Treatment Options and Continuity of Care in Metabolic-associated Fatty Liver Disease: A Multidisciplinary Approach.

The terms non-alcoholic fatty liver disease and non-alcoholic steatohepatitis have some limitations as they use exclusionary confounder terms and the use of potentially stigmatising language. Recently, a study with content experts and patients has been set to change this nomenclature. The term chosen to replace non-alcoholic fatty liver disease was metabolic dysfunction-associated steatotic liver disease (MASLD), which avoids stigmatising and helps improve awareness and patient identification. MASLD is the most common cause of chronic liver disease with an increasing prevalence, accounting for 25% of the global population. It is considered the hepatic manifestation of the metabolic syndrome with lifestyle playing a fundamental role in its physiopathology. Diet change and physical activity are the cornerstones of treatment, encompassing weight loss and healthier behaviours and a holistic approach. In Europe, there is no approved drug for MASLD to date and there is a substantial unmet medical need for effective treatments for patients with MASLD. This review not only provides an update on advances in evidence for nutrition and physical activity interventions but also explores the different therapeutic options that are being investigated and whose development focuses on the restitution of metabolic derangements and halting inflammatory and fibrogenic pathways.

Sustained increase of pinch strength after traction treatment for symptomatic distal interphalangeal joint osteoarthritis.

Background: Symptomatic distal interphalangeal joint osteoarthritis is a common joint disease that causes hand disability and reduces quality of life. There are few conservative treatment options for this condition. The purpose of this study was to investigate the effect of traction treatment on symptomatic distal interphalangeal joint osteoarthritis. Methods: This prospective, longitudinal study involved multiple time-series observations and within-subject controls. The most painful distal interphalangeal joints in patients with hand osteoarthritis were treated by daily, 15-min joint traction at home using a finger trap orthosis. The corresponding contralateral digits were used as within-subject controls. The primary outcome measure was two-point pinch strength, and the secondary outcome measures were radiographic findings and treatment adherence. Longitudinal and pairwise comparison analyses of the treated and control digits examined improvements in two-point pinch strength at months 1, 3, and 6 from baseline. The durability of treatment effects after treatment discontinuation was investigated at month 12. Results: Eighteen treated digits and 18 corresponding control digits were eligible for analysis. There was a significant increase in two-point pinch strength after 1-month traction, and this increase was maintained until month 6 despite the absence of radiographic changes. Compared to controls, significant improvement in two-point pinch strength relative to baseline was seen at every observation time point, with a moderate to large effect size. There was no time-treatment interaction. Treatment adherence was high. At months 3 and 6, around 60-80 % of digits were voluntarily treated. Pinch strength was comparable between months 6 and 12, with greater improvement than in the control group. Conclusion: Joint traction treatment can improve pinch strength in symptomatic distal interphalangeal joint osteoarthritis. Larger, randomized studies on traction treatment and the effect on hand function are warranted.

Cultivating Comfort: Examining Participant Satisfaction with Hypnotic Communication Training in Pain Management.

Context: One in four Canadians experiences chronic pain, yet insufficient services and restrictions surrounding prevailing treatments result in inadequate management and significant negative consequences for these individuals. Previous work indicates that hypnotic communication represents a promising complementary treatment; however, training protocols for healthcare professionals are underdeveloped and understudied. Aim: To evaluate the level of satisfaction for a training program on hypnotic communication in pain management clinics. Design: Qualitative study. Methods: Six health professionals who first completed the hypnotic communication training participated in 30 minutes virtual semi-structured interviews. These testimonials allowed them to elaborate on their user experience and potential areas for improvement. Thematic analysis using qualitative data management software NVIVO was conducted on the interview data. Results: Two themes emerged from the interviews. 1) Satisfaction: Participants expressed satisfaction on various structural aspects of the training, including the provided materials, atmosphere, training structure, presentation modalities, practical workshops, acquired knowledge, trainer quality, and training duration. 2) Areas for Improvement: Five main improvement suggestions were identified (providing more material; more practical workshops, more concrete and adapted; testimonials from former patients; follow-up training meeting; and continuing education). Implications for the Profession and/or Patient Care and Conclusion: The results improved the training program to help minimized inherent biases related to this technique, cut associated costs, and identify reasons that would explain its underutilization among medical professionals in Quebec. Our work highlights that healthcare professionals in chronic pain management clinics (eg, respiratory therapists, nurses) can incorporate this simple hypnotic communication technique into their usual care and contribute to the well-being of patients. Impact: This study aimed to address the lack of training protocols for healthcare professionals, that are underdeveloped and understudied. The main findings on participant' satisfaction and the areas of improvement for the training will help the refinement of the training to better suit healthcare professional's needs in hospitals and chronic pain facilities.

