Total Score Of Patients Research Articles

The effects of cognitive training on mild-to-moderate Alzheimer＇s disease patients

Objective To determine the efficacy of individual cognitive training （CT） in the treatment of cognitive and neuropsychiatric symptoms in patients with mild to moderate Alzheimer disease （ AD）. Methods A randomized, controlled, rater-blind clinical trial recruited 32 AD patients. AH patients were assigned to a CT group （n = 16） or a control group （a time and attention control, n = 16） for 10 weeks. All outcome measures were administered at baseline and follow-up. The cognitive status was evaluated using the Mini Mental State examination （MMSE） , a clock-drawing test （CDT） , Fuld＇s object memory evaluation （FOME） , a rapid verbal retrieval （RVR） , digit span assessments （DS） , block designing （BD）, and the A version of the trail making test （TMTA）. The patients＇ functional status was evaluated using an activities of daily living （ADL） scale. Any psychological and behavioural disorders were evaluated with the Neuropsychiatry Inventory （ NPI）. Results Patients receiving CT showed greater average improvements in NPI total score, TMT-A score and MMSE total score than the controis at week 10. There was no statistically significant benefit for CT-treated patients in terms of ADL score. Conclusions Cognitive training can raise the NPI total scores and MMSE total scores of patients with mild to moderate AD. Key words: Alzheimer＇s disease; Cognitive training; Randomized controlled trials

Social Anxiety in Patients With Parkinson's Disease

Social Anxiety in Patients With Parkinson's Disease

Tolerability and Efficacy of Armodafinil in Naïve Patients with Excessive Sleepiness Associated with Obstructive Sleep Apnea, Shift Work Disorder, or Narcolepsy: A 12-Month, Open-Label, Flexible-Dose Study with an Extension Period

This 12-month, open-label, flexible-dose study with an extension period evaluated the tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. Armodafinil-naïve, adult patients with excessive sleepiness associated with treated OSA (n = 170), SWD (n = 108), or narcolepsy (n = 50) received armodafinil (100-250 mg) once daily (treated OSA or narcolepsy) or before night shifts (SWD). Patients with OSA were regular users of continuous positive airway pressure (CPAP) therapy. Efficacy measures included the Clinical Global Impression of Improvement (CGI-I) and the Epworth Sleepiness Scale (ESS). Across the diagnosis groups, the most commonly occurring adverse event was headache (14%-24%). Forty-three patients (13%) and 13 patients (4%) were withdrawn because of adverse events and insufficient efficacy, respectively. Armodafinil did not adversely affect CPAP therapy. At the final visit, 80% (95% CI: 74.1, 86.7) of patients with treated OSA and 84% (72.7, 94.8) of patients with narcolepsy were rated on the CGI-I as at least minimally improved with regard to overall clinical condition; 98% (95.2, 100.0) of patients with SWD were rated as improved with regard to sleepiness during night shifts, including the commute to and from work. Armodafinil improved ESS total scores in patients with treated OSA (mean [SD] [95% CI] change from baseline, -7.3 [5.6] [-8.39, -6.30]) and patients with narcolepsy (-4.7 [6.0] [-7.41, -1.93]). Armodafinil administered for 12 months or more was generally well tolerated and improved wakefulness in patients with excessive sleepiness associated with treated OSA, SWD, or narcolepsy. Armodafinil improved the overall clinical condition of patients with treated OSA or narcolepsy.

