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Mean Improvement (mean + improvement)
Selected AbstractsUtilization of the 1320-nm Nd:YAG Laser for the Reduction of Photoaging of the HandsDERMATOLOGIC SURGERY, Issue 8 2004FAACS, Neil Sadick MD Background. Nonablative laser resurfacing has been shown to improve the appearance photoaged skin. Clinical improvement has been associated with dermal collagen remodeling. Objective. The objective was to determine the efficacy of a 1320-nm Nd:YAG laser for the treatment of photoaging hands. Methods. Seven patients with photoaged hands received six monthly treatments with a 1320-nm Nd:YAG laser. Improvement in skin smoothness was evaluated by objective and patient assessment using a 6-point improvement scale: 1=no improvement and 6=80% to 100% improvement. Results. Mild to moderate improvement was achieved as determined by both objective and patient assessment. Mean improvement by objective assessment was 2.4 points. Objective improvement was noted in four of seven patients, and these patients demonstrated a mean improvement score of 3.5 points. The mean improvement by patient assessment was 3.1 points. Conclusion. This case series demonstrates that the 1320-nm Nd:YAG laser with cryogen cooling can be effective for rejuvenation of photoaged hands. [source] Reliability, validity and responsiveness of a new leisure index: The Patient-Specific Leisure Scale (PSLS)MUSCULOSKELETAL CARE, Issue 3 2009Ingegerd Wikström Abstract Objectives:,To investigate the reliability, validity and responsiveness of a new Patient-Specific Leisure Scale (PSLS), constructed to identify goals and outcomes for individual patients with rheumatoid arthritis (RA). Methods:,Forty-nine patients with RA were used to evaluate test,retest reliability, and 100 consecutive RA patients were used for construct validity. Twenty-five RA patients, commencing with treatment on tumour necrosis factor (TNF) inhibitors, were evaluated before the start and after three months of therapy, to test responsiveness. The most important leisure activity (as judged by the patients) was used when evaluating reliability and validity. The perceived difficulty with each activity was scored from 0 to 10 (0 = able to perform activity without difficulty, 10 = unable to perform activity). Results:,Test,retest reliability indicated a good agreement (0.62,0.87) using weighted kappa. Construct validity was demonstrated by modest positive correlation between leisure activity and Health Assessment Questionnaire (HAQ) (rs = 0.27, p = 0.005) visual analogue scale (VAS) pain (rs = 0.28, p = 0.004) VAS global (rs = 0.22, p = 0.027), VAS fatigue (rs = 0.24, p = 0.013), joint index of 28 swollen joints (rs = 0.22, p = 0.027) and negative correlations with short-form-36 (SF-36) physical functioning (rs = ,0.18, p = 0.008), bodily pain (rs = ,0.31, p < 0.001), general health (rs = ,0.23, p = 0.019), vitality (rs = ,0.31, p < 0.001), social function (rs = ,0.24, p = 0.016) and role-emotional (rs = ,0.28, p = 0.005). Mean improvement for the most important leisure activity was 1.36, (p = 0.036, 95% confidence interval 0.10,2.62). Standardized response mean and effect size for the most important activity in PSLS was 1.05 and 0.72, respectively, and for HAQ 0.34 and 0.28, respectively. Conclusions:,PSLS appears to be feasible, reliable, valid and responsive for measuring leisure activities in RA. It provides both an individual result which is useful in clinical work, and results at a group level. Copyright © 2009 John Wiley & Sons, Ltd. [source] Ultraflex stents for the management of airway complications in lung transplant recipientsRESPIROLOGY, Issue 1 2003Prashant N. CHHAJED Objective: We present our experience with the use of the Ultraflex (nitinol) stents in the management of airway complications in lung transplant (LT) recipients. Methodology: Nine LT recipients underwent insertion of uncovered Ultraflex stents. Mean change in FEV1, duration to formation of granulation tissue and follow-up post-stent insertion were compared with results obtained in LT recipients who had undergone Gianturco stent (n = 10) and Wallstent insertion (n = 16). Results: Mean improvement in FEV1 after insertion of Gianturco, Wallstent