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Efficacious
Terms modified by Efficacious Selected AbstractsRizatriptan 5mg Is Not Efficacious for Migraine in AdolescentsHEADACHE, Issue 8 2002Morris Maizels MD No abstract is available for this article. [source] Evidence-based medical review update: Pharmacological and surgical treatments of Parkinson's disease: 2001 to 2004MOVEMENT DISORDERS, Issue 5 2005Christopher G. Goetz MD Abstract The objective of this study is to update a previous evidence-based medicine (EBM) review on Parkinson's disease (PD) treatments, adding January 2001 to January 2004 information. The Movement Disorder Society (MDS) Task Force prepared an EBM review of PD treatments covering data up to January 2001. The authors reviewed Level I (randomized clinical trials) reports of pharmacological and surgical interventions for PD, published as full articles in English (January 2001,January 2004). Inclusion criteria and ranking followed the original program and adhered to EBM methodology. For Efficacy Conclusions, treatments were designated Efficacious, Likely Efficacious, Non - Efficacious, or Insufficient Data. Four clinical indications were considered for each intervention: prevention of disease progression; treatment of Parkinsonism, as monotherapy and as adjuncts to levodopa where indicated; prevention of motor complications; treatment of motor complications. Twenty-seven new studies qualified for efficacy review, and others covered new safety issues. Apomorphine, piribedil, unilateral pallidotomy, and subthalamic nucleus stimulation moved upward in efficacy ratings. Rasagiline, was newly rated as Efficacious monotherapy for control of Parkinsonism. New Level I data moved human fetal nigral transplants, as performed to date, from Insufficient Data to Non- efficacious for the treatment of Parkinsonism, motor fluctuations, and dyskinesias. Selegiline was reassigned as Non - efficacious for the prevention of dyskinesias. Other designations did not change. In a field as active in clinical trials as PD, frequent updating of therapy-based reviews is essential. We consider a 3-year period a reasonable time frame for published updates and are working to establish a Web-based mechanism to update the report in an ongoing manner. © 2005 Movement Disorder Society [source] Psychologic Treatment for Hypertension Can Be EfficaciousPREVENTIVE CARDIOLOGY, Issue 1 2003Wolfgang Linden PhD The traditional view of psychologic treatments and their efficacy for treating primary hypertension is that they may be of some benefit for borderline hypertension and that they can be potentially useful adjuncts to medical treatment. This review challenges such cautious conclusions by critically analyzing previous reviews and by also considering innovative, newer clinical trials. One reason for cautious conclusions has been selective reviewing and a lack of well-designed trials. Measurement and study protocol differences as well as differences in treatment modality have all been shown to have major effects on observed outcomes. Studies that promise better results have the following characteristics: 1) use of 24-hour ambulatory monitoring as an end point to rule out white coat hypertension that does not need treatment in the first place; 2) inclusion of patients with truly elevated blood pressure at pretreatment; and 3) multicomponent treatments that are tailored to individual patient needs. [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] Efficacy and safety of duloxetine in the treatment of generalized anxiety disorder: a flexible-dose, progressive-titration, placebo-controlled trialDEPRESSION AND ANXIETY, Issue 3 2008Moira Rynn M.D. Abstract Generalized anxiety disorder (GAD), a prevalent and chronic illness, is associated with dysregulation in both serotonergic and noradrenergic neurotransmission. Our study examined the efficacy, safety, and tolerability of duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, for short-term treatment of adults with GAD. In a 10-week, double-blind, progressive-titration, flexible-dose trial, 327 adult outpatients with a DSM-IV,defined GAD diagnosis were randomized to duloxetine 60,120,mg (DLX, N=168) or placebo (PLA, N=159) treatment. The primary efficacy measure was mean change from baseline to endpoint in Hamilton Anxiety Scale (HAMA) total score. Secondary outcome measures included response rate (HAMA total score reduction ,50% from baseline), Clinician Global Impression,Improvement (CGI-I) scores, and Sheehan Disability Scale (SDS) scores. Patients who received duloxetine treatment demonstrated significantly greater improvement in HAMA total scores (P=.02); a higher response rate (P=.03), and greater improvement (P=.04) than patients who received placebo. Duloxetine-treated patients were also significantly more improved than placebo-treated patients on SDS global functional (P<.01) and work, social, and family/home impairment scores (P<.05). The rate of discontinuation due to adverse events (AEs) was higher for the duloxetine group compared with the placebo group (P=.002). The AEs most frequently associated with duloxetine were nausea, dizziness, and somnolence. Duloxetine was an efficacious, safe, and well-tolerated treatment that resulted in clinically significant improvements in symptom severity and functioning for patients with GAD. Depression and Anxiety 0:1,8, 2007. © 2007 Wiley-Liss, Inc. [source] Patients with a major depressive