded, single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix (IHM; Cook Medical) compared with polypropylene (PP) mesh using Lichtenstein's inguinal hernia repair in a 3-year outcomes study. Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks, 3 months, 6 months, and 1 year post procedure. Patient demographics, including comorbidities and nutrition status, were recorded. Intraoperative information including hernia type and location, procedure time, level of difficulty, degree of surgeon frustration, and surgical experience were collected. One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion. There were no significant differences in degree of difficulty and level of frustration between the 2 groups. At 1-year follow-up, 3 recurrences were diagnosed in the IHM group as compared with none in the PP group (p = 0.11). Persistent pain trended higher in the PP group (6% vs 4%). All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training (3 different attendings). No recurrences occurred in patients operated on by more senior surgeons. The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications. Surgeon experience appears to be a major factor affecting successful outcomes. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  7. Effect of endovenous lidocaine on analgesia and serum cytokines: double-blinded and randomized trial.

    Science.gov (United States)

    Ortiz, Michele Purper; Godoy, Maria Celoni de Mello; Schlosser, Rochelle Silveira; Ortiz, Rafael Purper; Godoy, Jõao Pedro Mello; Santiago, Eduardo Sagrillo; Rigo, Flávia Karine; Beck, Verônica; Duarte, Thiago; Duarte, Marta Maria Medeiros Frescura; Menezes, Miriam Seligman

    2016-12-01

    This trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus and hospital stay, and cytokine levels in patients undergoing laparoscopic cholecystectomies who received intravenous lidocaine in comparison with a control group. Prospective, longitudinal, double-blind, and randomized study. Operating room and postoperative recovery area. Forty-four American Society of Anesthesiologists I and II patients older than 17 years, undergoing laparoscopic cholecystectomy, under general anesthesia. The first group received intravenous lidocaine during the procedure until 1 hour postoperatively, whereas the second group received saline. Both groups received dipyrone and morphine patient-controlled analgesia. Pain was assessed by Visual Numeric Scale at rest and when coughing at different times after the end of the surgery. Blood samples were taken at the end of procedure and 24 hours later. The total morphine patient-controlled analgesia demand, the time for the first flatus, and the length of hospital stay were also recorded. Groups were similar in relation to sex (P= .2), age (P= .5), weight (P= .08), and length of surgery (P= .6). No differences were observed regarding the intensity of postoperative pain between the groups, either at rest (P= .76) or when coughing (P= .31), in morphine consumption (P= .9), and in the duration of ileus (P= .5) or length of hospital stay (P= .9). The inflammatory markers interleukin (IL)-1 (P= .02), IL-6 (Plidocaine group against the placebo group, except IL-10 (P= .01), that, because of its anti-inflammatory effects, increased its concentration. Intravenous lidocaine was not able to reduce postoperative pain, opioid consumption, and duration of ileus or length of hospital stay. However, its anti-inflammatory effect was noticeable. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Magnetic resonance therapy for knee osteoarthritis: a randomized, double blind placebo controlled trial.

    Science.gov (United States)

    Gökşen, Nurgül; Çaliş, Mustafa; Doğan, Serap; Çaliş, Havva T; Özgöçmen, Salih

    2016-08-01

    Therapeutic nuclear magnetic resonance therapy (MRT) works based on the electromagnetic fields. To investigate efficacy of MRT in knee osteoarthritis (OA). Prospective, randomized, double-blind, placebo controlled trial. Outpatient clinic, university hospital. Patients who had mild to moderate knee OA at a single knee joint and between 30-75-years-old were randomized by blinded chip cards (1:1). The treatment group received ten sessions of one hour daily MRT, controls received placebo MRT. All patients underwent clinical examination at baseline, after 2 weeks, and 12 weeks. Imaging included blindly assessed ultrasonography and magnetic resonance (MR) of the knee. Ninety-seven patients completed the study. Both groups improved significantly but the average change from baseline in outcome parameters was similar in MRT group (on VAS-pain,-2.6; WOMAC-pain, -2.09; WOMAC-stiffness, -1.81; WOMAC-physical, -1.96) compared to placebo after two weeks (VAS-pain,-1.6; WOMAC-pain, -1.91; WOMAC-stiffness, -1.27; WOMAC-physical, -1.54). Also changes were quite similar at the 12th week after the treatment. SF-36 components at 12th week improved but changes were not significant. Imaging arm also failed to show significant differences between groups in terms of cartilage thickness on US and MR scores. No adverse events were recorded. MRT is safe, but not superior to placebo in terms of improvement in clinical or imaging parameters after a 10-day course of treatment in mild to moderate knee OA. The present study does not promote use of a 10-day course of MRT in mild to moderate knee OA.

  9. Effects of Vitamin D on Endometriosis-Related Pain: A Double-Blind Clinical Trial.

    Science.gov (United States)

    Almassinokiani, Fariba; Khodaverdi, Sepideh; Solaymani-Dodaran, Masoud; Akbari, Peyman; Pazouki, Abdolreza

    2016-12-17

    BACKGROUND Endometriosis is a disabling disease of reproductive-age women. Dysmenorrhea, dyspareunia, and pelvic pain are the main symptoms of endometriosis. Its etiology is not clear. Endometriosis may have various causes, including vitamin D deficiency, but its effect is controversial. MATERIAL AND METHODS In this double-blind clinical trial, we enrolled patients with endometriosis diagnosed and treated by laparoscopy, with scores of at least 3 for of dysmenorrhea and/or pelvic pain at 8 weeks after surgical treatment. They were randomly prescribed vitamin D (50 000 IU weekly for 12 weeks) or placebo. Severity of pain in the 2 groups (placebo and treatment) was compared by VAS test at 24 weeks after surgical treatment. RESULTS There were 19 patients in the vitamin D group and 20 in the placebo group. Baseline characteristics in the 2 groups were similar. Following the treatment with vitamin D or placebo, we did not find significant differences in severity of pelvic pain (p=0.24) and dysmenorrhea (p=0.45) between the 2 groups. Mean pelvic pain at 24 weeks after laparoscopy in the vitamin D group was 0.84±1.74 and in placebo group it was 0.68±1.70 (p=0.513). Mean dysmenorrhea was 2.10±2.33 in the vitamin D group and 2.73±2.84 in the placebo group (p=0.45). CONCLUSIONS After ablative surgery for endometriosis, vitamin D treatment did not have a significant effect in reducing dysmenorrhea and/or pelvic pain.

  10. Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

    Science.gov (United States)

    Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

    2015-02-01

    Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

  11. Olanzapine versus haloperidol in the management of borderline personality disorder: a randomized double-blind trial.

    Science.gov (United States)

    Shafti, Saeed Shoja; Shahveisi, Bahman

    2010-02-01

    The newer atypical antipsychotics seem to be as effective as previous antipsychotics for impulsivity and aggressiveness of patients with borderline personality disorder (BPD). Objective of this assessment was to compare the effectiveness of olanzapine versus haloperidol in BPD. Twenty-eight female inpatients, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, criteria for BPD, were randomly entered in one of the 2 matching contemporaneous groups for an 8-week parallel double-blind study. This included the random assignment to olanzapine or haloperidol in a 1:1 ratio. Primary outcome measurements were as follows: Brief Psychiatric Rating Scale, Clinical Global Impression-Severity Scale, Buss-Durkee Hostility Inventory. Baselines were created at the beginning of the trial through patient assessments and final assessments at the end of the experiment. Analysis of effect size, calculation of confidence intervals and power analysis were also prepared. All of the patients from within both groups completed the study. Intragroup analysis at the eighth week interval revealed significant positive response by both olanzapine and haloperidol in comparison with the baseline (P < 0.05); however, the between-group analysis showed no significant difference, among the patients, at the end of the experiment. The analysis of specific Brief Psychiatric Rating Scale subscales in both groups revealed considerable and comparable improvements in anxiety, tension, depressive mood, and hostility. The effect size analyzes illustrated remarkable improvements with both groups. There seems to be no significant difference between olanzapine and haloperidol regarding the management of mental and behavioral symptoms of patients with BPD.

  12. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial.

    Science.gov (United States)

    Gontijo-Amaral, C; Ribeiro, M A G O; Gontijo, L S C; Condino-Neto, A; Ribeiro, J D

    2007-01-01

    To investigate the long-term effect of oral magnesium supplementation on clinical symptoms, bronchial reactivity, lung function and allergen-induced skin responses in children and adolescents with moderate persistent asthma. A double-blind randomized parallel placebo-controlled study. The patients were recruited from the Pediatric Outpatient Clinic, Division of Pulmonology, Allergy and Immunology, and followed at the Center for Investigation in Pediatrics at State University of Campinas Hospital, Brazil. Thirty-seven out of 72 patients met the study criteria. There were no dropouts. The 37 patients (aged 7-19 years, 19 males) were randomized in two groups: magnesium (n=18, 300 mg/day) and placebo (n=19), during 2 months. Both patient groups received inhaled fluticasone (250 microg twice a day) and salbutamol as needed. The primary outcome was bronchial reactivity evaluated with methacholine challenge test (PC20). After a follow-up of 2 months, the methacholine PC20 for testing bronchial reactivity has augmented significantly in the magnesium group only. The skin responses to recognized antigens have also decreased in patients treated with magnesium. The forced vital capacity (FVC), the forced expiratory volume at first second (FEV1), the forced expiratory flow at 25-75 and the FEV1/FVC ratio were similar in both groups. The magnesium group presented fewer asthma exacerbations and used less salbutamol compared to the placebo group. Oral magnesium supplementation helped to reduce bronchial reactivity to methacholine, to diminish their allergen-induced skin responses and to provide better symptom control in pediatric patients with moderate persistent asthma treated with inhaled fluticasone.

  13. Double blind, placebo-controlled trial of Tranexamic acid on recent internal hemorrhoid bleeding

    Directory of Open Access Journals (Sweden)

    Abdul A. Rani

    2002-12-01

    Full Text Available Double blind randomized placebo controlled trial was conducted to evaluate the efficacy of Tranexamic acid in 54 patients with recent hemorrhoid bleeding. Age, gender, body weight, height, grade of hemorrhoid, time of onset of recent bleeding were comparable between two groups. Analysis of haemostatic effect or stop bleeding as an immediate outcome of this study revealed that in the grade 2 patients, 23/23 (100% of tranexamic group and 18/23(78.26% of placebo group the bleeding stop. After 3 days of observation, there was statistically significant different for the rate of stop bleeding as well as at the end of observation. Bleeding stop earlier in the Tranexamic group with median 4 days (3-5 days, compare to placebo, median 11(9.55-12.45. Analysis of recurrent bleeding as an outcome of this study revealed that in the placebo group 9/18(50% of grade 2 patients and all grade 3 (100%patients suffered from recurrent bleeding. Since the days 4, both group have significant different time for recurrent bleeding and at the end of observation, cumulative probability of free of bleeding between two groups significantly different. Median still stop bleeding in the placebo group was 36 days, and the tranexamic group never reaches the median until the end of observation. Conclusion: tranexamic acid was an effective drug to stop recent hemorrhoid bleeding and prevent further recurrent bleeding, significantly better than placebo. (Med J Indones 2002;11: 215-21Keywords: Tranexamic acid, hemorrhoid bleeding, haemostatic effect, recurrent bleeding.

  14. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

    2015-05-01

    Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard. Copyright © 2015 Elsevier B.V. All rights reserved.

  15. Antiaggressive effect of cyproterone versus haloperidol in Alzheimer's disease: a randomized double-blind pilot study.

    Science.gov (United States)

    Huertas, David; López-Ibor Aliño, Juan J; Molina, Juan D; Chamorro, Lorenzo; Balanza, Juana; Jiménez, María P; Hornillos, Mercedes

    2007-03-01

    Alzheimer's disease (AD) is commonly accompanied by aggressive behavior. In the elderly, effective and safe antiaggressive treatment is lacking. Risks of antipsychotics in this population demand therapeutic alternatives. This randomized, double-blind, pilot trial examined the efficacy and safety of cyproterone in the treatment of agitated AD. The subjects were 27 elderly patients referred to the University Hospital of Guadalajara Psychogeriatric Clinic diagnosed with AD and associated aggressive behavior (mean Staff Observation Aggression Scale [SOAS] score >or=2). Each patient underwent a 15-day washout for psychotropics and then was randomly assigned to receive stable doses of either cyproterone (100 mg/day) or haloperidol (2 mg/day) for 90 days. The primary outcome measure was the SOAS score. This trial was conducted between October 27, 1993, and March 24, 1998. Of the 27 patients, 19 (70.4%) were women, and the mean age was 80.7 years. The trial was completed by 24 (88.9%) of the subjects (13 in the cyproterone group and 11 in the haloperidol group for 90 days). Three patients (11.1%) dropped out, all after adverse effects in the haloperidol group. Baseline aggression level in the sample was mild (mean SOAS score of 4.48 [SD = 2.04]). Efficacy analyses for all intent-to-treat patients showed that 9 (69.2%) in the cyproterone group achieved complete elimination of aggression at endpoint, in contrast to 2 patients (14.2%) in the haloperidol group (p = .012). Ten patients (71.4%) taking haloperidol had adverse events, compared with 4 (30.7%) taking cyproterone (p = .035). Cyproterone showed significantly better efficacy and safety than haloperidol in controlling mild aggression associated with AD. Additional research is needed to confirm if these results can be ratified in a larger study and generalized to patients whose aggression is more severe.

  16. Curcumin for the treatment of major depression: a randomised, double-blind, placebo controlled study.

    Science.gov (United States)

    Lopresti, Adrian L; Maes, Michael; Maker, Garth L; Hood, Sean D; Drummond, Peter D

    2014-01-01

    Curcumin, the principal curcuminoid derived from the spice turmeric, influences several biological mechanisms associated with major depression, namely those associated with monoaminergic activity, immune-inflammatory and oxidative and nitrosative stress pathways, hypothalamus-pituitary-adrenal (HPA) axis activity and neuroprogression. We hypothesised that curcumin would be effective for the treatment of depressive symptoms in individuals with major depressive disorder. In a randomised, double-blind, placebo-controlled study, 56 individuals with major depressive disorder were treated with curcumin (500 mg twice daily) or placebo for 8 weeks. The primary measure was the Inventory of Depressive Symptomatology self-rated version (IDS-SR30). Secondary outcomes included IDS-SR30 factor scores and the Spielberger State-Trait Anxiety Inventory (STAI). From baseline to week 4, both curcumin and placebo were associated with improvements in IDS-SR30 total score and most secondary outcome measures. From weeks 4 to 8, curcumin was significantly more effective than placebo in improving several mood-related symptoms, demonstrated by a significant group x time interaction for IDS-SR30 total score (F1, 53=4.22, p=.045) and IDS-SR30 mood score (F1, 53=6.51, p=.014), and a non-significant trend for STAI trait score (F1, 48=2.86, p=.097). Greater efficacy from curcumin treatment was identified in a subgroup of individuals with atypical depression. Partial support is provided for the antidepressant effects of curcumin in people with major depressive disorder, evidenced by benefits occurring 4 to 8 weeks after treatment. Investigations with larger sample sizes, over extended treatment periods, and with varying curcumin dosages are required. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. Methylphenidate, cognition, and epilepsy: A double-blind, placebo-controlled, single-dose study.

    Science.gov (United States)

    Adams, Jesse; Alipio-Jocson, Valerie; Inoyama, Katherine; Bartlett, Victoria; Sandhu, Saira; Oso, Jemima; Barry, John J; Loring, David W; Meador, Kimford

    2017-01-31

    To evaluate the potential efficacy of immediate-release methylphenidate (MPH) for treating cognitive deficits in epilepsy. This was a double-blind, randomized, single-dose, 3-period crossover study in patients with epilepsy and chronic cognitive complaints comparing the effects of placebo and MPH 10 and 20 mg given 1 week apart. Cognitive outcome was evaluated on the basis of an omnibus z score calculated from performance on the Conners Continuous Performance Test 3 (ability to discriminate between target and nontarget stimuli [d'] and hit reaction time standard deviation), Symbol-Digit Modalities Test, and Medical College of Georgia Paragraph Memory Test. Adverse events and seizure frequency were monitored. An open-label follow-up is reported elsewhere. Thirty-five adult patients with epilepsy participated, of whom 31 finished. Demographics included the following: mean age = 35.3 years (range 20-62 years), 13 men and 18 women, and baseline seizure frequency of 2.8 per month. Epilepsy types were focal (n = 24), generalized (n = 6), or unclassified (n = 1). Mean epilepsy duration was 12.5 years. A statistically significant performance benefit was present at both 10-mg (p = 0.030) and 20-mg (p = 0.034) MPH doses. No seizures were associated with either MPH dose. Adverse effects leading to withdrawal included cognitive "fogginess" (n = 1 on 20 mg), anxiety/agitation (n = 1 on 10 mg), and tachycardia (n = 1). One participant was lost to follow-up after one 20-mg dose without side effect. This single-dose study suggests that MPH may be effective in ameliorating some cognitive deficits in patients with epilepsy. Additional studies are required. NCT02178995. This study provides Class II evidence that single doses of MPH improve cognitive performance on some measures of attention and processing speed in patients with epilepsy and cognitive complaints. © 2016 American Academy of Neurology.

  18. EFFECT OF TURMERIC (CURCUMA LONGA ON OVERWEIGHT HYPERLIPIDEMIC SUBJECTS: DOUBLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Lekhani Pashine

    2012-07-01

    Full Text Available Objective: To evaluate the effect of turmeric (Curcuma longa on serum lipid profile in overweight hyperlipidemic subjects. Methods: This was a double blind randomised control study. The study was conducted in the Department of Medicine, CSM Medical University, Lucknow from July 2010-June 2011. A total of 120 subjects were interviewed using a pre-tested semi-structured schedule whose BMI>25 and total cholesterol>200 mg/dl and/or triglyceride>150 mg/dl, were divided randomly using random number table into 2 groups Group-I (Aquous extract of Turmeric-1.4 gm per day (n=53 and Group-II (Placebo (n=52 for three months. They were given the same color capsules without revealing their identity, with the instructions to take the contents of each pack twice a day before meal for 90 days. Subjects were asked to give their 12 hour fasting blood samples on 0, 30, 60 and 90 day. The paired t-test was used to compare the changes amongst follow-ups and unpaired t-test was used to compare between groups. p-value<0.05 was considered as significant. Results: At the baseline, both the groups were similar in anthropometric and clinical parameters. Treatment group produced significant (p<0.0001 reduction in lipid profiles such as serum total cholesterol, triglyceride and LDL-cholesterol and VLDL- cholesterol in hypercholesteremic group from 0 day to 30, 60 and 90 day of follow-ups. However, there was no significant change in the placebo group. The percentage reduction was higher in the subjects of Turmeric group as compared to Placebo. Conclusion: Aquous extract of Turmeric has shown lipid lowering properties among overweight hyperlipidemic subjects.

  19. Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: A crossover, double-blind, controlled trial

    Institute of Scientific and Technical Information of China (English)

    Paula VP Guerra; Luiza N Lima; Tassia C Souza; Vanessa Mazochi; Francisco J Penna; Andreia M Silva; Jacques R Nicoli; Elizabet V Guimaraes

    2011-01-01

    AIM: To evaluate the treatment off pediatric ffunctional chronic intestinal constipation (FCIC) with a probiotic goat yogurt. METHODS: A crossover double-blind fformula-con- trolled trial was carried out on 59 students (age range: 5-15 years) off a public school in Belo Horizonte, MG, Brazil, presenting a FCIC diagnostic, according to Roma Ⅲ criteria. The students were randomized in two groups to receive a goat yogurt supplemented with 109 colony fforming unit/mL Biffidobacterium longum (B. longum) (probiotic) daily or only the yogurt ffor a period off 5 wk (fformula). Affterwards, the groups were intercrossed another 5 wk. DDeffecation ffrequency, stool consistency and abdominal and deffecation pain were assessed. RESULTS: Both treatment groups demonstrated improvement in deffecation ffrequency compared to baseline. However, the group treated with probiotic showed most significant improvement in the first phase of the study. An inversion was observed affter crossing over, resulting in a reduction in stool when this group was treated by fformula. Probiotic and fformula improved stool consistency in the first phase of treatment, but the improvement obtained with probiotic was signifficantly higher (P = 0.03). In the second phase off treatment, the group initially treated with probiotic showed worseningstool consistency when using fformula. However, the difference was not significant. A significant improvement in abdominal pain and deffecation pain was observed with both probiotic and fformula in the ffirst phase off treatment, but again the improvement was more significant ffor the group treated with B. longum during phase I (P < 0.05). When all data off the crossover study were analyzed, signifficant difffferences were observed between probiotic yogurt and yogurt only ffor deffecation ffrequency (P = 0.012), deffecation pain (P = 0.046) and abdominal pain (P = 0.015). CONCLUSION: An improvement in deffecation ffrequen- cy and abdominal pain was observed using

  20. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial

    Science.gov (United States)

    ABBASKHANIAN, Ali; EHTESHAMI, Sara; SAJJADI, Sadegh; REZAI, Mohammad Sadegh

    2012-01-01

    Objective Breath holding spells (BHS) are common paroxysmal non-epileptic events in the pediatric population which are very stressfull despite their harmless nature. There has been no specific treatment found for the spells yet. The aim of this study was to evaluate the efficacy of piracetam (2-oxo-l-pyrrolidine) on these children. Materials & Methods In this randomized double blind clinical trial study, 150 children with severe BHS referred to our pediatric outpatient service were enrolled from August 2011 to July 2012. The patients were randomized into two equal groups. One received 40mg/kg/day piracetam and the other group received placebo, twice daily. Patients were followed monthly for three months. The number of attacks/month before and after treatment were documented. Results Of the enrolled patients, 86 were boys. The mean age of the patients was 17 months (range, 6 to 24 months). In the piracetam group, 1 month after treatment an 81% response to treatment was found. In the placebo group, none of the patients had complete remission and 7% of the cases had partial remission. Overall, control of breath-holding spells was observed in 91% of the patients in the group taking piracetam as compared with 16% in the group taking placebo at the end of the study. There was no significant difference detected between the groups regarding the prevalence of drug side effects. Conclusion A significant difference was detected between piracetam and placebo in prevention and controlling BHS. Piracetam (40mg/kg/day) had a good effect on our patients. PMID:24665274

  1. Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial.

    Science.gov (United States)

    Ballard, Clive; Margallo-Lana, Marisa; Juszczak, Edmund; Douglas, Simon; Swann, Alan; Thomas, Alan; O'Brien, John; Everratt, Anna; Sadler, Stuart; Maddison, Clare; Lee, Lesley; Bannister, Carol; Elvish, Ruth; Jacoby, Robin

    2005-04-16

    To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to change in cognitive performance. Randomised double blind (clinician, patient, outcomes assessor) placebo controlled trial. Care facilities in the north east of England. 93 patients with Alzheimer's disease, dementia, and clinically significant agitation. Atypical antipsychotic (quetiapine), cholinesterase inhibitor (rivastigmine), or placebo (double dummy). Agitation (Cohen-Mansfield agitation inventory) and cognition (severe impairment battery) at baseline and at six weeks and 26 weeks. The primary outcome was agitation inventory at six weeks. 31 patients were randomised to each group, and 80 (86%) started treatment (25 rivastigmine, 26 quetiapine, 29 placebo), of whom 71 (89%) tolerated the maximum protocol dose (22 rivastigmine, 23 quetiapine, 26 placebo). Compared with placebo, neither group showed significant differences in improvement on the agitation inventory either at six weeks or 26 weeks. Fifty six patients scored > 10 on the severe impairment battery at baseline, 46 (82%) of whom were included in the analysis at six week follow up (14 rivastigmine, 14 quetiapine, 18 placebo). For quetiapine the change in severe impairment battery score from baseline was estimated as an average of -14.6 points (95% confidence interval -25.3 to -4.0) lower (that is, worse) than in the placebo group at six weeks (P = 0.009) and -15.4 points (-27.0 to -3.8) lower at 26 weeks (P = 0.01). The corresponding changes with rivastigmine were -3.5 points (-13.1 to 6.2) lower at six weeks (P = 0.5) and -7.5 points (-21.0 to 6.0) lower at 26 weeks (P = 0.3). Neither quetiapine nor rivastigmine are effective in the treatment of agitation in people with dementia in institutional care. Compared with placebo, quetiapine is associated with significantly greater cognitive decline.

