Herney Andrés García-Perdomo

Nocebo effect in randomized clinical trials of antidepressants in children and adolescents: systematic review and meta-analysis

Objective: To compare the incidence of adverse events between active and placebo arms of randomized clinical trials in depressive children and adolescents (C&A) with antidepressant treatments, in order to look for similarities in both groups that allow to establish a possible nocebo effect. Methods: Systematic search strategy (January 1974–March 2013) in electronic databases, conference abstracts, and reference list of systematic reviews and included studies to identify parallel randomized placebo-controlled trials of antidepressants in C&A (<19 years) with major depressive disorder, and one or more interventions of any orally administered antidepressant. The pooled adverse events were calculated based on a fixed-effect model and statistical analysis involved the risk ratio (RR) of adverse events, with 95% confidence intervals (95% CI). Results: Sixteen studies were included in the review, of which seven studies with a sample of 1911 patients had data to include in the meta-analysis. There was similar risk for the incidence of adverse events between non-active and active group (global RR 1.04, 95% CI: 0.97–1.11). Conclusion: Depressive C&A allocated to placebo or active group had similar risk to develop adverse events. These similarities in both groups are attributed to the nocebo effect. It is of note that defining “nocebo” effects is challenging in clinical populations because adverse effects may be attributed to the intervention or may be manifestation of the disease itself. The inclusion of a no-treatment arm may be warranted. Nocebo effects are likely when adverse events of placebo mimic the adverse events of active treatment, as was the case here.

A meta-analysis of resuscitative endovascular balloon occlusion of the aorta (REBOA) or open aortic cross-clamping by resuscitative thoracotomy in non-compressible torso hemorrhage patients

BackgroundThe objective of this systematic review and meta-analysis was to determine the effect of REBOA, compared to resuscitative thoracotomy, on mortality and among non-compressible torso hemorrhage trauma patients.MethodsRelevant articles were identified by a literature search in MEDLINE and EMBASE. We included studies involving trauma patients suffering non-compressible torso hemorrhage. Studies were eligible if they evaluated REBOA and compared it to resuscitative thoracotomy. Two investigators independently assessed articles for inclusion and exclusion criteria and selected studies for final analysis. We conducted meta-analysis using random effect models.ResultsWe included three studies in our systematic review. These studies included a total of 1276 patients. An initial analysis found that although lower in REBOA-treated patients, the odds of mortality did not differ between the compared groups (OR 0.42; 95% CI 0.17–1.03). Sensitivity analysis showed that the risk of mortality was significantly lower among patients who underwent REBOA, compared to those who underwent resuscitative thoracotomy (RT) (RR 0.81; 95% CI 0.68–0.97).ConclusionOur meta-analysis, mainly from observational data, suggests a positive effect of REBOA on mortality among non-compressible torso hemorrhage patients. However, these results deserve further investigation.

A meta-analysis of intracranial hemorrhage in patients with brain tumors receiving therapeutic anticoagulation: comment.

Essentials Clinicians may be hesitant to administer anticoagulation in the setting of brain metastases or glioma. In this meta-analysis, we identified nine retrospective cohort studies that met inclusion criteria. Anticoagulation did not increase the risk of intracranial hemorrhage in brain metastasis. In the setting of glioma, anticoagulation resulted in 3.8-fold increase in intracranial hemorrhage. SummaryBackground Venous thromboembolism commonly occurs in patients with brain tumors. Because of the high rate of spontaneous intracranial hemorrhage (ICH), the safety of therapeutic anticoagulation is commonly questioned. Objective We performed a meta-analysis to evaluate whether therapeutic anticoagulation is associated with an increased risk of intracranial hemorrhage in patients with brain tumors. Patients/Methods A systematic literature search strategy was conducted. Summary statistics for ICH were obtained by calculating the odds ratio using a random effects model and heterogeneity across studies was estimated by the I2 statistic. Results A total of nine retrospective cohort studies met the criteria for inclusion. The odds ratio (OR) for ICH in patients receiving therapeutic anticoagulation versus those who did not receive anticoagulation was 2.13 (95% confidence interval [CI], 1.00–4.56; I2 = 46%). In studies evaluating anticoagulation in patients with brain metastases, there was no apparent increased risk of ICH (OR, 1.07; 95% CI, 0.61–1.88; I2 = 0%). However, in patients with glioma there was an increase in risk of ICH associated with the administration of anticoagulation (OR, 3.75; 95% CI, 1.42–9.95; I2 = 33%). Conclusions The risk of ICH in patients with brain tumors receiving therapeutic anticoagulation depends on the diagnosis of primary or metastatic brain tumors. Although anticoagulation was not associated with an increased risk of ICH in the setting of brain metastasis, its use resulted in a greater than 3-fold increased risk of ICH in patients with glioma.

