Clinical trial issues in weight-loss therapy

BACKGROUND: Overweight and obesity rates continue to increase nationally, generating significant interest in weight-loss therapies to address both the burden of obesity-associated chronic disease and individual concerns about appearance. Effective obesity therapies also have the potential for off-label use and unintended consequences. METHODS: The behavioral, pharmacologic, and surgical therapies for obesity are reviewed. Clinical trial issues common to chronic disease states and issues specific to obesity trials are examined. Finally, study designs for obesity therapy, including populations, control arms, sample size, and duration of therapy, are discussed.     

南漳县HIV/AIDS病人生命质量状况及心理暗示治疗效果

目的了解艾滋病病毒（HIV）感染者/艾滋病（AIDS）病人（简称HIV/AIDS病人）的生存质量状况,研究心理干预对HIV/AIDS病人生命质量改善的影响。方法采用现况研究方法,分析研究对象的生存质量及其影响因素,通过一对一心理咨询及使用复合维生素暗示疗法干预,观察干预前后的效果。结果 100例HIV/AIDS病人参与生存质量测定调查,回收有效问卷100份。HIV/AIDS病人生命质量量表各因子得分,除个人信仰/精神领域得分略高于全国常模外,生理、心理、独立性、社会关系、环境领域得分均低于常模,且生理、心理、独立性、社会关系与常模比较差异均有统计学意义（P〈0.01）。100例HIV/AIDS病人参与复合维生素暗示干预,3个月后,回收有效问卷97份,干预后在心理、独立性、环境领域因子的得分有所提高,且干预前后心理、独立性、环境维度因子分差异均有统计学意义（P〈0.01）。结论南漳县HIV/AIDS病人在接受抗病毒治疗之后生存质量水平低下,心理干预有效地改善HIV/AIDS病人的心理和独立性等方面状况。     

Psychological and psychiatric aspects of treatment of obesity and nonalcoholic fatty liver disease

Chronic illnesses incur a tremendous cost to American lives in dollars and quality of life. Outcomes in these illnesses are often affected by psychological, behavioral, and pharmacologic issues related to mental illness and psychological symptoms. This article focuses on psychological and psychiatric issues related to the treatment of obesity and nonalcoholic fatty liver disease (NAFLD), including available weight-loss interventions, the complex relationship between psychiatric disorders and obesity, and special considerations regarding use of psychiatric drugs in patients with or at risk for NAFLD and obesity. Recommendations for collaborative care of individuals with comorbid NAFLD and psychological disorders/symptoms are discussed.     

Psychiatric and behavioral aspects of cardiovascular disease: epidemiology, mechanisms, and treatment

Psychosocial and behavioral factors, including mood (depression, anxiety, anger, and stress), personality (Type A, Type D, and hostility), and social support, are associated with both the development and progression of cardiovascular disease. “Negative” emotions have been associated with increased rates of cardiovascular death and recurrent cardiac events, although the mechanisms responsible for this association remain unclear. A number of pathophysiological mechanisms have been proposed to explain these relationships, including hypothalamic-pituitary-adrenal axis dysregulation, platelet activation, and inflammation. Behavioral factors also have been implicated, such as nonadherence to prescribed medical therapies and physical inactivity. Several randomized trials of patients with cardiovascular disease have examined the impact of pharmacologic and behavioral treatments on hard cardiovascular disease events as well as on cardiovascular disease biomarkers of risk. Although psychological treatments generally have been shown to improve quality of life and psychological functioning among cardiac patients, the benefit of psychological interventions with respect to improving clinical outcomes has not been conclusively demonstrated.Full English text available from:www.revespcardiol.org     

Healthy coping, negative emotions, and diabetes management: a systematic review and appraisal

