A double-blind, placebo-controlled treatment trial of citalopram for major depressive disorder in older patients with heart failure: The relevance of the placebo effect and psychological symptoms

Background: Little is known about the treatment of depression in older patients with heart failure. This Study was developed to investigate the effectiveness of antidepressant treatment for major depressive disorder (MDD) in the elderly with heart failure. Methods: We enrolled 72 older outpatients with ejection fraction < 50 and diagnosed with MDD by the structured clinical interview for DSM-IV. Thirty-seven patients, 19 on citalopram and 18 on placebo, initiated an 8-week double-blind treatment phase. Measurements were performed with the 31-item Hamilton Rating Scale for Depression (Ham-D-31), the Montgomery-Asberg rating scale (MADRS) and the Systematic Assessment for Treatment Emergent Effects (SAFTEE). A psychiatrist followed up the patients weekly, performing a consultation for about 20 min to field complaints after the measurements. Results: A trend toward superiority of citalopram over placebo in reducing depression was observed in MADRS scores (15.05 + 9.74 vs 9.44 + 9.25, P = .082) but not on HAM-D scores. The depressive symptomatology significantly decreased in both groups (P < .001). The high rate of placebo response during the double-blind phase (56.3%) led us to conclude the study at the interim analysis with 37 patients. Conclusion: Citalopram treatment of MDD in older patients with heart failure is well-tolerated with low rates of side effects, but was not significantly more effective than placebo in the treatment of depression. Weekly psychiatric follow-up including counseling may contribute to the improvement of depression in this population. Scales weighted on psychological symptoms such as the MADRS are possibly better suited to measure depression severity and improvement in patients with heart failure. (C) 2009 Elsevier Inc. All rights reserved.

Aerobic training abolishes ambulatory blood pressure increase induced by estrogen therapy: A double blind randomized clinical trial

Emerging data reveal that oral estrogen therapy can increase clinic blood pressure (BP) in postmenopausal women; however, it is important to establish its effects on ambulatory BP, which is a better predictor for target-organ damage. Besides estrogen therapy, aerobic training is widely recommended for post-menopausal women, and it can decrease ambulatory BP levels. This study was designed to evaluate the effect of aerobic training and estrogen therapy on the ambulatory BP of post-menopausal women. Forty seven healthy hysterectomized women were randomly divided (in a double-blind manner) into 4 groups: placebo-control (PLA-CO = 12), estrogen therapy-control (ET-CO = 14), placebo-aerobic training (PLA-AT = 12), and estrogen therapy-aerobic training (ET-AT = 09). The ET groups received estradiol valerate (1 mg/day) and the AT groups performed cycle ergometer, 3x/week at moderate intensity. Hormonal status (blood analysis), maximal cardiopulmonary exercise test (VO(2) peak) and ambulatory BP (24-h, daytime and nighttime) was evaluated before and 6 months after interventions. A significant increase in VO(2) peak was observed only in women who participated in aerobic training groups (+4.6 +/- 1.0 ml kg(-1) min(-1), P=0.00). Follicle-stimulating hormone was a significant decreased in the ET groups (-18.65 +/- 5.19 pg/ml, P=0.00), and it was accompanied by an increase in circulating estrogen (56.1 +/- 6.6 pg/ml). A significant increase was observed in the ET groups for daytime (P=0.01) and nighttime systolic BP (P=0.01), as well as nighttime diastolic BP (P = 0.02). However, daytime diastolic BP was increased only in the ET-CO group (+3.4 +/- 1.2 mmHg, P=0.04), and did not change in any other groups. No significant effect was found in ambulatory heart rate. In conclusion, aerobic training abolished the increase of daytime ambulatory BP induced by estrogen therapy in hysterectomized, healthy, normotensive and postmenopausal women. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

