|Year : 2022 | Volume
| Issue : 2 | Page : 131-136
Effectiveness of smoking cessation interventions in dental settings: A randomized controlled trial
Ankita Piplani1, BC Manjunath2, Adarsh Kumar2, Manvi Srivastava3, Krishan Kumar4, Hansa Kundu2
1 National Oral Health Program, Ministry of Health and Family Welfare, Rohtak, Haryana, India
2 Department of Public Health Dentistry, Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India
3 Department of Pedodontics and Preventive Dentistry, KD Dental College and Hospital, Mathura, Uttar Pradesh, India
4 Department of Psychiatry, Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India
|Date of Submission||24-May-2021|
|Date of Decision||14-Aug-2021|
|Date of Acceptance||04-Apr-2022|
|Date of Web Publication||8-Jun-2022|
Department of Pedodontics and Preventive Dentistry, KD Dental College and Hospital, Mathura, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: Smoking is associated with increased overall morbidity and mortality. Globally, more than 6 million deaths per year are related to smoking. The aim of the study was to assess the effectiveness of motivational interviewing (MI), MI in combination with bupropion 150 mg (milligrams), and MI in combination with bupropion and nicotine chewing gums (2 mg) (nicotine replacement therapy [NRT]) in smoking cessation. Materials and Methods: A double-blind, 6-month, parallel, randomized controlled trial was conducted among healthy smokers who were motivated to quit smoking. Based on the sample size estimation, 132 heavy smokers with moderate-to-high dependence were randomized to one of the three intervention groups: A: MI + Placebo, B: MI + bupropion, and C: MI + NRT + bupropion. Interventions were delivered for 3 months. The main outcome was self-reported continuous abstinence rates at 6 months. The data were analyzed using the Mann–Whitney U test, Kruskal–Wallis test, Wilcoxon signed-rank test, and Pearson's Chi-square test with P value fixed at 0.05. Results: The study participants included predominantly males (98.5%) with a mean age of 35.1 ± 9.32 years. The overall continuous abstinence rate at 6 months was 18.9%. The continuous abstinence rates were 12.2%, 22.2%, and 23.4% in Group A, B, and C, respectively (P = 0.318). There was no significant difference in 7-day point prevalence abstinence from smoking at the end of 3 months in between the three groups (P = 0.06). Conclusion: MI plays a significant role in smoking cessation and offers benefits comparable to pharmacotherapies and hence can be used as an integral part of smoking cessation interventions.
Keywords: Bupropion, counseling, drug therapy, motivational interviewing, therapeutics, tobacco
|How to cite this article:|
Piplani A, Manjunath B C, Kumar A, Srivastava M, Kumar K, Kundu H. Effectiveness of smoking cessation interventions in dental settings: A randomized controlled trial. J Indian Assoc Public Health Dent 2022;20:131-6
| Introduction|| |
Globally, around 1.2 billion people are consuming tobacco and its products in one or other forms. The World Health Organization (WHO) has estimated that tobacco use in various forms is associated with the death of about six million people worldwide each year, with several of these deaths taking place prematurely. Hence, it is essential to adopt tobacco control and preventive strategies to reduce public health burden associated with tobacco.
Various studies have shown that the risk of mortality decreased to 50% among those who quit before 50 years of age. However, despite 40% smokers willing to quit, <5% are successful, which shows that there is a need for professional tobacco cessation services to increase quit rates. Professional smoking cessation interventions comprise pharmacological and nonpharmacological therapies. A Cochrane review of 12 randomized controlled trials assessing the efficacy of pharmacological therapy investigating the role of nicotine replacement therapy (NRT), bupropion, and varenicline showed that both NRT and bupropion perform similarly compared with placebo in helping people to quit. Furthermore, varenicline was found to be more effective than NRT or bupropion, when each is compared with placebo. Another review of nonpharmacological therapy found that motivational interviewing (MI) appears to be modestly successful as compared to usual care or brief advice. Interventions that combine pharmacotherapy and behavioral support increased success rates of smoking cessation compared to a minimal intervention or usual.