and Ultraflex stents was 670 ± 591 mL, 613 ± 221 mL and 522 ± 391 mL, respectively. No patient with an Ultraflex stent developed mucus plugging or stenosis at stent extremity at a follow up of 263 ± 278 days. The mean and median duration to stenosis at stent extremity for patients with Gianturco stents was 102 ± 85 days and 73 days, respectively, compared with 132 ± 87 days and 142 days, respectively, for patients with Wallstents. Stricture formation in the middle of the Ultraflex stent occurred bilaterally, at the level of anastomosis in one patient in whom stent placement was undertaken in the presence of inflammation. Stent migration in one patient was related to undersizing of the stent diameter relative to the airway diameter. A larger diameter relative stent was subsequently inserted successfully. Conclusion: Ultraflex stents appear to have fewer long-term complications when used in the management of airway complications following LT. [source] To POP or Not: Ossiculoplasty in Congenital Aural Atresia Surgery,THE LARYNGOSCOPE, Issue 8 2008Eric J. Dobratz MD Abstract Objectives/Hypothesis: To examine indications for ossiculoplasty (OP) in aural atresia surgery and to compare audiometric results and surgical revision rates between patients undergoing OP and those undergoing intact native chain reconstruction (INCR). Study Design: Retrospective chart review. Methods: Charts of patients undergoing surgery for congenital aural atresia were reviewed for demographic data, preoperative Jahrsdoerfer score, ossicular chain status, and audiometric data. Patients undergoing OP were compared with an equal number of age and Jahrsdoerfer grade-matched patients who had an INCR. The preoperative and postoperative average air-bone gap (ABG), speech reception thresholds (SRT), and rates of revision surgery were compared between the two groups. Results: Nineteen patients (20 ears) underwent OP during aural atresia repair and were compared with 20 matched patients who had INCR. Mean age, Jahrsdoerfer score, preoperative ABG, and SRT were similar for both groups. Mean postoperative audiometric follow-up was 33.1 months for the OP group and 20.4 months for the INC group (P = .24). Mean postoperative ABG was 33.8 dB HL for OP and 23.8 dB HL for INCR (P < .05). Mean improvement in ABG was 16.8 dB HL for OP and 29.9 dB HL for INCR (P < .001). Mean improvement in SRT was 24.6 dB HL for OP and 34.8 dB HL for INCR (P < .05). Nine ears (45%) in the OP group and four ears (20%) in the INCR group underwent revision surgery (P = .09). Conclusions: Patients reconstructed with their own intact native chain during aural atresia surgery have better audiometric outcomes than those undergoing OP and are less likely to undergo revision surgery. [source] A double-blind study of the efficacy of venlafaxine extended-release, paroxetine, and placebo in the treatment of panic disorderDEPRESSION AND ANXIETY, Issue 1 2007Mark H. Pollack M.D. Abstract To date, no large-scale, controlled trial comparing a serotonin,norepinephrine reuptake inhibitor and selective serotonin reuptake inhibitor with placebo for the treatment of panic disorder has been reported. This double-blind study compares the efficacy of venlafaxine extended-release (ER) and paroxetine with placebo. A total of 664 nondepressed adult outpatients who met DSM-IV criteria for panic disorder (with or without agoraphobia) were randomly assigned to 12 weeks of treatment with placebo or fixed-dose venlafaxine ER (75,mg/day or 150,mg/day), or paroxetine 40,mg/day. The primary measure was the percentage of patients free from full-symptom panic attacks, assessed with the Panic and Anticipatory Anxiety Scale (PAAS). Secondary measures included the Panic Disorder Severity Scale, Clinical Global Impressions,Severity (CGI-S) and ,Improvement (CGI-I) scales; response (CGI-I rating of very much improved or much improved), remission (CGI-S rating of not at all ill or borderline ill and no PAAS full-symptom panic attacks); and measures of depression, anxiety, phobic fear and avoidance, anticipatory anxiety, functioning, and quality of life. Intent-to-treat, last observation carried forward analysis showed that mean improvement on most measures was greater with venlafaxine