Sexuality in teenagers with epilepsy

Objectives: In adults with epilepsy it is well known that the epileptic syndrome, seizure frequency and antiepileptic drug use may influence sexual function and behavior. However, knowledge acquired with adult populations has been extrapolated to teenagers, based on the supposition that these patients are influenced by similar factors. This study aimed to evaluate aspects related to sexuality obtained from female adolescents with epilepsy. Methods: We carried out a prospective study of 35 female adolescents, with epilepsy, with ages from 10 to 20 years, and epileptic syndromes diagnosed according to ILAE criteria (1989). Information on sexual function and behavior of adolescents with epilepsy was evaluated by use of a standard questionnaire. Exclusion criteria were lack of menarche, previous endocrine or chronic clinical disorders, and moderate to severe mental retardation. Results: No differences were observed between the age at first sexual intercourse, sexual activity, libido and orgasm of adolescents with epilepsy when compared to controls. Epilepsy clinical variables Such as age of onset, duration and severity had no significant relationship with distinct aspects of sexual function and behavior. Conclusion: Adolescents with epilepsy represent a special patient group because, even with their chronic disorder, they have an active sexual life, despite the severity of their disorder. Therefore, aspects related to sexuality require special attention by health professionals when attending to adolescents with epilepsy. (C) 2008 Elsevier Inc. All rights reserved.

Management of Common Bile Duct Stones in Cirrhotic Patients with Coagulopathy: A Comparison of Supra-Papillary Puncture and Standard Cannulation Technique

Bleeding is not uncommon following endoscopic sphincterotomy. Supra-papillary puncture (SPP) might be safer than standard cannulation (SC) techniques in patients with coagulopathy. The aim of the study was to compare the safety and effectiveness of SPP and SC. This was a prospective case control intervention study. Decompensated cirrhotic patients with coagulopathy and choledocolithiasis underwent SC and SPP methods for biliary access. One hundred five patients (56 [53.3%] men, mean [SD] age 56 [15.8]) underwent ERCP. SC and SPP were performed in 63 and 42 patients, respectively. Biliary access was achieved in 56/63 (89%) and 40/42 (95%) of patients undergoing SC and SPP, respectively (P = 0.13; 95% CI [-0.16; 0.03]). Complications occurred in 10/63 (15.8%) patients undergoing SC and 5/42 (11.9%) SPP (P = 0.28; 95% CI [-0.17, 0.16]). Five (7.9%) and two (3.2%) episodes of post-sphincterotomy bleeding was seen in the SC and SPP groups, respectively (P = 0.36; 95% CI [-0.16, 0.05]). In contrast, three (4.8%) episodes of pancreatitis were seen in the SC and none in the SPP group (P = 0.05; 95% CI [0.001; 0.004]). A cost-effectiveness analysis demonstrated that SPP is an acceptable alternative at an ICER of US$ 5,974.92 per additional successful procedure. SPP is a safe and effective technique for the management of common bile duct stones in decompensated cirrhotic patients. Conditional to the willingness-to-pay and to the local ERCP-related costs, SPP is also a cost-effective alternative to the SC methods. SPP is associated with a lower rate of complications but larger studies to validate these findings are necessary.

Resolution of sexual dysfunction during acute treatment of major depression with milnacipran

Objective The sexual function and enjoyment questionnaire (SFEQ) was developed to assess and detect changes in sexual function in men and women. The aim of the present study was to use the SFEQ to evaluate the effects of the serotonin-noradrenaline reuptake inhibitor, milnacipran, in the treatment of depression in two culturally different populations. Methods The SFEQ was employed in two studies investigating milnacipran in the treatment of major depression: a 12-week open study in Brazil and a 6-week randomised controlled study in Europe. Results At endpoint, 61.3% (Brazil) and 78.4% (Europe) of patients had >= 50% reduction of baseline Hamilton Depression Rating (HAMD) score. All SFEQ items showed improvements in sexual function in both Studies at endpoint, 60% (Brazil) and 56% (Europe) of patients stating that their Sexual desire was as great as or greater than it had been before their depressive episode. Conclusions Milnacipran appears to improve sexual function in parallel with improvement in other symptoms of depression. The SFEQ is a sensitive instrument for measuring changes in sexual function and appears to be unaffected by Cultural differences as shown by similar findings in Brazil and Europe. Copyright (C) 2008 John Wiley & Sons, Ltd.

