Chris Bullen

Electronic cigarettes for smoking cessation: a randomised controlled trial

BACKGROUND Electronic cigarettes (e-cigarettes) can deliver nicotine and mitigate tobacco withdrawal and are used by many smokers to assist quit attempts. We investigated whether e-cigarettes are more effective than nicotine patches at helping smokers to quit. METHODS We did this pragmatic randomised-controlled superiority trial in Auckland, New Zealand, between Sept 6, 2011, and July 5, 2013. Adult (≥18 years) smokers wanting to quit were randomised (with computerised block randomisation, block size nine, stratified by ethnicity [Māori; Pacific; or non-Māori, non-Pacific], sex [men or women], and level of nicotine dependence [>5 or ≤5 Fagerström test for nicotine dependence]) in a 4:4:1 ratio to 16 mg nicotine e-cigarettes, nicotine patches (21 mg patch, one daily), or placebo e-cigarettes (no nicotine), from 1 week before until 12 weeks after quit day, with low intensity behavioural support via voluntary telephone counselling. The primary outcome was biochemically verified continuous abstinence at 6 months (exhaled breath carbon monoxide measurement <10 ppm). Primary analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000866000. FINDINGS 657 people were randomised (289 to nicotine e-cigarettes, 295 to patches, and 73 to placebo e-cigarettes) and were included in the intention-to-treat analysis. At 6 months, verified abstinence was 7·3% (21 of 289) with nicotine e-cigarettes, 5·8% (17 of 295) with patches, and 4·1% (three of 73) with placebo e-cigarettes (risk difference for nicotine e-cigarette vs patches 1·51 [95% CI -2·49 to 5·51]; for nicotine e-cigarettes vs placebo e-cigarettes 3·16 [95% CI -2·29 to 8·61]). Achievement of abstinence was substantially lower than we anticipated for the power calculation, thus we had insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes. We identified no significant differences in adverse events, with 137 events in the nicotine e-cigarettes group, 119 events in the patches group, and 36 events in the placebo e-cigarettes group. We noted no evidence of an association between adverse events and study product. INTERPRETATION E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events. Uncertainty exists about the place of e-cigarettes in tobacco control, and more research is urgently needed to clearly establish their overall benefits and harms at both individual and population levels. FUNDING Health Research Council of New Zealand.

Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial

Objectives To measure the short-term effects of an electronic nicotine delivery device (“e cigarette”, ENDD) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects. Design Single blind randomised repeated measures cross-over trial of the Ruyan V8 ENDD. Setting University research centre in Auckland, New Zealand. Participants 40 adult dependent smokers of 10 or more cigarettes per day. Interventions Participants were randomised to use ENDDs containing 16 mg nicotine or 0 mg capsules, Nicorette nicotine inhalator or their usual cigarette on each of four study days 3 days apart, with overnight smoking abstinence before use of each product. Main outcome measures The primary outcome was change in desire to smoke, measured as “area under the curve” on an 11-point visual analogue scale before and at intervals over 1 h of use. Secondary outcomes included withdrawal symptoms, acceptability and adverse events. In nine participants, serum nicotine levels were also measured. Results Over 60 min, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (p=0.006). No difference in desire to smoke was found between 16 mg ENDD and inhalator. ENDDs were more pleasant to use than inhalator (p=0.016) and produced less irritation of mouth and throat (p<0.001). On average, the ENDD increased serum nicotine to a peak of 1.3 mg/ml in 19.6 min, the inhalator to 2.1 ng/ml in 32 min and cigarettes to 13.4 ng/ml in 14.3 min. Conclusions The 16 mg Ruyan V8 ENDD alleviated desire to smoke after overnight abstinence, was well tolerated and had a pharmacokinetic profile more like the Nicorette inhalator than a tobacco cigarette. Evaluation of the ENDD for longer-term safety, potential for long-term use and efficacy as a cessation aid is needed. Trial registration No.12607000587404, Australia and New Zealand Clinical Trials Register

Effects of improved home heating on asthma in community dwelling children: randomised controlled trial

