Bleomycin electrosclerotherapy (BEST) for the treatment of vascular malformations. An International Network for Sharing Practices on Electrochemotherapy (InspECT) study group report.

BACKGROUND: Biomedical applications of electroporation are expanding out of the field of oncology into vaccination, treatment of arrhythmias and now in the treatment of vascular malformations. Bleomycin is a widely used sclerosing agent in the treatment of various vascular malformations. The application of electric pulses in addition to bleomycin enhances the effectiveness of the drug, as demonstrated by electrochemotherapy, which utilizes bleomycin in the treatment of tumors. The same principle is used in bleomycin electrosclerotherapy (BEST). The approach seems to be effective in the treatment of low-flow (venous and lymphatic) and, potentially, even high-flow (arteriovenous) malformations. Although there are only a few published reports to date, the surgical community is interested, and an increasing number of centers are applying BEST in the treatment of vascular malformations. Within the International Network for Sharing Practices on Electrochemotherapy (InspECT) consortium, a dedicated working group has been constituted to develop standard operating procedures for BEST and foster clinical trials. CONCLUSIONS: By treatment standardization and successful completion of clinical trials demonstrating the effectiveness and safety of the approach, higher quality data and better clinical outcomes may be achieved.

Chronic cough in adults: recommendations from an Italian intersociety consensus.

BACKGROUND: Chronic cough (CC) is a burdensome health problem in adult and older people, with a major impact on quality of life. Its management is often troublesome, and many guidelines have been released. Notwithstanding, a proportion of cases still do not reach a definite diagnosis and resolutive treatment. A coordinated approach between different specialists would be highly recommended, but its implementation in clinical practice suffers from the lack of shared protocols and poor awareness of the problem. The present consensus document has been implemented to address these issues. AIMS: To develop evidence-based recommendations for the management of adults with CC. METHODS: A 12-member expert task force of general practitioners, geriatricians, pneumologists, allergologists, otorhynolaringologists and gastroenterologists was established to develop evidence-based recommendations for the diagnostic and therapeutic approach to subjects with CC. A modified Delphi approach was used to achieve consensus, and the US Preventive Services Task Force system was used to rate the strength of recommendations and the quality of evidence. RESULTS: A total of 56 recommendations were proposed, covering 28 topics and concerning definitions and epidemiology, pathogenesis and etiology, diagnostic and therapeutic approach along with the consideration of specific care settings. CONCLUSION: These recommendations should ease the management of subjects with CC by coordinating the expertise of different specialists. By providing a convenient list of topics of interest, they might assist in identifying unmet needs and research priorities.

Coughing Can Be Modulated by the Hydration Status in Adolescents with Asthma.

A lower thirst sensitivity frequently characterizes children and adolescents. The daily water intake can be frequently insufficient for the homeostasis and the integrity of their airway epithelium. Little is known about the real-life relationship between dehydration and coughing in young students with asthma. The aim was to investigate the effect of dehydration on coughing in asthmatic students aged ≤16 years. A validated questionnaire aimed to investigate their respiratory history and cough incidence was used. Urine samples were also collected for assessing osmolality. Wilcoxon test, the Pearson Chi Square and the Fisher Exact Test were used; p < 0.05 was assumed as significant. Valid data were obtained from 305 healthy and 56 asthmatic students. Mean urine osmolality was significantly higher in asthmatic than in healthy students (1012 ± 197.7 vs. 863.0 ± 223.0 mOsm/kg, respectively; p < 0.001), particularly in symptomatic asthmatic students (1025 ± 191.6 mOsm/kg, p < 0.01). Both the incidence and duration of coughing episodes were directly related to the degree of urine osmolality (both p < 0.001). Dehydration affects the prevalence and the duration of a cough in asthmatic students aged ≤16 years. Adequate daily water intake should be stimulated in these subjects in order to contain their basic cough attitude.