episode responding to treatment with repetitive transcranial magnetic stimulation (rTMS) are resistant to the effects of rapid tryptophan depletionDEPRESSION AND ANXIETY, Issue 8 2007John P. O'Reardon M.D. Abstract Repetitive transcranial magnetic stimulation (rTMS) appears to be efficacious in the treatment of major depression based on the results of controlled studies, but little is known about its antidepressant mechanism of action. Mood sensitivity following rapid tryptophan depletion (RTD) has been demonstrated in depressed patients responding to SSRI antidepressants and phototherapy, but not in responders to electroconvulsive therapy (ECT). We sought to study the effects of RTD in patients with major depression responding to a course of treatment with rTMS. Twelve subjects treated successfully with rTMS monotherapy underwent both RTD and sham depletion in a double-blind crossover design. Depressive symptoms were assessed using both a modified Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory (BDI). The differential change in depression scores across the procedures was compared. No significant difference in mood symptoms was noted between RTD and the sham-depletion procedure on either continuous measures of depression, or in the proportions of subjects that met predefined criteria for a significant degree of mood worsening. Responders to rTMS are resistant to the mood perturbing effects of RTD. This suggests that rTMS does not depend on the central availability of serotonin to exert antidepressant effects in major depression. Depression Anxiety 24:537,544, 2007. © 2006 Wiley-Liss, Inc. [source] Double-Blind, Randomized, Placebo-Controlled Pilot Study of the Safety and Efficacy of Myobloc (Botulinum Toxin Type B) for the Treatment of Palmar HyperhidrosisDERMATOLOGIC SURGERY, Issue 3 2005Leslie Baumann MD Background Palmar hyperhidrosis is a problem of unknown etiology that affects patients both socially and professionally. Botulinum toxin type B (Myobloc), approved by the Food and Drug Administration for use in the treatment of cervical dystonia in the United States in December 2000, has subsequently been used effectively in an off-label indication to treat hyperhidrosis. There are sparse data, however, in the literature evaluating the safety and efficacy of BTX-B for the treatment of palmar hyperhidrosis. Objective We evaluated the safety and efficacy of Myobloc in the treatment of bilateral palmar hyperhidrosis. This was a double-blind, randomized, placebo-controlled study to report on the safety and efficacy of Myobloc. Methods Twenty participants (10 men, 10 women) diagnosed with palmar hyperhidrosis were injected with either Myobloc (5,000 U per palm) or a 1.0 mL vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/mL human albumin) into bilateral palms (15 Myobloc, 5 placebo). The participants were followed until sweating returned to baseline levels. The main outcome measures were safety, efficacy versus placebo, and duration of effect. Results A significant difference was found in treatment response at day 30, as determined by participant assessments, between 15 participants injected with Myobloc and 3 participants injected with placebo. The duration of action, calculated in the 17 participants who received Myobloc injections and completed the study, ranged from 2.3 to 4.9 months, with a mean duration of 3.8 months. The single most reported adverse event was dry mouth or throat, which was reported by 18 of 20 participants. The adverse event profile also included indigestion or heartburn (60%), excessively dry hands (60%), muscle weakness (60%), and decreased grip strength (50%). Conclusion Myobloc proved to be efficacious for the treatment of palmar hyperhidrosis. Myobloc had a rapid onset, with most participants responding within 1 week. The duration of action ranged from 2.3 to 4.9 months, with a mean of 3.8 months. The adverse event profile included dry mouth, indigestion or heartburn, excessively dry hands, muscle weakness, and decreased grip strength. MYOBLOC WAS PROVIDED FOR THIS STUDY BY ELAN PHARMACEUTICALS. [source] Do the old psychostimulant drugs have a role in managing treatment-resistant depression?ACTA PSYCHIATRICA SCANDINAVICA, Issue 4 2010G. Parker Parker G, Brotchie H. Do the old psychostimulant drugs have a role in managing treatment-resistant depression? Objective:, As the authors have observed clinical benefit from the psychostimulants methylphenidate and dexamphetamine for treating resistant melancholic and bipolar depression, those drugs were evaluated in a consecutively recruited sample of 50 such patients. Method:, Patients (27 bipolar, 23 unipolar) received either methylphenidate (n = 44) or dexamphetamine (n = 6), with 30 having it prescribed as an augmenting drug and 20 as monotherapy. At the final review, ranging from 6 weeks to 62 months (mean 57 weeks), 52% were still receiving their psychostimulant. Results:, Thirty-four per cent reported the psychostimulant as distinctly improving their depression, 30% reported some level of improvement and 36% reported no improvement and/or side-effects. For improvers, the modal dose of methylphenidate was 20 mg. Significant side-effects were reported by 18% (including one manic response), switching was rare and limited to the bipolar subjects, and most side-effects were minor. Any positive response occurred rapidly and loss of efficacy was rare. Testing of tricyclic levels in some