Mean Change In Total Score Research Articles

The effect of 8-week mindfulness counseling on sexual self-efficacy of women suffering from human immunodeficiency syndrome: A randomized controlled trial in Iran.

Sexual self-efficacy refers to a woman's belief that she can be sexually active and attractive for her sexual partner and has acceptable sexual function. One of the issues that may negatively affect sexual self-efficacy is HIV infection. The present study aimed to evaluate the effect of 8 weeks of counseling based on mindfulness on sexual self-efficacy of women affected with HIV. This was a randomized controlled trial involving 62 HIV-positive women in their reproductive age. Women in the intervention group were further divided into four groups. Each group received eight sessions of counseling based on mindfulness, while the control group received no intervention. A demographic questionnaire and sexual self-efficacy questionnaire were used to collect the data. The independent t test, χ 2, and repeated measure tests were used to analyze the data. The mean change of total score of sexual self-efficacy in Week 8 compared with before intervention was 37.04 (95% CI: 31.38-42.70, p < 0001) and in Week 12 compared with before intervention was 36.97 (95% CI: 31.59-42.34, p < 0.0001), while in the control group, it almost remained unchanged. The score of readiness for sexual relationship, sexual self-stimulation, intimacy without sexual intercourse, and orgasm improved significantly 8 and 12 weeks after intervention (p < 0.0001), whereas no significant differences were observed in these dimensions in the control group. The results of this study showed that 8 weeks of counseling based on mindfulness could significantly improve all dimensions of sexual self-efficacy and its total score in women affected with HIV. Thus, this method of counseling is recommended for HIV-positive women.

Effects of a multidisciplinary management program on symptom burden and medication adherence in heart failure patients with comorbidities: A randomized controlled trial

BackgroundComorbidities in heart failure (HF) are a complex clinical challenge. There is little data on the benefits of multidisciplinary postdischarge management programs in such patients. This study aimed to examine the effects of a multidisciplinary management program (MMP) on symptom burden and medication adherence in HF patients with comorbidities.MethodsIn this clinical trial study, 94 HF patients with comorbidities were assigned to intervention (n = 47) and control (n = 47) groups by the stratified-random method. The intervention group underwent MMP supervised by a nurse for two months after discharge, including multi-professional visits, telephone follow-ups, and an educational booklet. Medication adherence and symptom burden were assessed using Morisky Medication Adherence Scale (MMAS) and Edmonton Symptom Assessment Scale (ESAS), respectively, on three occasions: Before discharge, six weeks, and eight weeks after discharge.ResultsBoth groups almost matched at the baseline, and the most frequent comorbidities included myocardial infarction (MI), hypertension, peptic ulcer, and depression, respectively. The interactive effect of time in groups showed that mean changes in total scores of symptom burden and medication adherence were significantly different (P < 0.001) at other time points. A significant increase in medication adherence (P < 0.001) and a significant reduction in the burden of all symptoms were observed in the intervention group compared to the control group from Time 1 to Time 3.ConclusionsThe MMP (targeting comorbidity) is a promising strategy for managing symptoms and medication adherence in HF patients with comorbidities.

Effect of Health Education in Improving Knowledge, Attitudes and Practices of Preventable Cancers amongst Reproductive Age Women A Randomized Field Trial

Background: The increasing burden of preventable cancers among women in low-middle income countries call for urgent development of constructive health strategies. The aim of this study was to determine the effect of health education on knowledge, attitude and practices of reproductive age women about preventable cancers in two peri-urban communities of Lahore. Material and Methods: The study was a Randomized field trial and the data was collected from women of reproductive age from areas of Lahore Shadewal (SC) and Satokatla (SI). SC stands for control group and SI for interventional group. Number of participants was 235 in each group. A validated questionnaire was administered to evaluate knowledge, attitude and practices for prevention of reproductive cancers from both groups. Then during next visit to intervention group, a health education program in form of group discussion, role play and demonstration related to preventable cancers was arranged. After 2 weeks of previous visit, questionnaires were again filled. Same questionnaire was filled by the comparison group without giving any intervention. Results: Before intervention mean total score for knowledge was 4.24 ± 2.30 in SC group and 4.68 ± 2.99 in SI group. After educating, mean total score of SC group the score came out to be 5.91 ± 3.014 whereas in SI group it was improved to 20.57 ± 2.755. The mean change in total score of knowledge of SC group was 1.67 ± 2.62 and 15.89 ± 3.35 in SI group. The mean change was found to be highly significant in SI group when compared with SC group, (p&lt;0.001). The attitude and self-practice was also improved in SI group while females of SC showed no improvement, (p&gt;0.05). Conclutions: The study highlighted the need for educational programs to create awareness regarding regular screening of gynecological preventable cancers. Keywords: Females, Reproductive Age, Health education, Awareness, Cancers.

