Post-COVID-19 Symptoms in Adults with Asthma-Systematic Review.

BACKGROUND: Research on the longer-term sequelae of COVID-19 in patients with asthma is limited. OBJECTIVE: To assess the frequency and severity of long-term symptoms of COVID-19 in the population of asthma patients. METHODS: A systematic review of the published literature was conducted in accordance with the recommendations of the PRISMA statement. EMBASE, MEDLINE/PubMed, Web of Science, CINAHL, and Scopus Scholar were searched for terms related to asthma and post or long COVID-19, and for systematic reviews related to specific questions within our review, up to June 2022. RESULTS: Data from 9 references publications included in the review were extracted. A total of 1466 adult asthmatic patients with COVID-19 infection were described in all the publications mentioned above. Of the long-term symptoms reported after COVID-19, patients indicated: lower respiratory symptoms, fatigue, cognitive symptoms, psychological problems, and other such as skin rashes, gastrointestinal disorders, tachycardia, palpitations, ocular disorders, ageusia/hypogeusia, anosmia/hyposmia, and poor sleep quality. These symptoms in similar intensity were observed in the comparison groups without a diagnosis of asthma. CONCLUSIONS: The published data neither confirm nor deny that long-term COVID-19 symptoms in patients with asthma diagnosis are different in strength and frequency from patients without asthma diagnosis. To indicate associations between asthma and COVID-19 infection and severity, as well as the frequency of long-term symptoms of COVID-19, more longitudinal research is needed in chronic asthma patients with different phenotypes, intensity of treatment, and degree of asthma control.

Impact of Blood-Flow-Restricted Training on Arterial Functions and Angiogenesis-A Systematic Review with Meta-Analysis.

Despite growing evidence of the significant influence of blood-flow-restricted (BFR) training on different body functions, its impact on the vascular system, especially the arteries, is controversial. Therefore, the objective of our study was to analyze how BFR exercise, compared to other types of exercise without the restriction of blood flow, influences arterial functions and angiogenesis in adults. Studies comparing the effect of BFR versus non-BFR training on arterial parameters were divided into three categories: endothelial function, angiogenesis, and other vasculature functions. The search was based on Cochrane Library, PubMed®, and Embase, and 38 studies were included. The meta-analysis revealed a more significant improvement in flow-mediated dilatation (FMD) (p = 0.002) and the production of the primary angiogenesis biomarker vascular endothelial growth factor (VEGF) (p = 0.009) after BFR compared to non-BFR training (p = 0.002). The analysis of the pulse wave velocity, ankle-brachial index, systolic blood pressure, and heart rate did not show significant differences in changes between BFR and non-BFR training. The other parameters examined did not have sufficient data to be included in the meta-analysis. The results obtained present trends that suggest significant impacts of BFR training on endothelial functions and angiogenesis. There is still a lack of multicenter randomized clinical trials including many participants, and such studies are necessary to confirm the advantage of BFR over non-BFR activity.

Stimulation of the Vascular Endothelium and Angiogenesis by Blood-Flow-Restricted Exercise.

Blood-flow-restricted exercise (BFRE) has been gaining constantly increasing interest in rehabilitation, but its influence on endothelial functions has not been well studied yet. Our aim is to examine the influence of low-resistance BFRE on endothelial functions and angiogenesis. This prospective cross-over study involved 35 young healthy adults. They conducted a 21-min low-resistant exercise with blood flow restricted by pressure cuffs placed on arms and tights. They also did the same training but without blood flow restriction. Endothelial parameters and angiogenesis biomarkers were evaluated before and up to 20 min after exercise. Both types of exercise increased Flow-Mediated Dilatation (FMD) but elevation after BFRE was more significant compared to the controls. The stiffness index decreased only after BFRE, while the reflection index decreased significantly after both types of exercise but was higher after BFRE. Platelet endothelial cell adhesion molecule (PECAM-1) and vascular endothelial growth factor receptor 2 (VEGFR-2) concentrations were increased by both exercise types but elevations were higher after BFRE compared to the controls. Only BFRE elevated the mean serum CD34 protein concentration. Based on these results, we can assume that low-resistance BFR exercise stimulates angiogenesis and improves endothelial functions more significantly compared to the same training performed without blood flow restriction.