patients suggested that stimulant drugs may raise tricyclic levels in those who are rapid metabolizers. Conclusion:, Although this study was not controlled, the high success rate in a diagnostically refined sample implies that the psychostimulants may be efficacious for patients with melancholic and bipolar depression who have failed to respond to orthodox antidepressant drugs. [source] 5-Aminolevulinic Acid Photodynamic Therapy: Where We Have Been and Where We Are GoingDERMATOLOGIC SURGERY, Issue 8 2004Michael H. Gold MD Background. Photodynamic therapy, utilizing the topical administration of 20% 5-aminolevulinic acid, has generated a great deal of interest in the dermatology community over the past several years. Objective. The purpose of this article is to review the history of photodynamic therapy in dermatology and to review recent new advances with this technology that will increase its appeal to all dermatologists. Methods. A literature review and results of new clinical trials with regards to photorejuvenation and acne vulgaris treatments with 5-aminolevulinic acid photodynamic therapy are presented. Results. Short-contact, full-face 5-aminolevulinic acid photodynamic therapy treatments with a variety of lasers and light sources have shown to be successful in treating all facets of photorejuvenation and the associated actinic keratoses as well as disorders of sebaceous glands, including acne vulgaris. The treatments are relatively pain-free, efficacious, and safe. They are also making already available laser/light source therapies work better for acne vulgaris and photorejuvenation. Conclusions. The use of 5-aminolevulinic acid photodynamic therapy with short-contact, full-face broad-application therapy is now able to bridge the world of medical and cosmetic dermatologic surgery. This therapy is available for all dermatologists to utilize in the care of their patients. [source] Intense Pulsed Light Treatment of Photoaged Facial SkinDERMATOLOGIC SURGERY, Issue 8 2004Douglas E. Kligman MD Background. It has been reported that intense pulsed light is efficacious for rejuvenation of photoaged skin, specifically the improvement of appearance of telangiectases and solar lentigines. Objective. The objective was to define the treatment variables for photodamaged facial skin using a newer intense pulsed light system. Methods. Twenty-three female subjects received three treatments using double-stacked pulses with fluences of 24 and 30 J/cm2. Response to treatment was evaluated using digital photography. Three signs of photoaging were evaluated: surface texture/roughness, mottled hyperpigmentation, and erythema/telangiectases. Results. There was a shift in clinical grading from more to less severe on all three measures of photoaging. Conclusion. Intense pulsed light therapy was efficacious in ameliorating the clinical signs of photoaging. The device was well tolerated with minimal side effects. [source] Evidence-Based Review of the Use of Cryosurgery in Treatment of Basal Cell CarcinomaDERMATOLOGIC SURGERY, Issue 6 2003Agnieszka Kokoszka MD Background. Cryosurgery has been used to treat basal cell carcinoma (BCC), and it has many technical advantages over other methods. It is therefore important to establish its efficacy as a treatment for BCC. Objective. To review systematically the body of literature reporting on the efficacy of cryosurgery of BCC in terms of recurrence rates and cosmetic results. Methods. A review is given of MEDLINE, EMBASE, CancerLit, and the Cochrane Database of Systematic Reviews for studies that examined cryosurgery in treatment of BCC patients. Results. We found 13 noncontrolled prospective studies and 4 randomized clinical trials comparing cryosurgery to other methods of treatment for BCC. Because of the inability to double blind or placebo control treatment of BCC, none of the studies met criteria for A or B grade evidence, as defined by Sackett. Therefore, all studies were assigned grade C. Conclusions. According to the best evidence, recurrence rates of BCC treated with cryosurgery are low (less than 10%). Except in one study, recurrence rates are calculated based on clinical, rather than histologic diagnosis, which may cause the rates to appear somewhat lower than they actually are, especially with a short follow-up period. Cosmetic results of cryosurgery treatment reported in literature are described as good by most investigators. Overall, there are sufficient data to consider cryosurgery as a reasonable treatment for BCC. There are no good studies, however, comparing cryosurgery with other modalities, particularly with Mohs surgery, excision, or electrodesiccation and curettage so that no conclusion can be made whether cryosurgery is as efficacious as other methods. Also, there is no evidence on whether curetting the lesions before cryosurgery affects the efficacy of treatment. [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] Clinical Comparative Study Between Cryotherapy and Local Dermabrasion for the Treatment of Solar Lentigo on the Back of the HandsDERMATOLOGIC SURGERY, Issue 5 2000Dóris Maria Hexsel MD Background. Solar lentigo is a common and unsightly dermatosis that has a variety of proposed treatments. Objective. This study was done to assess the efficacy and the effectiveness of localized dermabrasion compared with cryotherapy with liquid nitrogen on solar lentigo on the back of the hands. Methods. Ten female patients aged 64,96 