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. 2023 May 5;2023(5):CD006103. doi: 10.1002/14651858.CD006103.pub8

Zincir 2013.

Study characteristics
Methods Study design: RCT
Country: Turkey
Setting: outpatient SC clinic in a hospital
Recruitment method: patients who presented at the SC outpatient clinic were included in the study on a voluntary basis
Participants 300 participants randomised; average age: 45.8 in those who stopped smoking and 40.8 in those who continued smoking; average boxes of cigarettes per year: 23.62 in those who stopped smoking and 23.26 in those who continued smoking; mean FTND: 5.9 in those who stopped smoking and 6.7 in those who continued smoking
Interventions
  • Bupropion 150 mg/day, started a week before the quit day and continued from day 1‐3, raised to 300 mg daily on day 4, with this dose maintained until the end of week 12

  • Varenicline 0.5 mg daily, raised to 1 mg daily at day 4, then to 2 mg daily at day 8, with this dose maintained until the end of week 12

  • NRT: administered using either a nicotine patch or nicotine gum, or a combination of both. Nicotine patches were used in their 3 forms containing 21, 14 and 7 mg of nicotine, and in cases of excessive nicotine craving, 2 mg nicotine gum was used. For each dose of nicotine patches, 4 weeks of administration in decreasing doses was recommended. The nicotine gum was started between 12 and 24 doses (2 mg) a day and gradually decreased.

Outcomes
  • SC: definition not specified; measured at 24‐28 weeks from study start

  • AEs: measured for unspecified period

Notes Funding: not reported
Author declaration of interests: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “…they were randomized to the pharmacological therapy groups”
Comment: no further information given
Allocation concealment (selection bias) Unclear risk Quote: “…they were randomized to the pharmacological therapy groups"
Comment: no further information given
Blinding (performance bias and detection bias)
All outcomes High risk Quote: “This was a naturalistic clinical follow‐up study."
Comment: those involved in the study were therefore unblinded
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 300 participants were randomised and 251 completed the study. Therefore 49/300 (16.3%) were lost to follow‐up overall. However, it is impossible to establish the number lost to follow‐up by group.
Selective reporting (reporting bias) Unclear risk Protocol unavailable
Other bias High risk Quote: “no adverse event was reported during the study”. This is highly unlikely to be correct when considering standard definitions of AEs. There is no explanation of how AEs were assessed in this study. In addition, the wording of the paper makes the final follow‐up slightly unclear. After discussion we judged final follow‐up to be 24‐28 weeks from study start, although quit rates are higher than would be expected at this time point.

AE: adverse event; BMI: Body Mass Index (kg/m2); CA: continuous abstinence; CAR: Continuous Abstinence Rate; cNRT: combined nicotine replacement therapy; CO: carbon monoxide; COPD: chronic obstructive pulmonary disease; CPD: cigarettes per day; CQR: continuous quit rate; CVD: cardiovascular disease; DSM‐IV:Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; ECG: electrocardiogram; EoT: end of treatment; FTND: Fagerström Test for Nicotine Dependence; ITT: intention‐to‐treat; LOCF: last observation carried forward; MA: meta‐analysis; MDD: major depressive disorder; MI: motivational interviewing; MIMS: Monthly Index of Medical Specialities; mCEQ: Modified Cigarette Evaluation Questionnaire; MNWS: Minnesota Nicotine Withdrawal Scale; NCT: National Clinical Trials (ClincialTrials.gov registry); NRT: nicotine replacement therapy; PA: prolonged abstinence; PPA: point‐prevalence abstinence; ppm: parts per million; QoL: quality of life; QSU‐brief: Brief Questionnaire of Smoking Urges; RCT: randomised controlled trial; SAE: serious adverse event; SC: smoking cessation; TQD: target quit date