A randomized, placebo-controlled trial of the effects of physical exercises and estrogen therapy on health-related quality of life in postmenopausal women

Objective: The purpose of this study was to evaluate the isolated and associated effects of estrogen therapy (estradiol valerate 1 mg/d orally) and physical exercise (moderate aerobic exercise, 3 h/wk) on health-related quality of life (HRQOL) and menopausal symptoms among women who had undergone hysterectomy. Design: A 6-month, randomized, double-blind, placebo-controlled clinical trial with 44 postmenopausal women who had undergone hysterectomy. The interventions were physical exercise and hormone therapy (n = 9), being sedentary and hormone therapy (n = 14), physical exercise and placebo (n = 11), and being sedentary and placebo (n = 10). HRQOL was assessed by a Brazilian standard version of the Medical Outcome Study Short-Forrn Health Survey and symptoms by Kupperman Index at baseline and after 6 months. Results: There was a decrease in symptoms in all groups, but only groups who performed physical exercise showed an increase in quality of life. Analysis of variance showed that changes in physical functioning (P = 0.001) and bodily pain (P = 0.012) scores over the 6-month period differed significantly between women who exercised and women who were sedentary, regardless of hormone therapy. Hormone therapy had no effect, and there was also no significant association between physical exercise and hormone therapy in HRQOL. Conclusions: Physical exercises can reduce menopausal symptoms and enhance HRQOL, independent of whether hormone therapy is taken.

A randomized double-blind placebo-controlled trial to increase feasibility of dobutamine stress echocardiography in patients with hypertension

Objective: To increase dobutamine stress echocardiography feasibility in patients with uncontrolled hypertension, we studied 729 consecutive patients referred for ischemia assessment. Methods: Patients with blood pressure ( BP) levels above 160/ 110 mm Hg were randomized to sublingual placebo or captopril ( 25 mg), and dobutamine stress echocardiography undertaken if BP decreased below 160/ 110 mm Hg after 15 minutes. Results: Of 149 patients ( 20%) with high BP levels, 104 ( 63 +/- 11 years, 51 male) were randomized. Baseline BP levels were similar for captopril ( 178 +/- 15/ 103 +/- 15 mm Hg) and placebo ( 181 +/- 17/ 103 +/- 15 mm Hg) groups. After intervention, 15 patients from captopril and 17 from placebo group had decreased BP ( 11% and 12% for systolic and 13% and 13% for diastolic BP, respectively). Five patients from placebo group ( P =.007) had to prematurely terminate the test because of hypertension ( BP > 220/ 120 mm Hg). Feasibility was similar for captopril and placebo groups ( 35% vs 25%, respectively, P = not significant). Conclusion: Although both captopril and placebo are effective in increasing dobutamine stress echocardiography feasibility in patients with uncontrolled BP, test interruption because of hypertension is less likely to occur after captopril administration.

Celecoxib as an adjunct in the treatment of depressive or mixed episodes of bipolar disorder: a double-blind, randomized, placebo-controlled study

Objective To investigate whether the cox-2 inhibitor celecoxib has antidepressant effects in bipolar disorder (BD) patients during depressive or mixed phases. Methods We studied 28 DSM-IV BD patients who were experiencing a depressive or mixed episode and were on a stable dose of a mood stabilizer or atypical antipsychotic medication. Subjects were randomized to receive 6 weeks of double-blind placebo or celecoxib (400 mg/day) treatment. Current mood stabilizer or antipsychotic medication remained at the same doses during the trial. Results Intention-to-treat analysis showed that the patients receiving celecoxib had lower Hamilton Depression Rating Scale (HamD) scores after 1 week of treatment compared to the patients receiving placebo, but this difference was not statistically significant (p=0.09). The improvement in the first week of treatment was statistically significant when the analysis included only the subjects who completed the full 6-week trial (p=0.03). The two groups did not differ significantly on depressive or manic symptoms from the second week until the end of the trial. Celecoxib was well tolerated with the exception of two subjects who dropped out of the study due to rash. Conclusions Our findings suggest that adjunctive treatment with celecoxib may produce a rapid-onset antidepressant effect in BD patients experiencing depressive or mixed episodes. Copyright (C) 2008 John Wiley & Sons, Ltd.