Extract ofGinkgo bilobaTreatment for Tardive Dyskinesia in Schizophrenia

Free radicals may be involved in the pathogenesis of tardive dyskinesia (TD). Extract of Ginkgo biloba (EGb) is a potent antioxidant possessing free radical-scavenging activities. The aim of the study was to evaluate the efficacy of EGb-761, a standardized extract given in capsule form, in treating TD in schizophrenia patients. Inpatients with DSM-IV-diagnosed schizophrenia and TD (n = 157) in a mainland China Veterans Affairs psychiatric hospital were randomly assigned to 12 weeks of treatment with either EGb-761, 240 mg/d (n = 78) or a placebo (n = 79) in a double-blind manner. Primary outcome measures were (1) change from baseline in the Abnormal Involuntary Movement Scale (AIMS) score and (2) proportion of patients with a ≥ 30% reduction in their AIMS total score at week 12. Secondary outcome measures included the Positive and Negative Syndrome Scale (PANSS) and cognitive performance as measured by the Continuous Performance Test-37 Version and the 3-card Stroop task. Patients were recruited for the study between December 2006 and May 2007. Of the 157 patients who were randomly assigned, 152 (96.8%) completed the study. EGb-761 treatment significantly decreased the AIMS total score in patients with TD compared to those who were given a placebo (2.13 ± 1.75 vs -0.10 ± 1.69; P < .0001), with 40 (51.3%) and 4 (5.1%) patients achieving response in the EGb-761 and placebo treatment groups, respectively. There were no between-group differences in the PANSS total score or cognitive measures from baseline to week 12. EGb-761 appears to be an effective treatment for reducing the symptoms of TD in schizophrenia patients, and improvement may be mediated through the well-known antioxidant activity of this extract. clinicaltrials.gov identifier: NCT00672373.

Does recurrent aphthous stomatitis affect quality of life? A prospective study with 128 patients evaluating different treatment modalities

Introduction: Quality of life measures are increasingly being used in the evaluation of oral disease outcome. To date, there has been less focus on oral health-related quality of life (OHR-QoL) measures for oral diseases in dermatologic literature. Objective: To test whether patients with recurrent aphthous stomatitis (RAS) report a lower OHR-QoL than the general population and to evaluate therapeutic regimens for RAS by using OHR-QoL measures. Method: A total of 128 patients and 40 controls were enrolled. A questionnaire entitled the 14-item oral health impact profile (OHIP-14) was completed. Forty-three (33%) of the patients were followed-up and completed the OHIP-14 following treatment. Results: The median total score of patients on colchicine before treatment was 21. Following use of colchicine, the total score was 10. There was a significant difference concerning the impact of oral health following use of oral colchicine. However, no reduction of OHIP-14 scores was observed in the topical treatment group. Conclusion: When the influence of one of the most common oral diseases such as RAS on OHR-QoL was taken into consideration, OHR-QoL provides an additional dimension that may help to improve the impact of a disease on an individual's life. In relation to this, colchicine seems to be one of the most effective management strategies used in RAS.

Validation of the Brazilian version of the quality of life scale for patients with Alzheimer's disease and their caregivers (QOL-AD)

Quality of life (QOL) has been extensively studied in clinical trials and in research on chronic degenerative diseases and dementia. The aim of this study was to assess the reliability and construct validity of the Brazilian version of the QOL scale in Alzheimer's disease (AD; QOL-AD). The QOL-AD was administered to 60 patients with mild or moderate AD and to their caregivers. The construct validation was accomplished through correlations amongst total scores of patients’ and caregivers’ reports on patients’ quality of life (PQOL and C-PQOL, respectively), and data related to cognitive impairment, depressive symptoms, functional performance, behavioral disturbances and a generic instrument of quality of life (WHOQOL-brief), as well as correlation of total score of caregivers’ reports on their own quality of life (CQOL) with the measurements cited above, QOL-AD patient reports, and depressive symptoms. The reliability was high for PQOL, C-PQOL, and CQOL versions (Cronbach's alpha = 0.80, 0.83, and 0.86, respectively). We observed significant correlations in the construct validity of all three versions regarding the variables associated with the disease and also with WHOQOL-brief. The scale took, on average, six min for each version. The results indicate reliability and construct validity of the Brazilian version of the QOL-AD in the studied sample.

A simple scoring system to evaluate the severity of acute-on-chronic liver failure in hepatitis B

To establish an objective, simple and sensitive scoring system to evaluate the severity of acute-on-chronic liver failure in hepatitis B. The clinical data of patients (194 survivals and 215 deaths) with acute-on-chronic liver failure in hepatitis B were collected and analyzed prospectively. 7 clinical indexes, including the hepatic encephalopathy, creatinine, prothrombin activity, serum total bilirubin, infection, the dimension of liver, the maximum depth of ascites, were scored objectively and simply from 0 to 4 points according to their severity. Then we calculated every patient's total score and divided the 409 patients into two groups: the one was 309 patients and the other is 100 patients. The first group was to establish the severity scoring system and define the cut-off-point, the second group was to test the severity scoring system. The total score of the 144 patients in the survival group was 6.9 +/- 3.2, 165 patients in the dead group was 15.8 +/- 4.0, respectively. There were significant differences (P < 0.01) between the two groups. The area under ROC curve was 0.953. The cut-off-point is 9.5. The sensitivity was 0.97, the specificity was 0.82. The second group patients' total score were divided into two groups: the one is > or = 10 score and the other is < or = 9 score. The prognosis of the first group was much worse than the second group, it's mortality rate was 87.5%; the second was 2.3%. There were significant differences between the two groups (P < 0.01). This scoring system was simple, sensitive and objective to evaluate the severity of acute-on-chronic liver failure in hepatitis B.

