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. 2021 Apr 29;2021(4):CD010216. doi: 10.1002/14651858.CD010216.pub5

Adriaens 2014.

Study characteristics
Methods Design: 3‐armed RCT; with all participants then assigned to nicotine EC (treated as cohort in this review)
Recruitment: Advertisement on university website, flyers on university campuses, emails to personnel and advertisement in local newspaper
Setting: Community and laboratory, Belgium
Study start date/end date: Not stated
Participants Total N: 48 provided data
Randomized to: EC1 16; EC2 17; control 17
Inclusion criteria:

  • Smoker for at least 3 years,

  • Smoking at least 10 cpd, not intending to quit in the near future but willing to try a less unhealthy alternative


Exclusion criteria:

  • Diabetes;

  • Severe allergies;

  • Asthma or other respiratory diseases; psychiatric problems;

  • Dependence on chemicals other than nicotine;

  • Pregnancy;

  • Breastfeeding;

  • Hypertension;

  • CV disease;

  • Currently using any kind of smoking cessation therapy; prior use of EC


56% women, mean age 44, mean cpd 19, mean FTCD 5.79, all unwilling to quit with no baseline EC use
Interventions EC: Refillable
Intervention: 2 intervention groups (EC1 and EC2) provided with EC and instructed to use EC or smoke ad libitum (EC1 group provided with Joyetech eGO‐C, EC2 group provided with Kanger T2‐CC) and provided guidance on EC use. For both types, provided 30 mL bottles of tobacco‐flavored e‐liquid (Dekang “Turkish Blend”), containing 18 mg/mL of nicotine. 4 bottles at baseline replenished at 4 weeks, keep any remaining after 8 weeks
Control: 6 bottles for 2 months at week 8 (half offered EC1, half offered EC2); no guidance on use
Outcomes 3 lab sessions over 2 months (weeks 1, 4 and 8), plus online questionnaires, further follow‐up at 3 and 6 m after last lab session
Cessation: measured but definition not provided, validated with eCO 5 ppm or less
Adverse events and biomarkers: eCO, salivary cotinine measured during lab sessions. Also collected craving and withdrawal symptoms via lab sessions, “benefits and complaints”, mood, EC usage
Study funding "No external funding for this study was obtained. Electronic cigarettes and e‐liquids were purchased at E‐cig4U (`t Rond 10, 4285 DE Woudrichem, The Netherlands; http://www.e‐cig4u.nl/) with balances of previous research funds obtained by Frank Baeyens."
Author declarations The authors declare no conflict of interest
Notes Randomization was for short‐term outcomes only
Additional data provided from authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomization was performed by using a randomization tool available on the website www.randomizer.org
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Unblinded but as this review only includes data on objective measurements and not cessation judged unlikely to affect outcomes
Blinding of outcome assessment (detection bias)
All outcomes Low risk Unblinded but as this review only includes data on objective measurements and not cessation judged unlikely to affect outcomes
Incomplete outcome data (attrition bias)
All outcomes Low risk 36 out of 48 completed follow‐up (11/16 in EC1 group, 12/17 in EC2 group, 13/17 in control group)
Selective reporting (reporting bias) Unclear risk Outcome reporting somewhat non‐traditional; for example, collecting complaints but not explicitly adverse events, and incidence of AEs not reported. Unable to find prospectively‐registered protocol