Original Article

Smoking Cessation Interventions and Continuous Abstinence

Rate at One Year
Raj Kumar, Alka S. Kushwah, Gopal C. Mahakud, Suraj Prakash and V.K. Vijayan

Department of Respiratory Medicine, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi, India

ABSTRACT

Background. Interventions for smoking cessation have become an urgent need because of the increased prevalence of tobacco
use, especially in developing countries. The aim of the present study is, therefore, to know the effect of counseling alone
and counseling with medication on tobacco cessation. Various parameters were also examined to gauge their effect on the
successful outcomes.
Methods. A total of 459 subjects (counseling alone group, n= 372; counseling with medication group, n= 87) were studied.
Counseling was given to all the subjects, while pharmacological treatment with bupropion (150 mg) was given based on
the severity of tobacco addiction.
Results. The mean age of patients in the counseling group and the medication group was 37.1±13.8 and 39.2±13.5 years,
respectively. Of the 459 patients, there were nine females who belonged to the counseling group. The average age starting
tobacco use was 20.6±6.5 and 20.3±6.9 years in the counseling group and the medication group, respectively. In the
counseling group, 78.8% of the subjects were smokers, 13.4% were tobacco chewers and 7.8% used both whereas, in the
medication group, 77% of the subjects were smokers, 9.2% were tobacco chewers and 13.8% used both. The continuous
abstinence rates among the 459 subjects at 1, 3, 6 and 12 months were 25.3%, 24.4%, 23.1% and 22.2%, respectively. The
continuous abstinence rates in the counseling group at 1, 3, 6 and 12 months were 17.2%, 16.7%, 15.9% and 15.1 %,
respectively, whereas in the medication group, the rates were 59.8%, 57.5%, 54.0% and 52.9%, respectively (p<0.001 for all
comparisons).
Conclusions. Significantly high continuous abstinence rate was seen in the medication group as compared to the counseling
group alone. [Indian J Chest Dis Allied Sci 2007; 49: 201-207]

Key words: Tobacco cessation, Bupropion, Continuous abstinence.

