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Nicotine Replacement Therapy for Smoking Cessation or Reduction: A Review of the Clinical Evidence [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan 16.

APPENDIX 2Characteristics of Included Studies

First Author,
Publication
Year, Country
Study
Design,
Length of
Study
Patient
Characteristics,
Sample Size
InterventionComparatorsMain Outcomes
Systematic review/Meta-analysis
Stead LF15 2012, UK, New ZealandSR of RCTsSmokers
  • N= 8 RCTs for high dose patch;
  • N=3 RCTs for combination of patch and guma
  • N=3 RCTs for lozenge (2 mg to 4 mg)b
  • Standard dose nicotine patch (vs. high dose)
  • Other NRTs(vs. combination)
  • Placebo or other NRTs (vs. nicotine lozenge)
  • Smoking cessation
  • Adverse events
Mills EJ13 2012, Multi-nations (Canada, UK and USA)SR of RCTscSmokers
  • N= 5 RCTs for high dose patch
  • N=2 RCTs for combination of patch and gum d
  • Standard dose nicotine patch (vs. high dose)
  • Other NRTs(vs. combination)
  • Smoking cessation
Moore D 25 2009, UKSR of RCTsSmokers (without intention to quit)
N=7 RCTs
NRT gum (4 RCTs)
NRT inhaler (2 RCTs)
Free choice of therapy (1 RCT)
Placebo
  • Smoking cessation
  • Smoking reduction
  • Adverse events
Randomized controlled trials
Chen HK 22 2013, TaiwanRCT Duration: 8 weeksSmokers (daily smoker, minimum cigarettes number not reported) in patients with schizophrenia
N=184
Nicotine transdermal patch 31.5mg/d for week 1–4
20.8 mg/d for week 5–8
Nicotine transdermal patch 20.8 mg/d for 8 weeks
  • Smoking cessation
  • Smoking reduction
Schnoll RA 27 2013, USA and CanadaRCT Duration: 8 weeksSmokers(≥ 10 cigarettes/d) with a faster rate of nicotine metabolism
N=87
Nicotine transdermal patch 42 mg/d for 7 daysNicotine transdermal patch 21 mg/d for 7 days
  • Smoking cessation
  • Adverse events
Tonnesen P 26 2012, Denmark. and GermanyRCT
Duration: 12 weeks
Smokers (>= 1 cigarette/d)
N=479
Nicotine mouth Sparye (with low-intensity counselling)Placebo (with low-intensity counselling)Smoking cessation
Adverse events
WDAE
Lam TH23 2012 P.R. China, USARCT Duration: 6 monthsSmokers (≥ 2 cigarettes/d) not willing to quit smoking or failed in previous attempts to quit using NRT
N=1154
NRT plus counsellingcounselling
  • Self-reported 7-day point-prevalence tobacco abstinence
  • validated quit rate
  • Self-reported reduction rate (≥50%) of cigarette consumptionf
Kralikova E 24 2009 Czech Republic, UK and FranceRCT Treatment duration: 9 months
Follow-up: to 12 months
Smokers ((≥ 15 cigarettes/d) not willing to quit smoking
N=314
Nicotine gum (4 mg) or inhaler (10 mg)Placebo gum or placebo inhalerAt 12 months
  • Smoking reduction ((≥50%) of daily cigarette consumptionf
  • Smoking cessation
Shiffman S28 2009, USARCT Treatment Duration: 8 weeksSmokers (minimum cigarettes number not reported) willing gradually reducing the number of cigarettes until they stop smoking
N=3297
Nicotine gum (2 mg or 4mg)Placebo
  • Smoking reduction (≥50%) of daily cigarette consumptionf
  • Smoking cessation

d=day(s); WDAE=Withdrew due to adverse events;

a

Combination of nicotine patch plus gum is included in this review because Nicorette Combo Quit consists of nicotine patch and gum, and no evidence was identified for the NRT specifically termed as Nicorette Combo Quit

b

Nicotine lozenge (2 mg or 4 mg) is included in this review because the strength of Nicorette Mini Lozenges are 2 mg or 4 mg, and no evidence was identified for the NRT specifically termed as Nicorette Mini Lozenges

c

Included only RCTs with at least 3 months posttarget quit date (TQD) with biochemical confirmation of smoking abstinence

d

However, the two studies of combination of nicotine patch plus nicotine gum included in the SR by Mills13 were already reported in the SR by Stead et al15. And also there was no pooled data. Therefore, only the high dose info was extracted in this review.

e

Nicotine mouth spray is included in this review because Nicorette Quick Mist is a nicotine mouth spray, and no evidence was identified for the NRT specifically termed as Nicorette Quick Mist.

f

Smoking reduction defined as ≥50% less of daily cigarette consumption versus baseline.

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Nicotine Replacement Therapy for Smoking Cessation or Reduction: A Review of the Clinical Evidence [Internet].

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