|Year : 2018 | Volume
| Issue : 4 | Page : 396-410
Smokeless tobacco cessation interventions: A systematic review
Suzanne Tanya Nethan1, Dhirendra Narain Sinha2, Kumar Chandan3, Ravi Mehrotra3
1 Division of Clinical Oncology, ICMR-National Institute of Cancer Prevention & Research, Noida, India
2 School of Preventive Oncology, Patna, India
3 WHO FCTC Global Knowledge Hub on Smokeless Tobacco, ICMR-National Institute of Cancer Prevention & Research, Noida, India
|Date of Submission||15-Dec-2017|
|Date of Web Publication||21-Jan-2019|
Dr Ravi Mehrotra
ICMR-National Institute of Cancer Prevention & Research, Plot I-7, Sector 39, Noida 201 301, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background & objectives: Smokeless tobacco (SLT) consumption is a global health issue with about 350 million users and numerous adverse health consequences like oral cancer and myocardial disorders. Hence, cessation of SLT use is as essential as smoking cessation. An update on the available literature on SLT cessation intervention studies is provided here.
Methods: Through an extensive literature search on SLT cessation intervention studies, using keywords such as smokeless tobacco, cessation, interventions, quitlines, brief advice, nicotine replacement therapy, nicotine gum, nicotine lozenge, nicotine patch, bupropion, varenicline, mHealth, etc., 59 eligible studies were selected. Furthermore, efficacy of the interventions was assessed from the reported risk ratios (RRs) [confidence intervals (CIs)] and quit rates.
Results: Studies were conducted in Scandinavia, India, United Kingdom, Pakistan and the United States of America, with variable follow up periods of one month to 10 years. Behavioural interventions alone showed high efficacy in SLT cessation; most studies were conducted among adults and showed positive effects, i.e. RR [CI] 0.87 [0.7, 1.09] to 3.84 [2.33, 6.33], quit rate between 9-51.5 per cent, at six months. Regular telephone support/quitlines also proved beneficial. Among pharmacological modalities, nicotine lozenges and varenicline proved efficacious in SLT cessation.
Interpretation & conclusions: Globally, there is limited information available on SLT cessation intervention trials, research on which must be encouraged, especially in the low-resource, high SLT burden countries; behavioural interventions are most suitable for such settings. Appropriate training/sensitization of healthcare professionals, and school-based SLT use prevention and cessation programmes need to be encouraged.
Keywords: Behavioural - intervention - nicotine replacement therapy - smokeless tobacco - tobacco dependence - tobacco use cessation
|How to cite this article:|
Nethan ST, Sinha DN, Chandan K, Mehrotra R. Smokeless tobacco cessation interventions: A systematic review. Indian J Med Res 2018;148:396-410
Smokeless tobacco (SLT) use, a form of tobacco consumed without combustion/burning, has become a global health issue with about 350 million users, maximally seen in the South-East Asian Region. Its use is associated with a myriad of adverse effects, with the major ones being oral cancer, myocardial infarction and other cardiovascular diseases.
Article 14 of the World Health Organization Framework Convention on Tobacco Control (WHO-FCTC) deals with tobacco addiction and dependence treatment measures. It states that 'each Party shall develop and disseminate appropriate, comprehensive and integrated guidelines based on scientific evidence and best practices, taking into account national circumstances and priorities, and shall take effective measures to promote cessation of tobacco use and adequate treatment for tobacco dependence.' The formulation of this Article demonstrates the fact that the FCTC realizes the addictive potential of tobacco. Hence, the same came into existence at the Conference of the Parties 4 with the objective of development of effective treatment guidelines and measures to promote adequate treatment for tobacco dependence, by the member Parties. However, the average implementation of Article 14, as reported in the Global Progress Report on Implementation of the WHO-FCTC in 2016, has not been significant, i.e. 50 per cent, between 2012 and 2016, as compared to the other substantive articles of the Convention. According to the guidelines of Article 14, tobacco cessation has multiple dimensions to it, comprising behavioural interventions [brief advice, telephone counselling via national toll-free quitlines (NQLs)], pharmacotherapy, nicotine replacement therapy (NRT) and non-nicotine therapy - bupropion and varenicline, involvement of the healthcare system/healthcare workers, noting individual's tobacco use.