Bleomycin electrosclerotherapy in therapy-resistant venous malformations of the body.

OBJECTIVE: Bleomycin is one of the most commonly used agents in sclerotherapy for slow-flow vascular malformations worldwide. However, its efficiency remains unknown. The objective of the present study was to assess whether reversible electroporation combined with bleomycin would increase the sclerotherapy effect in patients with previously unsuccessfully treated venous malformations (VMs). METHODS: We performed, to the best of our knowledge, the first retrospective observational case series from January 2019 to January 2020 of 17 patients (20 lesions) with symptomatic VMs, who had previously undergone at least two unsuccessful invasive treatments. Reversible electroporation was performed with various electrodes and directly injected bleomycin. All patient records, magnetic resonance imaging data, documentation of previous treatments, and data regarding the intervention, complications, and clinical symptoms were analyzed. RESULTS: The 17 VM patients (mean age, 20.8 ± 8.2 years; 9 females) had previously undergone an average of 4.2 invasive treatments. These patients had subsequently undergone 22 electrosclerotherapy sessions of 20 lesions. The median dose of bleomycin was 3 mg. The median magnetic resonance imaging-derived lesion volume before treatment was 24.9 cm3, which had decreased by 86% to 3.5 cm3 after treatment. After 3.7 months, eight patients were asymptomatic without residual symptoms and nine patients showed improvement. CONCLUSIONS: Bleomycin electrosclerotherapy appears to be an effective therapy for patients with VMs resistive to previous invasive therapy. Because of the small sample size and short follow-up period, our results should be examined further using a larger patient population.

Balneotherapy and hydrotherapy in chronic respiratory disease.

Chronic respiratory diseases (CRD) belong to major noncommunicable diseases (NCD) targeted by World Health Organization (WHO) NCD Action Plan and United Nations (UN) Sustainable Development Goal (STG) 3.4 to achieve 30% decline of mortality by the year 2030. Strong evidence is now available in the literature for therapeutic aquatic exercise interventions in improving health status of chronic obstructive pulmonary diseases (COPD) patients. However, gym-based exercises can be difficult for patients with COPD who are mainly elderly and often have co-morbidities-such as severe arthritis and obesity-which may impair their ability to exercise at an adequate intensity. Besides improving respiratory function and health status in COPD, exercise in water helps overcoming patient's fears and promote socialization, contrasting the risk of depression, which is a major condition often associated with long term COPD condition. Susceptibility to respiratory infections plays a role in exacerbations of COPD. Sulphur-rich water inhalations improve muco-ciliary clearance, reduce inflammatory cytokines production and inflammatory mucosal infiltration, reduce elastase secretion by neutrophils, preserving elastic properties of pulmonary interstitium and thus facilitating expectoration. Repeated cold water stimulations in COPD also reduce frequency of infections. Finally, sauna bathing reduces the risk of pneumonia. On the other side, hydrotherapy/balneotherapy also help obesity control, which is one of the most difficult NCD risk factors to modify and consequently is an important component of the WHO preventive strategy to achieve STG 3.4. Along with high prevalence and mortality, CRD cause increasing pharmaceutical and hospital costs. In this perspective, Health Resort Medicine should not be ignored as a resource in the WHO NCD strategy and Universal Health Coverage, providing a multi-stakeholder platform (including the network of health resorts and their facilities) able to give a real help to the achievement of UN goal STG 3.4 by the year 2030.

Acute cough in Italian children: parents' beliefs, approach to treatment, and the family impact.

