Evidence map›Paper›PMID 30722062›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2020

Reduction in Exposure to Selected Harmful and Potentially Harmful Constituents Approaching Those Observed Upon Smoking Abstinence in Smokers Switching to the Menthol Tobacco Heating System 2.2 for 3 Months (Part 1).

Christelle Haziza, Guillaume de La Bourdonnaye, Andrea Donelli, Valerie Poux, Dimitra Skiada, Rolf Weitkunat, Gizelle Baker, Patrick Picavet, Frank Lüdicke

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01989156 (A Randomized, Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Apparently Healthy Smokers Switching to the Tobacco Heating System 2.2 Menthol), which is not on this map. Cited by 42 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing 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.

NCT01989156 nacompletednot on this map

A Randomized, Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Apparently Healthy Smokers Switching to the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) or Observing Smoking Abstinence, Compared to Continuing to Use Menthol Conventional Cigarettes, for 5 Days in Confinement and Prolonged by 86 Days in an Ambulatory Setting

TypeinterventionalSponsorPhilip Morris Products S.A.Ran2013 to 2015Enrolled160ConditionsSmokingArmsTHS 2.2 Menthol (mTHS 2.2), Menthol Conventional Cigarette (mCC), Smoking Abstinence (SA)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Exposure to Heated Tobacco Products and Adverse Health Effects, a Systematic Review.International journal of environmental research and public health · 2021
    Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Review
  14. Observational
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Biomarkers of Exposure to Nicotine and Selected Toxicants in Individuals Who Use Alternative Tobacco Products Sold in Japan and Canada from 2018 to 2019.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025
    Article
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

9 authors.

Christelle HazizaPMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Guillaume de La BourdonnayePMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Andrea DonelliPMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Valerie PouxPMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Dimitra SkiadaPMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Rolf WeitkunatPMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Gizelle BakerPMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Patrick PicavetPMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
Frank LüdickePMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe Tobacco Heating System (THS) is a "heat-not-burn" tobacco product designed to generate significantly lower levels of harmful and potentially harmful constituents (HPHCs) and present lower risk of harm than cigarettes. This study assessed the exposure reduction to selected HPHCs in smokers switching to menthol Tobacco Heating System (mTHS) 2.2 compared with smokers continuing smoking menthol cigarettes (mCCs) and smoking abstinence (SA) for 5 days in a confined setting, followed by an 86-day ambulatory period.

methodsA total of 160 healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Biomarkers of exposure to 16 HPHCs were measured in blood and 24-hour urine. Safety was monitored throughout the study. Information was also gathered on product evaluation, product use, subjective effects, and clinical risk markers (co-publication Part 2).

resultsNicotine uptake was comparable in both exposure groups (mTHS:mCC ratio of 96% on day 90). On day 5, biomarker of exposure levels to other HPHCs were reduced by 51%-96% in the mTHS group compared with the mCC group, and these reductions were sustained for most biomarkers of exposure over ambulatory period. After 90 days of use, the level of satisfaction with mTHS and suppression of urge to smoke were comparable to mCC.

conclusionSwitching from mCCs to mTHS significantly reduced the exposure to HPHCs to levels approaching those observed in subjects who abstained from smoking for the duration of the study. IMPLICATIONS: This study compared the impact of switching to mTHS on biomarkers of exposure, relative to continued smoking or SA. CLINICAL SIGNIFICANCE:

trial registrationNCT01989156 (ClinicalTrials.gov).

Indexed as

Harm ReductionAdultAgedAntipruriticsBiomarkersElectronic Nicotine Delivery SystemsFemaleHealth BehaviorHot TemperatureHumansMaleMentholMiddle AgedRisk AssessmentSmokeSmokersAntipruriticsBiomarkersMentholSmoke

Identifiers

PMID30722062
PMCPMC7164581

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.