Table 3.
Evidentiary Basis for Conditional Recommendation Favoring Varenicline plus Patch over Patch Alone with Low-Certainty Evidence
| Certainty Assessment |
Number (or Percent) |
Effect (95% CI) |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Studies | Study Design | Risk of Bias | Inconsistency | Indirectness | Imprecision | Other Considerations | Varenicline + Nicotine | Varenicline Alone | Relative | Absolute (per 1,000 Patients) | ||
|
Seven-day point-prevalence tobacco abstinence, 6 mo or later (follow-up: mean, 6 mo; assessed with self-report, confirmed with exhaled carbon monoxide) | ||||||||||||
| 2 | RCT | Not serious | Not serious | Not serious | Not serious | None | 154/386 (39.9%) | 29.3% | RR, 1.36 (1.07–1.72) | 105 more (↑21–↑211) | High | Critical |
|
Seven-day point-prevalence tobacco abstinence during treatment (assessed with self-report, confirmed with exhaled carbon monoxide) | ||||||||||||
| 2 | RCT | Not serious | Not serious | Not serious | Not serious | None | 184/386 (47.7%) | 36.2% | RR, 1.31 (1.11–1.54) | 112 more (↑40–↑196) | High | Important |
|
Quality of life, not measured | ||||||||||||
| — | — | — | — | — | — | — | — | — | — | — | — | Important |
|
Serious adverse events (follow-up: mean, 6 mo; as reported) | ||||||||||||
| 3 | RCT | Not serious | Not serious | Not serious | Very serious | None | 4/444 (0.9%) | 1.4% | RR, 1.06 (0.27–4.05) | 1 more (↓10–↑42) | Low | Critical |
|
Relapse, not measured | ||||||||||||
| — | — | — | — | — | — | — | — | — | — | — | — | Important |
|
Other substance use, not measured | ||||||||||||
| — | — | — | — | — | — | — | — | — | — | — | — | Important |
|
Withdrawal, composite-symptoms rating (follow-up: mean, 4 wk; assessed with Mood and Physical Symptoms Scale; lower change score indicates better outcome; scale of 2–12) | ||||||||||||
| 1 | RCT | Serious | Not serious | Not serious | Very serious | None | 35 | 34 | — | MD, 0.04 lower (0–0) | Very low | Important |
|
Withdrawal, craving (follow-up: mean, 4 wk; assessed with Wisconsin Withdrawal Symptom Scale; lower score indicates better outcome; scale of 0–4) | ||||||||||||
| 1 | RCT | Serious | Not serious | Not serious | Serious | None | 110 | 87 | — | MD, 0.1 higher (↓0.19–↑0.39) | Low | Important |
Definition of abbreviations: ↑ = increase of; ↓ = decrease of; CI = confidence interval; MD = mean difference; RCT = randomized controlled trial; RR = relative risk.
Combination treatment using varenicline and nicotine patch showed benefit compared with varenicline and showed similar risk of severe adverse events. For complete evidence tables, together with references, explanations of certainty assessments, and results of the Evidence-to-Decision process, see online supplement.