Smoking cessation methods and their effectiveness
Objective and sources
Aim of this paper is to present the range of tools for quitting smoking, according to the most up-to-date evidence of efficacy. Sources were the 2020 Surgeon General Report on Smoking Cessation , which makes a systematic review of all the tools for quitting, the meta-analyzes of the Cochrane Tobacco Addiction Group , and the 2018 Report of the Tobacco Advisory Group of the Royal College of Physicians: Hiding in plain sight. Treating tobacco dependency in the NHS .
Characteristics of tobacco addiction
A smoker makes 6 to 30 attempts to be able to quit permanently. Cessation is therefore a complex process, to be framed as a chronic disease, characterized by frequent relapses, long-term management and intensive care approaches [4,5].
Population strategies to promote cessation
Among the strategies recommended by the Framework Convention on Tobacco Control of the World Health Organization (WHO-FCTC), price increase of tobacco products has a significant impact on cessation because it increases the likelihood of quit attempts. Smoking bans in public places, workplaces and health facilities and the voluntary development of smoke-free homes also record a significant impact because they reduce tobacco consumption and increase quit attempts. Even pictorial health warnings in tobacco packages with support information for quitting (such as the Italian National Health Institute [ISS] toll-free quitline), increase attempts. Similar results are also obtained with the introduction of plain package (with no colours and brands), which makes smoking less attractive. A last but fundamental measure is the development of anti-smoking media campaigns focused on smoking cessation. We present as case-studies some campaigns that have been on the air for about 10 years in the USA or in some European countries.
Anti-smoking media campaigns
The CDC campaign Tips from former smokers  has been on air in the USA since 2012 for 12-29 weeks per year. It is characterized by videos with testimonials who tell their difficulties in quitting and the impact of tobacco on their health. This campaign is accompanied by a website, where smokers can better know testimonials’ experiences, download information on how to quit and on the harm of smoking, contact the free quitline which has been active since 20 years in the whole US, and download a mobile application for supporting quitting. During the airing of the campaign in the 2012-2018 period, 16 million of smokers tried to quit thanks to the campaign and about one million in 7 years quit permanently (100,000-180,000 per year). In addition, 129,000 premature deaths were avoided and 7.3 billion dollars in smoking-related healthcare costs were saved .
The Stoptober campaign have been broadcast in the UK since 2012 , and in the Netherlands since 2014 . The similar Mois sans Tabac campaign has been broadcast in France since 2016 . All these campaigns are based on the social contagion theory and use social networks for reaching smokers. They have an intermediate goal for smokers, to quit smoking for 28 days (during the month of October), according to the methodology of setting SMART objectives (Specific, Measurable, Attainable, Realistic and Time-sensitive). They are also based on the offer of a range of supports, from the toll-free number for quitting to the support of smoking cessation centers, up to a website, apps for quitting, text messaging programs, use of social networks for peer support), according to the PRIME theory (Plans, Responses, Impulses, Motives and Evaluations). Smokers tried to quit in a climate of “social marathon”, promoted by the campaign itself. In the UK in 2015, 215,000 smokers tried to quit following the campaign; 50,000 smokers registered for the campaign in the Netherlands in 2016. During the first 6 years of Stoptober campaigns in the UK, there was an overall increase in quit attempts in October and a sufficiently large budget contributes to a greater impact of the campaign. These results encourage the further dissemination of Stoptober to other countries. Future research should clarify how the increase in quit attempts as a consequence of Stoptober translate into success and which of the ingredients in Stoptober have been most important in increasing quit attempts, especially among vulnerable groups [11-14].
In France, the 2014-2017 National Tobacco Reduction Plan provided the launch in 2016 of the Mois sans tabac media campaign, with a dedicated website, app and telephone line, the introduction of the plain tobacco package and the increase in the reimbursement of quitting treatments from 50 to 150 euro. The Plan resulted in a reduction of approximately one million smokers from 29.4% in 2016 to 26.9% in 2017 . The successive Plan (2018-2022) provided a price increase for cigarettes up to € 10 and the creation of the tobacco control fund: every year about 100 million euro from tobacco taxes (1%), are destined to develop regional tobacco control programs. According to the latest report from the National Observatory on Drugs and Drug Addiction, nearly 3.4 million smokers used smoking cessation treatments in 2018 compared to 2.7 million in 2017. The third edition of #MoisSansTabac in November 2018 recorded an increase in the number of participants: 242,000 against 158,000 in 2017 .
