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Primary Outcome Variable (primary + outcome_variable)
Selected AbstractsExtended treatment of older cigarette smokersADDICTION, Issue 6 2009Sharon M. Hall ABSTRACT Aims Tobacco dependence treatments achieve abstinence rates of 25,30% at 1 year. Low rates may reflect failure to conceptualize tobacco dependence as a chronic disorder. The aims of the present study were to determine the efficacy of extended cognitive behavioral and pharmacological interventions in smokers , 50 years of age, and to determine if gender differences in efficacy existed. Design Open randomized clinical trial. Setting A free-standing, smoking treatment research clinic. Participants A total of 402 smokers of , 10 cigarettes per day, all 50 years of age or older. Intervention Participants completed a 12-week treatment that included group counseling, nicotine replacement therapy (NRT) and bupropion. Participants, independent of smoking status, were then assigned randomly to follow-up conditions: (i) standard treatment (ST; no further treatment); (ii) extended NRT (E-NRT; 40 weeks of nicotine gum availability); (iii) extended cognitive behavioral therapy (E-CBT; 11 cognitive behavioral sessions over a 40-week period); or (iv) E-CBT plus E-NRT (E-combined; 11 cognitive behavioral sessions plus 40 weeks nicotine gum availability). Measurements Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at weeks 24, 52, 64 and 104. Findings The most clinically important findings were significant main effects for treatment condition, time and the treatment × time interaction. The E-CBT condition produced high cigarette abstinence rates that were maintained throughout the 2-year study period [(week 24 (58%), 52 (55%), 64 (55%) and 104 (55%)], and was significantly more effective than E-NRT and ST across that period. No other treatment condition was significantly different to ST. No effects for gender were found. Conclusions Extended cognitive behavioral treatments can produce high and stable cigarette abstinence rates for both men and women. NRT does not add to the efficacy of extended CBT, and may hamper its efficacy. Research is needed to determine if these results can be replicated in a sample with a greater range of ages, and improved upon with the addition of medications other than NRT. [source] Revealing and Resolving Patient Safety Defects: The Impact of Leadership WalkRounds on Frontline Caregiver Assessments of Patient SafetyHEALTH SERVICES RESEARCH, Issue 6 2008Allan Frankel Objective. To evaluate the impact of rigorous WalkRounds on frontline caregiver assessments of safety climate, and to clarify the steps and implementation of rigorous WalkRounds. Data Sources/Study Setting. Primary outcome variables were baseline and post WalkRounds safety climate scores from the Safety Attitudes Questionnaire (SAQ). Secondary outcomes were safety issues elicited through WalkRounds. Study period was August 2002 to April 2005; seven hospitals in Massachusetts agreed to participate; and the project was implemented in all patient care areas. Study Design. Prospective study of the impact of rigorously applied WalkRounds on frontline caregivers assessments of safety climate in their patient care area. WalkRounds were conducted weekly and according to the seven-step WalkRounds Guide. The SAQ was administered at baseline and approximately 18 months post-WalkRounds implementation to all caregivers in patient care areas. Results. Two of seven hospitals complied with the rigorous WalkRounds approach; hospital A was an academic teaching center and hospital B a community teaching hospital. Of 21 patient care areas, SAQ surveys were received from 62 percent of respondents at baseline and 60 percent post WalkRounds. At baseline, 10 of 21 care areas (48 percent) had safety climate scores below 60 percent, whereas post-WalkRounds three care areas (14 percent) had safety climate scores below 60 percent without improving by 10 points or more. Safety climate scale scores in hospital A were 62 percent at baseline and 77 percent post-WalkRounds (t=2.67, p=.03), and in hospital B were 46 percent at baseline and 56 percent post WalkRounds (t=2.06, p=.06). Main safety issues by category were equipment/facility (A [26 percent] and B [33 percent]) and communication (A [24 percent] and B [18 percent]). Conclusions. WalkRounds implementation requires significant organizational will; sustainability requires outstanding project management and leadership engagement. In the patient care areas that rigorously implemented WalkRounds, frontline caregiver assessments of patient safety increased. SAQ results such as safety climate scores facilitate the triage of quality improvement efforts, and provide consensus assessments of frontline caregivers that identify themes for improvement. [source] Suboccipital