Reduced Pharmacological Intervention of Prehospital Services for Acute Alcohol Intoxication during the COVID-19 Pandemic in A Large District of Southern Italy.

Background Stress during a pandemic increases the risk of alcohol consumption, which may require pharmacological management. Methods An observational single-center retrospective study was conducted from 1 January 2018 to 31 December 2021, and divided into 2-year periods (2018-2019 and 2020-2021). This study focused on calls to one of the emergency departments (EDs) of seven hospitals in the Bari (Italy) metropolitan area for patients requiring emergency services (ESs) who were either admitted or not admitted, due to their refusal. Results A 30% reduction in emergency calls for alcohol-related issues and a 41.17% reduction in calls for patients who refused to be admitted to the ED were observed during the pandemic. During the pandemic, an inverse association was found between pharmacological treatment and number of calls coded green (non-critical) and yellow (fairly critical) in patients admitted to EDs. An inverse association was also found for calls coded green in patients not admitted to EDs and pharmacological treatment. Metadoxine was administered in almost all alcohol-related emergencies, primarily in conjunction with drugs acting on the gastrointestinal tract, irrespective of age, the period considered, and whether patients were admitted or not admitted to the ED. Conclusions ES is the first and only out-of-hospital service encountered by numerous patients with alcohol-use disorders who refuse to be admitted to the ED. These patients should be directed by ES personnel to a multidisciplinary program to receive treatment for drinking, improve their quality of life, and reduce sanitation costs.

An Updated Review on Diabetic Nephropathy: Potential Mechanisms, Biomarkers, Therapeutic Targets and Interventional Therapies.

BACKGROUND: Diabetic nephropathy (DN), the primary risk factor for end-stage kidney disease (ESKD) that requires dialysis or renal transplantation, affects up to 50% of individuals with diabetes. OBJECTIVE: In this article, potential mechanisms, biomarkers, and possible therapeutic targets will be discussed, as well as their interventional therapies. METHODS: A literature review was done from databases like Google Scholar, PUBMEDMEDLINE, and Scopus using standard keywords "Diabetic Nephropathy," "Biomarkers," "Pathophysiology," "Cellular Mechanism," "Cell Therapy," "Treatment Therapies" from 2010- 2023. It has been studied that metabolic as well as hemodynamic pathways resulting from hyperglycemia act as mediators for renal disease. RESULTS: We identified 270 articles, of which 210 were reviewed in full-text and 90 met the inclusion criteria. Every therapy regimen for the prevention and treatment of DN must include the blocking of ANG-II action. By reducing inflammatory and fibrotic markers brought on by hyperglycemia, an innovative approach to halting the progression of diabetic mellitus (DN) involves combining sodium-glucose cotransporter-2 inhibitors with renin-angiotensin-aldosterone system blockers. When compared to taking either medicine alone, this method works better. AGEs, protein kinase C (PKC), and the renin-angiotensin aldosterone system (RAAS) are among the components that are inhibited in DN management strategies. CONCLUSION: Thus, it can be concluded that the multifactorial condition of DN needs to be treated at an early stage. Novel therapies with a combination of cell therapies and diet management are proven to be effective in the management of DN.

Pharmacotherapeutic advances in fibromyalgia: what's new on the horizon?