PURPOSE: The purpose of this systematic review is to assess the literature pertinent to healthy coping in diabetes management and to identify effective or promising interventions and areas needing further investigation. METHODS: A PubMed search identified 186 articles in English published between January 1, 1990, and July 31, 2006, addressing diabetes and emotion, quality of life, depression, adjustment, anxiety, coping, family therapy, behavior therapy, psychotherapy, problem solving, couples therapy, or marital therapy. RESULTS: Connections among psychological variables, behavioral factors, coping, metabolic control, and quality of life are appreciable and multidirectional. Interventions for which well-controlled studies indicate benefits for quality of life and/or metabolic control include general self-management, coping/problem-solving interventions, stress management, support groups, cognitive-behavioral therapy, behavioral family systems therapy, cognitive-analytic therapy, multisystemic therapy, medications for depression, and the Pathways intervention integrating case management, support of medication, and problem-solving counseling. CONCLUSIONS: Psychological, emotional, related behavioral factors, and quality of life are important in diabetes management, are worthy of attention in their own right, and influence metabolic control. A range of interventions that achieve benefits in these areas provide a base for developing versatile programs to promote healthy coping.     

Complementary and alternative medicine for IBS in adults: mind-body interventions

Standard treatment for IBS focuses on the management or alleviation of the predominant gastrointestinal presenting symptoms, such as diarrhea or constipation, often using pharmacological therapy. For many patients, this approach is unsatisfactory, and patients frequently seek the advice of complementary and alternative medicine (CAM) practitioners in order to explore other treatment options. CAM practices include a broad range of modalities, and mind-body interventions hold particular promise as treatment modalities for IBS because psychological factors could have an important role in IBS symptomatology and quality of life. Psychological stressors are postulated to result in gastrointestinal symptoms through alteration of intestinal function mediated by the autonomic nervous system, hypothalamic-pituitary-adrenal axis and immune system. Hypnotherapy has the strongest supportive evidence as a beneficial mind-body intervention for IBS. Clinical studies of hypnotherapy have uniformly shown improvement of gastrointestinal symptoms, anxiety, depression and quality of life in patients with IBS. Mindfulness meditation remains unstudied for IBS, but is theoretically attractive as a stress-reduction technique. There is a suggestion that relaxation therapy or multimodal therapy (a combination of relaxation therapy, education and psychotherapy) is beneficial for IBS. The most generally accepted psychological mind-body intervention is cognitive behavioral therapy, and clinical trials support the beneficial effects of cognitive behavioral therapy in patients with IBS.     

心理干预对2型糖尿病患者生命质量的影响

目的 探讨心理干预对2型糖尿病患者精神状态和生命质量的影响,为促进患者身心健康提供依据.方法 选取糖尿病患者160例,分为研究组和对照组.研究组给予针对性的心理干预治疗,对照组则不实施干预.入院1周内及出院前采用症状自评量表(SCL-90)和SF-36量表对两组2型糖尿病患者精神状态和生命质量进行测量.结果 干预后,研究组患者SCL-90量表评分显著低于对照组(P＜0.05),SF-36量表评分显著高于对照组(P＜0.05).结论 对2型糖尿病患者实施有效的心理干预能够提高其心理健康和生活质量水平,有利于促进患者的身心健康.     

Obesity an overview: Genetic conditions and recent developments in therapeutic interventions

Obesity is a complex disorder that is linked to many coexisting disorders. Recent epidemiological data have suggested that the prevalence of obesity is at an all-time high, growing to be one of the world's biggest problems. There are several mechanisms on how individuals develop obesity which includes genetic and environmental factors. Not only does obesity contribute to other health issues but it also greatly affects the quality of life, physical ability, mental strength and imposes a huge burden in terms of healthcare costs. Along with that, obesity is associated with the risk of mortality and has been shown to reduce the median survival rate. Obesity is basically when the body is not able to balance energy intake and output. When energy intake exceeds energy expenditure, excess calories will be stored as fat leading to weight gain and eventually obesity. The therapeutic market for treating obesity is composed of many different interventions from lifestyle intervention, surgical procedures to pharmacotherapeutic approaches. All of these interventions have their respective benefits and disadvantages and are specifically prescribed to a patient based on the severity of their obesity as well as the existence of other health conditions. This review discusses the genetic and environmental causes of obesity along with the recent developments in anti-obesity therapies.     

