INTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 1 2009
Scott J. Crow MD
Abstract Objective: The direct monetary costs for food and laxatives, diet pills, and diuretics used by individuals with bulimia nervosa (BN) have not been studied. Method: Ten participants with a presenting clinical diagnosis of BN completed a 7-day food record at the outset of treatment in order to provide estimates of weekly and yearly monetary costs for food and associated symptoms. Results: Participants reported means of 3.6 purge episodes, 2.5 objective binge episodes, and 2.4 subjective binge eating episodes per week. Mean total food costs were $106.98/week (SD = $53.88) or $5,581.79/year (SD = $2,811.58). Costs associated with binge eating and purging were 32.7% of all food costs (average: $1,599.45/year). Conclusion: Financial costs of bulimia symptoms are significant, and appear to constitute a substantial minority of all food spending by individuals with BN. © 2008 by Wiley Periodicals, Inc. Int J Eat Disord 2009 [source]

Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation , a 12-week, randomized, double-blind, placebo-controlled study

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2009
E. M. M. QUIGLEY
Summary Background, Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL). Aim, A randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy and safety of a selective, high-affinity 5-HT4 receptor agonist, prucalopride, in patients with chronic constipation [,2 spontaneous complete bowel movements (SCBMs)/week]. Methods, Placebo, 2 or 4 mg prucalopride was administered orally once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients with ,3 SCBMs/week, averaged over 12 weeks. Other assessments included BM frequency, constipation-related QoL and symptoms and tolerability. Results, Among 641 patients, significantly more patients taking prucalopride 2 or 4 mg (24%) than placebo (12%), achieved the primary efficacy endpoint (,3 SCBMs/week) or an increase of ,1 SCBMs/week; 43% and 47% vs. 28% respectively. Prucalopride-treated patients also achieved significantly greater satisfaction with treatment and bowel function, and improved perception of constipation severity and constipation-related QoL, compared with placebo. Most frequent treatment-related adverse events were headache, abdominal pain, nausea and diarrhoea (mainly during day 1). There were no differences in comparison to placebo in the incidence of serious adverse effects or cardiovascular events. Conclusion, Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation. [source]

Nocturnal Hemodialysis Is Better Than Quotidian Hemodialysis

HEMODIALYSIS INTERNATIONAL, Issue 1 2003
MP Kooistra
Background. It is unknown whether long nocturnal (6,7 times weekly 6,8 hours) hemodialysis (NHD) is better than frequent short hemodialysis (,daily', quotidian hemodialysis, QHD). Methods. A Dutch NHD pilot study (,Nocturne') started in December 2001. We can now evaluate effects of 4 months NHD in 14 patients. Baseline dialysis frequency was 3.5 or less (3.13 ± 0.23, M ± SD) in group A (n = 8), and 4 or more (5.0 ± 0.89) in group B (n = 6), weekly dialysis time was equal in both groups. Results. Single pool Kt/V, being higher in group B at baseline, increased in both groups (A: 3.1 ± 0.8/week to 9.5 ± 2.3, B: 3.8 ± 1.0 to 10.9 ± 4.1). Baseline nPCR, being higher in group B, increased in both groups (A: 1.0 ± 0.3 g/kg/week to 1.4 ± 0.3, and B: 1.2 ± 0.5 to 1.8 ± 0.5). Baseline albumin was higher in group B, and increased in group A (39.6 ± 3.7 g/l to 43.2 ± 1.5), not in B (41.4 ± 2.3 to 42.8 ± 2.3). Target weight increased only in group A (71.8 ± 10.5 kg to 75.3 ± 11.9), not in B (71.4 ± 25.5 to 71.3 ± 26.7). NHD resulted in normophosphatemia in both groups despite phosphate supplementation and cessation of phosphate binders. PTH decreased in both groups (A: 40.6 ± 38.0 pmol/l to 14.4 ± 11.7, B: 35.6 ± 37.7 to 22.4 ± 41.5). In both groups, pre- and postdialysis mean arterial pressure decreased (A: 106.8 ± 7.9 mmHg to 94.4 ± 12.1 and 97.3 ± 9.5 mmHg to 86.3 ± 8.2, B: 102.2 ± 28.4 to 89.4 ± 9.5 and 90.3 ± 26.8 to 82.7 ± 12.9). Antihypertensives were discontinued or markedly reduced. Fatigue, insomnia, prurigo, restlessness, appetite, physical condition, working ability and quality of life (SF36) improved significantly in both groups. Conclusion. This small pilot study suggests that phosphate and PTH control, blood pressure, uremic symptoms and quality of life improve when conventional hemodialysis or QHD patients switch to NHD. Nutritional parameters improve only in the previously conventionally treated group. [source]