ER or paroxetine than with placebo. No significant differences were observed between active treatment groups. Panic-free rates at end point with active treatment ranged from 54% to 61%, compared with 35% for placebo. Approximately 75% of patients given active treatment were responders, and nearly 45% achieved remission. The placebo response rate was slightly above 55%, with remission near 25%. Adverse events were mild or moderate and similar between active treatment groups. Venlafaxine ER and paroxetine were effective and well tolerated in the treatment of panic disorder. Depression and Anxiety 24:1,14, 2007. © 2006 Wiley-Liss, Inc. [source] Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian menINTERNATIONAL JOURNAL OF UROLOGY, Issue 6 2006YING LU GUO Aim:, Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. Methods:, This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). Results:, Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. Conclusions:, Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED. [source] MCMI-III personality complexity and depression treatment outcome following group-based cognitive,behavioral therapyJOURNAL OF CLINICAL PSYCHOLOGY, Issue 12 2007Mark A. Craigie This study investigated the association of personality disorder complexity to treatment outcome for depression following time-limited group-based cognitive,behavioral therapy. One hundred fifteen outpatients with a primary diagnosis of depression participated in the study. In this study, personality disorder complexity was determined by the degree of personality disorder comorbidity identified by the Millon Clinical Multiaxial Inventory-III (T. Millon, 1994). As predicted, analyses revealed that increasing personality disorder complexity was related to increasing baseline symptom severity and slightly poorer end-state functioning at posttreatment. However, results regarding clinically significant improvement and mean improvement in depression symptoms were less supportive of an association between personality disorder complexity and poorer treatment outcome. The implications of these findings for treatment planning are discussed. © 2007 Wiley Periodicals, Inc. J Clin Psychol 63: 1153,1170, 2007. [source] A direct comparison of pulsed dye, alexandrite, KTP and Nd:YAG lasers and IPL in patients with previously treated capillary malformations,LASERS IN SURGERY AND MEDICINE, Issue 6 2008David J. McGill MRCS(Ed) Abstract Introduction Several studies have reported laser treatment of Capillary Malformations (CMs) using systems other than pulsed dye lasers (PDL). Few, however, have compared different systems in the same patients. This study aimed to directly compare CM fading using five different systems. Methods Eighteen previously PDL-treated patients were test-patched using the alexandrite, KTP, and Nd:YAG lasers and intense pulsed light (IPL) with additional PDL patches as a control. Pre- and post-treatment videomicroscopy, and colour measurements using Munsell colour charts were carried out. Results Four patients failed to respond to any test patches. The alexandrite laser test patches had the largest mean improvement in Munsell colour following treatment (P,=,0.023) and resulted in CM fading in 10 patients, although 4 patients developed hyperpigmentation, and 1 patient scarring, following treatment. In addition, the alexandrite laser caused a significant decrease in mean post-treatment capillary diameter (P,=,0.007), which was not mirrored by the other systems. The KTP and Nd:YAG lasers were least effective, with fading seen in two patients for both systems, whilst IPL patches resulted in CM fading in six patients. In addition, five patients had further CM fading using double-passed PDL treatment. Mean pre-treatment capillary diameter measurements were predictive of those patients likely to respond to laser treatment. Conclusions Alexandrite laser treatment was the most effective, but resulted in hyperpigmentation and scarring in four patients, probably due to its deeper penetration and lower specificity for oxyhaemoglobin causing non-specific dermal damage. Double passing of the PDL can result in further CM fading even in previously treated patients. Videomicroscopy measurements of