  2. Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: A crossover, double-blind, controlled trial

    Science.gov (United States)

    Guerra, Paula VP; Lima, Luiza N; Souza, Tassia C; Mazochi, Vanessa; Penna, Francisco J; Silva, Andreia M; Nicoli, Jacques R; Guimarães, Elizabet V

    2011-01-01

    AIM: To evaluate the treatment of pediatric functional chronic intestinal constipation (FCIC) with a probiotic goat yogurt. METHODS: A crossover double-blind formula-controlled trial was carried out on 59 students (age range: 5-15 years) of a public school in Belo Horizonte, MG, Brazil, presenting a FCIC diagnostic, according to Roma III criteria. The students were randomized in two groups to receive a goat yogurt supplemented with 109 colony forming unit/mL Bifidobacterium longum (B. longum) (probiotic) daily or only the yogurt for a period of 5 wk (formula). Afterwards, the groups were intercrossed for another 5 wk. Defecation frequency, stool consistency and abdominal and defecation pain were assessed. RESULTS: Both treatment groups demonstrated improvement in defecation frequency compared to baseline. However, the group treated with probiotic showed most significant improvement in the first phase of the study. An inversion was observed after crossing over, resulting in a reduction in stool frequency when this group was treated by formula. Probiotic and formula improved stool consistency in the first phase of treatment, but the improvement obtained with probiotic was significantly higher (P = 0.03). In the second phase of treatment, the group initially treated with probiotic showed worseningstool consistency when using formula. However, the difference was not significant. A significant improvement in abdominal pain and defecation pain was observed with both probiotic and formula in the first phase of treatment, but again the improvement was more significant for the group treated with B. longum during phase I (P yogurt and yogurt only for defecation frequency (P = 0.012), defecation pain (P = 0.046) and abdominal pain (P = 0.015). CONCLUSION: An improvement in defecation frequency and abdominal pain was observed using both supplemented and non-supplemented yogurt, but an additional improvement with B. longum supplementation was obtained. PMID:22025880

  3. Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Cristina Buigues

    2016-06-01

    Full Text Available Aging can result in major changes in the composition and metabolic activities of bacterial populations in the gastrointestinal system and result in impaired function of the immune system. We assessed the efficacy of prebiotic Darmocare Pre® (Bonusan Besloten Vennootschap (BV, Numansdorp, The Netherlands to evaluate whether the regular intake of this product can improve frailty criteria, functional status and response of the immune system in elderly people affected by the frailty syndrome. The study was a placebo-controlled, randomized, double blind design in sixty older participants aged 65 and over. The prebiotic product was composed of a mixture of inulin plus fructooligosaccharides and was compared with placebo (maltodextrin. Participants were randomized to a parallel group intervention of 13 weeks’ duration with a daily intake of Darmocare Pre® or placebo. Either prebiotic or placebo were administered after breakfast (between 9–10 a.m. dissolved in a glass of water carefully stirred just before drinking. The primary outcome was to study the effect on frailty syndrome. The secondary outcomes were effect on functional and cognitive behavior and sleep quality. Moreover, we evaluated whether prebiotic administration alters blood parameters (haemogram and biochemical analysis. The overall rate of frailty was not significantly modified by Darmocare Pre® administration. Nevertheless, prebiotic administration compared with placebo significantly improved two frailty criteria, e.g., exhaustion and handgrip strength (p < 0.01 and p < 0.05, respectively. No significant effects were observed in functional and cognitive behavior or sleep quality. The use of novel therapeutic approaches influencing the gut microbiota–muscle–brain axis could be considered for treatment of the frailty syndrome.

  4. Intravenous Vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Suh Sang-Yeon

    2012-01-01

    Full Text Available Abstract Background Studies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration. Methods We evaluated the effect of intravenous vitamin C on fatigue in office workers. A group of 141 healthy volunteers, aged 20 to 49 years participated in this randomized, double-blind, controlled clinical trial. The trial group received 10 grams of vitamin C with normal saline intravenously, while the placebo group received normal saline only. Since vitamin C is a well-known antioxidant, oxidative stress was measured. Fatigue score, oxidative stress, and plasma vitamin C levels were measured before intervention, and again two hours and one day after intervention. Adverse events were monitored. Results The fatigue scores measured at two hours after intervention and one day after intervention were significantly different between the two groups (p = 0.004; fatigue scores decreased in the vitamin C group after two hours and remained lower for one day. Trial also led to higher plasma vitamin C levels and lower oxidative stress compared to the placebo group (p Conclusion Thus, intravenous vitamin C reduced fatigue at two hours, and the effect persisted for one day. There were no significant differences in adverse events between two groups. High dose intravenous vitamin C proved to be safe and effective against fatigue in this study. Trial Registration The clinical trial registration of this trial is http://ClinicalTrials.govNCT00633581.

  5. Zinc and copper supplementation in acute diarrhea in children: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mamtani Manju

    2009-05-01

    Full Text Available Abstract Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. Methods We conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl, zinc (Zn only, and zinc and copper (Zn+Cu together with standard treatment for acute diarrhea. Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups. Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children. Trial registration The study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383.

  6. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Peura, David A; Traxler, Barry; Kocun, Christopher; Lind, Tore

    2014-07-01

    To determine the efficacy of a 14-day regimen of esomeprazole 20 mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider. Adults with frequent heartburn ≥ 2 days per week in the past 4 weeks were randomly assigned to 14-day double-blind treatment with esomeprazole 20 mg once daily or placebo in 2 identical multicenter studies (ClinicalTrials.gov identifiers: NCT01370525, NCT01370538). The primary efficacy outcome was percentage of heartburn-free 24-hour days across 14 days. Secondary efficacy outcomes included heartburn resolution, defined as heartburn ≤ 2 days over 14 days, and percentages of subjects reporting ≤ 1 day with heartburn in the first and final weeks of treatment. Subjects recorded data in daily self-assessment diaries. The percentage of heartburn-free 24-hour days over 14 days was significantly higher (P esomeprazole 20 mg compared with placebo in study 1 (N = 331; 46.13% vs. 33.07%, respectively) and study 2 (N = 320; 48.00% vs 32.75%, respectively). Significantly more subjects treated with esomeprazole 20 mg had heartburn resolution over 14 days and in the first and final weeks compared with placebo. Within the first 4 days, the proportion of subjects with heartburn-free days was significantly greater with esomeprazole 20 mg versus placebo. Treatment was generally well tolerated, with a safety pattern consistent with the known profile for esomeprazole. A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications.

  7. Risk Factors for Severe Reactions during Double-Blind Placebo-Controlled Food Challenges.

    Science.gov (United States)

    Yanagida, Noriyuki; Sato, Sakura; Asaumi, Tomoyuki; Ogura, Kiyotake; Ebisawa, Motohiro

    2017-01-01

    Severe anaphylactic symptoms can occur during oral food challenges (OFCs). Thus, high-risk patients (e.g., patients with a history of anaphylaxis or high antigen-specific immunoglobulin E [IgE] levels) must carefully undergo OFCs in hospitals. We attempted to identify the risk factors for severe symptoms during OFC testing among high-risk patients. We retrospectively evaluated patients' characteristics and severe symptoms that were experienced during a double-blind placebo-controlled food challenge test performed before the patients underwent oral immunotherapy between June 2008 and June 2012. Patients were ≥5 years old and had an anaphylactic history or antigen-specific IgE (>30 kUA/L). Severe symptoms were defined using the grading of the Japanese Anaphylaxis Guidelines, which are modified from the European Academy of Allergology and Clinical Immunology Guidelines. We evaluated 393 cases with positive test results, including 98 cases with severe symptoms. The most frequent severe symptoms were respiratory (77%), gastrointestinal (28%), cardiovascular (27%), and neurological (13%) symptoms. Multivariate analysis revealed that the significant factors for a severe reaction were a history of anaphylaxis to the causative food (adjusted odds ratio [OR]: 2.147, p = 0.003), older age (per 1 year increase, adjusted OR: 1.102, p = 0.044), and an egg OFC (adjusted OR: 0.433, p = 0.003). The risk factors for a severe reaction to OFCs were a history of an anaphylactic reaction and older age. An egg OFC was associated with low risk of severe symptoms during OFC. Therefore, OFCs for patients with these risk factors should only be performed under specialist supervision with access to rapid treatment and full resuscitation equipment. © 2017 The Author(s) Published by S. Karger AG, Basel.

  8. Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial.

    Science.gov (United States)

    Poulsen, Mai Bang; Damgaard, Bodil; Zerahn, Bo; Overgaard, Karsten; Rasmussen, Rune Skovgaard

    2015-12-01

    Poststroke fatigue is common and reduces quality of life. Current evidence for intervention is limited, and this is the first placebo-controlled trial to investigate treatment of poststroke fatigue with the wakefulness promoting drug modafinil. The trial was randomized, double-blinded, and placebo-controlled. Patients were treated with 400-mg modafinil or placebo for 90 days. Assessments were done at inclusion, 30, 90, and 180 days. The primary end point was fatigue at 90 days measured by the Multidimensional Fatigue Inventory-20 general fatigue domain. Secondary end points included the Fatigue Severity Scale, the Montreal Cognitive Assessment, the modified Rankin Scale and the Stroke-specific quality of Life questionnaire. Adult patients with a recent stroke achieving a score of ≥12 on the Multidimensional Fatigue Inventory-20 general fatigue domain were consecutively included. Exclusion criteria were severe cognitive disabilities and contraindications for modafinil treatment. One thousand one hundred twenty-one patients with stroke were screened and 41 patients included, 21 received modafinil. The primary end point, the Multidimensional Fatigue Inventory-20 general fatigue score, did not differ between groups. Patients in the modafinil group obtained better scores on the Fatigue Severity Scale (P=0.02) and in some subscales of the stroke-specific quality of life questionnaire (0.001

  9. Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Levin, Frances R; Mariani, John J; Brooks, Daniel J; Pavlicova, Martina; Cheng, Wendy; Nunes, Edward V

    2011-07-01

    Cannabis dependence is a substantial public health problem. Behavioral treatments have shown promise, but there are no effective medications for cannabis dependence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, in treating cannabis dependence. 156 cannabis-dependent adults were enrolled in a randomized, double-blind, placebo-controlled, 12-week trial. After a 1-week placebo lead-in phase, participants were randomized to receive dronabinol 20mg twice a day or placebo. Doses were maintained until the end of week 8 and then tapered off over 2 weeks. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow back method. There was no significant difference between treatment groups in the proportion of participants who achieved 2 weeks of abstinence at the end of the maintenance phase (dronabinol: 17.7%; placebo: 15.6%). Although both groups showed a reduction in marijuana use over time, there were no differences between the groups. Treatment retention was significantly higher at the end of the maintenance phase on dronabinol (77%), compared to placebo (61%) (P=.02), and withdrawal symptoms were significantly lower on dronabinol than placebo (P=.02). This is the first trial using an agonist substitution strategy for treatment of cannabis dependence. Dronabinol showed promise, it was well-tolerated, and improved treatment retention and withdrawal symptoms. Future trials might test higher doses, combinations of dronabinol with other medications with complementary mechanisms, or with more potent behavioral interventions. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  10. Effects of Febuxostat in Early Gout: A Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Dalbeth, Nicola; Saag, Kenneth G; Palmer, William E; Choi, Hyon K; Hunt, Barbara; MacDonald, Patricia A; Thienel, Ulrich; Gunawardhana, Lhanoo

    2017-12-01

    To assess the effect of treatment with febuxostat versus placebo on joint damage in hyperuricemic subjects with early gout (1 or 2 gout flares). In this double-blind, placebo-controlled study, 314 subjects with hyperuricemia (serum uric acid [UA] level of ≥7.0 mg/dl) and early gout were randomized 1:1 to receive once-daily febuxostat 40 mg (increased to 80 mg if the serum UA level was ≥6.0 mg/dl on day 14) or placebo. The primary efficacy end point was the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint. Additional efficacy end points included change from baseline to month 24 in the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) scores for synovitis, erosion, and edema in the single affected joint, the incidence of gout flares, and serum UA levels. Safety was assessed throughout the study. Treatment with febuxostat did not lead to any notable changes in joint erosion over 2 years. In both treatment groups, the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint was minimal, with no between-group differences. However, treatment with febuxostat significantly improved the RAMRIS synovitis score at month 24 compared with placebo treatment (change from baseline -0.43 versus -0.07; P gout flares (29.3% versus 41.4%; P gout flares in subjects with early gout. © 2017 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

  11. Patient Satisfaction With Propofol for Outpatient Colonoscopy: A Prospective, Randomized, Double-Blind Study.

    Science.gov (United States)

    Padmanabhan, Anantha; Frangopoulos, Christoforos; Shaffer, Lynn E T

    2017-10-01

    Previous literature has shown that propofol has ideal anesthetic properties for patients undergoing colonoscopy, a common procedure at outpatient surgery centers. However, there is a paucity of information regarding patient satisfaction with propofol. The aim of this study was to evaluate patient satisfaction with propofol compared with nonpropofol (fentanyl/midazolam) anesthesia for outpatient colonoscopies. Safety and complications were secondary end points. This study was a double-blind, randomized, parallel-group controlled clinical trial (NCT 02937506). This study was conducted at a single ambulatory surgery center at an urban teaching community health system. Patients were scheduled for outpatient colonoscopy. Those with high-risk cardiac or pulmonary disease were excluded. Anesthesia personnel administered either fentanyl/midazolam (n = 300) or propofol (n = 300) for sedation during outpatient colonoscopy. A single, highly experienced endoscopist performed all colonoscopies. The primary outcomes measured were patient satisfaction (5-point Likert scale) and procedure complications. Data were collected on the day of endoscopy by the nursing staff of the postanesthesia care unit. A subinvestigator blinded to the randomization called patients 24 to 72 hours after discharge to obtain data on postprocedure problems and status of resumption of normal activities. Analysis was intention-to-treat. Fewer patients who received propofol remembered being awake during the procedure (2% vs 17% for fentanyl, p propofol (p propofol group (2.7% vs 11.7%, p propofol over a combination of fentanyl/midazolam as their anesthetic for outpatient colonoscopies. From a patient and provider perspective, propofol appears to be superior to fentanyl/midazolam for outpatient colonoscopy. See Video Abstract at http://links.lww.com/DCR/A445.

  12. Therapy of CF-Patients with Amitriptyline and Placebo - a Randomised, Double-Blind, Placebo-Controlled Phase IIb Multicenter, Cohort-Study

    National Research Council Canada - National Science Library

    Nährlich, Lutz; Mainz, Jochen G; Adams, Constantin; Engel, Corinna; Herrmann, Gloria; Icheva, Vanya; Lauer, Josefine; Deppisch, Caroline; Wirth, Andreas; Unger, Katy; Graepler-Mainka, Ute; Hector, Andreas; Heyder, Susanne; Stern, Martin; Döring, Gerd; Gulbins, Erich; Riethmüller, Joachim

    2013-01-01

    ... and infection susceptibility to pulmonary P. aeruginosa in these mice. To test for a beneficial effect of amitriptyline in vivo, we performed a phase IIb randomised, double-blind, placebo-controlled study...

  13. A double blind, randomised, parallel group study on the efficacy and safety of treating acute lateral ankle sprain with oral hydrolytic enzymes

    NARCIS (Netherlands)

    Kerkhoffs, G. M. M. J.; Struijs, P. A. A.; de Wit, C.; Rahlfs, V. W.; Zwipp, H.; van Dijk, C. N.

    2004-01-01

    Objective: To compare the effectiveness and safety of the triple combination Phlogenzym ( rutoside, bromelain, and trypsin) with double combinations, the single substances, and placebo. Design: Multinational, multicentre, double blind, randomised, parallel group design with eight groups structured

  14. Neurocognitive effects of adjunctive levetiracetam in children with partial-onset seizures: a randomized, double-blind, placebo-controlled, noninferiority trial

    National Research Council Canada - National Science Library

    Levisohn, Paul M; Mintz, Mark; Hunter, Scott J; Yang, Haichen; Jones, John

    2009-01-01

    ...). Randomized, double-blind, placebo-controlled, noninferiority safety study. Children (4-16 years; IQ > or =65) with > or =1 POS during 4 weeks before screening despite taking 1-2 antiepileptic drugs...

  15. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study

    National Research Council Canada - National Science Library

    Beaussier, M

    2007-01-01

    .... The role of continuous preperitoneal infusion of ropivacaine for pain relief and postoperative recovery after open colorectal resections was evaluated in a randomized, double-blinded, placebo-controlled trial...

  16. Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain

    NARCIS (Netherlands)

    C.W.J. van Tilburg (Cornelis); D.L. Stronks (Dirk); J.G. Groeneweg (George); F.J.P.M. Huygen (Frank)

    2017-01-01

    markdownabstract__Background:__ Investigate the effect of percutaneous radiofrequency compared to a sham procedure, applied to the ramus communicans for treatment of lumbar disc pain. __Methods:__ Randomized sham-controlled, double-blind, crossover, multicenter clinical trial. Multidisciplinary

  17. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial

    National Research Council Canada - National Science Library

    Tregnaghi, Miguel W; Sáez-Llorens, Xavier; López, Pio; Abate, Hector; Smith, Enrique; Pósleman, Adriana; Calvo, Arlene; Wong, Digna; Cortes-Barbosa, Carlos; Ceballos, Ana; Tregnaghi, Marcelo; Sierra, Alexandra; Rodriguez, Mirna; Troitiño, Marisol; Carabajal, Carlos; Falaschi, Andrea; Leandro, Ana; Castrejón, Maria Mercedes; Lepetic, Alejandro; Lommel, Patricia; Hausdorff, William P; Borys, Dorota; Ruiz Guiñazú, Javier; Ortega-Barría, Eduardo; Yarzábal, Juan P; Schuerman, Lode

    2014-01-01

    ...); other protocol-specified outcomes were also assessed. This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care...

  18. Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial

    National Research Council Canada - National Science Library

    Schmitz, Michael L; Zempsky, William T; Meyer, James M

    2015-01-01

    ... subjects compared with a sham placebo system. COMFORT-004, A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects, was a single-dose, parallel group study...

  19. Role of Enteric Supplementation of Probiotics on Late-onset Sepsis by Candida species in Preterm Low Birth Weight Neonates: A Randomized, Double Blind, Placebo-controlled Trial

    National Research Council Canada - National Science Library

    Roy, Amrita; Chaudhuri, Jasodhara; Sarkar, Debalina; Ghosh, Pramit; Chakraborty, Swapna

    2014-01-01

    .... This prospective, randomized, double blind trial investigating the supplementation of preterm infants with a probiotic was done from May 2012 to April 2013, with 112 subjects randomized into two groups...

  20. A randomized, double-blind, placebo-controlled clinical trial of fluoride varnish in preventing dental caries of Sjogrens syndrome patients

    National Research Council Canada - National Science Library

    Weini Xin; Katherine Chiu Man Leung; Edward Chin Man Lo; Mo Yin Mok; Moon Ho Leung

    2016-01-01

    .... Topical fluoride is commonly prescribed for caries prevention. Methods In this 24-month randomized, double-blind, placebo-controlled clinical trial, SS patients were randomly assigned to receive either fluoride varnish or placebo gel quarterly...

  1. Evaluation of effect of isoflavone on thyroid economy & autoimmunity in oophorectomised women: a randomised, double-blind, placebo-controlled trial

    National Research Council Canada - National Science Library

    Mittal, Niti; Hota, Debasish; Dutta, Pinaki; Bhansali, Anil; Suri, Vanita; Aggarwal, Neelam; Marwah, R K; Chakrabarti, Amitava

    2011-01-01

    ...) and estradiol levels in oophorectomised women. A randomized, double blind, placebo-controlled trial was conducted in 43 oophorectomised women to evaluate the effect of soy isoflavones (75 mg/day for 12 wk...

  2. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen

    NARCIS (Netherlands)

    Vranken, J. H.; Dijkgraaf, M. G. W.; Kruis, M. R.; van der Vegt, M. H.; Hollmann, M. W.; Heesen, M.

    2008-01-01

    The effective treatment of patients suffering from central neuropathic pain remains a clinical challenge, despite a standard pharmacological approach in combination with anticonvulsants and antidepressants. A randomized, double-blinded, placebo-controlled trial evaluated the effects of pregabalin on

  3. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Rest, O. van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Olde Rikkert, M.G.M.; Beekman, A.T.; Groot, L.C. de

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  4. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.; Staveren, van W.A.; Olderikkert, M.G.M.; Beekman, A.T.F.; Groot, de L.C.P.G.M.

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  5. Does high-dose metformin cause lactic acidosis in type 2 diabetic patients after CABG surgery? A double blind randomized clinical trial

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    Rahman Ghafari

    2011-06-01

    Full Text Available Metformin is a dimethyl biguanide oral anti-hyperglycemic agent. Lactic acidosis due to metformin is a fatal metabolic condition that limits its use in patients in poor clinical condition, consequently reducing the number of patients who benefit from this medication. In a double blind randomized clinical trial, we investigated 200 type 2 diabetic patients after coronary artery bypass surgery in the open heart ICU of the Mazandaran Heart Center, and randomly assigned them to equal intervention and control groups. The intervention group received regular insulin infusion along with 2 metformin 500 mg tablets every twelve hours, while the control group received only intravenous insulin with 2 placebo tablets every twelve hours. Lactate level, pH, base excess, blood glucose and serum creatinine were measured over five 12 h periods, with data averaged for each period. The primary outcome in this study was high lactate levels. Comparison between the 2 groups was made by independent Student’s t-test. To compare changes in multiple measures in each group and analysis of group interaction, a repeated measurement ANOVA test was used. There was no significant difference between the 2 groups regarding pH, base excess, or bicarbonate intake (P>0.05. No patient showed lactic acidosis in either group. Lactate levels were 23.0 vs 23.4 in the insulin-metformin and insulin only groups when the study was started, respectively. At the end of the study, those levels were 18.7 vs 18.9, respectively. In addition, the ANOVA repeated measurement test did not show a significant difference in terms of changes in the amount of lactate level between the 2 groups during the five measurement tests of the study period (P>0.05. High-dose metformin (1,000 mg twice daily with insulin does not cause lactic acidosis in type 2 diabetic patients after coronary artery

  6. Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Douglas Berger

    2015-08-01

    Full Text Available While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.

  7. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial.

