Pre-cessation nicotine replacement therapy: pragmatic randomized trial.

AIMS: To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months. DESIGN: Pragmatic randomized controlled trial. SETTING: New Zealand. PARTICIPANTS: Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone. MEASUREMENTS: The primary outcome was self-reported 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine-verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events. FINDINGS: Six months after quit day 125 (22.7%) participants in the pre-cessation group and 116 (21.0%) in the control group reported 7-day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: -3.2%, 6.6%). However, when pooled in a meta-analysis with other pre-cessation trials a moderate benefit of about a one-quarter increase in cessation rates was evident. There was no difference in adverse events between groups. CONCLUSIONS: In this, the largest pre-cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre-cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials.

A randomized trial of the effects of two novel nicotine replacement therapies on tobacco withdrawal symptoms and user satisfaction.

AIMS: To determine effects on craving, user satisfaction, and consumption patterns of two new nicotine replacement therapies (NRT) used for eight hours after overnight tobacco abstinence. DESIGN: In a within-subject, cross-over trial participants were randomly assigned Zonnic nicotine mouth spray (1 mg/spray), Zonnic nicotine lozenge (2.5 mg), Nicorette gum (4 mg) and placebo lozenge on each of four study days. SETTING: University research unit. PARTICIPANTS: Forty-seven dependent adult smokers. MEASUREMENTS: Participants rated their urges to smoke, irritability, concentration and restlessness before and during the first hour of product use on a 100-point scale. A subsample of 11 participants provided blood samples for nicotine analysis. FINDINGS: All active products reduced craving significantly more than placebo (mean reductions of 28.6, 25.8, 24.7 and 8.9 points for mouth spray, gum, lozenge and placebo). Mouth spray relieved craving faster than placebo and gum with significant reductions within five minutes of use (mean differences of -14.5 (95% CI: -23.0 to -6.0) and -10.6 (95% CI: -19.1 to -2.1) with placebo and gum respectively. Mouth spray produced a faster time to maximum plasma nicotine concentration (14.5 minutes, 95% CI: 8.0 to 21.0) compared to the lozenge (30.3 minutes, 95% CI: 21.1 to 39.5) and gum (45.8 minutes, 95% CI: 36.2 to 55.4). Maximum concentrations of blood nicotine were higher with mouth spray (10.0 ng/ml) and lozenge (10.8 ng/ml) compared to gum (7.8 ng/ml). Both lozenge and mouth spray were well tolerated. CONCLUSIONS: The mouth spray and lozenge are at least as effective as 4 mg nicotine gum in relieving craving suggesting that they are likely to be effective in aiding smoking cessation. The mouth spray may be particularly useful for acute craving relief.

Effects of moderate-dose omega-3 fish oil on cardiovascular risk factors and mood after ischemic stroke: a randomized, controlled trial.

BACKGROUND AND PURPOSE: Fish-derived omega-3 fatty acids have long been associated with cardiovascular protection. In this trial, we assessed whether treatment with a guideline-recommended moderate-dose fish oil supplement could improve cardiovascular biomarkers, mood- and health-related quality of life in patients with ischemic stroke. METHODS: Patients with CT-confirmed stroke were randomized to 3 g/day encapsulated fish oil containing approximately 1.2 g total omega-3 (0.7 g docosahexaenoic acid; 0.3 g eicosapentaenoic acid) or placebo oil (combination palm and soy) taken daily over 12 weeks. Serum triglycerides, total cholesterol and associated lipoproteins, selected inflammatory and hemostatic markers, mood, and health-related quality of life were assessed at baseline and follow-up. The primary outcome was change in triglycerides. Compliance was assessed by capsule count and serum phospholipid omega-3 levels (Australian Clinical Trials Registration: ACTRN12605000207617). RESULTS: One hundred two patients were randomized to fish oil or placebo. Intention-to-treat and per-protocol (>85% compliance) analyses showed no significant effect of fish oil treatment on any lipid, inflammatory, hemostatic, or composite mood parameters measured. Adherence to treatment based on pill count was good (89%) reflected by increased serum docosahexanoic acid (P<0.001) and eicosapentaenoic acid (P=0.0006) in the fish oil group. Analysis of oil composition, however, showed some degradation and potentially adverse oxidation products at the end of the study. CONCLUSIONS: There was no effect of 12 weeks of treatment with moderate-dose fish oil supplements on cardiovascular biomarkers or mood in patients with ischemic stroke. It is possible that insufficient dose, short duration of treatment, and/or oxidation of the fish oils may have influenced these outcomes.

A single-blind, randomized, crossover trial of the effects of a nicotine pouch on the relief of tobacco withdrawal symptoms and user satisfaction.