The impact of clinical and psychological factors on asthma control: the experience of a single asthma center in Poland.

OBJECTIVE: The asthma control test (ACT) is commonly used to identify patients with uncontrolled asthma. The goal of this study was to determine whether clinical parameters such as asthma history and medications, exacerbation rate, comorbidities, lung function, and socioeconomic status are risk factors for uncontrolled asthma assessed with the ACT, and to evaluate the psychological status of controlled and uncontrolled asthmatics. METHODS: Adult asthmatics (n = 104) were recruited from a single asthma center, Poland. Asthma control was assessed with the ACT, using <20 as the cutoff point for uncontrolled asthma. Data on clinical factors were collected and spirometry was performed. Patients completed the Asthma Quality of Life Questionnaire, General Health Questionnaire, Acceptance of Illness Scale, Life Orientation Test-Revised, and Eysenck's Personality Inventory. RESULTS: Asthma was uncontrolled in 42.3% of patients. Asthma exacerbations in the preceding 12 months and high inhaled corticosteroid (ICS) doses were identified as independent risk factors for uncontrolled asthma. Uncontrolled asthmatics had a significantly worse psychological status than controlled asthmatics. The groups did not differ in terms of personality traits, but in the controlled asthma group numerous significant correlations between psychological factors and personality traits were observed. In the uncontrolled asthma group, however, the occurrence of correlations between personality traits and other psychological variables was rarer. CONCLUSIONS: The study identified independent risk factors for uncontrolled asthma, namely, exacerbations in the recent 12 months and treatment with high-dose ICS. Uncontrolled asthmatics have a significantly worse psychological status than controlled asthmatics, irrespective of personality traits.

The influence of the trunk muscle activation on occlusion pressure and respiratory muscle strength in healthy participants: Randomized controlled trial.

OBJECTIVES: The purpose of the study was to check if the trunk muscle activation done in accordance with rules of the Bobath concept affects the occlusion pressure and respiratory muscle efficacy in forced breathing manoeuvres in healthy participants. DESIGN: Randomized controlled trial. Between-subjects design. PARTICIPANTS: Seventy-four healthy volunteers, aged 20-26 years, were recruited from medical students, randomly assigned to the experimental or control groups. INTERVENTION: The intervention in the experimental group was individual physiotherapy based on the Bobath concept. It was provided by qualified physiotherapist and lasted about 60 min. The Bobath concept is an inclusive, individualized therapeutic approach to optimize movement recovery, informed by contemporary movement and neuro-sciences. The control group participated in a 45-minute lecture on the importance of the stability of trunk muscle and the diaphragm position that is adequate for its respiratory work. The described interventions, in both groups, were performed once, between the initial and final measurement of the respiratory drive. OUTCOME MEASURES: The subjects underwent two assessments of the following variables: occlusion pressure (P0.1) and the respiratory muscle strength: maximal inspiratory pressure (PImax), maximal expiratory pressure (PEmax), maximal occlusion pressure (P0.1max) with the use of MasterScope Spirometer. In experimental group, the physiotherapy assessment was carried out before intervention. RESULTS: As a result of the applied intervention, P0.1 in the experimental group increased (p = 0.001; 82.45 vs 103.73), which was not observed in the control group (p = 0.629; 88.95 vs 85.83). The intervention did not change the results of all other outcomes including P0.1 max; PImax and PEmax. CONCLUSION: The activation of trunk muscles such as transversus abdominis, multifidius and muscles of the pelvic floor was found to improve the effectiveness of diaphragmatic work during tidal breathing as measured with P0.1 values. Established abdominal pressure, which stabilizes the trunk and prevents chest mobility, might be the reason why forced measurements (PImax, PEmax, P.01 max) remain unchanged.

The comparison between pulmonary rehabilitation with music therapy and pulmonary rehabilitation alone on respiratory drive, cortisol level and asthma control in patients hospitalized with asthma exacerbation.