    Science.gov (United States)

    Candiotti, Keith A; Bergese, Sergio D; Bokesch, Paula M; Feldman, Marc A; Wisemandle, Wayne; Bekker, Alex Y

    2010-01-01

    Dexmedetomidine (DEX) is increasingly being used as a sedative for monitored anesthesia care (MAC) because of its analgesic properties, "cooperative sedation," and lack of respiratory depression. In this randomized, multicenter, double-blind, Phase III Food and Drug Administration study, we evaluated the safety and efficacy of two doses of DEX for sedation of patients undergoing a broad range of surgical or diagnostic procedures requiring MAC. Three hundred twenty-six patients were randomized 2:2:1 to DEX 0.5 microg/kg, DEX 1 microg/kg, or saline placebo initial loading dose, followed by a maintenance infusion of 0.2-1.0 microg x kg(-1) x h(-1) of DEX (or equivalent volume of saline) titrated to a targeted level of sedation ( 4 and fentanyl for pain. The primary end-point was the percentage of patients not requiring rescue midazolam. Significantly fewer patients in the 0.5- and 1-microg/kg DEX groups required supplemental midazolam compared with placebo (59.7% [80/134], 45.7% [59/129] vs 96.8% [61/63], respectively; P < 0.001) and at lower doses to achieve an OAA/S < or = 4 before and during surgery compared with the saline group (1.4 and 0.9 mg vs 4.1 mg, respectively; P < 0.001, each group compared with placebo). Both DEX groups required significantly less fentanyl (84.8 and 83.6 microg vs 144.4 microg, respectively; P < 0.001, for both DEX groups versus placebo) for all surgical subtypes. Anesthesiologists indicated significantly increased ease of achieving and maintaining targeted sedation in both DEX groups compared with placebo with midazolam (P < 0.001). Patient satisfaction was significantly higher with DEX (P < or = 0.009, both groups versus placebo). Common adverse events with DEX were protocol-defined bradycardia and hypotension that were predominately mild to moderate in severity. The incidence of clinically significant respiratory depression (defined as a respiratory rate of < 8 or an oxygen saturation of < 90%) was lower in DEX-treated patients (P = 0

  8. Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.

    Directory of Open Access Journals (Sweden)

    Chris Fox

    Full Text Available Agitation in Alzheimer's disease (AD is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD.We recruited 153 participants with AD and clinically significant agitation from care-homes or hospitals for a double-blind randomised-controlled trial and 149 people started the trial of memantine versus placebo. The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory (CMAI. Secondary outcomes were: 12 weeks CMAI; 6 and 12 weeks Neuropsychiatric symptoms (NPI, Clinical Global Impression Change (CGI-C, Standardised Mini Mental State Examination, Severe Impairment Battery. Using a mixed effects model we found no significant differences in the primary outcome, 6 weeks CMAI, between memantine and placebo (memantine lower -3.0; -8.3 to 2.2, p = 0.26; or 12 weeks CMAI; or CGI-C or adverse events at 6 or 12 weeks. NPI mean difference favoured memantine at weeks 6 (-6.9; -12.2 to -1.6; p = 0.012 and 12 (-9.6; -15.0 to -4.3 p = 0.0005. Memantine was significantly better than placebo for cognition. The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD.Memantine did not improve significant agitation in people with in moderate-to-severe AD. Future studies are urgently needed to test other pharmacological candidates in this group and memantine for neuropsychiatric symptoms.ClinicalTrials.gov NCT00371059.International Standard Randomised Controlled Trial 24953404.

  9. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial

    Directory of Open Access Journals (Sweden)

    Pickering G

    2015-07-01

    Full Text Available Gisèle Pickering,1–3 Adrian Kastler,4 Nicolas Macian,1,2 Bruno Pereira,5 Romain Valabrègue,6 Stéphane Lehericy,6 Louis Boyer,4,7 Claude Dubray,1–3 Betty Jean4 1CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Centre d’Investigation Clinique – Inserm 1405, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU Gabriel Montpied, Clermont-Ferrand, Service d’Imagerie Ostéo-articulaire thoracique et neurologique, 5CHU Clermont-Ferrand, Délégation Recherche Clinique et à l’Innovation, Clermont-Ferrand, France; 6Institut du Cerveau et de la Moelle epiniere – ICM, Centre de NeuroImagerie de Recherche CENIR, Inserm U1127, CNRS UMR 7225, Sorbonne Universités, UPMC University Paris, Paris, France, Department of Neuroradiology, Groupe Hospitalier Pitié-Salpêtrière, Paris, France; 7UMR CNRS UdA 6284, Clemont-Ferrand, France Background: Paracetamol’s (APAP mechanism of action suggests the implication of supraspinal structures but no neuroimaging study has been performed in humans.Methods and results: This randomized, double-blind, crossover, placebo-controlled trial in 17 healthy volunteers (NCT01562704 aimed to evaluate how APAP modulates pain-evoked functional magnetic resonance imaging signals. We used behavioral measures and functional magnetic resonance imaging to investigate the response to experimental thermal stimuli with APAP or placebo administration. Region-of-interest analysis revealed that activity in response to noxious stimulation diminished with APAP compared to placebo in prefrontal cortices, insula, thalami, anterior cingulate cortex, and periaqueductal gray matter.Conclusion: These findings suggest an inhibitory effect of APAP on spinothalamic tracts leading to a decreased activation of higher structures, and a top-down influence on descending inhibition. Further binding and connectivity studies are needed to evaluate how APAP modulates pain, especially in the context of repeated

  10. Effect of calcium dobesilate on progression of early diabetic retinopathy: a randomised double-blind study.

    Science.gov (United States)

    Ribeiro, Maria L; Seres, Andras I; Carneiro, Angela M; Stur, Michael; Zourdani, Alain; Caillon, Patricia; Cunha-Vaz, José G

    2006-12-01

    The study was carried out to confirm the effect of calcium dobesilate (CaD) compared to placebo (PLA) on the blood-retinal barrier (BRB) permeability in early diabetic retinopathy (DR). Adults with type II diabetes and early diabetic retinopathy (below level 47 of ETDRS grading and PVPR between 20 and 50x10(-6)/ min, plasma-free fluorescein) were included in this double-blind placebo-controlled study. Treatment was 2 g daily for 24 months. The primary parameter, posterior vitreous penetration ratio (PVPR), was measured every 6 months by fluorophotometry. Secondary parameters were fundus photography, fluorescein angiography and safety assessments. Metabolic control was performed every 3 months. A total of 194 patients started the treatment (98 CaD, 96 PLA) and 137 completed the 24-month study (69 CaD, 68 PLA). Both treatment groups were comparable at baseline, with ETDRS level 10 in about 59% of patients. Mean PVPR change from baseline after 24 months was significantly (P=0.002) lower in the CaD group [-3.87 (SD 12.03)] than in the PLA group [+2.03 (SD 12.86)], corresponding to a 13.2% decrease in the CaD group and a 7.3% increase in the PLA group. PVPR evolution was also analysed by HbA1c classes ( or =9%) and results confirmed the superiority of CaD independently of the diabetes control level. A highly significant difference [CaD: -3.38 (SD 13.44) versus PLA: +3.50 (SD 13.70)] was also obtained in a subgroup of patients without anti-hypertensive and/or lipid-lowering agents (P=0.002 at 24 months). A further analysis of the secondary parameters showed significant changes in favour of CaD in the evolution from baseline to the last visit of haemorrhages (P=0.029), DR level (P=0.0006) and microaneurysms (P=0.013). Regarding safety, only 2.5% (n=5 patients/ events) of all adverse events reported were assessed as possibly or probably related to the test drug, while all serious adverse events were reported as unlikely. There was no statistical difference between groups

  11. Using auriculotherapy for osteoarthritic knee among elders: a double-blinded randomised feasibility study.

    Science.gov (United States)

    Suen, Lorna K P; Yeh, Chao Hsing; Yeung, Simon K W

    2016-07-29

    Osteoarthritic knee (OA knee) is a common condition in the elderly. Exploration of non-invasive complementary therapies for OA knee is warranted given the limitations of pharmacologic therapies. Auriculotherapy (AT) is a therapeutic method in which specific points on the auricle are stimulated to treat various disorders of the body, and the therapeutic value and synergistic effect of laser auriculotherapy (LAT) when combined with magneto-auriculotherapy (MAT) merits further investigation. This study adopted a double-blinded four-arm randomized placebo design. The aims of study are (1) to assess the feasibility of AT among elders with OA knee in a future large-scale study, including the use of blinding in subjects and evaluators, acceptance of treatment protocol, and estimating the effect size and attrition rate; and (2) to evaluate the preliminary effect of AT in elders with OA knee. Subjects were randomly divided into four groups with different modes of AT with/without placebo objects. A total of 43 subjects completed the 6-week intervention and post-assessment. Assessments included a numerical rating scale of pain (NRS), the timed-up-and-go test (TUGT), and standard goniometer measurements during knee flexion and extension, Kruskal-Wallis test was used to evaluate differences among groups, and Wilcoxon sign-ranked test for examining within-group comparison. Preliminary results indicated the absence of differences in the NRS, TUGT, and active/passive knee flexion and extension at baseline, as well as post-therapy, between the four groups. Even though the differences of these parameters between groups were not significant, the relative differences of NRS and TUGT in subjects who received combined MAT plus LAT were higher than those treated with MAT or LAT alone, or the placebo group. Four of the six parameters demonstrated significant within group differences in subjects who received MAT and/or LAT, whereas no significant differences were found in the placebo group

  12. No matrix effect in double-blind, placebo-controlled egg challenges in egg allergic children.

    Science.gov (United States)

    Libbers, L; Flokstra-de Blok, B M J; Vlieg-Boerstra, B J; van der Heide, S; van der Meulen, G N; Kukler, J; Kerkhof, M; Dubois, A E J

    2013-09-01

    Diagnostic and accidental food allergic reactions may be modified by the matrix containing the allergenic food. Previous studies of double-blind, placebo-controlled food challenges (DBPCFCs) with peanut found an effect of the fat content of the challenge matrix on the severity of the challenge reactions. The aim of this study was to examine whether the fat content of the food matrix is related to eliciting dose and reaction severity in DBPCFCs with heated hen's egg. Sensitized egg allergic children (n = 59) undergoing DBPCFCs with egg as a routine diagnostic procedure in our tertiary care centre were evaluated retrospectively. Three different recipes were used for the food matrix: vanilla pudding, pancake and minced meat, containing 22.8%, 31.9% and 52.7% fat (weighted average), respectively. The eliciting dose (i.e. the highest cumulative dose to which the child reacted) was analyzed by Kaplan-Meier log-rank statistic and by Cox regression. Reaction severity was quantified by using an index (range 1-12) and was analysed by multiple linear regression analysis. The overall influence of type of recipe on eliciting dose was not significant (P = 0.12). The rate of response to minced meat (with the highest fat content) was not significantly different from pudding [HR = 0.61 (0.26-1.45, P = 0.26) or pancake (HR = 1.41 (0.50-3.99), P = 0.52] after adjustment for confounders. The type of recipe did not influence the severity of the challenge reaction. The severity of the challenge reaction for minced meat compared to pudding and pancake was 1.06 (0.52-2.16), P = 0.87 and 0.81 (0.32-2.01), P = 0.64, respectively, after correction for confounders. In contrast to similar research with peanut, no significant influence of the fat content of the matrix was found on the eliciting dose or severity of the reaction in 59 DBPCFCs with hen's egg. Matrix fat content differences comparable to those reported here may not be an important co-determinant of reaction severity for all

  13. Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial.

    Science.gov (United States)

    Ley, Chit Moy; Ni, Qing; Liao, Xing; Gao, Huai-Lin; Robinson, Nicola

    2016-10-01

    To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes. This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study. This RCT failed to show a beneficial effect in reducing fibrinogen

  14. Paracetamol as a prophylactic analgesic for hysterosalpingography: A double blind randomized controlled trial

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    Elson, E.M.; Ridley, N.T.F

    2000-09-01

    AIM: To evaluate the effectiveness of paracetamol as a prophylactic analgesic for hysterosalpingography (HSG). DESIGN: A prospective double blind randomized controlled trial comparing one 1 g of paracetamol (SmithKline Beecham, Brentford, U.K.) to placebo taken 30 min before HSG. One hundred consecutive out-patients were studied prospectively. The analgesic effectiveness during the procedure and at 24 h and 1 week post procedure was analysed by a postal pain score questionnaire. Additional data on the ethnicity of the patient, sex and level of experience of the radiologist performing the hysterosalpingogram, the parity of the patient, the ease of the procedure, and whether pathology was identified were also recorded. RESULTS: Eighty-eight patients (88%) replied, 39 (44%) received paracetamol and 49 placebo (56%). During the procedure 3/39 (7%) of women in the paracetamol group were pain-free compared to 9/49 (18%) in the placebo group, which was not significant (P = 0.11). At 24 h, 15/39 (38%) of women in the paracetamol group were pain-free compared to 20/49 (41%) in the placebo group, which was not significant (P = 0.82). At 1 week, 27/39 (69%) of women in the paracetamol group were pain-free compared to 29/49 (59%) in the placebo group, which was not significant (P = 0.33). No significant difference in mean pain scores was determined during the procedure (P 0.91), or at 24 h post procedure (P = 0.94). Similarly, no difference in mean pain scores was identified with regard to the ethnicity of the patient, the sex of the radiologist performing the procedure, the level of experience of the radiologist performing the procedure, or whether pathology was present or not. Difficult cannulations were associated with higher mean pain scores, however, there was no difference in mean pain scores between the paracetamol or placebo groups for both easy and difficult cannulations. CONCLUSION: Paracetamol is not effective as a prophylactic analgesic for HSG. If a prophylactic

  15. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Maneeton B

    2013-07-01

    Full Text Available Benchalak Maneeton,1 Narong Maneeton,1 Manit Srisurapanont,1 Kaweesak Chittawatanarat2 1Department of Psychiatry, 2Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand Background: Atypical antipsychotic drugs may have low propensity to induce extrapyramidal side effects in delirious patients. This study aimed to compare the efficacy and tolerability between quetiapine and haloperidol in controlling delirious behavior. Methods: A 7-day prospective, double-blind, randomized controlled trial was conducted from June 2009 to April 2011 in medically ill patients with delirium. Measures used for daily assessment included the Delirium Rating Scale-revised-98 (DRS-R-98 and total sleep time. The Clinical Global Impression, Improvement (CGI–I and the Modified (nine-item Simpson–Angus Scale were applied daily. The primary outcome was the DRS-R-98 severity scores. The data were analyzed on an intention-to-treat basis. Results: Fifty-two subjects (35 males and 17 females were randomized to receive 25–100 mg/day of quetiapine (n = 24 or 0.5–2.0 mg/day of haloperidol (n = 28. Mean (standard deviation doses of quetiapine and haloperidol were 67.6 (9.7 and 0.8 (0.3 mg/day, respectively. Over the trial period, means (standard deviation of the DRS-R-98 severity scores were not significantly different between the quetiapine and haloperidol groups (-22.9 [6.9] versus -21.7 [6.7]; P = 0.59. The DRS-R-98 noncognitive and cognitive subscale scores were not significantly different. At end point, the response and remission rates, the total sleep time, and the Modified (nine-item Simpson–Angus scores were also not significantly different between groups. Hypersomnia was common in the quetiapine-treated patients (33.3%, but not significantly higher than that in the haloperidol-treated group (21.4%. Limitations: Patients were excluded if they were not able to take oral medications, and the sample size was small. Conclusion: Low

  16. Prevention of COPD exacerbation by lysozyme: a double-blind, randomized, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Fukuchi Y

    2016-04-01

    Full Text Available Yoshinosuke Fukuchi,1 Koichiro Tatsumi,2 Hiromasa Inoue,3 Yukinori Sakata,4 Kai Shibata,4 Hideaki Miyagishi,4 Yasuhiro Marukawa,4 Masakazu Ichinose5 1Department of Respiratory Medicine, Graduate School of Medicine, Juntendo University, Tokyo, 2Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, 3Department of Pulmonary Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, 4Eisai Co., Ltd., Tokyo, 5Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan Background/aim: Lysozyme (mucopeptide N-acetyl-muramyl hydrolase is widely used as a mucolytic and anti-inflammatory agent in Japan. We evaluated the effects of long-term lysozyme administration on COPD exacerbation. Methods: In a 1-year, randomized, double-blind, placebo-controlled, parallel trial, patients with moderate-to-severe COPD and one or more episodes of COPD exacerbation in the previous year before enrollment were selected. Lysozyme (270 mg or placebo was administered orally for 52 weeks as an add-on to the standard therapies such as bronchodilators. COPD exacerbation, pulmonary function, and COPD assessment test scores were analyzed. An exacerbation was defined as worsening of more than one symptom of COPD (cough, sputum volume, purulent sputum, or breathlessness leading to a change in medication. The primary endpoint was exacerbation rate. Results: A total of 408 patients were randomly assigned to the lysozyme and placebo groups. The baseline characteristics were similar between the two groups. The exacerbation rate was not significantly different between the two groups (1.4 vs 1.2; P=0.292, Poisson regression. However, a subgroup analysis showed that lysozyme might reduce exacerbation rate in patients with airway-dominant phenotype (1.2 vs 1.6. Moreover, the median time to first exacerbation was longer in patients with airway-dominant phenotype in the lysozyme group than that

  17. Levomepromazine versus chlorpromazine in treatment-resistant schizophrenia: a double-blind randomized trial

    Science.gov (United States)

    Lal, Samarthji; Thavundayil, Joseph X.; Nair, N.P. Vasavan; Annable, Lawrence; Ng Ying Kin, Ng M.K.; Gabriel, Antoine; Schwartz, George

    2006-01-01

    Objective We compared the effect of levomepromazine (LMP) with chlorpromazine (CPZ) in treatment-resistant schizophrenia (TRS). Methods We carried out a double-blind, parallel group study (n = 19/arm) with balanced randomization in blocks of 4 and stratification by sex. Subjects entered a 30-week trial, of which phases I–III were open: phase I (wk 0–6) baseline; phase II (wk 7–9) stepwise transition to haloperidol (HAL), 30 mg/d, plus benztropine (BT), 4 mg/d; phase III (wk 10–15) HAL, 40–60 mg/d, plus BT, 4–6 mg/d; phase IV (wk 16–20) stepwise transition to LMP or CPZ (500 mg/d) following randomization; phase V (wk 21–28) stepwise increase of LMP or CPZ (600–1000 mg/d, dose reduction permitted) to establish optimum dose; and phase VI (wk 29–30) optimized dose maintained. Criteria for TRS were based on those established by Kane et al in 1988. The criterion for a response to treatment was a reduction of 25% or more in total Brief Psychiatric Rating Scale score. Results Both LMP (p = 0.007) and CPZ (p = 0.030) improved TRS relative to baseline. Although there was no significant difference between the 2 groups in treatment response at study end point, hierarchical linear modelling of longitudinal outcome revealed a significant (p = 0.006) advantage of LMP over CPZ for the BPRS total score. Ten of 19 participants on LMP and 8 of 19 on CPZ met the criterion for treatment response, and 9 of the 18 responders did so on 200–700 mg/d phenothiazine. The mean dose of responders was 710 (standard deviation [SD] 265) mg/d (LMP) and 722 (SD 272) mg/d (CPZ). Akathisia was associated with a nonresponse to phenothiazines (p = 0.010). BPRS scores increased significantly on HAL (p = 0.006). Two of 19 participants on LMP and 5 of 19 on CPZ withdrew early from the study. Conclusion LMP and CPZ may be useful in the management of TRS. A modest advantage of LMP compared with CPZ was seen in longitudinal analysis. High doses of neuroleptics may contribute to TRS

  18. Posterior superior alveolar nerve blocks: a randomised controlled, double blind trial.

    Science.gov (United States)

    Singla, Himanshi; Alexander, Mohan

    2015-06-01

    Local anesthesia has been a boon for dentistry to allay the most common fear of pain among dental patients. Several techniques to achieve anesthesia for posterior maxillae have been advocated albeit with minor differences. We compared two techniques of posterior superior alveolar nerve block (PSANB), the one claimed to be "most accurate" to the one "most commonly used." This study was conducted to assess and compare the efficacy as well as complications of "the straight needle technique" to that of "the bent needle technique" for PSANB. We conducted a prospective, randomised, double blind study on 120 patients divided into two groups, using a 26-gauge, 38 mm long needle with 2 ml of 2 % lignocaine hydrochloride with 1:200,000 adrenaline solution. Objective symptoms were evaluated by a single investigator. Cold test using ice was used to evaluate the status of pulpal anesthesia. Data thus obtained was subjected to statistical analysis. Out of the 120 blocks, 19 blocks failed. Statistical analysis found straight needle technique to be more successful than the bent needle technique (p = 0.002). Both the techniques were equally effective for the first molar region on both right and left side (p = 0.66 on right side and p = 0.20 on left side). However, in the second and third molar region technique A was more effective than B (p = 0.01) on right side only. On Left side, both techniques were equally effective (p = 0.08). Sensitivity of the cold test was 82 % which is quite high but the specificity was 68 % which seems to be falling in the above average range only. Positive predictive value of 75 and negative predictive value of 76 was observed. We did not encounter any complications in this study. To the best of our knowledge, this is the first randomised controlled clinical study on PSANB techniques. This study suggests that the PSANB using the straight needle technique as advocated by Malamed [1] can be routinely and safely used to achieve anesthesia in

  19. Establishing optimal selenium status: results of a randomized, double-blind, placebo-controlled trial1234

    Science.gov (United States)

    Armah, Charlotte N; Dainty, Jack R; Hart, Dave J; Teucher, Birgit; Goldson, Andrew J; Broadley, Martin R; Motley, Amy K; Fairweather-Tait, Susan J

    2010-01-01

    Background: Dietary recommendations for selenium differ between countries, mainly because of uncertainties over the definition of optimal selenium status. Objective: The objective was to examine the dose-response relations for different forms of selenium. Design: A randomized, double-blind, placebo-controlled dietary intervention was carried out in 119 healthy men and women aged 50–64 y living in the United Kingdom. Daily placebo or selenium-enriched yeast tablets containing 50, 100, or 200 μg Se (≈60% selenomethionine), selenium-enriched onion meals (≈66% γ-glutamyl-methylselenocysteine, providing the equivalent of 50 μg Se/d), or unenriched onion meals were consumed for 12 wk. Changes in platelet glutathione peroxidase activity and in plasma selenium and selenoprotein P concentrations were measured. Results: The mean baseline plasma selenium concentration for all subjects was 95.7 ± 11.5 ng/mL, which increased significantly by 10 wk to steady state concentrations of 118.3 ± 13.1, 152.0 ± 24.3, and 177.4 ± 26.3 ng/mL in those who consumed 50, 100, or 200 μg Se-yeast/d, respectively. Platelet glutathione peroxidase activity did not change significantly in response to either dose or form of selenium. Selenoprotein P increased significantly in all selenium intervention groups from an overall baseline mean of 4.99 ± 0.80 μg/mL to 6.17 ± 0.85, 6.73 ± 1.01, 6.59 ± 0.64, and 5.72 ± 0.75 μg/mL in those who consumed 50, 100, or 200 μg Se-yeast/d and 50 μg Se-enriched onions/d, respectively. Conclusions: Plasma selenoprotein P is a useful biomarker of status in populations with relatively low selenium intakes because it responds to different dietary forms of selenium. To optimize the plasma selenoprotein P concentration in this study, 50 μg Se/d was required in addition to the habitual intake of ≈55 μg/d. In the context of established relations between plasma selenium and risk of cancer and mortality, and recognizing the important functions of

  20. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Higurashi Takuma

    2012-03-01

    Full Text Available Abstract Background Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF. ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. Methods/Design This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. Discussion This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with

