Part Three: Biomarker Changes in Cigarette Smokers Switched to Vuse Solo or Abstinence: A Randomized, Controlled Study

Abstract Biomarkers of exposure (BoE) can help evaluate exposure to combustion-related, tobacco-specific toxicants after smokers switch from cigarettes to potentially less-harmful products like electronic nicotine delivery systems (ENDS). This paper reports data for one (Vuse Solo Original) of three products evaluated in a randomized, controlled confinement study of BoE in smokers switched to ENDS. Subjects smoked their usual brand cigarette ad libitum for two days, then were randomized to one of three ENDS for a 7-day ad libitum use period, or to smoking abstinence. Thirteen BoE were assessed at baseline and Day 5, and percent change in mean values for each BoE was calculated. Biomarkers of potential harm (BoPH) linked to oxidative stress, platelet activation, and inflammation were also assessed. Levels decreased among subjects randomized to Vuse Solo versus Abstinence, respectively, for the following BoE: 42–96% vs. 52–97% (non-nicotine constituents); 51% vs. 55% (blood carboxyhemoglobin); and 29% vs. 96% (nicotine exposure). Significant decreases were observed in three BoPH: leukotriene E4, 11-dehydro-thromboxane B2, and 2,3-dinor thromboxane B2 on Day 7 in the Vuse Solo and Abstinence groups. These findings show that ENDS use results in substantially reduced exposure to toxicants compared to smoking, which may lead to reduced biological effects.

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A randomized, controlled, parallel group clinical study of cigarette smokers using an innovative oral tobacco-derived nicotine product to determine impact on cigarette consumption and biomarkers of exposure

10.21203/rs.2.22401/v1 ◽

2020 ◽

Author(s):

Jeffery Edmiston ◽

Qiwei Liang ◽

Jianmin Liu ◽

Mohamadi Sarkar

Keyword(s):

Test Group ◽

Cigarette Consumption ◽

Control Group ◽

Cigarette Smokers ◽

Randomized Controlled ◽

Biomarkers Of Exposure ◽

Parallel Group ◽

Ad Libitum ◽

Use Behavior ◽

Related Harm

Abstract Background: Despite the well-known health consequences of cigarettes, many adults still smoke. VERVE® Blue Mint Discs (Discs) are innovative, chewable, non-dissolvable oral tobacco-derived nicotine products designed for adult smokers (AS) interested in alternatives to cigarettes. We assessed impact of using Discs on product use behavior and biomarkers of exposure (BOE) in AS. Methods: In this randomized, two-arm, parallel group study, AS (n=154) not planning to quit in the next 30 days were randomized to either a Control Group (n=62) that continued smoking their own brand cigarettes or Test Group (n=92) with the option to use Discs for four weeks under ad libitum conditions. Changes from Baseline to End of Study (EOS) between the Groups were analyzed for CPD and BOEs to select harmful and potentially harmful constituents (HPHCs) – nicotine, NNK, benzene and carbon monoxide. Results: Most AS (78%) in the Test Group reduced their CPD (~20% on average, p<0.05), some (~9.4%) reducing by 50-99% and a few (~2.4%) switched completely to Discs. The changes in CPD was biochemically confirmed with significant reductions in COHb (p<0.05). Percent changes in BOEs for nicotine, NNK and benzene tended to be lower in participants using Discs compared to the Control Group indicating lower exposure to HPHCs. Conclusions: Overall, our results suggest that many AS reduced their cigarette consumption, and some switched completely to Discs. Switching completely from cigarettes to Discs, if sustained over time, may offer an opportunity for smoking-related harm reduction. (238 words)

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Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study

Nicotine & Tobacco Research ◽

10.1093/ntr/ntaa135 ◽

2020 ◽

Author(s):

Nathan Gale ◽

Michael McEwan ◽

Oscar M Camacho ◽

George Hardie ◽

James Murphy ◽

...