BACKGROUND: Acute cough is the most common symptom among children in primary care, but the impact of cough episodes was never investigated in Italian families. METHODS: A cross-sectional telephone survey was conducted on a representative sample of Italian families, randomly selected from general population; a specific and validated questionnaire was used. RESULTS: The sample (604 calls) was uniform by geographical distribution, and by children age and gender. Mean cough episode was 3.1/year, they were short lasting (only 4.7% > 2 weeks). Independent predictors of children cough episodes were parents' active smoking habit and work (p < 0.05). The mean nursery/school absenteeism was mostly < 7 days, but of a 7-15-day duration in near 30% of cases. The pediatrician was contacted immediately only by 25% of parents and a second consultation (mostly a lung physician) usually occurred after 2-3 weeks of cough. Meanwhile, home/pharmacist suggested remedies were adopted in 50-70% of cases. Usual prescriptions were mucolytics (85.8%), antitussive agents (55.6%), non-steroideal anti-inflammatory drugs (33.8%), antibiotics (regularly or episodically 80%), and corticosteroids (systemic steroids in less than 50%, but via aerosol in more than 80% of cases). Moreover, pediatricians claimed to use homeopathic drugs regularly or episodically in almost 50%. The respondents' willingness to spend out-of-pocket for an "effective remedy" against cough was of € 20 (>€ 30 in 18.4% of cases). CONCLUSIONS: Parents' actions against cough episodes were variable, depending on their beliefs, smoking habit, and occupational status. The parents' perceived efficacy of usual prescriptions is poor, and their willingness to pay out-of-pocket for an "effective remedy" against cough is high. The interest for alternative treatments is not negligible in these circumstances.

Antitussive therapy: A role for levodropropizine.

Cough is a protective reflex that serves to clear the airways of excessive secretions and foreign matter and which sometimes becomes excessive, and troublesome to patients. Cough is one of the most common reasons why individuals seek medical attention. A range of drugs have been developed in the past with antitussive activity and different mechanisms of action, but there are still very few safe and effective treatments available. The poor tolerability of most available antitussives is closely related to their action on the central nervous system (CNS). An international group of experts specialized in cough met to discuss the need to identify an effective antitussive treatment with a good tolerability profile. The aim of this expert review is to increase the knowledge about the cough mechanism and the activity of levodropropizine, a peripherally acting antitussive drug.

Influenza and influenza-like syndromes: the subjects' beliefs, the attitude to prevention and treatment, and the impact in Italian general population.

BACKGROUND: Influenza and influenza-like syndromes (I-LSs) are infectious diseases occurring on a seasonal basis which can lead to upper (URTI) and lower respiratory tract illness (LRTI) of different severity. The approach to these disorders is unfortunately not uniform. Aim of the study was to investigate real-life people beliefs, the attitude to their prevention and treatment, and their impact in general population. METHODS: A cross-sectional survey via Computer Assisted Telephone Interview (CATI) was carried out using a specific questionnaire investigating influenza episode rates, subjects behavior in case of influenza and I-LSs, and prescribed therapy. RESULTS: 1,202 subjects completed the questionnaire: median age was 46, 49% male, 20% active smokers. 57% of respondents experienced at least one episode of influenza or I-LS in the previous 12 months; episodes were usually home-managed, shorter than 2 weeks and more frequent in fall and winter (73% of the total). GP resulted the first health-care option (56%); almost 3% of respondents referred to the emergency room, and hospitalization occurred in 1%. Mucolytics resulted the most prescribed drugs (55%) followed by antibiotics and aerosol therapy (37-38%). Even if more than 70% of subjects considered vaccination essential, only 14% received influenza vaccination yearly and almost 60% had never received vaccination. Approximately 36% of respondents regarded homeopathy (namely Oscillococcinum) as an helpful alternative because of perceived as safer. CONCLUSIONS: Seasonal prevalence of I-LSs and influenza partially overlap. As virus identification is not a common procedure in daily practice, only a clinical discrimination is possible. Antibiotic prescription is still too high and largely inappropriate. Influenza vaccination is strongly encouraged, but different strategies are also used. Other approaches are receiving increasing attention in general population, and subjects' willingness to spend out-of-pocket for effective remedies is also increasing. The discrepancy between subjects' beliefs and health care actions likely reflects the insufficiency of institutional preventive strategies. In general, the approach to influenza and I-LSs appear variable and highly dependent of subjects' and their GPs' cultural beliefs.