  1. Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Pickering G

    2016-12-01

    Full Text Available Gisèle Pickering,1–3 Nicolas Macian,1,2 Claude Dubray,1–3 Bruno Pereira4 1University Hospital, CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Inserm, CIC 1405, UMR Neurodol 1107, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU de Clermont-Ferrand, Délégation Recherche Clinique Innovation, Clermont-Ferrand, France Background: Acetaminophen (APAP, paracetamol mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467 was carried out from May 30, 2011 to July 12, 2011. Methods: Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature, and a battery of cognitive tests were recorded before and after oral APAP (2 g or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. Results: APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P<0.05. Spatial planning and working memory initial thinking time were decreased (P=0.04. All other tests were not modified by APAP. APAP had an antinociceptive effect (P<0.01 and body temperature did not change. Conclusion: This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance

  2. Language-specific strategy for programming hearing aids - A double-blind randomized controlled crossover study.

    Science.gov (United States)

    Matsumoto, Nozomu; Suzuki, Nobuyoshi; Iwasaki, Satoshi; Ishikawa, Kazuha; Tsukiji, Hiroki; Higashino, Yoshie; Tabuki, Tomoko; Nakagawa, Takashi

    2017-11-17

    Voice-aligned compression (VAC) is a method used in Oticon's hearing aids to provide more comfortable hearing without sacrificing speech discrimination. The complex, non-linear compression curve for the VAC strategy is designed based on the frequency profile of certain spoken Western languages. We hypothesized that hearing aids could be further customized for Japanese-speaking users by modifying the compression curve using the frequency profile of spoken Japanese. A double-blind randomized controlled crossover study was performed to determine whether or not Oticon's modified amplification strategy (VAC-J) provides subjectively preferable hearing aids for Japanese-speaking hearing aid users compared to the same company's original amplification strategy (VAC). The participants were randomized to two groups. The VAC-first group received a pair of hearing aids programmed using the VAC strategy and wore them for three weeks, and then received a pair of hearing aids programmed using VAC-J strategy and wore them for three weeks. The VAC-J-first group underwent the same study, but they received hearing aids in the reverse sequence. A Speech, Spatial and Qualities (SSQ) questionnaire was administered before beginning to use the hearing aids, at the end of using the first pair of hearing aids, and at the end of using the second pair of hearing aids. Twenty-five participants that met the inclusion/exclusion criteria from January 1 to October 31, 2016, were randomized to two groups. Twenty-two participants completed the study. There were no statistically significant differences in the increment of SSQ scores between the participants when using the VAC- or the VAC-J-programmed hearing aids. However, participants preferred the VAC-J strategy to the VAC strategy at the end of the study, and this difference was statistically significant. Japanese-speaking hearing aid users preferred using hearing aids that were fitted with the VAC-J strategy. Our results show that the VAC strategy

  3. Double-blind, comparative study of milnacipran and paroxetine in Japanese patients with major depression

    Directory of Open Access Journals (Sweden)

    Kamijima K

    2013-04-01

    Full Text Available Kunitoshi Kamijima,1 Shinji Hashimoto,2 Eiichi Nagayoshi,2 Tsukasa Koyama3 1International University of Health and Welfare, Tochigi, 2Asahi-kasei Pharma Corporation, Tokyo, 3Ohyachi Hospital, Sapporo, Japan Background and methods: A double-blind, parallel-group, controlled study was performed to investigate if milnacipran was noninferior to paroxetine in terms of improvement in symptoms of depression in Japanese patients with major depressive disorders in a fixed-dose design. The efficacy and safety of milnacipran 200 mg/day were also assessed in comparison with those at the standard dose of 100 mg/day. Results: Changes in 17-item Hamilton depression rating scale (HAM-D total score (mean ± standard deviation for group M1 (milnacipran 100 mg/day, group M2 (milnacipran 200 mg/day, and group PX (paroxetine 30 or 40 mg/day were -12.9 ± 5.8, -12.8 ± 6.1, and -13.1 ± 6.2, respectively, and the estimated differences in total score for group PX (Dunnett's 95% simultaneous confidence interval were 0.1 (-1.1 to 1.3 for group M1 and 0.3 (-0.9 to 1.5 for group M2. The noninferiority of groups M1 and M2 to group PX was thus confirmed, because the upper confidence limit of differences between groups M1 and PX and between groups M2 and PX was less than 2.0. The estimated mean difference of change in HAM-D total score (95% confidence interval between groups M2 and M1 was 0.2 (-0.9 to 1.2, indicating a comparable change in total score for both groups. The incidence of treatment-related adverse events was 71.7% for group M1, 68.8% for group M2, and 69.3% for group PX, indicating no significant difference between the three groups. Conclusion: These results demonstrate that milnacipran 100 mg/day and 200 mg/day is not inferior to paroxetine in terms of efficacy and safety. Keywords: milnacipran, paroxetine, depression, noninferiority, Japan

  4. [Tetrazepam in the treatment of acute cervical syndrome. Randomized double-blind pilot study comparing tetrazepam and placebo].

    Science.gov (United States)

    Salzmann, E; Wiedemann, O; Löffler, L; Sperber, H

    1993-12-10

    In a double-blind study, 20 ambulatory patients with acute painful restriction of mobility of the cervical spine and overall marked impairment were treated for seven days with tetrazepam (150 mg or a lower dose from the third day onward) or placebo. Paracetamol was permitted in addition if required. Test criteria: The main criterion of efficacy was a summed score of three parameters: pain, restriction of mobility, and general impairment. The difference between the groups was statistically highly significant (p = 0.005). Tolerability was adjudged to be "very good" for the placebo group, and, on average, "good" for the tetrazepam group.

  5. Effect of aliskiren on proteinuria in non-diabetic chronic kidney disease: a double-blind, crossover, randomised, controlled trial

    OpenAIRE

    Lizakowski, Sławomir; Tylicki, Leszek; Renke, Marcin; Rutkowski, Przemysław; Heleniak, Zbigniew; Sławińska-Morawska, Maja; Aleksandrowicz, Ewa; Łysiak-Szydłowska, Wieslawa; Rutkowski, Bolesław

    2012-01-01

    Aim To evaluate the proteinuria-lowering effect of a renin inhibitor (aliskiren), compared to placebo and to an angiotensin-converting enzyme inhibitor (perindopril), in patients with non-diabetic chronic kidney disease. Methods A randomised, double-blind, crossover trial was performed in 14 patients with nondiabetic chronic kidney disease with 24-h mean proteinuria of 2.01 g (95% CI, 1.36–2.66) and estimated creatinine clearance of 93 ± 6.8 ml/min. The study consisted of five treatment perio...

  6. [The prophylaxis of benzodiazepine withdrawal syndrome in the elderly: the effectiveness of carbamazepine. Double-blind study vs. placebo].

    Science.gov (United States)

    Di Costanzo, E; Rovea, A

    1992-01-01

    A double-blind study was performed to evaluate carbamazepine for the prophylaxis of benzodiazepine withdrawal syndrome in elderly patients--a controversial subject despite the extensive use of such drugs in old age. Thirty-six outpatients aged > or = 60 yrs suffering from general anxiety disorders and benzodiazepine abuse underwent gradual discontinuation of benzodiazepine therapy in two groups, one treated with carbamazepine and one with placebo. The carbamazepine-treated group demonstrated a lower incidence of withdrawal symptoms rated according to the Physician Withdrawal Check List (p carbamazepine, which disappeared at lower dosages.

  7. Compound Danshen Dripping Pill for Treating Early Diabetic Retinopathy: A Randomized, Double-Dummy, Double-Blind Study

    Science.gov (United States)

    Luo, Dan; Qin, Yali; Yuan, Wei; Deng, Hui; Zhang, Youhua; Jin, Ming

    2015-01-01

    This randomized, double-dummy, double-blind study was to observe the therapeutic effects of compound Danshen dripping pill (CDDP) in treating early diabetic retinopathy (DR). All the 57 type 2 diabetes cases in nonproliferative diabetic retinopathy (NPDR) stage were divided into two groups randomly: 28 cases treated with CDDP as the treated group and 29 cases treated with calcium dobesilate as the control group. The best corrected visual acuity (BCVA) in the treated group was significantly improved after treatment when compared to that before treatment (P dobesilate for NPDR. In future DR treatments, CDDP may function as the auxiliary drug. PMID:26457110

  8. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-08-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  9. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-12-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  10. Anandron (RU 23908) associated with orchiectomy in stage D prostate cancer. Preliminary results of a randomized, double-blind study.

    Science.gov (United States)

    Namer, M; Amiel, J; Toubol, J

    1988-01-01

    A randomized, double-blind, multicenter trial was performed comparing the association of orchiectomy plus the nonsteroid antiandrogen Anandron (300 mg daily) to orchiectomy plus placebo in the treatment of patients with stage C or D prostate cancer. The results for 98 evaluable stage D patients with a median follow-up of 23.4 +/- 8.9 months are given. Although there was no statistically significant difference between the two treatments with regard to any parameter (subjective response, best objective response according to NPCP criteria, and progression-free interval and survival), the results were invariably in favor of the combined treatment, as already reported in other trials on Anandron.

  11. Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized double-blind placebo-controlled trial

    DEFF Research Database (Denmark)

    Bisgaard, Thue; Klarskov, Birthe; Kehlet, Henrik

    2003-01-01

    OBJECTIVE: To determine the effects of preoperative dexamethasone on surgical outcome after laparoscopic cholecystectomy (LC). SUMMARY BACKGROUND DATA: Pain and fatigue are dominating symptoms after LC and may prolong convalescence. METHODS: In a double-blind, placebo-controlled study, 88 patients...... were randomized to intravenous dexamethasone (8 mg) or placebo 90 minutes before LC. Patients received a similar standardized anesthetic, surgical, and multimodal analgesic treatment. All patients were recommended 2 days postoperative duration of convalescence. The primary endpoints were fatigue...... drug. Dexamethasone significantly reduced postoperative levels of CRP (P = 0.01), fatigue (P = 0.01), overall pain, and incisional pain during the first 24 postoperative hours (P

  12. Bacterial vaginosis: a double-blind randomized trial of the effect of treatment of the sexual partner

    DEFF Research Database (Denmark)

    Vejtorp, M; Bollerup, A C; Vejtorp, L

    1988-01-01

    In a double-blind randomized controlled trial we assessed the effect of metronidazole treatment of the male partner on the recurrence rate of bacterial vaginosis. Women who fulfilled the diagnostic criteria for bacterial vaginosis were treated with metronidazole given in single doses of 2 g on days...... 1 and 3. The sexual partners were randomized to receive either the same dosage of metronidazole or a placebo. A total of 107 pairs completed the study. One week after the start of treatment 89% of the women considered themselves improved or cured and 93% no longer had the diagnostic criteria...

  13. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults

    OpenAIRE

    McIntyre, Roger S.; Lophaven, Søren; Olsen, Christina K.

    2014-01-01

    The efficacy of vortioxetine 10 and 20 mg/d vs. placebo on cognitive function and depression in adults with recurrent moderate-to-severe major depressive disorder (MDD) was evaluated. Patients (18–65 yr, N = 602) were randomized (1:1:1) to vortioxetine 10 or 20 mg/d or placebo for 8 wk in a double-blind multi-national study. Cognitive function was assessed with objective neuropsychological tests of executive function, processing speed, attention and learning and memory, and a subjective cogni...

  14. A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease

    DEFF Research Database (Denmark)

    Schölmerich, Jürgen; Fellermann, Klaus; Seibold, Frank W

    2017-01-01

    Background and Aims: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis [TSO] versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease [CD]. Methods: Adults with active CD [n...... = 252] randomly received six fortnightly doses of 250, 2500, or 7500 TSO/15 ml suspension/day [TSO 250, TSO 2500, TSO 7500], or 15 ml placebo solution/day, in a double-blind fashion, with 4 weeks' follow-up. Primary endpoint was the rate of clinical remission [Crohn's Disease Activity Index [CDAI

  15. Long-Term Efficacy of Various Natural or “Green” Insecticides against Bed Bugs: A Double-Blind Study

    OpenAIRE

    Goddard, Jerome

    2014-01-01

    Bed bugs are resurging throughout the world, and, thus, effective pest control strategies are constantly needed. A few studies have evaluated 25(b) and other natural, or so-called “green” products, as well as over-the-counter insecticides for bed bugs, but additional studies are needed to determine efficacy of bed bug control products. This double-blinded research project was initiated to examine long-term effectiveness of six commercially available natural or “green” insecticides against bed...

  16. Safety and Efficacy Assessment of Two New Leprosy Skin Test Antigens: Randomized Double Blind Clinical Study

    Science.gov (United States)

    Rivoire, Becky L.; Groathouse, Nathan A.; TerLouw, Stephen; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Khadge, Saraswoti; Kunwar, Chatra B.; Macdonald, Murdo; Hawksworth, Rachel; Thapa, Min B.; Hagge, Deanna A.; Tibbals, Melinda; Smith, Carol; Dube, Tina; She, Dewei; Wolff, Mark; Zhou, Eric; Makhene, Mamodikoe; Mason, Robin; Sizemore, Christine; Brennan, Patrick J.

    2014-01-01

    Background New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. Methods A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. Findings In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens

  17. Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study.

    Directory of Open Access Journals (Sweden)

    Becky L Rivoire

    Full Text Available New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials.A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.. Healthy non-exposed subjects (n = 10 received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg of MLSA-LAM (n = 5 or MLCwA (n = 5 and control antigens [Rees MLSA (1.0 µg and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal, but involved only the 1.0 µg (high dose and 0.1 µg (low dose of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose, each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT leprosy patients, 20 household contacts of leprosy patients (HC, and 20 tuberculosis (TB patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration.In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50 showed induration against the high dose of each antigen, and 4% (2 of 50 reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens showed lower specificity (70% and 60

  18. Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study.

    Science.gov (United States)

    Rivoire, Becky L; Groathouse, Nathan A; TerLouw, Stephen; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Khadge, Saraswoti; Kunwar, Chhatra B; Kunwar, Chatra B; Macdonald, Murdo; Hawksworth, Rachel; Thapa, Min B; Hagge, Deanna A; Tibbals, Melinda; Smith, Carol; Dube, Tina; She, Dewei; Wolff, Mark; Zhou, Eric; Makhene, Mamodikoe; Mason, Robin; Sizemore, Christine; Brennan, Patrick J

    2014-01-01

    New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens showed lower specificity (70% and 60

  19. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial.

    Science.gov (United States)

    Dauvilliers, Yves; Bassetti, Claudio; Lammers, Gert Jan; Arnulf, Isabelle; Mayer, Geert; Rodenbeck, Andrea; Lehert, Philippe; Ding, Claire-Li; Lecomte, Jeanne-Marie; Schwartz, Jean-Charles

    2013-11-01

    Narcolepsy is characterised by excessive daytime sleepiness (EDS) and cataplexy. Histamine neurons are crucial to maintain wakefulness. We assessed the safety and efficacy of pitolisant (previously called BF2.649), a selective histamine H3 receptor inverse agonist that activates these neurons, in patients with narcolepsy. For this double-blind, randomised, parallel-group controlled trial, we recruited patients with narcolepsy from 32 sleep disorder centres in five European countries. Patients were eligible if they were aged 18 years or older, had not taken psychostimulants for at least 14 days, and had EDS (defined as an Epworth Sleepiness Scale [ESS] score of at least 14). Using a computer-generated randomisation sequence, we randomly allocated patients to receive pitolisant, modafinil, or placebo (1:1:1). Treatment lasted 8 weeks: 3 weeks of flexible dosing according to investigator's judgment (10 mg, 20 mg, or 40 mg a day of pitolisant; 100 mg, 200 mg or 400 mg a day of modafinil) followed by 5 weeks of stable dosing. Patients took four tablets a day in a double-dummy design to ensure masking. For the primary analysis, assessed in the intention-to-treat population, we assessed the superiority of pitolisant versus placebo, and the non-inferiority of pitolisant versus modafinil. This trial is registered with ClinicalTrials.gov, number NCT01067222. Between May 26, 2009, and June 30, 2010, we screened 110 patients, 95 of whom were eligible and randomly assigned to treatment: 30 to placebo, 32 to pitolisant, and 33 to modafinil. Over the 8-week treatment period, mean ESS score reductions were -3·4 (SD 4·2) in the placebo group, -5·8 (6·2) in the pitolisant group, and -6·9 (6·2) in the modafinil group. Our primary analysis of between-group differences in mean ESS score at endpoint (adjusted for baseline) showed pitolisant to be superior to placebo (difference -3·0, 95% CI -5·6 to -0·4; p=0·024), but not non-inferior to modafinil (difference 0·12, 95% CI -2

  20. Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

    Science.gov (United States)

    van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

    2014-02-01

    Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study

    Science.gov (United States)

    Thomson, M A; Jenkins, H R; Bisset, W M; Heuschkel, R; Kalra, D S; Green, M R; Wilson, D C; Geraint, M

    2007-01-01

    Objectives To assess the efficacy and safety of polyethylene glycol 3350 plus electrolytes (PEG+E) for the treatment of chronic constipation in children. Design Randomised, double blind, placebo controlled crossover trial, with two 2‐week treatment periods separated by a 2‐week placebo washout. Setting Six UK paediatric departments. Participants 51 children (29 girls, 22 boys) aged 24 months to 11 years with chronic constipation (lasting ⩾3 months), defined as ⩽2 complete bowel movements per week and one of the following: pain on defaecation on 25% of days; ⩾25% of bowel movements with straining; ⩾25% of bowel movements with hard/lumpy stools. 47 children completed the double blind treatment. Main outcome measures Number of complete defaecations per week (primary efficacy variable), total number of complete and incomplete defaecations per week, pain on defaecation, straining on defaecation, faecal incontinence, stool consistency, global assessment of treatment, adverse events and physical examination. Results The mean number of complete defaecations per week was significantly higher for children on PEG+E than on placebo (3.12 (SD 2.05) v 1.45 (SD 1.20), respectively; pchildren on PEG+E (41%) and placebo during treatment (45%). Conclusions PEG+E is significantly more effective than placebo, and appears to be safe and well tolerated in the treatment of chronic constipation in children. PMID:17626140

  2. Laparoscopic versus open appendectomy: what is the real difference? Results of a prospective randomized double-blinded trial.

    Science.gov (United States)

    Ignacio, R C; Burke, R; Spencer, D; Bissell, C; Dorsainvil, C; Lucha, P A

    2004-02-01

    The comparison of laparoscopic to open appendectomy has been reviewed in many retrospective and prospective studies. Some report shorter hospital stays, less postoperative pain, and earlier return to work while others fail to demonstrate such differences. We performed a prospective, randomized double-blinded trial to evaluate this ongoing debate. Fifty-two consecutive men presenting with signs and symptoms suggestive of acute appendicitis were randomized to undergo either laparoscopic appendectomy or open appendectomy. Length of operative times, hospital stay, lost work days, visual analog pain scores, and operative costs were compared. Length of stay averaged 21.5 h for the laparoscopic group and was not statistically different when compared to the open group. Perceived postoperative pain on postoperative days 1 and 7 were not statistically different between the two groups. Mean time to return to work was 11 days, and there was no statistical difference between groups. Operative costs were >600 dollars greater for the laparoscopic approach. In this prospective randomized double-blinded trial, laparoscopic appendectomy appears to confer no significant advantage over open appendectomy for postoperative pain or lost work days. It does carry an increase in operating room costs and, contrary to other reports, hospital stay is not shortened. Further studies are needed to determine if specific populations, such as the obese or women, may benefit from a minimally invasive approach to appendicitis.

  3. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it.

  4. Double-blinded, placebo-controlled study to evaluate an antipruritic shampoo for dogs with allergic pruritus.

    Science.gov (United States)

    Schilling, J; Mueller, R S

    2012-07-28

    Shampoo therapy is frequently used on pruritic dogs. However, there are few double-blinded, placebo-controlled studies of this form of therapy. This randomised, double-blinded, placebo-controlled study evaluated the efficacy of a commercial medicated shampoo (DermaTopic; Almapharm) containing chlorhexidine, lactoferrin, piroctone olamine, chitosan and essential fatty acids in 27 dogs with mild to moderate allergic pruritus without secondary skin infections. All dogs received shampoo therapy with either DermaTopic or a shampoo vehicle as placebo twice weekly for four weeks. The extent of pruritus was evaluated before the study and then on a daily basis by the owners using a visual analogue scale. Before beginning the treatment and after four weeks, the skin lesions were evaluated by an experienced clinician with a validated lesion score (Canine Atopic Dermatitis Extent and Severity Index - CADESI). The pruritus was reduced significantly by both DermaTopic and placebo. However, there was no significant difference between both groups. There was no statistically significant difference in the CADESI scores pre- and post-treatment in either group or between the two types of treatment. This study provides further evidence of the benefit of shampoo therapy for pruritic dogs.

  5. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    Directory of Open Access Journals (Sweden)

    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  6. Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study.

    Science.gov (United States)

    Pascual, Juan Carlos; Soler, Joaquim; Puigdemont, Dolors; Pérez-Egea, Rosario; Tiana, Thais; Alvarez, Enrique; Pérez, Víctor

    2008-04-01

    The aim of this double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of ziprasidone in the treatment of adult patients with borderline personality disorder. Sixty DSM-IV borderline personality disorder patients were included from March 2004 to April 2006 in a 12-week, single-center, double-blind, placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a 1:1 ratio following a 2-week baseline period. The Clinical Global Impressions scale for use in borderline personality disorder patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports related to affect, behavior, psychosis, general psychopathology domains, and clinical safety were included. Analysis of variance indicated no statistically significant differences between ziprasidone and placebo in the CGI-BPD. Nor were significant differences observed between groups in depressive, anxiety, psychotic, or impulsive symptoms. The mean daily dose of ziprasidone was 84.1 mg/day (SD = 54.8; range, 40-200). The drug was seen to be safe, and no serious adverse effects were observed. This trial failed to show a significant effect of ziprasidone in patients with borderline personality disorder. clinicaltrials.gov Identifier: NCT00635921.

  7. Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: randomized, double-blind crossover pilot study

    Directory of Open Access Journals (Sweden)

    Shammas NW

    2015-03-01

    Full Text Available Nicolas W Shammas,1 Gail A Shammas,1 Kathleen Keyes,2 Shawna Duske,1 Ryan Kelly,1 Michael Jerin3 1Midwest Cardiovascular Research Foundation, 2Cardiovascular Medicine, Private Corporation, 3St Ambrose University, Davenport, IA, USA Background: Patients with ischemic cardiomyopathy (ICM may continue to experience persistent chest pain and/or dyspnea despite pharmacologic therapy and revascularization. We hypothesized that ranolazine would reduce anginal symptoms or dyspnea in optimally treated ICM patients.Methods: In this randomized, double-blind, crossover-design pilot study, 28 patients with ICM (ejection fraction less or equal 40% were included after providing informed consent. A total of 24 patients completed both placebo and ranolazine treatments and were analyzed. All patients were on treatment with a beta blocker, an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker, and at least one additional antianginal drug. After randomization, patients received up to 1,000 mg ranolazine orally twice a day, as tolerated, versus placebo. The primary end point was change in angina as assessed by the Seattle Angina Questionnaire (SAQ, or in dyspnea as assessed by the Rose Dyspnea Scale (RDS. Change in the RDS and SAQ score from baseline was compared, for ranolazine and placebo, using the Wilcoxon signed rank test or paired t-test.Results: Patients had the following demographic and clinical variables: mean age of 71.5 years; male (82.1%; prior coronary bypass surgery (67.9%; prior coronary percutaneous intervention (85.7%; prior myocardial infarction (82.1%; diabetes (67.9%; and mean ejection fraction of 33.1%. No statistical difference was seen between baseline RDS score and that after placebo or ranolazine (n=20 (P≥0.05. There was however, an improvement in anginal frequency (8/10 patients (P=0.058, quality of life (8/10 patients (P=0.048, and mean score of all components of the SAQ questionnaire (n=10 (P=0.047 with ranolazine

  8. Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS): a study protocol for a double-blind, randomised, placebo-controlled, proof-of-concept study.

