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Treatment Efficacy (treatment + efficacy)
Selected AbstractsDistribution of Patients, Paroxysmal Atrial Tachyarrhythmia Episodes: Implications for Detection of Treatment EfficacyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 2 2001WILLIAM F. KAEMMERER Ph.D. Distribution of Paroxysmal Atrial Tachyarrhythmia Episodes.Introduction: Clinical trials of treatments for paroxysmal atrial tachyarrhythmia (pAT) often compare different treatment groups using the time to first episode recurrence. This approach assumes that the time to the first recurrence is representative of all times between successive episodes in a given patient. We subjected this assumption to an empiric test. Methods and Results: Records of pAT onsets from a chronologic series of 134 patients with dual chamber implantable defibrillators were analyzed; 14 had experienced > 10 pAT episodes, which is sufficient for meaningful statistical modeling of the time intervals between episodes. Episodes were independent and randomly distributed in 9 of 14 patients, but a fit of the data to an exponential distribution, required by the stated assumption, was rejected in 13 of 14. In contrast, a Weibull distribution yielded an adequate goodness of fit in 5 of the 9 cases with independent and randomly distributed data. Monte Carlo methods were used to determine the impact of violations of the exponential distribution assumption on clinical trials using time from cardioversion to first episode recurrence as the dependent measure. In a parallel groups design, substantial loss of power occurs with sample sizes < 500 patients per group. In a cross-over design, there is insufficient power to detect a 30% reduction in episode frequency even with 300 patients. Conclusion: Clinical trials that rely on time to first episode recurrence may be considerably less able to detect efficacious treatments than may have been supposed. Analysis of multiple episode onsets recorded over time should be used to avoid this pitfall. [source] Combination of narrow band UVB and topical calcipotriol for the treatment of vitiligoJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 5 2006EO Goktas Abstract Background, Narrow band ultraviolet B (NB-UVB) phototherapy has been used successfully for the treatment of vitiligo. Recently, topical calcipotriol has also been claimed to be effective, either as monotherapy or as a part of combination therapies. Objective, The aim of the present study was to compare the clinical efficacy of NB-UVB and NB-UVB plus topical calcipotriol in the treatment of vitiligo. Methods, NB-UVB treatment was given to 24 patients with generalized vitiligo three times weekly. Topical calcipotriol cream was only applied to the lesions located on the right side of the body. Treatment was continued for 6 months. Treatment efficacy was evaluated by determining the average response rates of the lesions at 3-month intervals. Results, The average response rates of patients receiving combination of NB-UVB plus calcipotriol and NB-UVB alone were 51 ± 19.6% and 39 ± 18.9%, respectively. The median cumulative UVB dose and number of UVB exposures for initial repigmentation were 6345 mj/cm2 (range; 2930,30980) and 18 (range; 12,67) for the combination therapy, and 8867.5 mj/cm2 (range; 2500,30980) and 24 (range; 15,67) for the narrow band UVB therapy, respectively. Conclusions, These findings indicate that concurrent topical calcipotriol potentates the efficacy of NB-UVB in the treatment of vitiligo. This combination not only provides earlier pigmentation with lower total UVB dosage and less adverse UVB effects, but also reduces the duration and cost of treatment as well. [source] Endoscopic band ligation could decrease recurrent bleeding in Mallory,Weiss syndrome as compared to haemostasis by hemoclips plus epinephrineALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2009S. LECLEIRE Summary Background, Mallory,Weiss syndrome (MWS) with active bleeding at endoscopy may require endoscopic haemostasis the modalities of which are not well-defined. Aim, To compare the efficacy of endoscopic band ligation vs. hemoclip plus epinephrine (adrenaline) in bleeding MWS. Methods, From 2001 to 2008, 218 consecutive patients with a MWS at endoscopy were hospitalized in our Gastrointestinal Bleeding Unit. In 56 patients (26%), an endoscopic haemostasis was required because of active bleeding. Band ligation was performed in 29 patients (Banding group), while hemoclip application plus epinephrine injection was performed in 27 patients (H&E group). Treatment efficacy and early recurrent bleeding were retrospectively compared between the two groups. Results, Primary endoscopic haemostasis was achieved in all patients. Recurrent bleeding occurred in 0% in Banding group vs. 18% in H&E group (P = 0.02). The use of hemoclips plus epinephrine (OR = 3; 95% CI = 1.15,15.8) and active bleeding at endoscopy (OR = 1.9; 95% CI = 1.04,5.2) were independent predictive factors of early recurrent bleeding. Conclusions, Haemostasis by hemoclips plus epinephrine was an independent predictive factor of rebleeding. This result suggests that band ligation could be the first choice endoscopic treatment for bleeding MWS, but requires further prospective assessment. [source] Effects of Lidocaine Infusion during Experimental Endotoxemia in HorsesJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 4 2010J.R. Peiró Background: The clinical efficacy of IV infusion of lidocaine for treatment of equine endotoxemia has not been studied. Hypothesis: Lidocaine infusion after exposure to lipopolysaccharide (LPS) will inhibit the inflammatory response and have inhibitory effects on the hemodynamic and cytokine responses to endotoxemia. Animals: Twelve horses. Methods: Two equal groups (n = 6): saline (GI) and lidocaine (GII). In all animals, endotoxin (500 ng/kg body weight [BW]) was injected intraperitoneally over 5 minutes. Twenty minutes later, animals received a bolus of GI or GII (1.3 mg/kg BW) over 5 minutes, followed by a 6-hour continuous rate infusion of GI or GII (0.05 mg/kg BW/min). Treatment efficacy was judged from change in arterial blood pressure, peripheral blood and peritoneal fluid (PF) variables (total and differential cell counts, enzyme activities, and cytokine concentrations), and clinical scores (CS) for behavioral evidence of abdominal