Benefits of a 3-week outpatient balneotherapy programme on patient-reported outcomes.

BACKGROUND: Analysis of the health profile of participants aged over 65 has been initiated in balneotherapy. AIMS: To determine the benefits of a 3-week outpatient balneotherapy program on patient-reported outcomes. METHODS: Our sample consisted of 1471 people. The average age of the study population was 72.5 years (± 5.1) and 67% of the participants were females. Symptoms intensity was measured by visual analogue scale, and health-related quality of life (HRQL) with the EQ5D questionnaire before and after the program. Changes of perceived functional status were rated using a 3-point Likert scale. RESULTS: The results indicated a significant increase in the fear of falling and a decrease in fatigue. EQ5D reveals a significant improvement after the program. The perceived change scores remained stable, except for anxiety/depression. CONCLUSIONS: The study indicated significant improvements of HRQL and a decrease of perception of fatigue and anxiety in elderly people participants in a 3-week balneological programme.

Measuring Active and Healthy Ageing: Applying a GENERIC Interdisciplinary Assessment Model Incorporating ICF.

OBJECTIVES: In this study we compared the chronological and bio-functional age between two German speaking cohorts 30 years apart applying a comprehensive and generic Active and Healthy Aging (AHA) assessment model incorporating ICF. METHODS: Single-centre, cross-sectional, observational, non-interventional, non-randomized trial at an University based women's hospital, division of Gynecological Endocrinology and Reproductive Medicine. All participants followed a standardized, holistic battery of biopsychosocial assessments consisting of bio-functional status (BFS), bio-functional age (BFA) and additional validated psychometric questionnaires. RESULTS: 462 non-pediatric, non-geriatric females were in the BeCS-14 cohort. The measured mean BFA was lower than the chronological age within the BeCS-14 cohort (regression coefficient 0.58) and comparable in the female LeCS-84 subcohort (regression coefficient age 0.85, communality age 76%). In detail, within the decades 35-45 years and 55-65 years the gradient of BFA increase (aging rate) was similar in both cohorts (decade 35-45 years: LeCS-84 4.08 ± 1.03 year equivalents and BeCS-14 4.78 ± 1.67 year equivalents; decade 55-65 years: LeCS-84 6.21 ± 1.29 year equivalents and BeCS-14 5.25 ± 1.18 year equivalents). Remarkably, within the LeCS-84 cohort the mean aging rate within the decade 45-55 years was significantly different from all other aging rates in both cohorts: 13.02 ± 1.05 year equivalents. However, within the BeCS-14 cohort the corresponding value was 4.83 ± 1.02 year equivalents thus indicating a continuous aging process across the adult life course. In BeCS-14, there was a significant age-related effect for cardiovascular performance and social stress exposition and younger age was associated with better cardiovascular performance while level of social stress exposition decreased in aging women. CONCLUSION: When comparing BeCS-14 and LeCS-84, the aging process seemed to be accelerated in women in LeCS-84 between 45 and 54 years of age. We can only speculate on the reasons, such as differences in the health care, political and social system. However, the differences observed support the use of our BFS/BFA assessment tool not only on an individual level (strengths/resources) but also population level following EIP-AHA requirements. Yet, it remains to be developed how the assessed health strengths/resources-profile may be integrated into AHA management.

Combining balneotherapy and health promotion to promote active and healthy ageing: the Balaruc-MACVIA-LR® approach.

Scaling up and replication of successful innovative integrated care models for chronic diseases is one of the targets of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA). MACVIA-LR® (MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon) is a Reference Site of the EIP on AHA. The main objective of MACVIA-LR® is to develop innovative solutions in order to (1) improve the care of patients affected by chronic diseases, (2) reduce avoidable hospitalization and (3) scale up the innovation to regions of Europe. The MACVIA-LR® project also aims to assess all possible aspects of medicine-including non-pharmacologic approaches-in order to maintain health and prevent chronic diseases. These approaches include hydrotherapy and balneotherapy which can be of great importance if health promotion strategies are considered. Balneotherapy at Balaruc-les-Bains focusses on musculoskeletal diseases and chronic venous insufficiency of the lower limbs. Each year, over 46,000 people attend an 18-day course related to a new falls prevention initiative combining balneotherapy and education. On arrival, each person receives a flyer providing information on the risk of fall and, depending on this risk, a course is proposed combining education and physical activity. A pilot study assesses the impact of the course 6 and 12 months later. This health promotion strategy for active and healthy ageing follows the FEMTEC (World Federation of Hydrotherapy and Climatotherapy) concept.