Antibiotic prophylaxis in breast reduction surgery: A systematic review and meta-analysis

OBJECTIVE To determine the effectiveness and harm of using antibiotic prophylaxis versus placebo or no intervention in patients undergoing breast reduction surgery to prevent surgical site infection. MATERIALS AND METHODS A search strategy was conducted in the MEDLINE, CENTRAL, EMBASE, and LILACS databases. Searches were also conducted in other databases and unpublished literature. Clinical trials were included without language restrictions. The risk of bias was evaluated with the Cochrane Collaborations tool. An analysis of fixed effects was conducted. The primary outcome was surgical site infection. The secondary outcomes were delayed wound healing and adverse effects. The measure of the effect was the risk difference (RD) with a 95% confidence interval (CI). The planned interventions were antibiotic prophylaxis versus placebo/no intervention. RESULTS Five articles were included in the qualitative and quantitative analysis. A total of 584 patients were included from the five studies. A low risk of bias was shown for most of the study items. The overall RD for surgical site infection was -0.08 (95% CI -0.14--0.03), favoring antibiotic prophylaxis compared with placebo. CONCLUSION Antibiotic prophylaxis lowers the incidence of surgical site infection in breast reduction surgery compared with placebo or no intervention.

Giant lymphedema of the penis and scrotum: a case report

Lymphedema of the penis and scrotum is a rare entity characterized by enlargement of the skin and subcutaneous tissue of the genital region due to lymphatic drainage impairment. This clinical condition is more frequent in tropical countries due to a higher incidence of filariasis, which, in turn, is the main etiology. We describe the case of a 33-year-old man with large lymphedema of the scrotum and penis due to an acute and chronic inflammatory process, foreign body granuloma, and marked hyalinization. Four consecutive surgical interventions were necessary to remove the great part of the affected tissue, which enabled satisfactory results and improved the patients quality of life.

Effectiveness of Phosphodiesterase 5 Inhibitors in the Treatment of Erectile Dysfunction in Patients with Spinal Cord Trauma: Systematic Review and Meta-Analysis

Objective: To determine the effectiveness of the Phosphodiesterase 5 (PDE5) Inhibitors for the treatment of erectile dysfunction in patients with spinal trauma. Methods: A systematic review and meta-analysis comparing PDE5 inhibitors versus placebo were carried out for clinical trials conducted between 1980 and 2014 that evaluated male patients older than 18 years, diagnosed with spinal cord trauma and erectile dysfunction. We designed a search strategy for Medline, CENTRAL, EMBASE and other electronic sources. Two investigators independently and blindly screened the studies for inclusion. A random effect meta-analysis was performed. Results: Six studies involving 963 patients were included. Male patients over 18 years with ED attributable or subsequent to traumatic spinal cord injury (SCI) were included from these studies. In 4 of these studies, patients were randomized to the treatment group receiving sildenafil and the comparison group was placebo. Out of the remaining 2 trials, one compared tadalafil against the placebo and the other vardenafil versus placebo. The improvement on SCIs with PDE5 inhibitors was found to be large (standardized mean difference 0.71; 95% CI 0.39-1.03), with a high heterogeneity (I2 = 74.4%). Conclusions: PDE5 inhibitors are effective for the treatment of erectile dysfunction secondary to SCI.

Efficacy of phosphodiesterase type 5 inhibitors for the treatment of distal ureteral calculi: A systematic review and meta-analysis

Purpose To determine the efficacy of phosphodiesterase type 5 inhibitors (PDE5i) as medical expulsive therapy (MET) for the treatment of distal ureteral calculi. Materials and Methods A search strategy was conducted in the MEDLINE, CENTRAL, and Embase databases. Searches were also conducted in other databases and unpublished literature. Clinical trials were included without language restrictions. The risk of bias was evaluated with the Cochrane Collaborations tool. An analysis of random effects due to statistical heterogeneity was conducted. The primary outcome was the expulsion rate of the distal ureteral calculus in 28 days. The secondary outcomes were the time to expulsion, side effects of treatment, and amount (mg) of nonopioid analgesia. The measure of the effect was the risk difference (RD) with a 95% confidence interval (CI). The planned interventions were PDE5i vs. placebo, tadalafil vs. placebo, and tadalafil vs. tamsulosin. Results Four articles were included in the qualitative and quantitative analysis. Records of 580 patients were found among the four studies. A low risk of bias was shown for the majority of the study items. The calculi expulsion rate had an RD of 0.26 (95% CI, 0.15–0.37) and a less prolonged expulsion as a secondary outcome with a mean difference of -4.39 days (95% CI, -6.69 to -2.09) in favor of PDE5i compared with the placebo. No significant difference was found for these outcomes when comparing tadalafil with tamsulosin. Conclusions Compared with a placebo, PDE5i could be effective as MET for the treatment of distal ureter calculi.

