PapersNicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow upCommentary: Progress on nicotine replacement therapy for smokers
BMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7179.285 (Published 30 January 1999) Cite this as: BMJ 1999;318:285Footnotes
Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up
- Thorsteinn Blondal, chest physician (thorsteinn.blondal{at}hr.is)a,
- Larus Jon Gudmundsson, research physiotherapista,
- Ingileif Olafsdottir, research nursea,
- Gunnar Gustavsson, clinical research managerb,
- Ake Westin, biostatisticianb
- aReykjavik Health Care Centre, Baronstigur 47, 101 Reykjavik and National University Hospital, Iceland
- bPharmacia and Upjohn, Box 941 S-251 09 Helsingborg, Sweden
- Department of Psychiatry, Tobacco Research Section and National Addiction Centre, Institute of Psychiatry, London SE5 8AF
- Correspondence to: Dr Blondal
Abstract
Objective: To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year.
Design: Placebo controlled, double blind trial.
Setting: Reykjavik health centre.
Subjects: 237 smokers aged 22-66 years living in or around Reykjavik.
Interventions: Nicotine patch for 5 months with nicotine nasal spray for 1 year (n=118) or nicotine patch with placebo spray (n=119). Treatment with patches included 15 mg of nicotine for 3 months, 10 mg for the fourth month, and 5 mg for the fifth month, whereas nicotine in the nasal spray was available for up to 1 year. Both groups received supportive treatment.
Main outcome measure: Sustained abstinence from smoking.
Results: The log rank test for 6 years (χ2=8.5, P=0.004) shows a significant association between abstinence from smoking and type of treatment. Sustained abstinence rates for the patch and nasal spray group and patch only group were 51% v 35% after 6 weeks (P=0.011 (χ 2), 95% confidence interval 1.17% to 3.32%), 37% v 25% after 3 months (P=0.045, 1.01% to 3.08%), 31% v 16% after 6 months (P=0.005, 1.27% to 4.50%), 27% v 11% after 12 months (P=0.001, 1.50% to 6.14%), and 16% v 9% after 6 years (P=0.077, 0.93% to 4.72%).
Conclusions: Short and long term abstinence rates show that the combination of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year is a more effective method of stopping smoking than using a patch only. The low percentage of participants using the nasal spray at 1 year, and the few relapses during the second year, suggest that it is not cost effective to use a nasal spray for longer than 7 months after stopping a patch.
Commentary: Progress on nicotine replacement therapy for smokers
- John Stapleton, senior lecturer (j.stapleton{at}iop.bpmf.ac.uk)
- aReykjavik Health Care Centre, Baronstigur 47, 101 Reykjavik and National University Hospital, Iceland
- bPharmacia and Upjohn, Box 941 S-251 09 Helsingborg, Sweden
- Department of Psychiatry, Tobacco Research Section and National Addiction Centre, Institute of Psychiatry, London SE5 8AF