INTRODUCTION: This review delves into Fibromyalgia Syndrome (FMS), a chronic pain condition demanding thorough understanding for precise diagnosis and treatment. Yet, a definitive pharmacological solution for FMS remains elusive. AREAS COVERED: In this article, we systematically analyze various pharmacotherapeutic prospects for FMS treatment, organized into sections based on the stage of drug development and approval. We begin with an overview of FDA-approved drugs, discussing their efficacy in FMS treatment. Next, we delve into other medications currently used for FMS but still undergoing further study, including opioids and muscle relaxants. Further, we evaluate the evidence behind medications that are currently under study, such as cannabinoids and naltrexone. Lastly, we explore new drugs that are in phase II trials. Our research involved a thorough search on PUBMED, Google Scholar, and clinicaltrials.gov. We also discuss the action mechanisms of these drugs and their potential use in specific patient groups. EXPERT OPINION: A focus on symptom-driven, combination therapy is crucial in managing FMS. There is also a need for ongoing research into drugs that target neuroinflammation, immunomodulation, and the endocannabinoid system. Bridging the gap between benchside research and clinical application is challenging, but it holds potential for more targeted and effective treatment strategies.

Efficacy and tolerability of chitin-glucan combined with simethicone (GASTRAP® DIRECT) in irritable bowel syndrome: A prospective, open-label, multicenter study.

BACKGROUND: Irritable bowel syndrome (IBS), defined according to the Rome IV diagnostic criteria, is a chronic functional gastrointestinal disorder characterized by recurrent abdominal pain related to altered bowel habits. First-line recommended treatments are limited to combining drugs targeting predominant symptoms, particularly pain (antispasmodics), constipation (laxatives), and diarrhea (loperamide), yielding only a limited therapeutic gain. GASTRAP® DIRECT is a class IIa medical formulation composed of a combination of chitin-glucan and simethicone indicated for the symptomatic treatment of gas-related gastrointestinal disorders by combining different mechanisms of action. AIM: To evaluate the efficacy, tolerability, and safety of 4-week GASTRAP® DIRECT treatment in patients with IBS. METHODS: In this prospective, multicenter, open-label trial, 120 patients with IBS received three sticks of GASTRAP® DIRECT (1.5 g/d of chitin-glucan and 0.75 mg/d of simethicone) per day for 4 weeks. The primary endpoint was the responder rate, defined as the number of patients whose abdominal pain score decreased by ≥ 30% from baseline to week (W) 4. The analysis was performed using the per-protocol set. Cardinal symptoms, impact of global symptoms on daily life, change in stool consistency, and improvement in defecatory disorders were evaluated. RESULTS: Overall, 100 patients were evaluated. At W4, 67% (95%CI: 57-75) showed improvement in abdominal pain (score: 5.8 ± 2.4 vs 2.9 ± 2.0, P < 0.0001). Similar improvements were observed for bloating [8.0 ± 1.7 vs 4.7 ± 2.9, P < 0.0001; 60% (95%CI: 50-70) responders], abdominal distension [7.2 ± 2.1 vs 4.4 ± 3.1, P < 0.0001; 53% (95%CI: 43-63) responders], and impact of global symptoms on daily life [7.1 ± 2.0 vs 4.6 ± 2.9, P < 0.0001; 54% (95%CI: 44-64) responders]. Stool consistency improved in most patients (90% and 57% for patients with liquid and hard stools, respectively). Overall, 42% of patients with defecatory disorders reported very much/considerable improvements by W2. No severe adverse event occurred, and tolerability was rated "good" or "very good" by 93% of patients. CONCLUSION: GASTRAP® DIRECT is safe and well tolerated, alleviating IBS symptoms rapidly in 2 weeks. This open-label study suggests that the combination of chitin-glucan and simethicone could be beneficial in patients with IBS.

Recent treatment and novel imaging studies evaluating treatment of internet gaming disorder: a narrative review.

