A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Safety of a Transdermal Gel that Delivers CO2 in the Treatment of Vulvovaginal Atrophy

被引:0
作者
Leibaschoff, Gustavo H. [1 ,2 ]
Navarro Arrieta, Carmen Teresa [3 ,4 ]
Garces Reyes, Carmen Leonor [5 ,6 ]
Melamed, Juliana L. [7 ,8 ]
机构
[1] Univ Buenos Aires, Fac Med, Ob Gyn, Buenos Aires, DF, Argentina
[2] World Soc Cosmet Gynecol, Dallas, TX 75225 USA
[3] Francisco De Miranda Natl Expt Univ, Sch Med, Falcon, Venezuela
[4] Clin Fertilidad Fertiaguerrevere, Caracas, Venezuela
[5] Univ Ctr Occidental Lisandro Alvarado, Sch Med, Barquisimeto, Venezuela
[6] LABPAT JRA SC, Caracas, Venezuela
[7] Univ Buenos Aires, Fac Med, Buenos Aires, DF, Argentina
[8] ICAM USA Acad, Dallas, TX USA
来源
SURGICAL TECHNOLOGY INTERNATIONAL-INTERNATIONAL DEVELOPMENTS IN SURGERY AND SURGICAL RESEARCH | 2021年 / 38卷
关键词
CARBON-DIOXIDE; POSTMENOPAUSAL WOMEN; MENOPAUSE; SYMPTOMS; THERAPY; CREAM;
D O I
暂无
中图分类号
R61 [外科手术学];
学科分类号
摘要
This prospective study aimed to assess the efficacy of a transdermal CO2 gel in promoting regeneration in the vulvovaginal area in postmenopausal women experiencing symptoms as part of genitourinary syndrome of menopause (GSM). Transdermal carboxytherapy refers to the application of CO2 through the skin's superficial layer, which is intended to increase oxygenation (through the Bohr effect) and angiogenesis, thus helping to reduce symptoms of GSM. In this study, 20 women with moderate or severe signs or symptoms of vulvovaginal atrophy were randomized to receive either transdermal CO2 therapy (n=10) or a placebo gel (ultrasound gel, n=10). The gels (transdermal CO2 gel or the placebo) were applied by the patients at home. The gels were applied in two treatment cycles (10 days of total treatment). Each cycle involved daily applications of the gel to the vulvovaginal area, from Monday to Friday, with no application on weekends. The Female Sexual Function Index (FSFI) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were used to gather standardized information, and biopsy samples were obtained from the vagina and vulva for histological analysis, both on the first day of treatment and 10 days after the final application of gel. Patients who received the transdermal CO2 gel showed significant improvements on the FSFI and DIVA questionnaires and the biopsies revealed that the CO2 gel had a regenerative effect on vulvovaginal tissues.
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页数:6
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