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BACKGROUND: Apathy is the most frequent neuropsychiatric symptom in patients with dementia of the Alzheimer's type (DAT). We analyzed the influence of apathy on the resource use of DAT patients and their caregivers.METHODS: Included were baseline data of 107 DAT patients from a randomized clinical trial on apathy treatment. The Resource Utilization in Dementia (RUD) instrument assessed costs over a 1-month period prior to baseline. Cost predictors were determined via a least absolute shrinkage and selection operator (LASSO).RESULTS: On average, total monthly costs were €3070, of which €2711 accounted for caregivers' and €359 for patients' costs. An increase of one point in the Apathy Evaluation Scale resulted in a 4.1% increase in total costs.DISCUSSION: Apathy is a significant cost driving factor for total costs in mild to moderate DAT. Effective treatment of apathy might be associated with reduced overall costs in DAT.

Background: Palliative patients frequently express a desire to die. Health professionals report uncertainty regarding potential risks of addressing it. Aim: We aim to evaluate effects of desire to die-conversations on palliative patients. Design: Within a prospective mixed-methods cohort study, we trained health professionals in dealing with desire to die. Afterwards, they held conversations about it with patients. Effects on depressiveness, hopelessness, wish to hasten death, death anxiety, patient-health professional-relationship, and will to live were evaluated at baseline (t0), 1 (t1), and 6 weeks afterwards (t2). Results were analyzed descriptively. Setting/participants: From April 2018 to March 2020, 43 health professionals asked 173 patients from all stationary and ambulatory palliative care settings (within 80 km radius) for participation. Complete assessments were obtained from n = 85 (t0), n = 64 (t1), and n = 46 (t2). Results: At t1, patients scored significantly lower on depressiveness (med = 8, M = 8.1, SD = 5.4) than at t0 (med = 9.5, M = 10.5, SD = 5.8) with Z = −3.220, p = 0.001 and Cohen’s d = 0.42. This was due to medium-severely depressed patients: At t1, their depressiveness scores decreased significantly (med = 9, M = 9.8; SD = 5.1) compared to t0 (med = 14, M = 15.2; SD = 3.9) with Z = −3.730, p ⩽ 0.000 and Cohen’s d = 1.2, but others’ did not. All other outcomes showed positive descriptive trends. Conclusions: Desire to die-conversations through trained health professionals do not harm palliative patients. Results cautiously suggest temporary improvement.

For the first time, our study presents wire myography data from renal interlobar arteries (RIAs) and mesenteric arteries of young adult rat offspring after intrauterine growth restriction (IUGR). Our data indicate that myogenic tone in RIAs is dysfunctional after IUGR. Furthermore, IUGR offspring suffer from mild arterial hypertension, glomerular hypertrophy, and increased urinary protein-to-creatinine ratio. Dysregulation of vascular tone in RIAs could be an important variable that impacts upon vulnerability toward glomerular injury after IUGR.

Background In the recent years, an increasing number of patients with multiple comorbidities (e.g. coronary artery disease, diabetes, hypertension) presents to the operating room. The clinical risk factors are accompanied by underlying vascular-endothelial dysfunction, which impairs microcirculation and may predispose to end-organ dysfunction and impaired postoperative outcome. Whether preoperative endothelial dysfunction identifies patients at risk of postoperative complications remains unclear. In this prospective observational study, we tested the hypothesis that impaired flow-mediated dilation (FMD), a non-invasive surrogate marker of endothelial function, correlates with Days at Home within 30 days after surgery (DAH30). DAH30 is a patient-centric metric that captures postoperative complications and importantly also hospital re-admissions. Methods Seventy-one patients scheduled for major abdominal surgery were enrolled. FMD was performed pre-operatively prior to major abdominal surgery and patients were dichotomised at a threshold value of 10%. FMD was then correlated with DAH30 (primary endpoint) and postoperative complications (secondary endpoints). Results DAH30 did not differ between patients with reduced FMD and normal FMD (14 (4) (median (IQR)) vs. 15 (8), P = 0.8). Similary, no differences between both groups were found for CCI (normal FMD: 21 (30) (median (IQR)), reduced FMD: 26 (38), P = 0.4) or frequency of major complications (normal FMD: 7 (19%) (n (%)), reduced FMD: 12 (35%), P = 0.12). The regression analyses revealed that FMD in combination with ASA status and surgery duration had no additional significant predictive effect for DAH30, CCI or Clavien-Dindo score. Conclusion FMD does not add predictive value with regards to DAH30, CCI or Clavien-Dindo score within our study cohort of patients undergoing abdominal surgery. Trial registration The study was registered in the German Clinical Trials Register (DRKS00005472), prospectively registered on 25/11/2013.