years with solar lentigo on the back of the hands were treated with dermabrasion or cryotherapy and observed over a 6-month period. Results. The postsurgery signs and symptoms were less intense and better tolerated with localized dermabrasion. More than 50% of the patients treated with cryotherapy still had hypochromia in the treated areas 6 months after treatment, compared with 11% of the patients treated with dermabrasion. The percentage of recurrence was the same with the both treatments (55.55%). Conclusion. Localized dermabrasion is an efficacious and effective technique comparable to cryotherapy for the treatment of solar lentigo on the back of the hands. [source] An overview of human papillomavirus infection for the dermatologist: disease, diagnosis, management, and preventionDERMATOLOGIC THERAPY, Issue 5 2010Michelle Forcier ABSTRACT Genital human papillomavirus (HPV) is a common, usually transient, dermatologic infection transmitted by genital contact that can cause a variety of anogenital diseases, including warts (condyloma), dysplasia (cervical, vaginal, vulvar, anal), and squamous cell carcinoma. A number of treatment modalities are available to treat anogenital warts, both patient- and provider-applied. Treatment is efficacious, but lesions can recur. Bivalent and quadrivalent vaccines are approved to prevent HPV infection. Both are indicated to prevent cervical cancer, while the quadrivalent vaccine is also approved to prevent vaginal/vulvar cancers as well as genital warts in males and females. Providers should clearly explain the natural history and potential sequelae of HPV disease, counsel patients on prevention strategies, and recommend vaccination as an effective method of prevention to their patients. [source] Treatment of varicella-zoster virus and postherpetic neuralgiaDERMATOLOGIC THERAPY, Issue 3 2000Daniel A. Carrasco ABSTRACT: Chickenpox is mostly a disease of childhood; shingles usually affects the elderly, but any age group may be afflicted. Although several proved pharmacologic agents are known to be efficacious in the acute phase of varicella-zoster infections, only three are FDA approved for use in immunocompetent zoster patients and one for the use in primary varicella infections. Ongoing studies with immunocompromised patients are determining whether higher doses of newer oral antivirals will be effective. While a cure for postherpetic neuralgia has not been found, effective treatment to reduce its duration and severity means early implementation of newer antiviral agents. While corticosteroids do not prevent postherpetic neuralgia, they do improve the quality of life when used in combination with acyclovir. Often, symptomatic relief with narcotics, topical anesthetics, and tricyclic antidepressants are necessary. [source] Cognitive-behavioural therapy for late-life anxiety disorders: a systematic review and meta-analysisACTA PSYCHIATRICA SCANDINAVICA, Issue 6 2008G. J. Hendriks Objective:, To examine and estimate the efficacy of cognitive-behavioural therapy (CBT) for late-life anxiety disorders. Method:, A systematic review and meta-analysis of randomized controlled trials comparing CBT with i) a waiting-list control condition and ii) an active control condition controlling for non-specific effects in patients aged over 60 years and suffering from an anxiety disorder. The main outcome parameter of individual studies, i.e. effect on anxiety, was pooled using the standardized mean difference (SMD). Results:, Seven papers fulfilled the inclusion criteria, including nine randomized controlled comparisons for 297 patients. Anxiety symptoms were significantly more reduced following CBT than after either a waiting-list control condition [SMD = ,0.44 (95 CI: ,0.84 ,0.04), P = 0.03] or an active control condition [SMD = ,0.51 (95 CI: ,0.81, ,0.21), P<0.001]. Additionally, CBT significantly alleviated accompanying symptoms of worrying and depression. Conclusion:, Cognitive-behavioural therapy is efficacious for the treatment of late-life anxiety disorders. [source] Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetesDIABETES OBESITY & METABOLISM, Issue 5 2007W. M. W. Bebakar Aim:, To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix® 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a subgroup of Western Pacific patients with type 2 diabetes inadequately controlled on oral monotherapy or oral combination therapy. Methods:, This 26-week, multi-centre, open-labelled, randomized, two-arm parallel trial consisted of a 2-week screening period, followed by 24 weeks of treatment. Subjects randomized to BIAsp30 treatment (n = 129) received BIAsp30 once daily (o.d.) at dinnertime between Week 2 and Week 14, and those not reaching treatment targets were switched to twice daily (b.i.d.) BIAsp30 at Week 14 (n = 50). Subjects randomized to the OAD-only arm (n = 63) continued with their previous OAD treatment and, in an attempt to reach treatment goals, the dose was optimized (but OAD unchanged) in accordance to local treatment practice and labelling. Results:, Significantly greater reductions in HbA1c over Weeks 0,13 with BIAsp30 (o.d.) vs. OAD-only treatment (1.16 vs. 0.58%; p < 0.001), and over Weeks 0,26, with BIAsp30 (o.d.) and BIAsp30 (b.i.d.) treatments vs. OAD-only treatment (1.24 vs. 1.34 vs. 0.67%; p < 0.01). Hypoglycaemic episodes were reported in 54% of the patients in BIAsp30 (o.d. and b.i.d. pooled) and 30% of the patients in OAD-only