Repolarization Spatial‐Time Current Abnormalities in Patients with Coronary Heart Disease

Magnetocardiography (MCG) is a new technique for visualizing a current distribution in the myocardium. In recent years, current distribution parameters (CDPs) have been developed based on the distribution. The CDPs reflect spatial-time current abnormalities in patients with coronary heart disease (CHD). However, the criteria and scoring method of the abnormalities using CDPs are still controversial. We measured MCG signals for 101 normal controls and 56 CHD patients (single-, double-, and triple-vessel diseases) using a MCG system. The CDPs (maximum current vector [MCV], total current vector [TCV], current integral map, and current rotation) during ventricular repolarization were analyzed. To evaluate the CDPs that are effective in distinguishing between normal controls and CHD patients, the areas under the receiver operating characteristic curve (A(z)) are calculated. Furthermore, the total scores ("0" to "4") of four CDPs with high A(z) values are also calculated. MCV and TCV angles at the T-wave peak had the highest A(z) value. Furthermore, TCV angular differences between the ST-T segment also had high A(z) values. Using the four CDPs, the averaged total score for patients with triple-vessel disease was the highest ("2.67") compared to the other groups (normal controls: 0.53). Furthermore, based on the assumption that subjects with a total score over "1" were suspected of having CHD, sensitivity and specificity were 85.7% and 74.3%, respectively. We concluded that the score and criteria using MCV and TCV during repolarization in CHD patients can reflect lesion areas and time changes of electrical activation dispersion due to ischemia.

P01-105 Saccadic eye movements in dementia, major depression and healthy controls - relationship with cognitive functions

We compared horizontal saccadic eye movements in patients with dementia (n=18), and age-matched patients with major depression (n=18) or healthy controls (n=18). Cognitive functions were evaluated using Mini-Mental-State-Examination (MMSE) and ADAS-cog.Results:Saccadic latency and number of saccadic intrusions were significantly (p&lt; 0.001) higher in patients with dementia relative to healthy controls and depressed patients. There were significant correlations between MMSE total score and latency (r = -0.78, p&lt; 0.01) or number of saccadic intrusions (r = -0.80, p&lt; 0.001) in the demential group. In addition, both saccadic parameters were significantly associated with ADAS-cog total score of patients with dementia, whereas the subscale “orientation” showed the strongest correlation with latency (r = 0.71, p&lt; 0.01) and intrusions (r = 0.74, p&lt; 0.01).There were no significant differences in saccadic eye movements between healthy controls and patients with major depression as a whole, or a subgroup of depressed patients with the worst cognitive performance (n=9).Conclusions:It seems that disturbances in horizontal saccadic eye movements in patients with dementia are related to the degree of cognitive deficits in these patients. On the other hand, the lack of alterations in horizontal saccadic eye movements in depressed patients despite poor cognitive performance indicates different mechanism.

PW08-01 Saccadic eye movements in dementia, major depression and healthy controls - relationship with cognitive functions

We compared horizontal saccadic eye movements in patients with dementia (n=18), and age-matched patients with major depression (n=18) or healthy controls (n=18). Cognitive functions were evaluated using Mini-Mental-State-Examination (MMSE) and ADAS-cog.Results:Saccadic latency and number of saccadic intrusions were significantly (p&lt; 0.001) higher in patients with dementia relative to healthy controls and depressed patients. There were significant correlations between MMSE total score and latency (r = -0.78, p&lt; 0.01) or number of saccadic intrusions (r = -0.80, p&lt; 0.001) in the demential group. In addition, both saccadic parameters were significantly associated with ADAS-cog total score of patients with dementia, whereas the subscale “orientation” showed the strongest correlation with latency (r = 0.71, p&lt; 0.01) and intrusions (r = 0.74, p&lt; 0.01).There were no significant differences in saccadic eye movements between healthy controls and patients with major depression as a whole, or a subgroup of depressed patients with the worst cognitive performance (n=9).Conclusions:It seems that disturbances in horizontal saccadic eye movements in patients with dementia are related to the degree of cognitive deficits in these patients. On the other hand, the lack of alterations in horizontal saccadic eye movements in depressed patients despite poor cognitive performance indicates different mechanism.