Efficacy and safety of the probiotic Lactobacillus paracasei LP-33 in allergic rhinitis: a double-blind, randomized, placebo-controlled trial (GA2LEN Study).

BACKGROUND/OBJECTIVES: An imbalance between Th1 and Th2 cells is involved in allergic rhinitis (AR) that may be improved by probiotics. To test the efficacy of the probiotic Lactobacillus paracasei subsp. paracasei LP-33, a double-blind, placebo-controlled, randomized trial was carried out in patients with AR to grass pollen treated with loratadine and presenting altered quality of life. SUBJECTS/METHODS: Subjects with persistent AR, symptomatic during the grass pollen season, and a positive skin test or specific immunoglobulin E to grass pollens were included by general practitioners (GPs). All received loratadine for 5 weeks. The primary end point was the improvement in Rhinitis Quality of Life (RQLQ) global score at the fifth week of LP-33 consumption compared with placebo (in addition to loratadine). Secondary end points included nasal and ocular symptoms (individual and total symptom scores), visual analogue scale and time of first exacerbation of the symptoms when loratadine was stopped. RESULTS: A total of 425 subjects were included. Using intent-to-treat analysis, the RQLQ global score decreased significantly more in the LP-33 group than in the placebo group (P=0.0255, difference=-0.286 (95% confidence interval (CI): -0.536; -0.035)). No significant differences were noted for the change of the rhinitis total symptom score 5 global score between groups (P=0.1288, difference=-0.452 (95% CI: -1.036; 0.132)). Significant differences in ocular symptoms (RQLQ) were observed between groups (P=0.0029, difference=-0.4087 (95% CI: -0.6768; -0.1407)). CONCLUSIONS: This study performed by GPs shows that LP-33 improves the quality of life of subjects with persistent AR who are currently being treated with an oral H1-antihistamine. Whereas nasal symptoms had not changed, ocular symptoms had consistently improved.

Epidemiology of cypress pollen allergy in Montpellier.

BACKGROUND: Cupressaceae pollen allergy is a worldwide winter pollinosis. Exposure to cypress pollen has increased enormously during recent decades, and cypress pollen allergy has become a major health problem, especially in Mediterranean countries. OBJECTIVES: We aimed to evaluate the prevalence of cypress pollen sensitization and allergy in the Montpellier area and the symptoms presented by sensitized patients. METHODS: We included all 6185 consecutive patients who were referred to our center for any allergic disorder during a 36-month period. For each patient, we evaluated skin prick test results, allergy symptoms, pulmonary function test results, and the need for allergen immunotherapy. RESULTS: We found that 20.7% of patients were sensitized to cypress pollen and 46.4% presented symptoms during the pollen season. The main symptoms were rhinoconjunctivitis and asthma. Oral allergy syndrome to peach was detected in 4% of sensitized and symptomatic patients. Allergen immunotherapy was necessary to control symptoms in 57.9% of cases. CONCLUSIONS: Cypress pollen allergy is one of the leading causes of respiratory allergy in the Montpellier area. Symptoms are often severe and include pollen-induced asthma. Moreover,many patients need allergen immunotherapy in order to achieve better control of their symptoms.

Prevention and control of childhood asthma and allergy in the EU from the public health point of view: Polish Presidency of the European Union.

The leading priority for the Polish Presidency of the Council of the European Union was to reduce health inequalities across European societies, and, within its framework, prevention and control of respiratory diseases in children. This very important paper contain proposal of international cooperation on the prevention, early detection and monitoring of asthma and allergic diseases in childhood which will be undertaken by the EU member countries as a result of EU conclusion developed during the Polish Presidency of the Council of the European Union. This will result in collaboration in the field of chronic diseases, particularly respiratory diseases, together with the activity of the network of national institutions and NGOs in this area. Paper also contains extensive analysis of the socio-economic, political, epidemiological, technological and medical factors affecting the prevention and control of childhood asthma and allergy presented during Experts presidential conference organized in Warsaw-Ossa 21-22 September 2011.

