Nicotine replacement therapy versus control for smoking cessation

Jamie Hartmann‐Boyce; Samantha C Chepkin; Weiyu Ye; Chris Bullen; Tim Lancaster

doi:10.1002/14651858.CD000146.pub5

Cochrane Database of Systematic Reviews

Nikotinersatztherapie versus Kontrolle zur Raucherentwöhnung

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DOI:

https://doi.org/10.1002/14651858.CD000146.pub5 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

31 mayo 2018see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Tabaquismo

Copyright:

Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Jamie Hartmann‐Boyce

Correspondencia a: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK

[email protected]
Samantha C Chepkin

Cochrane UK, Oxford, UK
Weiyu Ye

Oxford University Clinical Academic Graduate School, University of Oxford, Oxford, UK
Chris Bullen

National Institute for Health Innovation, University of Auckland, Auckland, New Zealand
Tim Lancaster

GKT School of Medical Education, King’s College London, London, UK

Contributions of authors

For the most recent version of this review: JHB and SC screened studies. Data extraction and risk of bias assessment was conducted by SC, WY and JHB. The review text was updated by JHB, SC and WY with review and suggestions from all other authors.

Sources of support

Internal sources

Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.

Editorial base for the Cochrane Tobacco Addiction Group
National Institute for Health Research School for Primary Care Research, UK.

Support for the Nuffiled Department of Primary Health Care Health Sciences, University of Oxford

External sources

National Institute for Health Research (NIHR), UK.

Infrastructure funding for the Cochrane Tobacco Addiction Group

Declarations of interest

CB was involved in a trial on pre‐cessation use of NRT (Bullen 2010)

SCC none known

JHB none known

TL none known

WY none known

Acknowledgements

Chris Silagy was originally the first author, contributed to updates until his death in 2001, and was listed as an author until 2008. Godfrey Fowler was also an author until 2008. Lindsay Stead, Rafael Perrera, and David Mant were authors until 2012. Mark Lodge assisted in the preparation of the initial version of this review. Ruth Ashenden provided technical support. Drs. Tjeder‐Burton, Campbell, Hjalmarson, Fagerström, Mori, Glover, Hughes, Fortmann, Killen, Varady, Ortega, Rose, Cunningham, Wilcox, and Graham co‐operated with our requests for clarification of previously‐reported data. Z. Ilic and L. Silagy assisted with translation of foreign language reports. P. Yudkin provided statistical advice on early updates. Marc Mooney provided copies of two papers we had not been able to obtain. We thank Annette Pluddemann for help in translating study reports. Jonathan Livingstone‐Banks assisted in finding studies for the current update.

JHB is funded in part by the NIHR Oxford Biomedical Research Centre (BRC).

Version history

Published

Title

Stage

Authors

Version

2018 May 31

Nicotine replacement therapy versus control for smoking cessation

Review

Jamie Hartmann‐Boyce, Samantha C Chepkin, Weiyu Ye, Chris Bullen, Tim Lancaster

https://doi.org/10.1002/14651858.CD000146.pub5

2012 Nov 14

Nicotine replacement therapy for smoking cessation

Review

Lindsay F Stead, Rafael Perera, Chris Bullen, David Mant, Jamie Hartmann‐Boyce, Kate Cahill, Tim Lancaster

https://doi.org/10.1002/14651858.CD000146.pub4

2008 Jan 23

Nicotine replacement therapy for smoking cessation

Review

Lindsay F Stead, Rafael Perera, Chris Bullen, David Mant, Tim Lancaster

https://doi.org/10.1002/14651858.CD000146.pub3

2004 Jul 19

Nicotine replacement therapy for smoking cessation

Review

Chris Silagy, Tim Lancaster, Lindsay F Stead, David Mant, Godfrey Fowler

https://doi.org/10.1002/14651858.CD000146.pub2

2002 Oct 21

Nicotine replacement therapy for smoking cessation

Review

Chris Silagy, Tim R Lancaster, Lindsay F Stead, David Mant, Godfrey Fowler

https://doi.org/10.1002/14651858.CD000146

Notes

Prof Chris Silagy died in December 2001. In recognition of his major contribution he remained as first author until 2007. The authorship changed from 2008 issue 1.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans; Male;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram for most recent update

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Forest plot of comparison: 1 Any type of NRT versus placebo/no NRT control, outcome: 1.1 Smoking cessation at 6+ months follow up.

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Figure 4

Funnel plot of comparison: 1 Any type of NRT versus placebo/no NRT control, outcome: 1.1 Smoking cessation at 6+ months follow up.

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Analysis 1.1

Comparison 1 Any type of NRT versus placebo/no NRT control, Outcome 1 Smoking cessation at 6+ months follow up.

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Analysis 2.1

Comparison 2 Subgroup: Definition of abstinence, Outcome 1 Nicotine gum. Smoking cessation.

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Analysis 2.2

Comparison 2 Subgroup: Definition of abstinence, Outcome 2 Nicotine patch: Smoking cessation.

