- Combining reduced-harm nicotine products, such as nicotine patches with a nicotine e-cigarette was superior to patches plus a nicotine-free e-cigarette for 6-month smoking abstinence among smokers motivated to quit with no indication of any serious harm in the short term.
Why this matters
- Findings are consistent with the findings from Cochrane review of e-cigarettes for smoking cessation and support evidence from randomised trials on the efficacy, effectiveness, and safety of e-cigarettes for smoking cessation.
- 1124 smokers were randomly assigned to receive 14 weeks (2 weeks before the agreed quit date) of 21 mg, 24 hours nicotine patches (n=125), patches plus an 18 mg/L nicotine e-cigarette (n=500), or patches plus a nicotine-free e-cigarette (n=499).
- Primary outcome: exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months after the agreed quit date.
- Funding: Health Research Council of New Zealand.
- The proportion of smokers who withdrew or were lost to follow-up by 6 months was higher in patches only vs patches + nicotine-free e-cigarette vs patches + nicotine e-cigarette group (50% vs 33% vs 32%).
- CO-verified continuous abstinence at 6 months was significantly higher in:
- patches + nicotine e-cigarette vs patches + nicotine-free e-cigarette group (7% vs 4%; risk difference [RD], 2.99; 95% CI, 0.17-5.81; P=.038),
- patches + nicotine e-cigarette vs patches only (7% vs 2%; RD, 4.60; 95% CI, 1.11-8.09; P=.05).
- The number of serious adverse events (SAEs) in the patches + nicotine e-cigarette group, patches + nicotine-free e-cigarette and patches only groups were 18, 27 and 4, respectively.
- Two life-threatening SAEs reported in the patches + nicotine e-cigarette and one in the patches + nicotine-free e-cigarette group.
- No significant between-group differences were noted for SAEs, and none were treatment-related.
- Recruitment target restricted the ability to do some comparisons.
- Follow-up was 10% higher than anticipated.