Electronic cigarettes for smoking cessation

Nicola Lindson; Ailsa R Butler; Hayden McRobbie; Chris Bullen; Peter Hajek; Rachna Begh; Annika Theodoulou; Caitlin Notley; Nancy A Rigotti; Tari Turner; Jonathan Livingstone-Banks; Tom Morris; Jamie Hartmann-Boyce

doi:10.1002/14651858.CD010216.pub8

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Figure 1

PRISMA diagram for 2023 update

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Figure 2

Risk of bias graph

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Figure 3

Risk of bias summary

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Figure 4

Funnel plot for comparison 4.4

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Figure 5

Network map for cessation

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Figure 6

Cessation network meta‐analysis

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Figure 7

Network map for adverse events

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Figure 8

Adverse events network meta‐analysis

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Figure 9

Network map for serious adverse events

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Figure 10

Serious adverse events network meta‐analysis

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Analysis 1.1

Comparison 1: Nicotine EC versus NRT, Outcome 1: Smoking cessation

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Analysis 1.2

Comparison 1: Nicotine EC versus NRT, Outcome 2: Adverse events

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Analysis 1.3

Comparison 1: Nicotine EC versus NRT, Outcome 3: Serious adverse events

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Analysis 1.4

Comparison 1: Nicotine EC versus NRT, Outcome 4: Carbon monoxide (ppm)

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Analysis 1.5

Comparison 1: Nicotine EC versus NRT, Outcome 5: Heart rate (bpm)

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Analysis 1.6

Comparison 1: Nicotine EC versus NRT, Outcome 6: Systolic blood pressure

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Analysis 1.7

Comparison 1: Nicotine EC versus NRT, Outcome 7: Blood oxygen saturation

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Analysis 1.8

Comparison 1: Nicotine EC versus NRT, Outcome 8: 3‐HPMA (pmol/mg creatinine)

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Analysis 1.9

Comparison 1: Nicotine EC versus NRT, Outcome 9: NNAL (pmol/mg creatinine))

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Analysis 1.10

Comparison 1: Nicotine EC versus NRT, Outcome 10: 2‐HPMA (pmol/mg creatinine)

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Analysis 1.11

Comparison 1: Nicotine EC versus NRT, Outcome 11: HMPMA (pmol/mg creatinine)

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Analysis 1.12

Comparison 1: Nicotine EC versus NRT, Outcome 12: PheT (pmol/mg creatinine)

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Analysis 1.13

Comparison 1: Nicotine EC versus NRT, Outcome 13: CEMA (pmol/mg creatinine)

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Analysis 1.14

Comparison 1: Nicotine EC versus NRT, Outcome 14: AAMA (pmol/mg creatinine)

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Analysis 1.15

Comparison 1: Nicotine EC versus NRT, Outcome 15: FEV1

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Analysis 1.16

Comparison 1: Nicotine EC versus NRT, Outcome 16: FEV1/FVC (%)

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Analysis 1.17

Comparison 1: Nicotine EC versus NRT, Outcome 17: PEF (L/min)

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Analysis 1.18

Comparison 1: Nicotine EC versus NRT, Outcome 18: Product use at 6+ months

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Analysis 2.1

Comparison 2: Nicotine EC versus varenicline, Outcome 1: Smoking cessation

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Analysis 2.2

Comparison 2: Nicotine EC versus varenicline, Outcome 2: Serious adverse events

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Analysis 3.1

Comparison 3: Nicotine EC versus heated tobacco, Outcome 1: Adverse events at 12 weeks

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Analysis 3.2

Comparison 3: Nicotine EC versus heated tobacco, Outcome 2: SAEs at 12 weeks

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Analysis 3.3

Comparison 3: Nicotine EC versus heated tobacco, Outcome 3: Carbon monoxide (ppm) absolute values at 12 weeks

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Comparison 3: Nicotine EC versus heated tobacco, Outcome 4: VO2 Max at 12 weeks

Analysis 3.4

Comparison 3: Nicotine EC versus heated tobacco, Outcome 4: VO₂ Max at 12 weeks

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Analysis 4.1

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 1: Smoking cessation

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Analysis 4.2

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 2: Adverse events

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Analysis 4.3

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 3: Serious adverse events

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Analysis 4.4

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 4: Carbon monoxide (ppm)

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Analysis 4.5

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 5: Heart rate

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Analysis 4.6

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 6: Systolic blood pressure

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Analysis 4.7

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 7: FeNO (ppb)