    Science.gov (United States)

    Ederoth, Per; Grins, Edgars; Dardashti, Alain; Brondén, Björn; Metzsch, Carsten; Erdling, André; Nozohoor, Shahab; Mokhtari, Arash; Hansson, Magnus J; Elmér, Eskil; Algotsson, Lars; Jovinge, Stefan; Bjursten, Henrik

    2016-12-15

    Acute kidney injury (AKI) after cardiac surgery is common and results in increased morbidity and mortality. One possible mechanism for AKI is ischaemia-reperfusion injury caused by the extracorporeal circulation (ECC), resulting in an opening of the mitochondrial permeability transition pore (mPTP) in the kidneys, which can lead to cell injury or cell death. Ciclosporin may block the opening of mPTP if administered before the ischaemia-reperfusion injury. We hypothesised that ciclosporin given before the start of ECC in cardiac surgery can decrease the degree of AKI. Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS) study is an investigator-initiated double-blind, randomised, placebo-controlled, parallel design, single-centre study performed at a tertiary university hospital. The primary objective is to assess the safety and efficacy of ciclosporin to limit the degree of AKI in patients undergoing coronary artery bypass grafting surgery. We aim to evaluate 150 patients with a preoperative estimated glomerular filtration rate of 15-90 mL/min/1.73 m 2 . Study patients are randomised in a 1:1 ratio to receive study drug 2.5 mg/kg ciclosporin or placebo as an intravenous injection after anaesthesia induction but before start of surgery. The primary end point consists of relative P-cystatin C changes from the preoperative day to postoperative day 3. The primary variable will be tested using an analysis of covariance method. Secondary end points include evaluation of P-creatinine and biomarkers of kidney, heart and brain injury. The trial is conducted in compliance with the current version of the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice guidelines E6 (R1) and was approved by the Regional Ethical Review Board, Lund and the Swedish Medical Products Agency (MPA). Written and oral informed consent is obtained before enrolment into the study. NCT02397213; Pre-results. Published by the BMJ

  9. Buspirone versus methylphenidate in the treatment of children with attention- deficit/ hyperactivity disorder: randomized double-blind study.

    Science.gov (United States)

    Mohammadi, Mohammad-Reza; Hafezi, Poopak; Galeiha, Ali; Hajiaghaee, Reza; Akhondzadeh, Shahin

    2012-01-01

    A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg) (group 1) or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2) for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD) and -15.60±7.81 (mean±SD) for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD) and -22.40±9.90 (mean±SD) for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of buspirone was

  10. Buspirone Versus Methylphenidate in the Treatment of Children with Attention- Deficit/ Hyperactivity Disorder: Randomized Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Shahin Akhondzadeh

    2012-11-01

    Full Text Available A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 1 or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2 for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD and -15.60±7.81 (mean±SD for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD and -22.40±9.90 (mean±SD for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of

  11. Heart bypass surgery

    Science.gov (United States)

    Off-pump coronary artery bypass; OPCAB; Beating heart surgery; Bypass surgery - heart; CABG; Coronary artery bypass graft; Coronary artery bypass surgery; Coronary bypass surgery; Coronary artery disease - CABG; CAD - CABG; Angina - ...

  12. Gastric bypass surgery

    Science.gov (United States)

    ... Y gastric bypass; Gastric bypass - Roux-en-Y; Weight-loss surgery - gastric bypass; Obesity surgery - gastric bypass Patient Instructions Bathroom safety - adults Gastric bypass surgery - discharge Laparoscopic gastric banding - discharge ...

  13. A double-blind study on the effect of discontinuation of gold therapy in patients with rheumatoid arthritis.

    Science.gov (United States)

    Van der Leeden, H; Dijkmans, B A; Hermans, J; Cats, A

    1986-01-01

    To assess the benefit of further gold treatment of rheumatoid arthritis (RA) patients who had already received more than 6 g of this metal, 24 such patients were included in a double-blind trial. Besides this "gold group" comprising 11 patients who received gold (Auromyose) in the same dosage schedule as before the study, the trial included a "placebo group" comprising 13 patients who received gold in a suspension diluted 1/100. In either group clinical, laboratory, and radiological data did not differ after 6 and 24 months in relation to the results at entry except for the serum gold concentrations, which were lower in the placebo group. We conclude that discontinuation of the treatment in RA patients who have received more than 6 g gold is not harmful to the patients for at least two years after withdrawal.

  14. A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Miller, I; Lynggaard, C D; Lophaven, S

    2011-01-01

    BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo......-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg....... Recruitment was terminated early due to expiry date of trial medication. RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after...

  15. Symptomatic treatment of premenstrual mastalgia in premenopausal women with lisuride maleate: a double-blind placebo-controlled randomized study.

    Science.gov (United States)

    Kaleli, S; Aydin, Y; Erel, C T; Colgar, U

    2001-04-01

    To determine the therapeutic effect of lisuride maleate on premenstrual mastalgia in premenopausal women. Double-blind randomized prospective study. Department of obstetrics and gynecology at a university hospital. Sixty women with premenstrual mastalgia were included in the study. Study and control groups consisted of 30 women each. Women enrolled in the study and control group were given one tablet daily (0.2 mg) of lisuride maleate or placebo orally for 2 months. Severity of mastalgia was evaluated using the visual analog scale. Severity of mastalgia and side effects of the drug administered. Mastalgia subsided significantly in women receiving lisuride maleate compared with controls. There were no significant side effects from lisuride maleate. Prolactin levels decreased significantly in the group receiving lisuride, which correlated well with pain resolution. Lisuride maleate may be useful for the symptomatic treatment of premenstrual mastalgia.

  16. Bioavailability is improved by enzymatic modification of the citrus flavonoid hesperidin in humans: A randomized, double-blind, crossover trial

    DEFF Research Database (Denmark)

    Nielsen, I.L.F.; Chee, W.S.S.; Bredsdorff, Lea

    2006-01-01

    Hesperidin is the predominant polyphenol consumed from citrus fruits and juices. However, hesperidin is proposed to have limited bioavailability due to the rutinoside moiety attached to the flavonoid. The aim of this study was to demonstrate in human subjects that the removal of the rhamnose group...... to yield the corresponding flavonoid glucoside (i.e., hesperetin-7-glucoside) will improve the bioavailability of the aglycone hesperetin. Healthy volunteers (n = 16) completed the double-blind, randomized, crossover study. Subjects randomly consumed hesperetin equivalents supplied as orange juice...... that the bioavailability of hesperidin was modulated by enzymatic conversion to hesperetin-7-glucoside, thus changing the absorption site from the colon to the small intestine. This may affect future interventions concerning the health benefits of citrus flavonoids....

  17. A randomized, double blind, placebo controlled study of spirulina supplementation on indices of mental and physical fatigue in men.

    Science.gov (United States)

    Johnson, Morgan; Hassinger, Lauren; Davis, Joshua; Devor, Steven T; DiSilvestro, Robert A

    2016-01-01

    Spirulina may increase people's ability to resist mental and physical fatigue. This study tested that hypothesis in a randomized, double blinded, placebo controlled study in men. After 1 week, a 3 g/day dose of spirulina produced a small, but statistically significant increase in exercise output (Kcals consumed in 30 min exercise on a cross trainer machine). A mathematical based mental fatigue test showed improved performance 4 h after the first time of supplementation as well as 8 weeks later. Similarly, a subjective survey for a sense of physical and mental fatigue showed improvement within 4 h of the first supplementation as well as 8 weeks later. These results show that spirulina intake can affect fatigue in men.

  18. A double-blind placebo-controlled trial of omeprazole on urinary pH in healthy subjects

    DEFF Research Database (Denmark)

    Osther, P J; Rasmussen, L; Pedersen, S A

    1992-01-01

    Urinary pH is related to urinary calculus formation as well as urinary infection. Omeprazole is an effective inhibitor of gastric acid secretion through inhibition of the parietal cell H+K+ATPase. In this study we have evaluated a possible effect of omeprazole on urine acidification. Ten healthy...... male subjects took placebo and omeprazole, 40 mg o.m., for 10 days in a double-blind placebo-controlled trial. Morning fasting urinary pH was measured on day 10 of each treatment course using a pH meter. No effect of omeprazole on urinary pH could be demonstrated. It is thus unlikely...... that it is necessary to take omeprazole treatment into consideration in stone screening. As omeprazole did not affect urinary pH, no urological side effects related to changes in urinary pH can be expected....

  19. Hand-arm vibration syndrome. A double-blind case-control study with a new esthesiometer.

    Science.gov (United States)

    Chatterjee, D S

    1994-07-01

    This double-blind case-control study on hand-arm vibration syndrome was sponsored by the Society of Occupation Medicine Golden Jubilee Travelling Scholarship Committee in 1987. It involved collaborative work between the author and the Department of Clinical Neurosciences, Institute of Occupational Health, Helsinki, Finland. The procedure consisted of administration of a questionnaire, clinical examination of subjects in the study group and depth-sense esthesiometry for all subjects including the controls. Of 34 subjects admitted to the study, 14 out of 15 patients were positively diagnosed as suffering from the syndrome and one out of 19 in the control group had a false positive result. The study showed that the new esthesiometer, although not totally objective, could be regarded as an effective tool for the diagnosis of hand-arm vibration syndrome in clinical and field studies.

  20. Adverse Events With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial.

    Science.gov (United States)

    Lemoel, Fabien; Contenti, Julie; Giolito, Didier; Boiffier, Mathieu; Rapp, Jocelyn; Istria, Jacques; Fournier, Marc; Ageron, François-Xavier; Levraut, Jacques

    2017-12-01

    The goal of our study was to compare the frequency and severity of recovery reactions between ketamine and ketamine-propofol 1:1 admixture ("ketofol"). We performed a multicentric, randomized, double-blind trial in which adult patients received emergency procedural sedations with ketamine or ketofol. Our primary outcome was the proportion of unpleasant recovery reactions. Other outcomes were frequency of interventions required by these recovery reactions, rates of respiratory or hemodynamic events, emesis, and satisfaction of patients as well as providers. A total of 152 patients completed the study, 76 in each arm. Compared with ketamine, ketofol determined a 22% reduction in recovery reactions incidence (p ketamine. We found a significant reduction in recovery reactions and emesis frequencies among adult patients receiving emergency procedural sedations with ketofol, compared with ketamine. © 2017 by the Society for Academic Emergency Medicine.

  1. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study

    DEFF Research Database (Denmark)

    Hauge, Anne W; Asghar, Mohammed S; Schytz, Henrik W

    2009-01-01

    BACKGROUND: Migraine with aura is thought likely to be caused by cortical spreading depression (CSD). Tonabersat inhibits CSD, and we therefore investigated whether tonabersat has a preventive effect in migraine with aura. METHODS: In this randomised, double-blind, placebo-controlled crossover...... trial, 40 mg tonabersat once daily was compared with matched placebo in patients who had at least one aura attack per month during the past 3 months. Randomisation was by computer-generated list. Patients kept a detailed diary to enable objective diagnosis of each attack as migraine with aura, migraine...... without aura, or other type of headache. Primary endpoints were a reduction in aura attacks with or without headache and a reduction in migraine headache days with or without an aura. Analysis was per protocol. This trial is registered, number NCT00332007. FINDINGS: 39 patients were included in the study...

  2. Effects of training and of verapamil on exercise capacity in patients recovering from myocardial infarction. A double-blind study.

    Science.gov (United States)

    Rossi, P; Giordano, A; Tamiz, A; Schiavo, B; Minuco, G

    1979-01-01

    Physical training causes an increase of aerobic capacity in normal and cardiac patients. The influences of training plus placebo and training plus verapamil have been studied in a double-blind randomized trial on 40 patients recovering from actue myocardial infarction. The two groups were comparable as to clinical characteristics, initial work capacity, and amount of stress tolerated during the training sessions. The training produced a significant increase of total work capacity and maximum VO2, in both groups; the difference between the means of the two groups was not significant. The variation of heart rate, rate pressure product at different work loads and cardiac volume after training were significantly lower in the verapamil group. The anginal threshold did not change in the placebo group and showed a trend to increase in patients treated with verapamil. These results suggest that carefully observed rehabilitation markedly improves the physical capacity of the patients after acute myocardial infarction. Such improvement is enhanced by treatment with verapamil.

  3. Comparison of Moisturizing Creams for the Prevention of Atopic Dermatitis Relapse: A Randomized Double-blind Controlled Multicentre Clinical Trial.

    Science.gov (United States)

    Åkerström, Ulf; Reitamo, Sakari; Langeland, Tor; Berg, Mats; Rustad, Lisbeth; Korhonen, Laura; Lodén, Marie; Wirén, Karin; Grände, Mats; Skare, Petra; Svensson, Åke

    2015-05-01

    Atopic dermatitis (AD) affects adults and children and has a negative impact on quality of life. The present multicentre randomized double-blind controlled trial showed a barrier-improving cream (5% urea) to be superior to a reference cream in preventing eczema relapse in patients with AD (hazard ratio 0.634, p = 0.011). The risk of eczema relapse was reduced by 37% (95% confidence interval (95% CI) 10-55%). Median time to relapse in the test cream group and in the reference cream group was 22 days and 15 days, respectively (p = 0.013). At 6 months 26% of the patients in the test cream group were still eczema free, compared with 10% in the reference cream group. Thus, the barrier-improving cream significantly prolonged the eczema-free time compared with the reference cream and decreased the risk of eczema relapse. The test cream was well tolerated in patients with AD.

  4. Pre-emptive triple analgesia protocol for tonsillectomy pain control in children: double-blind, randomised, controlled, clinical trial.

    Science.gov (United States)

    El-Fattah, A M A; Ramzy, E

    2013-04-01

    This double-blind, controlled, parallel-group study was designed to determine the efficacy of pre-emptive triple analgesia for paediatric post-tonsillectomy pain management. One hundred and thirty-five children were randomised into two groups: pre-emptive triple analgesia (n = 55) and control (n = 80). Pain was assessed using a visual analogue scale (in hospital) and the Parent's Postoperative Pain Measure (at home), and scores recorded. Visual analogue scale scores on awakening and for 6 hours post-surgery were significantly better in the study group than the control group (p Measure scores of control group children were significantly higher within the first 3 post-operative days (p = 0.000), with a greater percentage of children experiencing significant pain and requiring more analgesia. The proposed multimodal, pre-emptive analgesia protocol for paediatric post-tonsillectomy pain results in less post-operative pain, both in hospital or at home.

  5. Treatment of cryptorchidism with human chorionic gonadotropin or gonadotropin releasing hormone. A double-blind controlled study of 243 boys

    DEFF Research Database (Denmark)

    Christiansen, P; Müller, J; Buhl, S

    1988-01-01

    We have conducted a modified double-blind study on the effect of human chorionic gonadotropin (hCG), gonadotropin releasing hormone (GnRH) and placebo on bilateral and unilateral maldescended testes. One hundred and fifty-five boys with bilateral and 88 boys with unilateral cryptorchidism fulfilled...... the inclusion criteria and completed the treatment protocol. The boys were between 1 and 13 years of age. hCG was administered as intramuscular injections twice weekly for 3 weeks. GnRH and placebo were given intranasally. hCG was superior to GnRH and placebo in the treatment of bilateral maldescended testes (p...... = 0.0009). Both testes descended in 25% of the boys following treatment with hCG, and improvement in the position of the testes was obtained in a further 25% of the cases. hCG administration resulted in complete testicular descent in 14% of boys with unilateral cryptorchidism compared with 3 and 0...

  6. Acute neurocognitive response to methylphenidate among survivors of childhood cancer: a randomized, double-blind, cross-over trial.

    Science.gov (United States)

    Conklin, Heather M; Khan, Raja B; Reddick, Wilburn E; Helton, Susan; Brown, Ronald; Howard, Scott C; Bonner, Melanie; Christensen, Robbin; Wu, Shengjie; Xiong, Xiaoping; Mulhern, Raymond K

    2007-10-01

    To investigate the acute efficacy and adverse side effects of methylphenidate (MPH) among survivors of childhood cancer [acute lymphoblastic leukemia (ALL) or brain tumor (BT)] with learning impairments. Participants (N = 122) completed a two-day, in-clinic, double-blind, cross-over trial during which they received MPH (0.60 mg/kg of body weight) and placebo that were randomized in administration order across participants. Performance was evaluated using measures of attention, memory, and academic achievement. A significant MPH versus placebo effect was revealed on a measure of attention, cognitive flexibility, and processing speed (Stroop Word-Color Association Test). Male gender, older age at treatment, and higher intelligence were predictive of better medication response. No significant differences were found for number or severity of adverse side effects as a function of active medication. MPH shows some neurocognitive benefit and is well tolerated by the majority of children surviving ALL and BT.

  7. Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study.

    Science.gov (United States)

    Benussi, Alberto; Koch, Giacomo; Cotelli, Maria; Padovani, Alessandro; Borroni, Barbara

    2015-10-01

    Numerous studies have highlighted the possibility of modulating the excitability of cerebellar circuits using transcranial direct current stimulation. The present study investigated whether a single session of cerebellar anodal transcranial direct current stimulation could improve symptoms in patients with ataxia. Nineteen patients with ataxia underwent a clinical and functional evaluation pre- and post-double-blind, randomized, sham, or anodal transcranial direct current stimulation. There was a significant interaction between treatment and time on the Scale for the Assessment and Rating of Ataxia, on the International Cooperative Ataxia Rating Scale, on the 9-Hole Peg Test, and on the 8-Meter Walking Time (P cerebellar transcranial direct current stimulation can transiently improve symptoms in patients with ataxia and might represent a promising tool for future rehabilitative approaches. © 2015 International Parkinson and Movement Disorder Society.

  8. Efficacy evaluation of a cosmetic slimming treatment for the waist and hips: a double-blind study.

    Science.gov (United States)

    2015-01-01

    The aim of this study was to evaluate by clinical and noninvasive instrumental evaluations the efficacy and tolerance of a cosmetic topical slimming treatment specific for light/moderate adipose pannicula at the level of the waist and hips. The protocol was performed as a double-blind active vs placebo trial in 110 volunteers for a period of 4 weeks, with an additional visit 4 weeks after the last product application. The following clinical/instrumental evaluation was performed during the visit: clinical assessment of hip-abdomen adipose pannicula, circumference measurements, ultrasonographic evaluation of adipose pannicula thickness, and plicometry. At the end of treatment, the slimming activity of the study product resulted in clinically different results than placebo, determined by a significant decrease in abdomen/hips circumferences and considerable reduction of abdomen/hips adipose pannicula thickness. The tolerability of the product was good and the enrolled volunteers expressed their full satisfaction with the studied product.

  9. Efficacy of a topical cosmetic slimming treatment for postmenopausal women: a randomized, double-blind, placebo controlled trial.

    Science.gov (United States)

    Pluchino, N; Santoro, A N; Sparavigna, A; Vesnaver, R; Cenni, A; Oliva, M; Genazzani, A R

    2013-02-01

    The aim of this paper was to evaluate by clinical and non-invasive instrumental evaluations, the efficacy and the tolerance of a cosmetic slimming treatment for menopausal women used topically (for at least 3 years) under dermatological control. A controlled double blind, randomised study was performed to compare the slimming efficacy of the cosmetic slimming treatment versus placebo after 4 weeks of treatment. Cosmetic slimming treatment twice a day for 4 weeks reduced abdomen and hips fat, with no significant variation in body weight in comparison with the placebo. The present study evidenced the clinical effectiveness and women satisfaction of a slimming treatment specifically studies for postmenopausal adipose tissue with potential interesting consequences on measures of quality of life and on health-care programs.

  10. A DOUBLE-BLIND, PLACEBO-CONTROLLED EVALUATION OF THE ANXIOLYTIC EFFICACY FF AN ETHANOLIC EXTRACT OF WITHANIA SOMNIFERA

    Science.gov (United States)

    Andrade, Chittaranjan; Aswath, Anitha; Chaturvedi, S.K.; Srinivasa, M.; Raguram, R.

    2000-01-01

    A double-blind, placebo-controlled study was conducted to evaluate the efficacy an ethanolic extract of Aswagandha (Withania somnifera), in patients with ICD-10 anxiety disorders. The sample comprised 39 subjects, of whom 20 received the drug and 19 received placebo. The two groups were sociodemographically and clinically similar at baseline. At 2 and 6 weeks follow-up, data from approximately 85% of patients in each group were available for analysis. Statistical trends favouring the drug were observed at both time points. At 6 weeks, significantly more patients met a priori response criteria in the drug group (88.2%) as compared with the placebo group (50%). The drug was well-tolerated and did not occasion more adverse effects than did placebo. It is concluded that this ethanolic extract of Withania somnifera has useful anxiolytic potential and merits further investigation. PMID:21407960

  11. Effects of sertindole on cognition in clozapine-treated schizophrenia patients - a double-blinded, randomized, placebo-controlled trial

    DEFF Research Database (Denmark)

    Nielsen, R E; Levander, S; Nielsen, Jimmi

    . Method:  A 12-week, double-blinded, randomized, placebo-controlled, augmentation study of patients treated with clozapine. Participants were randomized 1:1 to receive 16 mg of sertindole or placebo as adjunctive treatment to clozapine. Results:  Participants displayed substantial cognitive deficits......Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Objective:  To assess the cognitive effects of sertindole augmentation in clozapine-treated patients diagnosed with schizophrenia. Cognition is secondary outcome of the trial...... changes in cognitive test performance, and found no significant correlations. Conclusion:  The clozapine-treated patients displayed marked cognitive deficits at baseline. Adding sertindole did not improve or worsen cognitive functioning, which is in line with previous negative studies of the effect...

  12. [Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

    Science.gov (United States)

    Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

    2015-04-01

    To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  13. Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Franciane Schneider

    2015-04-01

    Full Text Available OBJECTIVE To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. METHOD This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27 and experimental (24. RESULTS There is statistically significant evidence (p-value = 0.0120 that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402. CONCLUSION Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  14. Botulinum toxin type A-a novel treatment for provoked vestibulodynia? Results from a randomized, placebo controlled, double blinded study

    DEFF Research Database (Denmark)

    Petersen, Christina Damsted; Giraldi, Annamaria; Lundvall, Lene

    2009-01-01

    INTRODUCTION: Vestibulodynia is an increasingly recognized problem among women and is often difficult to treat. AIM: This randomized, double blinded, placebo-controlled study aimed to evaluate the efficacy of Botox in the treatment of vestibulodynia. METHODS: Sixty-four women were randomized...... to receive Botox (N = 32) or saline placebo (N = 32). Botulinum toxin A (20 I.E.) diluted in 0.5 mL saline or 0.5 mL saline was injected in the musculus bulbospongiosus at baseline. MAIN OUTCOME MEASURES: Pain was measured monthly on a visual analog scale (VAS) Likert scale. Sexual function was measured...... using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale at baseline and at 3 and 6 months follow up. Quality of life was measured using the 36-item short-form (SF-36). RESULTS: Sixty women (94%) completed the 6 months follow up. Both Botox and placebo produced significantly...