Nerve Blocks for Suppression of Chronic Migraine: Safety, Efficacy, and Predictors of OutcomeHEADACHE, Issue 6 2010Silvia Weibelt RN (Headache 2010;50:1041-1044) Background., Approximately 1 in 50 Americans is afflicted by chronic migraine (CM). Many patients with CM describe cervicogenic headache. Options for treating CM effectively are at present quite limited. Objective., To determine the safety and efficacy of occipital nerve blocks (ONBs) used to treat cervicogenic chronic migraine (CCM) and to identify variables predictive of a positive treatment response. Methods., Using a uniform dose and injection paradigm, we performed ONBs consecutively on a series of patients presenting with CCM. Patients were stratified according to specific findings found to be present or absent on physical examination. A positive treatment outcome was defined as a 50% or greater reduction in headache days per month over the 30 days following treatment relative to the 30-day pre-treatment baseline. We used a 5-point Likert scale as one of the secondary outcome variables. Results., We treated 150 consecutive patients with unilateral (37) or bilateral (113) ONBs. At the 1-month follow-up visit 78 (52%) exhibited evidence of a positive treatment response according to the primary outcome variable, and 90 (60%) reported their headache disorder to be "better" (44; 29%) or "much better" (46; 30%). A total of 8 (5%) patients reported adverse events within the ensuing 72 hours, and 3 (2%) experienced adverse events that reversed spontaneously but required emergent evaluation and management. Conclusion., For suppression of CCM, ONBs may offer an attractive alternative to orally administered prophylactic therapy. [source] Lack of effects between rupatadine 10,mg and placebo on actual driving performance of healthy volunteersHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2007Eric Vuurman Abstract Introduction Rupatadine fumarate is a potent, selective, histamine H1 -receptor antagonist and PAF inhibitor with demonstrated efficacy for the relief of allergic rhinitis. Rupatadine does not easily cross the blood,brain barrier and is believed to be non-sedating at therapeutic doses. Consequently, rupatadine should show no impairment on car driving. Objective This study compared the acute effects of rupatadine, relative to placebo and hydroxyzine (as an active control), on healthy subjects' driving performance. Methods Twenty subjects received a single dose of rupatadine 10,mg, hydroxyzine 50,mg, or placebo in each period of this randomized, double-blind, three-way crossover study. Two hours postdosing, subjects operated a specially instrumented vehicle in tests designed to measure their driving ability. Before and after the driving tests ratings of sedation were recorded. Results There was no significant difference between rupatadine and placebo in the primary outcome variable: standard deviation of lateral position (SDLP); however, hydroxyzine treatment significantly increased SDLP (p,<,0.001 for both comparisons). Objective (Stanford sleepiness scale) and subjective sedation ratings (Visual Analogue Scales) showed similar results: subjects reported negative effects after hydroxyzine but not after rupatadine. Conclusion Rupatadine 10,mg is not sedating and does not impair driving performance. Copyright © 2007 John Wiley & Sons, Ltd. [source] Preoperative determinants of common bile duct stones during laparoscopic cholecystectomyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 11 2008A. J. Sheen Summary Introduction:, The aim of this study is to determine whether there are any clinical or biochemical predictors of common bile duct (CBD) stones in patients undergoing laparoscopic cholecystectomy. Methods:, A prospective database of nearly 1000 laparoscopic cholecystectomies performed under the care of a single surgeon with a standardised technique between 1999 and 2006, was analysed. Clinical presentation, ultrasound and immediate preoperative biochemical results as well as the operative cholangiogram findings were reviewed. Routine cholangiography was attempted in most patients and the primary outcome variable was the detection of bile duct stones. The data was analysed using chi-squared test for categorical variables. The significant variables on univariate analysis were further characterised to identify the independent predictors of bile duct stones using a logistic regression model (significance p < 0.05). Results:, A total of 757 of 988 patients (77%) underwent cholangiography. Male-to-female ratio was 1 : 3 with a median age of 54 years (range: 17,93). Ten per cent of patients had bile duct stones identified on cholangiography. On univariate analysis, jaundice (p = 0.019), cholangitis (p < 0.001), alanine transaminase > 100 (p = 0.024), alkaline phosphatase (ALP) > 350 (p < 0.001) and CBD > 10 mm (p = 0.01) were significant markers for predicting bile duct stones. Bilirubin > 30 (×2 normal) was found not to be significant (p = 0.145). On a logistic regression model, ALP > 350 and/or cholangitis were found to be independent predictive factors of CBD stones (odds ratio 6.1). Conclusions:, If a policy of routine intra-operative cholangiography is not adopted, a history of cholangitis or a raised ALP immediately preoperatively should lead to a high suspicion of CBD stones. [source] Jumping Improves Hip and Lumbar Spine Bone Mass in Prepubescent Children: A Randomized Controlled TrialJOURNAL OF BONE AND MINERAL RESEARCH, Issue 1 2001Robyn K. Fuchs Abstract Physical activity during childhood is advocated as one strategy for enhancing peak bone mass (bone mineral content [BMC]) as a means to reduce osteoporosis-related fractures. Thus, we investigated the effects of high-intensity jumping on hip and lumbar spine bone mass in children. Eighty-nine prepubescent children between the ages of 5.9 and 9.8 years were randomized into a jumping (n = 25 boys and n = 20 girls) or control group (n = 26 boys and n = 18 girls). Both groups participated in the 7-month exercise intervention during the school day three times per week. The jumping group performed 100, two-footed jumps off 61-cm boxes each session, while the control group performed nonimpact stretching exercises. BMC (g), bone area (BA; cm2), and bone mineral density (BMD; g/cm2) of the left proximal femoral neck and lumbar spine (L1-L4) were assessed by dual-energy X-ray absorptiometry (DXA; Hologic QDR/4500-A). Peak ground reaction forces were calculated across 100, two-footed jumps from a 61-cm box. In addition, anthropometric characteristics (height, weight, and body fat), physical activity, and dietary calcium intake were assessed. At baseline there were no differences between groups for anthropometric characteristics, dietary calcium intake, or bone variables. After 7 months, jumpers and controls had similar increases in height, weight, and body fat. Using repeated measures analysis of covariance (ANCOVA; covariates, initial age and bone values, and changes in height and weight) for BMC, the primary outcome variable, jumpers had significantly greater 7-month changes at the femoral neck and lumbar spine than controls (4.5% and 3.1%, respectively). In repeated measures ANCOVA of secondary outcomes (BMD and BA), BMD at the lumbar spine was significantly greater in jumpers than in controls (2.0%) and approached statistical significance at the femoral neck (1.4%; p = 0.085). For BA, jumpers had significantly greater increases at the femoral neck area than controls (2.9%) but were not different at the spine. Our data indicate that jumping at ground reaction forces of eight times body weight is a safe, effective, and simple method of improving bone mass at the hip and spine in children. This program could be easily incorporated into physical education classes. [source] The Importance of Emergency Medicine in Organ Donation: Successful Donation Is More Likely When Potential Donors Are Referred From the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 9 2009Glen E. Michael MD Abstract Objectives:, This study sought to identify factors that are associated with successful organ retrieval among patients referred to organ procurement services for potential organ donation. Particular attention was paid to the frequency, patient characteristics, and outcomes of patients referred for donation from the emergency department (ED). Methods:, For this retrospective cohort study, data were collected on all solid-organ donor referrals made to a single organ procurement organization serving 78 hospitals over a 45-month period. Data retrieved included patient age, sex, race, referral site (ED vs. inpatient), and mechanism of injury. Outcome of referral (organs retrieved or not) was the primary outcome variable. Pearson chi-square and Student's t-tests were used for bivariate statistical analysis. Multiple logistic regression analysis was used to determine which variables remained associated with organ retrieval after controlling for potential confounders. Results:, A total of 6,886 donor referrals were made in the study population. Of these, 155 were excluded due to incomplete data, leaving 6,731 subjects for analysis. Using bivariate statistical analysis, we found that successful organ retrieval was associated with younger age (donor mean age 40.8 years, 95% confidence interval [CI] = 39.1 to 42.5 vs. nondonor mean age 59.4, 95% CI = 58.9 to 59.9), mechanism of injury (p < 0.001), and referral from the ED (ED 15.5% retrieved, inpatient 5.9%, odds ratio [OR] = 2.92, 95% CI = 2.32 to 3.67). After controlling for potential confounders with multiple logistic regression, referral from the ED remained