Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial.

Archives of Gynecology and Obstetrics
Attila Louis MajorEtienne Marc Grandjean

Abstract

The 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. 216 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. Regression 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%,...Continue Reading

References

Mar 1, 1979·Applied and Environmental Microbiology·J P Murray, S J Laband
Jul 1, 1990·British Journal of Obstetrics and Gynaecology·L FrostP M Larsen
Aug 17, 1999·Infectious Diseases in Obstetrics and Gynecology·M M HolmesS T Vermillion
May 6, 2004·JAMA : the Journal of the American Medical Association·Lynn SadlerLesley McCowan
Oct 14, 2004·Virchows Archiv : an International Journal of Pathology·Giovanni NegriEduard Egarter-Vigl
Jan 18, 2006·Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc·Maria BenevoloAmina Vocaturo
Aug 18, 2009·American Journal of Obstetrics and Gynecology·Marta del PinoJaume Ordi
Aug 24, 2012·Obstetrics and Gynecology·Christoph GrimmPaul Speiser
Apr 4, 2013·Journal of Lower Genital Tract Disease·Hormuzd A KatkiWalter K Kinney
Jan 5, 2014·American Journal of Obstetrics and Gynecology·Lisa RahangdaleLinda van Le
Dec 4, 2014·American Journal of Obstetrics and Gynecology·Peter HillemannsMark H Einstein
Dec 5, 2014·APMIS : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica·Larissa Bastos Eloy da CostaLiliana A Lucci De Angelo Andrade
Mar 5, 2016·Obstetrics and Gynecology·Stephanie GeislerPaul Speiser
Mar 25, 2019·Case Reports in Women's Health·Tirza WoutersJurgen M J Piek
Jun 27, 2019·BJOG : an International Journal of Obstetrics and Gynaecology·J NorenhagN Brusselaers
Nov 14, 2019·Archives of Pathology & Laboratory Medicine·Philip E CastleUNKNOWN p16 IHC Study Panel
Apr 2, 2020·Fertility and Sterility·Jacques Donnez

❮ Previous
Next ❯

Methods Mentioned

BETA
negative
of
biopsy
genotyping
atomic absorption spectrometry
biopsies

Clinical Trials Mentioned

ISRCTN11009040

Software Mentioned

CINtec
Stata®
CINtec®

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.