Objective To assess whether non-polluting, more effective home heating (heat pump, wood pellet burner, flued gas) has a positive effect on the health of children with asthma. Design Randomised controlled trial. Setting Households in five communities in New Zealand. Participants 409 children aged 6-12 years with doctor diagnosed asthma. Interventions Installation of a non-polluting, more effective home heater before winter. The control group received a replacement heater at the end of the trial. Main outcome measures The primary outcome was change in lung function (peak expiratory flow rate and forced expiratory volume in one second, FEV1). Secondary outcomes were child reported respiratory tract symptoms and daily use of preventer and reliever drugs. At the end of winter 2005 (baseline) and winter 2006 (follow-up) parents reported their child’s general health, use of health services, overall respiratory health, and housing conditions. Nitrogen dioxide levels were measured monthly for four months and temperatures in the living room and child’s bedroom were recorded hourly. Results Improvements in lung function were not significant (difference in mean FEV1 130.7 ml, 95% confidence interval −20.3 to 281.7). Compared with children in the control group, however, children in the intervention group had 1.80 fewer days off school (95% confidence interval 0.11 to 3.13), 0.40 fewer visits to a doctor for asthma (0.11 to 0.62), and 0.25 fewer visits to a pharmacist for asthma (0.09 to 0.32). Children in the intervention group also had fewer reports of poor health (adjusted odds ratio 0.48, 95% confidence interval 0.31 to 0.74), less sleep disturbed by wheezing (0.55, 0.35 to 0.85), less dry cough at night (0.52, 0.32 to 0.83), and reduced scores for lower respiratory tract symptoms (0.77, 0.73 to 0.81) than children in the control group. The intervention was associated with a mean temperature rise in the living room of 1.10°C (95% confidence interval 0.54°C to 1.64°C) and in the child’s bedroom of 0.57°C (0.05°C to 1.08°C). Lower levels of nitrogen dioxide were measured in the living rooms of the intervention households than in those of the control households (geometric mean 8.5 μg/m3 v 15.7 μg/m3, P<0.001). A similar effect was found in the children’s bedrooms (7.3 μg/m3 v 10.9 μg/m3, P<0.001). Conclusion Installing non-polluting, more effective heating in the homes of children with asthma did not significantly improve lung function but did significantly reduce symptoms of asthma, days off school, healthcare utilisation, and visits to a pharmacist. Trial registration Clinical Trials NCT00489762.

A Theory-Based Video Messaging Mobile Phone Intervention for Smoking Cessation: Randomized Controlled Trial

Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called “STUB IT”) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. Methods A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. Results The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation. Trial registration Australian New Zealand Clinical Trials Registry Number: ACTRN12606000476538; http://www.anzctr.org.au/trial_view.aspx?ID=81688 (Archived by WebCite at http://www.webcitation.org/5umMU4sZi)

After the smoke has cleared: evaluation of the impact of a new national smoke-free law in New Zealand

Background: The New Zealand 2003 Smoke-free Environments Amendment Act (SEAA) extended existing restrictions on smoking in office and retail workplaces by introducing smoking bans in bars, casinos, members’ clubs, restaurants and nearly all other workplaces from 10 December 2004. Objective: To evaluate the implementation and outcomes of aspects of the SEAA relating to smoke-free indoor workplaces and public places, excluding schools and early learning centres. Methods: Data were gathered on public and stakeholder attitudes and support for smoke-free policies; dissemination of information, enforcement activities and compliance; exposure to secondhand smoke (SHS) in the workplace; changes in health outcomes linked to SHS exposure; exposure to SHS in homes; smoking prevalence and smoking related behaviours; and economic impacts. Results: Surveys suggested growing majority support for the SEAA and its underlying principles among the public and bar managers. There was evidence of high compliance in bars and pubs, where most enforcement problems were expected. Self reported data suggested that SHS exposure in the workplace, the primary objective of the SEAA, decreased significantly from around 20% in 2003, to 8% in 2006. Air quality improved greatly in hospitality venues. Reported SHS exposure in homes also reduced significantly. There was no clear evidence of a short term effect on health or on adult smoking prevalence, although calls to the smoking cessation quitline increased despite reduced expenditure on smoking cessation advertising. Available data suggested a broadly neutral economic impact, including in the tourist and hospitality sectors. Conclusion: The effects of the legislation change were favourable from a public health perspective. Areas for further investigation and possible regulation were identified such as SHS related pollution in semi-enclosed outdoor areas. The study adds to a growing body of literature documenting the positive impact of comprehensive smoke-free legislation. The scientific and public health case for introducing comprehensive smoke-free legislation that covers all indoor public places and workplaces is now overwhelming, and should be a public health priority for legislators across the world as part of the globalisation of effective public health policy to control the tobacco epidemic.

