Long-Term Therapy with Corticosteroids in Nasal Polyposis: A Bone Metabolism Assessment.

Chronic rhinosinusitis associated with nasal polyposis (RSCwNP) affects 4% of the general population. As chronic condition, it requires chronic pharmacological treatment, whereas the surgical approach becomes necessary in obstructive and/or complicated cases. Intranasal and systemic corticosteroids (CS) represent the "Gold Standard" treatment for RSCwNP. The present study aimed to evaluate the side effects of prednisone in a group of patients with RSCwNP treated with long-term CS. In particular, attention was focused on bone disorders (osteopenia and osteoporosis) and prospective fracture risk increase. Forty patients (26 females, mean age 55.70 ± 14.03 years) affected by RSCwNP have been enrolled. Control group included 40 healthy subjects (17 females, mean age 56.37 ± 13.03 years). Nasal endoscopy, skin prick tests, nasal cytology, and bone densitometry were evaluated in all subjects. The likelihood of impaired bone metabolism (osteopenia or osteoporosis) was superimposable in both groups. Within RSCwNP group, no parameter was statistically significant in predicting a metabolism alteration.

Focus on gastroesophageal reflux (GER) and laryngopharyngeal reflux (LPR): new pragmatic insights in clinical practice.

Introduction: Gastroesophageal reflux (GER) is a common disease usually limited to the oesophagus. Laryngopharyngeal reflux (LPR) is an inflammatory reaction of the mucosa of pharynx, larynx, and other associated upper respiratory organs, caused by a reflux of stomach contents outside the oesophagus. LPR is considered to be a relatively new clinical entity with a vast number of clinical manifestations which are treated sometimes empirically and without a correct diagnosis. However, there is disagreement between specialists about its definition and management: gastroenterologists consider LPR to be a substantially rare manifestation of gastroesophageal reflux disease (GERD), whereas otolaryngologists believe that LPR is an independent, but common in their practice, disorder. Patients suffering from LPR firstly consult their general practitioners, but a multidisciplinary approach may be fruitful to define a unified strategy based on specific medications and behavioural changes. The present Supplement would review the topic, considering LPR and GER characteristics, pathophysiology, diagnostic work-up, and new therapeutic strategies also comparing different specialist points of view and patient populations. In particular, new insights derive from an interesting gel compound, containing magnesium alginate and E-Gastryal® (hyaluronic acid, hydrolysed keratin, Tara gum, and Xantana gum). In particular, two very large Italian surveys were conducted in real-world setting, such as outpatient clinics. The most relevant outcomes are presented and discussed in the current Issue. Actually, laryngopharyngeal reflux (LPR) is considered an extraesophageal manifestation of the gastroesophageal reflux disease (GERD). Both GERD and its extraesophageal manifestation are very common in clinical practice. Both disorders have a relevant burden for the society: about this topic most of pharmaco-economic studies were conducted in the United States. In population-based studies, 19.8% of North Americans complain of typical symptoms of GERD (heartburn and regurgitation) at least weekly (1). Also in the late 1990s, GERD accounted for $9.3 to $12.1 billion in direct annual healthcare costs in the United States, higher than any other digestive disease. As a result, acid-suppressive agents were the leading pharmaceutical expenditure in the United States. The prevalence of GERD in the primary care setting becomes even more evident when one considers that, in the United States, 4.6 million office encounters annually are primarily for GERD, whereas 9.1 million encounters include GERD in the top 3 diagnoses for the encounter. GERD is also the most frequently first-listed gastrointestinal diagnosis in ambulatory care visits (2, 3) Extraesophageal manifestations of reflux, including LPR, asthma, and chronic cough, have been estimated to cost $5438 per patient in direct medical expenses in the first year after presentation and $13,700 for 5 years.

Evaluation of the effectiveness of a polyhexanide and propyl betaine-based gel in the treatment of chronic wounds.

AIM: The objective of this multicenter observational clinical study was to evaluate the therapeutic effects of a polyhexanide and propyl betaine-based gel in the treatment of patients of every age, affected by chronic skin wounds. METHODS: One hundred twenty-four patients (60% females, from 4-day-old to 91-year-old, mean age 59) were treated with polyhexanide/propyl betaine (Prontosan® Wound Gel, B. Braun) applied directly on the surface of the wound and in the possible undermining, in combination with a secondary dressing. At the baseline visit and at subsequent checks were evaluated the wound diameter and characteristics (the wound bed and the surrounding skin and edges appearance, level and type of exudate) and local pain at dressing change. RESULTS: The assessment and analysis between the initial visit and the final one showed the following results: the wound size and pain characteristics have decreased substantially and significantly (P<0.001) both in the size of the wounds (length: -17.5 ± 21.4 cm, width: -15.5 ± 21.1 cm; area: -8.3 ± 16.7 cm²) and in the intensity of pain perceived by the patient (Visual Analogue Scale [VAS]: -4.67 ± 2.7; Face, Legs, Activity, Cry, Consolability [FLACC] Scale <1 ± 4); for patients younger than 3 years, the scale used was FLACC. Wound bed: it was found a significant increase in the percentage of improvement in patients; 90% of them showed a reduction in the wound size, while 80% of them showed a relative reduction in pain compared with that observed during the baseline visit, with the wound bed cleansed, granulating or re-epithelializing. Just as significant was the decrease in percentage of subjects with wounds with fibrinous and partially necrotic bed, and/or with biofilm. Edges of the wound and periwound skin: the percentage of patients who have shown during the treatment an improvement in the clinical condition both of the wound edges and the surrounding skin has significantly increased, with a number of cases (75%) who have reached complete skin integrity. In a smaller percentage, already at the initial visit, the wound edges (28%) or the peristomal skin (18%) have been found undamaged. Exudate: there was a reduction in the level of exudate, with 74% of patients who showed no exudate at the final visit, compared with 15% of patients with non-exudative wounds at baseline. CONCLUSION: The treatment of chronic skin wounds through the use of a polyhexanide/propyl betaine-based gel, in combination with a secondary dressing, showed significant improvements, such as a 30% reduction of pain at dressing change, the reduction in the size and characteristics of the wounds and a reduction in the levels of exudate. All these factors have contributed to a reduction in the number of dressings, thus reducing the overall cost of treatment.

Specific immunotherapy in children: the evidence.

Specific immunotherapy (SIT) is the only treatment able to not only act on the symptoms of allergy but also act on the causes. At present, SIT may be administered in two forms: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). SCIT represents the standard modality of treatment while SLIT has recently been introduced into clinical practice and today represents an accepted alternative to SCIT. The main advantages of SIT that are lacking with drug treatment are long-lasting clinical effects and alteration of the natural course of the disease. This prevents the new onset of asthma in patients with allergic rhinitis and the onset of new sensitizations. The mechanism of action of both routes is similar; they modify peripheral and mucosal Th2-responses into a prevalent Th1-polarization with subsequent reduction of the allergic inflammatory reaction. Both have long-term effects for years after they have been discontinued, although for SLIT these evidences are insufficient. To date several guidelines have defined indications, controindications, side-effects, and clinical aspect for SCIT and SLIT. New forms of immunotherapy, allergen products and approaches to food allergy and atopic eczema represents the future of SIT.

Visual analogue scale assessment of nasal obstruction might define patients candidates to spirometry.

BACKGROUND: Asthma may be frequently associated with allergic rhinitis. Bronchial obstruction is a characteristic of asthma and spirometry is a cardinal step in asthma diagnosis. However, spirometry is rarely suitable in medical office. Visual Analogue Scales (VAS) is frequently used in common practice. OBJECTIVE: This study aimed at evaluating the suitability of the use of VAS assessment of nasal obstruction to define patients with allergic rhinitis candidates for spirometry. METHODS: 1728 patients with allergic rhinitis were consecutively evaluated. Clinical examination, skin prick test, VAS assessment, and spirometry were performed in all patients. RESULTS: 7.9% of patients had impaired FEV1 values and 24.5% had impaired FEF25-75 values. A VAS value < 3.3 might identify with good reliability patients with impaired FEF25-75 values, such as having initial bronchial airflow limitation. CONCLUSIONS: This study, performed in a large cohort of subjects, highlights the close link between upper and lower airways and shows the possible suitability of the use of nasal obstruction VAS assessment to define patients with allergic rhinitis candidates for spirometry.

Assessment of the bronchodilation test by visual analog scale in the selection of patients with rhinitis for screening spirometry.

