Table 3.
Author | Treatment regimen | Placebo | Delivery system (by investigator/patient) | Disease | Number treated/placebo | Regression treated (%)/placebo (%) | Remission treated (%)/placebo (%) | FU, after end of treatment | |
---|---|---|---|---|---|---|---|---|---|
1 | Sidhu 1997 [14] | 20 mg of 5-FU for 24 h (one application) | Cytotoxic drug delivery system without 5FU | Bilaminar bioadhesive polymeric film | CIN1–2 | 48/46 | 67%/72% (p = 0.76) | 6 months | |
2 | Rahangdale 2014 [13] | 2 g of 5% 5-FU once every 2 weeks for a total of 16 weeks (eight applications) | Observation, no placebo | Vaginal applicator (+ tampon) (by patient) | CIN2 | 28/27 | 93%/56% (p = 0.01) | 86%/44% | 10 weeks |
3 | Meyskens 1994 [28] | 1.0 ml of 0.375% atRA or a placebo cream for 24 h. Start: daily for 4 days; months 3 and 6: daily for 2 days (eight applications) | Polyethylene glycol 400, butylated hydroxytoluene, 55% alcohol | Cervical cap + collagen sponge (by investigator) | CIN2 CIN3 | 75/66 40/51 | 43%/27% (p = 0.41) 25%/31% (p = 0.33) | 21 months | |
4 | Ruffin 2004 [29] | 0.16–0.28% - 0.36% atRA or placebo daily for four consecutive days (four applications) | Same carrier base to compound atRA | cervical cap + collagen sponge (by investigator) | CIN2 CIN3 | 29–32–34/24 16–12–13/14 |
83–87–74%/70% 57–58–35%/57% |
62–50–50% /62% 44–50–14/21% |
11 weeks |
5 | Van Pachterbeke 2009 [16] | 3 ml cidofovir 2% in Intrasite gel (for 4 h) or placebo, three applications in 1 week | Sterile water + Intrasite gel | Cervical cap (by investigator) | CIN2–3 | 23/25 | 61%/20% (p = 0.01) | 6 weeks | |
6 | Grimm 2012 [30] | 6.25 mg imiquimod (overnight) | 2 g Adeps solidus | Vaginal suppositories (by patient) | CIN2–3 | 28/27 | 79%/41% (p = 0.009) | 50%/15% (p = 0.08) | 4 weeks |
week 1–2: 1 suppo/w | |||||||||
week 3–4: 2 suppo/w | |||||||||
week 5–16: 3 suppo/w | |||||||||
(max. 42 applications) |
CIN cervical intraepithelial neoplasia, FU follow-up, mIU million international units