Nurse-led intervention for the management of bariatric surgery patients: A systematic review

The prevalence of obesity has become a global health concern, and severe obesity is associated with various chronic diseases and decreased quality of life. Bariatric surgery has shown success in treating obesity. Nevertheless, some patients experience weight regain and unsatisfactory outcomes. Multidisciplinary interventions have been shown to improve postoperative outcomes. Case managers, often specialized nurses, play a crucial role in patient support and coordination of care. However, the diverse design of case-managing interventions hinders the assessment of their success. Thus, the aim of this review is to identify the most successful structural characteristics of case-managing interventions, with or without the support of e-Health, in the process of perioperative management of bariatric surgery patients. A systematic literature review was conducted following the PRISMA guidelines. PubMed, MEDLINE, EBSCOhost, and CINAHL databases were searched for relevant studies published in the last 10 years. Eligible studies included randomized controlled trials, controlled clinical studies, case studies, or observational studies that evaluated perioperative care in bariatric surgery. The PICO framework was used to frame the search strategy. The initial search yielded 225 articles, of which 10 studies met the inclusion criteria. Nurse-led case-managing interventions with a multidisciplinary approach showed positive results in weight loss, physical activity, and quality of life. Patient-centered care models were found to promote adherence to treatment and patient satisfaction. E-Health technologies improved quality of life but not weight loss. The duration of behavioral interventions and the long-term outcomes after surgery remained unclear. Nurse-led case-management interventions, with a focus on behavioral change and multidisciplinary approaches, show promise in improving outcomes in bariatric surgery patients. Patient-centered care models and longer term interventions may contribute to sustained weight loss and better postoperative outcomes. Further research is needed to determine the optimal duration of interventions and the long-term effects on weight maintenance.     

Methods and applications of quality-of-life measurement during antihypertensive therapy

The measurement and evaluation of health-related quality of life during antihypertensive therapy has contributed to physicians' understanding of how patients respond to therapy in terms of physical, psychological, and social well-being. Comparative clinical trials of antihypertensive drug therapies have demonstrated that treatment produces no perceptible improvements in health status. Thus, the "burden" of the therapeutic regimen from the patient's perspective is greatly magnified. Research has also demonstrated that patient expectation and preference are important components of quality-of-life assessment when the purpose of this assessment is to predict or explain human behavior. Drug properties, including mechanism of action and pharmacokinetics, have been shown to influence the impact of drug side effects and the degree to which patients tolerate therapy. Researchers have attempted to standardize the construct of quality of life to have broad applications in health care policy and management; however, clinical research in hypertension should focus on the components of health-related quality of life that influence patient outcomes with regard to behaviors affecting adherence. Antihypertensive agents that maximize patient acceptance and quality of life are now available. Future quality-of-life research should be directed toward learning more about human behavior so that adherence to nonpharmacologic interventions such as diet and exercise will be enhanced.     

Psychosocial Factors Associated with Noncardiac Chest Pain and Cardiac Syndrome X

Abstract Cardiac syndrome X, the triad of angina pectoris, positive exercise electrocardiogram (ECG) for myocardial ischemia and angiographically smooth coronary arteries, is associated with increased psychological morbidity, debilitating symptomatology and a poor quality of life. Patients with noncardiac chest pain (NCCP) are often similarly affected. The psychological morbidity noted among this patient population has been linked with a number of psychosocial factors, including impaired social support, traumatic life events, the negative impact of menopause among female sufferers, and an awareness of a family history of coronary heart disease (CHD). Cognitive behavioral therapy (CBT), group support, physical activity and relaxation techniques have been investigated as treatments for psychological morbidity among this patient group with varying degrees of success. While clinicians should be aware of the psychological aspect of patients with NCCP and cardiac syndrome X, further research is needed in order to establish a comprehensive physiological and psychological treatment regimen.     