pain or discomfort during the study. Results: Compared with the control group, horses treated with lidocaine had significantly lower CS and serum and PF tumor necrosis factor-, (TNF-,) activity. At several time points in both groups, total and differential cell counts, glucose, total protein and fibrinogen concentrations, and alkaline phosphatase, creatine kinase, and TNF-, activities were significantly different from baseline values both in peripheral blood and in PF. Conclusions and Clinical Importance: Lidocaine significantly decreased severity of CS and inhibited TNF-, activity in PF. [source] Rotigotine improves restless legs syndrome: A 6-month randomized, double-blind, placebo-controlled trial in the United States,,§MOVEMENT DISORDERS, Issue 11 2010Wayne A. Hening MD Abstract This randomized, double-blinded, placebo-controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6-month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score , 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were ,4.5 (95% CI: ,6.9, ,2.2) for 2 mg/24 hr rotigotine, ,5.2 (95% CI: ,7.5, ,2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 ,0.65 (95% CI: ,1.0, ,0.3) and ,0.9 (95% CI: ,1.3, ,0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period. © 2010 Movement Disorder Society [source] Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in parkinsonismMOVEMENT DISORDERS, Issue 6 2003Francesca Mancini MD Abstract Drooling is a frequent symptom in Parkinson's disease (PD), occurring in almost 75% of all patients. Although it is now well known that drooling in PD is the result of swallowing difficulties rather than excessive saliva production, few treatments have been developed to reduce it. Clinical studies suggest that botulinum toxin A (BTX) injections into salivary glands are effective in decreasing drooling in PD patients. In this double-blind, placebo-controlled study, 20 patients with parkinsonism (idiopathic PD or multiple system atrophy), were randomly assigned to receive 450 U of BTX (Dysport; Ipsen, Berkshire, UK) or 2 ml of placebo, injected into the parotids and submandibular glands under ultrasonographic guidance. Treatment efficacy and safety were assessed at baseline, 1 week and 3 months after BTX injections using clinical scales (Drooling Severity and Drooling Frequency scales) and side effects surveillance. After treatment, the average secretion of saliva in the BTX group was significantly lower than in the placebo group, as appraised by clinical measurements. No side effects were observed in either group. BTX injection into parotids and submandibular glands, under ultrasonographic guidance, is an effective and safe treatment for drooling in parkinsonism. © 2003 Movement Disorder Society [source] Low-dose etanercept therapy in moderate to severe psoriasis in KoreanTHE JOURNAL OF DERMATOLOGY, Issue 8 2008Jung Im NA ABSTRACT Etanercept is a fully humanized soluble tumor necrosis factor (TNF)-, receptor that competitively inhibits the interaction of TNF-, with cell-surface receptors. It was approved as monotherapy for psoriasis in the USA in 2004, but in Korea, no clinical reports on its use for psoriasis are available. We performed a retrospective analysis of 26 moderate-to-severe psoriasis patients who had been treated with etanercept. Patients received twice-weekly injections of 25 mg etanercept s.c. for at least 4 weeks. When the patients achieved a 50% reduction of the psoriasis area severity index (PASI 50) they received once-weekly injections, then biweekly injections were provided for maintenance. Patients were evaluated biweekly by clinical photographs and PASI scoring. Treatment efficacy was as follows. A PASI 75 was achieved in 14 patients (54%) and the mean number of injections before achieving a PASI 75 was 10 ± 7.5. Patients whose initial PASI was less than 10 (iPASI < 10) showed an earlier response (2.6 ± 1.3 weeks) and a higher PASI 75 rate (63%), than with iPASI , 10 (6.9 ± 4.5 weeks, 50%). Eight patients (31%) received additional phototherapy or systemic therapy because of insufficient responses or for faster improvements and they were excluded in the efficacy evaluation. Adverse events were observed in eight patients (31%), but were not serious. This is the first report on the effectiveness of low-dose etanercept regimen on Asian psoriasis patients. Results in this study showed that low-dose etanercept therapy is effective for moderate-to-severe Asian psoriasis patients, and it may be a valuable treatment option even for relatively moderate psoriasis patients not responsive to conventional treatment. In addition, the medical cost was relatively low compared to that of the standard regimen for white patients. [source] Long-interval T2-weighted subtraction magnetic resonance imaging: A powerful new outcome measure in multiple sclerosis trialsANNALS OF NEUROLOGY, Issue 5 2010Bastiaan Moraal MD Objective To compare long-interval T2-weighted subtraction (T2w-Sub) imaging with monthly gadolinium-enhanced T1-weighted (Gd-T1w) imaging for (1) detection of active lesions, (2) assessment of treatment efficacy, and (3) statistical power, in a multiple sclerosis (MS), phase 2, clinical trial setting. Methods Magnetic resonance imaging (MRI) data over 9 months from 120 patients (61 treatment, 59 placebo) from the oral temsirolimus trial were used. T2w-Sub images were scored for active lesions, independent of the original reading of the monthly Gd-T1w images. Treatment efficacy was evaluated using the nonparametric Mann-Whitney U test, and parametric negative binomial (NB)-regression and power calculations were conducted. Results Datasets from 116 patients (58 treatment, 58 placebo) were evaluated. The mean number of T2w-Sub lesions in the treatment group was 3.0 (±4.6) versus 5.9 (±8.8) for placebo; the mean cumulative number of new Gd-T1w lesions in the treatment group was 5.5(±9.1) versus 9.1(±17.2) for placebo. T2w-Sub imaging showed increased power to assess treatment efficacy compared with Gd-T1w imaging, when evaluated by Mann-Whitney U test (p = 0.017 vs p = 0.177), or NB-regression without (p = 0.011 vs p = 0.092) or with baseline adjustment (p < 0.001 vs p = 0.002). Depending on the magnitude of the simulated treatment effect, sample size calculations showed reductions of 22 to 34% in the number of patients (translating into reductions of 81,83% in the number of MRI