BMC public health 21(1), 1295 (2021). doi:10.1186/s12889-021-11206-9, Published by BioMed Central, London

Background Although desire to die of varying intensity and permanence is frequent in patients receiving palliative care, uncertainty exists concerning appropriate therapeutic responses to it. To support health professionals in dealing with patients´ potential desire to die, a training program and a semi-structured clinical approach was developed. This study aimed for a revision of and consensus building on the clinical approach to support proactively addressing desire to die and routine exploration of death and dying distress. Methods Within a sequential mixed methods design, we invited 16 palliative patients to participate in semi-structured interviews and 377 (inter-)national experts to attend a two-round Delphi process. Interviews were analyzed using qualitative content analysis and an agreement consensus for the Delphi was determined according to predefined criteria. Results 11 (69%) patients from different settings participated in face-to-face interviews. As key issues for conversations on desire to die they pointed out the relationship between professionals and patients, the setting and support from external experts, if required. A set of 149 (40%) experts (132/89% from Germany, 17/11% from 9 other countries) evaluated ten domains of the semi-structured clinical approach. There was immediate consensus on nine domains concerning conversation design, suggestions for (self-)reflection, and further recommended action. The one domain in which consensus was not achieved until the second round was “proactively addressing desire to die”. Conclusions We have provided the first semi-structured clinical approach to identify and address desire to die and to respond therapeutically – based on evidence, patients’ views and consensus among professional experts. Trial registration The study is registered in the German Clinical Trials Register (DRKS00012988; registration date: 27.9.2017) and in the Health Services Research Database (VfD_DEDIPOM_17_003889; registration date: 14.9.2017).

In paediatrics, clinical study data are limited, especially on herbal medicinal products. To address this gap, 2063 datasets from the paediatric population were evaluated in the PhytoVIS data base. By screening for paediatric data, information on indication, gender, treatment, co-medication and tolerability were evaluated. The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety. The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events. The data shed light on a still neglected field of phyto-pharmacotherapy by giving information on the use of herbal medicines in an unselected cohort of paediatric patients. The results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.What is Known:• In Germany, about 85% of children receive one or more herbal medicinal products per year.• Despite international initiatives to promote clinical research in paediatrics, there are still many gaps of knowledge in the use of drugs in paediatrics.What is New:• The PhytoVIS project evaluated 2063 data sets from the paediatric population using herbal medicinal products.• The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety, and 84% of the patients rated the therapy as very good or good without adverse events.

Purpose. This study investigated an inhalation solution containing ectoine, a bacterial-derived extremolyte, for the treatment of acute bronchitis and acute respiratory infections in comparison with saline inhalation solution. Methods. This prospective, controlled, observational study comprised an inclusion visit (day 1), a final visit (day 7), and a follow-up questionnaire (day 17). The treatment itself was administered from day 1 to day 7. The Bronchitis Severity Score, patients’ general health, general effectiveness of the treatment, tolerability, and adverse events were compared between two groups. Results. In total, 135 patients were recruited; 79 patients received ectoine inhalation solution and 56 saline inhalation solution. After treatment, symptom scores decreased significantly in both groups (P < 0.05); the reduction in symptom scores was slightly greater in the ectoine group than in the saline group. The first significant reduction in symptom scores (P < 0.05) occurred earlier in the ectoine group than in the saline group. The differences in the area under the curve for the symptoms of dyspnea and auscultation findings were significant in favor of ectoine (P < 0.05). After treatment, more patients and physicians in the ectoine group assessed their or their patients’ condition as “completely recovered” or “greatly improved” than those in the saline group. Almost all patients and physicians assessed the tolerability of both treatments as “good” or “very good”. Conclusions. Ectoine inhalation solution seems to be slightly more effective than saline inhalation solution for the treatment of acute bronchitis and acute respiratory infections.

