Efficacy of in-house estrogen-containing cream for treatment of atrophic vaginitis in postmenopausal women, a randomized, double-blind, placebo-controlled trial
Abstract
Background: Atrophic vaginitis is the common symptoms encountered during postmenopausal period caused by estrogen deficiency. The traditional treatment with vaginal Premarin cream® is not available, now. This study aimed to evaluate efficacy of in-house estrogen-containing cream for treatment of atrophic vaginitis in postmenopausal women compare with placebo.
Materials and Methods: A randomized, double blinded, placebo-controlled study was conducted at department of Obstetrics and Gynecology, Sanpasitthiprasong Hospital, involving twenty postmenopausal women with symptomatic atrophic vaginitis. All participants were randomized into two groups: 1) control group which received cream base containing cetyl alcohol, stearyl alcohol, spermaceti, methyl paraben, propyl paraben, glycerin, sodium lauryl sulfate and water 2) intervention group which received in-house estrogen-containing cream (0.625 mg/tab mix together with cream base) apply daily for 1 week then twice weekly for a 11 weeks (total 12 weeks
period). The change of vaginal maturation index (VMI), most bothersome symptoms (MBS) and vaginal pH were evaluated at randomized time, 4 weeks and 12 weeks after treatment.
Results: Twenty postmenopausal women had completely followed up. The study group had significant increased vaginal maturation index at 4 weeks and 12 weeks compared with control group (p= 0.045, 0.005), median VMI 8.75, 61.50, 68.75 VS 15.09, 27.50, 15.00 at 0, 4, and 12 weeks, respectively. There is no significant improvement in all vaginal symptoms, MBS score, vaginal pH. No significant endometrial thickness change was observed. Conclusion: In-house estrogen-containing cream was superior to placebo in increased vaginal maturation index after 4 weeks of administration with no evidence of endometrial stimulatory effect.
Keywords: estrogen-containing cream, postmenopausal atrophic vaginitis, vaginal maturation index,
most bothersome symptoms