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Analysis 4.8

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 8: FEV1 (l)

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Analysis 4.9

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 9: FEV1/FVC

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Analysis 4.10

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 10: NNAL (pmol/mg creatinine)

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Analysis 4.11

Comparison 4: Nicotine EC versus non‐nicotine EC, Outcome 11: Product use at 6+ months

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Analysis 5.1

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 1: Smoking cessation

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Analysis 5.2

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 2: Adverse events

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Analysis 5.3

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 3: Serious adverse events

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Analysis 5.4

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 4: Carbon monoxide (ppm)

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Analysis 5.5

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 5: Heart rate (bpm)

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Analysis 5.6

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 6: Systolic blood pressure

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Analysis 5.7

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 7: Blood oxygen saturation

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Analysis 5.8

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 8: 3‐HPMA (SMD)

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Analysis 5.9

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 9: NNAL (SMD)

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Analysis 5.10

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 10: 2‐HPMA (pmol/mg creatinine)

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Analysis 5.11

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 11: HMPMA (pmol/mg creatinine)

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Analysis 5.12

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 12: PheT (pmol/mg creatinine)

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Analysis 5.13

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 13: CEMA (pmol/mg creatinine)

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Analysis 5.14

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 14: AAMA (pmol/mg creatinine)

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Analysis 5.15

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 15: S‐PMA (nanograms)

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Analysis 5.16

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 16: FEV1 (SMD)

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Analysis 5.17

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 17: FEF 25‐75 (litres/second))

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Analysis 5.18

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 18: PEF 25‐75 (litres/minute)

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Analysis 5.19

Comparison 5: Nicotine EC versus behavioural support only/no support, Outcome 19: FEV1/FVC

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Analysis 6.1

Comparison 6: Higher versus lower nicotine content, Outcome 1: Smoking cessation

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Analysis 6.2

Comparison 6: Higher versus lower nicotine content, Outcome 2: Serious adverse events

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Analysis 6.3

Comparison 6: Higher versus lower nicotine content, Outcome 3: Carbon monoxide (ppm)

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Analysis 6.4

Comparison 6: Higher versus lower nicotine content, Outcome 4: Heart rate

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Analysis 6.5

Comparison 6: Higher versus lower nicotine content, Outcome 5: Systolic blood pressure

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Analysis 6.6

Comparison 6: Higher versus lower nicotine content, Outcome 6: FeNO (ppb)

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Analysis 6.7

Comparison 6: Higher versus lower nicotine content, Outcome 7: FEV1 (l)

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Analysis 6.8

Comparison 6: Higher versus lower nicotine content, Outcome 8: FVC (l)

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Analysis 6.9

Comparison 6: Higher versus lower nicotine content, Outcome 9: FEV1/FVC

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Analysis 6.10

Comparison 6: Higher versus lower nicotine content, Outcome 10: NNAL (pg/mg creatinine) at 24 weeks

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Analysis 6.11

Comparison 6: Higher versus lower nicotine content, Outcome 11: Product use at 6+ months

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Analysis 7.1

Comparison 7: Tobacco vs. menthol flavour, Outcome 1: Serious adverse events

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Analysis 7.2

Comparison 7: Tobacco vs. menthol flavour, Outcome 2: NNAL (ng/g)

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Analysis 7.3

Comparison 7: Tobacco vs. menthol flavour, Outcome 3: FEV1 (% predicted)

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Analysis 7.4

Comparison 7: Tobacco vs. menthol flavour, Outcome 4: FEV1/FVC

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Analysis 8.1

Comparison 8: Refillable versus cartridge, Outcome 1: Exhaled CO

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Analysis 9.1

Comparison 9: Nicotine salt EC versus free‐base nicotine EC, Outcome 1: Smoking cessation

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Analysis 9.2

Comparison 9: Nicotine salt EC versus free‐base nicotine EC, Outcome 2: Product use at 6+ months

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Analysis 10.1

Comparison 10: Non‐nicotine EC versus behavioural support only/no support, Outcome 1: Smoking cessation

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Analysis 10.2

Comparison 10: Non‐nicotine EC versus behavioural support only/no support, Outcome 2: Adverse events at 12 weeks

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Analysis 10.3

Comparison 10: Non‐nicotine EC versus behavioural support only/no support, Outcome 3: Serious adverse events at 24 weeks