The completely dry rate: A critical re-evaluation of the outcomes of slings

NEUROUROLOGY AND URODYNAMICS, Issue 7 2005
Kathleen C. Kobashi
Abstract Objective To critically evaluate sling outcomes and revisit the realistic goals of anti-incontinence surgery. Materials and Methods A review of an Institutional Review Board-approved prospective database revealed the outcomes of four different sling techniques that are utilized at our institution. Results Four hundred ninety-eight patients had a mean follow-up varying from 9 to 24 months (range 6,50) after undergoing one of four different sling techniques utilized at our institution. The techniques had similar results with regard to completely dry rate, overall success rate, and rate of urgency regardless of the variation in follow-up time. Success was defined as completely dry or leakage =,1/week or =,70% improved by questionnaire in those patients who leaked 1/week. Success, by this definition, varied from 74.9% to 85.7%, but the completely dry rate varied from 36.1% to 45.2%. An additional 31.0% to 33.3% leaked =,1/week, and of the remaining patients, 24.5% to 44.4% considered themselves =,70% improved despite leakage >,1/week. Urge incontinence was reported by 24.4% to 33.3% of patients. Conclusion As surgeons, we must constantly reevaluate the outcomes and purposes of the procedures we perform on our patients. © 2005 Wiley-Liss, Inc. [source]

Duloxetine vs placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trial

BJU INTERNATIONAL, Issue 3 2004
R.J. Millard
OBJECTIVES To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women. PATIENTS AND METHODS The study included 458 women aged 27,79 years enrolled in a double-blind, placebo-controlled trial. The patients with predominantly SUI were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or duloxetine 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the incontinence episode frequency (IEF) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF <14 and ,14). Analysis of covariance was used to analyse I-QOL scores. RESULTS The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of ,,14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine (P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial. CONCLUSIONS These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America. [source]

Modulation of Wnt signaling influences fracture repair

JOURNAL OF ORTHOPAEDIC RESEARCH, Issue 7 2010
David E. Komatsu
Abstract While the importance of Wnt signaling in skeletal development and homeostasis is well documented, little is known regarding its function in fracture repair. We hypothesized that activation and inactivation of Wnt signaling would enhance and impair fracture repair, respectively. Femoral fractures were generated in Lrp5 knockout mice (Lrp5,/,) and wild-type littermates (Lrp5+/+), as well as C57BL/6 mice. Lrp5,/, and Lrp5+/+ mice were untreated, while C57BL/6 mice were treated 2×/week with vehicle or anti-Dkk1 antibodies (Dkk1 Ab) initiated immediately postoperatively (Day 0) or 4 days postoperatively (Day 4). Fractures were radiographed weekly until sacrifice at day 28, followed by DXA, pQCT, and biomechanical analyses. Lrp5,/, mice showed impaired repair compared to Lrp5+/+ mice, as evidenced by reduced callus area, BMC, BMD, and biomechanical properties. The effects of Dkk1 Ab treatment depended on the timing of initiation. Day 0 initiation enhanced repair, with significant gains seen for callus area, BMC, BMD, and biomechanical properties, whereas Day 4 initiation had no effect. These results validated our hypothesis that Wnt signaling influences fracture repair, with prompt activation enhancing repair and inactivation impairing it. Furthermore, these data suggest that activation of Wnt signaling during fracture repair may have clinical utility in facilitating fracture repair. © 2010 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 28:928,936, 2010 [source]

KINETICS AND HYDROLYSIS PARAMETERS OF TOTAL FRUCTOOLIGOSACCHARIDES OF ONION BULBS: EFFECTS OF TEMPERATURE REGIMES AND CULTIVARS

JOURNAL OF FOOD BIOCHEMISTRY, Issue 1 2007
NOUREDDINE BENKEBLIA
ABSTRACT This work studied the percentage of hydrolysis, observed hydrolysis rate constant (kobs), half-life time (t1/2) and kinetics of degradation of the total fructooligosaccharides (FOS) of three different onion bulb cultivars (Yellow Spanish, Red Amposta and Tenshin) kept during 6 months under three temperature regimes, 10, 15 and 20C. The percentage of hydrolysis of FOS was higher at 20C than at 10C and ranged from 47 to 58% at 10C, from 63 to 68% at 15C and from 74 to 83% at 20C. The kobs ranged from 27 × 10,3 to 36 × 10,3/week at 10C and from 41 × 10,3/week to 47 × 10,3/week at 15C, while at 20C, it was high and was about kobs 56 × 10,3/week.. The t1/2 decreased when temperature increased, and varied from 19.5 to 26.0 weeks at 10C, from 14.6 to 16.8 weeks at 15C and from 9.4 to 12.3 weeks at 20C, indicating that high degree of polymerization (DP) FOS have shorter lives than low DP FOS. Linear regression and kinetics of hydrolysis have shown that FOS hydrolysis is higher at 20C, with a coefficient of regression ranging between 0.87 and 0.99. Apparently, FOS hydrolysis is temperature independent, and storage time had more effect on the higher DP FOS than on the lower DP FOS. [source]

Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2006
C. RENDELI
Summary Aim, To compare the therapeutic effectiveness and tolerability of low daily doses of polyethylene glycol 4000 vs. lactulose in the treatment of neurogenic constipation in children with myelomeningocele. Methods, Sixty-seven children with chronic neurogenic constipation were randomized allocated to receive either polyethylene glycol 4000 (0.50 g/kg) or lactulose (1.5 g/kg) for 6 months. Patients or their parents reported frequency and modality of evacuation and side effects on a diary card. Primary outcome was bowel frequency ,3/week, and the second one was side effects at the end of treatment. Results, Complete remission of constipation was reported by a significantly (P < 0.01) higher number of patients treated with polyethylene glycol compared with lactulose. At the end of the study, 46% patients of polyethylene glycol group and 22% of the lactulose group were asymptomatic. Compared with lactulose, patients treated with polyethylene glycol reported higher bowel frequency (5.1 vs. 2.9 bowel movements/week, P < 0.01) and reduction of encopresis. Neither lactulose nor polyethylene glycol caused clinically-significant serious side effects and palatability was similar. Conclusions, Polyethylene glycol 4000 compared with lactulose provided a higher success rate, without significant side effects, for the treatment of constipation in myelomeningocele children. [source]

Comparison between different dialysate calcium concentrations in nocturnal hemodialysis

HEMODIALYSIS INTERNATIONAL, Issue 2 2007
Nigel D. TOUSSAINT
Abstract Benefits of dialysate with greater calcium (Ca) concentration are reported in nocturnal hemodialysis (NHD) to prevent Ca depletion and subsequent hyperparathyroidism. Studies with patients dialyzing against 1.25 mmol/L Ca baths demonstrate increases in alkaline phosphatase (ALP) and parathyroid hormone (PTH) and increasing dialysate Ca subsequently corrects this problem. However, whether 1.5 or 1.75 mmol/L dialysate Ca is most appropriate for NHD is yet to be determined, and differences in the effect on mineral metabolism of daily vs. alternate daily NHD have also not been well defined. We retrospectively analyzed mineral metabolism in 48 patients, from 2 institutions (30 at Monash and 18 at Geelong), undergoing home NHD (8 hr/night, 3.5,6 nights/week) for a minimum of 6 months. Thirty-seven patients were dialyzed against 1.5 mmol/L Ca bath and 11 patients against 1.75 mmol/L. We divided patients into 4 groups, based on dialysate Ca and also on the hours per week of dialysis, <40 (1.5 mmol/L, n=29 and 1.75 mmol/L, n=8) or ,40 (n=4 and 7). We compared predialysis and postdialysis serum markers, time-averaged over a 6-month period, and the administration of calcitriol and Ca-based phosphate binders between 1.5 and 1.75 mmol/L Ca dialysate groups. Baseline characteristics between all groups were similar, with a slightly longer, but nonsignificant, duration of NHD in both 1.75 mmol/L dialysate groups compared with 1.5 mmol/L. The mean predialysis Ca, phosphate, and Ca × P were similar between the 1.5 and 1.75 mmol/L groups, regardless of NHD hr/week. Postdialysis Ca was significantly greater, with 1.75 vs. 1.5 mmol/L in those dialyzing <40 hr/week (2.64±0.19 vs. 2.50±0.12 mmol/L, p=0.046), but postdialysis Ca × P were similar (2.25±0.44 vs. 2.16±0.29 mmol2/L2, p=0.60). Parathyroid hormone was also lower with 1.75 vs. 1.5 mmol/L baths in the <40 hr/week groups (31.99±26.99 vs. 14.47±16.36 pmol/L, p=0.03), although this difference was not seen in those undertaking NHD ,40 hr/week. Hemoglobin, ALP, and albumin were all similar between groups. There was also no difference in vitamin D requirement when using 1.75 mmol/L compared with the 1.5 mmol/L dialysate. Multivariate analysis to determine independent predictors of postdialysis serum Ca showed a statistically significant positive association with predialysis Ca, dialysate Ca, and total NHD hr/week. An elevated dialysate Ca concentration is required in NHD to prevent osteopenia but differences in serum markers of mineral metabolism between 1.5 and 1.75 mmol/L Ca dialysate in NHD in our study were few. This was similar for patients undertaking NHD <40 or ,40hr/week, although differences in the frequency of NHD may also be as important as dialysate Ca with regard to serum Ca levels. With concerns that prolonged higher Ca levels contribute to increased cardiovascular mortality, the optimal Ca dialysate bath is still unknown and further studies addressing bone metabolism with larger NHD numbers are required. [source]

Kava in Arnhem Land: a review of consumption and its social correlates

DRUG AND ALCOHOL REVIEW, Issue 3 2000
Alan R. Clough
Abstract The debate about the effects and public health importance of the way Aboriginal people drink kava has been confounded by claims, based on anecdote, of imputed health effects. Anecdote and comment have promoted the perception that dosage levels among Aboriginal people are much greater than in Pacific island societies. In this paper we review published data about kava consumption, and evaluate it with respect to information collected from observation of one Aboriginal community in Arnhem Land (Northern Territory) where people tend to consume kavaat a steady tempo; 37g of kava powder containing around 3800mg of kava lactones in 670ml of water in an hour. The highest levels of consumption in Arnhem Land have been reported to be up to 900g/week of kava powder with heavy consumers drinking at least 610g/week, levels comparable to estimates for Pacific-island societies. The significance of a steady drinking tempo means that an individual's weekly kava consumption relates directly to the amount of time spent drinking which, in turn, is correlated with categories of social setting of drinking (p < 0.0002). Lone drinkers appear to be the heaviest users while lowest consumption takes place in private domestic situations, where people enjoy kava as part of family group activities. Surrogates of consumption levels may be found in local socio-economic circumstances. This approach may be useful when more direct measurement of consumption is difficult or impossible. [source]

Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation , a 12-week, randomized, double-blind, placebo-controlled study

Patient-Reported Outcomes with Botulinum Toxin Type A Treatment of Glabellar Rhytids: A Double-Blind, Randomized, Placebo-Controlled Study

DERMATOLOGIC SURGERY, Issue 2007
FACS, STEVEN FAGIEN MD
BACKGROUND Global patient-reported outcomes do not evaluate specific aspects of treatment that are important to patients. OBJECTIVE The objective was to evaluate self-perception of age and specific outcomes that are important to patients receiving botulinum toxin type A or placebo for moderate to severe glabellar lines (using the Facial Line Outcomes Questionnaire to assess how much facial lines bother them, make them look older, detract from their facial appearance, prevent a smooth facial appearance, and make them look tired, stressed, or angry). METHODS AND MATERIALS In the double-blind phase of this 12-week study, 70 patients were randomly assigned to treatment with 20 U botulinum toxin type A (BOTOX Cosmetic) or placebo. At Week 4, those still with moderate or severe glabellar lines were offered open-label 20 U botulinum toxin type A. RESULTS Median glabellar line severity was significantly lower after botulinum toxin treatment than after placebo. Compared with placebo, botulinum toxin also resulted in significantly superior patient assessments and a greater proportion of patients considering they looked younger than their current age. CONCLUSIONS Botulinum toxin type A can achieve specific goals of treatment that are important to patients and help them feel that they look younger than their current age. [source]

Botulinum Toxin Type A Treatment of Multiple Upper Facial Sites: Patient-Reported Outcomes

DERMATOLOGIC SURGERY, Issue 2007
JEAN CARRUTHERS MD
BACKGROUND Aesthetic treatment planning must address subjects' goals and include subject-reported outcomes. OBJECTIVE The objective was to compare the effect of botulinum neurotoxin type A (BoNTA) with placebo on subject-reported outcomes and to assess the utility of 64 U of BoNTA to treat the entire upper face. METHODS Forty female subjects were randomized to receive 64 U of BoNTA or identical placebo injections (double-masked) divided among 16 sites of the upper face and were followed for 12 weeks. Subjects unimproved at Week 4 were eligible for open-label BoNTA treatment and were followed through Week 16. Main outcome measures were scores on seven items of the Facial Line Outcomes Questionnaire (FLO-7) and results on the Self-Perception of Age (SPA) for assessing age of appearance relative to actual age. RESULTS BoNTA treatment resulted in significant improvements on the FLO-7 scores that were maintained throughout the study. BoNTA treatment also reduced age of appearance in a majority of subjects. Placebo had no effects on any measure. No serious adverse events occurred. CONCLUSION Sixty-four-unit BoNTA treatment of upper facial rhytids safely and significantly improves subject-reported outcomes, as measured by the FLO-7 and SPA, and results in a younger, more satisfying, relaxed appearance. [source]

Intense Pulsed Light for the Treatment of Refractory Melasma in Asian Persons

DERMATOLOGIC SURGERY, Issue 9 2004
Chia-Chen Wang MD
Background. Patients with dermal or mixed-type melasmas are often refractory to various treatments. Intense pulsed light has been used to treat melanocytic lesions with promising results. Objective. The purpose of this study was to clarify the effectiveness of intense pulsed light for refractory melasma in Asian persons. Methods. Seventeen patients were treated with intense pulsed light, during four sessions at 4-week intervals. The patients were also given 4% hydroquinone cream and broad-spectrum sunscreens to prevent and treat postinflammatory hyperpigmentation. Sixteen patients in the control group were treated with hydroquinone cream and sunscreens. The treatment efficacy was evaluated using reflectance spectrophotometer and patient satisfaction questionnaire. Results. Patients in the intense pulsed light group achieved an average of 39.8% improvement in relative melanin index, compared to 11.6% improvement in the control group (p<0.05) at Week 16. Six (35%) patients in the intense pulsed light group had more than 50% improvement, compared to two (14%) patients in the control group. Two patients in the intense pulsed light group, however, experienced transient postinflammatory hyperpigmentation, and partial repigmentation was noted 24 weeks after the last treatment session. Conclusion. Intense pulsed light is a safe and effective treatment for refractory melasma in Asian persons, with minimal side effects. Further treatment sessions are required for maintenance therapy. [source]

Treatment of erythrodermic psoriasis in HCV+ patient with adalimumab

DERMATOLOGIC THERAPY, Issue 2009
Antonio Giovanni Richetta
ABSTRACT Erythrodermic psoriasis is a severe and disabling variant of psoriasis. The authors present the case of a 48-year-old man with psoriasis and hemophilia presented with a history of hepatitis C virus (HCV) infection treated with pegylated interferon alpha-2a and ribavirin therapy. At the end of antiviral therapy, skin manifestation progressively worsened, becoming erythrodermic, with lack of efficacy of steroid therapy. The authors decided to start biological therapy with induction dose of adalimumab (Humira, Abbott Laboratories, Abbott Park, Chicago, IL) 80 mg at Week 0 and 40 mg weekly. In our case, this resulted in a highly effective and safe treatment. [source]