Bronchodilator therapy for chronic cough.

Experimental studies indicate that airway calibre increases the sensitivity of the afferents involved in the cough reflex but it has proved difficult to demonstrate that airway calibre increases the sensitivity of the afferents involved in the cough reflex. Therefore, bronchodilators might have a role, although rather minor, in the treatment of cough. However, although bronchodilators represent the standard of care in the treatment of airway obstruction associated with asthma or COPD, controversy persists regarding the mechanism(s) by which these agents alleviate cough. Furthermore, the available evidence indicates that the effects of bronchodilators on cough are rather inconsistent in humans and casts doubt on the appropriateness of the common practice of using bronchodilators in the treatment of patients with cough without any other evidence of airway obstruction. Regrettably, appropriate long-term trials specifically aimed at evaluating the clinical efficacy of bronchodilators in pathologic cough have not yet been performed. Therefore, properly executed clinical studies of bronchodilators in various types of acute and chronic pathologic cough are required.

Survey on attitudes of Italian pediatricians toward cough.

CONTEXT: Children's cough is a daily concern for most pediatricians. The management of both acute and chronic cough requires a systematic and comprehensive approach. Despite the approved protocols for management, the pediatric assessment of cough and the corresponding prescribing attitude frequently do not fit these protocols, which can be affected by parental suggestions - sometimes substantially. OBJECTIVE: The objective of this study was to investigate both the perception and the behavior of a representative sample of Italian pediatricians toward cough in real life. METHODS: A specific questionnaire consisting of 18 questions was prepared. The questionnaire was completed by 300 pediatricians (all members of PAIDOSS: Italian National Observatory on Health of Childhood and Adolescence) who represented ~300,000 children. RESULTS: A vast majority of children have cough throughout the year (99.3% of respondents have cough during autumn/winter and 64.7% in spring/summer). Allergic disease is the most frequent suspected cause of chronic cough in children (53%), and this is supported by the high demand for consultations: 73% seek the opinion of allergologists, 62% of otorhinolaryngologists and only 33% of pulmonologists. The majority of pediatricians (92%) reported that they prescribe therapy in acute cough regardless of cough guidelines. Moreover, the survey pointed out the abuse of aerosol therapy (26% in acute cough and 38% in chronic cough) and of antibiotics prescription (22% in acute cough and 42% in chronic cough). CONCLUSION: Our survey suggests that some Italian pediatricians' therapeutic attitudes should be substantially improved in order to achieve better management of cough in children and to minimize the burden of cough.

A reappraisal of the mucoactive activity and clinical efficacy of bromhexine.

Since its introduction to the market in 1963, bromhexine, an over-the-counter drug, has been investigated for its activity in animal models and in humans with diverse respiratory conditions. Bromhexine is a derivate of the Adhatoda vasica plant used in some countries for the treatment of various respiratory diseases. Bromhexine has been found to enhance the secretion of various mucus components by modifying the physicochemical characteristics of mucus. These changes, in turn, increase mucociliary clearance and reduce cough. Principal clinical research studies were primarily developed in an era when stringent methodological approaches and good clinical practices were not developed yet. Clinical studies were conducted mainly in patients with chronic bronchitis and in patients with various respiratory diseases, and demonstrated the efficacy of bromhexine in improving respiratory symptoms. Furthermore, the co-administration of antibiotics with bromhexine amplified the actions of the antibiotic. Although the clinical evidence shows only modest but positive results, bromhexine is indicated for its mucoactive activity. Larger trials with adequate methodology are required to identify when treatment with bromhexine can improve clinical outcomes.

A Randomized Clinical Trial Comparing the Effects of Antitussive Agents on Respiratory Center Output in Patients With Chronic Cough.