INTRODUCTION in developed countries.2-4

Interventions for smoking cessation have become an
urgent need because of the increased prevalence of
tobacco use, especially in developing countries. Until
the 1940s, tobacco was considered harmless, but
subsequently, laboratory and clinical research studies
have confirmed that tobacco is a hazard to health. On an
average, smoke from a cigarette contains around 4000
chemicals, some of which are highly toxic and about 40
of them can cause cancer. The World Health
Organization (WHO) estimates that around 1.1 billion
people worldwide use tobacco, constituting one-third of
the entire population aged 15 years and above. Globally,
47% of men and 12% of women smoke. 1 By the year
2020, tobacco will become the single leading cause of
death, causing one out of every eight deaths.2 World-
wide, tobacco consumption is responsible for around
three million deaths annually, two-thirds of which occur
[Received: March 13, 2007; accepted after revision: July 5, 2007]
Correspondence and reprint requests: Dr Raj Kumar, Department of Respiratory Medicine, Vallabhbhai Patel Chest
Institute, University of Delhi, Delhi-110 007, India; Phone: 91-11-27667102, 27667667, Extn-144; Fax: 91-11-27667420;
E-mail: rajkumar_27563@yahoo.co.in.
According to a report from the Indian Council of
Medical Research (ICMR), there are 184 million tobacco
users in India, which include 40 million cigarette
smokers, 80 million bidi smokers and 60 million using
chewable forms of tobacco. In India, tobacco use among
the male and female population has been estimated to
be around 23.2% and 4% in urban, and 33.6% and 8.8%
in rural areas, respectively.5 The mortality burden of
tobacco-related deaths have been estimated at 800,000
deaths annually.5 In developing countries such as India,
where awareness levels are low, the first step towards a
tobacco-free society includes anti-tobacco education and
medical help for those willing to quit.5
In the past few years, there has been an increase in
tobacco research and several new therapeutic modalities
have been developed. Tobacco cessation therapies that
have proven effective range from simple counseling to
intensive interventions using medications, either
202 Smoking Cessation Interventions
nicotine replacement therapy (NRT) or bupropion, in
combination with cognitive-behavioural therapy.6-10
Among these therapies, bupropion is the only
antidepressant drug approved by the United States (US)
Food and Drug Administration for the treatment of
tobacco addiction. In the United States, bupropion,
which has potential side effects in patients predisposed
to seizures, has been widely used.11, 12
A number of studies had compared the medication
therapy with placebo. However, there are only a few
studies that had compared therapy involving
counseling alone with counseling with medication. In
the present study, counseling alone was compared with
counseling with medication (bupropion SR). Various
parameters were examined to gauge their effect on the
successful outcome at 12 months.
MATERIAL AND METHODS
Screening and Subjects
A total of 693 subjects (678 males and 15 females)
attended the Tobacco Cessation Clinic (TCC) at
Vallabhbhai Patel Chest Institute, Delhi, India, over a
period of three years (2001-2004). Of these, 459 subjects
were followed up prospectively for one year and
included in the study. These subjects had approached
TCC for quitting on their own, through posters, banners
displayed or through motivation by others who had
already enrolled themselves.
A pre-treatment questionnaire was filled up taking
into consideration of the tobacco use and willingness to
quit. The baseline assessment of the subjects included
the following parameters: age, sex, religion, marital
status, occupation, smokeless tobacco use, age at which
smoking started, number of cigerettes/bidis smoked
per day, level of nicotine dependence (through the
Fagerstrom test), use of other potentially-addictive
substances (especially alcohol), previous attempts to
quit tobacco use, physical health problems, family
history of tobacco use, presence of concomitant diseases,
reasons for starting tobacco use, current reason for
tobacco cessation.
The level of nicotine dependence was considered low
for individuals with scores 0-4, average with scores 5-7,
and high with scores above 7 in Fagerstrom test.13,14
Breath carbon monoxide (CO) level in parts per million
(PPM) was measured during each visit. Expired CO was
measured with a CO-oximeter (Mini Smokerlyzer,
Bedfont Scientific Ltd).13
Interventions
Interventions for the subjects (n=459) depended on the
severity of dependence as measured by the Fagerstrom
test.14 For subjects with Fagerstrom test score 0 to 4
(n=372) intervention consisted exclusively of
R. Kumar et al
individualised medical counseling. For those with
Fagerstrom test score ≥ 5, (n=87) intervention comprised
individualised medical counseling with medication. In
this group subjects received 150 mg of bupropion
sustained release (SR) initially once a day for three days
and then twice a day for seven weeks.
Treatment Period
Target quit date was preferentially the eighth day of
starting the treatment. The subjects were assessed
weekly and given a brief (<15 minutes) individual
counseling session for tobacco cessation. Physician's
advice was based on the National Cancer Institute's
‘5A’, i.e., Ask, Advice, Assess, Assist, Arrange. 15
Counseling topics included motivation, identification of
tobacco triggers, coping responses and use of
medications. Self-reported abstinence was confirmed by
measuring CO concentration in expired air at every
visit.
Follow-up Period
A total of 719 follow-up visits were made by the subjects
at TCC. Follow-up assessment was done weekly for the
first seven weeks, monthly for the next three months
and then at 6th, 9th and 12th months. The other subjects
were contacted regularly telephonically and in some
cases personal visits were done. In some cases patients
were contacted in different small educational
programmes at Vallabhbhai Patel Chest Institute. A brief
face-to-face personalised anti-tobacco advise was given
at each visit during the initial seven weeks. Follow-up
assessment was made by self-reporting of abstinence at
each visit to TCC or contact during the above-
mentioned situations. Carbon monoxide level was
measured in breath to validate the claim of abstinence in
the past 24 hours perior to each visit. Withdrawal
symptoms, such as craving, irritability, anxiety,
depressed mood, difficulty in concentrating,
restlessness, increased appetite, anger and difficulty in
sleeping were recorded. The continuous abstinence and
reduction in the number of cigarette/bidi smoked were
assessed. The subjects were considered to be
continuously abstinent if they had not smoked after the
quit day, as confirmed by a CO concentration of 6 PPM
or less at all clinic visits during the 12-month study.
‘Reduced’ was considered when the subjects reduced
the use of tobacco by more than 50 percent. A reduction
of less than 50% was taken as ‘no change’. A subject was
considered ‘lost to follow up’ when there was no follow
up after the initial visit.
Statistical Analysis
For maintaining database, statistical analysis and data
handling, SPSS software system was used. The results
are presented in percentages and means with standard
2007; Vol. 49 The Indian Journal of Chest Diseases & Allied Sciences 203