capillary diameter before treatment may be predictive of the likelihood for patient's to respond to laser treatment. Lesers Surg. Med. 40:390,398, 2008. © 2008 Wiley-Liss, Inc. [source] Meta-analysis of the efficacy of the acetonic kava-kava extract WS®1490 in patients with non-psychotic anxiety disorders,PHYTOTHERAPY RESEARCH, Issue 3 2005Steffen Witte Abstract Introduction: The herbal medicinal product kava-kava, used for treating anxiety disorders, was assessed positively by the Cochrane Review. However, it was withdrawn from the market in Switzerland and Germany due to cases of liver failure and ,unproven' efficacy. Methods: A protocol for the meta-analysis based on patient source data was written, a literature search was done, and six placebo-controlled, randomized trials with the kava extract WS®1490 were identified. The endpoints were the change in HAMA during treatment (continuous and binary). Results: WS®1490 has an effective success rate of OR=3.3 (95% confidence interval of 2.09,5.22) in patients with non-psychotic anxiety disorders. The continuous outcome supports this result: mean improvement with WS®1490 by 5.94 (95% confidence interval ,0.86 to 12.8) points on the HAMA scale better than placebo. Kava seems to be more effective in females and in younger patients. Discussion: This meta-analysis has no publication bias, no remarkable heterogeneity and is based on trials with high methodological standards. It is concluded that WS®1490, and possibly other kava extracts, are effective. Therefore they remain alternatives to benzodiazepines, selective serotonin re-uptake inhibitors (SSRIs) and other antidepressants in the treatment of non-psychotic anxiety disorders. Copyright © 2005 John Wiley & Sons, Ltd. [source] Efficacy of 308-nm excimer light for Japanese patients with psoriasisTHE JOURNAL OF DERMATOLOGY, Issue 11 2009Yusuke NIWA Abstract Ultraviolet irradiation therapy, including psoralen and ultraviolet A therapy and narrow-band ultraviolet B (310,312 nm) therapy, is a widely used and highly efficient treatment modality for psoriasis. Therapy with 308-nm excimer light has been reported to be effective for the treatment of psoriasis vulgaris. To evaluate the efficacy of 308-nm excimer light therapy for Japanese psoriasis patients, seven patients (six men and one woman) with plaque-type psoriasis were treated with 308-nm excimer light at 7,14-day intervals. The Psoriasis Severity Index (PSI) was calculated for individual plaques in order to assess the effectiveness of the therapy. A 74.9% mean improvement in the PSI was observed after 10 treatment sessions. These results suggested that targeted irradiation with 308-nm excimer light leads to rapid and selective improvement in plaque-type psoriatic lesions without unnecessary radiation exposure to the surrounding unaffected skin. [source] Eczema workshops reduce severity of childhood atopic eczemaAUSTRALASIAN JOURNAL OF DERMATOLOGY, Issue 2 2009Elizabeth J Moore ABSTRACT An intervention study was conducted to assess the effectiveness of a nurse-led eczema workshop in reducing the severity of atopic eczema in infants, children and adolescents. Ninety-nine new patients referred to the Dermatology Department of The Royal Children's Hospital in Melbourne, Australia, for the management of atopic eczema were randomized to receive care from an eczema workshop or a dermatologist-led clinic. Patients were followed-up 4 weeks after the intervention. The primary outcome was the severity of eczema as determined by scores obtained using the Scoring of Atopic Dermatitis (SCORAD) index at a 4-week follow-up visit. The secondary outcome was a comparison of treatments used in both clinics. At the 4-week review the mean improvement in SCORAD was significantly greater in those patients attending the eczema workshop than those attending the dermatologist-led clinic (,9.93, 95% confidence interval ,14.57 to ,5.29, P < 0.001). Significantly more patients from the eczema workshop improved from moderate severity eczema at baseline to mild at review. There was greater adherence to eczema management in the eczema workshop compared with the dermatologist-led clinic. In this study, patients attending the eczema workshop had a greater improvement