Internet Gaming Disorder (IGD) is an emerging public health concern; effective treatments are still under development. This mini-review focuses on summarizing the main scientific evidence from psychological, pharmacological, brain imaging, and emerging treatment approaches for IGD. We searched PubMed and Scopus databases using keywords related to IGD and treatment. Cognitive behavioral therapy (CBT) is the most extensively researched psychological treatment for IGD, supported by several randomized controlled trials (RCTs). Other promising approaches include mindfulness, relapse prevention, abstinence protocols, and family therapy. Pharmacological treatments like bupropion and escitalopram have shown benefits, especially when IGD is comorbid with conditions like major depressive disorder. However, the quality of evidence is moderate for psychological interventions but low to moderate for pharmacological approaches. Emerging treatments such as transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), and electro-acupuncture have demonstrated efficacy in reducing IGD symptoms and modulating brain activity. Brain imaging techniques like functional magnetic resonance imaging (fMRI) have provided insights into the neural mechanisms underlying IGD and treatment effects, although these studies lack randomized controlled designs. While multimodal approaches show promise, larger, well-designed RCTs are needed to establish effective IGD treatments.

New Pharmacological Therapies in the Treatment of Epilepsy in the Pediatric Population.

Epilepsy is a disorder characterized by abnormal brain neuron activity, predisposing individuals to seizures. The International League Against Epilepsy (ILAE) categorizes epilepsy into the following groups: focal, generalized, generalized and focal, and unknown. Infants are the most vulnerable pediatric group to the condition, with the cause of epilepsy development being attributed to congenital brain developmental defects, white matter damage, intraventricular hemorrhage, perinatal hypoxic-ischemic injury, perinatal stroke, or genetic factors such as mutations in the Sodium Channel Protein Type 1 Subunit Alpha (SCN1A) gene. Due to the risks associated with this condition, we have investigated how the latest pharmacological treatments for epilepsy in children impact the reduction or complete elimination of seizures. We reviewed literature from 2018 to 2024, focusing on the age group from 1 month to 18 years old, with some studies including this age group as well as older individuals. The significance of this review is to present and compile research findings on the latest antiseizure drugs (ASDs), their effectiveness, dosing, and adverse effects in the pediatric population, which can contribute to selecting the best drug for a particular patient. The medications described in this review have shown significant efficacy and safety in the studied patient group, outweighing the observed adverse effects. The main aim of this review is to provide a comprehensive summary of the current state of knowledge regarding the newest pharmacotherapy for childhood epilepsy.

Efficacy and Safety of Pharmacological Treatment in Patients with Complex Regional Pain Syndrome: A Systematic Review and Meta-Analysis.

Complex regional pain syndrome (CRPS) is a disabling condition that usually affects the extremities after trauma or surgery. At present, there is no FDA-approved pharmacological treatment for patients with CRPS. We performed this systematic review and meta-analysis to evaluate the efficacy and safety of pharmacological therapies and determine the best strategy for CRPS. We searched the databases, including PubMed, Embase, Cochrane, Web of Science, Scopus, and ClinicalTrials.gov, for published eligible randomized controlled trials (RCTs) comparing pharmacological treatment with placebo in CRPS patients. Target patients were diagnosed with CRPS according to Budapest Criteria in 2012 or the 1994 consensus-based IASP CRPS criteria. Finally, 23 RCTs comprising 1029 patients were included. We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to rate certainty (confidence in evidence and quality of evidence). Direct meta-analysis showed that using bisphosphonates (BPs) (mean difference [MD] -2.21, 95% CI -4.36--0.06, p = 0.04, moderate certainty) or ketamine (mean difference [MD] -0.78, 95% CI -1.51--0.05, p = 0.04, low certainty) could provide long-term (beyond one month) pain relief. However, there was no statistically significant difference in the efficacy of short-term pain relief. Ketamine (rank p = 0.55) and BPs (rank p = 0.61) appeared to be the best strategies for CRPS pain relief. Additionally, BPs (risk ratio [RR] = 1.86, 95% CI 1.34-2.57, p < 0.01, moderate certainty) and ketamine (risk ratio [RR] = 3.45, 95% CI 1.79-6.65, p < 0.01, moderate certainty) caused more adverse events, which were mild, and no special intervention was required. In summary, among pharmacological interventions, ketamine and bisphosphonate injection seemed to be the best treatment for CRPS without severe adverse events.