group. All episodes were minor or symptomatic, except for one in each treatment group, which was major. Conclusions:, Initiating BIAsp30 treatment is a safe and more effective way to improve glycaemic control in Western Pacific patients with type 2 diabetes inadequately controlled with oral monotherapy or oral combination therapy compared with optimizing oral combination therapy alone. In patients not reaching treatment target on BIAsp30 (o.d.), treatment with BIAsp30 (b.i.d.) should be considered. [source] Truth and the Enigma of KnowabilityDIALECTICA, Issue 4 2007Bernhard Weiss Since its disc overy by Fitch, the paradox of knowability has been a thorn in the anti-realist's side. Recently both Dummett and Tennant have sought to relieve the anti-realist by restricting the applicability of the knowability principle , the principle that all truths are knowable , which has been viewed as both a cardinal doctrine of anti-realism and the assumption for reductio of Fitch's argument. In this paper it is argued that the paradox of knowability is a peculiarly acute manifestation of a syndrome affecting anti-realism, against which Dummett's and Tennant's manoeuvres are not finally efficacious. The anti-realist can only cope with the syndrome by being much clearer about her notion of knowability. In fact, she'll have to offer an account which relativises the notion of knowability both to the world at which knowability is assessed and to the content of the proposition to which it is applied. This is not, however, merely an ad hoc manoeuvre to counter the problematic syndrome; rather it is just what we should expect from the anti-realist's intuitive use of the notion. A preliminary investigation indicates that there is no way of providing a general, systematic explanation of such a notion of knowability and thus an inherent restriction on the principle of knowability , but one differing from those offered by either Dummett or Tennant , is developed. [source] Amisulpride: a review of its efficacyin schizophreniaACTA PSYCHIATRICA SCANDINAVICA, Issue 400 2000H. J. Möller Objective: To assess the efficacy of the new atypical antipsychotic drug, amisulpride. Method: Studies comparing the efficacy of amisulpride with that of haloperidol and risperidone, respectively, are reviewed. Outcome measures were Clinical Global Impression, Brief Psychiatric Rating Scale (BPRS), and Positive And Negative Symptom Scale (PANSS) scores. Results: Amisulpride was at least as effective as haloperidol and risperidone in the improvement of positive symptoms, and significantly more efficacious than haloperidol in reducing PANSS negative subscores (P=0.038) in patients with acute exacerbations. Amisulpride demonstrated a greater improvement in BPRS total scores (P<0.05) and PANSS negative subscores (P=0.0001) than haloperidol after 12 months of treatment in chronic schizophrenic patients with acute exacerbations. Conclusion: Amisulpride can thus be considered for use as first-line treatment of acute and chronic schizophrenia. [source] Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagusDISEASES OF THE ESOPHAGUS, Issue 1 2010Bruce D. Greenwald SUMMARY Endoscopic cryotherapy is a new technique for ablation of esophageal dysplasia and neoplasia. Preliminary studies have shown it to be safe and effective for this indication. The objective of this study is to characterize safety, tolerability, and efficacy of low-pressure liquid nitrogen endoscopic spray cryotherapy ablation in a large cohort across multiple study sites. Parallel prospective treatment studies at four tertiary care academic medical centers in the U.S. assessed spray cryotherapy in patients with Barrett's esophagus with or without dysplasia, early stage esophageal cancer, and severe squamous dysplasia who underwent cryotherapy ablation of the esophagus. All patients were contacted between 1 and 10 days after treatment to assess for side effects and complications of treatment. The main outcome measurement was the incidence of serious adverse events and side effects from treatment. Complete response for high-grade dysplasia (HGD) (CR-HGD), all dysplasia (CR-D), intestinal metaplasia (CR-IM) and cancer (CR-C) were assessed in patients completing therapy during the study period. A total of 77 patients were treated for Barrett's high-grade dysplasia (58.4%), intramucosal carcinoma (16.9%), invasive carcinoma (13%), Barrett's esophagus without dysplasia (9.1%), and severe squamous dysplasia (2.6%). Twenty-two patients (28.6%) reported no side effects throughout treatment. In 323 procedures, the most common complaint was chest pain (17.6%) followed by dysphagia (13.3%), odynophagia (12.1%), and sore throat (9.6%). The mean duration of any symptoms was 3.6 days. No side effects were reported in 48% of the procedures (155/323). Symptoms did not correlate with age, gender, diagnosis, or to treatment early versus late in the patient's or site's experience. Logit analysis showed that symptoms were greater in those with a Barrett's segment of 6 cm or longer. Gastric perforation occurred in one patient with Marfan's syndrome. Esophageal stricture developed in three, all successfully treated with dilation. In 17 HGD patients, cryotherapy produced CR-HGD, CR-D, and CR-IM of 94%, 88%, and 53%, respectively. Complete regression of cancer and HGD was seen in all seven patients with intramucosal carcinoma or stage I esophageal cancer. Endoscopic spray cryotherapy ablation