Summary of findings for the main comparison. Summary of findings for imiquimod versus placebo.
| Imiquimod compared with placebo for usual‐type vulval intraepithelial neoplasia | |||||
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Patient or population: women with usual‐type vulval intraepithelial neoplasia Settings: outpatient Intervention: imiquimod 5% cream Comparison: placebo | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | |
| Assumed risk (risk in study population) | Corresponding risk | ||||
| Placebo | Imiquimod | ||||
| Response to treatment at 5 to 6 months ‐ overall response | 24 per 1000 | 285 per 1000 (76 to 1000) | RR 11.95 (3.21 to 44.51) | 104 (3 studies) | ⊕⊕⊕⊕ high |
| Response to treatment at 5 to 6 months ‐ complete response | 0 per 1000 | not estimable | RR 14.40 (2.97 to 69.80) | 104 (3 studies) | ⊕⊕⊕⊕ high |
| Response to treatment at 12 months ‐ overall response | 87 per 1000 | 791 per 1000 (207 to 1000) | RR 9.10 (2.38 to 34.77) | 47 (1 study) | ⊕⊕⊕⊝ moderate1 |
| Response to treatment at 12 months ‐ complete response | 0 per 1000 | Not estimable | RR 18.24 (1.12 to 296.41) | 47 (1 study) | ⊕⊕⊕⊝ moderate1 |
| Progression to vulval cancer at 12 months | 56 per 1000 | 28 per 1000 (3 to 288) | RR 0.48 (0.05 to 4.93) | 47 (1 study) | ⊕⊕⊝⊝ low1,2 |
| HPV DNA persistence | 923 per 1000 |
397 per 1000 (240 to 665) |
RR 0.43 (0.26 to 0.72) | 47 (1 study) | ⊕⊕⊕⊕ high |
| Pain ‐ any grade | 269 per 1000 | 922 per 1000 (484 to 1000) | RR 3.43 (1.80, 6.52) | 52 (1 study) | ⊕⊕⊕⊕ high |
| Dose reductions | 28 per 1000 | 218 per 1000 (45 to 1000) | RR 7.77 (1.61 to 37.36) | 83 (2 studies) | ⊕⊕⊕⊕ high |
| The risk in the cidofovir group is based on the assumed risk on the comparison group and the relative effect of the intervention and its 95% CI. CI: confidence interval; RR: risk ratio | |||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | |||||
1Downgraded due to imprecision.
2Downgraded due to sparse data (few events).