BACKGROUND: Cough is produced by the same neuronal pool implicated in respiratory rhythm generation, and antitussive drugs acting at the central level, such as opioids, may depress ventilation. Levodropropizine is classified as a nonopioid peripherally acting antitussive drug that acts at the level of airway sensory nerves. However, the lack of a central action by levodropropizine remains to be fully established. We set out to compare the effects of levodropropizine and the opioid antitussive agent dihydrocodeine on the respiratory responses to a conventional CO2 rebreathing test in patients with chronic cough of any origin. METHODS: Twenty-four outpatients (aged 39-70 years) with chronic cough were studied. On separate runs, each patient was randomly administered 60 mg levodropropizine, 15 mg dihydrocodeine, or a matching placebo. Subsequently, patients breathed a mixture of 93% oxygen and 7% CO2 for 5 min. Fractional end-tidal CO2 (Fetco2) and inspiratory minute ventilation (V˙i) were continuously monitored. Changes in breathing pattern variables were also assessed. RESULTS: At variance with dihydrocodeine, levodropropizine and placebo did not affect respiratory responses to hypercapnia (P < .01). The ventilatory increases by hypercapnia were mainly accounted for by a rise in the volume components of the breathing pattern. CONCLUSIONS: The results are consistent with a peripheral action by levodropropizine; the assessment of ventilatory responses to CO2 may represent a useful tool to investigate the central respiratory effects of antitussive agents. TRIAL REGISTRY: European Union Clinical Trials Register (EudraCT No.: 2013-004735-68); URL: https://www.clinicaltrialsregister.eu/.

WITHDRAWN: NSAID and Antitussives in Patients With Upper Respiratory Tract Infection-Related Cough: A Good Combination?

The Publisher regrets that this article is an accidental duplication of an article that has already been published in Eur Respir J. 46 (2015) PA3852, http://dx.doi.org/10.1183/13993003.congress-2015.PA3852. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.

Cough: impact, beliefs, and expectations from a national survey.

BACKGROUND: Cough is one of the most common discomforts affecting general population, which can disrupt subjects' quality of life due to its physical, social, and psychological effects. Aim of the study was to investigate the impact of cough and related beliefs of general population. METHODS: A cross-sectional telephone survey was carried out by means of a specific, validated questionnaire on a representative sample of Italian general population. All the interviews were carried out according to the Computer Assisted Telephone Interview (CATI) methodology by expert, professional interviewers. Distributions of all answers were calculated in the overall sample. RESULTS: A total of 1,251 subjects (mean age: 49 years; females 44.2 %) completed the interviews. The overall number of telephone calls was 5362, and the corresponding redemption rate was 1/4.3 (23.%). The sample was representative of national population in terms of geographical distribution, age, gender, and smoking habit. The majority of respondents was convinced that cough is merely a symptom of several different diseases, but 46.4 % of respondents affirmed that cough should be regarded as "a disease" per se. Only 29.1 % of subjects say that they usually do not complain of any cough over the year, while 18.4 % reported ≥ 3 episodes of cough/year. These episodes have a duration ranging 10-30 days in 19.9 % of subjects, and > 30 days in 6.9 % of subjects. The majority of respondents is worried about their cough only after 1 week, but 76.9 % of subjects is much more worried if cough affects a child. After a few days of cough, 23.1 % of subjects use domestic remedies; 20.9 % ask their pharmacist, and 33.4 % their doctor, being GPs (69.6 %) and lung physicians (16.2 %) the most asked professionals. The occurrence of bronchitis, pneumonia, upper airway infections, and allergic troubles are the most feared events. The majority of respondents are convinced that antibiotics and steroids should not be regarded as the gold standard for treating persistent cough (61.2 and 58.2 %, respectively), while anti-tussive drugs and aerosols in general are regarded as the most effective strategies (69.1 and 74.1 %, respectively). Moreover, 33.8 % of the sample is in favour of homeopathic drugs, while 23.2 % had already used an homeopathic anti-tussive syrup, and 27.6 % of subjects are really interested in using the homeopathic approach. The willingness to pay for an effective anti-tussive remedy was: 46.3 % up to 10 €; 27.8 % up to 20 €, and 13.3 % more than 20 €. CONCLUSIONS: Cough confirms its high impact in Italy, and a substantial proportion of individuals regards cough as "a disease". Only one out of three Italians refers to their doctor, but when cough is already persistent. Cough in children is much more feared than in adults. The majority of Italians have a proper and conservative position versus both antibiotic and the systemic steroid uses against cough. The Italian attitude to aerosol therapy confirms very high. Differently from the cough guidelines, anti-tussive drugs are highly valued among Italian people. The attitude and the interest to homeopathic anti-tussive remedies proves high. Finally, the willingness to pay for an effective anti-tussive remedy is quite high in Italy.