A study on the status of social supports for patients with advanced cancer and nursing interventions

Objective To observe the status of social supports of the patients with advanced cancer and probe the effective nursing measures to improve the social supports of the patients.Methods Social support rating scaleof Xiao Shui-yuan was applied to investigate the social support state of a total of 58 advanced cancer patients and 63 patients with chronic diseases.Results The total score of patients with advanced cancer was(32.86±6.86),of patients with chronic diseases was(41.83±7.88).Compared with chronic disease group,the patients with advanced cancer received less social supports(P<0.05).The marriage state and economic income were significant factors to influence social support.Conclusions The patients with advanced cancer received less social supports than patients with chronic disease.Nursing staff should evaluate the status of social supports correctly,provide health education on patients and members in the net of social supports,make use of relative resources,then improve the social support level of the patients. Key words: Advanced cancer; Social supports; Nursing

P3-430: Impact of cognitive impairment on the reliability and construct validation of the QOL-AD scale

Background: To assess the impact of cognitive impairment on the internal consistency and construct validity of the Brazilian version of the Quality of Life (QOL) in Alzheimer’s disease (AD) evaluation scale (QOL-AD) (Logsdon, 1999). Methods: The scale was administered to a sample of 60 patients with probable AD, with mild (n 30) and moderate (n 30) dementia, according to NINCDS-ADRDA and DSM-III-R criteria, respectively. Internal consistency was evaluated through Cronbach’s alpha coefficient. Construct validity was determined as follows: 1) Correlation between total scores of patients’ and caregivers’ reports about patients’ QOL with the results of the following measures: MMSE, Geriatric depression screening scale (GDS), Cornell scale for depression in dementia, Physical and Instrumental-Self Maintenance scales (IADLs and BADLs), Neuropsychiatric inventory (NPI) and socio-economic level and; 2) Correlation of the total score of the scale with a generic QOL instrument (WHOQOLbrief). All analyses were performed for both groups of severity. Results: The reliability was excellent for both groups of dementia severity. In mild dementia the patient’s and the relative’s versions in relation to the patient’s QOL (alpha 0.81 and 0.75, respectively). In moderate dementia the alpha values were 0.80 for patient’s report and 0.83 for relative’s report in relation to the patient’s QOL. In the construct validation of the patient’s version for mild dementia, we obtained significant correlations with GDS (-0.76, p 0.01), Cornell (-0.53, p 0.01), NPI (-0.46, p 0.05) and the total score of WHOQOL-brief (0.89, p 0.01). In the caregiver’s version about patient’s quality of life we registered significant correlations with the following measures: GDS (-0.48, p 0.01), Cornell (-0.57, p 0.01), IADLs(-0.36, p 0.05), NPI (-0.62, p 0.01) and total score of WHOQOLbrief(1.00, p 0.01). In the patient’s version for moderate dementia we obtained significant correlations with GDS (-0.45, p 0.05), Cornell (-0.46, p 0.05) and total score of WHOQOL-brief (0.90, p 0.01). In the caregiver’s version about patient’s QOL, significant correlations emerged with Cornell (-0.68, p 0.01), IADLs (-0.41, p 0.05), BADLs (-0.49, p 0.01), NPI (-0.67, p 0.01) and total score of WHOQOL-brief (0.69, p 0.01). Conclusions: The reliability and construct validity of QOL-AD were kept independent from the severity of the disease in this sample of AD patients with mild and moderate dementia.

