Tsukahara 2010
| Methods | Country: Japan Setting: Cessation clinic in Fukuoka University Hospital Aim: To test the efficacy and safety of varenicline for smoking cessation in Japanese smokers Dates conducted: Aug 2008 ‐ November 2009 Study Design: Randomised controlled open‐label trial Study name: The VN‐SEESAW Study |
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| Participants | 32 adult smokers, motivated to quit, allocated to varenicline (16) or nicotine patch (16). 75% men, mean age 46, mean CPD 28 (varenicline), 25 (patch), mean TDS (addiction) score 7.6, mean Brinkman index score (CPD x yrs smoking) 702. 71% had tried to quit previously, and 7% had used nicotine patches before Standard pharmacotherapy trial exclusion criteria, plus attendance at any smoking cessation clinic during previous 12m | |
| Interventions | 1. Open‐label varenicline 1.0 mg x 2/day for 12 wks, following 1 wk titration 2. Open‐label nicotine patch for 8 wks (52.5 mg/day for 4 wks, 35 mg/day for 2 wks, 17.5 mg/day for 2 wks) No non‐treatment or placebo control group Varenicline group received 8 clinic visits and nicotine group 5 visits over 12 wks, with 5 brief counselling sessions (≤ 10 mins) | |
| Outcomes | CO‐confirmed CAR at 9 ‐ 12 wks, and self‐reported at 9 ‐ 24 wks by phone interview Validation by expired CO < 8 ppm at 12 wks, but not at 24 wks Other outcomes: Safety and tolerability by wk 12, using MNWS at wks 2, 4, 8 and 12. Also used Stress Check List and Strait‐trait Anxiety Inventory Dropouts and losses to follow‐up were included in the analyses as continuing smokers (ITT analysis) Attrition in treatment phase was 12.5% from each group | |
| Treatment type | Medication: VARENICLINE / NRT OPEN‐LABEL | |
| Notes | The study was supported by the Japanese Ministry of Education, Science and Culture, Fukuoka University and FU‐Global program Not included in main MA, as no placebo group New for 2010 update | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "by computer" allocating men: women 3:1 to reflect Japanese smoking prevalence (M: 40%, F: 12%). |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | High risk | Participants and personnel were not blinded to treatment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
| Selective reporting (reporting bias) | Low risk | All expected and predicted outcomes covered |
| Other bias | Unclear risk | None noted |