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Analysis 11.1

Comparison 11: Non‐nicotine EC + NRT versus NRT, Outcome 1: Smoking cessation

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Analysis 11.2

Comparison 11: Non‐nicotine EC + NRT versus NRT, Outcome 2: Adverse events

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Analysis 11.3

Comparison 11: Non‐nicotine EC + NRT versus NRT, Outcome 3: Serious adverse events

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Analysis 12.1

Comparison 12: Non‐nicotine EC versus NRT, Outcome 1: Smoking cessation

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Analysis 12.2

Comparison 12: Non‐nicotine EC versus NRT, Outcome 2: Adverse events

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Analysis 12.3

Comparison 12: Non‐nicotine EC versus NRT, Outcome 3: Serious adverse events

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Analysis 12.4

Comparison 12: Non‐nicotine EC versus NRT, Outcome 4: Change in carbon monoxide (ppm) at 6 months

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Analysis 13.1

Comparison 13: Advice to use e‐cigarettes compared to no advice to use e‐cigarettes, Outcome 1: Smoking cessation

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Analysis 13.2

Comparison 13: Advice to use e‐cigarettes compared to no advice to use e‐cigarettes, Outcome 2: Adverse events at 3 months

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Analysis 13.3

Comparison 13: Advice to use e‐cigarettes compared to no advice to use e‐cigarettes, Outcome 3: Serious adverse events at 3 months

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Analysis 13.4

Comparison 13: Advice to use e‐cigarettes compared to no advice to use e‐cigarettes, Outcome 4: Product use at 6+ months

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Analysis 14.1

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 1: Smoking cessation

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Analysis 14.2

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 2: Adverse events

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Analysis 14.3

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 3: Serious adverse events

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Analysis 14.4

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 4: Carbon monoxide (ppm)

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Analysis 14.5

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 5: FeNO (ppb)

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Analysis 14.6

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 6: FEV1 (%)

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Analysis 14.7

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 7: FVC (%)

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Analysis 14.8

Comparison 14: Nicotine EC + NRT versus non‐nicotine EC + NRT, Outcome 8: Study product use at 6+ months

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Analysis 15.1

Comparison 15: Nicotine EC + NRT versus NRT, Outcome 1: Smoking cessation

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Analysis 15.2

Comparison 15: Nicotine EC + NRT versus NRT, Outcome 2: Adverse events

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Analysis 15.3

Comparison 15: Nicotine EC + NRT versus NRT, Outcome 3: Serious adverse events

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Analysis 16.1

Comparison 16: Nicotine EC + varenicline vs. varenicline, Outcome 1: Adverse events at 12 weeks

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Analysis 16.2

Comparison 16: Nicotine EC + varenicline vs. varenicline, Outcome 2: Serious adverse events at 12 weeks

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Summary of findings 1. Nicotine EC compared to NRT for smoking cessation

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Nicotine EC compared to NRT for smoking cessation
Patient or population: People who smoke Setting: Various settings in New Zealand, UK, USA Intervention: Nicotine EC Comparison: NRT
Outcomes	Events with NRT	Events with Nicotine EC	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Smoking cessation at 6 months to 1 year Assessed with biochemical validation	Study population		RR 1.59 (1.29 to 1.93)	2544 (7 RCTs)	⊕⊕⊕⊕ HIGH	‐
	6 per 100	10 per 100 (8 to 12)	RR 1.59 (1.29 to 1.93)	2544 (7 RCTs)	⊕⊕⊕⊕ HIGH	‐
Adverse events at 4 weeks to 6‐9 months Assessed by self‐report	Study population		RR 1.03 (0.91 to 1.17)	2052 (5 RCTs)	⊕⊕⊕⊝ MODERATE^a	‐
	23 per 100	24 per 100 (21 to 27)	RR 1.03 (0.91 to 1.17)	2052 (5 RCTs)	⊕⊕⊕⊝ MODERATE^a	‐
Serious adverse events at 4 weeks to 1 year Assessed via self‐report and medical records	Study population		RR 1.20 (0.90 to 1.60)	2411 (6 RCTs)	⊕⊕⊝⊝ LOW^b	2 studies reported no events; effect estimate based on the four studies in which events were reported
	4 per 100	5 per 100 (4 to 6)	RR 1.20 (0.90 to 1.60)	2411 (6 RCTs)	⊕⊕⊝⊝ LOW^b
*The estimated number of events in the intervention group (and its 95% confidence interval) is based on the assumed number of events in the comparison group and the relative effect of the intervention (and its 95% CI). For cessation, the assumed number of events in the control group is based on assumed quit rates for NRT assuming receipt of limited behavioural stop‐smoking support (as per Hartmann‐Boyce 2018a). The assumed risk for adverse events and serious adverse events is a weighted mean average of quit rates across control groups in contributing studies. CI: Confidence interval; RCT: randomized controlled trial; RR: Risk ratio
GRADE Working Group grades of evidence High 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 one level due to imprecision; CIs consistent with benefit and harm ^bDowngraded two levels due to imprecision; fewer than 300 events and CIs encompass clinically important harm and clinically important benefit