INTRODUCTION: Much emphasis is being placed on the role of music therapy as an easy-to-use, noninvasive and relatively cheap method of asthma treatment. The objective of this interventional double-blinded randomized controlled trial was to assess whether music therapy, as a complementary modality to pulmonary rehabilitation, can help to improve respiratory drive, asthma control and quality of life in patients with asthma exacerbation. METHODS: Hospitalized patients with asthma exacerbation enrolled in the study were randomly assigned to experimental (music therapy) or control (popular science program) group. Both groups during hospitalization received standard pharmacotherapy accompanied by respiratory physiotherapy. Respiratory drive, asthma control, quality of life and serum cortisol in all participants were assessed at the beginning and at the end of their hospitalizations. RESULTS: The experimental group consisted of 39 asthmatics and 34 subjects with asthma were assigned to the control group. During the hospitalization, the levels of the inspiratory occlusion pressure for the first 0.1 s of inspiration (P0.1) decreased (p = 0.004) and the maximum P0.1 increased (p = 0.041) only in the experimental group. The serum cortisol level decreased in both groups (p = 0.001). The changes in asthma control and quality of life did not reach significant levels in either subject group. CONCLUSION: Passive music therapy and its effects on the mental state of patients seem to improve the efficiency of the respiratory system. The results of this experimental study demonstrate that a complementary music therapy has beneficial effects on the treatment of asthma exacerbations in adults.

Correction: Offline Digital Education for Postregistration Health Professions: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration.

[This corrects the article DOI: 10.2196/12968.].

The Comorbidity of Chronic Obstructive Pulmonary Disease and Peripheral Artery Disease - A Systematic Review.

The comorbidity of peripheral arterial disease (PAD) and chronic obstructive pulmonary disease (COPD) is obvious from a clinical point of view, especially as smoking is an important risk factor for both. Another factor connecting these two clinical conditions is chronic inflammation, which plays a crucial role in their pathophysiology. The aim of this study was to present the prevalence of COPD in patients with PAD, as well as the prevalence of PAD in COPD patients confirmed in all patients by two reliable methods: spirometry and ankle-brachial index (ABI), respectively. The MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews were searched to identify the potentially eligible publications from the previous 10 years. The published characteristics of different PAD and COPD populations were analyzed. A database search identified 894 records. Reliable criteria of both COPD and PAD diagnosis were used only in seven publications. The prevalence of PAD among patients with COPD ranged from 8.5 to 81.4%. The severity of the disease and the exclusion of nonsmokers or symptomatic patients from the analyses were important factors affecting this parameter. The prevalence of COPD in patients with PAD was measured reliably only in one study and assessed as 27.2%. The comorbidity of COPD and PAD is a relatively common occurrence. There are very few publications addressing this issue based on reliable diagnostic criteria, especially in the field of PAD. In the case of COPD and PAD patients, spirometry and ABI measurements are worth considering as noninvasive screening tests for COPD and PAD, respectively.

Posture commonly and considerably modifies stenosis of left common iliac and left renal veins in women diagnosed with pelvic venous disorder.

OBJECTIVE: Pelvic venous incompetence or pelvic congestion syndrome (commonly referred to as pelvic venous disorder [PVD]) is increasingly diagnosed, especially in multiparous women. This may be either primary or secondary to pelvic venous outflow obstruction-left common iliac vein (LCIV) or left renal vein (LRV) stenosis. Intravascular ultrasound (IVUS) examination performed in the supine position is commonly used for diagnosis of LRV and LCIV stenosis; however, body position may affect the cross-sectional area (CSA) of both of these veins during IVUS. The aim of the study was to test the hypothesis that postural changes may significantly affect the CSA of the LRV and LCIV. METHODS: A single-arm, single-center cohort study of women suffering from PVD was performed at a tertiary hospital in Poland. It comprised consecutive patients with either pelvic vein reflux or suggestion of LCIV or LRV obstruction but no signs of deep venous thrombosis. IVUS examination of the iliac veins, inferior vena cava, and LRV was performed in the supine position. IVUS of the LRV and LCIV was performed also with a Valsalva maneuver and with patients lying on the left side and standing. A 60% CSA reduction was used as a cutoff value between significant and nonsignificant vein stenosis. RESULTS: A total of 41 women were examined. Significant stenosis of the LRV was seen in 22 patients (55%) supine but in only 4 (10%) patients studied when lying on the left side and in 27 (67.5%) patients studied while standing. Significant stenosis of the LCIV was seen in 26 supine patients (63.4%), in 8 lying on the left side (19.5%), and in 10 (24.4%) standing. CONCLUSIONS: Postural changes dramatically affect CSA of the LCIV and LRV and thus the degree of stenosis in women diagnosed with PVD. Stenosis found in patients while supine often disappears when the position is changed to lying on the left side or to standing. Therapeutic decisions based on assessment of CSA reduction in the supine position are likely to be inadequate.