using low-pressure liquid nitrogen in the esophagus is safe, well-tolerated, and efficacious. [source] Neoadjuvant therapy as a paradigm to develop systemic cancer therapyDRUG DEVELOPMENT RESEARCH, Issue 7 2008Guru SonpavdeArticle first published online: 23 DEC 200 Abstract Neoadjuvant systemic therapy preceding definitive surgical resection permits the in vivo assessment of tumor response and induces pathologic downstaging in several malignancies. Since pathologic complete response (pCR) and biologic activity can be determined rapidly, the signal of efficacy of a systemic regimen is evident with a relatively small number of patients before long-term follow-up. Additionally, emerging data suggest that modulation of pharmacodynamic biomarkers after brief neoadjuvant therapy may correlate with long-term clinical outcomes. Early evidence for in vivo resistance and elucidation of mechanisms of resistance may assist with selection of rational combinations of agents as subsequent therapy to improve outcomes. Evidence of biologic anti-tumor activity in target-enriched subsets can be determined with a small number of patients in proof of principal pilot trials. Biologic activity against molecular targets and downstream anti-proliferative and pro-apoptotic activity may help with the selection of the lowest effective dose, which may lead to efficacious and safe therapy. Therefore, this paradigm has the potential to enable the efficient use of resources and accelerate the pace of systemic therapy development. It may also be possible to determine molecular and biologic characteristics that predict for sensitivity. Drug Dev Res 69:388,397, 2008. © 2008 Wiley-Liss, Inc. [source] Novel agents to override imatinib resistance mechanismsDRUG DEVELOPMENT RESEARCH, Issue 7 2008Asumi Yokota Abstract Chronic myelogenous leukemia (CML) is a disorder of hematopoietic stem cells that results from the Philadelphia chromosome (Ph) created through translocation of human chromosomes 9 and 22. The resulting Bcr-Abl fusion protein has constitutively high tyrosine kinase activity that causes transformation of hematopoietic stem cells. Imatinib mesylate (IM) was developed as a specific Bcr-Abl kinase inhibitor and is efficacious in treating Ph-chromosome-positive (Ph+) leukemias such as CML and Ph+ acute lymphoblastic leukemia (ALL). Within a few years of its introduction to the clinic, IM has dramatically altered the first-line therapy for CML. Although most newly diagnosed CML patients in the chronic phase (CP) achieved durable responses when treated with IM, resistance to IM has become a major problem in patients with advanced-stage disease. The most important mechanism of IM resistance are point mutations within the Abl kinase domain; therefore, there is an urgent need for novel agents that can inhibit mutated Bcr-Abl. In this review, we describe novel Bcr-Abl tyrosine kinase inhibitors, the so-called "Super Gleevec" inhibitors. Drug Dev Res 69:398,406, 2008. © 2008 Wiley-Liss, Inc. [source] Role of botulinum toxin in migraine therapyDRUG DEVELOPMENT RESEARCH, Issue 7 2007Wilhelm J. Schulte-Mattler Abstract Botulinum toxin effectively blocks the release of acetylcholine from motor nerve terminals. Thus, botulinum toxin injections are well established in the treatment of disorders in which patients are impaired by involuntary muscle contractions. A remarkable pain reduction was frequently observed in these patients, and in vitro studies showed that botulinum toxin reduces not only the release of acetylcholine, but also the release of neuropeptides involved in pain perception. It was therefore hypothesized that botulinum toxin may help patients with pain not caused by muscular contractions, such as migraine or chronic daily headache, which includes chronic migraine. So far, the results of randomized, double-blind, placebo controlled trials on botulinum toxin in a total of 2,612 patients with migraine or with chronic daily headache were published. A superiority of botulinum toxin compared with placebo injections could not clearly be confirmed in any of the studies. One hypothesis derived from these results was that subgroups of patients with migraine can be defined in whom botulinum toxin may be efficacious. This hypothesis awaits confirmation. Interestingly, the efficacy of both botulinum toxin and placebo injections was found to be significant and similar to the efficacy of established oral migraine treatment. This finding may help explain the enthusiasm that followed the first open-label use of botulinum in patients with migraine. Drug Dev Res 68:397,402, 2007. © 2008 Wiley-Liss, Inc. [source] Geographic Scale and Grass-Roots Internationalism: The Liverpool Dock Dispute, 1995,1998,ECONOMIC GEOGRAPHY, Issue 3 2000Noel Castree Abstract: In the context of ongoing debates over the effects of "globalization" on organized labor and, specifically, recent experiments in labor internationalism, this paper examines the geography of the Liverpool dock dispute, 1995,98. The dispute has rarely been subject to a serious analysis of its causes and trajectory. This is surprising since it was not only the most protracted industrial dispute in recent British history but also the hub of a relatively novel form of transnational labor organizing: namely, a form of grass-roots internationalism organized largely outside the formal apparatuses of national and international unionism. In the paper I focus on the nature and