Smoking Cessation Clinical Trial
Official title:
Comparing the Effectiveness of Nicotine Patch With Gum Versus Nicotine Patch Alone in Smoking Cessation in Hong Kong Primary Care Clinics
The prevalence of cigarette smoking has dropped to 10% in Hong Kong (HK) in 2017, however,
smoking still kills 5700 persons per year. Studies suggest that abstinence rates are higher
with combined NRT than single NRT, although local data on safety and benefits of combined NRT
are lacking.
This is a one-year, two-arm, parallel randomized trial in 20 HK public clinics. The aim is to
compare the effectiveness of combined NRT with single NRT among HK Chinese. 560 chronic
smokers, who smoked ≥10 cigarettes/day for ≥ 1 year, were randomized to either intervention
or usual care.
Intervention group received counseling and nicotine patch & gum. Usual care group received
counselling and nicotine patch only. Primary outcome was smoking abstinence rate at 52 weeks.
Secondary outcomes included smoking abstinence rate at 4, 12, & 26 weeks. Crude odds ratio
(combined NRT vs. single NRT) and p-value were reported from logistic regression without
adjustment; for trend analysis, adjusted odds ratio (AOR) and p-value were reported from
Generalized Estimating Equation (GEE) (controlling for time). All AORs were adjusted for age,
sex, baseline CO and clusters.
Background Globally, smoking causes six million deaths a year1. By 2030, if current trends
continue, the number of deaths will rise to eight million. According to Hong Kong Thematic
Household Survey Reports, although the prevalence of current smokers among aged 15 and over
has dropped from 15.3% in 2006 to 10.8% in 2017 in Hong Kong, smoking still kills 5700
persons per year and contributes to 14% of all deaths from non-communicable diseases. Thus,
enhancement in smoking cessation would be crucial in improving health all smokers.
Among all pharmacological treatment for smoking cessation, evidences showed that oral
treatment such as Varenicline is the most clinically effective smoking cessation medication9.
However, there have been concerns about its adverse effect on neuropsychiatric and
cardiovascular aspects. Besides, many smokers are reluctant to use it due to fear of its high
rate of side effects and being medicalized for smoking cessation. The use of nicotine
replacement therapy (NRT) has been largely studied, and, over the last decade, many studies
had been carried out to compare the effect of monotherapy with combined nicotine replacement
therapy. While the effect of monotherapy had been found to be small in heavy smokers due to
significant withdrawal symptoms, combined NRT is believed to provide a stable baseline
nicotine level by means of nicotine patch plus intermittent usage of short acting NRT e.g.
gums, lozenges or inhalers for withdrawal symptoms. Several studies have shown that combined
NRT is associated with lower withdrawal scores and higher 6-month quit rates (26.9 to 36.9%)
when compared with monotherapies (19-23%)18-21. Combined NRT has also been shown to be safe
as trials of combining various NRTs did not report that combination treatment produced
increased adverse events.
In Hong Kong, Hospital Authority is one of the major service providers for smoking cessation.
The target recipients of our smoking cessation service are primarily patients attending
public general out-patient clinics (GOPCs) for management of chronic illnesses such as
hypertension and diabetes mellitus, as well as patients with episodic complaints. Through
effective interventions provided in the smoking cessation service, it is aimed that their
medical conditions could be further improved. However, as majority of these smokers have
moderate or above nicotine dependence, how effective is combined NRT compared to single NRT
in this Chinese population is unknown.
Hypothesis:
Combined NRT gives a higher abstinence rate than single NRT.
Objective:
This study aims to compare the effectiveness of combined NRT with single NRT in Hong Kong
primary care clinics.
Assessment Patients were seen at baseline for assessment, and then at 4 weeks, 12 weeks, 26
weeks and 52 weeks. Study medication was given at baseline and at week 4. In baseline
assessment, smoking history including daily cigarette consumption and past quitting method,
past medical health, drug history and allergy would be obtained. In follow up visits patients
were assessed on nicotine withdrawal symptoms, carbon monoxide level, side effects from
treatment and medication compliance. Counselling would be given in all follow up visits.
Pharmacological interventions Patients were randomized to either intervention or usual care
for smoking cessation. Nicotine replacement therapy (NRT) was given for 8 weeks in both arms.
Intervention consisted of counseling and combined NRT of nicotine patch and gum. Usual care
involved counseling and single NRT of nicotine patch. NRT patch regimen used in usual care
was the same as that in intervention group.
Data analysis Baseline characteristics were reported and compared by treatment groups,
two-sample t test was conducted for continuous variables and Chi-square test for categorical
variables. At each visit, crude odds ratio (OR) (combined NRT vs. single NRT) was reported,
simple logistic regression was utilized without adjustment first, and then adjusted for
potential confounders, age, sex, baseline CO level and cluster site of the subject
recruitment. The overall treatment effect (combined NRT vs. single NRT) over the study period
was estimated by Generalized Estimating Equation (GEE). In the GEE model, time (repeated
measures at 4, 12, 26, and 52 weeks) was included as a continuous covariate, adjusted odds
ratio (AOR) was reported and treatment-time interaction was tested. Potential confounders
were also adjusted for in the GEE model. As GEE only uses non-missing records, missing at
complete random was assumed to avoid bias. To support the random missing assumption,
supplementary analysis was conducted for missingness pattern Furthermore, imputation was
conducted under a conservative scenario of 'all missing records as "failure", i.e., not
quit'. Statistical significance level was set at two-sided p<0.05 for all tests. Analysis was
conducted by R version 3.2.235. Side effects from NRT were also recorded from both groups.
Chi-squared test was used to compare the difference.
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