Subterranean Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease.

Pulmonary rehabilitation (PR) has been recommended as an integral part of treatment for patients with chronic obstructive pulmonary disease (COPD). Climate therapy in salt mine chambers has been found of benefit in chronic respiratory diseases. The study compares long-term effects of underground PR in the Wieliczka Salt Mine with that conducted on the surface. There were 42 COPD patients enrolled in the study, with FEV1/FVC <0.7 predicted and post-bronchodilator reversibility <12%, randomized into pulmonary rehabilitation in the mine (Group I, n = 23) and PR on the surface (Group II, n = 19). The outcomes consisted of lung function variables, exercise performance (6-min walk test - 6MWT), dyspnea (mMRC), and compliance with the disease and quality of life (COPD Assessment Test - CAT) and BODE index, compared at baseline (P0), end (P1), and 6 months after pulmonary rehabilitation (P2). The findings were that subterranean pulmonary rehabilitation significantly reduced CAT score (p < 0.001), BODE index (p = 0.004), and dyspnea (mMRC) (p = 0.001) and increased distance in 6MWT (p < 0.001), compared with its equivalent conducted on the surface. Further, beneficial effect of subterranean treatment was sustained during the following half a year as opposed to the effect noticed on patients treated on the surface. We conclude that subterranean pulmonary rehabilitative treatment reduces symptoms and improves exercise tolerance to a greater and sustained extent, compared to a similar treatment on the surface, in patients suffering from COPD.

Offline Digital Education for Postregistration Health Professions: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration.

BACKGROUND: The shortage and disproportionate distribution of health care workers worldwide is further aggravated by the inadequacy of training programs, difficulties in implementing conventional curricula, deficiencies in learning infrastructure, or a lack of essential equipment. Offline digital education has the potential to improve the quality of health professions education. OBJECTIVE: The primary objective of this systematic review was to evaluate the effectiveness of offline digital education compared with various controls in improving learners' knowledge, skills, attitudes, satisfaction, and patient-related outcomes. The secondary objectives were (1) to assess the cost-effectiveness of the interventions and (2) to assess adverse effects of the interventions on patients and learners. METHODS: We searched 7 electronic databases and 2 trial registries for randomized controlled trials published between January 1990 and August 2017. We used Cochrane systematic review methods. RESULTS: A total of 27 trials involving 4618 individuals were included in this systematic review. Meta-analyses found that compared with no intervention, offline digital education (CD-ROM) may increase knowledge in nurses (standardized mean difference [SMD]=1.88; 95% CI 1.14 to 2.62; participants=300; studies=3; I2=80%; low certainty evidence). A meta-analysis of 2 studies found that compared with no intervention, the effects of offline digital education (computer-assisted training [CAT]) on nurses and physical therapists' knowledge were uncertain (SMD 0.55; 95% CI -0.39 to 1.50; participants=64; I2=71%; very low certainty evidence). A meta-analysis of 2 studies found that compared with traditional learning, a PowerPoint presentation may improve the knowledge of patient care personnel and pharmacists (SMD 0.76; 95% CI 0.29 to 1.23; participants=167; I2=54%; low certainty evidence). A meta-analysis of 4 studies found that compared with traditional training, the effects of computer-assisted training on skills in community (mental health) therapists, nurses, and pharmacists were uncertain (SMD 0.45; 95% CI -0.35 to 1.25; participants=229; I2=88%; very low certainty evidence). A meta-analysis of 4 studies found that compared with traditional training, offline digital education may have little effect or no difference on satisfaction scores in nurses and mental health therapists (SMD -0.07; 95% CI -0.42 to 0.28, participants=232; I2=41%; low certainty evidence). A total of 2 studies found that offline digital education may have little or no effect on patient-centered outcomes when compared with blended learning. For skills and attitudes, the results were mixed and inconclusive. None of the studies reported adverse or unintended effects of the interventions. Only 1 study reported costs of interventions. The risk of bias was predominantly unclear and the certainty of the evidence ranged from low to very low. CONCLUSIONS: There is some evidence to support the effectiveness of offline digital education in improving learners' knowledge and insufficient quality and quantity evidence for the other outcomes. Future high-quality studies are needed to increase generalizability and inform use of this modality of education.