EClinicalMedicine 39, 101082 (2021). doi:10.1016/j.eclinm.2021.101082, Published by Elsevier, Amsterdam

Key Points Question Is bupropion an effective and safe treatment for apathy in nondepressed patients with dementia of Alzheimer type? Findings In this 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial, 54 patients received bupropion and 54 received placebo. The mean change in the Apathy Evaluation Scale–Clinician Version score was not statistically significant between the treatment groups. Meaning Bupropion did not improve apathy in patients with dementia of Alzheimer type without depressed mood., This randomized clinical trial examines the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type., Importance Apathy is a frequent neuropsychiatric symptom in dementia of Alzheimer type and negatively affects the disease course and patients’ and caregivers’ quality of life. Effective treatment options are needed. Objective To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type. Design, Setting, and Participants This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019. Interventions Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study. Main Outcomes and Measures Change on the Apathy Evaluation Scale–Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks. Results A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, –0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, –1.66; 95% CI, –3.01 to –0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, –2.92; 95% CI, –5.89 to 0.06; P = .05) and cognition (mean change, –0.27; 95% CI, –3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups. Conclusions and Relevance Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood. Trial Registration EU Clinical Trials Register Identifier: 2007-005352-17

Objective: Although desire to die (DD) of varying intensity and permanence is frequent in patients with advanced cancer and those receiving palliative care, uncertainty exists concerning appropriate therapeutic responses to it. To support health professionals in dealing with patients´ potential DD, a training program and a semi-structured clinical interview guideline was developed. This study aimed for a revision of and consensus building on the clinical guideline to support proactively addressing DD and routine exploration of death and dying distress. Methods: Within a sequential mixed methods design, we invited 16 palliative patients to participate in semi-structured interviews and 377 (inter-)national experts to attend a two-round Delphi process. Interviews were analyzed using qualitative content analysis and an agreement consensus for the Delphi was determined according to predefined criteria. Results : 11 (69%) patients from different settings participated in face-to-face interviews. As key issues for conversations on DD they pointed out the relationship between professionals and patients, the setting and support from external experts, if required. A set of 149 (40%) experts (132/89% from Germany, 17/11% from 9 other countries) evaluated ten domains of the clinical guideline. There was immediate consensus on nine domains concerning conversation design, suggestions for (self-)reflection, and further recommended action. The one domain in which consensus was not achieved until the second round was “proactively addressing DD”. Conclusions : We have provided the first semi-structured clinical guideline to identify and address DD and to respond therapeutically – based on evidence, patients’ views and consensus among (inter-)national professional experts. Trial registration: German Clinical Trials Register (No. DRKS00012988).

Additional file 1. Semi-structured interview guideline; Interview guideline with all questions for patient interviews.

Additional file 2. Semi-structured clinical approach for addressing Desire to Die; Finalized version of the clinical approach after revision through patient interviews and consensus finding through Delphi process.

This study compared the effectiveness and tolerability of alpha-tocopherol acetate nasal spray (ATANS) to those of beclomethasone nasal spray (BNS) and loratadine (LT) for the treatment of pollen-induced allergic rhinitis. This active-controlled, patient-preference, observational trial lasted 7 days. Tested variables were nasal symptoms, endoscopic examination, additional medications, general effectiveness, safety, and tolerability. Of 116 patients, 63 patients decided to use ATANS, 32 BNS and 21 LT. During the treatment, the mean daily rhinitis symptom score decreased significantly in all groups. The 7‑day mean score in the ATANS group (0.98) was comparable to that of the BNS group (0.92) and significantly higher than that of the LT group (0.70, P

