Summary of findings 1. Nicotine EC compared to NRT for smoking cessation.
| Nicotine EC compared to NRT for smoking cessation | ||||||
| Patient or population: People who smoke Setting: New Zealand, UK, USA Intervention: Nicotine EC Comparison: NRT | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with NRT | Risk with Nicotine EC | |||||
| Smoking cessation at 6 months to 1 year Assessed with biochemical validation |
Study population | RR 1.53 (1.21 to 1.93) | 1924 (4 RCTs) | ⊕⊕⊕⊝ MODERATEa | ‐ | |
| 6 per 100 | 9 per 100 (7 to 12) | |||||
| Adverse events at 4 weeks to 6 months Assessed by self‐report |
Study population | RR 0.98 (0.80 to 1.19) | 485 (2 RCTs) | ⊕⊕⊝⊝ LOWb | ‐ | |
| 45 per 100 | 44 per 100 (36 to 53) | |||||
| Serious adverse events at 4 weeks to 1 year Assessed via self‐report and medical records |
Study population | RR 1.44 (0.94 to 2.19) | 1183 (3 RCTs) | ⊕⊕⊝⊝ LOWc | 1 study reported no events; effect estimate based on the two studies in which events were reported | |
| 5 per 100 | 7 per 100 (5 to 11) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). For cessation, the assumed risk in the control group is based on assumed quit rates for NRT assuming receipt of limited behavioral stop‐smoking support (as per Hartmann‐Boyce 2018a). The assumed risk for adverse events and serious adverse events is a weighted mean average of quit rates across control groups in contributing studies. CI: Confidence interval; RCT: randomized controlled trial; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded one level due to imprecision; small number of events (< 300 overall). bDowngraded two levels due to imprecision; only 2 studies contribute data. cDowngraded two levels due to imprecision; confidence intervals encompass clinically‐important harm as well as clinically important benefit.