Fetal handedness and head position preference: A developmental study

DEVELOPMENTAL PSYCHOBIOLOGY, Issue 3 2001
J.I.P. de Vries
Abstract Hand,head contacts were observed by means of serial ultrasound recordings in 10 healthy fetuses from 12 to 38 weeks of gestational age. Contacts were distinguished as being unimanual or bimanual, and if unimanual, whether they were made with the right or left hand. Both types of contact and ones made unimanually with the right or left hand were identified at each age as to whether they were associated with a preferential head position. A strong unimanual bias was evident at each age except for Week 36. At this age, there was a bimanual bias. Unimanual contacts did not develop a lateralized preference, and neither type of contact established a stable relationship with head position. Furthermore, there was no evidence to support the suggestion that hand contact and head position codevelop to form a preferred ipsilateral synergy. Findings are discussed relative to contradictory evidence from other fetal and neonatal studies. © 2001 John Wiley & Sons, Inc. Dev Psychobiol 39: 171,178, 2001 [source]

Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes

DIABETES OBESITY & METABOLISM, Issue 5 2007
W. 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]

Early intervention with second-generation antipsychotics in first-episode psychosis: results of an 8-week naturalistic study

EARLY INTERVENTION IN PSYCHIATRY, Issue 1 2010
Richard C. Josiassen
Abstract Objective: The objective was to compare short-term effectiveness of aripiprazole with three other second-generation antipsychotics (SGAs) in the treatment of first-episode psychosis. Method: In a naturalistic, ,single-blind' design, 60 subjects experiencing their first psychotic episode were treated for 8 weeks with aripiprazole (n = 19), risperidone (n = 16), olanzapine (n = 14) or quetiapine (n = 11). Medication and dosing decisions were made by treating psychiatrists, constrained to once-a-day dosing, low initial doses and no clozapine. Weekly ratings were obtained using the Positive and Negative Syndrome Scale (PANSS), Simpson-Angus Rating Scale and Barnes Akathasia Rating Scale. Weight and vital signs were also collected weekly. Results: The group presented with severe psychotic symptoms (mean baseline PANSS total score of 105.2), which were reduced rapidly (P < 0.0005). The between-group and group by time interaction terms were non-significant. Similar reductions were seen across all PANSS sub-scales. At Week 1 the mean PANSS Activation Scale score was reduced more with olanzapine than in the other groups (P < 0.002). Few instances of extrapyramidal symptoms occurred; all were sporadic and did not require treatment. Group body weight increased by 7.3% over the study. Vital signs remained unchanged. Conclusions: Early intervention with low doses of four SGAs led to rapid symptom reduction in first-episode psychotic patients with severe psychopathology. Although no clear medication advantages were observed in the short term, longer duration studies with larger samples will be required for determining efficacy, rates of compliance, relapse prevention and diminished incidence of extrapyramidal signs and symptoms. [source]

Pecan Effects on Serum Lipoproteins and Dietary Intakes of Hyperlipidemic Individuals Consuming Self-Selected Diets

FAMILY & CONSUMER SCIENCES RESEARCH JOURNAL, Issue 3 2005
Wanda A. Eastman
Pecan-supplemented diets were studied in 17 hyperlipidemic individuals who were randomly assigned to pecan (6 women, 2 men, age 46±6 years [mean±SD]) or control (7 women, 2 men, age 53±10 years). The pecan group consumed 68g of pecans/day for 8 weeks. Total fat, monounsaturated fat, and polyunsaturated fat intakes were significantly higher in the pecan group. LDL cholesterol was lowered in the pecan group from 152±21 mg/dL at entrance to 136±22 at Week 4 but was 153±33 by Week 8. LDL cholesterol was significantly lower in the pecan group than controls at Week 4 (136±22 mg/dL versus 173±60). Total cholesterol in the pecan group was 233±19 mg/dL at entrance and 221±18 by Week 4 but was 232±35 by Week 8. Total cholesterol was significantly lower in the pecan group (221±18 mg/dL) than controls (257±60) at Week 4. Pecans in diets of hyperlipidemic individuals did not have sustained serum lipid lowering. [source]

Quetiapine versus olanzapine for the treatment of negative symptoms in patients with schizophrenia

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 4 2006
Pinkhas Sirota
Abstract Negative symptoms are considered the most debilitating and refractory aspect of schizophrenia, being associated with poor social, occupational and global outcomes. Conventional antipsychotics have limited efficacy against these symptoms and poor tolerability profiles. Atypical antipsychotics are an alternative treatment, and this 12-week, randomised, flexibly dosed study compared the efficacy, safety and tolerability of quetiapine and olanzapine in this regard. Of the 40 patients who entered the study (32 male; 8 female), 19 were randomised to quetiapine (mean dose 637,mg/day, mean treatment duration 80 days) and 21 to olanzapine (mean dose 16,mg/day, mean treatment duration 78 days). Quetiapine and olanzapine were similarly effective: in each treatment group significant improvements at Week 12 were observed for negative symptom scores on the SANS and the PANSS, and for subscale scores of affective flattening and alogia on the SANS. Both treatments were well tolerated in this patient population, with no worsening of extrapyramidal symptoms in either case. Anxiety and insomnia were the most common adverse events (,7% of patients in each group), but were not drug-related. Although this is a small study with limited power, the results support the effectiveness of quetiapine and olanzapine in treating the negative symptoms of schizophrenia. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Clinical efficacy and safety of oral terbinafine in fungal mycetoma

INTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 2 2006
Bassirou N'Diaye MD
Objectives, An open-label study was performed to assess the efficacy and safety of terbinafine in the treatment of eumycetoma. Methods, Single-center, open-label study, including 27 patients with signs and symptoms of eumycetoma which had developed within 5 years and was confirmed by mycological examination. The intention-to-treat population (n = 23) received 500 mg of terbinafine bid for 24,48 weeks. Efficacy evaluations included clinical signs and symptoms (e.g. sinuses open or closed, degree of tumefaction, and emission of grains either present or absent); mycological examinations from Week 24 onwards; and investigators' overall assessment of efficacy (cure, improved since baseline, unchanged since baseline, or deterioration since baseline). Safety evaluations included monitoring of adverse events, laboratory assessments, vital signs and physical examinations. Results, Good clinical improvement was seen in patients who completed the study (n = 20). Tumefaction was absent or improved in 80% of patients; sinuses were closed in 50% of patients, and grain emissions were absent in 65% of patients. Of the 16 patients who had repeat mycological assessment, four (25%) were mycologically cured. In the investigators' overall opinion at the end of the study, five (25%) were cured and 11 (55%) were clinically improved. The majority of adverse events reported were mild to moderate, and consistent with the known tolerability profile of terbinafine. Conclusion, High-dose terbinafine (1000 mg/day) is well tolerated and clinically effective in patients with eumycetoma, a difficult-to-treat subcutaneous mycoses. [source]

Weight fluctuations during early refeeding period in anorexia nervosa: Case reports

INTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 2 2005
ak Yücel MD
Abstract Objective This study reports wide weight fluctuations during a week of early refeeding for 2 patients with anorexia nervosa and discusses possible mechanisms. Method Laboratory tests that consist of complete blood count, biochemistry panel, and serum protein levels were performed. Fluid intake and daily urine output of the patients were measured. Results Laboratory tests were within normal limits for both patients except for leukopenia in one patient. By the end of the Week 1, both patients had achieved significant weight gain (9 kg and 3 kg, respectively) concurrent with edema. Their daily fluid intake and urine output measurements indicated increased total body water levels. Discussion Although the pathophysiology of refeeding edema is not entirely understood, it is well known that insulin induces sodium retention by increasing distal tubular sodium reabsorbtion. In our patients, refeeding-induced insulin secretion may be chiefly responsible for the edema and weight gain during the early refeeding period. © 2005 by Wiley Periodicals, Inc. [source]

Quinacrine and hydroxychloroquine, a forgotten combination for patients with active systemic lupus erythematosus in Australasia?

INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 1 2003
Daniel W. T. Ching
Abstract In 1994, A 39-year-old Female Patient With Systemic Lupus Erythematosus (Sle) Was Diagnosed As Having Lupus-induced Serositis. She Was Commenced On Hydroxychloroquine (Hcq) And Prednisone. Her Disease Kept Relapsing Whenever She Was Tailed Off Prednisone. In 1997, Quinacrine (Qn) Was Commenced, And Prednisone Was Gradually Stopped. Her Disease Has Remained In Remission On The Combination Of Hcq And Qn. In December 2000 She Ran Out Of Qn For A Week, And Within This Period She Started To Experience Fatigue And Polyarthralgia Again. Quinacrine Is Available From Compounding Pharmacies, And Is Relatively Cheap. The Combination Of Hcq And Qn In The Treatment Of Sle Should Be Considered More Often. [source]

Safety and Immunogenicity Profile of the Concomitant Administration of ZOSTAVAX and Inactivated Influenza Vaccine in Adults Aged 50 and Older