Prospective study of the efficacy of antibiotics versus antitussive drugs for the management of URTI-related acute cough in children.

BACKGROUND: Acute cough is one of the most frequent symptoms prompting a visit to a health care provider, usually following a viral upper respiratory tract infection (URTI). The disproportionate use of antibiotics in children with URTIs, recently highlighted in the medical literature, could lead to associated side effects, without any beneficial effect. Although an early, albeit inappropriate, antibiotic prescription increases parental satisfaction, URTIs are predominantly viral infections and are generally self-limiting. Therefore the aim of this study was to analyze the effectiveness of antibiotics compared to symptomatic drugs (central and peripheral antitussives) on URTI-related cough in a pediatric population. METHODS: This is a prospective observational study of 330 children who required pediatric consultation for acute cough. Severity, frequency and type of cough were assessed at baseline and after 6 days of treatment (antitussives n = 123, antibiotics n = 89 or combination of them n = 38) or no treatment (n = 80). The outcome of cough management after 6 days was analyzed in terms of resolution, improvement, no change or worsening of symptoms. Study assessments were performed using a standardized questionnaire administered to parents. RESULTS: Between children treated with antitussives or antibiotics, there was a statistically significant difference in the resolution of cough. Moreover, if considering peripheral antitussives, the resolution of cough was significantly higher with antitussives than with antibiotics (p < 0.01). There was no difference in cough resolution between children treated with antitussives and those receiving a combination of antibiotics and antitussives, either central and peripheral antitussives. CONCLUSION: Antibiotics are generally not useful nor appropriate in treating acute cough due to the common cold. Furthermore, inappropriate antibiotic use introduces the possibility of adverse side effects as well as promotion of antibiotic resistance. The findings of the present study suggest that antitussives, especially peripherally acting agents, represent an effective treatment option for acute pediatric cough caused by URTIs.

WITHDRAWN: Treatment Effect of Combination of Nsaid and Antitussives in Patients With URTI-Related Cough.

The Publisher regrets that this article is an accidental duplication of an article that has already been published in Eur Respir J. 46 (2015) PA3852, http://dx.doi.org/10.1183/13993003.congress-2015.PA3852. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.

WITHDRAWN: Combination of NSAID and Antitussives in Treatment of URTI Related Cough: An Observational Study.

The Publisher regrets that this article is an accidental duplication of an article that has already been published in Eur Respir J. 46 (2015) PA3852, http://dx.doi.org/10.1183/13993003.congress-2015.PA3852. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.

Short-term effects of a nicotine-free e-cigarette compared to a traditional cigarette in smokers and non-smokers.