in eczema severity thanpatients attending a dermatologist-led clinic, supporting collaborative models of service provision. [source] Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trialBRITISH JOURNAL OF DERMATOLOGY, Issue 5 2005S.R. Feldman Summary Background, Psoriasis is a chronic disease that significantly diminishes the health-related quality of life (HRQOL). Infliximab is a chimeric, tumour necrosis factor , monoclonal antibody that has been shown to improve the signs and symptoms of plaque psoriasis. Objectives, The objective of this study was to evaluate the effect of infliximab induction therapy on the HRQOL of patients with severe plaque psoriasis. Methods, In this double-blind, placebo-controlled trial, 249 patients were randomly assigned to receive intravenous infusions of 3 or 5 mg kg,1 of infliximab or placebo and were treated at weeks 0, 2 and 6. Patients completed the Dermatology Life Quality Index (DLQI) at baseline and week 10. Results, Infliximab induction therapy resulted in a substantial improvement in HRQOL. At week 10, patients in the infliximab 3- and 5-mg kg,1 groups showed a median percentage improvement in DLQI scores of 84·0% and 91·0%, respectively, compared with 0% in the placebo group (P < 0·001). The median decrease from baseline in DLQI score at week 10 was 8·0 and 10·0 for the 3 and 5 mg kg,1 infliximab groups, respectively, compared with 0 in the placebo group (P < 0·001). Thirty-three per cent and 40% of patients in the 3 and 5 mg kg,1 infliximab groups, respectively, had a DLQI score of 0 at week 10, compared with 2% in the placebo group (P < 0·001). There was a strong correlation between the percentage change from baseline at week 10 in Psoriasis Area and Severity Index (PASI) scores and the percentage change in DLQI scores during the same period (Spearman's correlation, 0·61, P < 0·001). When the infliximab and placebo treatment groups were combined, patients with at least 75% improvement in PASI scores between baseline and week 10 had a greater mean improvement in DLQI scores (81%) than those with 50,75% improvement in PASI during the same period (60%). Conclusions, Infliximab induction therapy resulted in significant improvement in HRQOL in patients with severe psoriasis. [source] Antiepileptic monotherapy significantly impairs normative scores on common tests of executive functionsACTA NEUROLOGICA SCANDINAVICA, Issue 3 2009E. Hessen Background,,, Understanding how antiepileptic (AED) monotherapy influences normative test scores is of importance in the clinic for correct interpretation of neuropsychological profiles. Previous studies have primarily reported minor influence on neuropsychological raw scores, and the clinical relevance of these findings is unclear. Aim of the study ,To obtain a clinical valid answer to this question, we analysed changes in T-scores after AED withdrawal in a large group of well-controlled epilepsy patients, for tests previously shown to be sensitive to AED withdrawal. Methods ,We report outcomes on measures of choice reaction time from the California Computerized Assessment Package, on the Controlled Oral Word Association Test and on the Stroop Color-Word Interference Test. Results ,Significantly improved T-scores were revealed after AED withdrawal on five of the six tests of executive functions with mean improvement of 5 T-scores. Comparable results were achieved in the subgroup taking carbamazepine, with a mean improvement of 6.2 T-scores. Conclusion ,The present results suggest that T-scores for computerized tests of choice reaction time and tests of verbal fluency and response inhibition may be significantly impaired as a consequence of AED monotherapy, and that careful interpretation of these scores is required in diagnostic assessment of patients receiving AED monotherapy. [source] A Multicenter, Placebo-Controlled, Double-Blind, Randomized Study of Efficacy and Safety of Ocinaplon (DOV 273,547) in Generalized Anxiety DisorderCNS: NEUROSCIENCE AND THERAPEUTICS, Issue 2 2010Pál Czobor Preclinical studies demonstrated that ocinaplon, a positive allosteric modulator of GABAA receptors, possesses anxiolytic-like actions at doses devoid of the side effects typically associated with benzodiazepines. The