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. 2023 Jun 19;2023(6):CD013308. doi: 10.1002/14651858.CD013308.pub2

Summary of findings 3. Higher‐dose compared to lower‐dose nicotine patch for smoking cessation.

Higher‐dose compared to lower‐dose nicotine patch for smoking cessation
Patient or population: people who smoke
Setting: any; studies conducted in: Australasia, Europe, USA
Intervention: higher‐dose nicotine patch
Comparison: lower‐dose nicotine patch
Outcomes Anticipated absolute effects* (95% CI) Relative effect
(95% CI) № of participants
(studies) Certainty of the evidence
(GRADE) Comments
Risk with lower‐dose nicotine patch Risk with higher‐dose nicotine patch
Smoking cessation ‐ 42/44 mg versus 21/22 mg (24‐hour patches) Study population RR 1.09
(0.93 to 1.29) 1655
(5 RCTs) ⊕⊕⊕⊝
Moderatea
238 per 1000 260 per 1000
(222 to 307)
Smoking cessation ‐ 25 mg versus 15 mg (16‐hour patches) Study population RR 1.19
(1.00 to 1.41) 3446
(3 RCTs) ⊕⊕⊕⊝
Moderatea,b
123 per 1000 146 per 1000
(123 to 173)
Smoking cessation ‐ 21 mg versus 14 mg (24‐hour patches) Study population RR 1.48
(1.06 to 2.08) 537
(1 RCT) ⊕⊕⊕⊝
Moderatec
167 per 1000 248 per 1000
(177 to 348)
Overall SAEs ‐ 42/44 mg versus 21/22 mg (24 hr patches) Study population RR 5.01
(0.87 to 28.82) 1023
(2 RCTs) ⊕⊕⊝⊝
Lowd,e
2 per 1000 10 per 1000
(2 to 56)
Overall SAEs ‐ 21 mg versus 14 mg (24‐hour patches) Study population Not estimable 537
(1 RCT) ⊕⊕⊝⊝
Lowf No events in either arm
Not estimable Not estimable
Treatment withdrawals ‐ 42/44 mg versus 21/22 mg (24‐hour patches) Study population RR 4.99
(1.60 to 15.50) 554
(2 RCTs) ⊕⊕⊝⊝
Lowe,f
11 per 1000 54 per 1000
(17 to 168)
Treatment withdrawals ‐ 21 mg versus 14 mg (24‐hour patches) Study population RR 0.77
(0.36 to 1.64) 537
(1 RCT) ⊕⊕⊝⊝
Lowd
55 per 1000 42 per 1000
(20 to 89)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; NRT: nicotine replacement therapy; RCT: randomised controlled trial; RR: risk ratio; SAEs: serious adverse events
GRADE Working Group grades of evidenceHigh certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded by one level due to imprecision: confidence intervals encompass no difference as well as a clinically significant difference.
bWe rated most studies at low or unclear risk of bias. We did not downgrade the certainty of the evidence, as limiting the analysis only to studies we judged to be at low risk of bias resulted in a consistent effect estimate and 95% confidence interval.
cDowngraded by one level due to imprecision: fewer than 300 events overall.
dDowngraded by two levels due to imprecision: fewer than 100 events in total and confidence intervals encompass no difference as well as a clinically significant difference.
eOne of the two studies was at high risk of bias, but judged unlikely to affect this outcome.
fDowngraded by two levels due to imprecision: fewer than 100 events in total.