significantly associated with successful organ retrieval (OR = 1.52, 95% CI = 1.18 to 1.97), as did age (OR = 0.96, 95% CI = 0.96 to 0.97) and mechanism of injury (p < 0.001). On regression analysis, race emerged as a significant predictor of organ retrieval (p < 0.001). Medically suitable patients referred from the ED were significantly more likely on bivariate analysis to have consent for donation granted compared to patients referred from inpatient settings (OR = 1.48, 95% CI = 1.03 to 2.12), but this association was not found to be significant on regression analysis (OR = 1.37, 95% CI = 0.93 to 2.02). Conclusions:, Referral of potential organ donors from the ED is associated with an increased likelihood of successful organ retrieval. The authors conclude that further attention and resources should be directed toward the role of emergency medicine (EM) in the organ procurement process, owing to the relatively high likelihood of successful organ retrieval among patients referred from the ED. [source] Evaluation of enamel matrix derivative as an adjunct to non-surgical periodontal therapyJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 8 2003Mauricio A. Gutierrez Abstract Objectives: The aim of this study was to evaluate the adjunctive use of enamel matrix derivative (EMD) on periodontal healing following nonsurgical periodontal therapy (scaling and root planing , SRP). Material and methods: The study was performed as an intraindividual, longitudinal trial of 3 months duration with a double-blinded, split-mouth, controlled, and randomized design. Twenty-two patients with moderate to severe chronic periodontitis were enrolled in the study. In each patient, two sites with pocket depths 5 mm and with radiographic angular bone defects >3 mm were selected. Baseline examination included measurement of probing pocket depth (PPD) and clinical attachment levels (CAL). The presence or absence of plaque and bleeding on probing at selected sites was also recorded. Following initial examination, full-mouth SRP was performed. Study sites were then treated with 24% EDTA for 2 min, followed by thorough irrigation with sterile saline. The sites were then randomized. The experimental site received subgingival application of enamel matrix derivative (Emdogain®, BIORA AB, Malmo, Sweden). The control site received no additional treatment. At 3 months, all sites were re-examined. The response to therapy in experimental and control sites was evaluated, using change in probing depth and CAL as the primary outcome variables. Statistical analysis (paired t -tests) was used to compare response to treatment in control versus experimental sites. Results: Statistically significant changes in PPD and CAL were seen in both treatment groups from baseline to 3 months. The mean PPD reduction was 2.3±0.5 mm for control sites and 2.0±0.3 mm for experimental sites. The mean CAL gain was 1.8±0.4 mm for control sites, and 1.4±0.3 mm for experimental sites. Statistical analysis, however, revealed no significant difference in PPD reduction or CAL gain between experimental and control groups (p>0.4). In addition, no difference was found between treatment groups in bleeding or plaque indices at 3 months. Conclusion: The findings from the present study do not support the use of EMD during routine, nonsurgical debridement of periodontal pockets as measured 3 months post SRP. Zusammenfassung Ziel: Das Ziel dieser Studie war die Evaluation eines adjunktiven Gebrauchs von Schmelzmatrixderivaten (EMD) auf die parodontale Heilung nach nicht chirurgischer parodontaler Therapie (Wurzelreinigung und ,glättung, scaling und root planing , SRP). Material und Methoden: Die Studie wurde als eine intraindividuelle, für 3 Monate longitudinale Studie mit einem doppelt blinden, split-mouth, kontrolliertem und randomisiertem Protokoll durchgeführt. 22 Patienten mit moderater bis schwerer chronischer Parodontitis wurden in die Studie einbezogen. Bei jedem Patient wurden zwei Flächen mit Sondierungstiefen5 mm und mit radiographisch feststellbaren angulären Knochendefekten>3 mm ausgesucht. Die Basisuntersuchung umfasste die Messung der Sondierungstiefen (PPD) und des klinischen Stützgewebeniveaus (CAL). Die An- oder Abwesenheit von Plaque und Provokationsblutung an den ausgesuchten Flächen wurden auch dokumentiert. Nach der anfänglichen Untersuchung wurde eine alle Zähne betreffende SRP durchgeführt. Die Studienflächen wurden dann mit 24% EDTA für zwei Minuten behandelt, gefolgt von einer sorgsamen Spülung mit steriler Kochsalzlösung. Die Flächen wurden dann randomisiert. Die experimentellen Flächen erhielten eine subgingivale Applikation von Schmelzmatrixderivaten (Emdogain®, BIORA AB, Malmö, Schweden). Die Kontrollflächen erhielten keine zusätzliche Behandlung. Zum dritten Monat wurden alle Flächen reexaminiert. Die Antwort