|Year : 2018 | Volume
| Issue : 2 | Page : 103-108
Breaking the hurdle with three tobacco cessation interventions in your life: A randomized controlled trial
Ravneet Malhi, Basavaraj Patthi, Ashish Singla, Kuldeep Dhama, Lav Kumar Niraj, Irfan Ali
Department of Public Health Dentistry, Divya Jyoti College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India
|Date of Submission||13-Jan-2018|
|Date of Acceptance||04-Apr-2018|
|Date of Web Publication||24-May-2018|
Department of Public Health Dentistry, Divya Jyoti College of Dental Sciences and Research, Modinagar, Uttar Pradesh
Dr. Ravneet Malhi
Department of Public Health Dentistry, Divya Jyoti College of Dental Sciences and Research, Ajit Mahal, Niwari Road, Modinagar, Ghaziabad - 201 204, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: The escalating burden of noncommunicable ailments has imposed a major public health challenge. Smoking tobacco has claimed over 3 million lives worldwide and is the first and foremost source of morbidity among all age groups. Multimodal interventions ought to be infused in to revert the addicted individuals to better life. Aim: This study aimed to assess the effectiveness of three different tobacco termination interventions in patients attached to the outpatient unit of a health-care institute. Materials and Methods: A tobacco cessation interventional study was performed on those patients who were randomly allocated to three different study groups composed of counseling group (Group I), nicotine replacement therapy group (Group II), and a combination of the both (Group III). For this, a carbon monoxide (CO) monitoring device, “Fagerstrom Test for Nicotine Dependence,” and specially prepared structured questionnaires were utilized. The interventions were planned and observations were assessed at baseline (preintervention) and at 12th week (postintervention). Intra- and inter-group comparisons were carried out statistically by means of one-way ANOVA test with post hoc pair-wise comparisons using Tukey's test. Results: The highest significant (P ≤ 0.05) mean nicotine addiction score variation of 2.44 from pre- to post-intervention was noted among Group III patients and intragroup comparison revealed a similar significant variance among Group III patients, i.e., 3.68 mean at baseline which reduced to 1.24 at follow-up. Inter- and intra-group assessments of mean score differences in the level of CO were noted to be highest among Group III patients. Conclusion: Even though the utilization of the pharmacologic methodologies available for smoking termination substantively mends the likelihood of realizing efficacious abstinence, the best upshots for cessation are accomplished when pharmacologic techniques are combined with behavioral means to treatment as the modus operandi of tobacco dependence counseling.
Keywords: Interventions, nicotine, oral health, public health, tobacco
|How to cite this article:|
Malhi R, Patthi B, Singla A, Dhama K, Niraj LK, Ali I. Breaking the hurdle with three tobacco cessation interventions in your life: A randomized controlled trial. J Indian Assoc Public Health Dent 2018;16:103-8
| Introduction|| |
Intensifying the affliction of noncommunicable diseases along with numerous oral conditions is linked with tobacco usage. They have tunneled to a crucial public health crisis in India, with 275 million adults consuming different forms of tobacco., Tobacco smoking steers over three million deaths per year worldwide and, if the existing smoking trends continue, the annual mortality will surpass 10 million by the year 2030 as per the updated factsheet of the World Health Organization (WHO).
Hence, the damaging and the harmful health effects warrant the prerequisite for the immediate tobacco interruption programs and regulations. There are several means in which the menace of tobacco can be countered and diminished if there lie a strong political will and collective societal commitment to strengthen tobacco control. The smoking control interventions array from behavioral support (counseling and advice) to medicinal therapies.,
“Offer help to leave tobacco use” in people dependent on nicotine is one of the six established policies acknowledged by the WHO to magnify the combat against the epidemic of tobacco. Further, tobacco dependency treatments are also effective through an expansive range of populations. Several effective medications are accessible for tobacco addiction, and clinicians should reassure their use by every patients struggling to quit smoking.,
Many trials have evaluated the properties of nicotine replacement therapy (NRT) in smoking cessation. Varied nicotine delivery systems have reported success rates in the range of 17%–35%., The Cochrane database review of NRT concludes that it increases quit rates by 1.5–2 folds, regardless of the types of setting.
Further, many guidelines recommend the combination of both of these therapies to accomplish the maximal benefit. When a drug treatment is concomitant with efficacious counseling or interactive treatments, it ought to produce a better abstinence rate. Moreover, as the tobacco cessation programs require multiple visits, most of the studies regarding the efficacy of the different tobacco termination interventions have been conducted in the hospital on patients where their compliance and reinforcement is easy.
