IntroductionThis umbrella review is the frst to systematically examine psychological trauma as a transdiagnostic risk factor across psychiatric conditions.ObjectivesThis review aimed to be the frst ...to evaluate whether psychological trauma fulflilled criteria as a transdiagnostic risk factor cutting across various diagnostic categories and spectra. Transdiagnosticity will be assessed against the framework of the TRANSD criteria (Fusar-Poli, World Psychiatry 2019; 18 361-362). The paper additionally aimed to analyse the association of psychopathology with specifc trauma type.MethodsWe searched Pubmed, Scopus, and PsycNET databases from inception until 01/05/2021 for systematic reviews/meta-analyses evaluating the association between psychological trauma and at least one diagnosed mental disorder. We re-calculated the odds ratio (OR), then classifed the association as convincing, highly suggestive, suggestive, or weak, based on the number of cases and controls with and without psychological trauma, random-efects p value, the 95% conf- dence interval of the largest study, heterogeneity between studies, 95% prediction interval, small-study efect, and excess significance bias. Additional outcomes were the association between specifc trauma types and specific mental disorders, and a sensitivity analysis for childhood trauma. Transdiagnosticity was assessed using TRANSD criteria. The review was pre-registered in Prospero CRD42020157308 and followed PRISMA/MOOSE guidelines.ResultsFourteen reviews met inclusion criteria, comprising 16,277 cases and 77,586 controls. Psychological trauma met TRANSD criteria as a transdiagnostic factor across diferent diagnostic criteria and spectra. There was highly suggestive evidence of an association between psychological trauma at any time-point and any mental disorder (OR=2.92) and between childhood trauma and any mental disorder(OR=2.90). Regarding specifc trauma types, convincing evidence linked physical abuse (OR=2.36) and highly suggestive evidence linked sexual abuse (OR=3.47) with a range of mental disorders, and convincing evidence linked emotional abuse to anxiety disorders (OR=3.05); there were no data for emotional abuse with other disorders.Image:Image 2:ConclusionsThese fndings highlight the importance of preventing early traumatic events and providing trauma-informed care in early intervention and psychiatric services.Disclosure of InterestNone Declared
Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and ...psychological trauma. Therefore, a trauma-focused psychotherapy, such as eye movement desensitization and reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients and if its potential is boosted with the addition of MtCS.
Forty-five patients with FM and a history of traumatic events will be randomly allocated to Waiting List, EMDR + active-MtCS, or EMDR + sham-MtCS. Therapists and patients will be kept blind to MtCS conditions, and raters will be kept blind to both EMDR and MtCS. All patients will be evaluated at baseline, post-treatment, and follow-up at 6 months after post-treatment. Evaluations will assess the following variables: sociodemographic data, pain, psychological trauma, sleep disturbance, anxiety and affective symptoms, and wellbeing.
This study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtCS.
ClinicalTrials.gov NCT04084795 . Registered on 2 August 2019.
Rationale
Clozapine has proven to be superior to other antipsychotic drugs in the treatment of schizophrenia but is under-prescribed due to its potentially severe side effects. Clozapine-induced ...sialorrhea (CIS) is a frequent and extremely uncomfortable side effect, which remains understudied.
Objectives
To examine the prevalence of diurnal and nocturnal CIS in a sample of patients treated with clozapine, and to evaluate its impact on quality of life.
Methods
We conducted a cross-sectional, observational study of 130 patients with schizophrenia spectrum disorders treated with clozapine. The prevalence of CIS was evaluated via specific sialorrhea scales. None of the patients included in the study was receiving a specific treatment for hypersalivation during the study period. Possible associations between sialorrhea and clinical and quality of life variables were analyzed.
Results
Of 130 subjects, 120 (92.3%) suffered from CIS. Eighty-one (62.31%) suffered from diurnal CIS, 115 (88.56%) from nocturnal CIS, and 85 (65.38%) suffered from both. Significant positive associations between quality of life and diurnal CIS (
B
= 0.417;
p
= 2.1e − 6,
R
2
= 0.156) and nocturnal CIS (
B
= 0.411;
p
= 7.7e − 6,
R
2
= 0.139) were detected. Thirty per cent of the subjects reported a moderate to severe negative impact of sialorrhea on their quality of life.
Conclusions
The present study suggests that CIS is highly prevalent in patients with schizophrenia and has an important impact on quality of life in one-third of our sample. Therefore, the inclusion of a systematic evaluation and treatment of CIS in standard clinical practice is highly recommended.
Trial registration
Clinical Trials (
https://clinicaltrials.gov
) under reference NCT04197037.
To quantify the degree of pain experienced by patients who undergo ultrasound-guided transrectal prostate biopsy in standard clinical practice and assess the clinical factors associated with ...increased pain.
Analysis of a multicenter series of patients with prostate biopsy according to standard clinical practice. The biopsy was performed transrectally with a protocol of local anesthesia on the posterolateral nerve bundle. The pain was assessed at 20minutes into the procedure using the visual analog scale (0-10). The degree of pain was analyzed, and the association was studied using a univariate/multivariate analysis of selected clinical variables and the degree of pain.
