Clinical Evidence
95.7%
CIN 1 regression
2X
(DOUBLE)
vs. control
48%
Significant improvement in ectopy pattern*
*severe ectropion >2/3
65%
Reached an optimum pH
Regression of cervical lessions1,2,3,4
N = 999 women
With abnormal Pap tests were enrolled in a multicentre, retrospective, case-control study.
The treatment arm consisted of patients submitted to local therapy with Colpofix®. The control arm comprised patients who did not receive any therapy.
6 months of follow-up
Colpofix® increases regression of CIN 1 lesions to 95.7% after 6 months of follow-up.
Colpofix® gel represents a valid alternative to a “wait and see” strategy in patients affected by CIN 1.
Stentella P, Biamonti A, Carraro C, et al. Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: A retrospective, case-control study. Minerva Ginecol 2017; 69(5): 425-30.
HPV clearance4
N = 784 women
With positive HPV tests or diagnosed by biopsy with CIN 1 were enrolled in a retrospective case-control study.
Group A performed treatment with Colpofix® vaginal gel (1 application per day for 20 days per month for 3 months). Group B was the control group.
6 months of follow-up
After 6 months of follow-up, Colpofix® doubles HPV clearance compared to untreated patients.
Colpofix® was able to improve overall vaginal health; this effect seemed to positively impact the risk of persistence and progression of CIN.
Lavitola G, Della Corte L, De Rosa N, et al. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. BioMed Res Int 2020; (3b): 1-8.
Epithelialisation4
N = 784 women
With positive HPV tests or diagnosed by biopsy with CIN 1 were enrolled in a retrospective case-control study.
Group A performed treatment with Colpofix® vaginal gel (1 application per day for 20 days per month for 3 months). Group B was the control group.
6 months of follow-up
Colpofix® improves the ectopy pattern by 48% after 6 months of follow-up, which is 4 times more than in untreated patients.
Lavitola G, Della Corte L, De Rosa N, et al. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. BioMed Res Int 2020; (3b): 1-8.
N = 784 women
With positive HPV tests or diagnosed by biopsy with CIN 1 were enrolled in a retrospective case-control study.
Group A performed treatment with Colpofix® vaginal gel (1 application per day for 20 days per month for 3 months). Group B was the control group.
6 months of follow-up
Colpofix® increases the extension (>20%) of metaplasia by 114.5% after 6 months of follow-up.
Colpofix® was able to improve overall vaginal health; this effect seemed to positively impact the risk of persistence and progression of CIN.
Lavitola G, Della Corte L, De Rosa N, et al. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. BioMed Res Int 2020; (3b): 1-8.
Vaginal microbiota – pH4
N = 784 women
With positive HPV tests or diagnosed by biopsy with CIN 1 were enrolled in a retrospective case-control study.
Group A performed treatment with Colpofix® vaginal gel (1 application per day for 20 days per month for 3 months). Group B was the control group.
6 months of follow-up
65% reduction in patients with vaginal pH >4.5 at 6 month follow-up with Colpofix®
The presence of leucorrhoea, a positive Whiff test, and basic vaginal pH correlate with an at least doubled risk of persistence of CIN lesions at the cervical level
Lavitola G, Della Corte L, De Rosa N, et al. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. BioMed Res Int 2020; (3b): 1-8.
Summary
1 Scardamaglia P, Carraro C, Mancino P, Stentella P. Efficacia del carbossimetilbetaglucano nella regressione delle alterazioni citologiche cervicali di basso grado HPV correlate [Effectiveness of the treatment with beta-glucan in the HPV-CIN 1 lesions]. Minerva Ginecol. 2010 Oct;62(5):389-93. Italian. PMID: 20938424.
2 Laccetta G, Carrone A, Burratti M, Mancino P. Effect of the treatment with β-glucan in women with cervical cytologic report of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (L-SIL). Minerva Ginecol. 2015 Apr;67(2):113-20. Epub 2015 Feb 5. PMID: 25668505
3 Stentella P, Biamonti A, Carraro C, Inghirami P, Mancino P, Pietrangeli D, Votano S, Lazzari P, DE Medici C. Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: a retrospective, case-control study. Minerva Ginecol. 2017 Oct;69(5):425-430. doi: 10.23736/S0026-4784.17.04053-9. PMID: 28675291.
4 Lavitola G, Della Corte L, De Rosa N, Nappi C, Bifulco G. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. Biomed Res Int. 2020 Apr 27;2020:5476389. doi: 10.1155/2020/5476389. PMID: 32420349; PMCID: PMC7201736.
Scardamaglia 2010
Read and download the full article here: https://www.minervamedica.it/en/journals/minerva-obstetrics-gynecology/article.php?cod=R09Y2010N05A0389
Laccetta 2015
Read and download the full article here: https://www.minervamedica.it/en/journals/minerva-obstetrics-gynecology/article.php?cod=R09Y2015N02A0113
Stentella 2017
Read and download the full article here: https://www.minervamedica.it/en/journals/minerva-obstetrics-gynecology/article.php?cod=R09Y2017N05A0425
Lavitola 2020
Read and download the full article here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201736/