Increased risk of asthma attacks and emergency visits among asthma patients with allergic rhinitis: a subgroup analysis of the investigation of montelukast as a partner agent for complementary therapy [corrected].

BACKGROUND: Inadequately controlled allergic rhinitis (AR) in asthmatic patients can contribute towards increased asthma exacerbations and poorer symptom control, which may increase medical resource use. We assessed asthma-related medical resource use and attacks in asthmatic patients who did and did not have concomitant AR and were adding montelukast or salmeterol to baseline treatment with inhaled fluticasone. METHODS: A post hoc resource use analysis of a 52-week, double-blind multicentre clinical trial (Investigation of Montelukast as a Partner Agent for Complementary Therapy) [corrected] including 1490 adults with chronic asthma, aged 15-72 years, with FEV(1) 50-90% of predicted and > or =12% increase in FEV(1) after salbutamol administration, treated with either montelukast 10 mg daily or salmeterol 50 microg twice daily in addition to fluticasone 200 microg, was undertaken. Asthma-related medical resource use included medical visits (defined as either an unscheduled visit [to a general practitioner, a specialist or a non-medical provider] or a specialist visit), emergency room visits and hospitalizations during follow-up. Asthma attacks were defined as the worsening of asthma requiring unscheduled visit, emergency visit, hospitalization or oral/intravenous/intramuscular corticosteroids. RESULTS: A self-reported history of concomitant AR was identified in 60% of the patients (n=893). Univariate analysis suggests that significantly more patients with concomitant AR experienced emergency room visits (3.6% vs. 1.7%, P=0.029) and asthma attacks (21.3% vs. 17.1%, P=0.046). Multivariate analysis adjusting for treatment group, age and baseline asthma severity confirmed these results since the presence of concomitant AR in patients with asthma increases the likelihood of emergency room visit (odds ratio (OR)=2.35, 95% confidence interval (CI)=1.12-4.80) and asthma attack (OR=1.35, 95% CI=1.03-1.77). Patients with asthma alone compared with patients with both conditions did not differ in terms of unscheduled or specialist visits and hospitalizations. CONCLUSIONS: Presence of self-reported concomitant AR in patients with asthma resulted in a higher rate of asthma attacks and more emergency room visits compared with asthma patients without concomitant AR.

Characteristics of intermittent and persistent allergic rhinitis: DREAMS study group.

BACKGROUND: In the Allergic Rhinitis and its Impact on Asthma (ARIA) classification, intermittent and persistent rhinitis were proposed to replace seasonal and perennial allergic rhinitis (AR). AIM: To better understand the ARIA classification of rhinitis. METHODS: A cross-sectional study was carried out in 591 patients consulting ENT or allergy specialists for AR and 502 control subjects. The diagnosis of AR was based on a score for allergic rhinitis (SFAR) > or =7. Patients were classified according to the four ARIA classes (mild intermittent, mild persistent, moderate/severe intermittent and moderate/severe persistent). Allergen sensitization (skin prick tests (SPTs) or specific IgE) and co-morbidities were examined according to the ARIA classes. RESULTS: Ten percent of patients had mild intermittent rhinitis, 14% mild persistent rhinitis, 17% moderate/severe intermittent rhinitis and 59% moderate/severe persistent rhinitis. Most patients with intermittent rhinitis had a pollen sensitivity, but 5% had a single house dust mite (HDM) sensitization. Over 50% of patients with persistent rhinitis were allergic to pollens or HDM. Asthma was present in 24% of rhinitis patients and in only 2% of the control population (P<0.0001). Patients with moderate/severe persistent rhinitis had the highest asthma prevalence (33%). DISCUSSION: Intermittent and persistent rhinitis are not synonymous of seasonal and perennial rhinitis. Most patients consulting specialists have severe rhinitis. Asthma prevalence increases with duration and severity of rhinitis supporting the ARIA major recommendation that patients with persistent rhinitis should be evaluated for asthma.