Keyword(s):

Smoking Cessation ◽

Cigarette Smoking ◽

Tobacco Product ◽

Ambulatory Setting ◽

Controlled Study ◽

Control Group ◽

Clinical Trial Registration ◽

Randomized Controlled ◽

Biomarkers Of Exposure ◽

Never Smokers

Abstract Introduction Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes. Aims and Methods This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90. Results In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers. Conclusion glo is a reduced-exposure tobacco product. Implications This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely. Clinical trial registration ISRCTN81075760.

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Effect of auditory guided imagery on glucose levels and on glycemic control in children with type 1 diabetes mellitus

Journal of Pediatric Endocrinology and Metabolism ◽

10.1515/jpem-2015-0150 ◽

2016 ◽

Vol 29 (2) ◽

Cited By ~ 1

Author(s):

Renana Gelernter ◽

Gila Lavi ◽

Livia Yanai ◽

Ronit Brooks ◽

Yakira Bar ◽

...

Keyword(s):

Glycemic Control ◽

Guided Imagery ◽

Glucose Monitoring ◽

Background Music ◽

Controlled Study ◽

Glucose Levels ◽

Randomized Controlled ◽

Interstitial Glucose ◽

Change In Mean

AbstractTo assess the effect of auditory guided imagery (AGI) on glucose levels, glycated hemoglobin (HbAA blinded randomized controlled study comparing the effect of AGI accompanied by background music and background music solely (BMS). The study included 13 children, (7–16 years). The participants were connected to continuous glucose monitoring system for 5 days (short phase), and the outcome measure was the change in mean interstitial glucose concentration (IGC). Participants listened to the recording twice a week for 12 weeks (long phase), and the outcome measures were changes in QOL and in HbAMean IGC decreased in both AGI and BMS groups while listening. HbAListening to AGI is a potential approach for improving glycemic control and glucose levels in youth with T1DM, but further research is required.

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Efficacy and safety of iontophoresis combined sodium salicylate in acquired plantar keratoderma-a randomized controlled study

International Journal of Research in Dermatology ◽

10.18203/issn.2455-4529.intjresdermatol20214919 ◽

2021 ◽

Vol 8 (1) ◽

pp. 101

Author(s):

Shreya P. Somani ◽

Bhavsh N. Astik ◽

Hita H. Mehta ◽

Milan D. Jhavar

Keyword(s):

Sodium Salicylate ◽

Randomized Controlled Study ◽

Treatment Modalities ◽

Controlled Study ◽

Mean Values ◽

Randomized Controlled ◽

Number Of Patients ◽

Significant Difference ◽

Group A ◽

Group B

Background: Palmoplantar keratoderma is a heterogenous group of disorders, hereditary or acquired, characterized by thickening of palms and soles. Though it is not a life-threatening condition, it affects individual’s quality of life. As treatment of keratoderma has always been troublesome, upgraded treatment modalities which improves keratoderma efficiently are always encouraged.Methods: In this randomized controlled study, patients of plantar keratoderma of age group of 18-65 years were randomly divided in group A and group B. In group A, iontophoresis combined sodium salicylate was offered to patients twice weekly for 8 weeks of duration, during which DC current was supplied at 5-15 mA for 10 min of duration. Whereas, in group B patients applied topical salicylic acid 12% ointment at home twice a day for 8 weeks.Results: Our study of 70 patients of keratoderma, revealed diffuse (94%) pattern of involvement with female preponderance (55.7%) and occupation wise, most common among laborers (54.2%) followed by housewives (27.1%). Statistically significant number of patients showed reduction in severity grading of parameters, in both groups at end of 8 weeks. Same way, mean values of parameter grading significantly reduced at 8 weeks in both the groups. But intergroup values showed no significant difference. Mean EASI (Eczema Area Severity Index) score showed statistically significant reduction in group B as compared to group A at 8th week. Percentage of reduction of EASI score was also significantly higher in group B at end of treatment.Conclusions: Here both treatment modalities are safe and effective, topical being slightly more efficacious than iontophoresis. So, we can conclude that no additional privilege of drug delivery through iontophoresis.

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