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. 2021 Sep 14;2021(9):CD010216. doi: 10.1002/14651858.CD010216.pub6

Kumral 2016.

Study characteristics
Methods Design: Prospective randomized clinical trial
Recruitment: All patients admitted to a smoking cessation clinic at the Department of Otorhinolaryngology‐Head and Neck Surgery, Okmeydanı Training and Research hospital
Setting: Smoking cessation clinic, Turkey
Study start date: March 2013; Study end date: November 2013
Participants Total N: 98 but analysis excludes 16 from intervention and 10 from control who did not stop smoking; thus 72 analyzed
N per arm: EC: 58 (42 ana lysed); Non‐EC 40 (30 ana lysed)
Inclusion criteria:
  • Smoked at least one pack of cigarettes a day for at least 5 years.


Exclusion criteria:
  • History of allergic rhinitis, chronic sinusitis, vasomotor rhinitis, asthma, malignancy, or surgery in upper respiratory tract;

  • Age under 18;

  • Use of psychoactive drugs


Inclusion based on specific population characteristic: No
44% women; mean age 36; mean cpd and mean FTND not specified
Motivated to quit: “All patients were willing to quit smoking”
E‐cigarette use at baseline: Not specified
Interventions EC: Unclear
EC arm: “used EC to quit smoking” – allowed to select brand and flavor, used “medium density” liquid (11 ‐ 12 mg/ml) (no further detail given)
Non‐EC arm: Received cognitive behavioral therapy (no further detail given)
Outcomes 3 Months
Sino‐nasal outcome test (SNOT‐22) via self‐administered questionnaire, to evaluate changes in subjective symptoms. Saccharin transit test to evaluate nasal mucociliary clearance (MCC) function which authors state is “an important defence mechanism”
Study funding Not specified
Author declarations Not specified
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “Patients participating in the study were randomly divided into two groups; EC smokers (group 1) and non‐EC smokers (group 2).”
No further detail provided
Allocation concealment (selection bias) Unclear risk No information given
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants were not blinded. The trial is described as single‐blinded and outcome assessors were blinded. No placebo used
Blinding of outcome assessment (detection bias)
All outcomes High risk Self‐reported outcome data, participants not blinded and unequal amounts of support between arms
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Dropout rate not clear. Only ana lysed people who quit
Selective reporting (reporting bias) Low risk All expected outcomes reported