According to the Global Adult Tobacco Survey conducted in 2016–2017, tobacco is consumed by 28.6% of the total population of India. Smoking forms of tobacco are consumed by 10.7% of the population, while smokeless tobacco is consumed by 21.4% and 38.5% of the total smokers attempted to quit smoking. Since, there is paucity of research in India conducted to assess the effectiveness of behavioural therapy for smoking cessation with or without pharmacotherapy in dental settings. Thus, the present randomized controlled trial was conducted to assess the effectiveness of MI, MI in combination with bupropion (150 mg), and MI in combination with nicotine chewing gums (2 mg) plus bupropion (150 mg). The primary outcome of the trial included continuous abstinence (quitting) at 6 months and 7-day point prevalence abstinence at 3 months in the different intervention groups.
| Materials and Methods|| |
A 6–month, concurrent, parallel, randomized controlled trial was performed at tobacco cessation clinic of Postgraduate Institute of Dental Sciences (PGIDS), Rohtak (Haryana). Ethical approval was taken from the institutional ethical review board before the initiation of the trial (PGIDS/IEC/2015/73).
Recruitment of the participants
The general public was informed about the tobacco cessation intervention program through newspaper pamphlets, smoking cessation camps, and radio talk. Participants were also recruited from the outpatient department of the dental institution. The participants who fulfilled the following inclusion and exclusion criteria were included in the trial.
- Smokers of age 18–50 years
- Smokers who use to smoke 1 bidi (hand-rolled tobacco leaves) or cigarette per day for the past 1 year,,
- Smokers motivated to quit smoking
- Smokers with Fagerström nicotine dependence score of 5 or more (moderate-to-high dependence)
- Smokers who gave written informed consent.
- Smokers with any systemic diseases
- Abuse of alcohol
- Use of smokeless tobacco
- History of seizures and severe head trauma
- Allergy to any medication.
The sample size of the present study was calculated by taking P1 (continuous abstinence rates at 3 months in the medication group) = 57.5% and P2 (continuous abstinence rates at 3 months in the counseling group) = 16.7%, which were taken from the study done in 2007 (Kumar, 2007) as it was anticipated that the 3-month results obtained from the present study will be similar to this study. The sample size at 95% confidence interval and 80% power was calculated to be 22 in each group. Taking the attrition rate as 50%, the final sample size in each group was estimated at 44, making a total of 132 study participants.
Out of the total 850 interested participants screened over a period of 10 months (November 2015 to August 2016), 132 participants fulfilling the inclusion and exclusion criteria were included in the study. An investigator, not related to the trial, prepared a lot of 50 sealed envelopes of each group (for a total of 150 so that the last participant would not be left with only one option). Further, at the randomization visit, one sealed envelope was withdrawn using the lottery method of randomization to determine which form of intervention the participant will receive. The outcome of the trial was recorded by the investigator not related to the trial. Both the participants and the investigator were blinded to the intervention used.
The intervention was given to the study participants for a period of 3 months with follow-up of smoking status to 6 months. Quit date was set after 1 week of the medication (usually the 8th day). Participants were randomly recruited to the three intervention groups, namely:
- MI + placebo (composed of starch and lactose) (Group A)
- MI + bupropion (150 mg) (Group B)
- MI + bupropion + nicotine chewing gums (2 mg) (Group C).
At baseline, 30-min MI session was given to study participants in all three groups followed by 15-min session on further weekly follow-up visits for 3 months. Counseling was done using the five principles of MI (express empathy, support self-efficacy, develop discrepancy, roll with resistance, and avoid arguing). The stage of change of the participant was assessed and accordingly patients were assisted to set a quit date. Further, the counseling was done for coping with the withdrawal symptoms, controlling lapses, and the need of obtaining assistance from family and friends. Along with MI, participants in Group A received a placebo tablet once on the 1st, 2nd, and 3rd day of treatment and twice daily for the rest of the intervention period; participants in Group B received 150 mg of bupropion once on the 1st, 2nd, and 3rd day of treatment and twice daily for the rest of the intervention period; and the participants in Group C received 150 mg of bupropion once on the 1st, 2nd, and 3rd day of treatment and twice daily for the rest of the intervention period along with a tapering frequency of 2 mg nicotine chewing gum (up to 15 pieces/day) for 3 months. Participants were asked to maintain a daily diary for recording their smoking frequency, symptoms of nicotine withdrawal, and intervention used.