scans) needed to detect a significant treatment effect in favor of T2w-Sub imaging. Interpretation Compared with monthly Gd-T1w imaging, long-interval T2w-Sub MRI exhibited increased power to assess treatment efficacy, and could greatly increase the cost-effectiveness of phase 2 MS trials by limiting the number of patients, contrast injections, and MRI scans needed. ANN NEUROL 2010;67:667,675 [source] Effect of caffeic acid phenethyl ester on treatment of experimentally induced methicillin-resi,stant Staphylococcus epidermidis endophthalmitis in a rabbit modelCELL BIOCHEMISTRY AND FUNCTION, Issue 6 2007Özlem Y Abstract This study investigated the anti-inflammatory effects of caffeic acid phenethyl ester (CAPE), a natural bee-produced compound, and compared it with corticosteroids in the treatment of experimentally induced methicillin-resistant Staphylococcus epidermidis (MRSE) endophthalmitis in addition to intravitreal antibiotics. An experimental endophthalmitis model was produced in 24 New Zealand albino rabbits by unilateral intravitreal injection of 0.1,ml of 4.7,×,104 colony-forming units (CFU) methicillin-resistant S. epidermidis. The animals were then divided randomly into three treatment groups and a control group, group 1 (six rabbits), received only intravitreal vancomycin (1.0,mg/0.1,ml); group 2 (six rabbits), received both intravitreal vancomycin (1.0,mg/0.1,ml) and intravitreal dexamethasone (400,µg/0.1,ml) and group 3 (six rabbits), received both intravitreal vancomycin (1.0,mg/0.1,ml) and subtenon CAPE (10,mg/0.3,ml) after 24,h post-infection. No treatment was given to the control group. Treatment efficacy was assessed by clinical examination, vitreous culture and histopathology. There were no statististically significant differences between clinical scores of all groups in examinations at 24 and 48,h post-infection (p,=,0.915 and p,=,0.067 respectively), but in examinations at 72,h post-infection and after 7 days post-infection, although the clinical scores of treatment groups were not significantly different from each other, they were significantly lower than the control group (p,<,0.05). The culture results of all groups were sterile. As a result, CAPE was found to be as effective as dexamethasone in reducing inflammation in the treatment of experimental MRSE endophthalmitis when used with antibiotics. More studies are needed to determine the optimal administration route and effective dosage of this compound. Copyright © 2006 John Wiley & Sons, Ltd. [source] Differential Capture of Serum Proteins for Expression Profiling and Biomarker Discovery in Pre- and Posttreatment Head and Neck Cancer Samples,THE LARYNGOSCOPE, Issue 1 2008Gary L. Freed MD Abstract Introduction: A long-term goal of our group is to develop proteomic-based approaches to the detection and use of protein biomarkers for improvement in diagnosis, prognosis, and tailoring of treatment for head and neck squamous cell cancer (HNSCC). We have previously demonstrated that protein expression profiling of serum can identify multiple protein biomarker events that can serve as molecular fingerprints for the assessment of HNSCC disease state and prognosis. Methods: An automated Bruker Daltonics (Billerica, MA) ClinProt matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometer was used. Magnetic chemical affinity beads were used to differentially capture serum proteins prior to MALDI-TOF analysis. The resulting spectra were analyzed using postprocessing software and a pattern recognition genetic algorithm (ClinProt 2.0). An HNSCC cohort of 48 sera samples from 24 patients consisting of matched pretreatment and 6 to 12 month posttreatment samples was used for further analysis. Low-mass differentially expressed peptides were identified using MALDI-TOF/TOF. Results: In the working mass range of 1,000 to 10,000 m/z, approximately 200 peaks were resolved for ionic bead capture approaches. For spectra generated from weak cation bead capture, a k-nearest neighbor genetic algorithm was able to correctly classify 94% normal from pretreatment HNSCC samples, 80% of pretreatment from posttreatment samples, and 87% of normal from posttreatment samples. These peptides were then analyzed by MALDI-TOF/TOF mass spectometry for sequence identification directly from serum processed with the same magnetic bead chemistry or alternatively after gel electrophoresis separation of the captured proteins. We were able to compare this with similar studies using surface-enhanced laser desorption ionization (SELDI)-TOF to show this method as a valid tool for this process with some improvement in the identification of our groups. Conclusions: This initial study using new high-resolution MALDI-TOF mass spectrometry coupled with bead fractionation is suitable for automated protein profiling and has the capability to simultaneously identify potential biomarker proteins for HNSCC. In addition, we were able to show improvement with the MALDI-TOF in identifying groups with HNSCC when compared with our prior data using SELDI-TOF. Using this MALDI-TOF technology as a discovery platform, we anticipate generating biomarker panels for use in more accurate prediction of prognosis and treatment efficacies for HNSCC. [source] Barriers to effective drug addiction treatment for women involved in street-level prostitution: a qualitative investigationCRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 3 2007Frances M. Smith Objectives,To examine barriers to effective drug addiction treatment for women involved in street-level prostitution. Methods,A qualitative approach was selected to enable a detailed exploration, in an informal and unthreatening manner, of the barriers to drug addiction treatment from the women's perspective. Nine in-depth interviews were conducted with women who were involved in street-level prostitution. Transcripts of one-to-one interviews were analysed for recurrent themes using Interpretative Phenomenological Analysis. Results,Barriers to effective addiction treatment are present at psychological, interpersonal, and wider societal levels. Themes identified included: an impoverished sense of self-worth, a lack of trust and consistency in treatment, and the absence of a comprehensive treatment package. Conclusion,Current services could be improved by the provision of a structured treatment programme designed to target the specific physical