Methods and applications of quality-of-life measurement during antihypertensive therapy

The measurement and evaluation of health-related quality of life during antihypertensive therapy has contributed to physicians‘ understanding of how patients respond to therapy in terms of physical, psychological, and social well-being. Comparative clinical trials of antihypertensive drug therapies have demonstrated that treatment produces no perceptible improvements in health status. Thus, the ‘burden’ of the therapeutic regimen from the patient‘s perspective is greatly magnified. Research has also demonstrated that patient expectation and preference are important components of quality-of-life assessment when the purpose of this assessment is to predict or explain human behavior. Drug properties, including mechanism of action and pharmacokinetics, have been shown to influence the impact of drug side effects and the degree to which patients tolerate therapy. Researchers have attempted to standardize the construct of quality of life to have broad applications in health care policy and management; however, clinical research in hypertension should focus on the components of health-related quality of life that influence patient outcomes with regard to behaviors affecting adherence. Antihypertensive agents that maximize patient acceptance and quality of life are now available. Future quality-of-life research should be directed toward learning more about human behavior so that adherence to nonpharmacologic interventions such as diet and exercise will be enhanced.     

Critical review of complementary therapies in haemato-oncology

There is evidence of the increasing use of complementary and alternative medicine by Australians diagnosed with cancer. Given the increasing desire of cancer patients to use complementary and alternative medicine, it is important that clinicians have a good understanding of the evidence available in this field. This critical review aims to provide an overview of the current evidence pertaining to a range of complementary therapies that are used in a supportive role in the treatment of cancer patients. Treatment methods considered are acupuncture, music therapy, massage and touch therapies and psychological interventions. The efficacy of these complementary therapies in terms of improvement in symptoms and quality of life is examined. Evidence that relates to an effect on immune function and survival is also investigated.     

Effects of Exercise Interventions in Older Adults with Various Types of Dementia: Systematic Review

This comprehensive literature review analyzed relevant studies on the effects of exercise interventions for older adults with dementia. An extensive search of databases was conducted to identify relevant studies. Among the 64 reviewed studies, the highest number focused on Alzheimer’s disease, following by mixed dementia; none of the studies included older adults with Lewy body dementia or frontotemporal dementia. Methodological quality and risk of bias were evaluated based on Downs & Black’s Quality Index. A variety of exercise interventions have been shown to be beneficial for functional outcomes but there were mixed findings regarding the effects of exercise on cognitive function, behavioral and psychological symptoms, and overall quality of life. Not all high-frequency or longer-duration physical exercise interventions were associated with significant effects on cognitive function but positive outcomes of exercise intervention on cognitive ability were often accompanied by improvement in activities of daily living. More clinical trials are needed to determine how to motivate older adults with dementia to engage regularly in exercise and how group and individually tailored exercise programs may improve physical function and minimize behavioral and psychological symptoms associated with dementia.     

Conservative Management and Behavioral Modifications for Overactive Bladder

Overactive bladder is a chronic condition that has significant effects on quality of life. Management of this condition often emphasizes the use of anticholinergic therapy. However, there are often intolerable side effects that result in poor compliance with these medications. Conservative management and behavioral modification are effective management tools as initial therapies or in conjunction with medical therapy. This review focuses on nonpharmacologic therapies and their role in the management of overactive bladder.     

Low Weight and Overweightness in Older Adults: Risk and Clinical Management

The prevalence of individuals who are overweight or obese is growing exponentially in the United States and worldwide. This growth is concerning, as both overweightness and obesity lead to impaired physical function, decreased quality of life, and increased risk of chronic diseases. Additionally, overweightness and obesity are related to increased mortality among young and middle-aged adults. This weight-related risk of mortality is more ambiguous among older adults. In fact, obesity may be protective in this population, a relationship described as the “obesity paradox”. In this review we discuss the effects of overweightness and obesity among the elderly on cardiovascular disease and all-cause mortality, along with the risks of low weight. We conclude by discussing the goal of weight management among older adults, focusing particularly on benefits of preserving lean body mass and muscular strength while stabilizing body fat. Ideally, overweight or mildly obese elderly individuals should devise a plan with their physicians to maintain their weight, while increasing lean body mass through a plan of healthy diet, behavioral therapy, and physical activity.     

