scholarly journals Withdrawal Symptoms From E-Cigarette Abstinence Among Adult Never-Smokers: A Pilot Experimental Study

2019 ◽  
Vol 22 (5) ◽  
pp. 740-746 ◽  
Author(s):  
John R Hughes ◽  
Erica N Peters ◽  
Peter W Callas ◽  
Catherine Peasley-Miklus ◽  
Emmanuel Oga ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Interactive Voice Response ◽  
Small Sample Size ◽  
Small Sample ◽  
Withdrawal Symptoms ◽  
Clinical Trial Registration ◽  
Response System ◽  
Never Smokers ◽  
Regulatory Significance

Abstract Introduction Use of e-cigarettes among never-smokers has substantially increased; yet there are few descriptions of the consequences of such use. We assessed whether adult never-smokers can have withdrawal from cessation of e-cigarettes. Methods In an un-blinded pre-post clinical trial, 30 never-smoker daily e-cigarette users used their own nicotine-containing e-cigarette for 7 days followed by 6 days of biologically confirmed abstinence. Participants monitored symptoms of nicotine withdrawal nightly via an Interactive Voice Response system. They attended three lab visits/week to provide expired carbon monoxide and urine samples to determine compliance. Findings Abstinence increased all the DSM5 symptoms of tobacco withdrawal and this occurred in the majority of participants. The increase in severity of withdrawal was small and rarely impaired functioning. Conclusions Our finding suggests that withdrawal symptoms can occur in never-smokers who stop e-cigarettes abruptly. However, the severity of withdrawal appears to be small and may not be of clinical or regulatory significance. Although our sample size was small and thus replication tests of our results are indicated, it may be prudent to warn never-smokers that withdrawal symptoms may occur. Implications This study indicates that withdrawal symptoms can occur in never-smokers who are daily e-cigarette users. However, the severity of withdrawal from e-cigarette abstinence in never-smokers appears to be small and may not be of clinical or regulatory significance. Given our small sample size, replication of our results is warranted. Nevertheless, it might be prudent to warn never-smokers of addiction to e-cigarettes. Clinical Trial Registration = NCT02825459

scholarly journals Modulation of Cardiac Injury by ACE inhibitor/ARB in Patients with Severe COVID-19

2020 ◽  
Author(s):  
Beibei Du ◽  
Daoyuan Si ◽  
Bo Yang ◽  
Guohui Liu ◽  
Qian Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Small Sample Size ◽  
Cardiac Injury ◽  
Ventilatory Support ◽  
Small Sample ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Significant Difference ◽  
Ctni Level

Abstract Introduction: Cardiac injury occurs in 7-22% of patient hospitalized with COVID-19 and an elevation in troponin is associated with a 4.2-fold increase in the risk of mortality. Preliminary data showed ACEi/ARB usage might not increase mortaily in COVID-19 patients. However, it is unknown if cardiac injury in patients with severe COVID-19 can be modulated by ACEi/ARB usage during evolution of the cardiac injury.Methods: In 154 COVID-19 patients with cardiac injury, the effect of ACEi/ARB treatment (17 patients) was compared with 137 patients without ACEi/ARB treatment. Cardiac injury was indicated by cTnI level.Results: In ACEi/ARB treatment group and no ACEi/ARB treatment group, peak cTnI level did not show significant difference (150.5 pg/ml [31.75-1179], vs 207 pg/ml [54.65-989.4], respectively, P = 0.21). Evolution of Cardiac injury (temporal change of cTnI at day 6, 9, 12, 15, 18, 21, 24, 27, 30, and 33) showed no statistical difference. Mortality (ACEi/ARB group vs no ACEi/ARB group; 52.9% vs 69.9%, P = 0.17), atrial arrhythmias (11.7% vs 24.4%, P = 0.36), requirement for invasive ventilatory support (29.4% vs 48.2%, P = 0.14) also showed no significant difference in two groups.Conclusions: ACEi/ARB usage during the COVID-19 was not associated with exacerbation of cardiac injury. These data should be interpreted as essentially hypothesis-generating due to small sample size.Clinical Trial Registration: This retrospective study was registered in Chinese clinical trial registry (ChiCTR 2000031301).

scholarly journals Withdrawal Symptoms From E-Cigarette Abstinence Among Former Smokers: A Pre–Post Clinical Trial

2019 ◽  
Vol 22 (5) ◽  
pp. 734-739 ◽  
Author(s):  
John R Hughes ◽  
Erica N Peters ◽  
Peter W Callas ◽  
Catherine Peasley-Miklus ◽  
Emmanuel Oga ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Dependence ◽  
Interactive Voice Response ◽  
Withdrawal Symptoms ◽  
Time Pattern ◽  
Diagnostic And Statistical Manual ◽  
Severe Withdrawal ◽  
Tobacco Cigarette ◽  
Former Smokers ◽  
Never Smokers

Abstract Introduction The major aim of this study was to test whether abstinence from e-cigarettes causes withdrawal symptoms in former smokers. Methods We conducted an unblinded, within-participants, pre–post clinical trial in which 109 former smokers who were current daily electronic cigarette (e-cigarette) users used their own e-cigarette for 7 days followed by 6 days of biologically confirmed abstinence engendered via an escalating contingency payment system. Participants monitored symptoms of nicotine withdrawal daily via an Interactive Voice Response system. They also attended three laboratory visits per week for carbon monoxide and cotinine testing to verify abstinence. Results Half of participants completely abstained for a week. All the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) tobacco withdrawal symptoms, craving for e-cigarettes, craving for tobacco cigarettes, and the four possible new withdrawal symptoms (anhedonia, impulsivity, mood swings, and positive affect) increased during abstinence. Weight increased and heart rate decreased with abstinence. Symptoms showed the prototypical inverted U time pattern of a withdrawal state. The magnitude of withdrawal appeared to be somewhat less than that in a prior study of abstinent daily tobacco cigarette smokers. More severe withdrawal on the first 2 days of abstinence did not predict abstinence on the last day of the study. Conclusions Former smokers who are daily e-cigarette users transfer physical dependence on tobacco cigarettes to dependence on e-cigarettes. The severity of withdrawal from e-cigarettes appears to be only somewhat less than that from daily tobacco cigarette use. Replication tests that include placebo controls, testing for pharmacological specificity, and including never-smokers, non-daily e-cigarette users and dual users are indicated. Implications Our results indicate e-cigarettes can maintain physical dependence. This adverse effect should be included in any risk vs. benefit calculation. Also, potential and current e-cigarette users should be informed that abrupt cessation of e-cigarettes can cause withdrawal symptoms. Trial registration NCT02825459.