Drug abusers suffering from social phobia show more avoidance tendencies than patients with social phobia alone

Background: Comorbidity between social anxiety disorder (SAD) and substance use disorder (SUD) is elevated but little is known about the role of avoidance with regard to the aetiology and maintenance of these disorders. Aims: The objective of the study was to compare patients with SAD and comorbid SUD with patients suffering from SAD only with regard to fear and avoidance symptoms. Methods: Thirty patients presenting SAD and comorbid SUD were recruited by the local Substance Abuse Unit, and 26 patients with SAD only were identified within the general population by the research team. All patients were asked to answer the Liebowitz Social Anxiety Scale. Results: Patients suffering from SAD and SUD showed a higher avoidance/total score ratio. Avoidance contributed at mean to 49.7% (±4.9%) of the total score in patients with SAD and SUD, whereas its mean contribution was 46.5% (±3.1%) in patients with SAD only (effect size 0.77). Conclusions: Avoidance tendencies appear to be more prominent in patients suffer...

Reliability and validity of the Norwegian version of the Severe Impairment Battery (SIB)

The Severe Impairment Battery (SIB) is developed to test cognitive function in patients with dementia of moderate to severe degree. We have conducted a study to assess the inter-rater reliability and the validity of the Norwegian version of SIB. The reliability study comprised 30 patients, and the validity study 59 patients in nursing homes. We assessed Cronbach's alpha coefficient of the scale and the inter-rater reliability for the total SIB score and its nine sub scores between two testers by means of the Spearman's correlation coefficients. In the validity study we compared the SIB scores with the scores on the Clinical Dementia Rating Scale. The mean SIB score was 72.10 (SD 25.37). The Cronbach's alpha was 0.97, and the inter-rater reliability of total SIB score was Spearman's rho 0.85, and ranged from 0.46 to 0.76 for the nine sub-scores. The mean SIB score for patients with a CDR score <2 was 84.2(13.4), whereas total scores for patients with CDR 2 and 3 were 74 (18.9) and 48.4 (33.3), respectively. A cut-off point of 80.5 points gave the highest accuracy in discriminating between patients with CDR 2 and CDR 3, while a cut-off point of 87.5 best discriminated between CDR<2 and CDR 3. The study indicates that the Norwegian version of SIB is a reliable and valid test with which to evaluate the cognition in patients with dementia of moderate to severe degree.

Qualitative changes in symptomatology as an effect of treatment with escitalopram in generalized anxiety disorder and major depressive disorder

The purpose of this article is to examine the similarities and differences between patients with Major Depressive Disorder (MDD) versus Generalized Anxiety Disorder (GAD) versus MDD with anxiety symptoms. Data were analysed from all randomized double-blind clinical studies with escitalopram that measured symptoms using either Hamilton Anxiety Scale (HAMA) or Montgomery-Asberg Depression Rating Scale (MADRS). The contribution of each item of a scale to the total score was calculated before and after treatment, in remitters. Most single items of the HAMA contribute nearly equally in patients with GAD. In patients with MDD, four symptoms (i.e. anxious mood, tension, insomnia and concentration) contribute to most to the HAMA total score. In patients with GAD, three symptoms (tension, sleep and concentration) contribute two-thirds of the MADRS total score. In contrast, most MADRS items contribute equally to the total score in patients with MDD. After treatment to remission, the profile of residual symptoms MDD or GAD was similar to the symptom profile before treatment. Anxiety symptoms are very common in patients with MDD or GAD, and the symptomatic pattern is similar. In both disorders, the symptomatic pattern of residual symptoms is similar to the pattern of symptoms before treatment.

The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST): The Efficacy of Glutamatergic Agents for Negative Symptoms and Cognitive Impairments

Patients with schizophrenia frequently present with negative symptoms and cognitive impairments for which no effective treatments are known. Agents that act at the glycine site of the N-methyl-D-aspartic acid (NMDA) glutamatergic receptor have been suggested as promising treatments for moderate to severe negative symptoms and cognitive impairments. The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST) was a 16-week double-blind, double-dummy, parallel group, randomized clinical trial of adjunctive glycine, D-cycloserine, or placebo conducted at four sites in the United States and one site in Israel. The participants were 157 inpatients and outpatients who met DSM-IV criteria for schizophrenia or schizoaffective disorder and retrospective and prospective criteria for moderate to severe negative symptoms without marked positive, depressive, or extrapyramidal symptoms. The primary outcome measures were the average "rate of change" of Scale for the Assessment of Negative Symptoms (SANS) total scores and change in the average cognitive domain z scores. There were no significant differences in change in the SANS total score between glycine and placebo subjects or D-cycloserine and placebo subjects. A prespecified test for the site-by-treatment-by-time interaction was significant in post hoc tests. One site had greater reduction in the SANS total score for patients receiving D-cycloserine relative to patients receiving placebo. A second site had greater reduction in the SANS total score for placebo patients compared with glycine patients. There were no significant differences between glycine and placebo or D-cycloserine and placebo subjects on the average cognition z score. The study results suggest that neither glycine nor D-cycloserine is a generally effective therapeutic option for treating negative symptoms or cognitive impairments.

