Varenicline and counseling for vaping cessation: a double-blind, randomized, parallel-group, placebo-controlled trial.

BACKGROUND: Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping. METHODS: Design: Double-blind, randomized, parallel-group, placebo-controlled trial. SETTING: The study took place at a University-run smoking cessation center. PARTICIPANTS: People who exclusively use ECs daily and intend to quit vaping. INTERVENTION: A total of 140 subjects were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) plus counseling or placebo treatment (administered twice daily, for 12 weeks) plus counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. MAIN OUTCOMES AND MEASURES: The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. RESULTS: CAR was significantly higher for varenicline vs placebo at each interval: weeks 4-12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25-5.68], P = 0.011); weeks 4-24, 34.3% for varenicline with counseling and 17.2% for placebo with counseling (OR = 2.52, 95% CI = [1.14-5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related. CONCLUSIONS: The findings of the present RCT indicate that inclusion of varenicline in a vaping cessation program for people who use electronic cigarettes and intending to quit may result in prolonged abstinence. These positive findings establish a benchmark of intervention effectiveness, may support the use of varenicline combined with counseling in vaping cessation programs, and may also help guiding future recommendations by health authorities and healthcare providers. TRIAL REGISTRATION: The study has been registered in EUDRACT with Trial registration ID: 2016-000339-42.

The submucosal approach influences long-term outcomes of refractory obstructive rhinitis: A prospective study and a STROBE analysis.

OBJECTIVE: The surgical approach to refractory hypertrophy of the inferior turbinates is the main therapeutic choice in the management of its symptoms. Although submucosal approaches have demonstrated efficacy, long-term results are debated in the literature and show variable stability. Therefore, we compared the long-term outcomes of three submucosal turbinoplasty methods with regard to the efficacy and stability managing the respiratory disorders. DESIGN: Multicenter prospective controlled study. A computer-generated table was used to allocate participants to the treatment. SETTING: Two teaching and university medical centers. METHODS: We used the EQUATOR network for guidelines describing design, conduct, and reporting of studies and searched the references of these guidelines to identify further relevant publications reporting adequate study protocols. Patients with persistent bilateral nasal obstruction due to lower turbinate hypertrophy were prospectively recruited from our ENT units. Participants were randomly assigned to each treatment and then underwent symptom assessment by visual analog scales, endoscopic assessment at baseline and 12, 24 and 36 months after treatment. RESULTS: Of the 189 patients with bilateral persistent nasal obstruction initially assessed, 105 met the study requirements; 35 were located in the MAT group, 35 in the CAT group and 35 in the RAT group. Nasal discomfort was significantly reduced after 12 months with all the methods. The MAT group presented better outcomes for all VAS scores at the 1-year follow-up, greater stability at the 3-year follow-up for VAS results (p < 0.001 in all cases) and lower disease recurrence (5/35; 14.28 %). At the 3-year follow-up intergroup analysis, a statistically significant difference was confirmed except for RAA scores (H = 2.88; p = 0.236). Rhinorrhea (r = -0.400; p < 0.001) was demonstrated as a predictive factor of 3-year recurrence, while sneezing (r = -0.25; p = 0.011), and operative time needed (r = -0.23; p = 0.016) did not reach statistical significance. CONCLUSIONS: Long-term symptomatic stability varies depending on the turbinoplasty method used. MAT demonstrated greater efficacy in controlling nasal symptoms, presenting better stability in reducing turbinate size and nasal symptoms. In contrast, radiofrequency techniques presented a higher rate of disease recurrence both symptomatically and endoscopically.

Sensibility, specificity, and accuracy of the Sinonasal Outcome Test 8 (SNOT-8) in patients with chronic rhinosinusitis (CRS): a cross-sectional cohort study.

PURPOSE: To analyze as the primary endpoint the accuracy, sensitivity, and specificity of the SNOT-22 assessing CRS severity and to compare the results with a version of the SNOT-8 obtained from the nasal domain items. METHODS: Data were obtained from a prospective multicenter controlled study of dupilumab in adults with moderate-severe CRSwNP. EQUATOR and STROBE network guidelines were adopted. A multivariate logistic regression model was used to evaluate the accuracy of the model with the full (SNOT-22) and reduced (SNOT-8) item set to predict the severity outcome. RESULTS: SNOT-22 demonstrated an AUC of 0.885 (95% CI 0.825, - 0.945), and sensitivity and specificity of 91.49% (83.92-96.25%) and 69.23% (48.21-85.67%), respectively. Interestingly, after stepwise items elimination good outcomes were reported for SNOT-8, with an AUC of 0.818 (95% CI 0.744-0.892), achieving a sensitivity of 93.51% (85.49-97.86%) and specificity of 57.14% (40.96-72.28%). CONCLUSION: Psychometric analyses support the accuracy, sensitivity, and specificity of the nasal domains of SNOT-22 to assess the impact on HRQoL in patients with CRSwNP.