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2007
Boris Kerzner MD
OBJECTIVES: To evaluate the safety and immunogenicity of ZOSTAVAX administered concomitantly with inactivated influenza vaccine or sequentially in adults aged 50 and older. DESIGN: Randomized, blinded, placebo-controlled study. SETTING: Thirteen U.S. and seven European study sites. PARTICIPANTS: Three hundred eighty-two concomitantly, 380 sequentially vaccinated subjects. INTERVENTION: The concomitant vaccination group received influenza vaccine and ZOSTAVAX at separate injection sites on Day 1 and placebo at Week 4. The nonconcomitant vaccination group received influenza vaccine and placebo at separate injection sites on Day 1 and ZOSTAVAX at Week 4. MEASUREMENTS: Primary safety endpoints: vaccine-related serious adverse experiences (AEs) within 28 days postvaccination (PV); and diary card,prompted local and systemic AEs. Primary immunogenicity endpoints: geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline of varicella-zoster virus (VZV) antibody (Ab) at 4 weeks PV according to glycoprotein enzyme-linked immunosorbent assay (gpELISA) and GMT of influenza Ab for the three vaccine strains (2005,2006 influenza season) at 4 weeks PV according to hemagglutination inhibition assay. Secondary immunogenicity endpoint: influenza seroconversion rates (SCRs). RESULTS: No serious AEs related to ZOSTAVAX were observed during the study. VZV Ab GMTs 4 weeks PV for the concomitant and sequential groups were 554 and 597 gpELISA U/mL, respectively. The estimated VZV Ab GMT ratio was 0.9 (95% confidence interval (CI)=0.8,1.0), indicating noninferior (P<.001 for the null hypothesis of GMT ratio <0.67) responses. Estimated VZV Ab GMFR from baseline in the concomitant group was 2.1 (95% CI=2.0,2.3), indicating acceptable fold rise. Estimated GMT ratios (concomitant/sequential) for influenza strains A(H1N1), A(H3N2), and B were 0.9 (95% CI=0.8,1.1), 1.1 (95% CI=0.9,1.3), and 0.9 (95% CI=0.8,1.1), respectively, and SCRs were comparable across both groups, with more than 85% achieving titers of 1:40 or greater, meeting regulatory criteria. CONCLUSION: ZOSTAVAX and influenza vaccine given concomitantly are generally well tolerated in adults aged 50 and older. Ab responses were similar whether ZOSTAVAX and influenza vaccine were given concomitantly or sequentially. [source]

Efficacy and Safety of Rofecoxib 12.5 mg Versus Nabumetone 1,000 mg in Patients with Osteoarthritis of the Knee: A Randomized Controlled Trial

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2004
Alan J. Kivitz MD
Objectives: To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee. Design: A 6-week, randomized, parallel-group, double-blind, placebo-controlled study. Setting: One hundred thirteen outpatient sites in the United States. Participants: A total of 1,042 male and female patients aged 40 and older with OA of the knee (>6 months). Interventions: Rofecoxib 12.5 mg once a day (n=424), nabumetone 1,000 mg once a day (n=410), or placebo (n=208) for 6 weeks. Measurements: The primary efficacy endpoint was patient global assessment of response to therapy (PGART) over 6 weeks, which was also specifically evaluated over the first 6 days. The main safety measure was adverse events during the 6 weeks of treatment. Results: The percentage of patients with a good or excellent response to therapy as assessed using PGART at Week 6 was significantly higher with rofecoxib (55.4%) than nabumetone (47.5%; P=.018) or placebo (26.7%; P<.001 vs rofecoxib or nabumetone). Median time to first report of a good or excellent PGART response was significantly shorter in patients treated with rofecoxib (2 days) than with nabumetone (4 days, P=.002) and placebo (>5 days, P<.001) (nabumetone vs placebo; P=.007). The safety profiles of rofecoxib and nabumetone were generally similar, including gastrointestinal, hypertensive, and renal adverse events. Conclusion: Rofecoxib 12.5 mg daily demonstrated better efficacy over 6 weeks of treatment and quicker onset of OA efficacy over the first 6 days than nabumetone 1,000 mg daily. Both therapies were generally well tolerated. [source]

Journal of Gastroenterology and Hepatology celebrates the first Asia,Pacific Digestive Week, Sydney, September 2001

JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 4 2002
Geoffrey C Farrell
No abstract is available for this article. [source]

A Double-Blind, Placebo-Controlled Study With Quetiapine as Adjunct Therapy With Lithium or Divalproex in Bipolar I Patients With Coexisting Alcohol Dependence

ALCOHOLISM, Issue 10 2010
Mary Stedman
Background:, This study evaluated the efficacy of quetiapine versus placebo as an adjunct to lithium or divalproex in reducing alcohol consumption in patients with bipolar I disorder and coexisting alcohol dependence. Methods:, Male and female outpatients (21 to 60 years) with a history of bipolar I disorder and alcohol dependence were included in this 12-week, placebo-controlled study. Patients treated with lithium or divalproex (ongoing or assigned at screening) were randomized to receive quetiapine (dosed up to 400 mg/d over 7 days, followed by 300 to 800 mg/d flexible dosing until study end) or placebo. The primary outcome measure was the change in the proportion of heavy drinking days from baseline to Week 12 (as derived from the Timeline Followback method). Secondary outcome measures included time to the first consecutive 2 weeks of abstinence, changes from baseline to Week 12 in the proportion of nondrinking days, mean number of standardized drinks per day, and Clinical Global Impressions-Severity of Illness score. Results:, Of 362 enrolled patients (mean 38.6 years), 176 were randomized to receive quetiapine and 186 to placebo. The mean proportion of heavy drinking days at baseline was 0.66 in the quetiapine group and 0.67 in the placebo group. At Week 12, the mean change in the proportion of heavy drinking days was ,0.36 with quetiapine and ,0.36 with placebo (p = 0.93). No statistically significant differences in any of the secondary outcome measures were noted between the quetiapine and placebo groups. The incidence of adverse events was consistent with the previously known tolerability profile of quetiapine. Conclusions:, The efficacy of quetiapine in the treatment of bipolar disorder is already well established. In this study, however, quetiapine added to lithium or divalproex did not result in significantly greater improvement compared with placebo in measures of alcohol use and dependence in patients with bipolar I disorder and alcohol dependence. [source]