Bayesian modelling and ROC analysis to predict placebo responders using clinical score measured in the initial weeks of treatment in depression trials

* In major depressive disorder an appreciable percentage (40%) of patients in antidepressant trials will have a placebo response. * In these trials, early changes (i.e. within the first 4 weeks) of the clinical score scale (e.g. HAMD-17) are associated with response at end-point. * Unpredictable placebo response is one of the major reasons for clinical trial failure in the evaluation of antidepressant drugs. * Provides a model to describe the time course of individual and population placebo response. * Provides a methodology to forecast the individual probability to be placebo responder based on early HAMD-17 measurements with an assessment of the prognostic power. * Provides a methodological framework to implement a population enrichment strategy in the design of clinical trials for the assessment of novel antidepressant drugs. To develop a probabilistic and longitudinal model describing the time course of Hamilton's Rating Scale for Depression (HAMD-17) total score in patients with major depressive disorders treated with placebo and to develop predictive models to estimate the response at end-point given HAMD-17 measurements at weeks 2 and 4. Patients (n = 691) from seven clinical trials were analysed in WinBUGS using a Bayesian approach. The whole dataset was randomly split in a learning (359 patients for model definition) and a test dataset (332 patients for assessment of model predictive performance). The analysis of the learning dataset assumed uninformative priors, whereas the analysis of the test dataset used the posterior parameter estimates of the learning dataset as priors. ROC curve analysis estimated the optimal sensitivity/specificity cut-off between false-negative and false-positive rates and determined the prognostic allocation rule for patients to responder and nonresponder groups. A Weibull/linear model accurately described the population and individual HAMD-17 time course. The total area under the ROC curve, ranging from 0.76 (logistic model with data at week 2) to 0.86 (longitudinal model with data at week 4), provided a measure of the prognostic discriminatory power of early HAMD-17 measures using the two models. The best placebo-responder classification score (86.32% true and 13.68% false positive) was associated with the longitudinal model with HAMD-17 measures at week 4. Results showed the relevance of the Bayesian approach to predict HAMD-17 score at study end and to classify a patient as a placebo responder given the uncertainty in parameters derived from historical data and early HAMD-17 measurements.

Evaluation of a collaborative mental health program in primary care: effects on patient distress and health care utilization

Background: The effectiveness of a collaborative model of mental health treatment under conditions of routine care in a primary care setting has received limited evaluation. Potential effects include reduced symptoms and decreased healthcare utilization. Methods: The present study describes treatment outcome for 234 patients seen by a mental health professional in a primary care clinic using a collaborative model of care. Patients were seen for one session (n = 120), two sessions (n = 59), three sessions (n = 29), or four or more sessions (n = 26). Patients completed the Outcome Questionnaire-45 (OQ45) at every session. Results: OQ-45 total scores for patients seen for more than one appointment showed statistically significant reductions in psychological distress from first to last session for all groups. Pre-treatment health care utilization was unrelated to level of psychological distress at the first session. A comparison of health care utilization for the six month period before and after the first session showed a small but statistically significant increase in total number of medical visits. Conclusions: The results support the effectiveness of a collaborative model of mental health care for reducing symptoms in patients seen in a primary care setting. Patient’s overall healthcare utilization in the short term was largely unaffected.