Behavioural or psychological treatments in most cases use a cognitive-behavioral and motivational approach. There are also treatments based on the acceptance and commitment approach or on contingency management through monetary incentives.
Delivery methods range from the less to the more intensive approach: from self-help material tailored to different smokers’ features, to teachable moments, such as the brief advice to quit delivered by health professionals. Then, there are individual/group/telephone counseling interventions, administered in several sessions, such as the treatment paths developed at the national health system smoking cessation centers (CAF) or the phone calls made by the ISS toll-free quitline operators. Finally, there are digital interventions not yet well developed in Italy: interventions based on text messaging programs, websites, mobile phone applications and social networks. All these delivery methods have evidence of efficacy. Obviously, the most recent tools, such as applications on mobile phones and the use of social networks, given the recent introduction, still have few clinical trials, and therefore evidence is more limited for these tools.
Brief advice on smoking is effective when administered by physicians and other health professions, such as nurses or dental hygienists. It is based on the 5 As steps (Ask, Advise, Assess; Assist; Arrange), although in recent years the “AAR” model (Ask, Advise, Refer or Act) has become increasingly popular, where, after administering the first 2 As, health professionals send smokers to CAF or Quitlines. An opt-out approach is increasingly recommended, i.e. offering all smokers an offer of cessation at any encounter with the health system. In Italy there are gaps in the training of health personnel, given that the training curricula of doctors and health professionals do not include these teachings in most Italian Universities. To overcome this training gap, two remote training courses on brief advice are currently underway in Italy, one developed as part of a CCM 2019 project  and one developed by Società Italiana di Tabaccologia (SITAB) .
We present two 2 case-studies regarding brief advice: the introduction of smoking cessation in the Cancer Departments of the state of Ontario in Canada and the systematic approach of offering smoking cessation to smokers who come into contact with hospitals of the University of California .
Systematically offering smoking cessation interventions to ensure the maximum treatment benefit offered to cancer patients and framing smoking cessation as an instance of quality of care provided to cancer patients are the rationale behind the intervention in cancer departments that Ontario introduced in 2012. The main elements of this intervention were:
- developing a website with videos to train health personnel (doctors and nurses);
- to prepare and to distribute posters to hang in the clinics, with simple sentences to use (Table 1);
- leaflets for patients explaining the effects of smoking on surgery, radiotherapy and chemotherapy, with the key message of the initiative “it’s never too late to quit” (Table 2).
After 6 years from its introduction, in 2018-2019, results confirm the success of the initiative: 75% of patients were asked their smoking status and 25% of smokers accepted the referral to smoking cessation offered within the oncology departments or to the national or regional quitlines .
The systematic offering to smokers who come into contact with hospitals of Californian Universities is presented with the following sentence: “Every smoker. Every encounter”, provides that the smoker, at every encounter with California University hospitals, is offered the support of the California Quitline, through links with the electronic medical records.
Quitlines increased its activity in Italy after the introduction of the ISS toll-free Quitline number (800 554088) with pictorial health warnings in cigarette packages through the transposition of the European Directive 40/2014. The quitline protocols, as indicated by the World Health Organization , provide that, in addition to the first call, with the aim of fixing the quit day within the following month, further support calls to smokers should be made by quitline counselors at important moments of the quitting path (immediately after the quit day, at 3 days, one week; at 21 days, with a final follow-up at 6 months). The effectiveness is amply demonstrated, as evidenced by the Cochrane meta-analysis; there is a dose-response effect, based on the number of calls. It can be integrated with the use of quitting pharmacologic treatments. Promotional activity is essential: therefore, reporting the toll-free number on cigarette packages, during anti-smoking media campaigns, or on websites for quitting is essential for Quitlines. For example, in the US a Quitline business card that doctors and health professionals give to their smoking patients after the brief advice has been introduced. 