DUPLICATE: Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial

BackgroundThe first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD.MethodsThirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment.ResultsThe primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067).ConclusionA clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD.Trial registrationThe protocol was registered at Korean Clinical Trial Registry (CRIS-KCT0001810)

Repetitive transcranial magnetic stimulation therapy markedly reduces anxiety in adults with major depressive disorder: A retrospective analysis of 664 patients

Abstract Background: Patients with MDD commonly have comorbid anxiety that can severely affect quality of life and, in some cases, predicts inferior response to antidepressant treatment. Nonetheless, for some antidepressant treatments, it is also established that clinical improvement in depressive symptoms is accompanied by improvement in comorbid anxiety symptoms. However, there is limited information on the impact of treatment with TMS on the severity of comorbid anxiety symptoms in MDD patients. Methods: Patient data was extracted from a clinical registry of patients treated with left-sided high frequency TMS. Six hundred and sixty-four (664) patients were identified who demonstrated at least moderate depression and anxiety symptom severity prior to commencing treatment for MDD. These patients had total scores greater than 10 on both the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales. Patients were aged 22 to 70 years and had received a minimum course of 20 left-sided treatments. Results: GAD-7 response was defined as a postTMS decrease from baseline in GAD-7 scores ≥ 6 (minimally clinically important difference) and remission was defined as a final GAD-7 score < 5; 65.5% of patients (95% CI: 61.9%. 69.1%) were GAD-7 responders and 34% met the remission criterion. Mean change in the GAD-7 score was -8.0 ± 5.7 (p<0.0001). Mean change in total score on the PHQ-9 was -10.5±6.7 (p<0.0001), and 58.9% of patients demonstrated a 50% or greater improvement in PHQ-9 score. The correlation between change scores on the GAD-7 and PHQ-9 was 0.75 (p<00001), indicating substantial covariation. Conclusions: High frequency TMS may reduce symptoms of both anxiety and depression in adults with MDD. We will also contrast this group with significant co-morbid anxiety to MDD patients with low baseline levels of anxiety in likelihood of antidepressant response to TMS. Keywords: TMS, anxiety, depression, high frequency

Effect of personal activity intelligence (PAI) monitoring in the maintenance phase of cardiac rehabilitation: a mixed methods evaluation

BackgroundPersonal activity intelligence (PAI) is a single physical activity metric based upon heart rate responses to physical activity. Maintaining 100 PAI/week is associated with a 25% risk reduction in cardiovascular disease mortality and 50 PAI/week provides 60% of the benefits. The effect of utilising this metric within a cardiac population has not been previously investigated. The aim of this study was to determine the effect of PAI monitoring on the amount and/or intensity of physical activity for people in the maintenance phase of cardiac rehabilitation and to explore participants’ perceptions of this approach.MethodsA concurrent mixed methods approach was undertaken. Participants in the maintenance phase of cardiac rehabilitation monitored PAI for six weeks via a wearable physical activity monitoring device (WPAM). In the first three weeks participants were blinded to their PAI score. A quality-of-life questionnaire (EQ-5D-5L) was completed, and semi-structured interviews conducted to investigate attitudes to PAI monitoring. Daily PAI data was collected throughout the 6-week period.ResultsTwenty participants completed the trial. PAI earned/day was increased after participants could view their data (mean difference: 2.1 PAI/day (95% CI 0.3, 4.0), p = 0.027). The median change in percentage of days participants achieved a Total PAI score of 25 (p = 0.023) and 50 (p = 0.015) were also increased. The mean change in total scores for the EQ-5D-5L and EQVAS were improved after 6 weeks (0.6 ± 1.05; 95% CI (0.11–1.09); p = 0.019); (5.8/100; 95% CI (2.4–9.2); p = 0.002 respectively). Thematic framework analysis identified three global themes (perceptions on the WPAM, PAI and factors affecting exercise). Most participants stated motivation to exercise increased after they could view their PAI data. Many of the participants believed they would continue to use PAI long-term. Others were undecided; the latter primarily due to technical issues and/or preferring devices with greater functionality and attractiveness. All participants would recommend PAI.ConclusionThis exploratory study showed monitoring PAI via a WPAM increased the amount and/or intensity of physical activity within the cardiac population. Participants found PAI interesting, beneficial, and motivating. If technical issues, aesthetics, and functionality of the WPAM were improved, participants may continue to use the approach long-term. PAI may be a viable strategy to assist people with cardiac disease maintain physical activity adherence.

Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial

BackgroundThe first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. MethodsThirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. ResultsThe primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). ConclusionA clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD.

Agomelatine for the Treatment of Generalized Anxiety Disorder: A Meta-Analysis.

ObjectiveDespite multiple drugs available, a large proportion of patients with generalized anxiety disorder (GAD) do not show adequate response and remission. Thus, additional novel pharmacological agents are needed to increase treatment option for GAD. We aimed to investigate efficacy and safety of agomelatine in the treatment of GAD by conducting a meta-analysis.MethodsAn extensive search of multiple databases and clinical trial registries were conducted. Mean change in total scores on Hamilton Anxiety Rating Scale (HAM-A) from baseline to endpoint was our primary outcome measure. Secondary efficacy measures included response and remission rates, as defined by a 50% or greater reduction in HAM-A total scores and a score of 7 or less in HAM-A total scores at study endpoint respectively.ResultsFour published double blinded, randomized, placebo-controlled trials were included in this meta-analysis. Agomelatine more significantly (standardized mean difference = −0.56, p = 0.004) improved HAM-A total scores than placebo. The odds ratios (ORs) of agomelatine over placebo for response and remission rates were 3.75 (p < 0.00001) and 2.74 (p < 0.00001), respectively. Agomelatine was generally well tolerated with insignificance in dropout rate, somnolence, headache, nasopharyngitis, and dizziness compared with placebo. However, agomelatine showed significantly higher incidence of liver function increment (OR = 3.13, p = 0.01) and nausea (OR = 3.27, p = 0.02).ConclusionWe showed that agomelatine may be another treatment option in patients with GAD. However, the results should be interpreted and translated into clinical practice with caution because the meta-analysis was based on limited numbers of clinical trials.

Responsiveness of the Lymphedema Functioning, Disability, and Health Questionnaire for Upper Limb Lymphedema in Patients with Breast Cancer-Related Lymphedema.

Background: The Lymphedema Functioning, Disability, and Health questionnaire for Upper Limb Lymphedema (Lymph-ICF-UL) is a health-related quality-of-life questionnaire for patients with breast cancer-related lymphedema. Previous testing of this questionnaire showed very good psychometric properties; however, responsiveness has not yet been established. The aim of this study was to determine its internal and external responsiveness. Methods and Results: Ninety-five patients treated with decongestive lymphatic therapy in a longitudinal trial were recruited. Patients completed the Lymph-ICF-UL twice within a time interval of 7 weeks ("intensive group" receiving intensive treatment; n = 73) or 3 months ("stable group" receiving maintenance treatment; n = 22), and once the Global Perceived Effect (GPE) questionnaire at the second time point. The significance of change in scores and standardized response mean (SRM) were determined for the total and domain scores. Correlations between Lymph-ICF-UL and GPE were ascertained. In addition, the minimal clinical important difference (MCID) was determined. The Lymph-ICF-UL total score changed significantly in the intensive group (p < 0.001) and nonsignificantly for those in the stable group (p = 0.25). The SRM represented moderate responsiveness (0.65). Patients who reported a clinical improvement ( = responders) after intensive treatment showed a significant decrease in total score (p < 0.001), this was also the case for nonresponders (p < 0.001). Lymph-ICF-UL total and domain scores showed nonsignificant weak correlations with the GPE (p > 0.05). There was a significant difference in mean total score changes between responders and nonresponders (p < 0.001). MCID for the total score was 9%. Conclusion: The Lymph-ICF-UL is responsive to change after decongestive lymphatic therapy. No correlations were found between Lymph-ICF-UL change scores and GPE. Future studies should be conducted in a clinical setting, with more variability between participants and their treatment responses.

Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study

PurposeThis study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. MethodsA total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE). ResultsAt 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%–23.2%), primary patency was 89.1% (95% CI: 82.6%–93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%–94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%–9.4%) experienced MAEs, but none were determined to be related to device or procedure. ConclusionsThe LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries.

Effects of Saffron on Cognition, Anxiety, and Depression in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Double-Blind Placebo-Controlled Trial.

Cognitive decline, depression, and anxiety are among the major concerns in patients undergoing coronary artery bypass grafting (CABG). Crocus sativus L. (saffron) seems to be a promising candidate for treatment of these conditions. In this 12-week, randomized, double-blind, placebo-controlled clinical trial, men and women with on-pump CABG, who had Wechsler Memory Scale (WMS) score >70 and age <70 years, received either saffron capsules (15 mg/twice daily) or placebo. Patients were excluded if they had history of treatment with saffron or acetylcholinesterase inhibitors, comorbid neuropsychiatric disorders, serious medical conditions other than cardiovascular diseases, and hypersensitivity to herbal compounds. The primary outcome was defined as the difference in mean total score changes for WMS-Revised from the baseline to week 12 between the saffron and placebo groups. Secondary outcomes included difference in mean score changes from baseline to endpoint between the two treatment groups for Mini Mental Status Examination and subscales of Hospital Anxiety and Depression Scale ( www.irct.ir ; IRCT201408071556N63). No significant difference was detected in primary or secondary outcomes between the saffron and placebo groups. Also, no significant time × treatment interaction effect was found for any of the scales. The results of this trial do not support the hypothesis of potential benefits of saffron in treatment of CABG-related neuropsychiatric conditions.

Antidepressants augmented with aripiprazole in the treatment of major depressive disorder

IntroductionMajor depressive disorder (MDD) does not consistently respond to any single antidepressant (AD) therapy. Adjunctive therapy with atypical antipsychotics (AA) showed higher response rates compared with AD monotherapy. Aripiprazole, an oral quinolinone, is the first AA agent to be approved in the US as adjunctive treatment in adult patients with MDD.Aim The aim was to evaluate the efficacy and safety of adjunctive low-dose aripiprazole combined with AD versus AD monotherapy in patients with MDD with minimal improvement after 4 weeks of prior AD monotherapy.MethodsTen patients with MDD and a history of minimal improvement to 4 weeks of AD monotherapy (escitalopram 10–15 mg/day, sertralin 50–100 mg/day) were included in this study. The patients were randomly assigned to 2 groups: one (n = 5) with AD plus aripiprazole 5–7.5 mg/day and the other (n = 5) with AD alone. After baseline assessment, the subjects were followed up at weeks 2, and 4. The primary efficacy was the mean change in (HAM-D17) and CGI-I.ResultsThe aripiprazole group exhibited significantly better efficacy than the AD group in mean total score changes of HAM-D17 and CGI from the baseline to weeks 2, and 4. The item “work and social activities” of HAM-D 17 showed significant improvement at week 4, and the item “somatic symptoms (GI)” showed significant improvement at week 2.ConclusionsAdjunctive aripiprazole therapy significantly improved depressive symptoms in MDD who didn’t respond to AD monotherapy. Aripiprazole augmentation is an efficacious, well-tolerated and safe treatment for patients with MDD.

A randomized crossover trial on the effect of compression stockings on nausea and vomiting in early pregnancy.

IntroductionThis study aimed to assess the impact of wearing compression stockings on women’s quality of life (QoL) associated with nausea and vomiting in early pregnancy (NVP).MethodsIn this randomized, open, single-center, crossover study, 74 women were assigned 1:1 to 2 weeks with compression stockings followed by 2 weeks without or vice versa. The main outcomes were NVP-associated QoL, leg-related QoL, and dizziness, as assessed by the Nausea and Vomiting in Pregnancy Quality of Life (NVPQOL) questionnaire, Chronic Venous Disease Quality of Life (CIVIQ) questionnaire, and questions on dizziness at baseline and after each 2-week period, respectively. Daily NVP was assessed using the modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) questionnaire. Data were analyzed using Pearson’s chi-square and independent t-tests.ResultsFifty-eight women completed the study. QoL scores improved with compression treatment; changes in mean total scores were as follows: NVPQOL, −36.7 with compression vs −21.7 without (P<0.0001); and CIVIQ, −4.5 with compression vs +1.4 without (P=0.001). Mean dizziness scores were −3.2 with compression vs −0.4 without (P<0.0001). PUQE mean total score (standard deviation) was 4.9 (2.3) with compression vs 5.5 (2.2) without (P=0.042).DiscussionWearing of compression stockings in early pregnancy may improve nausea and vomiting-associated symptoms in addition to improving QoL factors.

Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate.

Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients’ lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6–17 years with an ADHD Rating Scale IV total score ≥28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95 % confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of −0.35 (95 % CI −0.42, −0.29) for LDX and −0.27 (−0.33, −0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score.Electronic supplementary materialThe online version of this article (doi:10.1007/s00787-015-0718-0) contains supplementary material, which is available to authorized users.

Vortioxetine: a meta-analysis of 12 short-term, randomized, placebo-controlled clinical trials for the treatment of major depressive disorder.

Vortioxetine was approved by the U.S. Food and Drug Administration (FDA) in September 2013 for treating major depressive disorder (MDD). Thus far, a number of randomized, double-blind, placebo-controlled clinical trials (RCTs) of vortioxetine have been conducted in patients with MDD. We performed a meta-analysis to increase the statistical power of these studies and enhance our current understanding of the role of vortioxetine in the treatment of MDD. We performed an extensive search of databases and the clinical trial registry. The mean change in total scores on the 24-item Hamilton Rating Scale for Depression (HAM-D) and the Montgomery- Åsberg Depression Rating Scale (MADRS) from the baseline were the primary outcome measures. The secondary efficacy measures were the response and remission rates, as defined by a 50% or greater reduction in HAM-D/MADRS total scores and as a score of 10 or less in the MADRS and 7 or less in the HAM-D total scores at the end of treatment. We included 7 published and 5 unpublished short-term (6-12 wk) RCTs in our meta-analysis. Vortioxetine was significantly more effective than placebo, with an effect size (standardized mean difference [SMD]) of -0.217 (95% confidence interval [CI] -0.313 to -0.122) and with odds ratios (ORs) for response and remission of 1.652 (95% CI 1.321 to 2.067) and 1.399 (95% CI 1.104 to 1.773), respectively. Those treated with vortioxetine did not differ significantly from those treated with selective norepinephrine reuptake inhibitors/agomelatine with regard to the SMD of the primary outcome measure (0.081, -0.062 to 0.223) or for response (OR 0.815, 95% CI 0.585 to 1.135) and remission (OR 0.843, 95% CI 0.575 to 1.238) rates. Discontinuation owing to lack of efficacy (OR 0.541, 95% CI 0.308 to 0.950) was significantly less common among those treated with vortioxetine than among those who received placebo, whereas discontinuation owing to adverse events (AEs; OR 1.530, 95% CI 1.144 to 2.047) was significantly more common among those treated with vortioxetine than among those receiving placebo. There was no significant difference in discontinuation rates between vortioxetine and comparators owing to inefficacy (OR 0.983, 95% CI 0.585 to 1.650), whereas discontinuation owing to AEs was significantly less common in the vortioxetine than in the comparator group (OR 0.728, 95% CI 0.554 to 0.957). Studies examining the role of vortioxetine in the treatment of MDD are limited. Although our results suggest that vortioxetine may be an effective treatment option for MDD, they should be interpreted and translated into clinical practice with caution, as the meta-analysis was based on a limited number of heterogeneous RCTs.

S123 Does Exercising With Domiciliary Non-invasive Ventilation (niv) Improve Quality Of Life (qol) In Patients With Severe Chronic Obstructive Pulmonary Disease (copd)?