Training of the investigator
Training of the investigator for enhancing counseling skills was done at the National Institute of Health and Family Welfare, New Delhi. Training for using tobacco cessation interventions was done under Tobacco-free Initiative from Indian Dental Association, New Delhi, and the National Institute of Mental Health and Neurosciences, Bengaluru, before starting the trial. The total training period comprised 10 days. The calibration of the counseling skills of investigator was done at the Department of Psychiatry, Postgraduate Institute of Medical Sciences, Rohtak.
Data collection included the collection of participants' demographic characteristics, family/friends' contact numbers, current smoking status, reason for quitting, previous quit attempts, duration of smoking, tobacco use in first-degree relatives, and Fagerström nicotine dependence scores through baseline assessment form. At each weekly follow-up visit, self-reported smoking status, smoking abstinence, withdrawal symptoms, any adverse effects, and Fagerström nicotine dependence scores were assessed through a follow-up pro forma.
The participants were followed up weekly during the intervention period of 3 months and further monthly for 3 months postintervention period. The participants who were not able to come for clinic MI sessions were followed through telephonic conversation.
Primary and secondary outcomes
The primary outcome was to assess continuous abstinence (quitting) at the end of 6 months. Continuous abstinence was defined as a self-report of not smoking even a puff after the completion of 3 months of intervention.
Secondary outcomes assessed were 7-day point prevalence abstinence at the end of 3 months; 7-day abstinence was defined as a self-report of no smoking in the past 7 days; the change in mean Fagerstrom nicotine dependence scores were seen from baseline to 6 months and finding the predictors of quitting.
Loss to follow-up
Patients who discontinued the study or were lost to follow-up at the end of 6 months were assumed to be smoking.
Validity of self-reported smoking status
Self-reported abstinence in effectiveness studies has been recommended by the Society for Research on Nicotine and Tobacco Subcommittee on biochemical verification and consistent with this recommendation biochemical verification for abstinence was not obtained in the present study.
For maintaining the database, statistical analysis was done using IBM Statistical Package for the Social Sciences (SPSS) Version 21. Normality of the data was checked using Shapiro–Wilk test and the data were found to be nonparametric. Intention-to-treat analysis was used. Data analysis strategy consisted of two phases. First, baseline variables in the groups were compared using the Mann–Whitney test, Kruskal–Wallis test, and Chi-square test to analyze continuous and categorical variables. Second, continuous abstinence at the end of 6 months and 7-day point prevalence abstinence at the end of 3 months were compared between the groups. The change in mean Fagerström nicotine dependence score from baseline to 6 months and within groups was assessed using Wilcoxon signed-rank test. Predictors of outcome and odds of quitting in different groups were studied using binary logistic regression analysis.
| Results|| |
Out of 850 interested participants screened over a period of 10 months (November 2015 to August 2016), 132 participants (15.5%) fulfilling the inclusion and exclusion criteria were included and randomized, with 49, 36, and 47 participants allocated to Group A, B, and C, respectively [Figure 1]. Baseline characteristics are detailed in [Table 1].
|Table 1: Demographic and smoking history of study participants, by treatment group|
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The proportion of the participants who achieved continuous abstinence at 6 months are described in [Table 2].
There was no significant difference in 7-day point prevalence abstinence from smoking at the end of 3 months in between the three groups (18.4% in Group A, 41.7% in Group B, and 31.9% in Group C; P = 0.06) However, the post hoc analysis revealed a significant difference in Group A and B (P = 0.017). All three groups showed a significant reduction in the mean Fagerström score at 6 months compared to baseline [Table 3]. Higher continuous abstinence was found among those participants who had made previous attempts to quit smoking, who did not have any other tobacco user in the family, whose reason to quit smoking was social concerns, and those who had attended more MI sessions as compared to others [Table 4].
|Table 4: Regression analysis of variables affecting quit rates at 6 months|
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A single participant in Group C reported serious adverse event, i.e., severe nasal bleeding during the 3rd week of the intervention. Thereafter, the intervention was stopped and the participant was hospitalized. The symptoms resolved soon after the hospitalization. The probable reason for this event is unknown.