For the success of an immunotherapy regimen, adherence is a major success factor. The goal of our study was to identify the factors that positively and negatively influence patient compliance, and to create strategies to improve it. Four questionnaires were designed for different patient groups: A - after immunotherapy; B - during immunotherapy; C - before immunotherapy; D - no experience with immunotherapy. From March to October 2008, 790 questionnaires were collected. For the first group, questionnaire A was answered by 272 patients. Of these, 15.8% had dropped out of immunotherapy. Women had higher dropout rates than men (16.8% vs. 12.3%). The following aspects of immunotherapy were viewed by the patients as negative: time consuming (69.5%), adverse reactions (62.5%), insufficient patient information (53.7%), no change in use of symptomatic medication (33.8%) and no change in symptoms (60.7%). Despite the mentioned drawbacks, 74% of all patients would still recommend allergen immunotherapy. Questionnaire B was completed by 281 patients. In this group, 8.7% had already considered dropping out. The following unfavourable aspects were identified: time consuming (66.2%), adverse reactions (61.9%), insufficient patient information (54.8%), no change in symptoms (51.2%) and use of symptomatic medication (47.0%). Despite this, up to 95.4% of all patients would recommend immunotherapy. Questionnaire C was filled-out by 55 patients. The following reasons were rated by the patients as "important" or "very important" for the decision to start hyposensitization: long-lasting symptom alleviation (100%), few adverse reactions (98.2%), comprehensive patient information (96.3%), easy integration into daily routine (89.1%), re-assessment of therapy by doctor (83.3%) and reduced need for symptomatic medication (81.8%). Questionnaire D was filled in by 182 participants. 89% had already heard the term hyposensitization before. Their general knowledge regarding this therapy was average (3.23 on a scale of 1 - 6; where 1 = optimum). Long-lasting symptom alleviation (99.5%), comprehensive patient information (97.8%), easy integration into daily routine (96.1%), reduced symptomatic medication use (92.6%) and re-assessment by doctor (88.8%) were considered "very important" or "important" characters in the desired immunotherapy regime. Adherence to the hyposensitization schedule is essential for its success. The treating doctor should aim at choosing the right therapy and working out an individualized patient treatment plan. Equally important is providing information to the patient throughout the duration of the treatment. The doctor should assist the patient to create an optimized time schedule to help make the therapy less time-consuming.

Background Clinical practice needs a common parameter that can provide an early, reliable estimation of the outcome of sublingual immunotherapy (SLIT) in an upcoming pollen season. We investigated whether the conjunctival provocation test (CPT) can predict the beneficial outcome of SLIT in patients with allergic rhinoconjunctivitis after 4 weeks of treatment. Methods We conducted two separate prospective, randomized, double-blind, placebo-controlled, multicenter trials. Adults 18–75 years of age received placebo or SLIT tablets containing tree or grass pollen allergoids and underwent CPTs. Participants receiving SLIT were divided into two groups (reactive, nonreactive) according to their CPT reactions after 4 weeks of treatment. These two groups were compared with regard to clinical outcome parameters (total combined score, rhinoconjunctivitis total symptom score, total rescue medication score, well days) assessed during the pollen season for the 14-day (tree) or 30-day (tree/grass) peaks and for the entire 60-day seasons. Participants’ global evaluations of therapy after completing treatment were also compared. Results The tree pollen trial randomized 188 participants; 182 participants were evaluable, 76 of whom received SLIT and were suitable for this post hoc analysis. The grass pollen trial included 90 participants; 82 participants were evaluable, 44 of whom underwent SLIT. Comparing SLIT participants who reacted to the CPT after 4 weeks (tree: 77.6%; grass: 79.5%) with those who ceased to show a reaction (tree: 22.4%; grass: 20.5%) (tree: P = 0.0001; grass: P = 0.003), the total combined score for the 14-day (P = 0.017) and 30-day peaks (P = 0.042) as well as the rhinoconjunctivitis total symptom score assessed for the 14-day peak (P = 0.024) were significantly lower in the nonreactive group of the tree pollen trial. In the grass pollen trial, the nonreactive group rated their SLIT treatment significantly better (P = 0.019). Conclusions Using clinically meaningful outcome parameters during the pollen season, both trials independently led to similar results when comparing participants’ reactions to the CPT 4 weeks after beginning SLIT. These results suggest that CPT allows an early estimation of allergic rhinoconjunctivitis symptoms before an upcoming season. Thus, the CPT can be used as a valuable parameter to predict the beneficial outcome of ongoing SLIT. Trial registration Both trials registered with the Medical Ethics Committee of the North Rhine Medical Council (EudraCT numbers 2012-004916-79 (grass pollen trial) and 2013-002129-43 (tree pollen trial)) and the German Federal Ministry of Health (Paul-Ehrlich-Institut).

