Abstract
PurposeThe effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated.Methods216 women aged 25–60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed.ResultsRegression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present.ConclusionSAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer.Trial registration numberISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040; retrospectively registered.
Highlights
Cervical cancer is the main cause of oncologic death in many developing countries, whereas in developed countries it is rare and mainly observed in postmenopausal women
The primary hypothesis was tested in the Full Analysis Set (FAS) i.e. Intention-to-Treat population (ITT) comprising 216 patients (Fig. 1)
SAM gel administration led to a significant treatment success shown by the increase of the regression rate of precancerous disease, 72.2% in the SAM gel arm vs 25.0% in the control arm
Summary
Cervical cancer is the main cause of oncologic death in many developing countries, whereas in developed countries it is rare and mainly observed in postmenopausal women. Till today the attempts to efficiently treat human papilloma virus (HPV)-related low grade lesions with a non-destructive method have failed, either due to important adverse events (Imiquimod, Interferon) or due to an unsatisfactory response (green tea, metronidazole-containing gel, 5-fluorouracil (5-FU) vaginal cream) [2,3,4]. Corrosive treatment of the cervical surface with topical 85% trichloroacetic acid in an outpatient setting showed promising results, but with not negligible vasovagal symptoms immediately after treatment [8]. An aqueous hydrocolloid vaginal gel was developed, containing highly dispersed silicon dioxide and DEFLAMIN® as active agents. The capacity of silicon dioxide to bind proteins, lipids, and lipoproteins non- and to bind potential pathogenic agents results from the property of the charged surface structure [9,10,11,12]. DEFLAMIN® is a combination of sodium selenite and citric acid, according to a patented formula with utmost antioxidative properties [13]
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