and psychological requirements of this population. Also, efforts to correct the fictitious, negative portrayals of women involved in prostitution are required, if treatment efficacy is to be improved. Copyright © 2007 John Wiley & Sons, Ltd. [source] A review of empirically supported psychological therapies for mood disorders in adultsDEPRESSION AND ANXIETY, Issue 10 2010Steven D. Hollon Ph.D. Abstract Background: The mood disorders are prevalent and problematic. We review randomized controlled psychotherapy trials to find those that are empirically supported with respect to acute symptom reduction and the prevention of subsequent relapse and recurrence. Methods: We searched the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to identify appropriate articles. Results: One hundred twenty-five studies were found evaluating treatment efficacy for the various mood disorders. With respect to the treatment of major depressive disorder (MDD), interpersonal psychotherapy (IPT), cognitive behavior therapy (CBT), and behavior therapy (BT) are efficacious and specific and brief dynamic therapy (BDT) and emotion-focused therapy (EFT) are possibly efficacious. CBT is efficacious and specific, mindfulness-based cognitive therapy (MBCT) efficacious, and BDT and EFT possibly efficacious in the prevention of relapse/recurrence following treatment termination and IPT and CBT are each possibly efficacious in the prevention of relapse/recurrence if continued or maintained. IPT is possibly efficacious in the treatment of dysthymic disorder. With respect to bipolar disorder (BD), CBT and family-focused therapy (FFT) are efficacious and interpersonal social rhythm therapy (IPSRT) possibly efficacious as adjuncts to medication in the treatment of depression. Psychoeducation (PE) is efficacious in the prevention of mania/hypomania (and possibly depression) and FFT is efficacious and IPSRT and CBT possibly efficacious in preventing bipolar episodes. Conclusions: The newer psychological interventions are as efficacious as and more enduring than medications in the treatment of MDD and may enhance the efficacy of medications in the treatment of BD. Depression and Anxiety, 2010. © 2010 Wiley-Liss, Inc. [source] Achieving remission with venlafaxine and fluoxetine in major depression: its relationship to anxiety symptomsDEPRESSION AND ANXIETY, Issue 1 2002Jonathan R.T. Davidson M.D., M.B.A. Abstract Venlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), produces significantly higher remission rates in depressed patients than do the selective serotonin reuptake inhibitors (SSRIs). In this analysis of pooled data, we explored the relationship between differences in treatment efficacy, early improvement of symptoms, and severity of baseline anxiety in depressed patients treated with either venlafaxine or fluoxetine. A pooled analysis was performed on data from 1,454 outpatients with major depression from five double-blind, randomized studies comparing the 6-week efficacy of venlafaxine (542 patients) with fluoxetine (555 patients). The Hamilton rating scale for depression (HAM-D) total and item scores were analyzed at different treatment times up to 6 weeks. Venlafaxine and fluoxetine both produced statistically significant higher response and remission rates compared with placebo starting from week 2 for response and weeks 3 to 4 for remission. Venlafaxine was statistically significantly superior to fluoxetine from week 3 until week 6 in respect of response rate, and from week 2 until week 6 for remission rate. After 1 week of treatment, greater improvement in individual symptoms was observed in the depressed mood, suicide, and psychic anxiety items of the HAM-D scale for both venlafaxine- and fluoxetine-treated patients compared with placebo. Improvement in psychic anxiety was statistically significantly greater with venlafaxine than with fluoxetine. The presence of baseline psychic anxiety correlated significantly to treatment outcome when analyzing the remission rates. In depressed patients with moderate anxiety (HAM-D psychic anxiety score ,2), venlafaxine statistically significantly increased remission rates compared with placebo from week 4 until week 6, while a significant effect of fluoxetine on remission rates was observed starting at week 6. Remission rates in the severely anxious depressed patients (score >2) were statistically significantly higher with venlafaxine than placebo starting from week 3 until the end of the study period, but no difference could be observed between fluoxetine and placebo. Baseline severity of psychic anxiety had a significant impact on remission rates after treatment of patients diagnosed with depression. Venlafaxine's superior remission rates in the more severely anxious patients and its ability to improve psychic anxiety as early as week 1 compared with fluoxetine suggest that venlafaxine's early efficacy on anxiety symptoms may be the basis for its superior efficacy in depression. Depression and Anxiety 16:4,13, 2002. © 2002 Wiley-Liss, Inc. [source] Open trial of nefazodone among Hispanics with major depression: Efficacy, tolerability, and adherence issuesDEPRESSION AND ANXIETY, Issue 3 2001J. Arturo Sánchez-Lacay M.D., M.P.H. Abstract The efficacy and tolerability of nefazodone in the treatment of major depression among Spanish-monolingual Hispanics was examined and compared to historical controls among English-speaking, predominantly non-Hispanic subjects. Fifty monolingual Hispanic outpatients with major depression and a HAM-D17 score ,18 were treated with nefazodone in a flexible-dose 8-week open-label protocol. Sixty-three percent of the intent-to-treat (ITT) sample with ,1 efficacy visit were considered responders according to CGI-I criteria, falling within the range of response rates (58,69%) reported in six prior nefazodone trials with non-Hispanic subjects. Significant improvement was found for the ITT and completer samples in HAM-D17, HAM-D28, and SCL-90 scores and in two measures of psychosocial functioning. Endpoint mean dose in the ITT sample was 379 mg/day (SD=170), also within the range of previous trials (321,472mg/day). Adverse effects were not elevated, with only dry mouth (8%) reported by >6% of subjects. However, 42% of the sample dropped out of treatment before study termination, usually because of side effects or due to family or work difficulties, a higher