BACKGROUND: A few studies have assessed the short-term effects of low-dose nicotine e-cigarettes, while data about nicotine-free e-cigarettes (NF e-cigarettes) are scanty. Concerns have been expressed about the use of NF e-cigarettes, because of the high concentrations of propylene glycol and other compounds in the e-cigarette vapor. METHODS: This laboratory-based study was aimed to compare the effects of ad libitum use of a NF e-cigarette or and a traditional cigarette for 5 min in healthy adult smokers (n = 10) and non-smokers (n = 10). The main outcome measures were pulmonary function tests, fraction of exhaled nitric oxide (FeNO) and fractional concentration of carbon monoxide (FeCO) in exhaled breath. RESULTS: The traditional cigarette induced statistically significant increases in FeCO in both smokers and non-smokers, while no significant changes were observed in FeNO. In non-smokers, the traditional cigarette induced a significant decrease from baseline in FEF75 (81 % ± 35 % vs 70.2 % ± 28.2 %, P = 0.013), while in smokers significant decreases were observed in FEF25 (101.3 % ± 16.4 % vs 93.5 % ± 31.7 %, P = 0.037), FEV1 (102.2 % ± 9.5 % vs 98.3 % ± 10 %, P = 0.037) and PEF (109.5 % ± 14.6 % vs 99.2 % ± 17.5 %, P = 0.009). In contrast, the only statistically significant effects induced by the NF e-cigarette in smokers were reductions in FEV1 (102.2 % ± 9.5 % vs 99.5 ± 7.6 %, P = 0.041) and FEF25 (103.4 % ± 16.4 % vs 94.2 % ± 16.2 %, P = .014). DISCUSSION: The present study demonstrated that the specific brand of NF e-cigarette utilized did not induce any majoracute effects. In contrast, several studies have shown that both traditional cigarettes and nicotine-containing e-cigarettes have acute effects on lung function. Our study expands on previous observations on the effects of NF e-cigarettes, but also for the first time describes the changes induced by smoking one traditional cigarette in a group of never smokers. CONCLUSIONS: The short-term use of the specific brand of NF e-cigarette assessed in this study had no immediate adverse effects on non-smokers and only small effects on FEV1 and FEF25 in smokers. The long-term health effects of NF e-cigarette use are unknown but worthy of further investigations. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02102191.

Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population.

BACKGROUND: The effectiveness of a homeopathic syrup on cough has been demonstrated in an adult population in a previous double-blind randomized study. The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. OBJECTIVES: The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. METHODS: Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. RESULTS: Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (-0.52 ± 0.66 in the homeopathic syrup group and -0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020). CONCLUSIONS: Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.

Socio-Economic and Clinical Factors as Predictors of Disease Evolution and Acute Events in COPD Patients.

BACKGROUND: Socio-economic, cultural and environmental factors are becoming increasingly important determinants of chronic obstructive pulmonary disease (COPD). We conducted a study to investigate socio-demographic, lifestyle and clinical factors, and to assess their role as predictors of acute events (mortality or hospitalization for respiratory causes) in a group of COPD patients. METHODS: Subjects were recruited among outpatients who were undertaking respiratory function tests at the Pneumology Unit of the Sant'Orsola-Malpighi Hospital, Bologna. Patients were classified according to the GOLD Guidelines. RESULTS: 229 patients with COPD were included in the study, 44 with Mild, 68 Moderate, 52 Severe and 65 Very Severe COPD (GOLD stage). Significant differences among COPD stage, in terms of smoking status and fragility index, were detected. COPD stage significantly affected the values of all clinical tests (spirometry and ABG analysis). Kaplan-Meier estimates showed a significant difference between survival curves by COPD stage with lower event-free probability in very severe COPD stage. Significant risk factors for acute events were: underweight (HR = 4.08; 95% CI 1.01-16.54), having two or more comorbidities (HR = 4.71; 95% CI 2.52-8.83), belonging to moderate (HR = 3.50; 95% CI 1.01-12.18) or very severe COPD stage (HR = 8.23; 95% CI 2.35-28.85). CONCLUSIONS: Our findings indicate that fragility is associated with COPD stage and that comorbidities and the low body mass index are predictors of mortality or hospitalization. Besides spirometric analyses, FeNO measure and comorbidities, body mass index could also be considered in the management and monitoring of COPD patients.