In spite of widespread use and adverse health consequences of SLT, there is a dearth of evidence-based published literature on SLT cessation as compared to that on smoking cessation. A systematic review and meta-analysis available for SLT cessation intervention trials was the Cochrane review reporting data till 2015, majorly for studies performed in the United States of America (USA), with a few in the Scandinavian countries. Here we provide a global update on the existing literature regarding studies on the demand reduction measures concerning SLT dependence and cessation, along with evidence-based discussion of the efficacy of each.
| Material & Methods|| |
To search the literature and systematically review the various demand reduction measures for SLT dependence and cessation, an online search strategy was performed since inception (1966) for PubMed to 2017, and the resultant data evaluated, as shown in [Figure 1].
|Figure 1: Flow chart showing search strategy.*These were the number of articles which were chosen for screening of their abstracts after excluding other articles deemed irrelevant based on their titles.|
Click here to view
Extensive PubMed and Google literature search was performed using a combination of keywords such as smokeless tobacco, cessation, interventions, dependence, treatment, quitlines, behavioural, brief advice, nicotine replacement therapy, nicotine gum, nicotine lozenge, nicotine patch, bupropion, varenicline, dentist, mHealth and mobile. This search produced 28,756 results, the titles of which were assessed and those not relevant were excluded. Abstracts of the remaining publications and full papers were reviewed to identify those that fulfilled the inclusion criteria. Among these, 59 articles were found to be of potential interest and were included.
The criteria for data selection, obtained from the search above, were as follows:
Studies performed for SLT cessation interventions; studies performed for cessation of both smoking and SLT but also reporting data specific to SLT cessation; those with the most recent results for consecutively reported studies; SLT cessation intervention studies performed either on adults or adolescents were included. Only English language literature was included.
Studies only for smoking cessation; studies for cessation of both smoking and SLT but not providing separate information for SLT cessation; literature reviews; repetitive data (example: extracts from already included Cochrane articles); articles on tobacco use screening and counselling; study protocols; studies with differing objectives; old published data for the same study; unavailability of the complete report for reference in case of lack of clarity of information in the abstract; documents in languages other than English, were excluded.
The current status of availability of the SLT dependence and cessation measures globally and the efficacy of each of the SLT cessation intervention was assessed based on the risk ratio (RR) [confidence intervals (CIs)] and quit rates reported for each of them in the various resultant studies.
| Results|| |
Behavioural interventions for smokeless tobacco (SLT) cessation
Twenty randomized controlled trials (RCTs) (case-control studies) on behavioural interventions for SLT cessation were reported; sixteen were conducted in the USA,,,,,,,,,,,,,,,, three in India,, while only one study was reported from Sweden. Most studies had majority of adult participants while three were conducted among the youth,,. Among the 19 studies having a follow up of six months or more, 10 studies reported statistically and clinically significant benefits with RR (CI) ranging between 1.33 (1.09, 1.63) and 3.84 (2.33, 6.33),,,,,,,,,, in five studies the CIs did not specify a clinical benefit but did not exclude one either, with an RR (CI) between 1.08 (0.84, 1.39) and 3.72 (0.79, 7.47),,,, and four studies had RRs just below or above one and relatively narrow CI suggesting no important benefit or harm i.e. RR (CI) from 0.87 (0.7, 1.09) upto 1.07 (0.87, 1.31),,,. Overall, the RR (CI) ranged from 0.87 (0.7, 1.09) to 3.84 (2.33, 6.33). The one case-control pilot study conducted by Jhanjee et al showed an RR (CI) of 1.80 (0.77, 4.25) at the end of three months of treatment [Table 1]. Therefore, the trials suggested a benefit of behavioural interventions in SLT cessation.