Application of Ultrasound Elastography for Assessing Intestinal Fibrosis in Inflammatory Bowel Disease: Fiction or Reality?

2020 ◽  
Vol 21 ◽  
Author(s):  
Roberto Gabbiadini ◽  
Eirini Zacharopoulou ◽  
Federica Furfaro ◽  
Vincenzo Craviotto ◽  
Alessandra Zilli ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Sample Size ◽  
Bowel Disease ◽  
Small Sample Size ◽  
Shear Wave Elastography ◽  
Small Sample ◽  
Ultrasound Elastography ◽  
Invasive Technique ◽  
Intestinal Fibrosis ◽  
Inflammatory Bowel

Background: Intestinal fibrosis and subsequent strictures represent an important burden in inflammatory bowel disease (IBD). The detection and evaluation of the degree of fibrosis in stricturing Crohn’s disease (CD) is important to address the best therapeutic strategy (medical anti-inflammatory therapy, endoscopic dilation, surgery). Ultrasound elastography (USE) is a non-invasive technique that has been proposed in the field of IBD for evaluating intestinal stiffness as a biomarker of intestinal fibrosis. Objective: The aim of this review is to discuss the ability and current role of ultrasound elastography in the assessment of intestinal fibrosis. Results and Conclusion: Data on USE in IBD are provided by pilot and proof-of-concept studies with small sample size. The first type of USE investigated was strain elastography, while shear wave elastography has been introduced lately. Despite the heterogeneity of the methods of the studies, USE has been proven to be able to assess intestinal fibrosis in patients with stricturing CD. However, before introducing this technique in current practice, further studies with larger sample size and homogeneous parameters, testing reproducibility, and identification of validated cut-off values are needed.

scholarly journals Confirming known planetary trends using a photometrically selected Kepler sample

2020 ◽  
Author(s):  
Jonah T Hansen ◽  
Luca Casagrande ◽  
Michael J Ireland ◽  
Jane Lin
Keyword(s):  
Sample Size ◽  
Robust Statistics ◽  
Narrow Band ◽  
Small Sample Size ◽  
Small Sample ◽  
Fitting Algorithm ◽  
Statistical Studies ◽  
The Rich ◽  
Host Stars ◽  
High Metallicity

Abstract Statistical studies of exoplanets and the properties of their host stars have been critical to informing models of planet formation. Numerous trends have arisen in particular from the rich Kepler dataset, including that exoplanets are more likely to be found around stars with a high metallicity and the presence of a “gap” in the distribution of planetary radii at 1.9 R⊕. Here we present a new analysis on the Kepler field, using the APOGEE spectroscopic survey to build a metallicity calibration based on Gaia, 2MASS and Strömgren photometry. This calibration, along with masses and radii derived from a Bayesian isochrone fitting algorithm, is used to test a number of these trends with unbiased, photometrically derived parameters, albeit with a smaller sample size in comparison to recent studies. We recover that planets are more frequently found around higher metallicity stars; over the entire sample, planetary frequencies are 0.88 ± 0.12 percent for [Fe/H] < 0 and 1.37 ± 0.16 percent for [Fe/H] ≥ 0 but at two sigma we find that the size of exoplanets influences the strength of this trend. We also recover the planet radius gap, along with a slight positive correlation with stellar mass. We conclude that this method shows promise to derive robust statistics of exoplanets. We also remark that spectrophotometry from Gaia DR3 will have an effective resolution similar to narrow band filters and allow to overcome the small sample size inherent in this study.

scholarly journals The use of diversity indices for local assessment of marine sediment quality

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Shinya Hosokawa ◽  
Kyosuke Momota ◽  
Anthony A. Chariton ◽  
Ryoji Naito ◽  
Yoshiyuki Nakamura
Keyword(s):  
Community Structure ◽  
Sample Size ◽  
Small Sample Size ◽  
Benthic Communities ◽  
Sediment Quality ◽  
Diversity Indices ◽  
Small Sample ◽  
Species Density ◽  
Local Case ◽  
Two Indices

AbstractDiversity indices are commonly used to measure changes in marine benthic communities. However, the reliability (and therefore suitability) of these indices for detecting environmental change is often unclear because of small sample size and the inappropriate choice of communities for analysis. This study explored uncertainties in taxonomic density and two indices of community structure in our target region, Japan, and in two local areas within this region, and explored potential solutions. Our analysis of the Japanese regional dataset showed a decrease in family density and a dominance of a few species as sediment conditions become degraded. Local case studies showed that species density is affected by sediment degradation at sites where multiple communities coexist. However, two indices of community structure could become insensitive because of masking by community variability, and small sample size sometimes caused misleading or inaccurate estimates of these indices. We conclude that species density is a sensitive indicator of change in marine benthic communities, and emphasise that indices of community structure should only be used when the community structure of the target community is distinguishable from other coexisting communities and there is sufficient sample size.

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