Summary of findings 1. Nicotine EC compared to NRT for smoking cessation

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Summary of findings 2. Nicotine EC compared to non‐nicotine EC for smoking cessation

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Nicotine EC compared to non‐nicotine EC for smoking cessation
Patient or population: People who smoke cigarettes Setting: Various settings in Canada, Italy, New Zealand, UK, USA Intervention: Nicotine EC Comparison: Non‐nicotine EC
Outcomes	Events with non‐nicotine EC	Events with Nicotine EC	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Smoking cessation at 6‐12 months Assessed with biochemical validation	Study population		RR 1.46 (1.09 to 1.96)	1613 (6 RCTs)	⊕⊕⊕⊝ MODERATE^a,b	‐
	7 per 100	10 per 100 (8 to 14)	RR 1.46 (1.09 to 1.96)	1613 (6 RCTs)	⊕⊕⊕⊝ MODERATE^a,b	‐
Adverse events at 1 week to 6 months Assessed via self‐report	Study population		RR 1.01 (0.91 to 1.11)	840 (5 RCTs)	⊕⊕⊕⊝ MODERATE^b	‐
	9 per 100	9 per 100 (8 to 10)	RR 1.01 (0.91 to 1.11)	840 (5 RCTs)	⊕⊕⊕⊝ MODERATE^b	‐
Serious adverse events at 1 week to 1 year Assessed via self‐report and medical records	Study population		RR 1.00 (0.56 to 1.79)	1412 (9 RCTs)	⊕⊕⊝⊝ LOW^c	5 studies reported no events; effect estimate based on the 4 studies in which events were reported
	3 per 100	3 per 100 (2 to 6)	RR 1.00 (0.56 to 1.79)	1412 (9 RCTs)	⊕⊕⊝⊝ LOW^c
*The estimated number of events in the intervention group (and its 95% confidence interval) is based on the assumed number of events in the comparison group and the relative effect of the intervention (and its 95% CI). For cessation, the assumed number of events in the control group is based on assumed quit rates for NRT assuming receipt of limited behavioural stop‐smoking support (as per Hartmann‐Boyce 2018a). The assumed risk for adverse events and serious adverse events is a weighted mean average of quit rates across control groups in contributing studies. CI: Confidence interval; RCT: randomized controlled trial; RR: Risk ratio
GRADE Working Group grades of evidence High 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
^aNot downgraded for risk of bias. One of four studies considered high risk of bias; removing this study increased the direction of the effect in favour of the intervention. ^bDowngraded one level due to imprecision; < 300 events overall ^cDowngraded two levels due to imprecision: confidence intervals encompass clinically significant harm as well as clinically significant benefit.

Summary of findings 2. Nicotine EC compared to non‐nicotine EC for smoking cessation

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Summary of findings 3. Nicotine EC compared to behavioural support only/no support for smoking cessation