Dental Amalgam and Multiple Sclerosis: A Systematic Review and Meta-Analysis

JOURNAL OF PUBLIC HEALTH DENTISTRY, Issue 1 2007
Kevin K. Aminzadeh Bsc Pharm
Abstract Objectives: Amalgam restorations have long been controversial due to their mercury content. Allegations that the mercury may be linked to nervous disorders such as Alzheimer's, chronic fatigue syndrome, and multiple sclerosis (MS) have fueled the calls for the removal of amalgam restorations from dentists' armamentarium. To explore and quantify the association between amalgam restorations and MS we have conducted a systematic review and meta-analysis of the literature. Methods: A systematic search in Medline (from 1966 to April 2006), EMBASE (2006, Week 16), and the Cochrane library (Issue 2, 2006) for English-language articles meeting specific definitions of MS and amalgam exposure was conducted. Studies were also identified using the references of retrieved articles. Studies were independently reviewed by two authors and disagreements were resolved by consensus. Studies were selected based on an a priori of defined criteria. Odds ratios (ORs) or relative risks were pooled using the random effects model. Heterogeneity was assessed using Q statistics. Results: The pooled OR for the risk of MS among amalgam users was consistent, with a slight, nonstatistically significant increase between amalgam use and risk of MS. Conclusion: Future studies that take into consideration the amalgam restoration size and surface area along with the duration of exposure are needed in order to definitively rule out any link between amalgam and MS. [source]

Current issues for nurse practitioners: Hyponatremia

JOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS, Issue 11 2007
Ruth Haskal NP-C (Adult Nurse Practitioner)
Abstract Purpose: To review the assessment, diagnosis, and management of hyponatremia (serum sodium <135 mEq/L), the most common electrolyte disturbance as a result of dysregulation of water balance in hospitalized or institutionalized patients. Data sources: Comprehensive search using keywords AVP receptor antagonists, hyponatremia, SIADH, conivaptan, tolvaptan, lixivaptan, nurse practitioner, and others was carried out using the National Library of Medicine (PubMed) Web site from which full-text articles were obtained. Meeting abstracts were obtained from scientific sessions including the American Society of Nephrology Renal Week 2004 and the Endocrine Society,s 87th Annual Meeting (2005). The Vaprisol (conivaptan hydrochloride injection) package insert was referenced and obtained from FDA.gov. Conclusions: A diagnosis of hyponatremia requires thorough investigation for underlying causes and prompt treatment to prevent poor patient outcomes. In clinical trials, a new class of drugs called the arginine vasopressin (AVP) receptor antagonists or aquaretics has been shown to be safe and effective for the treatment of hyponatremia. Among this class of agents, intravenous conivaptan hydrochloride, indicated for the treatment of euvolemic hyponatremia in hospitalized patients, is the first drug in class approved for use. Implications for practice: Elderly patients, and those with certain conditions such as heart failure, tuberculosis, cirrhosis, and head injury, may be at increased risk for hyponatremia. In hospitalized patients following surgery and the use of certain medications, hyponatremia is a common condition. A thorough understanding of the physiology of water balance and the risk factors associated with hyponatremia is essential for prompt and effective intervention. Awareness of the limitations of conventional therapies and the availability of new treatment options for hyponatremia allows clinicians to optimize patient care. [source]

Pulse itraconazole vs. continuous terbinafine for the treatment of dermatophyte toenail onychomycosis in patients with diabetes mellitus

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 10 2006
AK Gupta
Abstract Background, Oral terbinafine and oral itraconazole are two of the most common agents used for the treatment of toenail dermatophyte onychomycosis. Despite the fact that diabetic patients are more likely to have onychomycosis than normal individuals are, there is little research into the efficacy of standard oral regimens of terbinafine and itraconazole for onychomycosis in the diabetic population. Study design, We present a prospective, randomized, single-blind, parallel group, comparator-controlled, multi-centre study designed to assess the efficacy of the pulse itraconazole (200 mg twice daily, 1 week on, 3 weeks off, for 12 weeks) vs. continuous terbinafine (250 mg once daily for 12 weeks) oral therapies in the treatment of dermatophyte toenail distal and lateral subungual onychomycosis (DLSO) in the diabetic population. Efficacy parameters, Primary efficacy measures included mycological cure rate (negative KOH and culture) and effective cure (mycological cure plus nail plate involvement of 10% or less) at Week 48. Results, At Week 48, mycological cure was attained by 88.2% (30 of 34) and 79.3% (23 of 29) of patients in the itraconazole and terbinafine groups, respectively (P not significant). Effective cure (mycological cure with , 10% of nail plate involvement) was attained by 52.9% (18 of 34) of the itraconazole group and 51.7% (15 of 29) of the terbinafine group (P not significant). Three itraconazole patients experienced side effects in the form of gastrointestinal problems. There were no serious adverse events and no interactions with concomitant medications recorded. Discussion, Both continuous terbinafine and itraconazole pulse therapy are effective and safe in the management of dermatophyte toenail onychomycosis in people with diabetes. [source]