  15. Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

    Science.gov (United States)

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

    2014-02-01

    To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial

    DEFF Research Database (Denmark)

    Nøjgaard, Camilla; Hornum, Mads; Elkjaer, Margarita

    2009-01-01

    . DESIGN/PATIENTS: A randomized, double-blind, placebo-controlled multicenter study including patients from 14 European centers was performed. A total of 820 patients were entered; 806 were randomized. INTERVENTION: The active drug was transdermal GN (Discotrine/Minitran, 3M Pharma) 15 mg/24 hours; placebo...... with the PL group was not statistically significant (P = .11). Thirteen had mild pancreatitis (4 in the GN group, 9 in the PL group), 26 had moderate pancreatitis (9 in the GN group, 17 in the PL group), and 8 had severe pancreatitis (5 in the GN group, 3 in the PL group). Headache (P hypotension...... (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure. CONCLUSIONS: The trial showed...

  17. omega-3 Fatty acid treatment of women with borderline personality disorder: a double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Zanarini, Mary C; Frankenburg, Frances R

    2003-01-01

    The purpose of this study was to compare the efficacy of ethyl-eicosapentaenoic acid (E-EPA) and placebo in the treatment of female subjects with borderline personality disorder. The authors conducted an 8-week, placebo-controlled, double-blind study of E-EPA in 30 female subjects meeting Revised Diagnostic Interview for Borderlines and DSM-IV criteria for borderline personality disorder. Twenty subjects were randomly assigned to 1 g of E-EPA; 10 subjects were given placebo. Ninety percent of those in both groups completed all 8 weeks of the trial. Analyses that used random-effects regression modeling and controlled for baseline severity showed E-EPA to be superior to placebo in diminishing aggression as well as the severity of depressive symptoms. The results of this study suggest that E-EPA may be a safe and effective form of monotherapy for women with moderately severe borderline personality disorder.

  18. Double-blind, placebo-controlled study of dialectical behavior therapy plus olanzapine for borderline personality disorder.

    Science.gov (United States)

    Soler, Joaquim; Pascual, Juan Carlos; Campins, Josefa; Barrachina, Judith; Puigdemont, Dolors; Alvarez, Enrique; Pérez, Victor

    2005-06-01

    The aim of this study was to determine the efficacy and safety of dialectical behavior therapy plus olanzapine compared with dialectical behavior therapy plus placebo in patients with borderline personality disorder. Sixty patients with borderline personality disorder were included in a 12-week, double-blind, placebo-controlled study. All patients received dialectical behavior therapy and were randomly assigned to receive either olanzapine or placebo following a 1-month baseline period. Seventy percent of the patients completed the 4-month trial. Combined treatment showed an overall improvement in most symptoms studied in both groups. Olanzapine was associated with a statistically significant improvement over placebo in depression, anxiety, and impulsivity/aggressive behavior. The mean dose of olanzapine was 8.83 mg/day. A combined psychotherapeutic plus pharmacological approach appears to lower dropout rates and constitutes an effective treatment for borderline personality disorder.

  19. Caffeine improves endurance in 75-year old citizens. A randomized, double-blind, placebo-controlled, cross-over study

    DEFF Research Database (Denmark)

    Buchard Nørager, Charlotte; Jensen, Martin Bach; Madsen, Mogens Rørbæk

    2005-01-01

    This study investigated the effect of caffeine on physical performance in healthy citizens aged ≥70 yr. The randomized, double-blind, placebo-controlled, crossover study was conducted in 15 men and 15 women recruited by their general practitioner. Participants abstained from caffeine for 48 h...... and were randomized to receive one capsule of placebo and then caffeine (6 mg/kg) or caffeine and then placebo with 1 wk in between. One hour after intervention, we measured reaction and movement times, postural stability, walking speed, cycling at 65% of expected maximal heart rate, perceived effort...... during cycling, maximal isometric arm flexion strength, and endurance. Analysis was by intention to treat, and P Caffeine increased cycling endurance by 25% [95% confidence interval (CI): 13–38; P = 0.0001] and isometric arm flexion endurance by 54% (95% CI: 29–83; P...

  20. A double-blind trial of ethamsylate in the treatment of primary and intrauterine-device menorrhagia.

    Science.gov (United States)

    Harrison, R F; Cambell, S

    1976-08-07

    22 patients complaining of primary menorrhagia or menorrhagia associated with an intrauterine device (I.U.C.D.) were studied in a double blind trial with crossover of ethamsylate and placebo. Acutal menstrual blood-losses were calculated from the iron content of used sanitary material during one pre-trail menstrual period and four trial menstrual periods, during which patients received ethamsylate ("Dicynene") treatment during two menstrual cycles and placebo during two cycles. During ethamsylate treatment the mean menstrual blood-loss was reduced by 50% in patients with primary menorrhagia and by 19% in patients with an I.U.C.D. This difference between the two groups is probably accounted for by the differing values of initial blood-loss which was significantly higher in the group with primary menorrhagia. Tampon usage and the duration of bleeding were not significantly altered by ethamsylate treatment. Reported side-effects, which were not serious, were equally common during ethamsylate and placebo treatment.

  1. Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: Study protocol for a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Tran, Marie Thi Dao; Skovbjerg, Sine; Arendt-Nielsen, Lars

    2013-01-01

    a promising new treatment for refractory depression and can be targeted at the brain, thereby activating biochemical cell processes.Methods/Design: In a parallel, randomized, double-blind, placebo-controlled trial conducted at the Danish Research Centre for Chemical Sensitivities, the effects of PEMF in MCS...... follow-up according to a predefined timetable. The primary outcome will be a measurement of the impact of MCS on everyday life. The secondary outcomes will be measurements of MCS symptoms, psychological distress (stress, anxiety or depressive symptoms), capsaicin-induced secondary punctate hyperalgesia......, immunological markers in serum, and quality of life.Discussion: This trial will assess the effects of PEMF therapy for MCS. Currently, there is no treatment with a documented effect on MCS, and in terms of healthcare there is very little to offer these patients. There is thus a great need for well...

  2. A double blind trial to assess the value of alclofenac compared with phenylbutazone in the management of rheumatoid arthritis.

    Science.gov (United States)

    Chamberlain, M A; Wright, V

    1975-01-01

    A double-blind cross-over study using a double placebo technique was employed to compare the effectiveness of daily alclofenac 3 g and phenylbutazone 300 mg in rheumatoid arthritis. (2) Thirty-one patients with classical or definite rheumatoid arthritis entered the trial. Twenty-three patients completed the trial; eight patients were withdrawn while on alclofenac, six developing a rash and two having inadequate analgesia. (3) Relief of pain on both drugs was comparable. (4) When questioned at the end of the trial, sixteen patients preferred phenylbutazone, four preferred alclofenac. (5) No significant changes in laboratory values were found, apart from a slight mean fall in haemoglobin on phenylbutazone. (6) There were significantly more side effects on alclofenac and rashes were particularly prominent. PMID:237493

  3. Efficacy of topical chamomile management vs. placebo in patients with oral lichen planus: a randomized double-blind study.

    Science.gov (United States)

    Lopez Jornet, P; Aznar-Cayuela, C

    2016-10-01

    The purpose of this study was to compare the clinical therapeutic efficacy of topical applications of chamomile vs. a placebo for treating oral lichen planus (OLP). This double-blind study, randomly divided 60 patients with OLP into two groups, 30 treated with 2% Chamaemelum nobile gel (0.5 mL/3 times a day) and 30 treated with a placebo (Trial Registration NCT02421770). A visual analogue scale was used to rate pain, itching and burning sensation, and Thongprasom Index, the Oral Health Impact Profile 14 (OHIP-14) and the Hospital Anxiety-Depression Scale. Patients were evaluated at baseline and after 4 weeks of treatment. Patients treated with chamomile showed significant improvements after 4 weeks for pain (P chamomile showed a partial or total response, while only five subjects (17%) in the placebo group showed any improvement. The topical application of 2% chamomile gel is an effective treatment for OLP. © 2016 European Academy of Dermatology and Venereology.

  4. Treatment of knee osteoarthritis with pulsed electromagnetic fields: a randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Thamsborg, G; Florescu, A; Oturai, P

    2005-01-01

    OBJECTIVE: The investigation aimed at determining the effectiveness of pulsed electromagnetic fields (PEMF) in the treatment of osteoarthritis (OA) of the knee by conducting a randomized, double-blind, placebo-controlled clinical trial. DESIGN: The trial consisted of 2h daily treatment 5 days per...... (WOMAC) questionnaire. RESULTS: Within group analysis revealed a significant improvement in ADL, stiffness and pain in the PEMF-treated group at all evaluations. In the control group there was no effect on ADL after 2 weeks and a weak significance was seen after 6 and 12 weeks. Significant effects were...... years using between group analysis revealed a significant improvement for stiffness on treated knee after 2 weeks, but this effect was not observed for ADL and pain. CONCLUSIONS: Applying between group analysis we were unable to demonstrate a beneficial symptomatic effect of PEMF in the treatment...

  5. Effect of a dentifrice containing aloe vera on plaque and gingivitis control: a double-blind clinical study in humans

    Directory of Open Access Journals (Sweden)

    Sílvia Morgana Araújo de Oliveira

    2008-08-01

    Full Text Available The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15 - dentifrice containing Aloe vera - or the control group (n=15 - fluoridated dentifrice. Plaque index (PI and gingival bleeding index (GBI were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01. The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice.

  6. Clinical effect of a herbal dentifrice on the control of plaque and gingivitis: a double-blind study

    Directory of Open Access Journals (Sweden)

    Pannuti Claudio Mendes

    2003-01-01

    Full Text Available The aim of this randomized, double-blind clinical trial was to evaluate the effect of the Paradontax dentifrice on the reduction of plaque and gingivitis. Subjects were randomly allocated into either the test group (n = 15, Paradontax or the control group (n = 15, standard dentifrice with fluoride. Plaque levels were measured using the Turesky modification of the Quigley & Hein Plaque Index (PI, and gingivitis was evaluated with the Gingival Index (GI. Subjects were asked to brush their teeth with the allocated dentifrice, three times a day, for 21 days. There was no significant difference between groups in relation to the PI and GI medians, at baseline and at the end of the 21-day period. There was no significant reduction in PI in either the test or control groups. There was a significant decrease in GI in the test group. The authors concluded that there was no difference between the dentifrices in the reduction of plaque and gingivitis.

  7. Timegadine: more than a non-steroidal for the treatment of rheumatoid arthritis. A controlled, double-blind study

    DEFF Research Database (Denmark)

    Egsmose, C; Lund, B; Andersen, R B

    1988-01-01

    Timegadine is a tri-substituted guanidine derivative which inhibits both arachidonate cyclo-oxygenase and lipoxygenase activity. In a 24-week randomized double-blind controlled trial, timegadine 500 mg/day was compared with naproxen 750 mg/day in two groups of 20 patients with active rheumatoid....... In the naproxen group, only the Ritchie index improved. Differences between treatments, when present, were always in favour of timegadine. Serum alkaline phosphatase rose during the first 8 weeks of treatment in the timegadine group. A transient rise was also seen in the naproxen group. The side effects reported...... were mainly gastrointestinal and allergic, the latter being more frequently found in the timegadine group. Timegadine is superior to naproxen in controlling disease activity in rheumatoid arthritis, and appears to possess disease-modifying properties....

  8. Efficacy and safety of Citrus sudachi peel in obese adults: A randomized, double-blind, pilot study

    Directory of Open Access Journals (Sweden)

    Masashi Akaike

    2014-07-01

    Full Text Available Objective: This study was undertaken to explore the efficacy and safety of Citrus sudachi peel for metabolic risk factors in obese male and female adults. Background: Citrus sudachi Hort. ex Shirai (Rutaceae, called “sudachi”, is a small, round, green citrus fruit that is mainly cultivated in Tokushima Prefecture in Japan. Our group reported that Citrus sudachi peel powder improved glucose tolerance and dyslipidemia in Zucher-fatty rats and reduced hyperglycemia and hypertriglyceridemia in GK diabetic rats. Materials and Methods: We conducted a randomized, double-blind, placebo-controlled trial in 40 participants with abdominal obesity and metabolic risk factors including hypertension, impaired glucose tolerance and elevated triglyceride levels. Participants were randomized to receive either tablets that contained 1.3 g dried Citrus sudachi peel powder or placebo tablets for 12 weeks. The sudachi peel group included 14 males and 5 females with a mean age of 54.5 years, and the placebo group included 18 males and 2 females with a mean age of 51.9 years. Results: Physical status including body weight, waist circumference and blood pressure and laboratory markers including metabolic parameters were not different at any observation point between the two groups. However, among participants with serum triglyceride levels of more than 120 mg/dl, body weight, waist circumference and serum triglyceride levels were significantly decreased at several observation points after the start of treatment in the sudachi peel group but not in the placebo group. No serious adverse events were observed in the sudachi peel group. Conclusions: Citrus sudachi peel has the potential effect to safely improve abdominal obesity and lower serum levels of TG in obese individuals with hypertriglyceridemia. A large-scale randomized, double-blind clinical study targeting subjects with both abdominal obesity and high TG levels is needed to confirm the metabolic effects of

  9. Early report of randomized double blind clinical trial of hormonal therapy of carcinoma of prostate (CAP stage D2

    Directory of Open Access Journals (Sweden)

    Jagdeesh N Kulkarni

    2003-01-01

    Full Text Available Objectives: We herein report our experience of double blind randomized clinical trial comparing combined an-drogen blockade vs monotherapy in stage D2 CaP. Patients and Methods: Through June 1999 and May 2001, 100 patients of stage D2 CaP were randomized into placebo (44 and flutamide (42 group after orchiectomy in double blind fashion using the strictest criteria. All men and histological proof of CaP with bone metastasis dem-onstrated on imaging: bone scan and skeletal survey. These patients were further substratified according to number o f bony metastases into high volume disease (HVD>5 sites and low volume disease (LVD< 5 sites. The follow-up was at 3 month intervals. Criteria for decoding were clinical or serological progression and serious adverse effects. Results: Of the 100 patients recruited in the trial, 48 had HVD and 52 LVD. Treatmentwise they were almost equally distributed in flutamide group and placebo group. In the follow-up ranging front 6 to 24 months, 30 out of 100 patients (30% required decoding, reasons for decod-ing were progression of disease in 25 and serious adverse effects in remaining 5. These 25 patients were further analyzed according to treatment group, volume of metas-tasis pre -orchiectomy PSA and Gleason score. We observed that number of bony metastases had impact over the dura-tion of response to hormonal therapy. Discussion: We initiated this simple trial to address the issue of benefit of total androgen blockade over monotherapy in Indian population. In the initial analysis, we observed that treatment group did not make any impact over the response. While subset of prostate cancer with large number of bony metastases has higher propensity to convert into hormone refractory cancer Conclusions: Addition of flutamide did not provide ben-efit. We observed that large number of bony metastases had poor response to hormonal therapy, hence it requires large trial to substantiate this initial observation.

  10. Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rong Pei-Jing

    2012-12-01

    Full Text Available Abstract Background Depressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD is far from satisfactory. Vagus nerve stimulation (VNS is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response. This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention. Design One hundred twenty cases (60 males of volunteer patients with mild and moderate depression will be randomly divided into transcutaneous vagus nerve stimulation group (tVNS and sham tVNS group. The treatment period lasts 4 months and all clinical and physiological measurements are acquired at the beginning and the end of the treatment period. Discussion This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity, resulting in direct benefit to the patients suffering from these highly prevalent disorders. In addition, the results of this double-blinded clinical trial will shed new light on our understanding of acupuncture point specificity, and development of

  11. The effect of montelukast on wheal reactions in skin prick tests: a double-blind-placebo-controlled randomized trial.

    Science.gov (United States)

    Bulan, Keziban; Aydogan, Metin; Siraneci, Rengin; Aydogmus, Cigdem Yilmaz

    2013-10-01

    It is well-known that number of drugs may interfere with wheal reactions in skin prick test. However, the effect of long-term use of montelukast, a cystenil leukotriene receptor antagonist, on skin prick test hasn't been full elucidated. The aim of present study was to demonstrate the effect of montelukast on skin prick tests (SPT). This is a single-center, randomized, double-blinded, placebo-controlled study including two treatment periods with a wash-out interval. The subjects received montelukast (5 mg per day), fexofenadine HCl (60 mg per day) and placebo (lactose) with a double-blinded manner during 7- and 21-days treatment periods with a 14 days wash-out period. Dermatophagoides farinae (D. farinae) was used as the skin test material, while histamine as positive control and normal saline as negative control. Overall, 7 skin prick tests were performed at following time points: before treatment periods, on the last days of both treatment periods, 24 h after completion of treatment periods, and on the last day of 14-days interval. Sixty house dust mite (HDM) allergic children (23 girls and 37 boys) with allergic rhinitis and/or asthma completed the study. Mean age was 8.3 ± 2.0 years. In the fexofenadine group, a significant suppression was observed in post-treatment values when compared to baseline values in SPT with D. farinae (p = 0.019). In the montelukast group, no significant suppression was observed in SPT with D. farinae at all time points when compared to baseline. Our results showed that montelukast had no effect on measurements of SPT. Thus, we concluded that there is no need to discontinue the treatment in order to perform SPT in patients receiving montelukast, even in those on montelukast treatment for at least 21 days. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  12. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder.

    Science.gov (United States)

    Amsterdam, Jay D; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

    2009-08-01

    We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate generalized anxiety disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Sixty-one outpatients with mild to moderate GAD were enrolled, and 57 were randomized to either double-blind chamomile extract (n = 28) or placebo therapy (n = 29) for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory, Psychological Well Being, and Clinical Global Impression Severity scores and the proportion of patients with 50% reduction or more in baseline HAM-A score. We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (P = 0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or 3 adverse events or more was not significantly different between groups (P = 0.417). This is the first controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations.

  13. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ORAL MATRICARIA RECUTITA (CHAMOMILE) EXTRACT THERAPY OF GENERALIZED ANXIETY DISORDER

    Science.gov (United States)

    Amsterdam, Jay D.; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

    2013-01-01

    Objective We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate Generalized Anxiety Disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Materials & Methods 61 outpatients with mild to moderate GAD were enrolled and 57 were randomized to either double blind chamomile extract (n=28) or placebo (n=29) therapy for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory score, Psychological Well Being score, Clinical Global Impression Severity score, and the proportion of patients with ≥50% reduction in baseline HAM-A score. Results We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (p=0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or ≥3 adverse events was not significantly different between groups (p=0.417). Conclusion This is the first, controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations. PMID:19593179

  14. Caffeine intake, short bouts of physical activity, and energy expenditure: a double-blind randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    Pedro B Júdice

    Full Text Available PA energy expenditure (PAEE is the most variable component of Total Energy Expenditure (TEE and largely due to the balance of sedentary time (SedT and low intensity physical activity (LIPA. There has been an emergence for seeking an understanding of factors which determine variations in SedT, LIPA, and PAEE. Sedentary behavior and physical activity are relatively resistant to change by experimental dietary treatments and significant body weight changes. Although caffeine (Caf is by far the most heavily used nutritional agent ingested to promote a sense of vigor/alertness, it is still unknown if Caf is effective in increasing PAEE and physical activity. The aim of the study was to test the hypothesis that 2 daily doses of Caf (as a capsule to blind the treatment and divided equally during breakfast and lunch increase PAEE and TEE, and it would do so through increasing the frequent and brief bouts of physical activity (~1-5 min long through the day as measured by accelerometry. In 21 low Caf users (<100 mg day(-1, we used a double-blind crossover trial (ClinicalTrials.govID;NCT01477294 with two conditions (4-day each with a 3-day washout period randomly ordered as 5 mg kg(-1 day(-1 of Caf and maltodextrin as placebo (Plc. Resting energy expenditure (REE by indirect calorimetry, total energy expenditure (TEE from doubly labeled water, PAEE calculated as TEE-(REE+0.1TEE, and accelerometry measurements of both LIPA and MVPA were not different between conditions. However, regardless of caffeine or placebo, there were several significant relationships between brief bouts of LIPA and MVPA with PAEE. In conclusion, this double-blind study found that low and moderate-vigorous activity as well as the total volume of PAEE in free-living conditions is resistant to dietary caffeine intake that was equivalent to 5 cups of espresso or 7 cups of tea.ClinicalTrials.gov NCT01477294.

  15. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind,

  16. Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Jansen, Angelique G S C; Sanders, Elisabeth A M; Hoes, Arno W; van Loon, Anton M; Hak, Eelko

    2008-01-01

    OBJECTIVE: To evaluate the effects of influenza vaccination with or without heptavalent pneumococcal conjugate vaccination on respiratory tract infections (RTIs) in children. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled trial comprising 579 children age 18 to 72 months with

  17. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  18. A Double-Blind, Randomized, Placebo-Controlled Trial of Divalproex Extended-Release in the Treatment of Bipolar Disorder in Children and Adolescents

    Science.gov (United States)

    Wagner, Karen Dineen; Redden, Laura; Kowatch, Robert A.; Wilens, Timothy E.; Segal, Scott; Chang, Kiki; Wozniak, Patricia; Vigna, Namita V.; Abi-Saab, Walid; Saltarelli, Mario

    2009-01-01

    A double-blind study that involves 150 patients aged 10-17 on the effect of divalproex extended-release in the treatment of bipolar disorder shows that the drug was similar to placebo based on adverse events and that no treatment effect was observed in the drug. The drug is not suitable for treatment of youths with bipolar I disorder, mixed or…

  19. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    Science.gov (United States)

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  20. Does EEG-Neurofeedback Improve Neurocognitive Functioning in Children with Attention-Deficit/Hyperactivity Disorder? A Systematic Review and a Double-Blind Placebo-Controlled Study

    Science.gov (United States)

    Vollebregt, Madelon A.; van Dongen-Boomsma, Martine; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: The number of placebo-controlled randomized studies relating to EEG-neurofeedback and its effect on neurocognition in attention-deficient/hyperactivity disorder (ADHD) is limited. For this reason, a double blind, randomized, placebo-controlled study was designed to assess the effects of EEG-neurofeedback on neurocognitive functioning…

  1. A Randomized Double-Blind Study of Atomoxetine versus Placebo for Attention-Deficit/Hyperactivity Disorder Symptoms in Children with Autism Spectrum Disorder

    Science.gov (United States)

    Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.

    2012-01-01

    Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind treatment with 1.2 mg/kg/day atomoxetine or…

  2. Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in College Students with ADHD

    Science.gov (United States)

    DuPaul, George J.; Weyandt, Lisa L.; Rossi, Joseph S.; Vilardo, Brigid A.; O'Dell, Sean M.; Carson, Kristen M.; Verdi, Genevieve; Swentosky, Anthony

    2012-01-01

    Objective: To evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) was examined for ADHD participants over five…

  3. Brief Report: Oxytocin Enhances Paternal Sensitivity to a Child with Autism--A Double-Blind Within-Subject Experiment with Intranasally Administered Oxytocin

    Science.gov (United States)

    Naber, Fabienne B. A.; Poslawsky, Irina E.; van Ijzendoorn, Marinus H.; van Engeland, Herman; Bakermans-Kranenburg, Marian J.