However, there has been no documented literature on the efficacy of tobacco termination interventions on the hospital outpatients. Hence, an effort has been made in the current study to gauge the effectiveness of three different tobacco cessation interventions (counseling only, NRT alone, and a combination of these therapies) on patients attached to the outpatient unit of a tertiary health-care institute in West Uttar Pradesh, India.
| Materials and Methods|| |
A prospective, single-blinded, randomized controlled interventional study was carried out among patients attending the outpatient unit at a hospital, during the month of March 2017, and a total of 150 participants who satisfied the inclusion and exclusion criteria were selected for the study. The participants were marked as current smokers who described themselves as regular smokers and had smoked their last cigarette within the last 28 days of the screening.
- Outpatients at the hospital, within the age band of 18–60 years
- Participants who remained current users of “smoking form” of tobacco
- Confirmed to remain at their current address till the completion of the study.
- Terminal ailment (prognosis <12 months)
- Patients under psychiatric care
- Previous history of alcohol and/or illegitimate drug abuse in the past 12 months
- History of hypersensitive reactions toward nicotine or menthol
- Previous admission into the similar study
- Acute cerebrovascular accident
- Patients using smokeless type of tobacco
- Patients using both smoking and smokeless variants of tobacco.
Sample size determination
The sample size for the current study was calculated on the basis of the data acquired from the pilot study on the similar populace from the outpatient unit following the set criteria. For the present research, the sample size was determined at 95% confidence interval.
Sample size was calculated on the basis of the following formula:
N = (Zα+ Zβ) 2 × 2 × (S) 2/(d) 2
α is set at 5% (0.05) and β is set at 20% (0.20)
Zα is the Z variate of αerror = 1.96 (for 0.05 α)
Zβ is the Z variate of β error = 0.84 (for 0.2 β)
d is the smallest clinical important difference
S2 is the variance expected, SD is the standard deviation
Therefore, N= (1.96 + 0.084) 2 × 2 × (18) 2/(10) 2
Thus, in each group, fifty participants were considered.
Ethical committee clearance
The study protocol was sanctioned by the institutional review board and ethical committee (DJD/IEC/2014/A-023).
Medical officer permission
The permission and consent were obtained from the chief medical officer of the institution.
Study group consent
Voluntary informed consent and written permission were obtained from the study participants, after explaining the study in detail.
A specially prepared structured questionnaire was delivered to the study participants to know the demographic variables and history regarding the duration, form, and frequency of tobacco usage. “Fagerström Test of Nicotine Dependency Questionnaire” was also used to know the scores for nicotine dependence.
Carbon monoxide evaluation
Clinical evaluation of smoking was done by measuring the blown out carbon monoxide (CO) using a CO monitoring device, i.e., Mini Carbon Monoxide Meter (Shandong China Coal Industrial and Mining Supplies Group Co., Ltd. Shandong, China, ROHS-ISO-9001) that fulfilled the eligibility criteria.
The study composed of three arms of this interventional study – counseling group, NRT group, and a combination of both counseling and NRT groups. All the three study groups were subjected to their corresponding interventions for a span of 3 months.
The selected 150 study participants were randomly and equally assigned to the three intervention groups (50 participants in each group) for a time span of 3 months [Figure 1]. Participants were randomized on a 1:1:1 basis to the three groups using block randomization with variable block size of 5. A health center staff unaware of baseline scores performed random allocation. Participants were randomly allocated to three different study groups composed of counseling group (Group I) (20 min intervention with printed materials), NRT group (Group II) (6-week course), and a combination of the both (Group III) (counseling intervention with a 6-week sequential course of NRT).
|Figure 1: Flow of patients through the study. NRT – Nicotine replacement therapy|
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At the baseline evaluation, the study participants were subjected to the pretested questionnaire regarding the history, duration, form, and the number of cigarettes smoked per unit of time. Fagerström Test of Nicotine Dependency Questionnaire and clinical evaluation of smoking were carried out by measuring the exhaled CO using the CO monitoring device.
The intervention course for the study was 3 months. The participants in the counseling group were given tobacco cessation directives for a preliminary period of 20 min along with the written materials for reinforcement. Nicotine gums in the dosage of 4 mg per day were given to those who smoked 25 or more cigarettes per day and 2 mg per day to those who smoked less than 25 cigarettes per day and to the NRT group for the entire intervention period and this was scheduled for 12 weeks as follows:
- Weeks 1–6: A piece of gum every 1–2 h
- Weeks 7–9: A piece of gum every 2–4 h
- Weeks 10–12: A piece of gum every 4–8 h. The participants were instructed not to use more than 24 pieces of Nicotex (Cipla Inc., Mumbai) gum a day.