Background The Global Allergy and Asthma European Network (GA2 LEN) Taskforce has requested more data on correlations between various patient-reported outcomes (PROs) in clinical trials on allergy. We compared three tools-the Rhinitis Control Assessment Test (RCAT), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Rhinitis Total Symptom Score (RTSS)-to determine whether the RCAT alone is a sufficient primary outcome parameter in clinical trials on allergic rhinoconjunctivitis. Methods In two double-blind, placebo-controlled immunotherapy studies, 33 patients allergic to grass pollen and 94 to birch pollen completed two questionnaires (RCAT and RQLQ) and kept their own symptom diary from which the RTSS was calculated. Results Upon comparing RCAT and RQLQ results, we found strong correlations of r = -0.871 for grass pollen-allergic patients and r = -0.795 for birch pollen-allergic patients. The comparison between RCAT and RTSS results showed a strong correlation of r = -0.811 (grass pollen-allergic patients) and a moderate correlation of r = -0.539 (birch pollen-allergic patients). In the RCAT, 69.7% of grass pollen-allergic patients and 45.7% of birch pollen-allergic patients receiving guideline-concordant therapy were regarded as having insufficiently controlled symptoms. Conclusion The strong correlations suggest that the RCAT alone is equivalent to the RQLQ with respect to patients' symptom control and quality of life. Patients with uncontrolled symptoms can be identified using the RCAT. Hence, the physician can decide whether symptomatic therapy can be intensified or allergy immunotherapy should be administered.

Background A novel subcutaneous allergen immunotherapy formulation (gpASIT+™) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen–induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety. Methods This prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen–allergic adults to receive placebo or cumulative doses of 70, 170 or 370 μg LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen–specific immunoglobulins were analysed before and after treatment. Results Conjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 μg; P = .023), 46.3% (370 μg), and 38.6% (70 μg) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per-protocol set). Also, 39% of patients in the 170-μg group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen-binding assays revealed a highly significant (P < .001) dose-dependent reduction in IgE allergen binding across all treatment groups (70 μg: 17.1%; 170 μg: 18.8%; 370 μg: 26.4%). Specific IgG4 levels increased to 1.6-fold (70 μg), 3.1-fold (170 μg) and 3.9-fold (370 μg) (mPP). Conclusion Three-week immunotherapy with 170 μg LPP reduced CPT reactivity significantly and increased protective specific antibodies.

Aim: To determine the optimal effective and safe dose of sublingual immunotherapy tablets containing carbamylated monomeric allergoids in patients with grass pollen-induced allergic rhinoconjunctivitis. Methods: In this prospective, randomized, double-blind, active-controlled, multicenter, Phase II study, four different daily doses were applied preseasonally for 12 weeks. Results: Of 158 randomized adults, 155 subjects (safety population) received 300 units of allergy (UA)/day (n = 36), 600 UA/day (n = 43), 1000 UA/day (n = 39), or 2000 UA/day (n = 37). After treatment, 54.3, 47.6, 59.0 and 51.4% of patients, respectively, ceased to react to the highest allergen concentration in a conjunctival provocation test. Furthermore, the response threshold improved in 70.4, 62.9, 76.7 and 66.7% of patients, respectively. No serious adverse events occurred. Conclusion: This study found 1000 UA/day to be the optimal effective and safe dose.