BACKGROUND: The nose and bronchi are closely linked, and rhinitis often precedes the onset of asthma. Bronchial obstruction is a characteristic of asthma, and demonstration of its reversibility is a key element in diagnosis. However, reversibility testing requires a spirometer, which is rarely available in the doctor's office. Visual analog scales (VAS) are frequently used in daily practice. OBJECTIVE: This study evaluated the suitability of a VAS for assessing bronchodilation in patients with persistent allergic rhinitis as a means of selecting candidates for screening spirometry. METHODS: We evaluated 120 patients with moderate to severe persistent allergic rhinitis. All patients underwent a clinical examination, skin prick test, spirometry, bronchodilation test, and VAS. RESULTS: Patients with rhinitis showed significantly increased forced expiratory volume in the first second (FEV1) after the bronchodilation test (median, 11.5%). Positive results were observed in 60%, and VAS values increased (>30%) after the test. There was a significant relationship between deltaVAS and deltaFEV1 (P<.0001; r=0.482). CONCLUSION: This preliminary study shows that patients with moderate to severe persistent allergic rhinitis often experience an increase in FEV1 after the bronchodilation test. VAS assessment of the test might be useful when selecting candidates for spirometry for possible bronchial involvement.

Visual analogue scale assessment of respiration might be a surrogate for spirometry in allergic rhinitis.

Allergic rhinitis (AR) may be frequently associated with or precede asthma. Bronchial involvement in AR is usually detected by spirometry, however, spirometers are rarely available. The aim of this study is to verify the suitability of the use of visual analogue scales (VAS) as a surrogate for screening spirometry in assessing respiration in AR patients. One hundred twenty patients with allergic rhinitis were studied. VAS for respiration assessment and spirometry were performed in all patients. There was a significant, though weak, relationship between VAS assessment of respiration and FEV(1) (p=0.0076; r=0.244). In conclusion, this preliminary study suggests the use of VAS as screening to assess the respiration of patients with allergic rhinitis who may be candidates for spirometry.

Economic aspects of sublingual immunotherapy.

Allergic rhinitis and asthma have a very high prevalence and constitute a health problem with a relevant burden of disease, concerning medical and economical issues. Among the treatments of allergy, specific immunotherapy (IT) has the capacity to favourably alter the natural history of the disease both during and after its performance, and thus to reduce the direct and indirect costs of allergic rhinitis and asthma. A number of studies reported a cost reduction for traditional, subcutaneous IT (SCIT). We analyzed the available studies on economic evaluation of sublingual immunotherapy (SLIT) in children and adults. Articles were retrieved from Medline and Embase using the terms economic aspects, pharmacoeconomics, cost effectiveness, and sublingual immunotherapy. 18 articles were found in English language, 7 studies investigated the economic advantage of SLIT over standard drug treatment in subjects with respiratory allergy, and 2 of them included a comparison of costs of SCIT and SLIT. The data obtained provide evidence that SLIT is associated to economic advantages and/or monetary savings, specifically in terms of reduction of economic burden of the disease. Although the number of studies is still limited, the available data support a SLIT effect on sparing costs for respiratory allergy.

Pharmacoeconomics of subcutaneous allergen immunotherapy.

The current burden of allergic diseases, estimated by both direct and indirect costs, is very relevant. In fact the cost estimation for rhinitis amount globally to 4-10 billion dollars/year in the U.S. and to an average annual cost of 1089 euros per child/adolescent and 1543 euros per adult in Europe. The estimated annual costs in Northern America for asthma amounted to 14 billion dollars. Consequently, preventive strategies aimed at reducing the clinical severity of allergy are potentially able to reduce its costs. Among them, specific immunotherapy (SIT) joins to the preventive capacity the carryover effect once treatment is discontinued. A number of studies, mainly conducted in the US and Germany demonstrated a favourable cost-benefit balance. In the nineties, most surveys on patients with allergic rhinitis and asthma reported significant reductions of the direct and indirect costs in subjects treated with SIT compared to those treated with symptomatic drugs. This is fully confirmed in recent studies conducted in European countries: in Denmark the direct cost per patient/year of the standard care was more than halved following SIT; in Italy a study on Parietaria allergic patients demonstrated a significant difference in favor of SIT plus drug treatment for three years versus drug treatment alone, with a cost reduction starting from the 2nd year and increasing to 48% at the 3rd year, with a highly statistical significance which was maintained up to the 6th year, i.e. 3 years after stopping immunotherapy, corresponding to a net saving for each patient at the final evaluation of 623 euros per year; in France a cost/efficacy analysis comparing SIT and current symptomatic treatment in adults and children with dust mite and pollen allergy showed remarkable savings with SIT for both allergies in adults and children.