Impact of tobacco smoking and smoking cessation on cardiovascular risk and disease

Despite declines in smoking prevalence in many Western countries, tobacco use continues to grow in global importance as a leading preventable cause of cardiovascular disease. Tobacco smoke is both prothrombotic and atherogenic, increasing the risks of acute myocardial infarction, sudden cardiac death, stroke, aortic aneurysm and peripheral vascular disease. Even very low doses of exposure increase the risk of acute myocardial infarction. However, smoking cessation and second-hand smoke avoidance swiftly reduce this risk. While promising new agents are emerging, proven cost-effective and safe cessation interventions already exist, such as brief physician advice, counseling and nicotine replacement therapy. These should be routinely offered, where available, to all smokers. This is especially important for those at risk of, or with established and even acute, cardiovascular disease. Clinicians must play a more active role than ever before in supporting complete cessation in patients who smoke and in advocating for stronger tobacco control measures.

Saliva cotinine levels in users of electronic cigarettes

To the Editors: Electronic nicotine delivery systems (ENDS or electronic cigarettes) look like cigarettes but do not contain or burn tobacco. Instead, they comprise a battery-powered atomiser that produces a vapour for inhalation from cartridges containing humectants (propylene glycol or glycerol), flavours ( e.g. tobacco, mint or fruit) and nicotine. Many smokers report using ENDS to quit smoking or to substitute for tobacco in smoke-free places [1, 2]. ENDS do attenuate craving for tobacco, but appear to deliver little nicotine to the blood [3, 4]. Two studies have evaluated nicotine administration with different ENDS brands in ENDS-naive smokers [3, 4]. In one study, 32 smokers completed two 10-puff “vaping” bouts or smoked a cigarette [3]. In contrast to tobacco cigarettes, ENDS did not increase plasma nicotine reliably (plasma nicotine: 1.4 ng·mL−1 and 0.5 ng·mL−1, respectively, for two ENDS brands). In the other study, smokers used ENDS with a 16-mg nicotine cartridge for 5 min, a nicotine inhaler for 20 min or their usual cigarette for 5 min [4]. Nicotine concentration in plasma, measured after 60 min, was 1.3 ng·mL−1 for ENDS, 2.1 ng·mL−1 for inhalers and 13.4 ng·mL−1 for tobacco cigarettes, but one-third of participants showed no increase in blood nicotine while using the ENDS [4]. The time to maximum concentration of serum nicotine was shorter for ENDS (19.6 min) than for the nicotine inhaler (32.0 min), suggesting some absorption via the respiratory tract [4]. It is possible that serum nicotine levels would have been similar in ENDS and inhaler users, had ENDS users been allowed to use the devices for 20 min as for the inhaler. However, regular ENDS users may draw 120–175 puffs·day−1 on …

Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomised controlled trial in primary care

