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Original Research |

Gradual Versus Abrupt Smoking Cessation: A Randomized, Controlled Noninferiority TrialGradual Versus Abrupt Smoking Cessation

Nicola Lindson-Hawley, PhD; Miriam Banting, MSc; Robert West, PhD; Susan Michie, DPhil; Bethany Shinkins, DPhil; and Paul Aveyard, PhD
[+] Article, Author, and Disclosure Information

This article was published at www.annals.org on 15 March 2016.


From the University of Oxford, Oxford; University of Birmingham, Birmingham; and University College London, London, United Kingdom.

Note: Drs. Lindson-Hawley, Aveyard, Michie, and West are members of the United Kingdom Centre for Tobacco and Alcohol Studies (UKCTAS). UKCTAS receive funds from Cancer Research UK; Economic and Social Research Council; Medical Research Council; and National Institute for Health Research, under the auspices of the UK Clinical Research Collaboration.

Grant Support: From the British Heart Foundation.

Disclosures: Dr. Lindson-Hawley reports a grant from the British Heart Foundation to conduct the reported study and grants from the National Institute for Health Research outside the submitted work. Dr. West reports grants, personal fees, and nonfinancial support from Pfizer and and personal fees from GlaxoSmithKline outside the submitted work. Dr. Aveyard reports grants from United Kingdom Centre for Tobacco and Alcohol Studies and the National Institute for Health Research School for Primary Care Research during the conduct of the study; and personal fees from Pfizer and McNeil outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-2805.

Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.

Reproducible Research Statement:Study protocol: Published online (open access) at www.trialUpsjournal.com/content/10/1/69. Statistical code and data set: Available to approved persons through written agreements with the author team.

Requests for Single Reprints: Nicola Lindson-Hawley, PhD, Nuffield Department of Primary Care Health Sciences, University of Oxford, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, United Kingdom; e-mail, nicola.lindson-hawley@phc.ox.ac.uk.

Current Author Addresses: Drs. Lindson-Hawley, Shinkins, and Aveyard: Nuffield Department of Primary Care Health Sciences, University of Oxford, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, United Kingdom.

Ms. Banting: Primary Care Clinical Sciences, The Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.

Dr. West: Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, 1-19 Torrington Place, London WC1E 6BT, United Kingdom.

Dr. Michie: Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, United Kingdom.

Author Contributions:Conception and design: P.N. Aveyard, N. Lindson-Hawley, S. Michie, R. West.

Analysis and interpretation of the data: P.N. Aveyard, M. Banting, N. Lindson-Hawley, B. Shinkins, R. West.

Drafting of the article: P.N. Aveyard, N. Lindson-Hawley, B. Shinkins.

Critical revision for important intellectual content: P.N. Aveyard, N. Lindson-Hawley, S. Michie, B. Shinkins, R. West.

Final approval of the article: P.N. Aveyard, M. Banting, N. Lindson-Hawley, S. Michie, B. Shinkins, R. West.

Provision of study materials or patients: P.N. Aveyard, M. Banting, N. Lindson-Hawley.

Statistical expertise: B. Shinkins.

Obtaining of funding: P.N. Aveyard.

Administrative, technical, or logistic support: P.N. Aveyard, M. Banting, N. Lindson-Hawley.

Collection and assembly of data: P.N. Aveyard, M. Banting, N. Lindson-Hawley.


Ann Intern Med. 2016;164(9):585-592. doi:10.7326/M14-2805
© 2016 American College of Physicians
Text Size: A A A

Background: Most smoking cessation guidelines advise quitting abruptly. However, many quit attempts involve gradual cessation. If gradual cessation is as successful, smokers can be advised to quit either way.

Objective: To examine the success of quitting smoking by gradual compared with abrupt quitting.

Design: Randomized, controlled noninferiority trial. (International Standardized Randomized Controlled Trial Number Register: ISRCTN22526020)

Setting: Primary care clinics in England.