The role of psychopathology in perceiving, reporting and treating intermittent claudication: a systematic review.

INTRODUCTION: The aim of this systematic review is to investigate the association between mental health and intermittent claudication (IC) perception, reporting and treatment in subjects with peripheral artery disease (PAD). EVIDENCE ACQUISITION: Literature searches of experimental and observational studies published until February 1st, 2016 were conducted using the following electronic databases: Medline/PubMed and Embase. The selection criteria for the studies included a population of patients diagnosed with peripheral artery disease who reported symptoms of intermittent claudication and were assessed for any psychopathological states (depression, anxiety, mood and personality disorders), which in turn were analyzed with regard to the following: IC severity, symptom perception and reporting, patients' quality of life, treatment compliance and its effectiveness. The risk of bias was assessed using Cochrane Collaboration's tool and the Newcastle Ottawa Scales. The strength of recommendations was graded according to GRADE system. EVIDENCE SYNTHESIS: The literature search identified 1598 citations, of which 13 studies with varying risk of bias were included in the review. Depression, anxiety, and personality types were described in more than 800 patients with peripheral arterial disease who suffered from intermittent claudication. With regard to IC perception and reporting, individuals with higher levels of depression had lower levels of pain acceptance, were more dissatisfied with their function and control over function and had a poorer quality of life. In the case of the type D personality, the results were not consistent. Studies assessing the influence of psychopathology on IC severity and treatment also showed discrepant results. Some studies indicated no differences between type D and non-type D patients with regard to the Ankle Brachial Index as well as pain free (PFWD) and maximal walking distances (MWD). On the other hand, others revealed that type D and depressed patients terminated 6MWT prematurely due to the onset of symptoms and experienced a greater annual decline in 6-minute walk distance, fast walking velocity and short physical performance battery. With regard to treatment adherence, patients with no mental problems made the best recoveries. Hostility, aggressiveness and affect-liability were the greatest obstacles to compliance. CONCLUSIONS: Mental disorders might influence the way in which the symptoms of the disease are reported, coped with, and treated. However, the results of the review preclude recommending a routine psychological examination as one of basic diagnostic procedures in patients with peripheral artery disease suffering from IC.

Once-daily long-acting beta2-agonists/inhaled corticosteroids combined inhalers versus inhaled long-acting muscarinic antagonists for people with chronic obstructive pulmonary disease.