Background A relevant proportion of allergic rhinitis (AR) patients experience recurrent symptoms after successfully completing allergen immunotherapy (AIT). This prospective, controlled, non-interventional study used internationally standardised instruments to determine the clinical effects of a preseasonal, ultra-short-course booster AIT on clinical outcome parameters. Methods This two-arm study included patients aged ≥12 years with recurrent grass pollen–induced seasonal AR who had completed a successful course of any grass pollen AIT at least five years before enrolment. Overall, 56 patients received one preseasonal short-course booster AIT using tyrosine-absorbed grass pollen allergoids containing the adjuvant monophosphoryl lipid A (MPL®); 51 control patients received symptomatic medication. The combined symptom and medication score (CSMS) was recorded in the (peak) grass pollen season. Furthermore, concomitant (antiallergic) medication use, the patients'state of health, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) results, and safety/tolerability of the treatment were assessed. Results The CSMS in the peak grass pollen season was significantly lower in the booster AIT group (Δ=38.4%, P

Nasal blockage is the most bothersome symptom of acute rhinitis. Nasal decongestant sprays containing alpha-sympathomimetics, such as oxymetazoline and xylometazoline, have a rapid onset of action. However, this effect decreases with repeated application and, furthermore, the ciliary function of the nasal mucosa is practically paralyzed. Dexpanthenol promotes cell proliferation and protects the epithelium. Combining these two agents has demonstrated beneficial synergetic effects on the symptoms of acute rhinitis. In a post hoc analysis of a large-scale double-blind, active-controlled study including 152 patients, we could demonstrate that the benefit of added dexpanthenol appears as early as on the third day of the combined application of xylometazoline and dexpanthenol in terms of complete or near-to-complete freedom from symptoms. After 5 days, 47% of the patients were cured under the combined treatment compared with only 1% under xylometazoline monotherapy. These data show that the addition of dexpanthenol to an alpha-sympathomimetic nasal spray not only improves its tolerability but also further increases its effectiveness and leads to expedited cure. Funding: Klosterfrau Healthcare Group.

Introduction Allergen immunotherapy is the only treatment option for allergic rhinitis with disease-altering potential. It was the objective of this study to assess the effectiveness and tolerability of a 5-grass pollen tablet in a large population of non-selected grass pollen allergic patients, i.e. patients with different clinical profiles in daily clinical practice. Methods In a 2-year, prospective, open-label, multicenter, non-controlled, observational study patients were included from 327 centers across Germany. Rhinoconjunctivitis symptoms, symptomatic medication intake and adverse events were recorded. Results A total of 1482 patients aged 4–75 years were included. During the 2-year period of 5-grass pollen tablet therapy, mean rhinoconjunctivitis score decreased significantly in the overall study population by 65.5% (P

Marie-Luise Lemberg,1 Till Berk,2 Kija Shah-Hosseini,1 Elena-Manja Kasche,1,3 Ralph Mösges1 1Faculty of Medicine, Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany; 2Department of Trauma Surgery, University Hospital Zurich, Zurich, Switzerland; 3Center for Dermatology, Specific Allergology and Environmental Medicine, Hamburg, Germany Background: Many placebo-controlled studies have demonstrated that allergen immunotherapy (AIT) is an effective therapy for treating allergies. Both commonly used routes, subcutaneous (SCIT) and sublingual immunotherapy (SLIT), require high patient adherence to be successful. In the literature, numbers describing adherence vary widely; this investigation compares these two routes of therapy directly.Methods: All data were retrieved from the patient data management system of a center for dermatology, specific allergology, and environmental medicine in Germany. All 330 patients (aged 13–89 years) included in this study had commenced AIT between 2003 and 2011, thus allowing a full 3-year AIT cycle to be considered for each investigated patient.Results: In this specific center, SCIT was prescribed to 62.7% and SLIT to 37.3% of all included patients. The total dropout rate of the whole patient cohort was 34.8%. Overall, SLIT patients showed a higher dropout rate (39.0%) than did SCIT patients (32.4%); however, the difference between these groups was not significant. Also, no significant difference between the overall dropout rates for men and for women was observed. A Kaplan–Meier curve of the patient collective showed a remarkably high dropout rate for the first year of therapy.Conclusion: The analysis presented in this single-center study shows that most patients who discontinue AIT do so during the first year of therapy. Patients seem likely to finish the 3-year therapy cycle if they manage to adhere to treatment throughout the first year. Strategies for preventing nonadherence in AIT, therefore, need to be developed and standardized in future investigations. Keywords: adherence, dropout, nonadherence, SCIT, SLIT, allergic rhinitis, allergy, allergen immunotherapy