Participants: 697 adult smokers with tobacco addiction.

Intervention: Participants quit smoking abruptly or reduced smoking gradually by 75% in the 2 weeks before quitting. Both groups received behavioral support from nurses and used nicotine replacement before and after quit day.

Measurements: The primary outcome measure was prolonged validated abstinence from smoking 4 weeks after quit day. The secondary outcome was prolonged, validated, 6-month abstinence.

Results: At 4 weeks, 39.2% (95% CI, 34.0% to 44.4%) of the participants in the gradual-cessation group were abstinent compared with 49.0% (CI, 43.8% to 54.2%) in the abrupt-cessation group (relative risk, 0.80 [CI, 0.66 to 0.93]). At 6 months, 15.5% (CI, 12.0% to 19.7%) of the participants in the gradual-cessation group were abstinent compared with 22.0% (CI, 18.0% to 26.6%) in the abrupt-cessation group (relative risk, 0.71 [CI, 0.46 to 0.91]). Participants who preferred gradual cessation were significantly less likely to be abstinent at 4 weeks than those who preferred abrupt cessation (38.3% vs 52.2%; P = 0.007).

Limitations: Blinding was impossible. Most participants were white.

Conclusion: Quitting smoking abruptly is more likely to lead to lasting abstinence than cutting down first, even for smokers who initially prefer to quit by gradual reduction.

Primary Funding Source: British Heart Foundation.

Figures

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Figure 1.

Study flow diagram.

ITT = intention-to-treat.

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Figure 2.

Prequit exhaled CO concentration and CPD, by trial group.

Data presented are means and 95% CIs. On the x-axis, baseline visit refers to the 2 wk before quit day, visit −1 refers to 1 week before quit day, and visit 0 refers to 1 day before quit day. Mean CPD in the gradual-cessation group: baseline, 342; visit –1, 264; visit 0, 184. Mean CO concentration in the gradual-cessation group: baseline, 342 ppm; visit −1, 275 ppm; visit 0, 226 ppm. Mean CPD in the abrupt-cessation group: baseline, 355; visit −1, 299; visit 0, 237. Mean CO concentration in the abrupt-cessation group: baseline, 354 ppm; visit −1, 299 ppm; visit 0, 292 ppm. CO = carbon monoxide; CPD = cigarettes per day.

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Smoking Cessation: professional behavioral counseling plus adequate pharmacological treatment is not cold turkey.
Posted on March 24, 2016
Alain Braillon, MD
University Hospital, Amiens, France.
Conflict of Interest: None Declared
Lindson-Hawley and colleagues must be commended for their clinical trial comparing quitting smoking by gradual vs abrupt quitting.(1) Not only, there are too few clinical trials for treating the leading cause of major diseases (cancer, cardiovascular and pulmonary …) but also both arms provided the recommended treatment (behavioral counseling plus nicotine replacement therapy combining patches with faster acting forms, the ‘belt and braces’ strategy). Last but not least, there was no placebo group. These basic requirements are too rare, eg. among four recent trials about smoking cessation during pregnancy only one (also with West) was properly designed, the three others being flawed.(2)Evidently, this article provides a new but challenging paradigm to improve care. Moreover, the findings that the majority of those who did not achieve abstinence in both group said they would prefer to quit by gradual cessation in a future quit attempt.(1)
First, we can get rid of the Prochaska – di Clemente vicious circle that only provide inertia and despair. The present findings are in line with West and Sohal’s previous report which received too little attention.(3)
Second, we can carefully raise the bar of patient’s expectations when we counsel them for targets. Presently, some may confuse empathy with compassion, falling into a tearful solicitude, a behaviour that has only damaging results. Here is the first challenge, raising the bar must be done with care, and no doubts that the professionals involved in the trials had the skills for reassurance and support.
Third, this 22% success rate in patients recruited from general practitioner records with no demand for cessation shows evidence that advices and counsels for quitting are not usually performed as recommended by general practitioner.
Sadly, the lay media already claims this smart and comprehensive care is “cold turkey”.(http://edition.cnn.com/2016/03/15/health/quit-smoking-cold-turkey/index.html) No way, this is proactive counselling with behavioural support promoting self-efficacy by trained professional plus nicotine replacement therapy combining patches with faster acting forms to obtain result, rapidly.
Three decade ago the Health and Public Policy Committee recommended physicians take an active role in counselling patient to quit smoking.(4) It is time to move on and to train clinicians so they can achieve beginning proficiency in motivational interviewing.(5)