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Nicotine EC compared to behavioural support only/no support for smoking cessation
Patient or population: People who smoke Setting: Various settings in Canada, Italy, Switzerland, UK, USA Intervention: Nicotine EC Comparison: Behavioural support only/no support
Outcomes	Events with behavioural support only/no support	Events with Nicotine EC	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Smoking cessation at 6 to 12 months Assessed using biochemical validation	Study population		RR 1.88 (1.56 to 2.25)	5024 (9 RCTs)	⊕⊕⊝⊝ LOW^a	‐
	4 per 100	8 per 100 (6 to 9)	RR 1.88 (1.56 to 2.25)	5024 (9 RCTs)	⊕⊕⊝⊝ LOW^a	‐
Adverse events at 12 weeks to 6 months Assessed via self‐report	Study population		RR 1.22 (1.12 to 1.32)	765 (4 RCTs)	⊕⊕⊝⊝ LOW^a	‐
	66 per 100	80 per 100 (74 to 87)	RR 1.22 (1.12 to 1.32)	765 (4 RCTs)	⊕⊕⊝⊝ LOW^a	‐
Serious adverse events at 4 weeks to 8 months Assessed via self‐report and medical records	Study population		RR 0.89 (0.59 to 1.34)	3263 (10 RCTs)	⊕⊝⊝⊝ VERY LOW^a,b	5 of the 10 studies reported no SAEs; MA is based on pooled results from 5 studies.
	3 per 100	2 per 100 (1 to 4)	RR 0.89 (0.59 to 1.34)	3263 (10 RCTs)	⊕⊝⊝⊝ VERY LOW^a,b
*The estimated number of events in the intervention group (and its 95% confidence interval) is based on the assumed number of events in the comparison group and the relative effect of the intervention (and its 95% CI). For cessation, the assumed number of events in the control group is based on assumed quit rates for NRT assuming receipt of limited behavioural stop‐smoking support (as per Hartmann‐Boyce 2018a). The assumed risk for adverse events and serious adverse events is a weighted mean average of quit rates across control groups in contributing studies. CI: Confidence interval; MA: meta‐analysis; RCT: randomized controlled trial; RR: Risk ratio
GRADE Working Group grades of evidence High 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 two levels due to risk of bias. Due to lack of blinding and differential support between arms, judged to be at high risk of bias ^bDowngraded two levels due to imprecision; confidence intervals incorporate clinically significant benefit and clinically significant harm.

Summary of findings 3. Nicotine EC compared to behavioural support only/no support for smoking cessation

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Table 1. Summary of proportion of participants abstinent from smoking at 6+ months follow‐up: cohort studies of nicotine EC

Study	Motivated or unmotivated to quit smoking?	% abstinent
Cohort studies		6‐month	12‐month	18‐month	24‐month	Notes
Adriaens 2014 ^a	Unmotivated to quit	19.6% (10/51)	‐	‐	‐	Data from 8‐month follow‐up
Edwards 2023	"Willing to attempt to quit"	26.6% (8/30)	‐	‐	‐	‐
Caponnetto 2013b	Unmotivated to quit	‐	14% (2/14)	‐	‐	‐
Caponnetto 2021	Unmotivated to quit	35% (14/40)	‐	‐	‐	‐
Ely 2013 ^b	Motivated to quit	44% (21/48)	‐	‐	‐	‐
Pacifici 2015	Unmotivated to quit	‐	53% (18/34)	‐	‐	‐
Polosa 2011	Unmotivated to quit	23% (9/40)	‐	15% (6/40)	13% (5/40)	‐
Polosa 2014b	Unmotivated to quit	36% (18/50)	‐	‐	‐	‐
Polosa 2015	Not defined	42% (30/71)	41% (29/71)	‐	‐	‐
Price 2022	Not defined		5% (42/871)
^aTechnically an RCT but observational for purposes of EC analysis ^bAll participants (N = 48) used an EC, but 16 also used bupropion and 2 used varenicline

Table 1. Summary of proportion of participants abstinent from smoking at 6+ months follow‐up: cohort studies of nicotine EC

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Comparison 1. Nicotine EC versus NRT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Smoking cessation Show forest plot	7	2544	Risk Ratio (M‐H, Fixed, 95% CI)	1.59 [1.30, 1.93]

1.1.1 Not selected on pregnancy	6	2225	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [1.29, 1.93]
1.1.2 Pregnant population	1	319	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.45, 6.97]
1.2 Adverse events Show forest plot	5	2052	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.91, 1.17]

1.2.1 4 weeks	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.31, 1.73]
1.2.2 12 weeks	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.87, 1.31]
1.2.3 6 months	2	563	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.82, 1.24]
1.2.4 3 months after end of pregnancy	1	1110	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.84, 1.31]
1.3 Serious adverse events Show forest plot	6	2761	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.90, 1.60]

1.3.1 4 weeks	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.3.2 12 weeks	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	1.80 [0.86, 3.79]
1.3.3 6 months	2	563	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.81, 2.88]
1.3.4 1 year	1	698	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [0.77, 2.41]
1.3.5 3 months after end of pregnancy	1	1121	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.52, 1.31]
1.4 Carbon monoxide (ppm) Show forest plot	4	357	Mean Difference (IV, Fixed, 95% CI)	‐1.81 [‐3.64, 0.01]