dynamics of this "grass-roots internationalism" with a view to making two claims that have a wider thematic and theoretical relevance to the study of labor geographies. First, contrary to an emerging new orthodoxy in labor geography (and labor studies more generally), the Liverpool case in fact suggests that the necessity for labor to "up-scale" solidarity and struggle in the 1990s is much overstated. Second, the Liverpool case suggests that international labor organizing is only efficacious when considered in relation to two scales of struggle often thought increasingly irrelevant or ineffectual in a globalizing world: the local and the national. Thus, while those few analysts who have cited the Liverpool dispute, basing their assessments on secondhand knowledge, have held the dockers up as exemplars of a new form of labor internationalism, in this paper I suggest the need for a more complex and contingent appreciation of the multiscalar dynamics of labor struggles. In short, we have not yet reached the stage, even in a globalizing world, where labor's "spatial fixes" must be preeminently supranational. [source] Do Proper Accommodation Assignments Make a Difference?EDUCATIONAL MEASUREMENT: ISSUES AND PRACTICE, Issue 3 2007Examining the Impact of Improved Decision Making on Scores for English Language Learners Does it matter if students are appropriately assigned to test accommodations? Using a randomized method, this study found that individual students assigned accommodations keyed to their particular needs were significantly more efficacious for English language learners (ELLs) and that little difference was reported between students receiving incomplete or not recommended accommodations and no accommodations whatsoever. A sample of third and fourth grade ELLs in South Carolina (N = 272) were randomly assigned to various types of test accommodations on a mathematics assessment. Results indicated that those students who received the appropriate test accommodations, as recommended by a version of a computerized accommodation taxonomy for ELLs (the selection taxonomy for English language learners accommodations; STELLA), had significantly higher test scores than ELLs who received no accommodations or those who received incomplete or not recommended accommodation packages. Additionally, students who were given no test accommodations scored no differently than those students that received accommodation packages that were incomplete or not recommended, given the students' particular needs and challenges. These findings are important in light of research and anecdotal reports that suggest a general lack of systematicity in the current system of assigning accommodations and a tendency to give all available accommodations regardless of individual child characteristics. The results also have important implications for how future accommodation research should be structured to determine the benefits of particular accommodations and accommodation packages. This study would suggest that control and treatment groups should be assembled based on specific student needs in order for direct comparisons to be made. [source] How confident should we be that smoking cessation treatments work?ADDICTION, Issue 10 2009John R. Hughes ABSTRACT Aim To determine (i) the concordance among recent meta-analyses about which treatments for smoking cessation are efficacious; (ii) the similarity of odds ratios (ORs) across meta-analyses; and (iii) among the validated treatments, the proportion of studies that found higher quit rates. Methods Computerized literature search for meta-analyses during the last 5 years in PubMed and PsychInfo. Data were extracted from summary tables of overall effect of validated treatments. Results Fourteen meta-analyses agreed 100% on the presence/absence of efficacy of 17 proven treatments. The ORs differed by <0.5 in 72/76 of the comparisons of meta-analyses. Among 37 comparisons in 33 comparisons, >85% of the studies reported numerical superiority for the active treatment. Conclusions The efficacy of treatments for smoking cessation are extremely reliable. This argues for inclusion of treatment as an essential feature of tobacco control and clinical practice and argues for reimbursement of smoking cessation treatments on a par with other medical and behavioral disorders. [source] Advances in the enantioseparation of second-generation antidepressant drugs by electrodriven methodsELECTROPHORESIS, Issue 1 2006Roberto Mandrioli Abstract Stereochemistry is steadily increasing in importance in the development of new drugs, and the availability of pure enantiomer drugs can make therapy safer and more efficacious. In particular, almost all second-generation antidepressant drugs possess one or more chiral centres; however, only some of them are administered as single enantiomers. A fundamental part of the quality control of pharmaceutical formulations is the determination of enantiomeric excess and enantiomeric purity; this is also important for the therapeutic drug monitoring of depressed patients. For this purpose, efficient and reliable analytical methods are needed and electrodriven techniques (most of all CE, CEC and MEKC) are very efficient and inexpensive candidates for the role. In this review, the enantioselective electrodriven methods available for the analysis of second-generation antidepressant are presented and discussed. In particular, the following pharmacological classes