    2013-01-01

    Oxytocin seems associated with parenting style, and experimental work showed positive effects of intranasally administered oxytocin on parenting style of fathers. Here, the first double-blind, placebo-controlled, within-subject experiment with intranasal oxytocin administration to fathers of children with autism spectrum disorder (ASD) is…

  4. The effect of barusiban, a selective oxytocin antagonist, in threatened preterm labor at late gestational age: a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Thornton, Steven; Goodwin, Thomas M; Greisen, Gorm

    2009-01-01

    OBJECTIVE: The objective of the study was to compare barusiban with placebo in threatened preterm labor. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled, multicenter study. One hundred sixty-three women at 34-35 weeks plus 6 days, and with 6 or more contractions of 30 second...

  5. Laxation of critically ill patients with lactulose or polyethylene glycol : a two-center randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    van der Spoel, Johan I; Oudemans-van Straaten, Heleen M; Kuiper, Michael A; van Roon, Eric N; Zandstra, Durk F; van der Voort, Peter H J

    2007-01-01

    OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study.

  6. Laxation of critically ill patients with lactulose or polyethylene glycol: a two-center randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    van der Spoel, Johan I.; Oudemans-van Straaten, Heleen M.; Kuiper, Michael A.; van Roon, Eric N.; Zandstra, Durk F.; van der Voort, Peter H. J.

    2007-01-01

    OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study.

  7. Combining insulin with metformin or an insulin secretagogue in non-obese patients with type 2 diabetes: 12 month, randomised, double blind trial

    DEFF Research Database (Denmark)

    Lund, Søren S; Tarnow, Lise; Frandsen, Merete

    2009-01-01

    OBJECTIVES: To study the effect of insulin treatment in combination with metformin or an insulin secretagogue, repaglinide, on glycaemic regulation in non-obese patients with type 2 diabetes. DESIGN: Randomised, double blind, double dummy, parallel trial. SETTING: Secondary care in Denmark between...

  8. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study

    NARCIS (Netherlands)

    Lindeboom, J. A. H.; Frenken, J. W. H.; Valkenburg, P.; van den Akker, H. P.

    2005-01-01

    Aim To determine the value of clindamycin prophylaxis in the prevention of postoperative wound infections in patients undergoing endodontic surgery. Methodology This study included 256 patients undergoing endodontic surgery in a prospective double-blind placebo-controlled trial comparing oral

  9. Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients : a double-blind, randomized cross-over study

    NARCIS (Netherlands)

    Buijs, Ciska; Mom, Constantijne H.; Willemse, Pax H. B.; Boezen, H. Marike; Maurer, J. Marina; Wymenga, A. N. Machteld; de Jong, Robert S.; Nieboer, Peter; de Vries, Elisabeth G. E.; Mourits, Marian J. E.

    Purpose Breast cancer patients with treatment-induced menopause experience frequent and severe hot flashes (HF). We compared venlafaxine and clonidine for the treatment of HF with regard to side effects, efficacy, quality of life and sexual functioning. Methods In a double-blind, cross-over study,

  10. A 1-year multicenter randomized double-blind comparison of repaglinide and glyburide for the treatment of type 2 diabetes. Dutch and German Repaglinide Study Group

    NARCIS (Netherlands)

    Wolffenbuttel, B H; Landgraf, R

    OBJECTIVE: Repaglinide is a newly developed oral blood glucose-lowering agent that exerts its effect by stimulating insulin secretion. This multicenter study was designed to compare the efficacy and safety of this drug with glyburide in a 1-year randomized double-blind study of outpatients with type

  11. The efficacy of heparinization in prolonging patency of arterial and central venous catheters in children: A randomized double-blind trial

    NARCIS (Netherlands)

    de Neef, M.; Heijboer, H.; van Woensel, J. B. M.; de Haan, R. J.

    2002-01-01

    This study evaluates the efficacy of heparinization in prolonging patency of arterial and central venous catheters in children. A randomized double-blind trial in a tertiary 10-bed pediatric intensive care unit was used to evaluate 300 children (age older than 4 weeks, younger than 18 years). Trial

  12. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - A double-blind, randomised, multicentre study in adults

    NARCIS (Netherlands)

    Klek, S.; Chambrier, C.; Singer, P.; Rubin, M.; Bowling, T.; Staun, M.; Joly, F.; Rasmussen, H.; Strauss, B.J.; Wanten, G.J.; Smith, R.; Abraham, A.; Szczepanek, K.; Shaffer, J.

    2013-01-01

    PRECIS: The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion

  13. A randomized, placebo-controlled, double-blind trial on sulfadoxine-pyrimethamine alone or combined with artesunate or amodiaquine in uncomplicated malaria.

    NARCIS (Netherlands)

    Mockenhaupt, F.P.; Ehrhardt, S.; Dzisi, S.Y.; Bousema, T.; Wassilew, N.; Schreiber, J.; Anemana, S.D.; Cramer, J.P.; Otchwemah, R.N.; Sauerwein, R.W.; Eggelte, T.A.; Bienzle, U.

    2005-01-01

    The therapeutic efficacy of sulfadoxine-pyrimethamine (SP) alone, SP plus amodiaquine (AQ), and SP plus artesunate (AS) was assessed in a randomized, placebo-controlled, and double-blind trial among 438 children with uncomplicated Plasmodium falciparum malaria in northern Ghana. Clinical and

  14. Lack of effect of doxycycline on disease activity and joint damage in patients with rheumatoid arthritis. A double blind, placebo controlled trial

    NARCIS (Netherlands)

    Laan, W. van der; Molenaar, E.; Ronday, K.; Verheijen, J.; Breedveld, F.; Greenwald, R.; Dijkmans, B.; Tekoppele, J.

    2001-01-01

    Objective. To investigate the effects of doxycycline on disease activity and joint destruction in patients with rheumatoid arthritis (RA). Methods. A 36 week double blind, placebo controlled crossover trial was conducted. Patients (n = 66) received 50 mg doxycycline or placebo twice a day during 12,

  15. A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision

    DEFF Research Database (Denmark)

    Friis-Møller, Alice; Agren, MS; Ostenfeld, U

    2006-01-01

    The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide...

  16. Does EEG-neurofeedback improve neurocognitive functioning in children with attention-deficit/hyperactivity disorder? A systematic review and a double-blind placebo-controlled study

    NARCIS (Netherlands)

    Vollebregt, M.A.; Dongen-Boomsma, M. van; Buitelaar, J.K.; Slaats-Willemse, D.I.E.

    2014-01-01

    BACKGROUND: The number of placebo-controlled randomized studies relating to EEG-neurofeedback and its effect on neurocognition in attention-deficient/hyperactivity disorder (ADHD) is limited. For this reason, a double blind, randomized, placebo-controlled study was designed to assess the effects of

  17. EMLA for pain relief during arterial cannulation. A double-blind, placebo-controlled study of a lidocaine-prilocaine cream

    DEFF Research Database (Denmark)

    Nilsson, A; Danielson, K; Engberg, G

    1990-01-01

    The aim of the study was to evaluate the effect of a lidocaine-prilocaine cream (EMLA cream, Astra) in relieving pain during arterial cannulation. The study had a random, double-blind, placebo-controlled design and included altogether 90 patients. All the patients were premedicated with an opioid...

  18. A randomized double-blind study of atomoxetine versus placebo for attention-deficit/hyperactivity disorder symptoms in children with autism spectrum disorder.

    NARCIS (Netherlands)

    Harfterkamp, M.; Loo-Neus, G. van de; Minderaa, R.B.; Gaag, R.J. van der; Escobar, R.; Schacht, A.; Pamulapati, S.; Buitelaar, J.K.; Hoekstra, P.J.

    2012-01-01

    OBJECTIVE: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. METHOD: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind

  19. Reducing wound pain in venous leg ulcers with Biatain Ibu: A randomized, controlled double-blind clinical investigation on the performance and safety

    DEFF Research Database (Denmark)

    Gottrup, F.; Jorgensen, B.; Karlsmark, T.

    2008-01-01

    Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ib...

  20. Development of a standardized low-dose double-blind placebo-controlled challenge vehicle for the EuroPrevall project.

    NARCIS (Netherlands)

    Cochrane, S.A.; Salt, L.J.; Wantling, E.; Rogers, A.; Coutts, J.; Ballmer-Weber, B.K.; Fritsche, P.; Fernandez-Rivas, M.; Reig, I.; Knulst, A.; Le, T.M.; Asero, R.; Beyer, K.; Golding, M.; Crevel, R. van; Mills, E.N.; Mackie, A.R.

    2012-01-01

    BACKGROUND: Double-blind placebo-controlled food challenge (DBPCFC) is the gold standard for diagnosing food allergy. Standardized materials and protocols are essential for comparing DBPCFC results for multicentre studies such as EuroPrevall. This required the development and piloting of a

  1. Randomized double-blind controlled Phase I/IIa trial to assess the efficacy of malaria vaccine PfCS102 to protect against challenge with P. falciparum.

    NARCIS (Netherlands)

    Genton, B.; D'Acremont, V.; Lurati-Ruiz, F.; Verhage, D.F.; Audran, R.; Hermsen, C.C.; Wolters, L.; Reymond, C.; Spertini, F.; Sauerwein, R.W.

    2010-01-01

    The aim of this Phase I/IIa double-blind controlled trial was to test the efficacy of the sporozoite-based malaria vaccine PfCS 282-383 (PfCS102) to protect against Plasmodium falciparum parasitaemia. 16 volunteers were randomized to receive twice 30 mug of PfCS102 formulated in Montanide ISA 720 or

  2. Effects of interpleurally administered bupivacaine 0.5% on opioid analgesic requirements and endocrine response during and after cholecystectomy: a randomized double-blind controlled study

    NARCIS (Netherlands)

    Rademaker, B. M.; Sih, I. L.; Kalkman, C. J.; Henny, C. P.; Filedt Kok, J. C.; Endert, E.; Zuurmond, W. W.

    1991-01-01

    In 30 patients undergoing cholecystectomy, a randomized double-blind saline-controlled study was performed using interpleural 0.5% bupivacaine with or without epinephrine (5 micrograms.ml-1) in combination with 0.8% halothane inspired concentration in oxygen. The aim of the study was to investigate

  3. Efficacy of treatment in older depressed patients: a systematic review and meta-analysis of double-blind randomized controlled trials with antidepressants.

    Science.gov (United States)

    Kok, Rob M; Nolen, Willem A; Heeren, Thea J

    2012-12-10

    This systematic review evaluated all published double-blind, randomized controlled antidepressant trials (RCTs) of acute phase treatment of older depressed patients. Meta-analyses were conducted in 51 double-blind RCTs of antidepressants in older patients. The results were also compared with 29 double-blind RCTs that did not produce extractable data to enter the meta-analysis. All classes of antidepressant (TCA's, SSRIs and other antidepressants) were more effective than placebo in achieving response. In achieving remission however, only pooling all 3 classes of antidepressants together showed a statistically significant difference from placebo. No differences were found in remission or response rates between classes of antidepressants. TCAs were also equally effective compared with SSRIs in achieving response in more severely depressed patients. The numbers needed to treat (NNT) were 14.4 (95% CI 8.3-50) for one additional remission to antidepressants compared with placebo and 6.7 (95% CI 4.8-10) for response. The results of the double-blind RCTs that did not produce extractable data to enter the meta-analysis were in concordance with the RCTs that were included in the meta-analysis. Only 4 RCTs were found that have not been published. Few studies have focused on severely depressed older people. Antidepressant treatment in older depressed patients is efficacious. We could not demonstrate differences in effectiveness between different classes of antidepressants; this was also the case in more severely depressed patients. Copyright © 2012 Elsevier B.V. All rights reserved.

  4. The safety and efficacy of subcutaneous birch pollen immunotherapy - a one-year, randomised, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Bødtger, Uffe; Poulsen, L K; Jacobi, H H

    2002-01-01

    BACKGROUND: There is only very limited documentation of the efficacy and safety of high-dose subcutaneous birch pollen immunotherapy (IT) in double-blind, placebo-controlled (DBPC) studies. Birch pollen is a major cause of allergic morbidity in northern Europe and in eastern parts of North America...

  5. Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the randomized, double-blind, placebo-controlled study of fesoterodine in an aging population trial

    NARCIS (Netherlands)

    Wagg, Adrian; Khullar, Vik; Marschall-Kehrel, Daniela; Michel, Martin C.; Oelke, Matthias; Darekar, Amanda; Bitoun, Caty E.; Weinstein, David; Osterloh, Ian

    2013-01-01

    To assess the efficacy and safety of flexible-dose fesoterodine in elderly adults with overactive bladder (OAB). Twelve-week, randomized, double-blind, placebo-controlled trial. Sixty-one outpatient clinics in Europe, Israel, and Turkey. Seven hundred ninety-four individuals aged 65 and older (47%

  6. Omega 3/6 Fatty Acids for Reading in Children: A Randomized, Double-Blind, Placebo-Controlled Trial in 9-Year-Old Mainstream Schoolchildren in Sweden

    Science.gov (United States)

    Johnson, Mats; Fransson, Gunnar; Östlund, Sven; Areskoug, Björn; Gillberg, Christopher

    2017-01-01

    Background: Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods: We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active…

  7. Randomized, double-blind, placebo-controlled study to evaluate the effect of two dosing regimens of darbepoetin alfa in patients with heart failure and anaemia

    NARCIS (Netherlands)

    van Veldhuisen, Dirk J.; Dickstein, Kenneth; Cohen-Solal, Alain; Lok, Dirk J. A.; Wasserman, Scott M.; Baker, Nigel; Rosser, Dylan; Cleland, John G. F.; Ponikowski, Piotr

    Aims Anaemia is common in chronic heart failure (CHF) and associated with worse outcome. This randomized, double-blind, placebo -controlled study evaluated the effect of two darbepoetin alfa dosing regimens on haemoglobin (Hb) rate of rise and clinical effects in patients with CHF and anaemia.

  8. Efficacy of different doses of cimetidine in the treatment of reflux esophagitis. A review of three large, double-blind, controlled trials

    NARCIS (Netherlands)

    Tytgat, G. N.; Nicolai, J. J.; Reman, F. C.

    1990-01-01

    Four different cimetidine dosage regimens--800 mg u.i.d. HS or nocte, 800 mg u.i.d. dinnertime, 400 mg q.i.d., and 800 mg b.i.d.--were investigated for the treatment of reflux esophagitis in three independent large-scale, double-blind, controlled multicenter trials in which more than 1100 patients

  9. MUCIN-CONTAINING LOZENGES IN THE TREATMENT OF INTRAORAL PROBLEMS ASSOCIATED WITH SJOGRENS-SYNDROME - A DOUBLE-BLIND CROSSOVER STUDY IN 42 PATIENTS

    NARCIS (Netherlands)

    SGRAVENMADE, EJ; VISSINK, A

    Irreversible hyposalivation is a common sequela of Sjogren's syndrome and may lead to a decreased quality of the patient's life. The aim of this study was to evaluate the efficacy and therapeutic value of mucin-containing lozenges in reducing patients' complaints of hyposalivation. In a double-blind

  10. The effects of alcohol mixed with energy drink (AMED) on subjective intoxication and alertness : results from a double-blind placebo-controlled clinical trial

    NARCIS (Netherlands)

    van de Loo, Aurora J A E; van Andel, Nienke; van Gelder, Charlotte A G H; Janssen, Boris S G; Titulaer, Joep; Jansen, Jimmy; Verster, Joris C

    2016-01-01

    OBJECTIVE: The purpose of this double blind placebo controlled study was to examine if specific effects on subjective intoxication and alertness-sleepiness ratings could be demonstrated after consuming alcohol mixed with energy drink (AMED) when compared to consuming alcohol only (AO). METHODS: 56

  11. Efficacy of nicorandil versus propranolol in mild stable angina pectoris of effort: a long-term, double-blind, randomized study

    NARCIS (Netherlands)

    Meeter, K.; Kelder, J. C.; Tijssen, J. G.; Bucx, J. J.; Henneman, J. A.; Kerker, J. P.; Hugenholtz, P. G.

    1992-01-01

    Nicorandil is a potent coronary vasodilator. To assess its long-term antianginal effect, we designed a randomized, parallel double-blind trial of 6 weeks' duration comparing nicorandil (10 or 20 mg b.i.d.) with propranolol (40 or 80 mg t.i.d.). The study comprised 77 men with stable angina, no

  12. High phenylalanine levels directly affect mood and sustained attention in adults with phenylketonuria: a randomised, double-blind, placebo-controlled, crossover trial

    NARCIS (Netherlands)

    ten Hoedt, Amber E.; de Sonneville, Leo M. J.; Francois, Baudouin; ter Horst, Nienke M.; Janssen, Mirian C. H.; Rubio-Gozalbo, M. Estela; Wijburg, Frits A.; Hollak, Carla E. M.; Bosch, Annet M.

    2011-01-01

    The main debate in the treatment of Phenylketonuria (PKU) is whether adult patients need the strict phenylalanine (Phe)-restricted diet. Physicians and patients lack evidence-based guidelines to help them make well-informed choices. We have carried out the first randomised double-blind

  13. Is diltiazem effective in treating the symptoms of (tardive) dyskinesia in chronic psychiatric inpatients? A negative, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Loonen, A.J.M.; Verwey, H.A.; Roels, P.R.; Van Bavel, L.P.; Doorschot, C.H.

    1992-01-01

    Calcium channel blockers, antiarrhythmic drugs, such as verapamil and diltiazem, may decrease the symptoms of tardive dyskinesia. The efficacy and safety of administering 60 mg diltiazem hydrochloride, four times daily for a period of 3 weeks, was studied in a random, double-blind, crossover trial

  14. Laser therapy for onychomycosis in patients with diabetes at risk for foot complications : study protocol for a randomized, double-blind, controlled trial (LASER-1)

    NARCIS (Netherlands)

    Nijenhuis-Rosien, Leonie; Kleefstra, Nanne; Wolfhagen, Maurice J.; Groenier, Klaas H.; Bilo, Henk J. G.; Landman, Gijs W. D.

    2015-01-01

    Background: In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in

  15. A prospective, randomized, double-blinded, placebo-controlled trial of empirical teicoplanin in febrile neutropenia with persistent fever after imipenem monotherapy

    NARCIS (Netherlands)

    Erjavec, Z; de Vries-Hospers, HG; Halie, RM; Daenen, S

    Glycopeptide antibiotics are used extensively in the empirical treatment of febrile patients with neutropenia. To come to a more rational and restricted application of these expensive drugs and to reduce the risk of emergence of resistance, we carried out a prospective, double-blinded,

  16. Low doses of mirtazapine or quetiapine for transient insomnia : A randomised, double-blind, cross-over, placebo-controlled trial

    NARCIS (Netherlands)

    Karsten, Julie; Hagenauw, Loes A.; Kamphuis, Jeanine; Lancel, Marike

    Low doses of the antidepressant mirtazapine or the neuroleptic quetiapine are often prescribed off-label for insomnia. However, studies on the effects on sleep and hangover effects the following day are scarce. In this randomised, double-blind, cross-over, placebo-controlled trial, the influence of

  17. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon

    NARCIS (Netherlands)

    Mathus-Vliegen, E. M.; Tytgat, G. N.; Veldhuyzen-Offermans, E. A.

    1990-01-01

    A prolonged randomized, prospective, double-blind, crossover study, including a sham-sham-treated group, was undertaken to evaluate the efficacy and safety of a 500-mL gastric bubble (Ballobes; DOT ApS, Rödovre, Denmark) as an adjunct to diet, physical training, and behavioral modification. Only

  18. A Randomized Double-Blind Study of Atomoxetine Versus Placebo for Attention-Deficit/Hyperactivity Disorder Symptoms in Children With Autism Spectrum Disorder

    NARCIS (Netherlands)

    Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.

    Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind

  19. RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN THE TREATMENT OF PATIENTS WITH SEPSIS SYNDROME - RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

    NARCIS (Netherlands)

    FISHER, C. J.; DHAINAUT, J. F. A.; Opal, S. M.; Pribble, J. P.; BALK, R. A.; SLOTMAN, G. J.; IBERTI, T. J.; RACKOW, E. C.; SHAPIRO, M. J.; GREENMAN, R. L.; REINES, H. D.; SHELLY, M. P.; THOMPSON, B. W.; LABRECQUE, J. F.; Catalano, M. A.; KNAUS, W. A.; Sadoff, J. C.; ASTIZ, M.; CARPATI, C.; BONE, R. C.; FREIDMAN, B.; MURE, A. J.; BRATHWAITE, C.; SHAPIRO, E.; MELHORN, L.; TAYLOR, R.; KEEGAN, M.; OBRIEN, J.; SCHEIN, R.; PENA, M.; WASSERLOUF, M.; OROPELLO, J.; BENJAMIN, E.; DELGUIDICE, R.; EMMANUEL, G.; LIE, T.; Anderson, L.; Marshall, J.; DEMAJO, W.; ROTSTEIN, O.; FOSTER, D.; Abraham, E.; MIDDLETON, H.; Perry, C.; LEVY, H.; FRY, D. E.; SIMPSON, S. Q.; CROWELL, R. E.; Neidhart, M.; Stevens, D.; COFFMAN, T.; NARASIMHAM, N.; MERRICK, D. K.; BERGQUIST, W.; MATZEL, K. E.; HUEBLER, M.; Foulke, G. E.; ALBERTSON, T. E.; WALBY, W. F.; ALLEN, R. P.; Baughman, R.; HASSELGREN, P. O.; Fink, M. P.; FAVORITO, F.; THOMPSON, B. T.; CORBIN, R.; SHELLHORSE, G. Y.; FRAZIER, A.; White, S.; GARRARD, C.; ACOURT, C.; STORER, S.; GERVICH, D. H.; FOSHE, D.; BRASE, R.; BAGDAHN, A.; COONEY, R.; Smith, J. S.; MARTIN, L. F.; Vincent, J. L.; Friedman, G.; Berlot, G.; FLETCHER, J. R.; WILLIAMS, M. D.; WRIGHT, T. F.; Johnson, S.; FEILD, C.; WOLF, K.; MACINTYRE, N.; DUBIN, H. G.; DURKIN, M. R.; DUBIN, P. K.; STAUBACH, K. H.; FEIN, A. M.; SCHULMAN, D. B.; NIEDERMAN, M. S.; CHALFIN, D. B.; van Leeuwen, P. A. M.; Boermeester, M. A.; Schneider, A. J.; BANDER, J.; IMM, A.; BERNARD, G.; Nelson, L.; Stroud, M.; SAFCSAK, K.; CERRA, F.; RINDAL, J.; Mann, H.; HALPERN, N.; SILVERSTEIN, J.; ALICEA, M.; Sibbald, W. J.; MARTIN, C. M.; RUTLEDGE, F. S.; PETTI, K.; RUSSELL, J. A.; KRUGER, R.; DRUMMOND, A.; LANGE, P.; SEIFERT, T.; DUROCHER, A.; TENAILLON, A.; BOITEAU, R.; LHERM, T.; Lowry, S. F.; Coyle, S. M.; Barie, P. S.; DEMARIA, E.; SNYDMAN, D. R.; SCHWAITZBERG, S. D.; NASRAWAY, S. A.; GRINDLINGER, J.; SUMMER, W.; DEBOISBLANC, B.; WAHL, M.; ALESTIG, K.; GROSSMAN, J.; MAKI, D.; PAZ, H. L.; Weiner, M.; BIHARI, D.; Campbell, D.; BLEICHNER, G.; DAHN, M. S.; LANGE, M. P. A.; Hall, J.; POHLMAN, A.; WENZEL, R. P.; GROSSERODE, M.; COSTIGAN, M.; MILESKI, W.; WEIGELT, J.; YESTON, N.; IRIZARRY, C.; Ross, J.; ROBBINS, J.; NIGHTINGALE, P.; OWEN, K.; SANDSTEDT, S.; Berg, S.; SIMON, G. L.; SENEFF, M. G.; CONRY, K. M.; ZIMMERMAN, J. L.; Dellinger, R. P.; Johnston, R.; ALLEE, P.; GRANDE, P. O.; MYHRE, E.; DHAINAUT, J. F.; HAMY, I.; Mira, J. P.; HARMON, J.; White, J.; MCKIE, L.; SILVERMAN, H.; TUMA, P.; Bennett, D.; PORTER, J. C.; LAURELL, M. H.; Jacobs, S.; ASH, S.; Stiles, D. M.; PRIOR, M. J.; KNATTERUD, G.; TERRIN, M.; KUFERA, J.; WILKENS, P.; RA, K.; MONROE, L.; SPRUNG, C.; HAMILTON, C. M.; MATTHAY, R.; MCCABE, W.; TONASCIA, J.; WIEDEMAN, H.; Wittes, J.; CAMPION, G. V.; CROFT, C. R.; LUSTICK, R.; LOOKABAUGH, J.; GORDON, G. S.; NOE, L.; BLOEDOW, D.; SMITH, C. G.; BRANNON, D.; KUSH, R.; NG, D.; MOORE, E.; BAZEMORE, K.; GALVAN, M.; Wagner, D.; HARRELL, F.; STABLEIN, D.