About the smoking cessation websites, we present as case-studies the Commit to quit website launched by WHO for the 2021 World Tobacco Day ; the website of the National Cancer Institute (NCI), U.S.A. , the website of the Veneto Region Smettintempo . The WHO and NCI sites not only present information on health risks of smoking and the benefits of quitting, but also offer a range of tools to support smokers in their attempts to quit: apps, text messaging programs, social networks pages to find peer support. The site of the Veneto region and that of the NCI profile information on advice based on the type of smokers: indecisive smokers, smokers who want to quit, who cannot quit, who has already quit and want to find support to remain abstinent.
Among mobile applications, as a case-study, we present the SmokeBeat application  which, in addition to the classic functions of an app to support smokers to quit, also includes the use of a wearable device, similar to a wristwatch, which, based on the movements of the arm, counts the cigarettes smoked per day. It can get in touch with other smokers, in order to compare how many cigarettes a day are smoked and allow to set goals and have incentives if smokers reach the goals on schedule.
Medications approved by the Italian Medicines Agency (AIFA) are nicotine replacement therapy (NRT), bupropion, cytisine and varenicline. Cytisine, as varenicline, is a partial agonist for nicotine receptors; it is a galenic preparation derived from the flowers of the laburnum, and its efficacy is widely demonstrated. In Italy only 3%-4% use AIFA-approved treatments to quit [27,28]; in the UK, USA, Australia, Canada, on the other hand, about 33% -45% of smokers use pharmacotherapy. Part of this difference can be attributable to the fact that cessation treatments are non-refundable in Italy, except for varenicline for smokers with cardiovascular or pulmonological diseases after a treatment plan provided by a CAF doctor. While smoking a pack a day in Italy costs around 450-500 euro for 3 months, which is the standard treatment period for quitting, varenicline costs around 350euro, nicotine patch 300 euro, while cytisine only 50-100 euro. Using e-cigarettes to quit is also cheap, around 110-230 euro, depending on whether vapers buy liquids in stores or on the internet.
Over-the-counter medications such as the nicotine patch, administered without behavioural support provided by healthcare professionals, result in lower cessation rates than those reported in clinical trials. The combination of drugs is widely used (NRT + varenicline; nicotine patch + nicotine inhaler); moreover, prolonging the use of drugs for 6 months up to 1 year, instead of the standard period of 8-12 weeks, can reduce the likelihood of relapse. The combination of pharmacotherapy with behavioural support is the best strategy: the Cochrane Group tells us that using, for example, varenicline with no behavioral support, recorded a 37%; varenicline + individual behavioural support a 52%; varenicline + group behavioural support a 74% one-month cessation rate, respectively. Using two combinations of NRTs simultaneously with no behavioural support determines a 36%; with individual behavioural support a 50%; with group support a 71% one-month cessation rate, respectively.
Electronic cigarettes (e-cig)
Clinical trials showed that they help to quit and the effect is favoured if e-cig use is accompanied by behavioural support. However, the evidence is limited; there are few clinical trials, e-cigs in the market evolve rapidly, so much so that some clinical studies are related to past generation e-cigs; moreover, in clinical studies there is no adequate comparison with other medications, such as varenicline.
E-cigs can be used in a clinical setting (for example, at the CAF), as part of a treatment with intensive and repeated behavioural support, even in cases where pharmacological AIFA-approved treatments failed or for vulnerable patients (psychiatric, oncology patients).
Dual use certainly undermines its effectiveness; we know that in Italy about 70% of vapers also smoke tobacco cigarettes. Not everyone uses e-cig to quit smoking, but using the two products together doesn’t help quitting . Finally, longitudinal studies did not report as good results as that recorded in clinical trials because e-cig use in longitudinal studies is not accompanied by behavioural support, as occurs in clinical trials.
Continuing the use of e-cigs for more than one year after quitting tobacco smoking is not recommended because it poses unknown long-term health risks, especially for cardiovascular diseases, due to the presence of nicotine and particulate matter in e-cigs. Furthermore – and this is very important – the likelihood of relapse increases [29-34].