Background Allergic rhinitis has major impacts on sports performance of athletes. The present study aimed at determining the frequency of seasonal pollen allergy and analyzing the impacts of pollen allergy, the choice of allergy treatments and their benefits for sports performance in a group of professional and recreational athletes. Methods The study was conducted as a self-reported questionnaire survey. Subjects were recruited from the German Sport University and the Cologne Marathon 2014 during the peak pollen season of 2014. Results Athletes returned 636 completed questionnaires, 42.6% of participants reported suffering from a pollen allergy and 30.2% also suffered from asthma. Performance impairments were reported in more than 80% of allergic subjects. In all, 82.2% of subjects used symptomatic medications, 32.3% alternative therapies, and 47.6% allergen immunotherapy. Subjects who used immunotherapy had fewer impaired training bouts than those who used symptomatic and alternative therapies. The majority of subjects had concerns about allergy treatment such as side effects, negative impacts on sports performance and lack of long-term effects. Conclusions This study confirmed a high prevalence of pollen allergy among German athletes. The majority of allergic rhinitis athletes were undertreated, and the reason could be their reservations about allergy treatments. Pollen allergy tremendously reduced sports performance of athletes during the pollen season. This impact can be lessened with proper treatment such as immunotherapy. Better understanding of available treatment modalities should be provided to patients and physicians to improve sports performance of athletes suffering from pollen allergy.

Background In sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose. Methods In this double-blind, placebo-controlled dose-finding study, 131 patients with house dust mite-induced allergic rhinoconjunctivitis were randomized to 12-week treatments with 300 UA/day, 1000 UA/day, 2000 UA/day, 3000 UA/day or placebo. Conjunctival provocation tests (CPT) were performed before, during and after treatment. The change in mean allergic severity (primary endpoint), calculated from the severity of the CPT reaction, and the proportion of patients with an improved CPT threshold (secondary endpoint) determined the treatment effect. Results The mean allergic severity decreased in all groups, including the placebo group. It was lower in all active treatment groups (300 UA/day: 0.14, 1000 UA/day: 0.15, 2000 UA/day: 0.10, 3000 UA/day: 0.15) than in the placebo group (0.30). However, this difference was not statistically significant (P < 0.1). The percentage of patients with an improved CPT threshold was higher in the active treatment groups (300 UA/day: 73.9%; 1000 UA/day: 76.0%; 2000 UA/day: 88.5%; 3000 UA/day: 76.0%) than in the placebo group (64.3%). The difference between placebo and 2000 UA/day was statistically significant (P = 0.04). In 13 (10%) exposed patients, a total of 20 treatment-related adverse events of mild severity were observed. Conclusions The 12-week daily treatment using 2000 UA/day monomeric allergoid sublingual tablets is well tolerated and reduces the CPT reaction in house dust mite-allergic patients.

Purpose Catheter-related bloodstream infections affect patients in surgical and intensive care settings worldwide, causing complications, aggravation of existing symptoms and increased length of stay. The trial aimed at comparing two registered skin antiseptics with respect to their residual and therefore infection-preventing effects. Methods In a parallel, monocentric, prospective, triple-blind, randomized trial the difference in bacterial recolonization of catheter skin sites in central venous (CVC) and epidural catheters (EC) was investigated by comparing two alcoholic-based skin disinfectants. Patients receiving planned surgeries or intensive care were eligible for the trial. Those in the trial group received skin disinfection with the additive octenidine dihydrochloride (OCT) (n = 51), those in the control group were treated with benzalkonium chloride as additive (BAC) (n = 59) prior to catheter insertion. Randomization was carried out by assigning patients to groups week-wise. Endpoints of the investigation were skin colonization of the catheter site counted in colony forming units per swab at three time points: (1) prior to catheter insertion, on untreated skin; (2) directly after catheter insertion, prior to sterile coverage; (3) 48 h after catheter insertion. The hypothesis was tested by a Wilcoxon test with a two-sided alpha = 5 %. Results From second to third swab, recolonization of the catheter-surrounding skin was significantly lower in the trial group for both sorts of catheters: delta 2–3 OCT group: 0.72 (95 % CI: 0.42; 1.02); delta 2–3 BAC group: 1.97 (95 % CI: 1.45; 2.50); p

Background: Liposomal eye spray (LS) has been introduced for the treatment of dry eye. Whether LS can also relieve symptoms due to allergic rhinoconjunctivitis (ARC) has not yet been sufficiently investigated. Objectives: The aim of this study was to assess the onset of action, the reduction of allergy symptoms, and the safety of LS – a nonpharmacological treatment option – compared with those of antihistamine eye drops (AD). Methods: In this open, prospective, controlled, monocenter noninterventional study, adults with ARC received either LS or AD for the relief of eye irritation after a positive conjunctival provocation test (CPT). All patients completed a questionnaire before and after the CPT. Eye irritation was rated on a visual analogue scale (VAS) at 6 time points. Conjunctival redness was analyzed using objective digital analysis based on images taken during the study visit. Results: Data were collected from 40 patients (20 per group). In both groups, 80% of patients perceived an onset of action within 0–2 min after application of LS or AD following the CPT. Relief of eye irritation (as determined by VAS) increased throughout the visit for both groups. In the digital analysis, the mean proportion of redness of the eye decreased from 10.3 to 7.0% for LS and from 10.4 to 6.5% for AD, with the largest difference observed 10 min after application (LS: 8.9%; AD: 6.0%; p = 0.094). Conclusions: LS is a nonpharmacological treatment option for ARC, showing no significant difference or relevant numerical inferiority to AD in any parameter studied. It was generally safe and well tolerated.

Background: Systemic allergic reactions are a risk for allergen immunotherapy that utilizes intact allergen preparations. We evaluated the safety, efficacy and immune mechanisms of short-course treatment with adjuvant-free Lolium perenne peptides (LPP) following a 6-week dose-escalation protocol. Methods: In a prospective, dose-escalation study, 61 grass pollen–allergic patients received 2 subcutaneous injections of LPP once weekly for 6 weeks. Safety was assessed evaluating local reactions, systemic reactions and adverse events. The clinical effect of LPP was determined by reactivity to the conjunctival provocation test (CPT). Specific IgE, IgG 4 and blocking antibodies were measured at baseline (V1), during (V6) and after treatment (V8). Results: No fatality, serious adverse event or epinephrine use was reported. Mean wheal diameters after injections were, SCOPUS: ar.j, info:eu-repo/semantics/published

To document the effectiveness and safety of sublingual allergen immunotherapy (SLIT) with a five-grass pollen tablet (Oralair ) and compare different treatment options in a broad, non-selected population of patients in a real-world clinical setting.This was a 2 year, open, prospective, multicenter, single-arm, non-interventional study. Patients with a history of clinically relevant allergic symptoms caused by grass pollen, confirmed by skin prick testing, received treatment with the five-grass pollen tablet. Concomitant treatment with symptomatic medication and/or additional SLIT or subcutaneous immunotherapy (SCIT) was permitted. Twelve-month data are presented here. Effectiveness was assessed comparing a combined rhinoconjunctivitis (RC) score derived from the severity of rhinitis and conjunctivitis symptoms under treatment with retrospective data of the previous year.A total of 1408 patients participated in the study, of whom 434 were children/adolescents and 962 polyallergic. Compared with the grass pollen season preceding five-grass pollen tablet treatment, a statistically significant reduction of 49.9% was achieved in RC score for the total population (p 0.001), and an improvement in overall health was perceived by 90.9% of patients. The overall population of polyallergic patients derived similar benefits from treatment with the five-grass pollen tablet as monoallergic patients. The percentage reduction in RC score was larger in polyallergic patients taking no additional therapy (60.2%) than in those taking concomitant symptomatic medication (38.1%) or allergen immunotherapy (AIT) (50.8%). Within the last of these groups, RC score improved by 47.6% among patients receiving additional SCIT, versus 54.8% with additional SLIT. Adverse drug reactions, reported in 15.3% of study participants, were mostly local in nature and mild or moderate in intensity.After 1 year of treatment, polyallergic patients responded similarly to the five-grass pollen tablet as monoallergic patients. For polyallergic patients in whom additional treatment was needed, a second SLIT may be more beneficial than a SCIT or symptomatic co-medication.