|Table 1: Details of the smokeless tobacco (SLT) cessation intervention randomized controlled trials (RCT) and cohort studies|
Click here to view
Twelve non-case-control studies employing behavioural interventions for SLT cessation interventions were found, among which eight had a follow up of six months or more,,,,,,, and four had a follow up of less than six months,,,. Of these, two studies were performed in India,, one in Pakistan and United Kingdom (UK) and the rest were done in the USA,,,,,. Among the group having intervention/follow up of less than six months, the quit rate ranged from eight per cent (at the end of one month, Gala et al) to 58 per cent (after 1.5 months, Fisher et al),. The quit rate of SLT users in the trials having a longer follow up of six months or more was between 9 per cent (at six months, Walsh et al) and 51.5 per cent (after 12 months, Mishra et al), [Table 2].
|Table 2: Details of smokeless tobacco cessation intervention non case-control studies|
Click here to view
National toll-free quitlines (NQLs): Telephone support has been shown to be efficacious in SLT cessation. Among the aforementioned studies, 10 RCTs conducted in the USA, in which telephone support formed part of the intervention showed their benefit, with RR (CI) ranging between 1.32 (0.94, 1.86) and 3.84 (2.33, 6.33) [Table 1],,,,,,,,,. Four non case-control studies,,, reported a beneficial effect of telephone support for SLT cessation. A quit rate of 20 per cent among SLT users at the end of 18 months of the quitline activity in Rajasthan (India), a voluntary activity of Rajasthan Cancer Foundation, was reported. A media campaign (comprising of quitline component) in Nebraska (USA) reported a quit rate of 11.5 per cent at the end of 12 months and Eakin et al(USA) reported a quit rate of 16 per cent at the end of three months in their multi-component behavioural intervention programmes including frequent telephone contact/counselling with the SLT users. Mushtaq et al reported a quit rate of 43 per cent at the end of seven months; however, the intervention also involved delivery of NRT in addition [Table 2].
Pharmacotherapy for SLT cessation
Nicotine replacement therapy (NRT): Fifteen RCTs on NRT for SLT cessation were found. Twelve trials were performed in the USA,,,,,,,,,,, while three were conducted in the UK among Bangladeshi-resident women,,. Except one, the rest of the studies had adult participants. Among the 12 studies from the USA with a follow up of six or more months, neither nicotine patch,,,, nor nicotine gum, increased abstinence; however, the five studies of nicotine lozenges showed increased SLT abstinence, with RR (CI) between 0.73 (0.34, 1.55) and 1.53 (1.12, 2.09),,,, [Table 1]. In the Bangladeshi Stop Tobacco Project, NRT proved effective among 419 Bangladeshi female resident SLT users of UK with RR (CI) of 4.93 (2.02, 2.00) at four weeks, whereas the opposite was noted for nicotine gum or patch among 239 and 130 Bangladeshi origin participants living in the UK,, [Table 1].
Five non-case-control studies on NRT usage for SLT cessation were found. All were conducted among adults and had a follow up period of six months or more. Only one study was performed in Sweden and the rest in the USA,,,. Three studies tested the efficacy of nicotine gum alone in SLT cessation,,, while one study employed nicotine lozenge; Mushtaq et al, utilised nicotine gums, patches and lozenges in their participants. A higher benefit of nicotine lozenge in SLT cessation was also observed by Ebbert et al, i.e. 47 per cent quit rate at six months. The quit rate for NRT in general in SLT cessation ranged from 7 to 47 per cent [Table 2].
Non-nicotine therapy: A total of six RCTs, three each for bupropion and varenicline for SLT cessation, were found, and all were conducted among adults. All the three bupropion-related studies,, were performed in the USA, with one having a follow up of less than six months and the other two having a follow up period of more than six months,; however, none of these studies showed a positive effect on tobacco abstinence. The three trials of varenicline, were conducted in Scandinavia, USA and India with one having a follow up of less than six months and the other two having a follow up period of more than six months. These studies showed increased tobacco abstinence rates at six months compared to placebo [Table 1]. A single non-case-control pilot study in USA reported a quit rate of 15 per cent among adult participants at the end of 12 wk of treatment with varenicline and 10 per cent at the end of six months of follow up.
| Discussion|| |
Globally, a dearth in the published literature regarding SLT cessation intervention trials has been observed (only for 3% WHO-FCTC ratified Parties, i.e. 5/179 Parties - Sweden, Norway, India, United Kingdom and Pakistan, apart from the USA). Further, a deficiency in the tobacco cessation support availability in most low-resource and high SLT burden Parties has been reported in the MPOWER 2017, which is required to be strengthened.