of antidepressants will be considered: selective serotonin reuptake inhibitors (fluoxetine, citalopram, paroxetine, sertraline); norepinephrine reuptake inhibitors (reboxetine); serotonin and norepinephrine reuptake inhibitors (venlafaxine, milnacipran, duloxetine); and noradrenergic and specific serotonergic antidepressants (mirtazapine). [source] Does the standard intravenous solution of fentanyl (50 µg/mL) administered intranasally have analgesic efficacy?EMERGENCY MEDICINE AUSTRALASIA, Issue 1 2010Dianne Crellin Abstract Background: Intranasal (IN) fentanyl provides rapid and powerful non-parenteral analgesia in the ED. A concentrated solution of fentanyl (300 µg/mL) has been used in prior trials, yet many ED use the standard solution at a concentration of 50 µg/mL, which is widely available and of low cost. We set out to determine if this lower concentration of fentanyl is also efficacious. Methods: Prospective audit in children aged 5,18 years presenting with upper limb injuries. Patients received IN fentanyl (50 µg/mL) at 1.5 µg/kg. Patient assessed pain scores were collected 5, 10, 20, 30 and 60 min following IN fentanyl administration using a visual analogue scale or Bieri Faces , Revised scale. Parental scores were used if patients were unable to provide a score. Results: Of the 59 eligible patients, 36 were enrolled; median age was 6.8 years (range 5,15 years), and 89% (32/36) ultimately required fracture reduction. Median first dose of IN fentanyl was 1.4 µg/kg. Median pain scores dropped from 7 (interquartile range 5,10) pre-fentanyl to 5 (interquartile range 4,8) at 5 min and 2 (interquartile range 1,4) at 30 and 60 min. A total of 21 (58%) children did not require further analgesia in the ED. There were no adverse events. Conclusions: Standard i.v. concentration IN fentanyl (50 µg/mL) appears to have analgesic efficacy in children with upper limb injuries. [source] Anaphylaxis: Clinical concepts and research prioritiesEMERGENCY MEDICINE AUSTRALASIA, Issue 2 2006Simon GA Brown Abstract Anaphylaxis is a severe immediate-type hypersensitivity reaction characterized by life-threatening upper airway obstruction bronchospasm and hypotension. Although many episodes are easy to diagnose by the combination of characteristic skin features with other organ effects, this is not always the case and a workable clinical definition of anaphylaxis and useful biomarkers of the condition have been elusive. A recently proposed consensus definition is ready for prospective validation. The cornerstones of management are the supine position, adrenaline and volume resuscitation. An intramuscular dose of adrenaline is generally recommended to initiate treatment. If additional adrenaline is required, then a controlled intravenous infusion might be more efficacious and safer than intravenous bolus administration. Additional bronchodilator treatment with continuous salbutamol and corticosteroids are used for severe and/or refractory bronchospasm. Aggressive volume resuscitation, selective vasopressors, atropine (for bradycardia), inotropes that bypass the ,-adrenoreceptor and bedside echocardiographic assessment should be considered for hypotension that is refractory to treatment. Management guidelines continue to be opinion- and consensus-based, with retrospective studies accounting for the vast majority of clinical research papers on the topic. The clinical spectrum of anaphylaxis including major disease subgroups requires clarification, and validated scoring systems and outcome measures are needed to enable good-quality prospective observational studies and randomized controlled trials. A systematic approach with multicentre collaboration is required to improve our understanding and management of this disease. [source] Approaches to the development of medications for the treatment of methamphetamine dependenceADDICTION, Issue 2007Frank J. Vocci ABSTRACT Background Methamphetamine abuse has become an increasing problem in both the United States and globally with concomitant increases in adverse medical, social and environmental sequelae. Behavioral therapies have been used with some success to treat methamphetamine abusers and dependent individuals, but are not universally efficacious. Methamphetamine has a rich pharmacology that theoretically provides many opportunities for potential pharmacotherapeutic intervention. Nevertheless, there are no approved medications with an indication for treating methamphetamine abusers or addicts at this time. Aim To describe briefly how methamphetamine functions and affects function in brain and report how basic researchers and clinicians are attempting to exploit and exploiting this knowledge to discover and develop effective pharmacotherapies. Results Scientifically based approaches to medications development by evaluating medications that limit brain exposure to methamphetamine; modulate methamphetamine effects at vesicular monoamine transporter-2 (VMAT-2); or affect dopaminergic, serotonergic, GABAergic, and/or glutamatergic brain pathways that participate in methamphetamine's reinforcing effects are presented. Conclusion The evidence supports the rationale that pharmacotherapies to decrease methamphetamine use, or reduce craving during abstinence may be developed from altering the pharmacokinetics and pharmacodynamics of methamphetamine or its effects on appetitive systems in the brain. [source] | |||||||||||||||||||||||||||||||||||||||||||||||||