deviation (SD). Data analysis strategy consisted of two Table 1. Baseline characteristics of subjects in the two groups
phases. First, baseline variable in the two groups was Characteristics Counseling Counseling p value
compared using the student’s ‘t’ and Chi-square tests to Alone with Medication
analyse continuous and categorical variables, (n=372) (n=87)
respectively. Secondly, continuous abstinence rate was
Age (years) 37.6±13.8 39.2±13.5 0.532
compared between the two groups. Predictors of Sex
outcome were studied using univariate analysis and a Male 363 (97.6) 87 (100) 0.143
step-wise multiple logistic regression analysis16 to study Female 9 (2.4) 0
the multivariate predictors of outcomes. In this case, the Religion
Hindu 338 (90.9) 81 (93.1) 0.504
dependent variable was continuous abstinence rate at
Others 34 (9.1) 6 (6.9)
month 12 and the independent variables were the Education
baseline characteristics. A p value of less than 0.05 was Illiterate 25 (6.7) 2 (2.3) 0.160
considered significant. 1-8 standard 47 (12.6) 14 (16.1)
9-12 standard 107 (28.8) 32 (36.8)
> 12 standard 193 (51.9) 39 (44.8)
RESULTS Marital Status
Married 252 (67.7) 66 (75.9) 0.139
Unmarried 120 (32.3) 21 (24.1)
Out of 693 subjects assessed for the study, 234 have not
Area of Residence
yet completed their 12-month tenure, 459 subjects who Rural 41 (11.0) 7 (8.0) 0.414
have completed one year follow up were included in Urban 331 (89.0) 80 (92.0)
this study. The baseline characteristics of the two groups Occupation
are shown in table 1. There was no significant difference Business 88 (23.7) 27 (31.0) 0.212
between the two groups in baseline characteristics. The Student 94 (25.3) 14 (16.1)
Service 106 (28.5) 28 (32.2)
mean age of patients in the counseling group and the Others 84 (22.6) 18 (20.7)
medication group was 37.1±13.8 and 39.2±13.5 years, Age at Start of
respectively. Of 459 patients, there were only nine Smoking (years) 20.64±6.49 20.30±6.86 0.122
females who belonged to the counseling group. More Type of Smoking
than 90% of the subjects in both the groups were Hindu Smoking 293 (78.8) 67 (77.0) 0.144
Smokeless tobacco 50 (13.4) 8 (9.2)
by religion. The percentage of illiterates was low in both Both 29 (7.8) 12 (13.8)
the groups; 51.9% in the counseling group and 44.8% in Previous Quit Attempt
the medication group had more than 12th standard of Yes 262 (70.4) 59 (67.8) 0.632
education. In the counseling group, 67.7% were married No 110 (29.6) 28 (32.2)
while it was 75.9% in the medication group. Co-morbidity
Present 104 (28.0) 24 (27.6) 0.945
Approximately, 90% of the subjects in both the groups
Absent 268 (72.0) 63 (72.4)
were from urban areas; 77.4% in the counseling group Family History
and 79.3% in the medication group were either Present 124 (33.3) 20 (23.0) 0.061
businessmen or students or in service by occupation. Absent 248 (66.7) 67 (77.0)
The average age at the start of tobacco use was Figures in parentheses indicate percentages
20.64±6.49 and 20.30±6.86 years in the counseling group
and the medication group, respectively. In the tobacco use, 20 (22.9%) reduced its consumption, 15
counseling group, 78.8% of the subjects were smokers, (17.2%) had no change and none of the patients was lost
13.4% used smokeless tobacco and 7.8% were smokers to follow-up (Figure).
as well as tobacco chewers. In the medication group, The continuous abstinence rates for the 459 subjects
77% of the subjects were smokers, 9.2% used smokeless at 1, 3, 6, and 12 months were 25.3%, 24.4%, 23.1% and
tobacco and 13.8% were both smokers as well as tobacco 22.2%, respectively. The continuous abstinence rates in
chewers. In the past, 70.4% of the subjects in the the counseling group (n=372) at 1, 3, 6 and 12 months
counseling group and 67.8% in the medication group were 17.2% 16.7%, 15.9% and 15.1%, respectively,
had tried to quit smoking. There was no co-morbidity in whereas in the medication group (n=87), the abstinence
72% and 72.4% of the subjects in the counseling group rates were 59.8%, 57.5%, 54% and 52.9%, respectively.
and the medication group, respectively. The maximum Therefore, the continuous abstinence rates were
number of tobacco users in both the groups had a CO significantly higher in the medication group (p<0.001
level of 11-20 ppm, which denotes that they were heavy for all the comparisons). Out of 142 subjects who were
smokers. followed up for one year, the continuous abstinence
In the counseling group (n=372), 64 (17.2%) subjects rates at 1, 3, 6 and 12 months were 45%, 43.7%, 41.6%
quit tobacco, whereas 33 (8.9%) reduced its and 39.49%, respectively in the counseling group. Here
consumption, 45 (12.1%) had no change and 230 (61.8%) also continuous abstinence rates were significantly
were lost to follow-up. In the counseling with higher (p<0.05) in the medication group at 1, 3, and 12
medication group (n=87), 52 (59.8%) subjects quit months. Side effects, such as insomnia, dry mouth, were
204 Smoking Cessation Interventions R. Kumar et al