INTRODUCTION: We compared the effects of a 4-mg oral nicotine pouch (Zonnic pouch), with nicotine chewing gum and placebo pouch, on withdrawal discomfort after overnight tobacco abstinence. We also assessed participants' preferences, satisfaction, and consumption patterns. METHODS: This was a randomized, placebo-controlled, three-way crossover study of 30 adult smokers. After overnight tobacco abstinence, subjects reported on a Visual Analog Scale (VAS; 0-100) tobacco withdrawal symptoms (craving, irritability, difficulty concentrating, and restlessness) before use and during the first hour after first product use. They then used the product throughout the study day and in the evening reported product usefulness, temporary abstinence success, and satisfaction. RESULTS: In a multivariate analysis, area under the curve (craving vs. time) was reduced by 23 points 60 min after taking the study medication in the nicotine pouch group, compared with 15- and 8-point decreases in the gum and placebo groups, respectively. The difference in craving ratings between the pouch and placebo was significant (p = .002). Nicotine pouch reduced irritability more than gum (difference = 9.86; p = .01). For pouch users, the odds ratio for temporary tobacco abstinence (21.5 hr) during study days (compared with gum) was 2.8 (95% CI = 0.8-8.1). Compared with the gum, the pouch was rated as significantly more "helpful to stop smoking" (difference = 20.6; 95% CI = 2.4-38.9) and "pleasant to use" (difference = 17.3; 95% CI = 2.6-32.0). DISCUSSION: The Zonnic pouch appears to be as effective at relieving craving as nicotine gum and was subjectively favored over the gum. These results suggest that the pouch will be a helpful addition to the range of existing nicotine replacement treatments.

Smoking cessation using mobile phone text messaging is as effective in Maori as non-Maori.

AIMS: To determine whether a smoking cessation service using mobile phone text messaging is as effective for Maori as non-Maori. METHODS: A single-blind randomised controlled trial was undertaken with recruitment targeted to maximise the participation of young Maori. The intervention included regular, personalised text messages providing smoking cessation advice, support, and distraction. Maori text messages related to Maori language, support messages (in Maori and English) and information on Maori traditions. Text messaging was free for 1 month. After 6 weeks, the number of messages reduced from 5 per day to 3 per week until the 26-week follow-up. RESULTS: Participants included 355 Maori and 1350 non-Maori. Maori in the intervention group were more likely to report quitting (no smoking in the past week) at 6 weeks (26.1%) than those in the control group (11.2%) RR 2.34, 95% CI: 1.44-3.79. There was no significant difference between the RR for Maori and that for non-Maori (RR: 2.16, 95%CI: 1.72-2.71). CONCLUSIONS: A mobile phone-based cessation programme was successful in recruiting young Maori, and was shown to be as effective for Maori as non-Maori at increasing short-term self-reported quit rates. This shows clear potential as a new public health initiative.

Distribution of major health risks: findings from the Global Burden of Disease study.

BACKGROUND: Most analyses of risks to health focus on the total burden of their aggregate effects. The distribution of risk-factor-attributable disease burden, for example by age or exposure level, can inform the selection and targeting of specific interventions and programs, and increase cost-effectiveness. METHODS AND FINDINGS: For 26 selected risk factors, expert working groups conducted comprehensive reviews of data on risk-factor exposure and hazard for 14 epidemiological subregions of the world, by age and sex. Age-sex-subregion-population attributable fractions were estimated and applied to the mortality and burden of disease estimates from the World Health Organization Global Burden of Disease database. Where possible, exposure levels were assessed as continuous measures, or as multiple categories. The proportion of risk-factor-attributable burden in different population subgroups, defined by age, sex, and exposure level, was estimated. For major cardiovascular risk factors (blood pressure, cholesterol, tobacco use, fruit and vegetable intake, body mass index, and physical inactivity) 43%-61% of attributable disease burden occurred between the ages of 15 and 59 y, and 87% of alcohol-attributable burden occurred in this age group. Most of the disease burden for continuous risks occurred in those with only moderately raised levels, not among those with levels above commonly used cut-points, such as those with hypertension or obesity. Of all disease burden attributable to being underweight during childhood, 55% occurred among children 1-3 standard deviations below the reference population median, and the remainder occurred among severely malnourished children, who were three or more standard deviations below median. CONCLUSIONS: Many major global risks are widely spread in a population, rather than restricted to a minority. Population-based strategies that seek to shift the whole distribution of risk factors often have the potential to produce substantial reductions in disease burden.

Active and passive smoking and the risk of subarachnoid hemorrhage: an international population-based case-control study.

BACKGROUND AND PURPOSE: This study was undertaken to better clarify the risks associated with cigarette smoking and subarachnoid hemorrhage (SAH). METHODS: The study included 432 incident cases of SAH frequency matched to 473 community SAH-free controls to determine dose-dependent associations of active and passive smoking (at home) and smoking cessation with SAH. RESULTS: Compared with never smokers not exposed to passive smoking, the adjusted odds ratio for SAH among current smokers was 5.0 (95% confidence interval [CI], 3.1 to 8.1); for past smokers, 1.2 (95% CI, 0.8 to 2.0); and for passive smokers, 0.9 (95% CI, 0.6 to 1.5). Current and lifetime exposures showed a clear dose-dependent effect, and risks appeared more prominent in women and for aneurysmal SAH. Approximately 1 in 3 cases of SAH could be attributed to current smoking, but risks decline quickly after smoking cessation, even among heavy smokers. CONCLUSIONS: A strong positive association was found between cigarette smoking and SAH, especially for aneurysmal SAH and women, which is virtually eliminated within a few years of smoking cessation. Large opportunities exist for preventing SAH through smoking avoidance and cessation programs.