Sinus CT scans and mediator release in nasal secretions after nasal challenge with cypress pollens.

BACKGROUND: Involvement of paranasal sinuses has been suggested in allergic rhinitis but not clearly demonstrated. AIMS: To investigate the relationship between intermittent allergic rhinitis and computerized tomography (CT). METHODS: Twenty patients with intermittent rhinitis and sensitized to cypress pollens underwent unilateral nasal provocation tests (NPTs) using increasing concentrations of cypress pollens out of the pollen season. Sinus CT-scans were carried out just before a NPT and 24 h later. Nasal lavage was carried out just before a NPT, 30 min after a positive challenge and again 24 h later. Leucotriene C4/D4, intracellular adhesion molecule-1 and eosinophil cationic protein were measured in nasal secretions. RESULTS: Thirteen patients (65%) showed an alteration in their CT-scans after allergen challenge. Ten of them showed sinus changes controlateral to their allergenic provocation. Radiological changes mainly affected the osteomeatal complex and the ethmoid sinuses. Pre-existing abnormalities (13 of 20 cases) mainly concerned the maxillary sinuses. There was no correlation between CT-scan abnormalities and levels of mediators released in nasal secretions. CONCLUSIONS: We have shown that nasal allergen challenge can produce radiological changes in the paranasal sinuses. This mainly concerned the ethmoid sinuses.

Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma.

With new drugs being introduced to treat asthma it is timely to review criteria that can be used to assess efficacy in clinical trials. Anti-asthma drugs are classified into symptoms-modifying, symptom preventers and disease modifying agents. Attention is drawn to the types of experimental evidence required in preclinical studies to support further clinical development of a new therapy. Clinical trials demand careful selection of patients to maximise the strength of the efficacy signal according to the type of trial being designed. While provocation tests are useful in suggesting efficacy, negative tests do not necessarily indicate lack of anti-asthma activity. Therapeutic trial designs need to take account of duration of treatment, dose-response relationships and confirmatory trials. Outcome measures include symptoms, lung function, reduction in concomitant medication, exacerbations, quality of life and measures of inflammation. Interpretation of results need to include the clinical relevance of any changes as well as statistical significance. Special consideration needs to be given to the evaluation of drugs for acute severe asthma, asthma in children and older people, co-morbidity such as rhinitis, and inhaler devices. As with all drugs introduced into practice, careful attention needs to be paid to both short- and long-term safety.

Basophil activation during pollen season in patients monosensitized to grass pollens.

BACKGROUND: Basotest is a new basophil-activation test based upon the expression of CD63 (gp53) in the presence of allergens. It is an effective diagnostic test for pollen-allergic patients. However, it is not known whether Basotest results differ during the pollen season. METHODS: We examined the activation of basophils by Basotest in 13 patients sensitized only to grass pollen, before and during the pollen season, in order to assess whether Basotest could be used as a diagnostic test during the pollen season. Dose-response curves with 10-fold increasing concentrations of timothy grass pollen (10-4 to 100 AU) were carried out. RESULTS: Basophils were not activated spontaneously during the pollen season since the CD63 expression was below detectable levels before in vitro cell activation. A decreased percentage of activated basophils at the peak of activation was found in comparing the pre- and in-season tests, but all patients had a positive test. When basophil activation was at its peak, the allergen concentration was similar during the two periods. Moreover, the median area under the curve was significantly (P < 0.02) reduced during the season as compared to before the season. CONCLUSION: Basotest can therefore be used as a diagnostic test during the pollen season, but the allergen exposure needs to be characterized if quantitative studies are performed.

Montelukast or salmeterol combined with an inhaled steroid in adult asthma: design and rationale of a randomized, double-blind comparative study (the IMPACT Investigation of Montelukast as a Partner Agent for Complementary Therapy-trial).