Total number of subjects attended TCC

(n=693)

Total number of subjects completed one year

(n=459)

Counseling alone group Counseling with medication group

(n=372) (n=87)

Quitters (at one month) Quitters (at one month)

64 (17.2%) 52 (59.8%)

Quitters (at three months) Quitters (at three months)

62 (16.7%) 50 (57.5%)

Quitters (at six months) Quitters (at six months)

59 (15.9%) 47 (54.0%)

Quitters (at 12 months) Quitters (at 12 months)

56 (15.1%) 46 (52.9%)

Figure. Distribution of subjects between different groups and quit rate at different intervals [TCC = Tobacco Cessation Clinic].

observed in two and four subjects respectively in the
medication group.
Table 2 shows the parameters studied to gauge their
effect on the successful outcome that was defined as the
quitter status at 12 months. Multivariate predictors of
quitting using a step-wise multiple logistic regression
models had shown that subjects using medication with
bupropion (P=0.000) and advancing age (P=0.035) were
most likely to continue abstinence at the 12th month.
Thus, the presence of these two variables can predict
whether a person will remain continuously abstinent at
12 months with an accuracy of 79.3 percent.
DISCUSSION
Only 1.96% female tobacco users sought guidance for
smoking cessation despite a considerably higher
percentage of female tobacco users in urban areas. This
suggests that coming out with their tobacco habit is
considered to be a social stigma among females. This
problem needs to be addressed if they are to benefit
from tobacco cessation interventions.17 The average age
of the study subjects was 37.5 years and most of the
smokers had no tobacco-related diseases suggesting that
middle aged persons were most likely to seek help for
smoking cessation. A large number of the subjects were
self-motivated to quit smoking showing that these
subjects had the will power to quit and they wanted to
be helped at the clinic. The average age at which the
subjects began tobacco use was 20.6 years. These
findings are similar to other studies.9-11
In a study to determine the patterns of smoking in
2007; Vol. 49 The Indian Journal of Chest Diseases & Allied Sciences 205