aim of this study was to evaluate the effects of ocinaplon in a multicenter, double-blind proof-of-concept trial of male and female outpatients who met DSM-IV criteria for GAD with no coexisting depression, and had a baseline score of ,20 on the Hamilton Scale for Anxiety (HAM-A). Patients with <20% reduction in HAM-A to placebo in a single-blind 7-day run-in period were randomly assigned to treatment with ocinaplon 90 mg t.i.d. (n = 31) or placebo for 28 days (n = 29). Ocinaplon was more effective than placebo in reducing HAM-A scores (P= 0.009). Patients assigned to ocinaplon exhibited a mean improvement of 14.2 points (SE = 2.6) on the total score of the HAM-A scale at the conclusion of the trial, while patients assigned to placebo obtained a mean improvement of 6.3 points (SE = 2.0). A significant (P= 0.023) difference in improvement between ocinaplon and placebo was observed beginning at and continuing from 1-week after the initiation of dosing. The proportion of patients with treatment-emergent adverse events (TEAE) was not statistically significant between ocinaplon and placebo. One serious adverse event (SAE) occurred in the ocinaplon group that was considered possibly related to study medication (icterus following transaminase elevations). The patient had preexisting medical conditions that may have contributed to this SAE. A full recovery was observed with no residual effects. The overall safety profile revealed no patterns of TEAEs, including those effects typically associated with other anxiolytic and/or benzodiazepine compounds, such as sedation. Ocinaplon appears to be a well-tolerated and effective treatment for GAD. It produces a rapid onset of anxiolytic action absent the side effects (e.g., dizziness, sedation) typically reported following anxiolytic doses of benzodiazepines. [source] Persistence and Improvement of Nasolabial Fold Correction with Nonanimal-Stabilized Hyaluronic Acid 100,000 Gel Particles/mL Filler on Two Retreatment Schedules: Results up to 18 Months on Two Retreatment SchedulesDERMATOLOGIC SURGERY, Issue 2008RHODA S. NARINS MD BACKGROUND Nonanimal-stabilized hyaluronic acid (NASHA) fillers are frequently used for facial soft tissue augmentation. Their long-term efficacy and the effects of different retreatment schedules are not well established. OBJECTIVE This is an 18-month interim analysis of a 30-month study to evaluate the efficacy and persistence of NASHA 100,000 gel particles/mL filler with two different retreatment schedules. METHODS This multicenter, randomized, evaluator-blinded study enrolled 75 patients with moderate to severe nasolabial folds. Patients were randomized to retreatment of one nasolabial fold at 4.5 months and the contralateral fold at 9 months after correction of both folds at the initial visit. RESULTS Wrinkle Severity Rating Scale scores improved significantly (p<.001) from baseline, with mean improvements ranging from 1.1 to 1.7 grades. Almost all patients (97%) responded satisfactorily, and the efficacy of the retreatment schedules did not differ significantly. Adverse events, primarily swelling and bruising, occurred in 33% of patients; none were serious. CONCLUSION The improvements seen after initial treatment with NASHA 100,000 gel particles/mL filler persisted for up to 18 months with one retreatment. The response was equivalent for retreatment at 4.5 and 9 months. [source] Enhanced Left Ventricular Endocardial Border Delineation with an Intravenous Injection of SonoVue, a New Echocardiography Contrast Agent:ECHOCARDIOGRAPHY, Issue 8 2000A European Multicenter Study The safety and efficacy of SonoVue (also referred to as BR1), a new contrast agent for delineating endocardial border of the left ventricle after intravenous administration, was assessed. Two hundred and eighteen patients with suspected coronary artery disease undergoing fundamental echocardiography for the assessment of left ventricle were enrolled in a prospective multicenter, single blind, cross-over study with random sequence allocation of four different doses of SonoVue. Endocardial border definition in the apical and parasternal views was scored as O = not visible, 1 = barely visible, and 2 = well visualized before and after contrast