auf die Therapie bei den experimentellen und Kontrollflächen wurden evaluiert in Hinsicht der Veränderung der Sondierungstiefe und CAL als die primären Ergebnisvariablen. Statistische Analysen (gepaarter t -Test) wurden für den Vergleich der Behandlung zwischen experimentellen und Kontrollflächen genutzt. Ergebnisse: Statistisch signifikante Veränderungen bei der PPD und dem CAL wurden in beiden Behandlungsgruppen zwischen Basis und 3 Monaten beobachtet. Die mittlere PPD Reduktion betrug 2.3±0.5 mm für die Kontrollflächen und 2.0±0.3 mm für die experimentellen Flächen. Der mittlere CAL Gewinn betrug 1.8±0.4 mm für die Kontrollflächen und 1.4±0.3 mm für die experimentellen Flächen. Die statistischen Analysen erbrachten jedoch keine signifikanten Differenzen für PPD Reduktion und CAL Gewinn zwischen den experimentellen und Kontrollgruppen (p>0.4). Es wurden auch keine Differenzen zwischen den Gruppen hinsichtlich Provokationsblutung und Plaqueindex zum dritten Monat beobachtet. Schlussfolgerung: Die Ergebnisse von der vorliegenden Studie unterstützen nicht die Anwendung von EMD während der routinemäßigen nicht chirurgischen Reinigung der parodontalen Taschen, wie die Messungen drei Monate nach SRP. Résumé Objectif: Le but de cette étude fut d'évaluer l'utilisation des dérivés de la matrice amellaire (EMD) sur la cicatrisation parodontale après un traitement parodontal non chirurgical (détartrage et surfaçage radiculaire). Matériel et méthodes: L'étude fut conçue en essai longitudinal intra-individuel d'une durée de 3 mois randomisée, contrôlée en double aveugle et en bouche croisée. 22 patients atteints de parodontites chroniques modérées ou sévères furent enrôlés. Pour chaque patient, 2 sites avec des profondeurs de poches5 mm et des lésions osseuses angulaires radiographiques>3 mm furent sélectionnés. L'examen initial comportait la mesure des profondeurs de poche au sondage (PPD) et les niveaux cliniques d'attache (CAL). La présence ou l'absence de plaque et de saignement au sondage sur les sites sélectionnés furent aussi enregistrées. Après l'examen initial, un détartrage et un surfaçage complet étaient réalisés. Les sites étudiés étaient alors traités par de l'EDTA à 24% pendant 2 minutes, puis fortement rinçés avec du serum physiologique. Les sites étaient alors répartis aléatoirement. Le site expérimental recevait une application sous gingivale d'EMD (Emdogain®, BIORA AB, Malmo, Sweden). Le site contrôle ne recevait pas de traitement supplémentaire. A 3 mois, les sites étaient réévalués. La réponse au traitement était évaluée par les modifications de profondeur de poches et de niveau d'attache comme variables primaires. L'analyse statistique (Test t apparié) permit de comparer la réponse au traitement. Résultats: Des modifications statistiquement significatives de PPD et de CAL ont été observées dans les deux groupes de traitement. La réduction de PPD moyenne était de 2.3±0.5 mm pour les sites contrôles et de 2.0±0.3 mm pour les sites expérimentaux. Le gain de CAL moyen était respectivement de 1.8±0.4 mm et de 1.4±0.3 mm.L'analyse statistique, cependant, ne révélait pas de différences significatives entre les deux groupes (p>0.4). De plus, aucune différence n'apparaissait entre les groupes pour le saignement et les indices de plaque au troisième mois. Conclusion: Les données de cette étude n'étayent pas l'utilisation routinière d' EMD lors du débridement non chirurgical des poches parodontales lorsqu'on en mesure les résultats 3 mois après détartrage et surfaçage radiculaire. [source] Management of TMD: evidence from systematic reviews and meta-analysesJOURNAL OF ORAL REHABILITATION, Issue 6 2010T. LIST Summary, This systematic review (SR) synthesises recent evidence and assesses the methodological quality of published SRs in the management of temporomandibular disorders (TMD). A systematic literature search was conducted in the PubMed, Cochrane Library, and Bandolier databases for 1987 to September 2009. Two investigators evaluated the methodological quality of each identified SR using two measurement tools: the assessment of multiple systematic reviews (AMSTAR) and level of research design scoring. Thirty-eight SRs met inclusion criteria and 30 were analysed: 23 qualitative SRs and seven meta-analyses. Ten SRs were related to occlusal appliances, occlusal adjustment or bruxism; eight to physical therapy; seven to pharmacologic treatment; four to TMJ and maxillofacial surgery; and six to behavioural therapy and multimodal treatment. The median AMSTAR score was 6 (range 2,11). Eighteen of the SRs were based on randomised clinical trials (RCTs), three were based on case,control studies, and nine were a mix of RCTs and case series. Most SRs had pain and clinical measures as primary outcome variables, while few SRs reported psychological status, daily