Asthma patients who continue to experience symptoms despite taking regular inhaled corticosteroids represent a management challenge. Leukotrienes play a key role in asthma pathophysiology, and since pro-inflammatory leukotrienes are poorly suppressed by corticosteroids it seems rational to add a leukotriene receptor antagonist (LTRA) when a low to moderate dose of inhaled corticosteroids does not provide sufficient disease control. Long acting beta2-agonist (LABA) treatment represents an alternative to LTRAs and both treatment modalities have been shown to provide additional disease control when added to corticosteroid treatment. To compare the relative clinical benefits of adding either a LTRA or a LABA to asthma patients inadequately controlled by inhaled corticosteroids, a randomized, double-blind, multi-centre, 48-week study will be initiated at approximately 120 centres throughout Europe, Latin America, Middle East, Africa and the Asia-Pacific region in early 2000. The study will compare the oral LTRA montelukast with the inhaled LABA salmeterol, each administered on a background of inhaled fluticasone, on asthma attacks, quality of life, lung function, eosinophil levels, healthcare utilization, and safety, in approximately 1200 adult asthmatic patients. The requirements for study enrollment include a history of asthma, FEV1 or PEFR values between 50% and 90% of the predicted value together with > or = 12% improvement in FEV1 after beta-agonist administration, a minimum pre-determined level of asthma symptoms and daily beta-agonist medication. The study will include a 4-week run-in period, during which patients previously taking inhaled corticosteroids are switched to open-label fluticasone (200 microg daily), followed by a 48-week double-blind, treatment period in which patients continuing to experience abnormal pulmonary function and daytime symptoms are randomized to receive montelukast (10 mg once daily) and salmeterol placebo, or inhaled salmeterol (100 microg daily) and montelukast placebo. All patients will continue with inhaled fluticasone (200 microg daily). During the study, asthma attacks, overnight asthma symptoms, and morning peak expiratory flow rate will be assessed using patient diary cards; quality of life will also be assessed using an asthma-specific quality-of life questionnaire. The results of this study are expected to provide physicians with important clinical evidence to help them make a rational and logical treatment choice for asthmatic patients experiencing breakthrough symptoms on inhaled corticosteroids.

A comparison of topical mequitazine and disodium cromoglycate in allergic conjunctivitis induced by a specific conjunctival provocation test.

PURPOSE: Twenty-two people with a history of grass pollen allergic conjunctivitis were enrolled outside the pollen season in this study to compare the efficacy of 0.05% mequitazine eyedrops with topical 2% disodium cromoglycate. METHODS: This randomized, double-blind study compared right and left eyes. Subjects received 2% disodium cromoglycate eyedrops in one eye and mequitazine vehicle in the fellow eye 4 times daily for 4 days. For the last instillation, mequitazine vehicle was replaced by one drop of 0.05% mequitazine and 15 min later a conjunctival provocation test (CPT) with grass pollen was performed. RESULTS: The sum of the scores for hyperemia and itching, and total composite score were lower after 0.05% mequitazine than after 2% disodium cromoglycate (p < 0.0001 in each case). The allergen threshold dose which elicited a positive allergic response was higher in the mequitazine group (p < 0.001). Both treatments showed good tolerance upon instillation. No adverse events related to study treatment occurred. CONCLUSIONS: These results demonstrate the superior efficacy of a single drop of 0.05% mequitazine 15 min before CPT compared with 2% disodium cromoglycate 4 times daily for 4 days.

In vitro diagnosis of cypress pollen allergy by using cytofluorimetric analysis of basophils (Basotest).

BACKGROUND: Cupressaceae pollen allergy is a worldwide pollinosis, but its in vitro diagnosis is notoriously difficult. The Basotest is a newly available in vitro test for the detection of allergen-specific IgE based on the level of cellular activation of basophils by using flow cytometry. OBJECTIVES: The Basotest was compared with the measurement of cypress pollen-specific IgE in highly selected patients. METHODS: We analyzed 34 patients allergic to cypress pollen selected on the basis of a suggestive clinical history and positive skin test and nasal challenge responses to cypress pollen extract. We also analyzed 8 patients with positive skin test responses to cypress pollen extract who did not present symptoms during the pollen season (intermediate group) and 33 control subjects. Sensitivity, specificity, and efficiency of the Basotest and serum-specific IgE levels measured by using the CAP System were determined in patients allergic to cypress pollen. Histamine release was studied in a selected group of patients. RESULTS: The Basotest was more sensitive (91.2%) than the CAP System (76%) for the in vitro diagnosis of cypress pollen allergy. A dose-response curve was observed in basophils obtained from patients allergic to cypress pollen. There were no false-positive results with either test (specificity 100%). The results of the Basotest or those of the CAP System did not correlate with the patients' in vivo threshold sensitivity assessed by skin tests and nasal challenge. CONCLUSIONS: The Basotest was found to be an effective diagnostic test in patients allergic to cypress pollen.

