Clinical Bottom Line:
Extending the duration of nicotine patches to 24 weeks increases the likelihood of smoking cessation and slows relapse in healthy motivated quitters receiving behavioural support without increasing side effects.
Clinical Scenario:
Your partner has tried to quit smoking several times but has quickly relapsed each time. BEN+ (Best Evidence for Nursing) has notified you of a study about the effect of extended treatment with nicotine patches. You wonder whether extending the smoking cessation therapy might increase the chances your partner will finally stop smoking.
Clinical Questions:
Among smokers who want to quit, does extending the duration of nicotine replacement therapy increase the rate of smoking cessation?
Search Strategy:
Nil: BEN+ sends study titles to you based on your interests and user profile once you register at http://plus.mcmaster.ca/NP/Default.aspx?Page=1.
Citation:
Schnoll RA, Patterson F, Wileyto P, et al. Effectiveness of extended-duration transdermal nicotine therapy. Ann Intern Med 2010; 152:144-51.
Study Summary:
Two-arm, parallel group, randomised controlled trial conducted at University of Pennsylvania in the USA. Participants recruited through newspaper advertising. Overall, 3276 people responded, but majority did not meet inclusion criteria or did not want to attend in-person eligibility screening (2653). 575 participants were randomised. Participants had to be aged 18-65 years and have smoked 10 or more cigarettes per day for at least the past year. Exclusion criteria were pregnancy or lactation, uncontrolled hypertension, unstable angina, heart attack or stroke within previous six months, recent diagnosis of cancer or kidney or liver failure, history of organ transplant or Axis I psychiatric disorder, current diagnosis of diabetes, drug or alcohol dependence, current use of concomitant medication or treatment for nicotine addiction. Eight sessions of behavioural counselling over 22 weeks provided by five counsellors to all participants. Nicotine replacement delivered via standard transdermal patch (Nicoderm CQ 21 mg).
Extended duration group (n=287):
Transdermal nicotine patch for 24 weeks.
Standard care group (n=288):
Transdermal nicotine patch for eight weeks and placebo patch for 16 weeks.
Outcome:
primary outcome self-reported abstinence at week 24 verified by carbon monoxide level
(≤ 10 ppm). Smoking assumed if lost to follow-up, could not provide carbon monoxide sample or had carbon
monoxide levels > 10 ppm. Other outcomes included abstinence at week 52, time to relapse, cost effectiveness and side effects.
Validity:
Individual patients randomised by computer-generated randomisation. Investigators masked to treatment allocation. Participants and assessors blinded to treatment group. Follow-up was 76% at week 24 and 72% at week 52. Analysis was on an intention-to-treat basis with loss assumed to be treatment failures. Groups were similar at baseline. Overall the methodological quality of the study was high.
Results:
There were significantly more quitters in the group with extended duration patches than in the standard care group at 24 weeks (point prevalence) but not at 52 weeks. Prolonged abstinence was significantly greater in the extended duration group than in standard care and rate of relapse was slower in the extended care group in weeks 9-24. Overall, rates of serious adverse event were low with two more events in the extended care group than in standard care (3 versus 1).
Comments:
- Applicable to smokers motivated to quit and who are otherwise healthy. Should not be assumed to be applicable to smokers with co-morbidities.
- Type of behavioural support not described although support followed a manual and was supervised to ensure standardisation.
- Cost effectiveness analysis assumed perspective of cost to smoker, not cost to service provider or funder. Incremental cost effectiveness ratio US$2482 per additional quitter.s.
Reviewer:
Dr Andrew Jull, RN PhD, Associate Professor (School of Nursing), Nurse Advisor – Quality, Auckland District Health Board.
