Evidence map›Paper›PMID 23718718›Full record

Trial reportBMC medicine2013

Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial.

Peter Hajek, Katie Myers Smith, Al-Rehan Dhanji, Hayden McRobbie

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01184664 (Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke), which is not on this map. Cited by 25 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01184664 phase3completednot on this map

Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke

TypeinterventionalSponsorQueen Mary University of LondonRan2011 to 2011Enrolled117ConditionsTobacco Dependence, Smoking CessationArmsNicotine Patch, Placebo, Varenicline
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
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  4. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
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  14. Zonisamide Reduces Withdrawal Symptoms But Does Not Enhance Varenicline-Induced Smoking Cessation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Peter HajekUK Centre for Tobacco Control Studies, Wolfson Institute of Preventive Medicine, Barts & The London School of Medicine and Dentistry, Queen Mary, University of London, London Newark Street, London E1 2AT, UK.
Katie Myers Smith
Al-Rehan Dhanji
Hayden McRobbie

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNicotine replacement therapy (NRT) and varenicline are both effective in helping smokers quit. There is growing interest in combining the two treatments to improve treatment outcomes, but no experimental data exist on whether this is efficacious. This double-blind randomised controlled trial was designed to evaluate whether adding nicotine patches to varenicline improves withdrawal relief and short-term abstinence rates.

methods117 participants seeking help to stop smoking were randomly allocated to varenicline plus placebo patch or varenicline plus nicotine patch (15 mg/16 hour). Varenicline use commenced one week prior to the target quit date (TQD), patch use started on the TQD. Ratings of urges to smoke and cigarette withdrawal symptoms were collected weekly over 4 weeks post-TQD. Medication use and smoking status were established at 1, 4 and 12 weeks. Participants lost to follow-up were included as continuing smokers.

results92% of participants used both medications during the first week after the TQD. The combination treatment generated no increase in nausea or other adverse effects. It had no overall effect on urges to smoke or on other withdrawal symptoms. The combination treatment did not improve biochemically validated abstinence rates at 1 week and 4 weeks post-TQD (69% vs 59%, p=0.28 and 60% vs 59%, p=0.91, in the nicotine patch and placebo patch arm, respectively), or self reported abstinence rates at 12 weeks (36% vs. 29%, p=0.39, NS).

conclusionsThe efficacy of varenicline was not enhanced by the addition of nicotine patches, although further trials would be useful to exclude the possibility of type II error.

trial registrationClinicaltrials.gov REGISTRATION NUMBER: NCT01184664.

Indexed as

Tobacco Use Cessation DevicesAdultBenzazepinesDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesHumansMaleMiddle AgedNicotinic AgonistsQuinoxalinesSmokingSmoking CessationSubstance Withdrawal SyndromeTreatment OutcomeBenzazepinesNicotinic AgonistsQuinoxalinesVarenicline

Identifiers

PMID23718718
PMCPMC4231450

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.