enhancement. Analysis was performed by two pairs of off-site observers. Safety of SonoVue was also assessed. Results of our study indicated that the mean improvements in the endocardial border visualization score were as follows: 3.1 ± 7.8 (95% CI, 2.5 and 3.7) for 0.5 ml, 3.4 ± 8.0 (95% CI, 2.8 and 4.0) for 1 ml, 3.4 ± 7.9 (95% CI, 2.8 and 4.0) for 2 ml, and 3.7 ± 8.0 (95% CI, 3.1 and 4.3) for 4 ml (P < 0.05 for all doses from baseline). Changes from baseline in endocardial visualization scores were also seen in the apical views (P < 0.05) and they were dose-dependent (P < 0.001). Similar enhancements of endocardial visualization scores were observed in the apical views in patients with suboptimal baseline echocardiographic images. Diagnostic confidence for assigning a score and image quality also were significantly better following contrast enhancement. No significant changes in the laboratory parameters and vital signs were noted following contrast enhancement, and the side effects were minimal. It was concluded that SonoVue is safe and effective in delineating endocardial border, including in patients with suboptimal baseline images. [source] Topiramate Treatment of Chronic Migraine: A Randomized, Placebo-Controlled Trial of Quality of Life and Other Efficacy MeasuresHEADACHE, Issue 8 2009Stephen Silberstein MD Objective., To define yet more clearly the utility of topiramate in the treatment of chronic migraine, we evaluated prespecified secondary endpoints from a recent randomized, double-blind, placebo-controlled, multicenter clinical trial. Background., We previously reported that topiramate 100 mg per day produced a statistically significant reduction in mean monthly migraine/migrainous and migraine headache days compared with placebo treatment and that it was safe and generally well tolerated. Methods., Variables analyzed included between-treatment group differences in percent responders, change in the mean monthly rate of total headache days and headache-free days, change in average and worst daily headache severity, change in the mean monthly use of acute headache medications, and absolute change and percent change in a headache index. Additional analyses included evaluation of changes in: the associated symptoms of photophobia, phonophobia, and nausea; Migraine-Specific Quality of Life Questionnaire scores; Migraine Disability Assessment Scale scores; and Physician's and Subjects Global Impression of Change. Results., The intent-to-treat population consisted of 306 patients (topiramate, n = 153; placebo, n = 153). Categorical responder rates of reductions in mean monthly migraine/migrainous days for topiramate- vs placebo-treated subjects were as follows: for ,25% reduction: 68.6% vs 51.6% (P = .005); ,50%: 37.3% vs 28.8% (P = .093); and ,75%: 15.0% vs 9.2% (P = .061). The decrease in mean monthly total headache days and headache-free days for topiramate vs placebo treatment was 5.8 vs 4.7 days (P = .067). Compared with placebo, topiramate treatment resulted in statistically significant mean improvements in the Role Restrictive (P = .028) and Emotional Function (P = .036) domains of the Migraine-Specific Quality of Life Questionnaire, in the worst daily severity of migraine (P = .016), severity of photophobia (P = .032), frequency of vomiting (P = .018), photophobia (P = .038), phonophobia (P = .010), unilateral pain (P = .015), pulsatile pain (P = .023), and pain worsened because of physical activity (P = .047). In addition, there were trends observed (favoring topiramate) in average daily severity of migraine (P = .077), acute headache medication use (P = .127), severity of nausea (P = .098), frequency of nausea (P = .166), the Role Preventive domain of the Migraine-Specific Quality of Life Questionnaire (P = .061), and severity of phonophobia (P = .062). Conclusions., In addition to significantly reducing mean monthly migraine/migrainous and migraine headache days, treatment of chronic migraine with topiramate was effective with regard to several traditionally important and clinically relevant secondary outcomes in migraine prevention trials. Treatment with topiramate was well tolerated and not associated with serious adverse events. [source] | ||||||||||||||||||||||