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Analysis 3.1

Comparison 3 Subgroup: Level of behavioural support, Outcome 1 Nicotine gum. Smoking cessation.

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Analysis 3.2

Comparison 3 Subgroup: Level of behavioural support, Outcome 2 Nicotine patch. Smoking cessation.

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Analysis 4.1

Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 1 Community volunteer (treatment provided in medical setting).

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Analysis 4.2

Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 2 Smoking clinic.

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Analysis 4.3

Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 3 Primary care.

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Analysis 4.4

Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 4 Hospitals.

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Analysis 4.5

Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 5 Community volunteer (treatment provided in 'over‐the‐counter' setting).

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Analysis 4.6

Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 6 Antenatal clinic.

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Analysis 5.1

Comparison 5 NRT in pregnancy, Outcome 1 Smoking cessation.

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Analysis 6.1

Comparison 6 Palpitations in NRT vs placebo users, Outcome 1 Palpitations/chest pains.

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Summary of findings for the main comparison. Nicotine replacement therapy

Nicotine replacement therapy versus control for smoking cessation
Patient or population: people who smoke cigarettes Settings: clinical and non‐clinical, including over the counter Intervention: nicotine replacement therapy of any form
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Nicotine replacement therapy of any form
Smoking cessation at 6+ months follow‐up Follow‐up: 6 to 24 months	Study population		RR 1.55 (1.49 to 1.61)	64,640 (133 studies)	⊕⊕⊕⊕ high^{1, 2}
	105 per 1000	162 per 1000 (156 to 168)
	Limited behavioural support
	40 per 1000	62 per 1000 (60 to 64)
	Intensive behavioural support
	150 per 1000	232 per 1000 (224 to 242)
The corresponding risk* (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; RR: Risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Most studies are judged to be at unclear or high risk of bias, but restricting to only studies at low risk of bias did not significantly alter the effect. ²There are likely to be some unpublished trials with less favourable results that we were unable to identify, and a funnel plot showed some evidence of asymmetry. However, given the large number of trials in the review, this does not suggest the results would be altered significantly were smaller studies with lower RRs included.

Summary of findings for the main comparison. Nicotine replacement therapy

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Table 1. Nicotine replacement therapies available in the UK

Type	Available doses
Nicotine transdermal patches	Worn over 16 hours: 5 mg, 10 mg, 15 mg, 25 mg doses Worn over 24 hours: 7 mg, 14 mg, 20 mg, 21 mg, 30 mg doses*
Nicotine chewing gum	2 mg and 4 mg doses
Nicotine sublingual tablet	2 mg dose
Nicotine lozenge	1 mg, 1.5 mg, 2 mg and 4 mg doses
Nicotine inhalation cartridge plus mouthpiece	Cartridge containing 10 mg
Nicotine metered nasal spray	0.5 mg dose/spray
Nicotine oral spray	1 mg dose/spray
Information extracted from British National Formulary * 35 mg/24‐hour and 53.5 mg/24‐hour patches available in other regions.

Table 1. Nicotine replacement therapies available in the UK

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Comparison 1. Any type of NRT versus placebo/no NRT control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Smoking cessation at 6+ months follow up Show forest plot	133	64640	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [1.49, 1.61]

1.1 Gum	56	22581	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [1.40, 1.60]
1.2 Patch	51	25754	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [1.53, 1.75]
1.3 Inhalator	4	976	Risk Ratio (M‐H, Fixed, 95% CI)	1.90 [1.36, 2.67]
1.4 Intranasal spray	4	887	Risk Ratio (M‐H, Fixed, 95% CI)	2.02 [1.49, 2.73]
1.5 Tablets/lozenges	8	4439	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.32, 1.74]
1.6 Oral spray	1	479	Risk Ratio (M‐H, Fixed, 95% CI)	2.48 [1.24, 4.94]
1.7 Choice of NRT product	7	8288	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [1.25, 1.52]
1.8 Patch and inhalator	1	245	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.57, 1.99]
1.9 Patch and lozenge	1	308	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [1.01, 3.31]
1.10 Patch and gum	2	259	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.64, 2.06]
1.11 Patch, gum and lozenge	1	424	Risk Ratio (M‐H, Fixed, 95% CI)	15.0 [2.00, 112.54]

Comparison 1. Any type of NRT versus placebo/no NRT control

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Comparison 2. Subgroup: Definition of abstinence

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Nicotine gum. Smoking cessation Show forest plot	56	22581	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [1.40, 1.60]

1.1 Sustained 12 months	32	13737	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [1.31, 1.56]
1.2 Sustained 6 months	8	4187	Risk Ratio (M‐H, Fixed, 95% CI)	2.77 [2.14, 3.59]
1.3 PP/uncertain 12 months	8	2501	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [1.12, 1.55]
1.4 PP/uncertain 6 months	8	2156	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [1.20, 1.68]
2 Nicotine patch: Smoking cessation Show forest plot	49	23976	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [1.52, 1.75]