A total of 1188 patients with a median age of 64 years were analyzed. Thirty percent of the biopsies were diagnosed with a tumor. The median pain score was 2, with 65% of the patients reporting a pain score ≤2. The multivariate analysis showed that the prostate volume (RR, 1.34; 95% CI 1.01-1.77; P=.04), having a previous biopsy (RR, 2.25; 95% CI 1.44-3.52; P<.01), age (RR, .63; 95% CI .47-.85; P<.01) and feel palpation (RR, 1.95; 95% CI 1.28-2.96; P<.01) were factors independently associated with greater pain during the procedure.
Transrectal biopsy with local anesthesia is a relatively painless technique. Factors such as age, a previous biopsy, pain on being touched and prostate volume were associated with the presence of greater pain during the procedure.
Oral Availability of Bilastine Sádaba, B.; Gómez-Guiu, A.; Azanza, J. R. ...
Clinical drug investigation,
05/2013, Letnik:
33, Številka:
5
Journal Article
Recenzirano
Background and Objective
Bilastine (Bilaxten™) is a novel non-sedating H
1
receptor antagonist (antihistamine) developed in the dosage form of oral tablets and indicated for the treatment of allergic ...rhinitis (seasonal and perennial) and urticaria. Several clinical trials have been performed in order to determine the efficacy and safety of bilastine. The aim of this trial was to study the absolute oral bioavailability of bilastine in humans.
Methods
Twelve male and female adults were recruited into a single centre for a randomized, single-dose, open-label, controlled two-arm crossover study with a minimum 14-day washout period between the two single doses. Two single doses of bilastine were administered: a 20-mg oral tablet and a 10-mg intravenous formulation. Blood and urine samples were collected between 0 and 72 h post each administration. The clinical trial was carried out under quality assurance and quality control systems with standard operating procedures to ensure that the study was conducted and data generated in compliance with the protocol, Good Clinical Practice standards, International Conference on Harmonisation and other applicable regulations.
Results
Oral bioavailability of bilastine was 60.67 % with a 90 % parametric confidence interval of 53.79–67.56. The maximum bilastine concentration was measured 1.31 h after oral administration. Pharmacokinetic parameters were similar to those observed in previous studies. Tolerance to treatment was good, with no adverse events related to study medication.
Conclusion
The absorption of bilastine after oral administration to healthy subjects was rapid. The absolute oral bioavailability was moderate.
This umbrella review is the first to systematically examine psychological trauma as a transdiagnostic risk factor across psychiatric conditions. We searched Pubmed, Scopus, and PsycNET databases from ...inception until 01/05/2021 for systematic reviews/meta-analyses evaluating the association between psychological trauma and at least one diagnosed mental disorder. We re-calculated the odds ratio (OR), then classified the association as convincing, highly suggestive, suggestive, or weak, based on the number of cases and controls with and without psychological trauma, random-effects
p
value, the 95% confidence interval of the largest study, heterogeneity between studies, 95% prediction interval, small-study effect, and excess significance bias. Additional outcomes were the association between specific trauma types and specific mental disorders, and a sensitivity analysis for childhood trauma. Transdiagnosticity was assessed using TRANSD criteria. The review was pre-registered in Prospero CRD42020157308 and followed PRISMA/MOOSE guidelines. Fourteen reviews met inclusion criteria, comprising 16,277 cases and 77,586 controls. Psychological trauma met TRANSD criteria as a transdiagnostic factor across different diagnostic criteria and spectra. There was highly suggestive evidence of an association between psychological trauma at any time-point and any mental disorder (OR = 2.92) and between childhood trauma and any mental disorder (OR = 2.90). Regarding specific trauma types, convincing evidence linked physical abuse (OR = 2.36) and highly suggestive evidence linked sexual abuse (OR = 3.47) with a range of mental disorders, and convincing evidence linked emotional abuse to anxiety disorders (OR = 3.05); there were no data for emotional abuse with other disorders. These findings highlight the importance of preventing early traumatic events and providing trauma-informed care in early intervention and psychiatric services.
Post-traumatic stress disorder (PTSD) can occur in both adults and children/adolescents. Untreated PTSD can lead to negative long-term mental health conditions such as depression, anxiety, low ...self-concept, disruptive behaviors, and/or substance use disorders. To prevent these adverse effects, treatment of PTSD is essential, especially in young population due to their greater vulnerability. The principal aim of this meta-analysis was to examine the efficacy of eye movement desensitization and reprocessing (EMDR) therapy for PTSD symptoms in children and adolescents. Secondary objectives were to assess whether EMDR therapy was effective to improve depressive or anxious comorbid symptoms.
We conducted a thorough systematic search of studies published until January 2017, using PubMed, Medline, Scopus, and ScienceDirect as databases. All randomized controlled trials with an EMDR group condition compared to a control group, such as treatment as usual or another psychological treatment, were included. Meta-analysis was conducted with MetaNSUE to avoid biases related to missing information.
Eight studies (
= 295) met our inclusion criteria. EMDR therapy was superior to waitlist/placebo conditions and showed comparable efficacy to cognitive behavior therapy (CBT) in reducing post-traumatic and anxiety symptoms. A similar but non-statistically significant trend was observed for depressive symptoms. Exploratory subgroup analyses showed that effects might be smaller in studies that included more males and in more recent studies.
Despite the small number of publications, the obtained results suggest that EMDR therapy could be a promising psychotherapeutic approach for the treatment of PTSD and comorbid symptoms in young individuals. However, further research with larger samples is needed to confirm these preliminary results as well as to analyze differences in the efficacy of EMDR therapy versus CBT.
PDF