BACKGROUND: Three classes of inhaler medication are used to manage chronic obstructive pulmonary disease (COPD): long-acting beta2-agonists (LABA); long-acting muscarinic antagonists (LAMA); and inhaled corticosteroids (ICS). To encourage patient adherence, two classes of medication are often combined in a single medication device; it seems that once-daily dosing offers greatest convenience to patients and may markedly influence adherence. OBJECTIVES: To compare a once-daily combination of inhaled corticosteroid and long-acting beta2-agonist inhalers (ICS/LABA) versus inhaled long-acting muscarinic antagonists alone (LAMA) for people with chronic obstructive pulmonary disease (COPD). SEARCH METHODS: We performed an electronic search of the Specialised Register of the Cochrane Airways Group (14 May 2018), ClinicalTrials.gov (14 May 2018), and the World Health Organization International Clinical Trials Registry Platform (20 September 2017), then a search of other resources, including reference lists of included studies and manufacturers' trial registers (10 October 2017). Two pairs of review authors screened and scrutinised selected articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing once-daily administered ICS/LABA and LAMA in adults with COPD. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias in each study. We analysed dichotomous data as random-effects odds ratios (ORs) and continuous data as mean differences (MDs), both with 95% confidence intervals (95% CIs), using Review Manager 5. MAIN RESULTS: We included two studies with 880 participants. We identified one ongoing trial with planned recruitment of 80 participants. Included studies enrolled participants with both partially reversible and non-reversible COPD and baseline mean per cent predicted (%pred) forced expiratory volume in one second (FEV1) of 43.4 to 49.6. Both studies lasted 12 weeks. Both studies used the same combination of inhaled ICS/LABA (fluticasone furoate and vilanterol 100/25 mcg once daily; FF/VI) versus LAMA (18 mcg tiotropium; TIO). They were published as full articles, and neither study was at low risk of bias in all domains.Compared to the TIO arm, results for pooled primary outcomes for the FF/VI arm were as follows: mortality: OR 0.20, 95% CI 0.02 to 1.73, 880 participants (deaths reported only in the TIO arm), very low-quality evidence; COPD exacerbation (requiring short-burst oral corticosteroids or antibiotics, or both): OR 0.72, 95% Cl 0.35 to 1.50, 880 participants, very low-quality evidence; pneumonia: reported in both studies only during treatment with FF/VI: OR 6.12, 95% Cl 0.73 to 51.24, 880 participants, very low-quality evidence; and total serious adverse events: OR 0.96, 95% Cl 0.50 to 1.83, 880 participants, very low-quality evidence. None of the pneumonias were fatal. Compared to the TIO arm, we found no statistically significant difference for pooled secondary outcomes, including St George's Respiratory Questionnaire (SGRQ) mean total score change; hospital admissions (all-cause); disease-specific adverse events; mean weekly rescue medication use (results available from only one of the studies); and mean weekly percentage of rescue-free days for FF/VI. We found no statistically significant differences between ICS/LABA and LAMA for improvement in symptoms measured by the COPD Assessment Test (CAT score) nor for FEV1 (change from baseline trough in 24-hour weighted mean on treatment day 84). Many pooled estimates lacked precision. Data for other endpoints such as exacerbations leading to intubation and physical activity measures were not available in included trials. AUTHORS' CONCLUSIONS: Based on analysis of primary and secondary outcomes, we are uncertain whether once-daily ICS/LABA, combined in one inhaler, has a different efficacy or adverse effect profile compared to LAMA for treatment of people with COPD. However, the current review is based on only two trials with the main focus on primary outcomes other than those considered in this review. The short follow-up period and the very low quality of evidence limit our confidence in the result and increase uncertainty. Further trials of longer duration are needed. Current evidence is not strong enough to demonstrate important differences between inhalers in terms of effects, nor to establish that once-daily fluticasone/vilanterol 100/25 mcg and tiotropium 18 mcg are equivalent.

Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis.

BACKGROUND: Pediatric Phase I cancer trials are critical for establishing the safety and dosing of anti-cancer treatments in children. Their implementation, however, must contend with the rarity of many pediatric cancers and limits on allowable risk in minors. The aim of this study is to describe the risk and benefit for pediatric cancer Phase I trials. METHODS AND FINDINGS: Our protocol was prospectively registered in PROSPERO (CRD42015015961). We systematically searched Embase and PubMed for solid and hematological malignancy Phase I pediatric trials published between 1 January 2004 and 1 March 2015. We included pediatric cancer Phase I studies, defined as "small sample size, non­randomized, dose escalation studies that defined the recommended dose for subsequent study of a new drug in each schedule tested." We measured risk using grade 3, 4, and 5 (fatal) drug-related adverse events (AEs) and benefit using objective response rates. When possible, data were meta-analyzed. We identified 170 studies meeting our eligibility criteria, accounting for 4,604 patients. The pooled overall objective response rate was 10.29% (95% CI 8.33% to 12.25%), and was lower in solid tumors, 3.17% (95% CI 2.62% to 3.72%), compared with hematological malignancies, 27.90% (95% CI 20.53% to 35.27%); p < 0.001. The overall fatal (grade 5) AE rate was 2.09% (95% CI 1.45% to 2.72%). Across the 4,604 evaluated patients, there were 4,675 grade 3 and 4 drug-related AEs, with an average grade 3/4 AE rate per person equal to 1.32. Our study had the following limitations: trials included in our review were heterogeneous (to minimize heterogeneity, we separated types of therapy and cancer types), and we relied on published data only and encountered challenges with the quality of reporting. CONCLUSIONS: Our meta-analysis suggests that, on the whole, AE and response rates in pediatric Phase I trials are similar to those in adult Phase I trials. Our findings provide an empirical basis for the refinement and review of pediatric Phase I trials, and for communication about their risk and benefit.