Literature review of non-pharmacological treatment for patients with axial spondyloarthritis.

Axial spondyloarthritis (axSpA) is a chronic inflammatory disorder affecting the sacroiliac joints and axial spine. Along with pharmacotherapy, non-pharmacological interventions for axSpA are crucial and constitute the cornerstone of treatment. Here, we review the evidence for non-pharmacological treatment of axSpA as a basis for the 2023 Korean treatment recommendations for patients with axSpA. The effectiveness of the core non-pharmacological approaches, such as education, smoking cessation, and exercise, has been reaffirmed. High-quality research on surgical treatment is limited. However, total hip replacement is advised in patients with ongoing pain or disability and visible structural damage to the hip on imaging. Urgent spinal intervention should be considered in cases of acute spinal pain with neurological deficiency or concurrent unstable fractures. Evidence for complementary therapies, including spas and acupuncture, remains insufficient.

Female obesity: clinical and psychological assessment toward the best treatment.

Obesity is a heterogeneous condition which results from complex interactions among sex/gender, sociocultural, environmental, and biological factors. Obesity is more prevalent in women in most developed countries, and several clinical and psychological obesity complications show sex-specific patterns. Females differ regarding fat distribution, with males tending to store more visceral fat, which is highly correlated to increased cardiovascular risk. Although women are more likely to be diagnosed with obesity and appear more motivated to lose weight, as confirmed by their greater representation in clinical trials, males show better outcomes in terms of body weight and intra-abdominal fat loss and improvements in the metabolic risk profile. However, only a few relatively recent studies have investigated gender differences in obesity, and sex/gender is rarely considered in the assessment and management of the disease. This review summarizes the evidence of gender differences in obesity prevalence, contributing factors, clinical complications, and psychological challenges. In addition, we explored gender differences in response to obesity treatments in the specific context of new anti-obesity drugs.

An overview of the differences in the pharmacological management of post-traumatic stress disorder between women and men.

INTRODUCTION: Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition with a worldwide prevalence between 6% and 9%, and more common in the female than in the male sex. The aim of this paper is to review and comment on the different factors that might explain the discrepancies in the pharmacological management of women and men. AREAS COVERED: The available literature shows that there exists a vulnerability of women to develop PTSD that may depend on neurobiological as well as environmental/cultural factors. These variables might influence the clinical picture, the outcome and the response to specific treatments, given their consequences on the pharmacokinetics of commonly prescribed drugs. Women suffering from PTSD are more prone to consult and receive more prescriptions of psychotropic drugs than men. However, it is evident that the particular stages of a women's life such as pregnancy or breastfeeding might require a specific evaluation and care. EXPERT OPINION: It is necessary to explore the pharmacokinetics of compounds highlighting sex-related differences, and their safety during pregnancy and lactation. Taking care of differences between women and men should represent a main focus of research, while being a primary target towards a really tailored pharmacological treatment of PTSD.

Research of Arithmetic and Drawing Writing in Improving Communication and Cognitive Function in Patients with Mild-to-Moderate Dementia: A Cluster Randomized Controlled Trial.