A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression

Preliminary findings suggest that transcranial direct current stimulation (tDCS) can have antidepressant effects. We sought to test this further in a parallel-group, double-blind clinical trial with 40 patients with major depression, medication-free randomized into three groups of treatment: anodal tDCS of the left dorsolateral prefrontal cortex (active group-`DLPFC`); anodal tDCS of the occipital cortex (active control group-`occipital`) and sham tDCS (placebo control group-`sham`). tDCS was applied for 10 sessions during a 2-wk period. Mood was evaluated by a blinded rater using the Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory (BDI). The treatment was well tolerated with minimal side-effects that were distributed equally across all treatment groups. We found significantly larger reductions in depression scores after DLPFC tDCS [HDRS reduction of 40.4 % (+/-25.8%)] compared to occipital [HDRS reduction of 21.3 % ( +/-12.9%)] and sham tDCS [HDRS reduction of 10.4 % (+/-36.6%)]. The beneficial effects of tDCS in the DLPFC group persisted for 1 month after the end of treatment. Our findings support further investigation on the effects of this novel potential therapeutic approach - tDCS - for the treatment of major depression.

Small Bowel Endoscopy Using the Double-Balloon Technique: Four-Year Results in a Tertiary Referral Hospital in Brazil

Background: Double-balloon enteroscopy (DBE) allows evaluation and therapy for various small bowel diseases. In this series the outcome of a 4-year experience in a tertiary hospital school in Brazil is reported. Methods: A total of 457 consecutive DBE were performed in 418 patients from August 2004 to August 2008. 93 patients with several indications, whose aim was not the evaluation of suspected diseases of the small bowel mucosa, were excluded, therefore leaving 364 DBE in 325 patients for analysis. Data were retrospectively collected with regard to clinical, endoscopic findings, therapy and complications. Results: Among the 364 DBE performed in 325 patients, 143/325 were males (44%) and 182/325 females (56%) with a mean age of 48.6 +/- 15.7 years (range 17-89). Mean investigation time was 64 +/- 22 min (range 35-135). The depth of insertion beyond the ligament of Treitz was 230 +/- 85 cm (range 30-500) by the antegrade approach and 140 +/- 75 cm (range 0-320) by the retrograde approach. Total enteroscopy was achieved in 41.66% of the attempts (30 of 72 patients). Overall diagnostic yield was 54.95% (200 of 364 procedures) ranging from 0 to 100% in this series, depending on the indication. Angiodysplasia was the main diagnosis in 24.5% (49 of 200 procedures) and endoscopic treatment, including biopsies, hemostasis, tattooing and polypectomy were performed in 65.38% (238 of 364 procedures). No major complications were reported. Conclusions: DBE is a feasible, safe and well-tolerated procedure allowing endoscopic therapy. Selection of indications increases its diagnostic yield. Copyright (C) 2009 S. Karger AG, Basel

ERCP Using Double-Balloon Enteroscopy in Patients with Roux-en-Y Anatomy

Double-balloon enteroscopy (DBE) is a useful method for endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y anatomy. Depending on the distorted anatomy, endoscopic therapies with conventional scopes were very difficult or impossible before the advent of DBE and patients had to be submitted to a percutaneous or surgical approach. The case of 6 patients with different types of Roux-en-Y-altered anatomy in which DBE-ERCP was performed with 83.3% successful rate (5/6) is reported confirming recent data in the literature on the feasibility of this method. Copyright (C) 2009 S. Karger AG, Basel

Secondary Lymphangiectasia of the Small Bowel: Utility of Double Balloon Enteroscopy for Diagnosis and Management

Sporadic lymphangiectasias are commonly found throughout the small bowel and are considered to be normal. Not uncommonly, lymphangiectasias are pathologic and can lead to mid-gastrointestinal bleeding, abdominal pain and protein-losing enteropathy. Pathologic lymphangiectasias of the small bowel include primary lymphangiectasia, secondary lymphangiectasia and lymphaticovenous malformations. In this report we present three different cases of small bowel lymphangiectasia detected by double balloon enteroscopy. The patients were diagnosed with South American blastomycosis, tuberculosis and primary small bowel lymphangioma. Copyright (C) 2009 S. Karger AG, Basel

High and Low Frequency TENS Reduce Postoperative Pain Intensity After Laparoscopic Tubal Ligation A Randomized Controlled Trial

