Combined nicotine patch with gum versus nicotine patch alone in smoking cessation in Hong Kong primary care clinics: a randomised controlled trial

Maria K W Leung, Dan Bai, Benjamin H K Yip, M Y Fong, Petty M H Lai, Phoebe Lai, Irene S Y Lai, Zoe H W Lam, Andrew T F Leung, Dorothy K Y To, M T Wong, T K Wong, David V K Chao, Maria K W Leung, Dan Bai, Benjamin H K Yip, M Y Fong, Petty M H Lai, Phoebe Lai, Irene S Y Lai, Zoe H W Lam, Andrew T F Leung, Dorothy K Y To, M T Wong, T K Wong, David V K Chao

Abstract

Background: The prevalence of daily 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. The aim of this study is to compare the effectiveness of combined NRT with single NRT among HK Chinese.

Methods: This is a one-year, two-arm, parallel randomised trial. Five hundred sixty smokers, who smoked ≥10 cigarettes/day for ≥1 year, were randomized to combined and single NRT. Combined NRT group received counseling and nicotine patch & gum. Single NRT group received counselling and nicotine patch. Primary outcome was abstinence rate measured as self-reported 7-day point prevalence with CO validated at 52 weeks. Secondary outcomes included smoking abstinence rates at 4, 12, & 26 weeks. Crude odds ratio 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.

Results: Abstinence rates at 4, 12, 26 and 52 weeks were all higher in the combined NRT group (35.8, 21.9, 16.8, 20.1%) compared with the single NRT group (28, 16.8, 11.2, 14.3%). At 4 weeks, combined NRT group was more likely to quit smoking (OR 1.43, 95% CI, 1.00 to 2.05) than the single NRT group. From GEE analysis, combined NRT group had a significantly higher abstinence rate (23.6%) than the single NRT group (17.6%) across repeated measures at all-time points. Combined NRT group was more likely to quit smoking (OR 1.43, 95% CI, 1.15 to 1.77). No significant difference in the side effect profile was detected between groups.

Conclusions: Smokers given 8 weeks of combined NRT were more likely to quit smoking at 4, 12, 26 and 52 weeks compared with single NRT. Combined NRT was as well tolerated as single NRT and it should be further promoted in our community.

Trial registration: NCT03836560 from ClinicalTrial.gov , 9 Feb 2019.

Keywords: Combined nicotine replacement therapy; Effectiveness; Nicotine patch; Randomised controlled trial; Smoking cessation.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT workflow diagram
Fig. 2
Fig. 2
Abstinence rates across visits, by treatment group
Fig. 3
Fig. 3
Missing pattern analysis for primary outcome

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