Clinical efficacy of sublingual-swallow immunotherapy: a double-blind, placebo-controlled trial of a standardized five-grass-pollen extract in rhinitis.

Sublingual-swallow immunotherapy (SLIT) using high doses of standardized allergen extracts has been found to be effective in reducing allergic symptoms and medication needs. A double-blind, placebo-controlled study was carried out in a large number of patients to determine whether medication needs can be reduced by SLIT. Some 136 patients with grass-pollen rhinitis with or without mild asthma were studied. Patients received either placebo or SLIT with a standardized grass-pollen extract administered daily with increasing doses up to 300 IR (index of reactivity) from January to the end of July 1994. During the grass-pollen season, patients were instructed to use medications as required and to visit their doctors in case of asthma. Symptom-medications scores were assessed during the pollen season, and serum-specific IgG4 was measured before and at the end of SLIT. In the SLIT group, drug consumption dropped significantly throughout the pollen season (P < 0.02). Moreover, at the peak of the pollen season, betamethasone consumption was significantly reduced in the SLIT group (P < 0.02). Only one patient in the SLIT group had an asthma attack compared to eight patients in the placebo group (P < 0.02). IgG4 levels increased significantly in the SLIT group (P < 0.001) but without correlation with symptoms. Side-effects were comparable in both groups. This study indicates that SLIT in grass-pollen rhinitis is well tolerated, improves overall clinical symptoms, and reduces drug consumption and the need for oral corticosteroids.

[Does neoadjuvant radiochemotherapy augment the resectability of pancreatic cancers?]. / La radiochimiothérapie néoadjuvante augmente-t-elle la résécabilité des cancers du pancréas?

PURPOSE OF THE STUDY: Pre-operative radiochemotherapy is the most recent therapeutic option in the pre-operative downstaging of pancreatic cancer and in decreasing the rate of positive resection margins. The purpose of the study was to evaluate tolerance and efficacy of pre-operative radiochemotherapy in unresectable pancreatic cancers. MATERIAL AND METHODS: This study included seven cases of pancreatic cancer considered unresectable. The patients received preoperatively 50 grays within a 5-week period associated with 5 FU and Platin during the 1st and 5th weeks. RESULTS: After radiochemotherapy, tomodensitometric evaluation showed a minor response in two cases. A pancreatico-duodenectomy could be performed in these two patients without any increase of pre- or post-operative morbidity or mortality. CONCLUSIONS: The results of the study suggest that preoperative radiochemotherapy may increase pancreatic cancer resectability. This hypothesis should be confirmed by a prospective randomised trial.

Efficacy of mequitazine in comparison with placebo assessed by ocular challenge with allergen in allergic conjunctivitis.

Pharmacologic intervention in the management of allergic conjunctivitis was evaluated with different topical ocular agents in man. Their effect can be precisely assessed with the conjunctival provocation test (CPT). A potent specific H1-receptor antagonist, 0.05% mequitazine eye-drops, was tested in a double-blind randomized, placebo-controlled study using CPT with grass pollen allergens. Twenty healthy subjects allergic to grass pollen were included outside the pollen season after a positive CPT screening. They received one drop of 0.05% mequitazine in one eye and the vehicle in the contralateral eye in a random order, four times daily for 5 days. CPT was performed 15 min after the last instillation, and the threshold dose inducing a positive reaction was determined. Results were given by Abelson's composite score including redness, chemosis, tearing, and itching. Topical 0.05% mequitazine significantly reduced the composite score compared to placebo. The allergen threshold concentration which induced the positive conjunctival reaction was higher in mequitazine pretreated eyes. No side-effect was reported. These data clearly suggest that mequitazine has potential to treat allergic conjunctivitis.