Background: Transcutaneous electrical nerve stimulation (TENS) is an effective adjunctive therapy for postoperative pain; however, effects of different frequencies Of stimulation have not been systematically investigated. Laparoscopic sterilization (LS) causes significant pain in the early postoperative period and requires substantial postoperative medication. Therefore, we studied the effects of TENS on postoperative pain after LS through placement of Yoon fallopian rings in a prospective, randomized, double-blinded, and placebo-controlled study. Methods: Sixty-four patients undergoing LS for uterine tube ligation were randomly allocated to receive either active TENS or placebo TENS. Postoperative pain was evaluated using a standard I I-point numeric rating scale and the McGill Pain Questionnaire (MPQ)-pain rating index and number of words chosen. Both high frequency (100 Hz) and low frequency (4 Hz) TENS, at strong, but comfortable sensory intensity, were applied for 20 minutes through 4 electrodes placed around the surgical incision immediately after Surgery. Pain was assessed before and after application of TENS when patients were at postanesthesia care unit (PACU). Results: Both high and low frequency TENS significantly decreased postoperative pain intensity when compared with before administration of TENS using the numeric rating scale (P = 0.001), pain rating index (P = 0.001), and number of words chosen (P 0.001) compared with placebo TENS (P = 0.001). TENS in combination with standard pharmacologic analgesic treatment was efficacious for postoperative pain relief after LS. Conclusions: We recommend regular use of multimodal therapy with TENS and analgesic drugs after LS with placement of Yoon rings.

DOUBLE ANEUPLOIDY (48,XXY,+21) OF MATERNAL ORIGIN IN A CHILD BORN TO A 13-YEAR-OLD MOTHER: EVALUATION OF THE MATERNAL FOLATE METABOLISM

Double aneuploidy, (48,XXY,+21) of maternal origin in a child born to a 13-year-old mother: evoluation of the maternal folate metabolism: The occurrence of non-mosaic double trisomy is exceptional in newborns. In this paper, a 48,XXY,+21 child, the parental origin of the extra chromosomes and the evaluation of the maternal folate metabolism are presented. The infant was born to a 13-year-old mother and presented with the typical clinical features of Down syndrome (DS). The origin of the additional chromosomes was maternal and most likely resulted from errors during the first meiotic division. Molecular analysis of 12 genetic polymorphisms involved in the folate metabolism revealed that the mother is heterozygous for the MTHFR C677T and TC2 A67G polymorphisms, and homozygous for the mutant MTRR A66G polymorphism. The maternal homocysteine concentration was 4.7 mu mol/L, a value close to the one considered as a risk factor for DS in our previous study. Plasma methylmalonic acid and serum folate concentrations were 0.17 mu mol/L and 18.4 ng/mL, respectively. It is possible that the presence of allelic variants for the folate metabolism and Hey concentration might have favored errors in chromosomal disjunction (hiring gametogenesis in this young mother. To our knowledge, this is the first patient with non-mosaic Down-Klinefelter born to a teenage mother, resulting from a rare fertilization event combining an abnormal 25,XX,+21 oocyte and a 23,Y spermatozoon.

Inflammatory and functional effects of increasing asthma treatment with formoterol or double dose budesonide

Adding a long-acting beta(2)-agonist to inhaled corticosteroids (ICS) for asthma treatment is better than increasing ICS dose in improving clinical status, although there is no consensus about the impact of this regimen on inflammation. In this double-blind, randomized, parallel group study, asthmatics with moderate to severe disease used budesonide (400 mcg/day) for 5 weeks (run-in period); then they were randomized to use budesonide (800 mcg/day - BUD group) or budesonide plus formoterol (400 mcg and 24 mcg/day, respectively - FORMO group) for 9 weeks (treatment period). Home PEF measurements, symptom daily reporting, spirometry, sputum induction (for differential cell counts and sputum cell cultures), and hypertonic saline bronchial challenge test were performed before and after treatments. TNF-alpha, IL-4 and eotaxin-2 levels in the sputum and cell culture supernatants were determined. Morning and night PEF values increased in the FORMO group during the treatment period (p < 0.01), from 435 +/- 162 to 489 +/- 169 and 428 +/- 160 to 496 +/- 173 L/min, respectively. The rate of exacerbations in the FORMO group was lower than in the BUD group (p < 0.05). Neutrophil counts in sputum increased in both groups (p < 0.05) and leukocyte viability after 48 h-culture increased in the FORMO group (p < 0.05). No other parameter changed significantly in either group. This study showed that adding formoterol to budesonide improved home PEF and provided protection from exacerbations, although increase of leukocyte viability in cell culture may be a matter of concern and needs further investigation. (C) 2008 Elsevier Ltd. All rights reserved.