Objective: The aim of the study was to investigate the effectiveness of arithmetic and drawing writing on communication skills, quality of life, and cognitive impairment among people with mild and moderate dementia. Methods: We recruited 45 patients diagnosed with mild-to-moderate dementia into this study. The participants were randomly divided into arithmetic group (n = 14), drawing writing group (n = 16), and control group (n = 15). The arithmetic group was educated to understand the addition and subtraction formulas, then wrote down the correct answers between the number of 20 and 100. The drawing writing group was guided to name, draw, and write a given object. Both were trained by therapist for 12 weeks (40 minutes per week). Blinded assessors measured global cognitive function, communication skills, and quality of life using Mini-Mental State Examination (MMSE) scale, the subscales of Functional Assessment of Communication Skills scale and Quality of Life-Alzheimer's Disease scale at baseline and after 12 weeks' intervention. Results: After the 12-week intervention, the participants with mild-to-moderate dementia of the arithmetic writing group and the drawing writing group showed statistically significant improvement in communication skills and quality of life compared with the control group (social communication: 6.00 ± 0.69 vs. 6.06 ± 0.92 vs. 3.98 ± 1.33; basic needs communication: 6.32 ± 0.48 vs. 6.42 ± 0.53 vs. 4.25 ± 1.49; quality of life: 33.23 ± 5.34 vs. 34.07 ± 3.49 vs. 25.07 ± 2.60). In addition, MMSE scores of the arithmetic group tended to improve after the 12-week intervention (14.77 ± 3.06 vs. 17.31 ± 4.80, P < .01), but stabled in drawing writing group (14.27 ± 4.28 vs. 14.53 ± 5.26, P > .05) and significant decreased in the control group (13.73 ± 2.58 vs. 10.13 ± 3.23, P < .01). Conclusion: Arithmetic, drawing, and writing are effective in improving communication skills and quality of life; arithmetic also could delay the decline of cognitive function in people with mild-to-moderate dementia.

Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review.

Intrauterine devices (IUDs) are considered a reliable contraceptive option for women, but they can come with side effects. There is a disconnect in standard guidelines for IUD insertion within and without the U.S. The objective of this review was to address a gap in the literature regarding official procedures for pain management during IUD implantation. This scoping review was initiated using keywords to extract relevant articles from multiple databases: U.S. National Library of Medicine National Institutes of Health (PubMed), MEDLINE (Ovid), and Excerpta Medica dataBASE (EMBASE, Ovid). Initially, 457 articles were identified and after a rigorous screening and selection process, 37 articles were chosen to be further assessed to ascertain if they met the study's inclusion criteria. Those 37 articles were further evaluated fully to check for relevancy. From that process, 19 articles were chosen for the review, and all passed quality assessment evaluations using the JB Appraisal Tools. To best address the research question, the data from the 19 articles were divided into three categories: 1) circumstantial factors, 2) non-pharmacological methods, and 3) pharmacological methods. Circumstantially, women with previous vaginal deliveries experienced the lowest pain during the procedure, and nulligravid (never pregnant) women experienced the most pain. Lower pain scores were reported by lactating women compared to non-lactating. Black women experienced the most anticipated pain compared to other races. Regarding non-pharmacological methods, different insertion techniques, tools, and the use of a cold compress were found to not affect the level of pain during IUD insertion. Lastly, it was shown that pharmacological methods such as lidocaine gel, lidocaine paracervical block, and lidocaine combined with either diclofenac or prilocaine decreased pain scores at different time stamps of the procedure. Also, oral ketorolac and a vaginal combination of misoprostol and dinoprostone helped reduce pain. Findings from this scoping review revealed a lack of uniformity across practices when performing IUD insertions, possibly due to differences in procedures across circumstantial factors, non-pharmacological methods, and pharmacological methods. More research is needed to investigate the intricacies of pain with IUD insertion. Moving forward, especially following a potential increase in the use of IUDs after the reversal of Roe v. Wade, establishing this gap may lead to a more refined standardized protocol to mitigate pain with IUD insertions.

Emerging drugs in phase II and III clinical development for the treatment of alcohol use disorder.

