Does EMDR Therapy Have an Effect on Memories of Emotional Abuse, Neglect and Other Types of Adverse Events in Patients with a Personality Disorder? Preliminary Data

Background: Little is known about the effectiveness of trauma-focused therapies for memories of events not meeting the A-criterion of post-traumatic stress disorder (PTSD). Objective: Determining the effect of EMDR therapy on memories of emotional abuse, neglect and other types of adverse events in patients with a personality disorder (PD). Method: We conducted a secondary analysis of the data from our study, which aimed to determine the effectiveness of five sessions of EMDR therapy in 49 patients with a PD. Patients were divided into three different groups depending on their most prevalent type of adverse event. Data were analyzed with Generalized Estimating Equations. Results: Of all patients, 49% reported emotional neglect, 22.4% emotional abuse and 26.5% other types. Only one patient reported memories that predominantly fulfilled the A-criterion of PTSD. After five sessions of EMDR therapy, medium to large treatment effects for memories related to neglect (ds between 0.52 and 0.79), medium treatment effects for memories involving emotional abuse (ds between 0.18 and 0.59) and other types of adverse events were found (ds between 0.18 and 0.53). No significant differences in symptom reduction associated with the application of EMDR therapy among memories involving these three different types of adverse events could be revealed. Conclusions: The results support the notion that EMDR therapy is not only an effective therapy for memories related to A-criteria-worthy events, but that it also has a symptom-reducing effect on memories involving other types of adverse events. This suggests that EMDR might be a valuable addition to the treatment of PD without PTSD.

Pharmacovigilance Safety Monitoring in Clinical Trials

Pharmacovigilance is that the science and activities associated with the gathering, detection and assessment of adverse event data. Major purpose of pharmacovigilance is to gauge the benefit- risk profile of drug for better efficacy and safety to be used in patients. Pharmacovigilance plays a major role in rationale use of drug which provides the information about the adverse drug reactions which seen in patients. In terms of volume Indian Pharma industry is third largest in world and in terms of value id thirteen largest in world. India is also known as a hub for clinical research and drug development. There is a requirement of a global and standardized pharmacovigilance system in India for better safety assessment in India. In drug development process the only priority of clinical trials is to make sure patient safety during and after the trials. A critical component throughout the drug development life-cycle is monitoring patient safety. Patient must be treated consistent with the requirements and illness of patient therefore the utmost value is given to monitoring of patient safety in the least levels of drug development. Such monitoring may be a dynamic process so to approach safety monitoring. To ensure a systematic approach to safety monitoring pharmaceutical sponsor must work proactively and collaboratively with all stakeholders. We have to focus upon all the aspects of drug safety in clinical trials including basics of drug safety, regulatory aspects of drug safety, patient suitability for safety in trials, post marketing safety and causality risk assessment of the drug products.

Bronchoscopic Targeted Lung Denervation in Patients with Severe Asthma: Preliminary Findings

Treatment options for severe asthma are limited, particularly in those patients who do not meet criteria for biologicals. Targeted lung denervation (TLD) is the bronchoscopic ablation of the peribronchial vagal nerve trunks to reduce cholinergic stimulation of airway smooth muscle and submucosal glands. This report describes the experience of the first 2 asthma patients treated with TLD worldwide. The participants were 54 and 51 years of age, and both had severe asthma (GINA 5) (FEV₁: 53% and 113% of predicted; AQLQ scores: 5.3 and 4.4). Both participants were treated with TLD in a single day-case procedure under general anaesthesia. Lung function, health status, and adverse event data were collected at baseline and 12 months after TLD. No treatment-related serious adverse events were reported up to 12 months. Cough symptoms improved in both participants, and 1 participant reported a marked reduction in rescue medication use at 6 months. There were no significant changes in spirometry, lung volumes, or health status. In conclusion, TLD was performed safely in both participants, but more evidence is needed to clarify safety and efficacy of TLD in severe asthma. Therefore, further investigation of the treatment in severe asthma patients would be useful.

The evolving role of PARP inhibitors in advanced ovarian cancer

The field of ovarian cancer has been revolutionized with the use of poly (ADP-ribose) polymerase (PARP) inhibitors, which present greater inhibition effect in epithelial subtype due to high rates of homologous recombination deficiency. PARP inhibition exploits this cancer pitfall by disrupting DNA repair, leading to genomic instability and apoptosis. Three PARP inhibitors (olaparib, niraparib, and rucaparib) are now approved for use in women with epithelial ovarian cancer, while others are under development. Among women with BRCA1/2 mutations, maintenance PARP therapy has led to a nearly fourfold prolongation of PFS, while those without BRCA1/2 mutations experience an approximately twofold increase in PFS. Differences in trial design, patient selection and primary analysis population affect the conclusions on PARP inhibitors. Limited OS data have been published and there is also limited experience regarding long-term safety. With regard to toxicity profile, there are no differences in serious adverse events between the experimental and control groups. However, combining adverse event data from maintenance phases, a trend towards more events in the experimental group, compared with controls, has been shown. The mechanisms of PARP-inhibitor resistance include restoration of HR through reversion mutations in HR genes, leading to resumed HR function. Other mechanisms that sustain sufficient DNA repair are discussed as well. PARP inhibitors play a pivotal role in the management of ovarian cancer, affecting the future treatment choices. Defining exactly which patients will benefit from them is a challenge and the need for HRD testing to define ‘BRCA-ness’ will add additional costs to treatment.

One-Week High-Dose β-Alanine Loading Improves World Tour Cyclists’ Time-Trial Performance

Supplementation with β-alanine is becoming a common practice in high-performance athletes. The purpose of the present study was to investigate the effects of a one-week high-dose β-alanine loading phase employing a sustained-release powder on preserving the time-trial performance capacity of world tour cyclists during overreaching training. Per day, 20 g of sustained-release β-alanine was administered during one week (7 days) of intensive team training camp in a randomised balanced placebo-controlled parallel trial design, with six participants in each β-alanine (BA) or placebo (PLA) group. A 10-min time trial (10′ TT) was carried out to analyse performance and biochemical variables. Anthropometry, paresthesia, and adverse event data were also collected. Power-based relative training load was quantified. Compared to placebo, the BA improved mean power (6.21%, 37.23 W; 95% CI: 3.98–70.48 W, p = 0.046), distance travelled (2.16%, p = 0.046) and total work (4.85%, p = 0.046) without differences in cadence (p = 0.506) or RPE. Lactate (p = 0.036) and anion gap (p = 0.047) were also higher in the BA group, without differences in pH or Bicarbonate. High daily and single doses were well tolerated. One-week high-dose β-alanine loading with a sustained-release powder blend can help attenuate 10′ TT performance losses of world tour cyclists due to intensive training.

Adverse Event Data for Years 2018 to 2020 for Diabetes Devices

Unlike performance evaluations, which are often conducted under ideal conditions, adverse events occur during actual device use for people with diabetes. This report summarizes the number of adverse events for the years 2018 to 2020 for the 3 diabetes devices: blood glucose meters (BG), continuous glucose monitors (CGM), and insulin pumps. A text example of a CGM injury is provided. Possible reasons are suggested for trends. Whereas the rate per test result (events/usage) is exceedingly small, the rate per patient (events/people with diabetes that use insulin) is of concern. Hence, it is important to determine event causes and provide corrective actions. The first step is to put in place routine analysis of adverse event data for diabetes devices.