Bullen 2013.
| Study characteristics | ||
| Methods | Design: 3 parallel groups RCT Recruitment: People who smoke recruited from the community, via newspaper advertisements Setting: Research Unit, New Zealand Study start date: 6 September 2011; Study end date: 5 July 2013 |
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| Participants | Total N: 657. 289 nicotine EC (NEC), 295 patch, 73 non‐nicotine EC (PEC) Inclusion criteria: ≥ 18 years; smoked 10 or more cpd over past year; wanted to stop smoking Exclusion criteria: pregnancy and breastfeeding; sing cessation medicines or using other support to quit; heart attack, stroke, severe angina in the last 2 weeks; poorly‐controlled medical disorder; allergies, other chemical dependence. 62% women, mean age 42, ⅓ NZ Maori, smoking 18 cpd, mean FTND score 5.5 Motivated to quit E cigarette use at baseline: Not specified |
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| Interventions |
EC: Cig‐a‐like Randomized to NEC, PATCH or PEC use for 13 weeks (from 1 week prior to TQD)
All participants referred to Quitline and received an invitation to access phone‐ or text‐based support. This was accessed by < 10% |
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| Outcomes | Sustained (≤ 5 cigarettes allowed) validated (exhaled breath CO < 10 ppm) abstinence at 6 months ≥ 50% self‐reported reduction in baseline cigarettes at 6 months Participants reporting any adverse events Proportion of AEs that were serious Proportion of unrelated AEs |
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| Study funding | Health Research Council of New Zealand | |
| Author declarations | "We declare that we have received no support from any companies for the submitted work and have no non‐financial interests that might be relevant to the submitted work. ML, via his company Health New Zealand, previously did research funded by Ruyan (an e‐cigarette manufacturer). CB and HM have done research on Ruyan e‐cigarettes funded by Health New Zealand, independently of Ruyan. HM has received honoraria for speaking at research symposia, has received benefits in kind and travel support from, and has provided consultancy to, the manufacturers of smoking cessation drugs. NW has provided consultancy to the manufacturers of smoking cessation drugs, received honoraria for speaking at a research meeting and received benefits in kind and travel support from a manufacturer of smoking cessation drugs. JW has provided consultancy to the manufacturers of smoking cessation medications." | |
| Notes | Accessed support: NEC: 115/289; PATCH: 106/295; PEC: 26/73 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerized block randomization |
| Allocation concealment (selection bias) | Low risk | Computerized via study statistician |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | NEC and PEC were blind to treatment condition in relation to one another. No blinding for NEC/PEC vs PATCH conditions, but as NEC and PATCH were both active treatments performance bias judged unlikely |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | LTFU 22% (all considered to be smoking). Patch group had a higher LTFU and withdrawal than EC (loss to follow‐up 17% NEC, 27% patches, 22% PEC). However, minimal difference in per‐protocol and ITT analyses |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |