Vinnikov 2008

Methods	Country: Kyrgyzstan Setting: Mining company (Kumtor Operating Company) Aim: To test the efficacy and safety of cytisine for smoking cessation in a workplace setting Study Design: Double‐blind placebo‐controlled parallel‐group RCT Analysis: Logistic regression used to assess influence of cytisine use, age, weight, CPD, smoking duration, previous quit attempts, FTND score and exhaled CO levels
Participants	197 adult smokers, aged 20+, smoking at least 15 CPD, no prior use of cytisine, and motivated to quit Randomised to cytisine (100) or placebo (97). 26 (15 cytisine, 11 placebo) who took no medication were excluded from trial report 97% men, mean age 39, mean CPD 22, mean FTND 5.3, 86% had tried to quit previously; mean previous quit attempts 3.3 Exclusion criteria: Standard pharmacotherapy trial criteria
Interventions	Tabex tablets (1.5 mg cytisine): 1. First 3 days: 6 tabs per day; reduce smoking by half 2. Days 4 ‐ 12: 5 tabs per day; stop smoking completely 3. Days 13 ‐ 16: 4 tabs per day 4. Days 17 ‐ 20: 3 tabs per day 5. Days 21 ‐ 22: 2 tabs per day 6. Days 23 ‐ 25: 1 tab per day Placebo tablets, same regimen Treatment period was 25 days, with TQD Day 5. All participants received "behavior counselling" (no further detail)
Outcomes	Primary outcome: CO‐validated CAR from Day 5 to wk 8 Secondary outcome: CO‐validated CAR from Day 5 to wk 26 Validation was by expired CO ≤ 8ppm Other outcomes: Change in health‐related QoL measures, changes in body weight, adverse events, SAEs Attrition to 8 wks was 6 in cytisine group and 7 in placebo group; to 26 wks 10 in cytisine group and 16 in placebo group
Treatment type	Medication: CYTISINE [TABEX]
Notes	New for 2012 update Additional information supplied by the author
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization was done by independent statistician in an Excel programme and the randomization key was kept by an independent person"
Allocation concealment (selection bias)	Low risk	See above
Blinding (performance bias and detection bias) All outcomes	Low risk	"Nor patients neither investigators did not know where Tabex and where placebo were"; "follow‐up was blind".
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	26 participants who did not take a single treatment dose were excluded from denominators by authors (restored to our MAs)
Selective reporting (reporting bias)	Low risk	Expected and predicted outcomes reported