1.4.1 Absolute values at follow‐up	1	110	Mean Difference (IV, Fixed, 95% CI)	‐1.87 [‐5.15, 1.41]
1.4.2 Change from baseline	3	247	Mean Difference (IV, Fixed, 95% CI)	‐1.79 [‐3.98, 0.41]
1.5 Heart rate (bpm) Show forest plot	2	166	Mean Difference (IV, Fixed, 95% CI)	0.53 [‐1.76, 2.83]

1.5.1 Absolute values at follow‐up	1	111	Mean Difference (IV, Fixed, 95% CI)	‐0.74 [‐5.17, 3.69]
1.5.2 Change from baseline	1	55	Mean Difference (IV, Fixed, 95% CI)	1.00 [‐1.69, 3.69]
1.6 Systolic blood pressure Show forest plot	2	166	Mean Difference (IV, Fixed, 95% CI)	‐1.62 [‐3.59, 0.36]

1.6.1 Absolute values at follow‐up	1	111	Mean Difference (IV, Fixed, 95% CI)	1.00 [‐4.54, 6.54]
1.6.2 Change from baseline	1	55	Mean Difference (IV, Fixed, 95% CI)	‐2.00 [‐4.11, 0.11]
1.7 Blood oxygen saturation Show forest plot	2	165	Mean Difference (IV, Fixed, 95% CI)	‐0.14 [‐0.59, 0.30]

1.7.1 Absolute values at follow‐up	1	110	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.72, 0.32]
1.7.2 Change from baseline	1	55	Mean Difference (IV, Fixed, 95% CI)	0.00 [‐0.83, 0.83]
1.8 3‐HPMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.8.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.9 NNAL (pmol/mg creatinine)) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.9.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.10 2‐HPMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.10.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.11 HMPMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.11.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.12 PheT (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.12.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.13 CEMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.13.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.14 AAMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.14.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.15 FEV1 Show forest plot	2		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.15.1 Change from baseline	2		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.16 FEV1/FVC (%) Show forest plot	2	81	Mean Difference (IV, Fixed, 95% CI)	‐0.16 [‐1.83, 1.50]

1.16.1 Change from baseline	2	81	Mean Difference (IV, Fixed, 95% CI)	‐0.16 [‐1.83, 1.50]
1.17 PEF (L/min) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.17.1 Change from baseline	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.18 Product use at 6+ months Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. Nicotine EC versus NRT

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Comparison 2. Nicotine EC versus varenicline

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Smoking cessation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.2 Serious adverse events Show forest plot	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

2.2.1 12 weeks	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 2. Nicotine EC versus varenicline

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Comparison 3. Nicotine EC versus heated tobacco

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Adverse events at 12 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.2 SAEs at 12 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.3 Carbon monoxide (ppm) absolute values at 12 weeks Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.4 VO₂ Max at 12 weeks Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 3. Nicotine EC versus heated tobacco

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Comparison 4. Nicotine EC versus non‐nicotine EC

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Smoking cessation Show forest plot	6	1613	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [1.09, 1.96]

4.2 Adverse events Show forest plot	5	840	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.91, 1.11]

4.2.1 1 week	1	48	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [0.27, 8.19]
4.2.2 8 weeks	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.38, 3.66]
4.2.3 12 weeks	1	255	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.94, 1.08]
4.2.4 6 months	2	513	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.71, 1.34]
4.3 Serious adverse events Show forest plot	9	1412	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.56, 1.79]

4.3.1 1 week	1	48	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.3.2 4 weeks	1	74	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.3.3 8 weeks	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	3.50 [0.16, 78.19]
4.3.4 6 months	4	1009	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.52, 1.72]
4.3.5 1 year	2	257	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.4 Carbon monoxide (ppm) Show forest plot	6		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.4.1 Change from baseline	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.4.2 Absolute values at follow‐up	4		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.5 Heart rate Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.5.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.6 Systolic blood pressure Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.6.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.7 FeNO (ppb) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.7.1 Change from baseline	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.8 FEV1 (l) Show forest plot	1		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.8.1 Absolute values at follow‐up	1		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.9 FEV1/FVC Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.9.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.10 NNAL (pmol/mg creatinine) Show forest plot	2	363	Mean Difference (IV, Fixed, 95% CI)	‐0.02 [‐0.45, 0.41]

4.10.1 Change from baseline	1	148	Mean Difference (IV, Fixed, 95% CI)	15.27 [‐4.98, 35.52]
4.10.2 Absolute values at follow‐up	1	215	Mean Difference (IV, Fixed, 95% CI)	‐0.03 [‐0.46, 0.40]
4.11 Product use at 6+ months Show forest plot	3	874	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.94, 1.41]