Economic evaluation of sublingual immunotherapy: an analysis of literature.

Allergic rhinitis and asthma constitute a global health problem because of their very high prevalence and the consequent burden of disease, concerning medical and economical issues. Among the treatments of allergy, specific immunotherapy has the capacity to favourably alter the natural history of the disease both during and after its performance and thus to reduce the direct and indirect costs of allergic rhinitis and asthma. A number of studies reported such cost reduction for traditional, subcutaneous immunotherapy and recent data demonstrate that also sublingual immunotherapy (SLIT) is associated to economic advantages and/or monetary savings, specifically in terms of reduction of disease economic burden. Only few formal economic assessments of SLIT have been carried out so far, this article will present and discuss the published studies addressed to this issue. The data obtained, although the number of studies is still limited, provide preliminary evidence supporting a SLIT effect on sparing costs for respiratory allergy.

Nasal endoscopy in asthmatic children: assessment of rhinosinusitis and adenoiditis incidence, correlations with cytology and microbiology.

BACKGROUND: Upper respiratory airway diseases may induce a worsening of asthma. Sinusitis represents one of the most common chronic diseases. The association of asthma and sinusitis varies greatly in different studies, depending on diagnostic procedures. OBJECTIVE: The aims were: (i) to demonstrate that nasal endoscopy may be easily feasible in asthma at paediatric age; (ii) to evaluate the incidence of rhinosinusitis and adenoiditis in children with asthma by nasal endoscopy; (iii) to correlate inflammatory parameters such as cytology and microbiological cultures with nasal endoscopy findings. SUBJECTS AND METHODS: One hundred and forty-five asthmatic children were evaluated, 48 males and 97 females, with an average age of 7.27 years. Evaluated parameters were the incidence of rhinosinusal infections in asthmatic children, and the role of: (i) nasal endoscopy, (ii) nasal cytology, and (iii) nasal microbiology in their diagnoses. RESULTS: Nasal endoscopy was successfully performed on 128 patients. Twenty-six children had endoscopic rhinosinusitis alone, 10 had adenoiditis alone, and 35 showed endoscopic rhinosinusitis associated with adenoiditis. There were significant correlations between endoscopic rhinosinusitis and adenoiditis (P < 0.001), between clinical and endoscopic rhinosinusitis (P < 0.001), between endoscopic rhinosinusitis and adenoiditis and microbiology (P < 0.05 and P < 0.0001, respectively), and between microbiology and cytology (P < 0.05). CONCLUSION: This study shows that rhinosinusal infections are common in asthmatic children. Moreover, nasal endoscopy might represent a fruitful tool in the management of asthmatic children.

Health-related quality of life assessment in young adults with seasonal allergic rhinitis.

BACKGROUND: In health-related quality of life (HRQL) studies on allergic rhinitis, both disease-specific and generic questionnaires have been extensively used. Seasonal allergic rhinitis (SAR) has been studied mainly by focusing on symptomatology. The present study aimed to evaluate the SAR-HRQL by means of two questionnaires, the Medical Outcome Study Short Form Health Survey (SF-36) and a new instrument examining satisfaction in 32 aspects of daily life: the Satisfaction Profile (SAT-P). METHODS: Thirty-three patients with SAR (aged 33.5+/-8.5 years; 12 men, 21 women) were evaluated during and 2 months after the pollen season. Data were compared with reference samples by t-test, and baseline and follow-up HRQL scores were compared by a matched-pair test. RESULTS: Patients' HRQL scores collected during the pollen season were significantly lower than reference sample data in many SF-36 scores and in one SAT-P item. No differences emerged between SF-36 and SAT-P scores collected outside the pollen season and reference sample scores. Compared to baseline, outside the pollen season, patients reported significantly higher scores in the following SF-36 scales: physical functioning (P=0.002), physical role (P=0.00001), bodily pain (P=0.01), and vitality (P=0.008); and significantly higher scores in only two SAT-P items (physical well-being [P=0.009] and resistance to stress [P=0.01]). CONCLUSIONS: Our data confirm the utility of using symptomatologic and health-status questionnaires in evaluating the HRQL of SAR patients. More general quality of life questionnaires may prevent the symptomatologic and functional problems from being adequately recognized and managed. SAT-P can be a fruitful additional tool in HRQL evaluation.