rate than previously reported for nefazodone (21,33%). This open trial finds nefazodone to be an efficacious treatment for major depression among monolingual Hispanics, with comparable efficacy to previous controlled trials among non-Hispanic subjects. Double-blind studies are required to confirm this comparable efficacy. Mean endpoint doses and adverse effect rates similar to previous trials do not support the need for reduced doses of nefazodone among Hispanics. However, an elevated rate of treatment discontinuation threatens treatment efficacy among this population. Causes for this elevated rate require explanation, given the apparently unremarkable pattern of adverse effect reports. Depression and Anxiety 13:118,124, 2001. © 2001 Wiley-Liss, Inc. [source] Four-Year Follow-up on Endovascular Radiofrequency Obliteration of Great Saphenous RefluxDERMATOLOGIC SURGERY, Issue 2 2005Robert F. Merchant MD Background Endovascular radiofrequency obliteration has been used since 1998 as an alternative to conventional vein stripping surgery for elimination of saphenous vein insufficiency. Objective To demonstrate the long-term efficacy of this treatment modality. Methods Data were prospectively collected in a multicenter ongoing registry. Only great saphenous vein above-knee treatments were included in this study. Eight hundred ninety patients (1,078 limbs) were treated prior to November 2003 at 32 centers. Clinical and duplex ultrasound follow-up was performed at 1 week, 6 months, and 1, 2, 3, and 4 years. Results Among 1,078 limbs treated, 858 were available for follow-up within 1 week, 446 at 6 months, 384 at 1 year, 210 at 2 years, 114 at 3 years, and 98 at 4 years. The vein occlusion rates were 91.0%, 88.8%, 86.2%, 84.2%, and 88.8%, respectively; the reflux-free rates were 91.0%, 89.3%, 86.2%, 86.0%, and 85.7%, respectively; and the varicose vein recurrence rates were 7.2%, 13.5%, 17.1%, 14.0%, and 21.4%, respectively, at each follow-up time point at 6 months, and 1, 2, 3, and 4 years. Patient symptom improvement persisted over 4 years. Conclusions Endovascular temperature-controlled radiofrequency obliteration of saphenous vein reflux exhibits an enduring treatment efficacy clinically, anatomically, and hemodynamically up to 4 years following treatment. ROBERT F. MERCHANT, MD, AND OLIVIER PICHOT, MD, ARE PAID CONSULTANTS TO VNUS MEDICAL TECHNOLOGIES, WHICH PROVIDED FINANCIAL SUPPORT FOR THIS STUDY. [source] Treatment of Port-Wine Stain Birthmarks Using the 1.5-msec Pulsed Dye Laser at High Fluences in Conjunction with Cryogen Spray CoolingDERMATOLOGIC SURGERY, Issue 4 2002Kristen M. Kelly MD Background. The majority of port-wine stain (PWS) patients treated with the pulsed dye laser (PDL) do not achieve complete blanching. Safe administration of higher fluences has been proposed as a means of improving treatment efficacy. Objective. To determine the safety and efficacy of PWS treatment with the 1.5-msec PDL at high fluences in conjunction with cryogen spray cooling. Methods. Twenty PWS patients were treated with the PDL in combination with cryogen spray cooling utilizing a 7 or 10 mm spot size and fluences ranging from 6 to 15 J/cm2. Before and after treatment photographs were compared on a blinded basis. Results. No scarring or skin textural changes occurred. Blanching scores were as follows: 20% of patients achieved 75% or greater blanching after an average of 3.3 treatments, 30% achieved 50,74% blanching, 20% achieved 25,49% blanching, and 30% achieved less than 25% blanching. Conclusion. In conjunction with cryogen spray cooling, the PDL can be safely used at high fluences. At this time it is not clear that the use of higher fluences improves treatment efficacy; however, as other aspects of PWS laser treatment are optimized, safe administration of higher fluences is likely to be advantageous. [source] Closure of the Greater Saphenous Vein with Endoluminal Radiofrequency Thermal Heating of the Vein Wall in Combination with Ambulatory Phlebectomy: Preliminary 6-Month Follow-upDERMATOLOGIC SURGERY, Issue 5 2000Mitchel P. Goldman MD Background. Incompetence of the saphenofemoral junction with reflux into the greater saphenous vein is one cause of chronic venous hypertension which may lead to the development of varicose and telangiectatic leg veins. Therefore treatment is necessary. Objective. To evaluate a novel method for closing the incompetent greater saphenous vein at its junction with the femoral vein through an endoluminal approach. Methods. Ten patients with reflux at the saphenofemoral junction into the greater saphenous vein were treated with radiofrequency heating of the vein wall through an endoluminal catheter. Patients were evaluated at 3 and 6 months to determine treatment efficacy as well as adverse sequelae. Results. All treated patients achieved complete closure of the saphenofemoral junction and greater saphenous vein. Complete treatment took an average of 20 minutes. Adverse sequelae were minimal, with 2 of 12 patients having mild erythema for 2,3 days. Conclusion. Endoluminal radiofrequency thermal heating of an incompetent greater saphenous vein has been shown to be easily accomplished and efficacious throughout the 6-month follow-up period. [source] University of Michigan Addiction Research Center (UMARC): development, evolution, and directionADDICTION, Issue 6 2010Robert A. Zucker ABSTRACT A historical summary is provided of the evolution of the University of Michigan Addiction Research Center (UMARC) since its origins in 1988. Begun as an National Institutes of Health (NIH) research center within a Department of Psychiatry and focused solely upon alcohol and aging, early work emphasized treatment efficacy, differential outcome studies and characterization of the neurophysiological and behavioral manifestations of chronic alcoholism. Over the last 15 years, UMARC has extended its research focus along a number of dimensions: its developmental reach has been extended etiologically by studies of risk early in the life span, and by way of work on earlier screening and the development of early, brief treatment interventions. The addiction focus has expanded to include other drugs of abuse. Levels of analysis have also broadened, with work on the molecular genetics and brain neurophysiology underlying addictive processes, on one hand, and examination of the role of the social environment in long-term course of disorder on the other hand. Activities have been facilitated by several research training programs and by collaborative relationships with other universities around the United States and in Poland. Since 2002, a program for research infrastructure development and collaboration has been ongoing, initially with Poland and more recently with Ukraine, Latvia and Slovakia. A blueprint for the future includes expanded characterization of the neurobiology and genetics of addictive processes, the developmental environment, as well as programmatic work to address the public health implications of our ability to identify risk for disorder very early in life. [source] Treatment of Acute Stroke with Recombinant Tissue Plasminogen Activator and AbciximabACADEMIC EMERGENCY MEDICINE, Issue 12 2003Daniel C. Morris MD Objectives: Preclinical data suggest that treatment of acute ischemic stroke (AIS) with the combination of recombinant tissue plasminogen activator (rt-PA) and abciximab may increase efficacy and decrease the rate of symptomatic intracranial hemorrhage (sICH). The authors report pilot data of five AIS patients with half-dose rt-PA and abciximab as part of an ongoing phase I safety trial with sICH as the primary outcome. Methods: Five patients with AIS were treated with the combination of half-dose rt-PA (0.45 mg/kg) and abciximab (0.25 mg/kg bolus followed by a 0.125 ,g/kg/min infusion over 12 hours). Head computed tomographic scan was obtained after 24 hours of treatment onset. Results: Four patients received the combination of half-dose abciximab and rt-PA without major complications. One patient experienced a parenchymal hematoma type-1 ICH without significant decline of his neurological status. The average National Institutes of Health Stroke Scale change at discharge in comparison with pretreatment was ,5.4 ± 7.0, and the median change was 6 points with a range of 4 points (worsening) to ,13 points (improvement) (p = 0.07) based on a one-sided t-test. Conclusions: Administration of rt-PA and abciximab to AIS patients was completed without difficulty. No sICH were observed; however, 20% (1 out of 5) experienced an asymptomatic ICH. Based on our observation of five patients, there was a trend of treatment efficacy; however, these results need to be confirmed in a larger-scale placebo-controlled clinical trial. [source] The Modified Atkins DietEPILEPSIA, Issue 2008Eric H. Kossoff Summary In 2003, a case series was published describing the benefits of a less restrictive ketogenic diet (KD) started as an outpatient without a fast and without any restrictions on calories, fluids, or protein. This "Modified Atkins Diet" (MAD) restricts carbohydrates to 10 g/day (15 g/day in adults) while encouraging high fat foods. Now 5 years later, there have been eight prospective and retrospective studies published on this alternative dietary therapy, both in children as well as adults. In these reports, 45 (45%) have had 50,90% seizure reduction, and 28 (28%) >90% seizure reduction, which is remarkably similar to the traditional KD. This review will discuss basics and tips to best provide the MAD, evidence for its efficacy, suggestions about the role of ketosis in dietary treatment efficacy, and its side effect profile. Lastly, the possible future benefits of this treatment for new-onset seizures, adults, neurologic conditions other than epilepsy, and developing countries of the world will be discussed. [source] An evidence-based approach to equine parasite control: It ain't the 60s anymoreEQUINE VETERINARY EDUCATION, Issue 6 2010R. M. Kaplan Summary Most veterinarians continue to recommend anthelmintic treatment programmes for horses that derive from knowledge and concepts more than 40 years old. However, much has changed since these recommendations were first introduced and current approaches routinely fail to provide optimal or even adequate levels of parasite control. There are many reasons for this. Recent studies demonstrate that anthelmintic resistance in equine parasites is highly prevalent and multiple-drug resistance is common in some countries, but few veterinarians take this into account when making treatment decisions or when recommending rotation of anthelmintics. Furthermore, the current approach of treating all horses at frequent intervals was designed specifically to control the highly pathogenic large strongyle, Strongylus vulgaris. But this parasite is now quite uncommon in managed horses in most of the world. Presently, the cyathostomins (small strongyles) are the principal parasitic pathogens of mature horses. The biology and pathogenesis of cyathostomins and S. vulgaris are very different and therefore require an entirely different approach. Furthermore, it is known that parasites are highly over-dispersed in hosts, such that a small percentage of hosts harbour most of the parasites. The common practices of recommending the same treatment programme for all horses despite great differences in parasite burdens, recommending prophylactic treatment of all horses without indication of parasitic disease or knowing what species of parasites are infecting the horses, recommending use of drugs without knowledge of their efficacy and failing to perform diagnostic (faecal egg count) surveillance for estimating parasite burdens and determining treatment efficacy, are all incompatible with current standards of veterinary practice. Consequently, it is necessary that attitudes and approaches to parasite control in horses undergo a complete overhaul. This is best achieved by following an evidence-based approach that takes into account all of these issues and is based on science, not tradition. [source] What non-prescription treatments do UK women with breast cancer use?EUROPEAN JOURNAL OF CANCER CARE, Issue 3 2006S. CATT phd Understanding the self-prescribing behaviours of patients as well as their attitudes towards prescribed medication regimens is essential if healthcare professionals are to support treatment adherence and avoid unwanted pharmacological interactions and compromises in treatment efficacy. Evidence shows that women with breast cancer are particularly likely to use complementary and alternative therapies. This paper describes the reported treatment profile of a sample of 208 women with breast cancer in the UK. The information was gathered as part of a study exploring the preferences for injection or tablets in the administration of breast cancer treatment. Almost two-thirds of the sample were currently taking prescribed breast cancer treatment, mostly a single hormone therapy. Prescribed medications for co-morbid diseases were also common, and 53% of the women were self-medicating mainly with supplements, principally vitamins, various oils and minerals. In line with other studies, higher levels of education, socio-economic status and internal locus of control were associated with non-prescription use as well as a body mass index <30. [source] State-of-the-art methodologies in alcohol-related health services researchADDICTION, Issue 11s3 2000Harold I. Perl Many of the failures to replicate clinical findings of treatment efficacy in more realistic field and community settings can be attributed to inappropriate research designs and other methodological shortcomings. In order to increase research designers' awareness of existing methodologies that may be better suited to answer the critical questions inherent in health services research on alcohol-related issues, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) convened an expert conference with three specific goals: (1) to identify the critical issues involved in alcohol services research; (2) to develop a primer that explicated each key area; and (3) to compile the resulting primers into an accessible resource for researchers, policy makers and consumers. The 9 papers in this special supplement are the product of that conference and are organized broadly around three phases of the research process: study design and implementation, data collection and use, and the analysis and interpretation of data. A final summary paper discusses the issues and offers a synthesis of key themes as well as some direction for the future. [source] Prevention of respiratory infections in the elderlyGERIATRICS & GERONTOLOGY INTERNATIONAL, Issue 3 2002Mutsuo Yamaya The risk of nosocomial infections is 3,5-fold higher among older patients than among younger adults. Both the increased incidence of respiratory infections and the high mortality among older people are a consequence of a number of age-related factors, including coexisting illnesses, therapeutic interventions, and the aging process itself. Risk factors for the development of respiratory infections in older people can be broadly classified into factors that alter host defenses and factors that increase exposure to bacteria. These factors combine to adversely affect the person's capacity to defend against pathogens of the upper and lower respiratory tract. Despite the availability of potent new antimicrobials, the increasingly limited treatment efficacy of these antimicrobials is related to emerging microbial resistance. Recently, new methods of treating respiratory infections according to the mechanisms of infection have been introduced. Effective methods of preventing respiratory infections in older people were reviewed. [source] Review of quality of life: menorrhagia in women with or without inherited bleeding disordersHAEMOPHILIA, Issue 1 2008M. SHANKAR Summary., The objectives of this study were to identify the impact of menorrhagia on the health-related quality of life (HRQOL) of women in general and those with inherited bleeding disorders and to identify the commonly used tools in assessing quality of life. A review of studies evaluating quality of life in women suffering from menorrhagia was conducted. Data sources used included electronic databases Medline and Embase. Reference lists and bibliographies of the relevant papers and books were hand-searched for additional studies. Eighteen of the 53 studies identified measured quality of life prior to treatment of menorrhagia. Ten of the studies used a validated measure of quality of life. Five studies involving a total of 1171 women with menorrhagia in general and using SF-36 were considered for further review. The mean SF-36 scores in women with menorrhagia were worse in all the eight scales when compared with normative scores from a general population of women. Three studies, involving 187 women, assessed the quality of life in women with menorrhagia and inherited bleeding disorders. None of these studies used a validated HRQOL score making it difficult for comparison. However, all reported poorer scores in study women compared to the controls. In conclusion, HRQOL is adversely affected in women with menorrhagia in general and in those with inherited bleeding disorders. HRQOL evaluation is useful in the management of women with menorrhagia for assessment of treatment efficacy. [source] Behavioral Facilitation of Medical Treatment of Headache: Implications of Noncompliance and Strategies for Improving AdherenceHEADACHE, Issue 2006Jeanetta C. Rains PhD Clinical recommendations were gleaned from a review of treatment adherence published in the regular issue of Headache (released in tandem with this supplement). The recommendations include: (1) Nonadherence is prevalent among headache patients, undermines treatment efficacy, and should be considered as a treatment variable; (2) Calling patients to remind them of appointments and recalling those who miss a scheduled appointment are fundamentally the most cost-effective adherence-enhancing strategies, insofar as failed appointment-keeping acts as a ceiling on all future treatment and adherence efforts; (3) Simplified and tailored medication regimens improve adherence (eg, minimized number of medications and dosings, fixed-dose combinations, cue-dose training, stimulus control); (4) Screening and management of psychiatric comorbidities, especially depression and anxiety, is encouraged; (5) The concept of self-efficacy as a modifiable psychological process often can be employed to predict and improve adherence. [source] Involved field radiotherapy for limited stage Hodgkin lymphoma: balancing treatment efficacy against long-term toxicitiesHEMATOLOGICAL ONCOLOGY, Issue 3 2009Jayant S. Goda Abstract Limited stage Hodgkin lymphoma (HL) refers to patients with stage IA or IIA disease in the absence of any bulky mass or unfavourable prognostic factors. In this group, the long-term disease control with treatment can be expected in more than 90%, and management has now been directed to make strategies to reduce late morbidities related to therapy. With the advent of very effective chemotherapy, the role of radiation therapy has evolved from a first line single modality treatment, to an adjuvant therapy following brief cycles of chemotherapy. Optimal radiation volume and dose parameters have been refined in the combined modality setting. Furthermore, with the progress in diagnostic functional imaging and advances in radiotherapy, it is possible to accurately deliver low to moderate doses of radiation to defined regions resulting in durable control of disease. This review will evaluate the literature that shapes the current standard of care in limited stage Hodgkin lymphoma with special emphasis on the use of limited field radiotherapy. Copyright © 2009 John Wiley & Sons, Ltd. [source] The effect of focal adhesion kinase gene silencing on 5-fluorouracil chemosensitivity involves an Akt/NF-,B signaling pathway in colorectal carcinomasINTERNATIONAL JOURNAL OF CANCER, Issue 1 2010Yuying Chen Abstract Multicellular resistance (MCR) is produced because multicellular spheroids (MCSs) are formed with a broad cell,cell connection when cultured in three-dimensions, which limits the clinical treatment efficacy in solid tumors. Focal adhesion kinase (FAK) plays an important role in apoptosis, survival and cell adhesion between cells and their extracellular matrix. In this study, we investigated the expressions of FAK, Akt and NF-,B in human colorectal cancer (CRC), and the effects of FAK gene silencing on MCSs formation and 5-fluorouracil (5-FU) chemosensitivity in colon carcinoma MCSs culture cells. In CRC samples, FAK, Akt and NF-,B were overexpressed. The positive expression of FAK correlated notably with lymph node metastasis and cellular differentiation. Positive expressions of Akt and NF-,B were significantly related to cellular differentiation and lymph node metastasis, respectively. Furthermore, positive expression of FAK correlated with that of Akt and NF-,B. The expression of FAK was inhibited significantly by a small hairpin RNA targeting FAK. Knockdown of FAK reversed the formation and aggregation of MCSs, significantly decreased the 50% inhibitory concentration of 5-FU, and markedly increased MCS culture cells apoptosis. These effects were associated with reduced levels of Akt and NF-,B. These results indicate that suppressing FAK expression potentiated 5-FU-induced cytotoxicity and contributed to its chemosensitizing effect by suppressing Akt/NF-,B signaling in colon carcinoma MCS culture cells. These data also imply that FAK mediates MCR of CRC through the survival signaling pathway FAK/Akt/NF-,B. [source] Anorexia nervosa treatment: A systematic review of randomized controlled trials,INTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 4 2007Cynthia M. Bulik PhD Abstract Objective: The RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center (RTI-UNC EPC) systematically reviewed evidence on efficacy of treatment for anorexia nervosa (AN), harms associated with treatments, factors associated with treatment efficacy, and differential outcome by sociodemographic characteristics. Method: We searched six major databases for studies on the treatment of AN from 1980 to September 2005, in all languages against a priori inclusion/exclusion criteria focusing on eating, psychiatric or psychological, or biomarker outcomes. Results: Thirty-two treatment studies involved only medications, only behavioral interventions, and medication plus behavioral interventions for adults or adolescents. The literature on medication treatments and behavioral treatments for adults with AN is sparse and inconclusive. Cognitive behavioral therapy may reduce relapse risk for adults with AN after weight restoration, although its efficacy in the underweight state remains unknown. Variants of family therapy are efficacious in adolescents, but not in adults. Conclusion: Evidence for AN treatment is weak; evidence for treatment-related harms and factors associated with efficacy of treatment are weak; and evidence for differential outcome by sociodemographic factors is nonexistent. Attention to sample size and statistical power, standardization of outcome measures, retention of patients in clinical trials, and developmental differences in treatment appropriateness and outcome is required. © 2007 by Wiley Periodicals, Inc. Int J Eat Disord 2007 [source] Profiling bacterial survival through a water treatment process and subsequent distribution systemJOURNAL OF APPLIED MICROBIOLOGY, Issue 1 2005D. Hoefel Abstract Aims:, To profile fractions of active bacteria and of bacteria culturable with routine heterotrophic plate count (HPC) methods through a typical water treatment process and subsequent distribution system. In doing so, investigate how water treatment affects both bacterial abundance and diversity, and reveal the identities of active bacteria not detected by traditional HPC culture. Methods and Results:, Profiling active fractions was performed by flow cytometric cell sorting of either membrane-intact (BacLightTM kit) or enzymatically active (carboxyfluorescein diacetate, CFDA) bacteria, followed by eubacterial 16S rDNA-directed PCR and denaturing gradient gel electrophoresis (DGGE). Water treatment significantly reduced active bacterial numbers detected by the BacLightTM kit and CFDA assay by 2·89 and 2·81 log respectively. Bacterial diversity was also reduced from >20 DGGE bands in the active fractions of reservoir water to only two bands in the active fractions of finished water. These two bands represented Stenotrophomonas maltophila, initially culturable by HPC, and a Burkholderia -related species. Both species maintained measurable traits of physiological activity in distribution system bulk water but were undetected by HPC. Conclusions:, Flow cytometric cell sorting with PCR-DGGE, to assess water treatment efficacy, identified active bacteria from a variety of major phylogenetic groups undetected by routine HPC. Following treatment S. maltophila and a Burkholderia -related species retained activity and entered distribution undetected by HPC. Significance and Impact of the Study:, Methods used here demonstrate how water treatment operators can better monitor water treatment plant efficacy and assess distribution system instability by the detection and identification of active bacteria recalcitrant to routine HPC culture. [source] | |||||||||||||||||||||||||||||||||||||||||||||||||