The NRT plus counseling group was subjected to counseling as mentioned above and also offered a 6-week regimen of NRT.
Follow-up and final evaluation
After and along the intervention period, the abstinence from the tobacco use or decline in the frequency and quantity of tobacco use was evaluated by a pretested questionnaire and clinical analysis of the participants by measuring the respired CO using the CO monitoring device.
The participants were thoroughly motivated and communicated prior to the origination of the trial. During the course of the study, participants were addressed with clear and open communication and, along the course of recall visits, prompts were sent to them prior to the recall through phone calls and messages and again a reminder on the day of recall were directed to them to report for examination in their flexible hours, thus assuring no attrition.
The procured data were entered into the Microsoft Excel (Microsoft Corporation) and were subjected to the statistical analysis using SPSS software version 19.0 (SPSS Inc., Chicago, IL, USA). To compare abstains at each follow-up, Chi-square test was utilized, and the decline in the amount of smoking between the groups was compared by one-way ANOVA test with post hoc pair-wise comparisons using Tukey's test.
| Results|| |
The mean age of the study participants in counseling group was 48.32 ± 13.785 years, in NRT group, it was 45.34 ± 16.455 years, and in counseling and NRT groups together, it was 48.26 ± 13.710 years. Bulk of the study participants, i.e., 87.3% were male and, of them, 92% were married. Most of the participants (90%) were routine smokers and 64% were those who smoked greater than 15 cigarettes per day. Among them, 72% were smoking for the past 5–10 years [Table 1].
The highest change in mean nicotine dependence score was seen in Group III, i.e., 2.44 ± 0.57 (65.82%) from baseline to 3 months, followed by Group II where 1.80 ± 0.60 (54.42%) change in the mean score was observed and the least change in the mean nicotine dependence score was noted in Group I, i.e., 0.88 ± 0.68 (23.46%). It also shows intergroup comparison of change in CO level between baseline and 3-month interval. The average change in score for the level of CO from baseline to follow-up was observed in Group III, i.e., 14.90 ± 3.98 (82.76%) followed by Group II in which 14.90 ± 4.82 (81.02%) change was observed and the least change in mean scores of carbon dioxide level was observed in Group I, i.e., 3.10 ± 1.82 (16.80%). An increased variation in the mean scores of amount of cigarettes smoked, i.e., 14.94 ± 4.71 (77.77%) in Group III followed by Group II, i.e., 12.52 ± 6.05 (71.05%) and the least change in scores was observed in Group I, i.e., 9.86 ± 5.42 (50.60%) [Table 2].
|Table 2: Intergroup comparison of change in nicotine dependence scores, carbon monoxide level, and amount of cigarette smoked between baseline and 3 months' interval|
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An increased change was observed in Group III, i.e., 3.68 ± 0.513 mean at baseline and reformed to 1.24 ± 0.431 at follow-up, followed by Group II where 3.26 ± 0.723 mean was observed at baseline and changed to 1.46 ± 0.503 at follow-up and lesser change was noted in Group I, i.e., 3.58 ± 0.609 mean at baseline to 2.70 ± 0.647 at follow-up. It also displays the intragroup comparison of change in the mean score level of CO, which was appreciated to be mean of 17.88 ± 5.228 observed at baseline in Group I and changed to 14.74 ± 4.398 at follow-up. Whereas in Group II, 18.30 ± 5.369 mean was observed at baseline and changed to 3.36 ± 1.352 at follow-up and in Group III at baseline 17.88 ± 4.134 mean was observed and changed to 2.98 ± 1.169 at follow-up [Table 3].