The most important problem with e-cigs is that they are not sold exclusively to those who want to quit smoking. In Italy, e-cig use in adolescents has greatly increased from 2014 onwards [35-36]. Furthermore, it is now certain that adolescents or young adults who start vaping are more likely to later initiate smoking (“gateway” effect). It is therefore important for e-cigs to maximize the positive effects associated with cessation and at the same time to minimize the adverse effects associated with initiation among young people.
Finally, we do not know much about the entry into the Italian market from 2019 of e-cigs with nicotine salts (fourth generation e-cigs).
Individual treatments with very limited evidence of efficacy: acupuncture
Acupuncture compared to sham acupuncture presents weak evidence of a small benefit in the short term only, not in the long term. Acupuncture is less effective than NRT and is no better than behavioural support alone. There is limited evidence that acupressure is superior to short-term sham acupressure, but no long-term evidence. Continuous acupressure on the points of the ear recorded the greatest short-term effect. Evidence on laser stimulation is inconsistent. Electrostimulation studies do not show a greater benefit than dummy electrostimulation.
Proposal to relaunch tobacco control in Italy with a focus on smoking cessation
It would be appropriate to develop population interventions with a funding of 5-10 million euro from post-COVID funds to relaunch smoking cessation in Italy. These are the main elements:
- Development of a national anti-smoking media campaign such as Stoptober (UK, the Netherlands) or Mois sans tabac (France), with website and tools to support cessation, (text messaging programs; chatbot and app to quit to smoke);
- Strengthening the ISS toll-free Quitline, the NHS smoking cessation centers, and online training programs on brief advice to quit for all health professions;
Furthermore, it would be useful to develop the following legislative interventions that mainly require lobbying activities:
- Increase in the price of tobacco products (including heated tobacco products);
- Reimbursement of cessation treatments (drugs and behavioral treatments);
- Ban on advertising of e-cig and heated tobacco product devices.
Figures and tables
|ELEMENTO||DESCRIZIONE||FRASI DA DIRE E AZIONI DA FARE|
|Ask (chiedi)||A tutti i nuovi pazienti con tumore deve essere chiesto se fumano o hanno smesso di recente||“Fuma sigarette? Ha usato sigarette o altri prodotti negli ultimi 6 mesi?”|
|Documentare la risposta del paziente e la data nella cartella clinica cartacea o elettronica|
|Advise (consiglia)||A tutti i fumatori ed ex fumatori recenti verrà offerto un consiglio personalizzato ed empatico sui vantaggi di smettere di fumare per il trattamento contro il cancro||“Smettere di fumare/rimanere astinente è una delle cose migliori che può fare per aiutare il trattamento oncologico ad agire al meglio e per ridurre gli effetti collaterali. Essere liberi dal fumo ridurrà anche la possibilità che il tumore ritorni, o che si sviluppi un altro tipo di tumore”|
|Documentare nella cartella clinica se il consiglio è stato dato|
|Act (invia)||Tutti i fumatori e i soggetti che hanno smesso di recente devono essere indirizzati a un servizio per smettere di fumare||“Capisco che smettere di fumare/restare astinente può essere difficile, ma è più facile con un supporto. La invierò a...”|
|Facilitare l’invio a un servizio di supporto e documentare in cartella il tipo di aiuto selezionato dal paziente o se l’aiuto è stato rifiutato|
|INTERVENTO CHIRURGICO||Se smette di fumare, il rischio di infezioni e complicazioni dopo l’intervento si riduce. Smettere di fumare rende l’intervento più sicuro e aiuta a recuperare più velocemente dopo l’intervento|
|RADIOTERAPIA||Funziona meglio quando i livelli di ossigeno sono normali nel corpo. Fumando, i livelli di ossigeno calano drasticamente. Smettere di fumare permette alla radioterapia di lavorare al meglio e riduce gli effetti collaterali|
|CHEMIOTERAPIA||Il fumo contiene sostanze chimiche che possono abbassare i livelli di chemioterapici nel sangue, rendendoli meno efficaci. Smettere di fumare permette ai farmaci chemioterapici di lavorare al meglio|
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