Bupropion Extended Release Compared With Escitalopram

To compare the effects on sexual functioning and the antidepressant efficacy of once-daily bupropion extended release (XL) and escitalopram in adults with major depressive disorder (MDD). Adult outpatients with moderate to severe DSM-IV-defined MDD and normal sexual functioning were randomly assigned to receive bupropion XL (300-450 mg/day; N = 276), escitalopram (10-20 mg/day; N = 281), or placebo (N = 273) for up to 8 weeks in 2 identically designed, randomized, double-blind, parallel-group studies (study 1 conducted from February 6, 2003, to June 10, 2004; study 2 conducted from January 21, 2003, to June 15, 2004). Data were analyzed prospectively for each study individually, and pooled data were analyzed retrospectively. In both the individual studies and the pooled dataset, the incidence of orgasm dysfunction at week 8 (primary endpoint) and the incidence of worsened sexual functioning at the end of the treatment period were statistically significantly lower with bupropion XL than with escitalopram (p < .05), not statistically different between bupropion XL and placebo (p > or = .067), and statistically significantly higher with escitalopram than with placebo (p < or = .001). The percentages of patients with orgasm dysfunction at week 8 in study 1, study 2, and the pooled dataset, respectively, were 13%, 16%, and 15% with bupropion XL; 32%, 29%, and 30% with escitalopram; and 11%, 8%, and 9% with placebo. The respective percentages of patients with worsened sexual functioning at the end of the treatment period were 18%, 22%, and 20% with bupropion XL; 37%, 34%, and 36% with escitalopram; and 14%, 16%, and 15% with placebo. Mean changes in Changes in Sexual Functioning Questionnaire scores for all domains at week 8 were statistically significantly worse for escitalopram compared with bupropion XL (p < or = .05). Separation from placebo could not be established at a statistical .05 level for bupropion on 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score. However, escitalopram showed statistical superiority to placebo on HAM-D-17 total score in one of the 2 studies and in the pooled data. Bupropion XL did not statistically differ from escitalopram with respect to mean change in HAM-D-17 total score, HAM-D-17 response or remission rates, percentage of patients much or very much improved on Clinical Global Impressions-Improvement scale scores, or mean changes in the Hospital Anxiety and Depression (HAD) scale total score or Clinical Global Impressions-Severity of Illness scale score at week 8. Bupropion XL had a sexual tolerability profile significantly better than that of escitalopram with similar HAM-D-17 remission rates and HAD total scores in patients with MDD.

Effect of the 2004 Mid Niigata Prefecture Earthquake on Patients with Endocrine Disorders

A major earthquake (Richter scale magnitude 6.8) struck the Chuetsu district of Niigata Prefecture, Japan, a rural area with mountain villages, on October 23, 2004. Strong aftershocks (Grade 5-6 on the Japanese intensity scale, JIS) continued for 2 months. We analyzed the earthquake's impact on 229 patients with various endocrine disorders [6 central diabetes insipidus (CDI), 16 adrenal insufficiency (AI) including 5 panhypopituitarism, 10 ACTH isolated deficiency and 1 Addison's disease, 145 Graves' disease and 62 Hashimoto's disease]. The status of patients with CDI or AI was not adversely affected by the earthquake. Twenty-eight (19%) patients with Graves' disease developed more severe hyperthyroidism; the incidence of developing more severe hyperthyroidism increased with greater degrees of hyperthyroidism. Three (5%) patients with Hashimoto's disease developed increased TSH concentrations. Most patients stayed in their own houses following the first shock. The median PTSD total score for all patients was low. However, the PTSD total score in patients with CDI or Hashimoto's disease was significantly higher than in other patients, while the subscore of mental status in patients with AI was significantly much lower than in other patients. In patients with Hashimoto's disease, patients whose hypothyroidism worsened had higher total and environmental effects score than patients whose hypothyroidism remained stable. Comparing patients whose hyperthyroidism became more severe to those in whom it remained stable, as well as on multiple logistic regression analysis, serum TRAb was found to be a risk factor for developing more severe hyperthyroidism. In conclusion, our findings indicate that Graves' disease patients need to maintain their euthyroid state with a low serum TRAb titer to prevent the development of further thyroid dysfunction after an earthquake, and that all patients should continue to take their medication, since it is likely that their lives will be interrupted by environmental effects owing to earthquake-shock, especially patients with CDI or Hashimoto's disease. Due to the risk of medical facility closure during a disaster, all patients should always have a note or copy of their medical records, including medical history and medications used, to avoid relying on patients remembering their drug names and doses. Furthermore, appropriate information should be provided by all means possible, including the mass media, to affected individuals, particularly those with AI, to decrease the occurrence of adverse consequences.