activities, or quality of life. There is some evidence that the following can be effective in alleviating TMD pain: occlusal appliances, acupuncture, behavioural therapy, jaw exercises, postural training, and some pharmacological treatments. Evidence for the effect of electrophysical modalities and surgery is insufficient, and occlusal adjustment seems to have no effect. One limitation of most of the reviewed SRs was that the considerable variation in methodology between the primary studies made definitive conclusions impossible. [source] Redrawing organ distribution boundaries: Results of a computer-simulated analysis for liver transplantationLIVER TRANSPLANTATION, Issue 8 2002Richard B. Freeman MD For several years, the Organ Procurement and Transplantation Network/United Network for Organ Sharing (UNOS) Liver and Intestinal Transplantation Committee has been examining effects of changes and proposed changes to the liver allocation system. The Institute of Medicine recently recommended that the size of liver distribution units be increased to improve the organ distribution system. Methods to achieve this and the potential impact on patients and transplant centers of such a change are evaluated in this study. In hypothetical scenarios, we combined geographically contiguous organ procurement organizations (OPOs) in seven different configurations to increase the size of liver distribution units to cover populations greater than 9 million persons. Using the UNOS Liver Allocation Model (ULAM), we examined the effect of 17 different organ allocation sequences in these proposed realignments and compared them with those predicted by ULAM for the current liver distribution system by using the following primary outcome variables: number of primary liver transplantations performed, total number of deaths, and total number of life-years saved. Every proposed new liver distribution unit plan resulted in fewer primary transplantations. Many policies increased the total number of deaths and reduced total life-years saved compared with the current system. Most of the proposed plans reduced interregional variation compared with the current plan, but no one plan consistently reduced variation for all outcome variables, and all reductions in variations were relatively small. All new liver distribution unit plans led to significant shifts in the number of transplantations performed in individual OPOs compared with the current system. The ULAM predicts that changing liver distribution units to larger geographic areas has little positive impact on overall results of liver transplantation in the United States compared with the current plan. Enlarging liver distribution units likely will result in significant shifts in organs across current OPO boundaries, which will have a significant impact on the activity of many transplant centers. [source] COMPARISON OF THE EFFECTS OF TULOBUTEROL PATCH AND SALMETEROL IN MODERATE TO SEVERE ASTHMACLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 11 2006Osamu Nishiyama SUMMARY 1Although the clinical effects of the tulobuterol patch have been reported to include an increase in morning peak expiratory flow (PEF) values and a decrease of symptoms and the frequency of the rescue use of inhaled short-acting b2 -adrenoceptor agonists, no trials comparing the efficacy of the tulobuterol patch to other standard inhaled long-acting b2 -adrenoceptor agonists have yet been conducted. The aim of the present study was to compare the clinical effects of the patch formulation of tulobuterol with those of inhaled salmeterol in moderate to severe asthma. 2Fifty-four patients with moderate to severe asthma, whose conditions were suboptimally controlled despite receiving inhaled corticosteroids, were recruited. The study was a prospective, randomized trial of cross-over design comparing the effects of 4 weeks treatment with tulobuterol patch, 2 mg once daily, and salmeterol, 50 mg twice daily. The mean prebronchodilator morning PEF during the last 14 days of each treatment period and health-related quality of life (HRQoL) were the primary outcome variables. The HRQoL was assessed using the St George's Respiratory Questionnaire. 3Forty-four patients (81.5%) completed the trial and were included in the analysis. The mean morning PEF and HRQoL score were significantly improved in both the salmeterol (P < 0.0001 and P < 0.05, respectively) and the tulobuterol patch (P < 0.01 and P < 0.05, respectively) treatment periods compared with the run-in period. Although the mean morning PEF was significantly higher in the salmeterol-treated group than in the tulobuterol-treated group (P < 0.001), the HRQoL scores were comparable. 4The tulobuterol patch may be useful as a controller medication in addition to inhaled corticosteroids in moderate to severe asthma. [source] | ||||||||||