INTRODUCTION: Alcohol Use Disorder (AUD) poses an ongoing significant global health burden. AUD is highly prevalent and affects not only the individuals with AUD, but also their communities and society at large. Even though pharmacotherapy is an integral part of AUD treatment, the few available substances show limited efficacy and limited clinical impact. Thus, there is a need for new innovative pharmacotherapeutic approaches. AREAS COVERED: This paper provides a comprehensive review of drugs approved for the treatment of AUD as well as those currently in phase II and III development. Data from recent clinical trials has been reviewed and supplemented by additional literature based on a systematic search of the PubMed database and clinical trials registries. Compounds discussed include disulfiram, naltrexone, nalmefene, acamprosat, baclofen, sodium oxybate, doxazosin, varenicline, zonisamide, gabapentin, apremilast, ibudilast, ivermectin, tolcapone, mifepristone, suvorexant, ketamine, psilocybin, semaglutide, oxytocin and cannabidiol. EXPERT OPINION: Even though the majority of the discussed compounds lack sufficient evidence to support their efficacy, multiple promising new treatment options are currently under investigation. Future research has to consider specific phenotypes and subgroups of AUD as well as a possible enhancement of the effects of psychotherapy through combination with pharmacotherapy. Practitioners should be encouraged to use available compounds to support existing therapeutic regimens.

5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment.

BACKGROUND: Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer. METHODS: The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0-10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups. DISCUSSION: The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines. TRIAL REGISTRATION: IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023.

A Female-Specific Treatment Group for ADHD-Description of the Programme and Qualitative Analysis of First Experiences.

Background: The diagnostics and treatment of attention-deficit/hyperactivity disorder (ADHD) in women remain insufficient. Fluctuations of reproductive hormones during the premenstrual period, postpartum period, and (peri)menopause are neglected, even though they impact ADHD symptoms and associated mood disorders. Therefore, we created a female-specific treatment group for women with ADHD and premenstrual worsening of ADHD and/or mood symptoms. Methods: We describe the group programme and underlying rationale, offering a qualitative analysis of the participants' evaluation. Results: The seven bi-weekly sessions foreground the menstrual cycle and address several ADHD-specific topics in relation to this cyclical pattern. Concurrently, women track their menstrual cycle and (fluctuating) ADHD and mood symptoms with an adjusted premenstrual calendar. In total, 18 women (25-47 years) participated in three consecutive groups. We analysed the evaluation of the last group. Participants experienced the group as a safe and welcoming space. Recognition was valued by all. The topics discussed were deemed valuable, and the structure suited them well. Completing the premenstrual calendar augmented the awareness and recognition of individual cyclical symptoms. A lifespan approach increased self-understanding. Participants took their menstrual cycle more seriously, prioritising self-acceptance and self-care. Conclusions: Exploring a cyclical approach in a group setting seems to be a positive addition to treatment for female ADHD.

Care for Social Isolation and Loneliness in a Case With Late-Onset Delusional Disorder.

Late-onset psychosis refers to the development of psychotic symptoms after the age of 40 and can encompass various conditions like schizophrenia, mood disorders with psychotic features, and delusional disorder. Non-pharmacological interventions are critically important in older adults with psychosis, especially considering the lack of evidence for the efficacy of antipsychotics and the high risk of side effects. Social isolation is recognized as one of the risks of late-onset psychosis, and interventions to eliminate this risk are becoming increasingly important in Japan, where social isolation among older people is widespread as society ages. We present a case of late-onset delusional disorder in which multidimensional interventions for social isolation and loneliness, which have significant impacts on symptoms, were effective in achieving persistent remission. The case involved a woman in her mid-70s who began to complain of paranoia that taking a painkiller recommended by her husband caused persistent pain. Her husband's hospitalization and the deterioration of her relationship with her children resulted in her becoming socially isolated, which intensified her delusions and led to aggressive behavior and depression. Although antipsychotic medications had a limited effect, remission was achieved through supportive psychotherapy, cognitive therapy, family education, participation in group occupational therapy, and the introduction of daycare services, which were implemented to reduce loneliness and social isolation. Specifically, supportive psychotherapy and family education for her loneliness, awareness of another possible cause of pain that she developed through Socratic questioning, and environmental adjustments played important roles in preparing her to accept cognitive therapy, achieve delusional remission, and maintain her state of remission, respectively. The interventions implemented in this case provide insights for addressing social isolation and loneliness in late-onset psychosis.