Do asthmatics benefit from music therapy? A systematic review.

OBJECTIVE: To determine the effectiveness of music therapy in asthma. METHODS: Searches for experimental and observational studies published between 01.01.92 and 31.12.13 were conducted through electronic databases: Medline/PubMed, Embase, SportDiscus, Cochrane Library, Teacher Reference Centre, Web of Science, Academic Search Complete, PsycINFO, PsycARTICLES, PEDro and Scopus. The selection criteria included any method of music therapy applied to patients with asthma, with respect to asthma symptoms and lung function. Two reviewers screened the records independently. The risk of bias was assessed using the Cochrane Collaboration's tool. Strength of recommendation was graded according to GRADE recommendation. RESULTS: The literature search identified 867 citations, from which 8 (three RCTs and five nRCTs) low and high risk of bias studies were included in the review. All RCTs used music listening as a form of complementary treatment. One RCT of the low risk of bias indicated positive effects on lung function in mild asthma. In two others, despite the decrease in asthma symptoms, music was not more effective than the control condition. In two nRCTs a decrease in asthma symptoms was reported as an effect of playing a brass or wind instrument; in two nRCTs the same effect was observed after music assisted vocal breathing exercises and singing. Mood improvement, decrease of depression and anxiety were also observed. CONCLUSION: The paucity, heterogeneity, and significant methodological limitations of available studies allow for only a weak recommendation for music therapy in asthma. This study highlights the need for further research of mixed methodology.

Mild asthmatics benefit from music therapy.

OBJECTIVE: The aim of the study was to evaluate the effectiveness of pulmonary rehabilitation with music therapy in patients with asthma. METHODS: Seventy-six selected inpatients (54 women and 22 men; mean age = 56.4 years; SD = 11.8) with stable asthma underwent pulmonary rehabilitation in two groups: standard versus music therapy. RESULTS: After the intervention, an increase in analyzed spirometric values (forced expiratory volume at the first second (FEV(1)), FEV(1) as a percentage of vital capacity (FEV(1) % FVC), forced expiratory flow at 25%, 50%, and 75% of vital capacity (FEF(25), FEF(50), and FEF(75), respectively), and peak expiratory flow) was observed in both the groups (p < .05) but without any intergroup differences (p > .05). A greater increase of mean FEV(1) % FVC, FEF(50), and FEF(75) values was observed only in the patients with mild asthma from the music therapy group (p < .05). In both the groups, a dyspnea reduction was noted (p < .001). However, it was influenced neither by the type of rehabilitation nor by the gender (p > .05), but the interaction of these variables was significant (p = .044). A dyspnea reduction was observed in women in both the groups (p < .001) and in men in the music therapy group only (p = .001). A change in the value of anxiety (6.43, SD = 7.73) on the 10th day compared with the first day of the study was noticed (p < .001). However, this change was not influenced by the type of rehabilitation, gender, or a combination of these two variables (p > .05). CONCLUSION: Music therapy improves the respiratory function in patients with mild asthma and reduces dyspnea mainly in men with asthma.

[Music therapy as a part of complex healing]. / Muzykoterapia jako skladowa kompleksowego leczenia.

Music therapy is a method which takes the adventage of therapeutic influence of musie on psychological and somatic sphere of the human body. Its therapeutic properties are more and more used. Current scientific research have proved its modifying influence on vegetative, circulatory, respiratory and endocrine systems. Works devoted to the effects of musie on the patients' psychological sphere have also confirmed that it reduces psychopathologic symptoms (anxiety and depression), improves self-rating, influences quality and disorders of sleep, reduces pain, improves moral immunity and patients' openness, readiness, co-operation in treatment process. Music therapy is treated as a method which complements conventional treatment and makes up part of an integral whole together with physiotherapy, kinesitherapy and recuperation.