The effect of non-pharmacological interventions on psychological stress and quality of life of parents of children with retinoblastoma: A protocol for systematic review and meta-analysis

Background:Retinoblastoma is the most common malignant tumor in infancy and early childhood. Due to the high incidences of intracranial metastasis and distant metastasis, retinoblastoma not only threatens the life of affected children, but also brings heavy mental stress to their parents. A strong mental stress often leads to anxiety, depression, and other adverse emotions, which is very unfavorable to the treatment and prognosis by generating great psychological pressure and reducing the quality of life of the family. Reducing the psychological stress of the parents and improving the quality of life of the family are beneficial to the treatment and prognosis of retinoblastoma in children. However, there are no recommended non-pharmacological therapies to reduce the psychological stress and improve the quality of life of the parents of children with retinoblastoma. This study aims to evaluate the effects of non-pharmacological therapies on psychological stress and quality of life of parents of children with retinoblastoma through a meta-analysis, thus providing clinical evidence.Methods:Randomized controlled trials reporting the effects of non-pharmacological therapies on psychological stress and quality of life of parents of children with retinoblastoma published before 2021 November will be searched in online databases, including the China National Knowledge Infrastructure, Wanfang, Chinese Scientific Journal Database, China Biomedical Literature Database, PubMed, Embase, The Cochrane Library, and Web of Science databases. The Cochrane Quality Assessment Manual will be used to assess the quality of the included literatures. Meta-analysis will be performed using Revman 5.4 software.Results:This study will evaluate the effects of non-pharmacological therapies on psychological stress and quality of life of parents of children with retinoblastoma via grading anxiety scores, depression scores, and quality-of-life scores.Conclusion:This study will provide a reliable evidence-based basis for non-pharmacological interventions on parents of children with retinoblastoma.Ethics and dissemination:Ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms. This review would be disseminated in a peer-reviewed journal or conference presentations.OSF REGISTRATION NUMBER:     

Psychological complications in sickle cell disease

This review examines the evidence for some of the common psychological complications found across the life span of patients with sickle cell disease (SCD), which are likely to be encountered by haematologists responsible for their medical management. Electronic searches of medical and psychological databases were conducted with a focus on three main areas: psychological coping, quality of life and neuropsychology. Psychological complications were identified in both children and adults with SCD, and included inappropriate pain coping strategies; reduced quality of life owing to restrictions in daily functioning, anxiety and depression; and neurocognitive impairment. There were wide variations in design and consistency of the studies, therefore, some caution needs to be observed in the findings. Moreover, interventional studies were lacking in some areas such as neuropsychology. Utilization of psychological interventions including patient education, cognitive behavioural therapy, and special educational support to help improve the quality of life of patients are recommended.     

Cognitive and psychological issues in emphysema

Various psychological and cognitive difficulties have been documented in patients with emphysema. The aim of this article is to review prior literature on the prevalence of these difficulties in emphysema, as well as identify specific studies demonstrating improvement in these areas after therapy. Traditional therapies such as continuous and intermittent oxygen therapy and comprehensive pulmonary rehabilitation are reviewed. In general, these studies demonstrate reductions in symptoms of depression and anxiety as well as specific improvements in complex attention and verbal fluency. In a more recent study, patients with emphysema who underwent lung volume reduction surgery (LVRS) demonstrated improved psychomotor speed, verbal memory, and naming skills at 6 months compared with patients with emphysema who were in comprehensive rehabilitation only. The patients with emphysema who had LVRS also demonstrated greater decline in depressive symptoms compared with the rehabilitation patients at 6 months. There were no associations between improved neuropsychological tests and changes in depression, exercise tests, pulmonary function, oxygenation, or quality of life scores, and thus the mechanism of behavioral improvement identified in the patients who underwent LVRS remained unclear. Overall, studies suggest that psychological and cognitive improvements occur subsequent to a variety of medical and behavioral treatment therapeutic approaches, and that LVRS appears to have an advantage for some patients with emphysema.