1 Lindson-Hawley N, Banting M, West R; Michie S; Shinkins B,
Aveyard P. Gradual versus abrupt smoking cessation. A randomized, controlled noninferiority trial. Ann Intern Med 2015 Online doi:10.7326/M14-2805
2 Braillon A, Bewley S. Trials on physical activity for smoking cessation in pregnancy missed a trick or two. BMJ 2015;350:h3554.
3 West R, Sohal T. "Catastrophic" pathways to smoking cessation: findings from national survey. BMJ 2006;332:458.
4 Anonymous. Methods for stopping cigarette smoking. Health and Public Policy Committee, American College of Physicians. Ann Intern Med 1986;105:281-91.
5 Hall K, Staiger PK, Simpson A, Best D, Lubman DI. After 30 years of dissemination, have we achieved sustained practice change in motivational interviewing? Addiction 2015. Online Jul 28. doi: 10.1111/add.13014.
Gradual vs Abrupt Smoking Cessation
Posted on March 24, 2016
John Hughes, Elias Klemperer
University of Vermont
Conflict of Interest: Dr Hughes has received consulting and speaking fees from several companies that develop or market pharmacological and behavioral treatments for smoking cessation (including nicotine replacement therapies) or harm reduction and from several non-profit organizations that promote tobacco control. Mr Klemperer has no potential conflicts.
Drs Lindson-Hawley and colleagues suggest several interpretations of their finding that gradual cessation produces worse outcomes than abrupt cessation. We would like to add three others. First, their study included smokers already motivated to quit smoking. Gradual reduction has also been used in smokers not motivated to quit smoking. With this group, gradual reduction motivates smokers to make a quit attempt and increases the probability of eventual abstinence compared to no treatment 1, probably because such reduction increases self-efficacy, teaches coping skills needed to avoid smoking, and reduces dependence 2, 3; thus, it is important to distinguish between using reduction to motivate smokers to quit and using it to help those already motivated.

Second, the analyses of the paper were based on the appropriate “intent-to-treat” principle; however, we note that the “abrupt” cessation group reduced by 29% prior to the quit date and surely many in the reduction group did not reduce as requested. . Thus, to test the effect of reduction per se on quitting, it might be of interest to test whether the amount of reduction mediated the worse outcome on the reduction treatment.

Third, the reduction goal in their study was to reduce by 75% over 2 weeks. This is a more ambitious goal than all of the 10 studies in the Cochrane review on gradual reduction2 and is in stark contrast to the current European guidelines for gradual cessation when using nicotine replacement therapy which allow up to 6 months to reduce. The decisions for the ambitious reduction was based on two prior studies (however, both of the studies cited were done over 13 years ago and have yet to be published), plus our studies suggest that smokers lose motivation to quit over time4, 5. Nevertheless, it is possible that the poor outcome in the gradual condition was because the reduction goal was too challenging and that many participants who did not make the set reduction goals were discouraged and this undermined self-efficacy leading to worse outcomes. It may be that setting easier goals more readily increases self-efficacy which increases quitting. On the other hand easier goals would mean less practice not smoking and less decrease in dependence.