Comparison 4. Nicotine EC versus non‐nicotine EC

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Comparison 5. Nicotine EC versus behavioural support only/no support

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Smoking cessation Show forest plot	9	5024	Risk Ratio (M‐H, Fixed, 95% CI)	1.88 [1.56, 2.25]

5.2 Adverse events Show forest plot	4	765	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [1.12, 1.32]

5.2.1 12 weeks	2	657	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [1.11, 1.30]
5.2.2 16 weeks	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.67, 2.07]
5.2.3 6 months	1	58	Risk Ratio (M‐H, Fixed, 95% CI)	11.00 [0.64, 190.26]
5.3 Serious adverse events Show forest plot	10	3263	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.59, 1.34]

5.3.1 4 to 6 weeks	2	246	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.3.2 8 weeks	1	240	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.06, 1.35]
5.3.3 12 weeks	2	858	Risk Ratio (M‐H, Fixed, 95% CI)	3.69 [0.21, 66.17]
5.3.4 16 weeks	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.3.5 6 months	3	1577	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.49, 1.31]
5.3.6 8 months	1	292	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.68, 4.70]
5.4 Carbon monoxide (ppm) Show forest plot	11		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.4.1 Change from baseline	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.4.2 Absolute values at follow‐up	9		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.5 Heart rate (bpm) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.5.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.6 Systolic blood pressure Show forest plot	3	298	Mean Difference (IV, Fixed, 95% CI)	‐2.30 [‐3.91, ‐0.69]

5.6.1 Change from baseline	1	168	Mean Difference (IV, Fixed, 95% CI)	‐2.68 [‐4.38, ‐0.98]
5.6.2 Absolute values at follow‐up	2	130	Mean Difference (IV, Fixed, 95% CI)	1.11 [‐3.95, 6.18]
5.7 Blood oxygen saturation Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.7.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.8 3‐HPMA (SMD) Show forest plot	2		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.8.1 Absolute values at follow‐up	1		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.8.2 Change from baseline	1		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.9 NNAL (SMD) Show forest plot	5		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.9.1 Absolute values at follow‐up	2		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.9.2 Change from baseline	3		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.10 2‐HPMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.10.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.11 HMPMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.11.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.12 PheT (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.12.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.13 CEMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.13.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.14 AAMA (pmol/mg creatinine) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.14.1 Absolute values at follow‐up	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.15 S‐PMA (nanograms) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.15.1 12 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.16 FEV1 (SMD) Show forest plot	2	714	Std. Mean Difference (IV, Fixed, 95% CI)	0.15 [‐0.01, 0.31]

5.16.1 Change from baseline	2	714	Std. Mean Difference (IV, Fixed, 95% CI)	0.15 [‐0.01, 0.31]
5.17 FEF 25‐75 (litres/second)) Show forest plot	2	555	Mean Difference (IV, Fixed, 95% CI)	‐0.06 [‐0.18, 0.06]

5.17.1 Change from baseline	2	555	Mean Difference (IV, Fixed, 95% CI)	‐0.06 [‐0.18, 0.06]
5.18 PEF 25‐75 (litres/minute) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.18.1 Change from baseline	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5.19 FEV1/FVC Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.19.1 Change from baseline	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 5. Nicotine EC versus behavioural support only/no support

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Comparison 6. Higher versus lower nicotine content

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Smoking cessation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.2 Serious adverse events Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.2.1 1 year	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
6.2.2 6 months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
6.3 Carbon monoxide (ppm) Show forest plot	3	348	Mean Difference (IV, Fixed, 95% CI)	‐0.92 [‐1.71, ‐0.13]

6.3.1 Change from baseline	2	309	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐1.70, ‐0.10]
6.3.2 Absolute values at follow‐up	1	39	Mean Difference (IV, Fixed, 95% CI)	‐1.66 [‐6.65, 3.33]
6.4 Heart rate Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.4.1 12 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6.5 Systolic blood pressure Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.5.1 12 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6.6 FeNO (ppb) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.6.1 12 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6.7 FEV1 (l) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.7.1 12 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6.8 FVC (l) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.8.1 12 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6.9 FEV1/FVC Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.9.1 12 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6.10 NNAL (pg/mg creatinine) at 24 weeks Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.11 Product use at 6+ months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 6. Higher versus lower nicotine content