Among withdrawal symptoms, depressed mood was significantly higher in Group A as compared to Group B and C after 1 month of the intervention (P = 0.05). At 6 months, withdrawal symptoms did not vary significantly among the groups.
Loss to follow-up
Overall, 50.8% of the patients were loss to follow-up at the end of 6 months (51%, 47.2%, and 53.2% in Group A, Group B, and Group C, respectively; P = 0.86).
| Discussion|| |
In the present study, we found that there was no significant difference in the continuous abstinence achieved at 6 months among all the three groups (P = 0.31). The effectiveness of interventions was, as expected, most evident during the intervention period and declined during the follow-up. Almost 18.9% of smokers were able to quit smoking.
To the best of our knowledge, this is the first study to evaluate the effectiveness of MI, MI in combination with bupropion, and MI in combination with bupropion and nicotine chewing gums (NRT) in smoking cessation in dental settings.
The WHO and the Centers for Disease Control and Prevention have recommended that the behavioral counseling should be used in the treatment of smoking. MI is a unique approach to behavioral change, probably because positive and long-lasting results most likely happen when a person becomes actively and personally involved in change. In the present study, the effectiveness of the behavioral intervention could be seen by no significant difference in the continuous abstinence achieved in between the groups at 6 months.
The pharmacotherapies used in this study were in accordance with the recommendations of the US Public Health Service on Smoking and Health. Results from meta-analysis suggest that combination therapy is statistically better than monotherapy in smoking cessation treatment for achieving 3, 6, and 12 months abstinence rates. However, continuous abstinence (quit rates) at 6 months in the present study showed no significant difference in between the groups [Table 2]. The lower results with combination therapy might be due to the highest loss to follow-up in this group as compared to the other groups (51% in Group A, 47.2% in Group B, and 53.2% in Group C). As the results are based on intention to treat therefore, all loss to follow-ups were considered as smokers. Moreover, participants in Group C smoked significantly higher number of cigarettes and bidis (hand-rolled tobacco leaves) at baseline as compared to the other two groups (P = 0.004) [Table 1]. However, all three groups showed a significant reduction in the mean Fagerström score at 6 months compared to baseline depicting the effectiveness of all three interventions [Table 3].
Many factors enhance the quit rates when supported by tobacco cessation therapies. In the present study also, a participant with previous quitting attempts, having no tobacco user in the family; socially concerned about their habit and those who have attended more MI sessions had the best chance of achieving continuous abstinence at 6 months [Table 4] and the finding is in line with the previous studies. Multiple contacts timed around a quit attempt were effective in encouraging smoking cessation, such as being in daily contact with other smokers reduced the likelihood of success in quitting and less number of smokers in social network or workplace smoking restrictions and any intervention that promotes reduced consumption is likely to increase the eventual chances of smoking cessation.,,,
The nicotine present in the tobacco smoke is very addictive; hence, when a smoker stops smoking, a nicotine withdrawal syndrome ensues, categorized as irritability, anxiety, insomnia, lack of concentration, and dysphoria. The present study showed physical and psychological discomfort during the period of smoking cessation in smokers treated with or without pharmacotherapy. These adverse effects are reversible and typically disappeared after 3–4 weeks.
The strength of this study is that only moderate-to-high nicotine dependence smokers were recruited for the interventions as there is insufficient evidence of the effectiveness of medications in light smokers. Even though motivation to stop smoking was high in this sample, quit rates (continuous abstinence) were modest, demonstrating that even motivated smokers had difficulty in quitting.
The small sample size, short follow-up duration, and higher drop-out rates can be considered limitations of this study. The external validity of this trial is limited as the participants tend to be in better general health and were motivated than those in typical primary care population. Second, all participants received the extensive sessions of MI, which is uncommon in general health-care settings.
| Conclusion|| |
Our study showed that there was no significant difference in quit rates/continuous abstinence in between the groups at 6 months. Seven-day point prevalence abstinence at 3 months was significantly higher in Group B as compared to Group A. MI alone was also effective in helping participants to achieve continuous abstinence; hence, it can be used as routine therapy to all smokers by health-care professionals.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]