Introduction and objectives Patients with severe COPD experience breathlessness leading to exercise limitation impacting on QoL. Pulmonary rehabilitation (PR) can improve QoL, but those with the severest disease are frequently hospitalised and cannot readily access PR. Previous studies have trialled positive pressure as a means of relieving ventilatory load, allowing more severe COPD patients to exercise.1 Studies have assessed mixed pathology or stable COPD patients.2,3 In this study, we have assessed patients with severe COPD admitted to hospital with Type 2 respiratory failure and acidosis treated with acute NIV. Methods 18 patients (11 female), recruited during admission were randomised into 3 groups. Group 1 received standard hospital physiotherapy care; Group 2 exercised on NIV (Trilogy 100, Philips-Respironics) with a mean pressure support of 10 cmH2O twice weekly during admission; Group 3 exercised on NIV twice weekly during hospital admission and continued this at home for 3 months post-discharge. Exercising included weights, pedal cycling and walking. QoL was assessed using the St Georges Respiratory Questionnaire (SGRQ) and the London Chest Activities of Daily Living Questionnaire (LCADL). Mean changes in total scores for SGRQ and LCADL were compared between baseline and at 3 months (M3). Data are mean±SD or mean (range). Results The group (n = 18) age was 66.5 years [46–97], FEV1: 25% predicted [9–51%] and MRC score 3 [1–4]). 3/18 patients died during the study. The results are presented in [Table 1][1]. Conclusion Patients exercising with NIV, in hospital and at home twice weekly (Group 3) showed the greatest improvement in QoL, compared to the other two groups. The use of NIV during exercise at home may assist patients unable to access pulmonary rehabilitation.

P.2.e.016 Cariprazine in the treatment of acute mania in bipolar disorder: a double-blind, placebo-controlled, phase III trial

Background: This Phase III, randomized, double-blind, placebo-controlled study investigated the efficacy and tolerability of flexibly-dosed cariprazine in patients with acute manic or mixed episodes associated with bipolar I disorder. Methods: Patients were randomized to 3 weeks of double-blind treatment with cariprazine 3–12 mg/day (n¼158) or placebo (n¼154). The primary efficacy parameter was change from baseline to Week 3 in Young Mania Rating Scale (YMRS) total score. The secondary efficacy parameter was change from baseline to Week 3 in Clinical Global Impressions-Severity (CGI-S) score. Results: Mean change from baseline to Week 3 in YMRS total score was significantly greater for patients receiving cariprazine 3–12 mg/day versus placebo (P¼0.0004). Significant differences between groups in YMRS total score mean change were observed by Day 4 (first postbaseline assessment) and maintained throughout double-blind treatment (all assessments, Po0.01). Cariprazine also demonstrated statistically significant superiority over placebo on YMRS response (Z50% improvement: cariprazine, 58.9%; placebo, 44.1%; P¼0.0097) and remission (YMRS total scorer12: cariprazine, 51.9%; placebo, 34.9%; P¼0.0025) and mean change in CGI-S (P¼0.0027) score and Positive and Negative Syndrome Scale (PANSS) (P¼0.0035) total score. The most common cariprazine-related (Z10% and twice placebo) treatment emergent adverse events (TEAEs) were akathisia, extrapyramidal disorder, tremor, dyspepsia, and vomiting. Mean change from baseline in metabolic parameters were generally small and similar between groups. Limitations: Lack of active comparator arm; short duration of study. Conclusion: In this study, cariprazine 3–12 mg/day was effective and generally well tolerated in the treatment of manic and mixed episodes associated with bipolar I disorder. & 2014 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

Escitalopram for Treatment of Night Eating Syndrome

The primary objective of this study was to examine the short-term effects of escitalopram on symptoms of night eating syndrome (NES) in a randomized controlled clinical trial. A total of 40 patients with NES were randomly assigned to double-blind treatment with escitalopram 20 mg (n = 20) or placebo (n = 20) for 12 weeks. Escitalopram was started at 10 mg/d with a dosage increase to 20 mg/d after 4 weeks; placebo dosing was identical. The primary end point was a mean change in total score of the Night Eating Questionnaire (NEQ). At 12 weeks, mean (SE) change in NEQ total score was -13.0 (1.6) and -10.6 (2.2) in the escitalopram and placebo groups, respectively (F(1,37) = 2.5, P = 0.124). There was a marginal interaction effect between response to escitalopram and race (F(1,34) = 4.0, P = 0.052), with a favorable effect for white patients (F(1,20) = 6.0, P = 0.024) but not for black patients (F(1,13) = 0.6, P = 0.453). Seven patients in the escitalopram group, compared with 6 patients in the placebo group, showed a 50% NEQ score reduction (P = 0.736). Sixteen patients in the escitalopram group and 12 patients in the placebo group no longer met NES criteria (P = 0.168). Twelve patients in the escitalopram group were classified as responders according to the Clinical Global Impression Improvement scale compared with 7 patients in the placebo group (P = 0.113). No significant between-group differences were found for weight, mood ratings, or adverse events. We conclude that escitalopram treatment for 12 weeks was not superior to placebo in reducing NES symptoms as measured by the NEQ.