    1994-01-01

    Objective.-To further define the safety and efficacy of recombinant human interleukin 1 receptor antagonist (rhlL-1ra) in the treatment of sepsis syndrome. Study Design.-Randomized, double-blind, placebo-controlled, multicenter, multinational clinical trial. Population.-A total of 893 patients with

  20. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults

    DEFF Research Database (Denmark)

    Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre

    2013-01-01

    The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...

  1. The safety and efficacy of subcutaneous birch pollen immunotherapy - a one-year, randomised, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Bødtger, U; Poulsen, Lars K.; Jacobi, H H

    2002-01-01

    There is only very limited documentation of the efficacy and safety of high-dose subcutaneous birch pollen immunotherapy (IT) in double-blind, placebo-controlled (DBPC) studies. Birch pollen is a major cause of allergic morbidity in northern Europe and in eastern parts of North America....

  2. CT scan-evaluated outcome of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a randomised, multicentre, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Hannemann, P.F.; van Wezenbeek, M.R.; Kolkman, K.A.; Twiss, E.L.; Berghmans, C.H.; Dirven, P.A.; Brink, P.R.; Poeze, M.

    2014-01-01

    We hypothesised that the use of pulsed electromagnetic field (PEMF) bone growth stimulation in acute scaphoid fractures would significantly shorten the time to union and reduce the number of nonunions in a randomised, double-blind, placebo-controlled multicentre trial. A total of 102 patients (78

  3. Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women

    NARCIS (Netherlands)

    Dewulf, E.M.; Cani, P.D.; Claus, S.P.; Fuentes, S.; Puylaert, P.G.B.; Neyrinck, A.M.; Bindels, L.B.; Vos, de W.M.; Gibson, G.R.; Thissen, J.P.; Delzenne, N.M.

    2013-01-01

    OBJECTIVE: To highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans (ITF prebiotics) in obese women. METHODS: A double blind, placebo controlled, intervention study was performed with 30 obese women treated with ITF prebiotics

  4. A randomized trial of the topical effect of antifibrinolytic epsilon aminocaproic Acid on coronary artery bypass surgery without cardiopulmonary bypass.

    Science.gov (United States)

    Gurian, Danilo Bortolotto; Meneghini, Adriano; Abreu, Luiz Carlos de; Murad, Neif; Matos, Leandro Luongo de; Pires, Adilson Casemiro; Valenti, Vitor E; Breda, João Roberto

    2014-09-01

    We assessed the effect of the topical application of epsilon-aminocaproic antifibrinolytic acid (EACA) on the pericardium of patients submitted to coronary artery bypass graft (CABG) without the use of cardiopulmonary bypass (CPB). This is a prospective, randomized, and double-blind study. We evaluated 26 patients with chronic coronary heart disease indicated for CABG without CPB (EACA and placebo groups). The analysis of the postoperative hematological results showed no difference between groups in hemoglobin and hematocrit. There was no difference between the groups regarding the postoperative bleeding through the drains in the first 24 hours, 48 hours, and accumulated loss until removal of drains. The use of EACA in patients undergoing CABG without CPB presented no difference in the reduction of the amount of bleeding and the need for blood transfusions. © The Author(s) 2013.

  5. Heart bypass surgery - discharge

    Science.gov (United States)

    Off-pump coronary artery bypass - discharge; OPCAB - discharge; Beating heart surgery - discharge; Bypass surgery - heart - discharge; CABG - discharge; Coronary artery bypass graft - discharge; Coronary artery ...

  6. Quality of life in patients with leg ulcers: results from CHALLENGE, a double-blind randomised controlled trial.

    Science.gov (United States)

    Meaume, S; Dompmartin, A; Lok, C; Lazareth, I; Sigal, M; Truchetet, F; Sauvadet, A; Bohbot, S

    2017-07-02

    We recently showed the superiority of a matrix metalloproteinase (MMP) modulating dressing (foam impregnated with NOSF, nano-oligosaccharide factor) compared with a lipidocolloid matrix (TLC) control dressing in median wound area reduction (WAR). Here we report the results from the same study assessing the performance and safety of TLC-NOSF in the local management of venous leg ulcers (VLUs) or mixed leg ulcers and determining its impact on the patient's health-related quality of life (HRQoL). A superiority randomised double-blind controlled trial was conducted on patients presenting with a non-infected leg ulcer (VLUs or mixed leg ulcers) of predominantly venous origin (ABPI >0.8), with a surface area ranging from 5 to 50cm(2) and a duration of 6 to 36 months. Patients were randomly allocated to either the TLC-NOSF matrix foam (UrgoStart) dressing group or to the neutral TLC foam dressing group (UrgoTul Absorb). All received appropriate compression therapy and the wounds were assessed blindly (clinical examination, wound area tracing and photographic record) every 2 weeks for a period of 8 weeks, or until complete closure. A secondary endpoint, described here, was the patient's HRQoL, documented by the patient, through the EuroQol 5D tool (EQ-5D) questionnaire and visual analogue scale (VAS). In total, 187 patients were randomised to either the TLC-NOSF group (n=94) or the control dressing group (n=93). The two groups were well balanced at baseline with regard to wound and patient characteristics. In the HRQoL questionnaire (EQ-5D), the pain/discomfort and anxiety/depression dimensions were significantly improved in the TLC-NOSF group versus the control one (pain/discomfort: 1.53±0.53 versus 1.74±0.65; p=0.022, and anxiety/depression: 1.35±0.53 versus 1.54±0.60, p=0.037). The VAS score was better in the test group compared with the control group (72.1±17.5 versus 67.3±18.7, respectively), without reaching significance (p=0.072). Acceptability and tolerance

  7. Effect of Uric Acid-Lowering Agents on Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Borgi, Lea; McMullan, Ciaran; Wohlhueter, Ann; Curhan, Gary C; Fisher, Naomi D; Forman, John P

    2017-02-01

    Higher levels of serum uric acid are independently associated with endothelial dysfunction, a mechanism for incident hypertension. Overweight/obese individuals are more prone to endothelial dysfunction than their lean counterparts. However, the effect of lowering serum uric acid on endothelial dysfunction in these individuals has not been examined thoroughly. In this randomized, double-blind, placebo-controlled trial of nonhypertensive, overweight, or obese individuals with higher serum uric acid (body mass index ≥25 kg/m 2 and serum uric acid ≥5.0 mg/dL), we assigned subjects to probenecid (500-1000 mg/d), allopurinol (300-600 mg/d), or matching placebo. The primary outcome was endothelium-dependent vasodilation measured by brachial artery ultrasound at baseline and 8 weeks. By the end of the trial, 47, 49, and 53 participants had been allocated to receive probenecid, allopurinol, and placebo, respectively. Mean serum uric acid levels significantly decreased in the probenecid (from 6.1 to 3.5 mg/dL) and allopurinol groups (from 6.1 to 2.9 mg/dL) but not in the placebo group (6.1 to 5.6 mg/dL). None of the interventions produced any significant change in endothelium-dependent vasodilation (probenecid, 7.4±5.1% at baseline and 8.3±5.1% at 8 weeks; allopurinol, 7.6±6.0% at baseline and 6.2±4.8% at 8 weeks; and placebo, 6.5±3.8% at baseline and 7.1±4.9% at 8 weeks). In this randomized, double-blind, placebo-controlled trial, uric acid lowering did not affect endothelial function in overweight or obese nonhypertensive individuals. These data do not support the hypothesis that uric acid is causally related to endothelial dysfunction, a potential mechanism for development of hypertension. © 2016 American Heart Association, Inc.

  8. A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial.

    Science.gov (United States)

    Nieman, David C; Shanely, R Andrew; Luo, Beibei; Dew, Dustin; Meaney, Mary Pat; Sha, Wei

    2013-11-25

    The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietary supplement (Instaflex™ Joint Support, Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function in adults with self-reported joint pain. Instaflex™ is a joint pain supplement containing glucosamine sulfate, methylsufonlylmethane (MSM), white willow bark extract (15% salicin), ginger root concentrate, boswella serrata extract (65% boswellic acid), turmeric root extract, cayenne, and hyaluronic acid. Subjects included 100 men and women, ages 50-75 years, with a history (>3 months) of joint pain, and were randomized to Instaflex™ or placebo (3 colored gel capsules per day for 8 weeks, double-blind administration). Subjects agreed to avoid the use of non-steroidal anti-inflammatory drugs (NSAID) and all other medications and supplements targeted for joint pain. Primary outcome measures were obtained pre- and post-study and included joint pain severity, stiffness, and function (Western Ontario and McMaster Universities [WOMAC]), and secondary outcome measures included health-related quality of life (Short Form 36 or SF-36), systemic inflammation (serum C-reactive protein and 9 plasma cytokines), and physical function (6-minute walk test). Joint pain symptom severity was assessed bi-weekly using a 12-point Likert visual scale (12-VS). Joint pain severity was significantly reduced in Instaflex™ compared to placebo (8-week WOMAC, ↓37% versus ↓16%, respectively, interaction effect P = 0.025), with group differences using the 12-VS emerging by week 4 of the study (interaction effect, P = 0.0125). Improvements in ability to perform daily activities and stiffness scores in Instaflex™ compared to placebo were most evident for the 74% of subjects reporting knee pain (8-week WOMAC function score, ↓39% versus ↓14%, respectively, interaction effect P = 0.027; stiffness score, ↓30% versus ↓12%, respectively

  9. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

    Directory of Open Access Journals (Sweden)

    U. C. Adler

    2011-01-01

    Full Text Available Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1 in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654 and 8th weeks (P = .965 of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine were −3.04 (95% CI −6.95, 0.86 and −2.4 (95% CI −6.05, 0.77 at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of

  10. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  11. Escitalopram in the Treatment of Adolescent Depression: A Randomized, Double-Blind, Placebo-Controlled Extension Trial

    Science.gov (United States)

    Robb, Adelaide; Bose, Anjana

    2013-01-01

    Abstract Objective The purpose of this study was to evaluate the extended efficacy, safety, and tolerability of escitalopram relative to placebo in adolescents with major depressive disorder (MDD). Methods Adolescents (12–17 years) who completed an 8-week randomized, double-blind, flexible-dose, placebo-controlled, lead-in study of escitalopram 10–20 mg versus placebo could enroll in a 16–24-week, multisite extension trial; patients maintained the same lead-in randomization (escitalopram or placebo) and dosage (escitalopram 10 or 20 mg/day, or placebo) during the extension. The primary efficacy was Children's Depression Rating Scale-Revised (CDRS-R) change from the lead-in study baseline to treatment week 24 (8-week lead-in study plus 16-week extension); the secondary efficacy was Clinical Global Impressions-Improvement (CGI-I) score at week 24. All efficacy analyses used the last observation carried forward (LOCF) approach; sensitivity analyses used observed cases (OC) and mixed-effects model for repeated measures (MMRM). Safety was evaluated via adverse event (AE) reports and the clinician-rated Columbia-Suicide Severity Rating Scale (C-SSRS). Results Following lead-in, 165 patients enrolled in the double-blind extension (82 placebo; 83 escitalopram); 40 (48.8%) placebo and 37 (44.6%) escitalopram patients completed treatment. CDRS-R total score improvement was significantly greater for escitalopram than for placebo (p=0.005, LOCF; p=0.014; MMRM). Response rates (CDRS-R ≥40% reduction from baseline [adjusted and unadjusted] and CGI-I ≤2) were significantly higher for escitalopram than for placebo (LOCF); remission rates (CDRS-R ≤28) were 50.6% for escitalopram and 35.7% for placebo (p=0.002). OC analyses were not significantly different between groups. The most frequent escitalopram AEs (≥5% and more frequent than placebo) were headache, nausea, insomnia, vomiting, influenza-like symptoms, diarrhea, and urinary tract infection. Most AEs were

  12. Coronary Artery Bypass Grafting

    Science.gov (United States)

    ... Health Topics / Coronary Artery Bypass Grafting Coronary Artery Bypass Grafting What Is Coronary artery bypass grafting (CABG) ... multiple coronary arteries during one surgery. Coronary Artery Bypass Grafting Figure A shows the location of the ...

  13. BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study

    Directory of Open Access Journals (Sweden)

    Franciska Gyulai

    2015-01-01

    Full Text Available Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the comparison of the results obtained at the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores. The Oswestry scores and Quality of Life Scale scores showed no change. In patients with knee arthrosis, the comparison of the first and second measurements showed no significant improvement in the abovementioned parameters, while the comparison of the first and third scores revealed a significant improvement in the Fatigue Scale scores and in the vitality test on the Quality of Life Scale. Conclusions. Our study showed that BEMER physical vascular therapy reduced pain and fatigue in the short term in patients with chronic low back pain, while long-term therapy appears to be beneficial in patients with osteoarthritis of knee.

  14. Efficacy and safety of retapamulin ointment as treatment of impetigo: randomized double-blind multicentre placebo-controlled trial.

    Science.gov (United States)

    Koning, S; van der Wouden, J C; Chosidow, O; Twynholm, M; Singh, K P; Scangarella, N; Oranje, A P

    2008-05-01

    Impetigo is a common skin infection, primarily caused by Staphylococcus aureus and mainly occurring in children. It is usually treated topically with antibiotics to achieve a quick cure and prevent spread of the infection. Worldwide, resistance rates of S. aureus against commonly used antibiotics are rising. Retapamulin belongs to a newly developed class of antibiotics for the treatment of uncomplicated skin infections. Our aim was to compare the efficacy and safety of topical application of retapamulin ointment with topical placebo ointment in the treatment of primary impetigo. In a randomized, double-blind, multicentre study, patients received either topical retapamulin ointment 1% twice daily for 5 days or topical placebo. Patients were enrolled into the study for 14 days and attended the clinic for three visits during which clinical and laboratory evaluations were performed. Two hundred and thirteen patients were randomized, with 139 evaluable patients in the retapamulin group and 71 in the placebo group. Based on the primary efficacy endpoint of clinical response after 7 days (intention to treat), retapamulin ointment was superior to placebo (success rate 85.6% vs. 52.1%; Pimpetigo, offering a new treatment option.

  15. A double-blind, randomized, placebo-controlled trial of oral isotretinoin in the treatment of recalcitrant facial flat warts.

    Science.gov (United States)

    Olguin-García, María Guadalupe; Jurado-Santa Cruz, Fermín; Peralta-Pedrero, María Luisa; Morales-Sánchez, Martha Alejandra

    2015-02-01

    Abstract Background: Recalcitrant facial flat warts are caused by human papillomavirus and may persist for years despite treatment. Isotretinoin has demonstrated benefits in the treatment of recalcitrant, genital and common warts, but placebo-controlled trials have not been performed. To determine whether isotretinoin is safe and effective for recalcitrant facial flat warts. Isotretinoin 30 mg/day or placebo was administered to 16 and 15 patients, respectively, in double-blind, randomized fashion for 12 weeks. Cutaneous lesions were assessed and adverse events including serologic and ophthalmologic changes were recorded. It is considered that warts were recalcitrant if the patient was treated for at least 3 years with at least three of the following options: retinoids, 5-fluorouracil, imiquimod and cryotherapy using liquid nitrogen. Each patient in the istotretinoin group showed complete clearance of all flat warts, while none of the patients in the placebo group showed any improvement (p=0.0001). The most frequent adverse event was cheilitis. There were no statistically significant changes in the laboratory findings. The study design does not permit complete blinding of the dermatologist who can easily recognize the adverse effects of isotretinoin. The clinical findings, however, were so dramatic that this would not have impacted the findings. Another limitation of the study is a lack of follow-up to assess for recurrence after the drug was discontinued. Isotretinoin is an effective treatment for recalcitrant flat facial warts with a well-known, manageable safety profile.

  16. Postoperative Etoricoxib versus Ketoprofen Administration for Pain Management after Total Knee Arthroplasty: A Randomized, Double-Blind Controlled Study

    Directory of Open Access Journals (Sweden)

    Simona Cionac Florescu

    2015-01-01

    Full Text Available Objective. This randomized double-blind study compared the analgesic efficacy and tolerability of etoricoxib versus ketoprofen in 165 patients with elective total primary knee arthroplasty. Methods. After ethical committee approval, 165 patients were randomized in 3 groups: the etoricoxib group (E receiving etoricoxib 120 mg/day, at the end of surgery and in the first postoperative day; the ketoprofen group (K receiving ketoprofen 2 pills of 100 mg/day, the first at the end of surgery and then 1 pill every 12 hours in the surgery day and the first postoperative day; the placebo group (P. All groups received postoperatively the same analgesia protocol when NRS is over 3 with IV Perfalgan and morphine. The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose, the total amount of morphine administered in the surgery day and the first postoperative day, and the frequency of patients with side effects and necessary amount of adjuvant medication. Results. The baseline demographic characteristics were similar among the 3 groups. In both study days etoricoxib provided an analgesic effect superior to placebo and to ketoprofen, the total administered morphine being significantly lower in etoricoxib group. There were no statistically significant differences between groups regarding the side effects.

  17. Effects of kinesiotaping on foot posture in participants with pronated foot: a quasi-randomised, double-blind study.

    Science.gov (United States)

    Luque-Suarez, Alejandro; Gijon-Nogueron, Gabriel; Baron-Lopez, Francisco Javier; Labajos-Manzanares, Maria Teresa; Hush, Julia; Hancock, Mark Jonathan

    2014-03-01

    To investigate whether kinesiotaping improves excessive foot pronation compared with sham kinesiotaping. Quasi-randomised, double-blind study. One primary care centre. One hundred and thirty participants were screened for inclusion. Sixty-eight participants with pronated feet [Foot Posture Index (FPI)≥ 6] were enrolled, and the follow-up rate was 100%. Participants were allocated into one of two groups: an experimental kinesiotaping group (KT1) and a sham taping group (KT2). Measures were collected by a blinded assessor at baseline, and 1 minute, 10 minutes, 60 minutes and 24 hours after taping. The primary outcome was total FPI score, and the secondary outcome was rear-foot FPI score. There were no significant differences in total FPI score between kinesiotaping and sham taping at any time point. Similarly, there were no significant differences in rear-foot FPI score, apart from at 60-minute follow-up when the difference between groups was significant (P=0.04) but the effect size was very small (0.85 points on the rear-foot FPI score between -6 and +6). Kinesiotaping does not correct foot pronation compared with sham kinesiotaping in people with pronated feet. Copyright © 2013 Chartered Society of Physiotherapy. All rights reserved.

  18. Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Rondón, C; Campo, P; Salas, M; Aranda, A; Molina, A; González, M; Galindo, L; Mayorga, C; Torres, M J; Blanca, M

    2016-07-01

    The effects of allergen immunotherapy (AIT) on local allergic rhinitis (LAR) are largely unknown. We conducted the first randomized, double-blind, placebo-controlled (DBPC), phase II trial of D. pteronyssinus (DP) subcutaneous AIT (DP-AIT) on LAR (clinicaltrials.gov identifier: NCT02123316). Thirty-six LAR patients received Pangramin PLUS DP or placebo for 24 months. The primary endpoints were symptoms, medication scores, and medication-free days. The secondary included skin test, serum specific IgE and IgG4, nasal allergen provocation test (NAPT), and adverse events. AIT-DP produced significant improvements in both primary and secondary endpoints vs placebo. After 12 months of AIT-DP, we detected a significant and marked increase in allergen tolerance with negative NAPT in 50% of patients, and significant increases of serum sIgG4. Immunotherapy was well tolerated; no systemic reactions were reported. This study demonstrated that AIT-DP is a safe and clinically effective treatment for LAR, confirming that LAR is a new indication for AIT. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. [Effects levocabastine ophthalmic solution (H1 receptor antagonist) on symptoms of vernal conjunctivitis. A prospective, randomized double-blind study].

    Science.gov (United States)

    Graue, E

    1994-01-01

    A double blind, prospective and randomized study was carried out in forty patients with clinical diagnosis of vernal conjunctivitis and eosinophilia in conjunctival scrapings. They were divided in two randomized groups of 20 patients each. One of the groups received levocabastine ophthalmic solution and the other saline solution drops. The mean age of the study group was 9.1 years old with a vernal conjunctivitis history of 44 months. The control group mean age was 10.1 years old and a history of vernal conjunctivitis of 48 months prior the enter of the study. One group received levocabastine 0.5 mgrs/ml while the other balanced saline solution, one drop every 12 hours per seven days. The patients evaluated their symptoms through a visual analogic scale (every day). Data collected was analyzed, for the first, third and seventh day, through U-Mann Whitney statistical analysis. Epiphora and photophobia showed a significant improvement. Itching, edema and foreign body sensation showed improvement in the levocabastine group but without statistical significance. Hyperthermia remained the same in both groups studied.

  20. [Use of corticosteroids after esophageal dilations on patients with corrosive stenosis: prospective, randomized and double-blind study].

    Science.gov (United States)

    Camargo, Marcelo Amade; Lopes, Luiz Roberto; Grangeia, Tiago de Araújo Guerra; Andreollo, Nelson Adami; Brandalise, Nelson Ary

    2003-01-01

    To determine triancinolone intralesional injections effects in association with esophageal dilations in corrosive stenosis cases, by means of a double-blind and randomized study. Fourteen adults patients (6 men and 8 women) with severe esophageal corrosive stenosis were randomized in two groups: Group A: treated by esophageal dilations and posterior triancinolone 10 mg/ml intralesional injection; Group B: treated by esophageal injections and posterior saline solution 0,9% injection (placebo). New applications were made based on the patient symptomatology. It had been analysed dilation frequency, obtained diameters and dysphagia before and after the research, for 12 months. Eleven patients had ingested sodium hydroxide, two had ingested ammoniac and one had taken muriatic acid. There was no statistic difference (p > 0.05) in dilation frequency and dysphagia between the groups. However, an improvement in obtained diameter was observed in the corticosteroids group in comparison with control group (p < 0.05). By comparing groups before and after steroids, the final results were very favorable in group A CONCLUSION: Multiple intralesional injections of triancinolone hexacetonide 10 mg/ml in association with esophageal dilations increase obtained diameters in succeeding sessions.