Studies assessing the efficacy of SLT cessation interventions, especially behavioural interventions, must be carried out by all countries, especially those having a high burden of SLT consumption, as behavioural interventions have been found to have maximum benefit in SLT cessation as compared to pharmacotherapy,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,. The Cochrane review (2015) on the SLT cessation intervention trials also showed results along similar lines, with behavioural interventions proving most efficacious for SLT cessation. Another Cochrane review (2012) also suggested almost similar efficacy of behavioural interventions in both smoking and SLT cessation. The importance of behavioural intervention in the form of brief advice by healthcare professionals for successful SLT cessation has also been undermined and not much research has been performed. The Global Adult Tobacco Survey (GATS) performed in India, Bangladesh, Kenya, Pakistan, Thailand and Uganda reported a considerable variation while tobacco cessation counselling by health professionals (greater consideration for smokers than SLT users). Two trials in India have been performed successfully utilizing brief advice for tobacco cessation among both smokers and SLT users i.e. an overall quit rate of 67.3 per cent was reported by Kaur et al, and 2.6 per cent by Sarkar et al, however, the quit rate for SLT users has not been mentioned separately. There is also a lack of formal training for tobacco cessation among health profession students and school personnel, as seen in the Global Health Professions Student Survey and Global School Personnel Survey, respectively. Hence, the same must be encouraged and expanded up to the grass root level, i.e. among health workers working in the villages. However, the likelihood of healthcare professionals giving brief advice will be more if tobacco use is recorded in the medical history; but only 20 per cent of countries follow this.
Quitlines and telephone support for SLT cessation have proven efficacious as noted in literature,,,,,,,,,,,,,. In a Cochrane review, the pooled risk ratio of 10 studies conducted in the USA, in which telephone support formed part of the intervention, indicated benefit in SLT cessation. It was also noted that a combination of oral examination and telephone support was more beneficial (RR- 2.07, CI-1.61, 2.66), than oral examination alone. However, according to the MPOWER 2017 data, only one-third, i.e. 31 per cent, Parties have NQLs, the establishment of which needs to be encouraged. In addition, the phone number of the quitlines could be mentioned on the SLT product packet health warnings. To ensure broader coverage, the primary healthcare system, services for treating tuberculosis and human immunodeficiency virus/acquired immunodeficiency syndrome, dental set-ups and non-communicable diseases programmes could also be involved.
mHealth services for SLT cessation can be employed as an easy and cost-effective option, especially in the low-income group countries, for smoking cessation. Very few WHO-FCTC ratified countries have provided this facility (24 Parties). A national, bilingual mCessation programme (tobacco cessation through mobile text messages) was started in 2016 in India. Evaluation at the end of the first year, of more than 12,000 registered users, demonstrated an average quit rate of about seven per cent among both smokers and SLT users six months after enrolment. Based on the information from 12 studies reported in the Cochrane review, 2016 (performed mostly in high-income countries such as USA, Australia, UK, Switzerland, New Zealand), smokers who received the mobile phone-based support were around 1.7 times more likely to quit than those who did not, proving this intervention efficacious, which could also be utilized for SLT cessation.
Most studies had adult participants. SLT prevention and cessation programmes must be facilitated in schools such as Project MYTRI, especially among students of the lower strata of the society and with a higher early tobacco usage initiation tendency (smoking and/or SLT or both).
In conclusion, SLT cessation intervention-based research needs encouragement globally, especially in the low-income group countries which are deficient in tobacco cessation support. Behavioural interventions have been proven to be an efficacious and feasible modality for tobacco cessation in all settings (low and high resource). Sensitization and imparting of training regarding the same to health professionals and SLT use prevention and cessation-related school programmes need to be encouraged.
Financial support & sponsorship: None.
Conflicts of Interest: None.
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