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Comparison 7. Tobacco vs. menthol flavour

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Serious adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7.2 NNAL (ng/g) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7.2.1 Change from baseline	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
7.3 FEV1 (% predicted) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7.3.1 Change from baseline	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
7.4 FEV1/FVC Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7.4.1 Change from baseline	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 7. Tobacco vs. menthol flavour

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Comparison 8. Refillable versus cartridge

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
8.1 Exhaled CO Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 8. Refillable versus cartridge

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Comparison 9. Nicotine salt EC versus free‐base nicotine EC

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
9.1 Smoking cessation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

9.2 Product use at 6+ months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 9. Nicotine salt EC versus free‐base nicotine EC

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Comparison 10. Non‐nicotine EC versus behavioural support only/no support

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
10.1 Smoking cessation Show forest plot	2	388	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [0.81, 3.25]

10.2 Adverse events at 12 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

10.3 Serious adverse events at 24 weeks Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 10. Non‐nicotine EC versus behavioural support only/no support

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Comparison 11. Non‐nicotine EC + NRT versus NRT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
11.1 Smoking cessation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

11.2 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

11.3 Serious adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

11.3.1 6 months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 11. Non‐nicotine EC + NRT versus NRT

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Comparison 12. Non‐nicotine EC versus NRT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
12.1 Smoking cessation Show forest plot	2	314	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.64, 1.54]

12.2 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

12.2.1 6 months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
12.3 Serious adverse events Show forest plot	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

12.3.1 6 months	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
12.4 Change in carbon monoxide (ppm) at 6 months Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 12. Non‐nicotine EC versus NRT

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Comparison 13. Advice to use e‐cigarettes compared to no advice to use e‐cigarettes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
13.1 Smoking cessation Show forest plot	2	2652	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.88, 1.19]

13.2 Adverse events at 3 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

13.3 Serious adverse events at 3 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

13.4 Product use at 6+ months Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 13. Advice to use e‐cigarettes compared to no advice to use e‐cigarettes

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Comparison 14. Nicotine EC + NRT versus non‐nicotine EC + NRT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
14.1 Smoking cessation Show forest plot	2	1039	Risk Ratio (M‐H, Fixed, 95% CI)	1.77 [1.07, 2.94]

14.2 Adverse events Show forest plot	2	677	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.93, 1.32]

14.2.1 8 weeks	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.78, 1.99]
14.2.2 12 weeks	1	607	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.90, 1.31]
14.3 Serious adverse events Show forest plot	2	1069	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.38, 1.14]

14.3.1 8 weeks	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.11, 3.34]
14.3.2 6 months	1	999	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.37, 1.19]
14.4 Carbon monoxide (ppm) Show forest plot	2	70	Mean Difference (IV, Fixed, 95% CI)	‐1.73 [‐4.44, 0.98]

14.4.1 change from baseline	1	25	Mean Difference (IV, Fixed, 95% CI)	‐1.40 [‐4.26, 1.46]
14.4.2 absolute values at follow‐up	1	45	Mean Difference (IV, Fixed, 95% CI)	‐4.60 [‐13.02, 3.82]
14.5 FeNO (ppb) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

14.5.1 6 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
14.6 FEV1 (%) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

14.6.1 6 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
14.7 FVC (%) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

14.7.1 6 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
14.8 Study product use at 6+ months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 14. Nicotine EC + NRT versus non‐nicotine EC + NRT

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Comparison 15. Nicotine EC + NRT versus NRT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
15.1 Smoking cessation Show forest plot	2	980	Risk Ratio (M‐H, Fixed, 95% CI)	3.53 [1.93, 6.44]

15.2 Adverse events Show forest plot	3	1984	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.83, 1.11]

15.2.1 12 weeks	2	421	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.69, 1.11]
15.2.2 7 months	1	1563	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.82, 1.19]
15.3 Serious adverse events Show forest plot	4	2245	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.46, 3.42]

15.3.1 5 weeks	1	7	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
15.3.2 12 weeks	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	3.00 [0.13, 70.30]
15.3.3 6 months	1	625	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.39, 3.27]
15.3.4 7 months	1	1563	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 15. Nicotine EC + NRT versus NRT

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Comparison 16. Nicotine EC + varenicline vs. varenicline

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
16.1 Adverse events at 12 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

16.2 Serious adverse events at 12 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 16. Nicotine EC + varenicline vs. varenicline

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