Table 2. Predictor of outcomes studied in the two groups literate with a minimum of elementary education. Most
(dependent variable: continuous abstinence at 12 months) of the subjects were students, businessmen and others
Factor No. in Quitters No. in non- p value belonging to the middle or higher income group. This
Group Quitter Group may be due to the fact that the clinic is situated at the
Age (years) place surrounded by more than 10 colleges and having
0-19 2 16 0.035 business centers. Although bidi is the most common
20-39 51 198 tobacco product smoked in India, only 22% of bidi
40-59 32 116 smokers attended the clinic in the present study.
≥ 60 17 27 Cigarette smokers (47.1%) formed the majority of
Sex
Male 100 350 1.000
subjects, while 9.4% of the subjects used both bidi as
Female 2 7 well as cigarette. There were 12.6% smokeless tobacco
Religion users and 8.9% used both smoking as well as smokeless
Hindu 95 324 0.452 tobacco. Such a high percentage of cigarette smokers
Others 7 33 may be due to the site of the clinic.
Education
All tobacco users who had made a prior quit attempt
Illiterate 3 24 0.382
1-8 standard 16 45 (69.9%) presented on their own without any help from
9-12 standard 34 105 a physician or the use of any medication. This is very
> 12 standard 49 183 important, as a physician’s advise encourages tobacco
Marital Status cessation. A meta-analysis done in 1988 showed an
Married 75 243 0.292
overall cessation rate of 8.4% at six months with brief
Unmarried 27 114
Area of Residence (less than 15 minutes) physician’s advise.18 Since then,
Rural 6 42 0.087 there have been several large studies on physician’s
Urban 96 315 advise that have shown quit rates of up to 10 percent.19,20
Occupation In the present study, the quit rate at six months and 12
Business 23 92 0.667 months by physician’s advise were 15.9% and 15.1%,
Student 21 87
Service 33 101
respectively.
Others 25 77 An analysis of the two most weighted questions in
Type of Tobacco Use the Fagerstrom test (time elapsed before the first
Smoking 82 278 0.163 cigarette and number of cigarette smoked per day)
Smokeless tobacco 8 50 showed that 35.1% of the subjects smoked their first
Both 12 29
cigarette within five minutes of waking up and 34%
Age at the Start of
Tobacco Use (years) smoked 11 to 20 cigarettes per day. These data are
0-20 68 211 0.276 consistent with those published earlier.13 This shows the
21-30 26 121 degree of dependence and indicates that one-third of
>30 8 25 subjects seeking tobacco cessation treatment fit into a
Duration of Tobacco Use
severely nicotine profile as described by Kunze et al.21
(years)
0-10 34 157 0.139 The degree of dependence could be related to the
11-20 29 92 average age of subjects in a sample population and is in
>20 39 108 keeping with a recent study of smokers in Europe,
Alcohol Use which reports that the most severely nicotine-
Yes 15 47 0.688 dependent smokers fall within the range of 35-65 years
No 87 310
Previous Quit Attempt
of age.22
Yes 78 243 0.103 Several randomised studies have compared the
No 24 114 smoking status with drug and placebo group and
Co-morbidity reported continuous abstinence rates at six months and
Present 27 101 0.718 12 months.10-14, 21-30 Nerin et al23 assessed a comprehensive
Absent 75 256
smoking prevention and treatment programme on 1600
Family History
Present 31 113 0.809 employees of a company. Adherence to therapy was
Absent 71 244 seen in 80% of patients and rate of abstinence was 57.5%
Fagerstrom Score at six months. In another study, it was found that the
0-6 60 219 0.646 continuous abstinence rate from week 4 to 7 was 46% in
>7 42 138 the bupropion SR group compared with 23% in the
Method Used
Counseling 56 316 0.000
placebo group. At month 12, the continuous abstinence
Medication 46 41 rates were 21% for the bupropion SR group and 11% for
the placebo group.24
Delhi, it has been observed that the highest prevalence In a multi-centre, randomised study25 of 629 subjects,
of smoking was among illiterates. 17 However, in the it has been found that the continuous abstinence rates
present study, the subjects seeking help were mostly from week 4 to 26 and 4 to 52 continued to be more than
206 Smoking Cessation Interventions
double for bupropion SR compared with placebo (27 vs
11%; 22 vs 9%). Another randomised, placebo-controlled
trial of 509 smokers, 26 revealed that the continuous
abstinence rates in bupropion group and placebo group
were 41% and 21% for week 4 to 7, and 25% and 13% for
weeks 4 to 26, respectively. Confirmed abstinence rates
at the end of seven weeks of treatment were found to be
36% in the bupropion SR group and 19% in the placebo
group.27 At 26 weeks, the quit rates were 21% in the
treatment and 13.7% in the placebo groups.
In a study of 893 individuals10 that accessed the use
of bupropion, placebo, nicotine patch, or nicotine patch
plus bupropion, the rate of smoking cessation was 48%