|Table 3: Intragroup comparison of change in nicotine dependence scores and carbon monoxide level between baseline and 3 months' interval|
Click here to view
| Discussion|| |
Tobacco dependence is a chronic, relapsing medical illness which further leads to nicotine dependency and affects individual's quality of life. In India, it is projected that nearly one million deaths occur due to tobacco use every year., Hence, to counter the tobacco epidemic, many steps have been taken worldwide and it can be seen through numerous studies conducted in India and South East Asian region, where they have implied the improvement in tobacco control over 5 years such as increased smoking cessation rates with reduced tobacco consumption and delayed smoking initiation among adolescents., However, there are still evidences of tobacco usage. Hence, to reduce this growing evidence, there are two main interventions to facilitate tobacco cessation, i.e., pharmacological and nonpharmacological. Pharmacotherapy has a valuable role in handling tobacco dependence, whereas nonpharmacological interventions have their own importance as they are cost-effective. However, the efficacy of drug treatments is multiplied when linked to effective counseling or behavioral treatments which give better abstinence rates, even in resistant cases with frequent relapses.,,,
The present research has enabled a comprehensive comparative evaluation of three most viable techniques of tobacco cessation on an outpatient setup. It was found through this study that most of the participants (90%) were routine smokers. Of them, almost 64% were those who smoked more than 15 cigarettes per day and 72% were smoking for the past 5–10 years. After the smoking cessation interventions, it was observed that NRT and NRT + counseling groups were having better results than counseling alone, which was statistically significant. There was no significant variance found between NRT alone and NRT + counseling groups. This finding might be due to the reason that NRT plus brief counseling was a more practically applicable approach than counseling alone. The results are in settlement with the study performed by Molyneux et al. in Nottingham City, UK, where they presented a smoking cessation package providing NRT with brief counseling, significantly increased point prevalence abstinence at year 1 of hospital inpatients, and counseling alone had negligible effect on smoking cessation in these patients.
In case of scores for nicotine dependence, more percentage change (65.8%) was established in Group III (NRT + counseling) than that of other groups, which was found to be highly significant (P < 0.001), and this was due to the reason that NRT use is related with significantly lower exposure to nicotine. The results are in agreement with a study done by Shahab et al. in London (2014) where they concluded that NRT use was related with significantly lower contact to nicotine than among current smokers. Further, in a study carried out by Tønnesen et al. (2006) in Denmark, it was found that NRT was efficient for smoking cessation in patients with all stages of chronic obstructive pulmonary disorders and also in smokers who consumed 15 cigarettes per day, but no statistically significant effect of more intensive behavioral support was observed in this study. The present study also found 82.76% drop in CO level in Group III (NRT + counseling) at follow-up than Group I (counseling) because of reduction in smoking. On the other side, less change has been seen in-between Group III (NRT + counseling) and Group II (NRT). The variance was found to be statistically significant and results of this study are in agreement to a study conducted by Kasza et al. (2013) in Canada, where it was noted that lower expired CO levels at baseline and a longer extent of pharmacological treatment remained significant predictors of efficacious smoking cessation. These outcomes are in agreement with the study done by Zhang et al. in Ontario (2015), in which it was observed that, when using NRT to quit, the majority (86%) used it for fewer than the suggested duration of 8–12 weeks. NRT users smoked extra cigarettes per day and had strained to quit more often in the past compared with persons who did not use NRT. The study done by Savant et al. in Pune, India, also found tobacco cessation rates to be quite low among the counseling group alone (individual and group counseling) and there was a 6% reduction in individual counseling group compared to a 7.5% reduction in group counseling after 6 months.
Overall findings of this study infer that NRT plus counseling was more efficacious than counseling alone and no statistically significant difference was found between NRT plus counseling and NRT alone. As such, clinicians have a vital role in screening patients in need of tobacco dependence treatment and to endorse appropriate pharmacologic agents that are proved to reliably increase moderation rates for smokers who are willing to quit, but NRTs are not solutions in themselves to the public health problem of cigarette use. Rather, their use must be deliberated as part of comprehensive anticipation and cessation programs.
A concerted multimodal effort could realize a dream of “tobacco-free world.” Conversely, apart from the strengths of the study in effectively comparing the “interventions” on hospital outpatients, a source of bias that might have crept in was the over dependence upon self-reported cessation status as some of the participants might have misquoted their smoking status (smokers who were identified as quitters) and, moreover, in this study, only the short-term intervention effects (3 months) were assessed, but long-term assessments (12 months) would be needed to assess the endurance of interventional effects.
The findings from the present study point out the requisite for establishing an appropriate educational, preventive, and treatment measure coupled with efficient surveillance for smoking cessation. NRT reduces the physiological and psychomotor extraction symptoms and increases the possibility of asceticism from smoking. NRT plus counseling should be recommended because counseling alone does not keep the individual stirred to stop smoking.
| Conclusion|| |
Various efficacious methods are accessible for interfering with the reinforcement of smoking. Indeed, many existing cessation treatments, including NRT, may be viewed as attenuating the positive and/or negative reinforcing effects of smoking. NRT that exists for more than two decades has proved to be harmless and efficacious for stopping smoking. Effective treatments pooled with behavioral support and the 5 As framework of smoking cessation should be presented to every smoker who is interested to stop smoking. Although the use of the pharmacologic methods available for smoking cessation substantively improves the probability of achieving fruitful abstinence, the best consequences for cessation are realized when pharmacologic agents are combined with behavioral methodologies to treatment, such as tobacco dependence counseling.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]