title: The practicability and surgeons' subjective experiences with vaginal danazol before an operative hysteroscopy.
abstract: This randomized, double blind, placebo-controlled study compared the usefulness of danazol 400mg vaginally versus 600mg orally in women as a preoperative preparation for hysteroscopic surgery. Ninety-one fertile women were randomly allocated to Group A (46 patients received 400mg of danazol placed into the posterior vaginal fornix and three oral tablets of commercially available folic acid as a placebo), and Group B [45 women treated with 600mg of danazol orally (200mg three times daily) and two vaginal tablets of Lactobacillus rhamnosus as a placebo]. The patients underwent an operative hysteroscopy, transvaginal sonography, blood tests, and a histological assay. A visual analog scale (VAS) score to compute the degree of the surgeon's satisfaction was used. The outcome measures were as follows: an evaluation of the changes in the endometrial thickness, the prevalence of endometrial atrophy, changes in the blood tests, any collateral effects, the degree of difficulty and view, the duration of the surgical procedure, any complications during the operative hysteroscopy and associated side effects, and the surgeon's satisfaction with the endometrial preparation. The vaginal administration route was associated with a more pronounced effect on the endometrial thickness. Significantly more patients receiving vaginal danazol (45/46) had a hypotrophic endometrium than those receiving oral danazol (37/45, P<0.01). In addition, the patients receiving danazol vaginally had a shorter operating time, lower infusion volume, fewer side effects, and a higher surgeon satisfaction. Vaginal danazol adequately prepares the endometrium for an operative hysteroscopy by thinning the endometrium effectively with few side effects and little impact on the metabolic parameters.
authors.affiliation: Department of Pediatrics, Obstetrics and Reproductive Medicine, Section of Obstetrics and Gynecology, University of Siena, Siena, Italy. florio@unisi.it
authors.forename: Pasquale
authors.initials: P
authors.lastname: Florio
authors.forename: Marco
authors.initials: M
authors.lastname: Filippeschi
authors.forename: Alberto
authors.initials: A
authors.lastname: Imperatore
authors.forename: Liliana
authors.initials: L
authors.lastname: Mereu
authors.forename: Mario
authors.initials: M
authors.lastname: Franchini
authors.forename: Stefano
authors.initials: S
authors.lastname: Calzolari
authors.forename: Luca
authors.initials: L
authors.lastname: Mencaglia
authors.forename: Pietro
authors.initials: P
authors.lastname: Litta
mesh_terms: D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D003613:Danazol / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004717:Endometrium / Q000187:drug effects / Q000473:pathology / Q000601:surgery; D004965:Estrogen Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015907:Hysteroscopy / Q000379:methods*; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D004965:Estrogen Antagonists; D003613:Danazol