Objective To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care. Design Open label randomised control trial: IMPACT (IMProving Adherence using Combination Therapy). Setting 54 general practices in the Auckland and Waikato regions of New Zealand, July 2010 to August 2013. Participants 513 adults (including 257 indigenous Māori) at high risk of cardiovascular disease (established cardiovascular disease or five year risk ≥15%) who were recommended for treatment with antiplatelet, statin, and two or more blood pressure lowering drugs. 497 (97%) completed 12 months’ follow-up. Interventions Participants were randomised to continued usual care or to fixed dose combination treatment (with two versions available: aspirin 75 mg, simvastatin 40 mg, and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg). All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists. Main outcome measures Primary outcomes were self reported adherence to recommended drugs (antiplatelet, statin, and two or more blood pressure lowering agents) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months. Results Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months (81% v 46%; relative risk 1.75, 95% confidence interval 1.52 to 2.03, P<0.001; number needed to treat 2.9, 95% confidence interval 2.3 to 3.7). Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group: for antiplatelet treatment it was 93% fixed dose combination v 83% usual care (P<0.001), for statin 94% v 89% (P=0.06), for combination blood pressure lowering 89% v 59% (P<0.001), and for any blood pressure lowering 96% v 91% (P=0.02). Self reported adherence was highly concordant with dispensing data (dispensing of all four recommended drugs 79% fixed dose combination v 47% usual care, relative risk 1.67, 95% confidence interval 1.44 to 1.93, P<0.001). There was no statistically significant improvement in risk factor control between the fixed dose combination and usual care groups over 12 months: the difference in systolic blood pressure was −2.2 mm Hg (−4.5 v −2.3, 95% confidence interval −5.6 to 1.2, P=0.21), in diastolic blood pressure −1.2 mm Hg (−2.1 v −0.9, −3.2 to 0.8, P=0.22) and in low density lipoprotein cholesterol −0.05 mmol/L (−0.20 v −0.15, −0.17 to 0.08, P=0.46). The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups (fixed dose combination 16 v usual care 18 (P=0.73), 99 v 93 (P=0.56), respectively). Fixed dose combination treatment was discontinued in 94 participants (37%). The most commonly reported reason for discontinuation was a side effect (54/75, 72%). Overall, 89% (227/256) of fixed dose combination participants’ general practitioners completed a post-trial survey, and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment (206/227, 91%), blood pressure control (180/220, 82%), cholesterol control (170/218, 78%), tolerability (181/223, 81%), and prescribing according to local guidelines (185/219, 84%). When participants were asked at 12 months how easy they found taking their prescribed drugs, most responded very easy or easy (224/246, 91% fixed dose combination v 212/246, 86% usual care, P=0.09). At 12 months the change in other lipid fractions, difference in EuroQol-5D, and difference in barriers to adherence did not differ significantly between the treatment groups. Conclusions Among this well treated primary care population, fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance. Acceptability was high for both general practitioners and patients, although the discontinuation rate was high. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12606000067572.

Diagnostic Accuracy of Nicalert Cotinine Test Strips in Saliva for Verifying Smoking Status

Semiquantitative immunoassay technology, in the form of rapid test strips, offers a less time-consuming and less costly alternative to other methods of verifying self-reported smoking status, such as gas chromatography-nitrogen phosphorus detection (GC). Unfortunately, information on the validity and reliability of some test strips in urine and saliva samples is not always available. This paper describes the diagnostic accuracy of one type of test strip currently available (NicAlert cotinine test strips; NCTS). GC was used as the reference standard and saliva as the sample medium. The study involved 86 people (41 smokers and 45 nonsmokers) aged 18 years or over, who were able to understand written English and provide written consent. Pregnant women, women with infants less than 6 weeks old, and people who had eaten 30 min prior to sample collection were excluded. Two saliva samples were collected simultaneously from each participant, with one sample tested using NCTS and the other by GC analysis. People with at least 10 ng/ml cotinine (in both tests) in their saliva were considered smokers. NCTS were found to have a specificity of 95% (95% CI 89%-100%), a sensitivity of 93% (95% CI 85%-100%), a positive predictive value of 95% (95% CI 89%-100%), and a negative predictive value of 93% (95% CI 86%-100%). The use of NCTS is a valid and reliable method, compared with GC, to test saliva samples for verification of smoking status.

Environmental influences on food security in high-income countries

Food security is a fundamental human right yet many people are food insecure, even in high-income countries. Reviewed here is the evidence for the physical, economic, sociocultural, and political environmental influences on household food security in high-income countries. The literature was evaluated using the ANGELO framework, which is a lens developed for understanding the environmental factors underpinning the obesity pandemic. A review of the literature identified 78 articles, which mostly reported on cross-sectional or qualitative studies. These studies identified a wide range of factors associated with food security. Foremost among them was household financial resources, but many other factors were identified and the complexity of the issue was highlighted. Few studies were prospective and even fewer tested the use of interventions other than the supplemental nutrition assistance program to address food security. This indicates a solution-oriented research paradigm is required to identify effective interventions and policies to enhance food security. In addition, comprehensive top-down and bottom-up interventions at the community and national levels are urgently needed.