John R Hughes, Elias M Klemperer

Vermont Center for Behavior and Health, Departments of Psychiatry and Psychological Science, University of Vermont


Reference List

(1) Wu P, Wilson K, Dimoulas P, Mills EJ. Effectiveness of smoking cessation therapies: A systematic review and meta-analysis. BioMed Central Public Health, www biomedcentral com/1471-2458/6/300 2006;6.
(2) Lindson N, Aveyard P, Hughes JR. Reduction versus abrupt cessation in smokers who want to quit. Cochrane Database of Systematic Reviews, www cochranedatabase org 2010.
(3) Hughes J, Solomon L, Livingston A, Callas P, Peters E. A randomized, controlled trial of gradual cessation (aided by NRT) vs. abrupt cessation of smoking. Drug Alcohol Depend 2010;111:105-113.
(4) Hughes J, Callas P. Is delaying a quit attempt associated with less success? Nicotine & Tobacco Research 2011;13:1228-1232.
(5) Hughes J, Russ C, Messig M. Association of delaying a quit attempt with smoking cessation success: A secondary analysis. J Substance Abuse Tx. In press 2013.


"Abrupt smoking cessation" stands for pre-cessation nicotine replacement
Posted on April 1, 2016
Macé M. Schuurmans, MD
Division of Pulmonology, University Hospital Zurich, Switzerland
Conflict of Interest: None Declared
Lindson-Hawley et al. report a randomized trial comparing two different smoking cessation strategies using nicotine replacement therapy (NRT) (1). The abrupt-cessation strategy led to higher quit rates at one and six months when compared to a gradual-cessation strategy.
When looking at the details one realizes that what is termed “abrupt-cessation” is not what one generally would expect it to be: Smoking cessation with complete quitting of smoking on the target quit date and immediate initiation of NRT, as generally recommended in the package insert of NRT. This was not done. The abrupt strategy in this trial is less “abrupt” and unprepared as it may seem because it included pre-cessation NRT (use of a nicotine patch for two weeks before the quit date whilst continuing to smoke) and participants were given the task “to identify the times of the day when cigarettes would be the hardest to give up and plan strategies to avoid relapse after the quit day” in this 2-week phase (1). After the target quit date both treatment groups received the same NRT.
This strategy is not (yet) a standard procedure and not (yet) widely recommended in guidelines. This strategy is not generally called “abrupt-cessation”, but rather “pre-treatment with NRT” or “pre-cessation NRT” and has been studied for more than a decade (2).
“Gradual-cessation” is a concept where smoking is generally faded out over 2-3 weeks aiming for complete cessation of smoking within this time frame. “Gradual” may be perceived by smokers as lengthily process where cigarette consumption is slowly reduced. In this group additional use of short-acting NRT was recommended, but largely underused. Interestingly, the gradual reduction was appealing to a large portion of smokers and was associated with failure to succeed in quitting smoking. Under-dosing of short-acting NRT is common and may be related to instructions for their use. In my experience informing about the maximal daily dose permitted and encouraging patients to consume initially at least half the maximal dose increases usage and success.
Although the study was well designed and performed, the terminology used to describe the successful strategy was misleading: Even reputable organizations oversaw the fact that the “abrupt” strategy included two weeks of pre-cessation nicotine patch (3). It is a missed opportunity to communicate the simple details of the successful strategy in this trial. This shortcoming is likely to jeopardize the translation of the relevant findings of this study into clinical practice.

References:

(1) Lindson-Hawley N, Banting M, West R, Michie S, Shinkins B, Aveyard P. Gradual Versus Abrupt Smoking Cessation: A Randomized, Controlled Noninferiority Trial. Ann Intern Med. 2016 Mar 15. doi: 10.7326/M14-2805.

(2) Schuurmans MM, Diacon AH, van Biljon X, Bolliger CT. Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial. Addiction. 2004 May;99(5):634-40

(3) Noon MA. Cold turkey better for smoking cessation. http://www.chestphysician.org/specialty-focus/pulmonary-medicine/article/cold-turkey-better-for-smoking cessation/e532db755c3f4b57dc116fc06f1b3579.html
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