title: A prospective, randomized, double-blind study of vaginal microflora and epithelium in women using a tampon with an apertured film cover compared with those in women using a commercial tampon with a cover of nonwoven fleece.
abstract: Healthy women with normal menstrual cycles were randomly assigned to use either a test tampon during cycle 1 and a reference tampon during cycle 2 or a reference tampon during cycle 1 and a test tampon during cycle 2. Tampons were identical except for their cover materials: apertured film for the test tampon and nonwoven fleece for the reference tampon. Product use was doubly blinded. Qualitative and quantitative analyses of vaginal cultures were done pre-, mid-, and postmenstrually for a broad panel of microorganisms, colposcopy was performed, and diary reports were collected; 101 of 105 enrolled subjects completed the study. Midmenstrual findings for a variety of organisms differed from pre- and postmenstrual observations whether subjects were using test or reference tampons. No statistically significant differences were noted in prevalence or colony counts at premenstrual versus mid- and postmenstrual visits for most microorganisms. Prevalences of Gardnerella and anaerobic gram-negative rods were significantly different between tampons at the premenstrual visit, when unusually low values were observed for the test and reference tampons, respectively. None of the changes or differences in microflora were considered to be clinically significant. It is noteworthy, however, that declines in the prevalence and abundance of Lactobacillus during the menstrual periods were less pronounced during the use of both test and reference tampons than those reported from previous studies. Colposcopy showed no abnormal findings with either tampon and no changes in vaginal or cervical epithelial integrity. Thus, all evidence from both microbiological and colposcopic evaluations indicates that the apertured film cover of the test tampon is as safe as the nonwoven cover of the reference tampon.
authors.affiliation: Scientific and Medical Affairs, Johnson & Johnson Consumer and Personal Products Worldwide, 199 Grandview Road, Skillman, NJ 08558, USA. DChase@cpcus.jnj.com
authors.forename: David J
authors.initials: DJ
authors.lastname: Chase
authors.forename: Berenike P
authors.initials: BP
authors.lastname: Schenkel
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Fahr
authors.forename: Ulrich
authors.initials: U
authors.lastname: Eigner
mesh_terms: D000293:Adolescent; D000328:Adult; D001419:Bacteria / Q000145:classification / Q000254:growth & development*; D002175:Candida / Q000254:growth & development; D015169:Colony Count, Microbial; D003127:Colposcopy; D004311:Double-Blind Method; D004926:Escherichia coli / Q000254:growth & development; D005260:Female; D016975:Gardnerella / Q000254:growth & development; D006801:Humans; D007778:Lactobacillus / Q000254:growth & development; D008597:Menstrual Cycle; D052576:Menstrual Hygiene Products / Q000009:adverse effects; D008875:Middle Aged; D013211:Staphylococcus aureus / Q000254:growth & development; D013289:Streptococcaceae / Q000254:growth & development; D014621:Vagina / Q000382:microbiology*