Heydari 2012
| Methods | Country: Tehran, Iran Setting: Smoking cessation clinics in the Tobacco Prevention and Control Research Centre, Shahid Beheshti University of Medical Sciences Aim: To evaluate the effectiveness of varenicline in the Iranian community of tobacco quitters and compare it with other treatment methods Study Design: 3‐arm randomised parallel clinical study Dates conducted: 2009 ‐ 2010 Analysis: 91 participants per group were required |
|
| Participants | 272 treatment‐seeking participants: Brief advice (91), NRT (92), varenicline (89). 41.2% women, mean age 42.5 yrs, mean FTND 5.5 | |
| Interventions | All participants were managed by the same physician. All received brief (5 mins) education and counselling at 4 x weekly sessions. TQD was day 14 1. Control group: no pharmacotherapy 2. NRT: 8 wks of 15 mg NRT patches 3. 8 wks of 1 mg x 2/day varenicline (titrated 1st wk) |
|
| Outcomes | Abstinence at 6m and 12m, in person or by phone, verified by expired CO (cut‐off value not given) | |
| Treatment type | Medication: VARENICLINE / NRT | |
| Notes | Funding: Masih Daneshvari Hospital Research Institute, Tehran New for 2016 update |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Smokers who attended the clinic for help in quitting were divided randomly" |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label; blinding of outcome assessors not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition: "Participants entered the study of their own accord and none left the study" |
| Selective reporting (reporting bias) | High risk | No information on potential differences between phone‐ and in‐person reporting of abstinence at 6m and 12m, nor of whether all such claims of abstinence were biochemically verified No information on SAEs, if any |
| Other bias | Unclear risk | Participants were all previous quit‐attempters Varenicline was given for 8 wks, i.e. ⅔ of the normal regimen, presumably to align it with the NRT dosage pattern Abstinence‐by‐gender data (Table 2) appears to contain an error for women on NRT at 12m; we have ignored this finding in favour of the combined‐genders data |