2.1 Sustained 12 months	21	7622	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]
2.2 Sustained 6 months	9	8613	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [1.51, 1.92]
2.3 PP/uncertain 12 months	9	3856	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [1.44, 1.93]
2.4 PP/uncertain 6 months	10	3885	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [1.32, 2.04]

Comparison 2. Subgroup: Definition of abstinence

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Comparison 3. Subgroup: Level of behavioural support

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Nicotine gum. Smoking cessation Show forest plot	55	21759	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [1.40, 1.61]

1.1 Low intensity support	17	11257	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [1.46, 1.88]
1.2 High intensity individual support	18	6891	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [1.18, 1.49]
1.3 High intensity group‐based support	20	3611	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [1.40, 1.76]
2 Nicotine patch. Smoking cessation Show forest plot	49	23657	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [1.56, 1.79]

2.1 Low intensity support	15	7310	Risk Ratio (M‐H, Fixed, 95% CI)	1.76 [1.54, 2.02]
2.2 High intensity individual support	25	12709	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [1.47, 1.81]
2.3 High intensity group‐based support	10	3638	Risk Ratio (M‐H, Fixed, 95% CI)	1.65 [1.43, 1.90]

Comparison 3. Subgroup: Level of behavioural support

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Comparison 4. Subgroup: Recruitment/treatment setting

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Community volunteer (treatment provided in medical setting) Show forest plot	65	24597	Risk Ratio (M‐H, Fixed, 95% CI)	1.62 [1.53, 1.72]

1.1 Nicotine gum	28	8336	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.28, 1.53]
1.2 Nicotine patch	27	11214	Risk Ratio (M‐H, Fixed, 95% CI)	1.74 [1.59, 1.91]
1.3 Nicotine inhalator	2	443	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [0.98, 3.27]
1.4 Nicotine tablet/lozenge	7	3405	Risk Ratio (M‐H, Fixed, 95% CI)	1.95 [1.61, 2.36]
1.5 Nicotine intranasal spray	2	412	Risk Ratio (M‐H, Fixed, 95% CI)	1.85 [1.16, 2.95]
1.6 Combination of NRT	1	308	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [1.01, 3.31]
1.7 Nicotine oral spray	1	479	Risk Ratio (M‐H, Fixed, 95% CI)	2.48 [1.24, 4.94]
2 Smoking clinic Show forest plot	12	3300	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [1.48, 1.96]

2.1 Nicotine gum	6	1283	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [1.30, 1.91]
2.2 Nicotine inhalator	2	533	Risk Ratio (M‐H, Fixed, 95% CI)	1.96 [1.30, 2.95]
2.3 Nicotine intranasal spray	2	475	Risk Ratio (M‐H, Fixed, 95% CI)	2.15 [1.44, 3.20]
2.4 Nicotine patch	2	1009	Risk Ratio (M‐H, Fixed, 95% CI)	1.61 [1.18, 2.19]
3 Primary care Show forest plot	24	11974	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [1.33, 1.69]

3.1 Nicotine gum	16	7277	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [1.35, 1.85]
3.2 Nicotine patch	7	4419	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.15, 1.71]
3.3 Choice of NRT products	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [0.83, 2.30]
4 Hospitals Show forest plot	13	7037	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [1.24, 1.55]

4.1 Nicotine gum	3	2194	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.86, 1.43]
4.2 Nicotine patch	6	2492	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.10, 1.78]
4.3 Combination of NRT	2	326	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.64, 1.52]
4.4 Choice of NRT products	2	2025	Risk Ratio (M‐H, Fixed, 95% CI)	1.59 [1.36, 1.86]
5 Community volunteer (treatment provided in 'over‐the‐counter' setting) Show forest plot	9	13163	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.26, 1.55]

5.1 Nicotine gum	2	3297	Risk Ratio (M‐H, Fixed, 95% CI)	3.79 [2.60, 5.52]
5.2 Nicotine patch	5	3542	Risk Ratio (M‐H, Fixed, 95% CI)	1.88 [1.38, 2.55]
5.3 Tablets/lozenges	1	1034	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.89, 1.32]
5.4 Choice of product	1	5290	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [1.03, 1.37]
6 Antenatal clinic Show forest plot	4	1675	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.92, 1.62]

6.1 Nicotine gum	1	194	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.50, 2.65]
6.2 Nicotine patch	2	1300	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.85, 1.66]
6.3 Choice of NRT products	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	1.45 [0.69, 3.03]

Comparison 4. Subgroup: Recruitment/treatment setting

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Comparison 5. NRT in pregnancy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Smoking cessation Show forest plot	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Abstinence at end of pregnancy	6	2129	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [1.04, 1.69]
1.2 Abstinence at longest post partum follow‐up	4	1675	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.90, 1.86]

Comparison 5. NRT in pregnancy

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Comparison 6. Palpitations in NRT vs placebo users

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Palpitations/chest pains Show forest plot	15	11074	Odds Ratio (M‐H, Fixed, 95% CI)	1.88 [1.37, 2.57]

Comparison 6. Palpitations in NRT vs placebo users

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Nikotinersatztherapie versus Kontrolle zur Raucherentwöhnung

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