Mortalidad perioperatoria y factores asociados en pacientes sometidos a nefrectomía radical

OBJECTIVE To determine the incidence and related factors of perioperative mortality associated with radical nephrectomy in patients with renal tumours in a tertiary hospital. MATERIAL AND METHODS We conducted a cross-sectional study that reviewed the medical records of patients undergoing radical nephrectomy between January 1, 2007 and December 31, 2011 in a tertiary university hospital (Cali, Colombia). We measured sociodemographic variables and factors that may be associated with perioperative mortality. The statistical analysis was performed using STATA. RESULTS We analysed 57 patients who underwent radical nephrectomy, 54.4% of whom were male, whose ages ranged from 14 to 81 years. All tumours had a unilateral presentation; 96.5% of the tumours were solid renal lesions, and 3.5% were cystic lesions. The most frequent histological findings were clear cell (63.2%), papillary (8.7%) and chromophobe cell (5.2%) renal carcinoma. There were no complications in 27 (47.3%) of the patients. According to the Clavien-Dindo classification of surgical complications, 16 (28%) patients had minor (grades i and ii) complications and 9 (15.6%) had major (grades iii and iv) complications, with an overall perioperative mortality (grade v) of 8.7% (5 patients). CONCLUSIONS The perioperative mortality at 30 days for patients with nonmetastatic renal carcinoma who underwent radical nephrectomy at a tertiary university hospital in Cali, Colombia, was 4.1% (2 patients).

Pharmacologic interventions to treat renal colic pain in acute stone episodes: Systematic review and meta-analysis

OBJECTIVE To assess effectiveness of pharmacologic interventions to relieve pain in patients suffering an acute stone episode. METHODS Relevant trials that included patients with acute renal colic and radiological findings of urinary stones were identified in four databases. The main outcome was pain relief evaluated by Visual Analogue Scale score (VAS). RESULTS In overall, diclofenac was superior to other NSAIDs for pain relief (MD of -12.57 [95% CI: -19.26, -5.88]). Paracetamol was superior to morphine for pain reduction at 30minutes (MD of -3.92 [95% CI: -6.41, -1.43]) and also to placebo at 15minutes (MD of -24.77 [95% CI: -33.19, -16.35]) and at 30minutes (MD of -16 [95% CI:-29, -2.96]) after drug administration. Finally, diclofenac was superior to paracetamol for pain reduction at 60 (MD of 6.60 [95% CI: 4.37, 8.83]) and 90minutes (MD of 3.4 [95% CI: 2.01, 4.79]). CONCLUSIONS Diclofenac was superior to other NSAIDs and paracetamol for diminishing pain in patients suffering an acute stone episode. Paracetamol was superior to morphine and placebo for short pain relief. Future trials should address the role of paracetamol in the management of pain in patients suffering an acute stone episode.

Systematic review and meta-analysis of the association between psoriasis and metabolic syndrome

Background: Several studies have shown a relationship between psoriasis and metabolic syndrome (MS), but no meta‐analysis has been restricted to studies that adjusted for confounders. Objective: To determine the association between psoriasis and MS. Methods: A systematic review and meta‐analysis of observational studies on psoriasis and MS in adults was performed from MEDLINE, Scopus, SciELO, Google Scholar, Science Direct, and LILACS from inception to January 2016. We performed a random effects model meta‐analysis for those studies reporting adjusted odds ratios (ORs) with 95% confidence intervals (CIs). The subgroup analysis was related to geographic location, diagnosis criteria and risk of bias. Results: In all, 14 papers including a total of 25,042 patients with psoriasis were analyzed. We found that MS was present in 31.4% of patients with psoriasis (OR, 1.42; 95% CI, 1.28‐1.65). Middle Eastern studies (in Israel, Turkey, and Lebanon) (OR, 1.76, 95% CI, 0.86‐2.67) reported a greater risk for MS than European studies (in Germany, Italy, the United Kingdom, Norway, and Denmark) (OR, 1.40; 95% CI, 1.25‐1.55). Limitations: Few adjusted studies existed, and there was inconsistency between publications. Conclusion: Because of the increased risk for MS, clinicians should consider screening patients with psoriasis for metabolic risk factors.