for nicotine patch; 60.2% for bupropion; 66.5% for
nicotine patch plus bupropion and 33.8% for placebo.
The better effectiveness of the medications in this study,
as compared to the study by Hurt et al16 with bupropion,
could be because of the exclusion of a large number of
the psychiatric patients.
In a 6-month study, the continuous smoking
abstinence at 7 week is 43% of the subjects in the
bupropion group and 18% in the placebo group.28 After
26 weeks, 18% and 7%, subjects respectively, were
continuously abstinent. The continuous abstinence rates
from week 4 to 7 were found to be significantly higher
in participants receiving bupropion SR than in those
receiving placebo 29 (28% vs 16%). The continuous
abstinence rates from week 4 to 12 (18% vs 10%) and
week 4 to 26 (16% vs 9%) were also higher in
participants receiving bupropion SR than in those
taking placebo. Hurt et al16 had shown that continuous
abstinence rate was higher in the bupropion group than
in the placebo group at study week 24 (17 weeks after
randomisation) (52.3% vs 42.3%) but did not differ
between groups after week 24. Gonzales et al31 found
that participants receiving bupropion SR, 27% remained
abstinent throughout the period from week 4 to 7
compared with 5% of participants receiving placebo.
Rodriguez Artalejo et al 32 found that the rate of
continuous abstinence at 12 months was 20.2% for the
intervention group versus 8.7% for the control group.
Withdrawal symptoms such as irritability, insomnia,
anxiety were common in the subjects receiving
counseling only. This shows the beneficial effect of
bupropion in reducing the withdrawal symptoms as
compared to the counseling alone, which helps the
subjects in the quitting process. Bupropion reduces the
withdrawal symptoms and nicotine replacement
therapy (NRT) has been used in various studies.10, 29 In a
study, 24 the adverse events were higher in the
bupropion SR group compared with placebo (insomnia
24% vs 15%; dry mouth 13% vs 5%). In another study,25
six percent of the participants (n=36) discontinued the
study medication due to an adverse event (bupropion
SR, n=17; placebo, n=19). The craving decreased
significantly more with bupropion than with placebo
during the treatment period.26 Subjects on bupropion SR
experienced a greater mean reduction in depression
R. Kumar et al
symptoms at week 6 than those taking placebo.27 The
most common adverse events were insomnia and
headache.10 Dizziness, insomnia and pruritus appeared
more frequently in the bupropion group than in the
placebo group. 28 Symptoms of tobacco craving and
withdrawal were attenuated in those receiving
bupropion SR.29 In the study by Hurt et al,16 37 subjects
stopped treatment prematurely because of adverse
events; the frequency was similar among all groups. In
another study, 11 participants receiving placebo (5%)
and 19 receiving bupropion SR (8%) stopped taking the
study medication because of an adverse event.31 In our
study, the side effects were insomnia (n=2) and dry
mouth (n=4) respectively.
Aubin et al26 found that abstinent subjects gained
significantly less weight at week 7 with bupropion than
with placebo. Ahluwalia et al27 found that those taking
bupropion SR gained less weight than those taking
placebo. The weight gain at seven weeks was
significantly less in the combined-treatment group than
in the bupropion group and the placebo group. 10 Low
level of nicotine dependence, high motivation, absence
of smoking-related diseases, long duration of previous
quit attempts, male gender, low level of current alcohol
problems and living as a couple were predictive of
successful cessation, but no outcome predictors were
identified that might indicate that certain subgroups of
smokers would benefit more than others from treatment
with bupropion. 26 In the present study, those who
received bupropion and advancing age could be
predicted to remain continuously abstinent at 12
months with an accuracy of 73.3 percent.
In the present study, the rates of continuous
abstinence at 1, 3, 6 and 12 months were 25.3%, 24.4%,
23.1% and 22.2%, respectively. The continuous abstinent
rate was higher in the medication group than in the
counseling group. This highlights the effectiveness of
bupropion with counseling for tobacco cessation in
Indian subjects as well. Significantly high continuous
abstinence rate was seen in the bupropion group as
compared to the counseling alone group. Beneficial
effects on weight gain and a reduction in withdrawal
symptoms such as insomnia, dry mouth or altered taste
make bupropion an efficacious and cost-effective for
tobacco cessation.
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208 The Indian Journal of Chest Diseases & Allied Sciences 2007; Vol. 49

Full text articles published in IJCDAS from July-September

2003 onwards can be accessed online on Internet through the
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