Nonsteroidal Anti-Inflammatory Drugs in Schizophrenia

Mounting evidence suggests that inflammation is involved in the pathogenesis of schizophrenia. This evidence implies that anti-inflammatory agents are potentially useful therapeutic strategies in schizophrenia. This article quantitatively summarizes the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) to augment antipsychotic treatment to reduce schizophrenia symptom severity. An electronic search was performed using MEDLINE, Embase, the National Institutes of Health Web site clinicaltrials.gov, Cochrane Schizophrenia Group entries in PsiTri, and the Cochrane Database of Systematic Reviews. The following basic search terms were used: schizophrenia, nonsteroidal anti-inflammatory drug, and NSAID together with the name of each specific NSAID (ibuprofen, diclofenac, naproxen sodium, and acetylsalicylic acid). We applied no year or language restrictions. Studies were selected if they met the following inclusion criteria: (1) randomized, double-blind, placebo-controlled trials regarding augmentation of antipsychotic medication with an NSAID, (2) patients included had a diagnosis of a schizophrenia spectrum disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, and (3) studies reported sufficient information to compute common effect size statistics, or corresponding authors could supply these data upon request. The primary outcome measure was the mean change in total score on the Positive and Negative Syndrome Scale (PANSS). Secondary outcome measures included positive and negative symptom subscores of the PANSS. We could include 5 double-blind, randomized, placebo-controlled trials, reporting on 264 patients. Four studies applied celecoxib, and 1 used acetylsalicylic acid. We found a mean effect size of 0.43, which was significant at P = .02 in favor of NSAIDs on total symptom severity. For positive symptom severity, the mean standardized difference was 0.34 (P = .02). For severity of negative symptoms the mean standardized difference was 0.26 (P = .03). These results suggest that NSAID augmentation could be a potentially useful strategy to reduce symptom severity in schizophrenia. As these are the first studies on a relatively new strategy and the included sample size is modest, these results should be interpreted with caution. However, augmentation with acetylsalicylic acid may have the additional benefit of reducing cardiac and cancer mortality in schizophrenia. We therefore believe that application of NSAIDs in schizophrenia deserves further investigation as augmentation of antipsychotic treatment and reducing comorbid somatic diseases.

Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: A randomized controlled study

The combination of tiotropium and fluticasone propionate/salmeterol (FSC) is commonly used to treat chronic obstructive pulmonary disease (COPD), but no study had evaluated the effectiveness of tiotropium plus FSC with 250μg of fluticasone propionate. Our aim was to assess whether tiotropium (18μg once daily) plus FSC (250/50μg twice daily) provides better clinical outcomes compared to tiotropium monotherapy. In this 24-week, randomized, open label, multicenter two-arm parallel study, 479 patients received tiotropium plus FSC (n=237) or tiotropium alone (n=242). After 24 weeks of treatment, the triple-inhaled treatment group had a significant improvement in pre-bronchodilator FEV(1) (L) compared to the tiotropium-only group (0.090L vs. 0.038L; P=0.005). Regarding health-related quality of life, the mean change in total score on the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) was -6.6 points in the tiotropium plus FSC group, but -1.5 points in the tiotropium-only group (P=0.001). In the subgroup of GOLD stage II patients with COPD, treatment with tiotropium plus FSC also improved FEV(1) compared to tiotropium alone (0.088L vs. 0.030L; P=0.011) and improved the total SGRQ-C score than tiotropium alone (-4.5 points vs. -1.0 points, respectively). This triple-inhaled treatment approach did not induce more adverse events, such as pneumonia. Over the course of 24 weeks, FSC (250/50μg twice daily) added to tiotropium provided greater improvement in lung function and quality of life in patients with COPD (FEV(1)≤65%) than tiotropium alone.