Varenicline for smoking cessation in individuals who smoke cigarettes and use electronic cigarettes: a double-blind, randomised, placebo-controlled phase 3 trial.

Background: The efficacy and safety of varenicline for smoking cessation among individuals who smoke tobacco cigarettes and also use electronic cigarettes (known e-cigarettes or vapes) have not been studied. We aimed to address this knowledge gap and examine predictors for smoking abstinence. Methods: In this double-blind, placebo-controlled, single-centre randomised trial in Italy, we enrolled adults who had used an e-cigarette daily for at least 12 months and who also smoked at least one tobacco cigarette per day and had a willingness to quit smoking. 155 participants were randomly assigned to receive either varenicline (n = 78) or matched placebo (n = 77). Varenicline (1 mg, administered twice daily for 12 weeks) was given in combination with smoking cessation counseling in dual users with an intention to quit smoking. Participants in both treatment groups received the same smoking cessation counselling throughout the whole duration of the study. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up. The primary efficacy endpoint was continuous abstinence rate (CAR) in weeks 4-12. Secondary efficacy endpoints were the CAR in weeks 4-24 and 7-day point prevalence of smoking abstinence at weeks 12 and 24. This study is registered in EUDRACT, 2016-000339-42. Findings: Between November 2018, and February 2020, 114 participants (61 in the varenicline group and 53 in the placebo group) completed the intervention phase at week 12 and 88 participants (52 in the varenicline group and 36 in the placebo group) completed the follow-up phase at week 24. CARs were significantly higher for the varenicline vs placebo at each time-point: 50.0% vs 16.9% (OR = 4.9; 95% CI, 2.3-10.4; P < 0.0001) between weeks 4 and 12; and 48.7% vs 14.3% (OR = 5.7; 95% CI, 2.6-12.3; P < 0.0001) between weeks 4 and 24. The 7-day point prevalence of smoking abstinence was also higher for the varenicline than placebo at each time point. Adverse events were rated as mild or moderate and rarely led to treatment discontinuation. Interpretation: Our findings indicate that inclusion of varenicline in a cessation programme for adults who smoke and use e-cigarettes with an intention to quit smoking could result in smoking abstinence without serious adverse events. In the absence of evidence from other smoking cessation methods, it could be useful to suggest the use of varenicline in cessation programmes specifically designed to help dual users stop smoking. Further research in larger and more generalisable populations is required to strengthen such a suggestion. Funding: Global Research Award for Nicotine Dependence, an independently reviewed competitive grants programmeme funded by Pfizer.

Development of a Web-App for the Ecological Momentary Assessment of Dietary Habits among College Students: The HEALTHY-UNICT Project.

The transition from adolescence to adulthood is a critical period for the development of healthy behaviors. Yet, it is often characterized by unhealthy food choices. Considering the current pandemic scenario, it is also essential to assess the effects of coronavirus disease-19 (COVID-19) on lifestyles and diet, especially among young people. However, the assessment of dietary habits and their determinants is a complex issue that requires innovative approaches and tools, such as those based on the ecological momentary assessment (EMA). Here, we describe the first phases of the "HEALTHY-UNICT" project, which aimed to develop and validate a web-app for the EMA of dietary data among students from the University of Catania, Italy. The pilot study included 138 students (mean age 24 years, SD = 4.2; 75.4% women), who used the web-app for a week before filling out a food frequency questionnaire with validation purposes. Dietary data obtained through the two tools showed moderate correlations, with the lowest value for butter and margarine and the highest for pizza (Spearman's correlation coefficients of 0.202 and 0.699, respectively). According to the cross-classification analysis, the percentage of students classified into the same quartile ranged from 36.9% for vegetable oil to 58.1% for pizza. In line with these findings, the weighted-kappa values ranged from 0.15 for vegetable oil to 0.67 for pizza, and most food categories showed values above 0.4. This web-app showed good usability among students, assessed through a 19-item usability scale. Moreover, the web-app also had the potential to evaluate the effect of the COVID-19 pandemic on students' behaviors and emotions, showing a moderate impact on sedentary activities, level of stress, and depression. These findings, although interesting, might be confirmed by the next phases of the HEALTHY-UNICT project, which aims to characterize lifestyles, dietary habits, and their relationship with anthropometric measures and emotions in a larger sample of students.