Three-Day Combination Treatment for Vulvovaginal Candidosis with 200 mg Clotrimazol Vaginal Suppositories and Clotrimazol Cream for the Vulva is Significantly Better than Treatment with Vaginal Suppositories Alone – an Earlier, Multi-Centre, Placebo-Controlled Double Blind Study

Abstract

!Problem: According to the guidelines, acute vulvovaginal candidosis (VVC) may be treated vaginally, through a combination of vaginal treatment and cream for the vulva or orally. However, there is a lack of investigations into whether combined treatment for the vagina and vulva achieves better results than vaginal treatment alone. Method: In 1999, 160 patients with vulvovaginal candidosis from ten German gynaecological practices were included in a study and treated on a randomised basis with three 200 mg clotrimazol vaginal suppositories = clotrimazol 2 % cream (verum n = 79) or + placebo (active-ingredientfree cream base n = 79). The examinations took place before treatment (T1), six to eight days following the end of treatment (T2) and approximately four weeks following the end of treatment (T3). In addition to demographic data, the clinical findings of each investigation were documented in a standardised way and a native preparation and a fungal culture were taken. The doctor and patient evaluated the healing process and tolerance. The main efficacy variables were the pre/ post difference scores for extravaginal redness. Results: On T1, there was no difference between the two groups. By T2, there was a significant difference in the extent of extravaginal redness between the verum and the placebo groups (p = 0.0002), as well as in the subgroup of the per-protocol analysis (verum 64, placebo 70 patients, p = 0.0015). Genital itching or burning had entirely disappeared in 51 % and 56% of patients respectively in the verum group and in only 30 % and 45 % of patients in the placebo group on T2 (p = 0.0181). There was no difference in intravaginal redness on T1 and T2 in either group. The overall assessment by the doctor went accordingly (p = 0.0004). On T1, the extravaginal fungal culture was positive in 75 women in the verum group and in 76 women in the placebo group. On Neben den demografischen Daten wurden bei jeder Untersuchung standardisiert die klinischen Befunde dokumentiert sowie ein Nativpräparat und eine Pilzkultur abgenommen. Arzt und Patientin beurteilten den Heilungsverlauf und die Verträglichkeit. Primäre Wirksamkeitsvariable waren die Prä-/Post-Differenz der Scores für die extravaginale Rötung. Ergebnisse: An T1 bestanden keine Unterschiede in beiden Gruppen. Zum Zeitpunkt T2 war zwischen der Verum-und der Placebogruppe die extravaginale Rötung signifikant verschieden (p = 0,0002), ebenso in der Untergruppe der PerProtocol-Analyse (Verum 64, Placebo 70 Patientinnen, p = 0,0015). Der genitale Juckreiz bzw. das Brennen waren bei 51 bzw. 56 % der Verumgruppe und bei nur 30 bzw. 45 % der Placebogruppe an T2 ganz verschwunden (p = 0,0181). Bei der intravaginalen Rötung gab es an T1 und T2 in beiden Gruppen keinen Unterschied. Die ärztliche Gesamtbeurteilung fiel entsprechend aus (p = 0,0004). Bei T1 war die extravaginale Pilzkultur in der Verum-vs. der Placebogruppe bei 75 vs. 76 Frauen positiv, an T2 aber bei 51,9 vs. 73,1 %

Clotrimazole for Vulvovaginal Candidosis: More Than 45 Years of Clinical Experience

“…Similarly, the single use of clotrimazole 10% internal cream or clotrimazole 500 mg ovule (soft capsule) yielded mycological cure rates that were comparable to those following a single dose of clotrimazole 500 mg vaginal tablet. In cases of vulvar involvement, the combined use of intravaginal clotrimazole and external clotrimazole cream provided more favorable treatment results than intravaginal clotrimazole alone [ 22 ]. In all studies, topical clotrimazole was well tolerated.…”

Guidelines for the management of dermatomycosis (2019)

“…206 Based on the above, intravaginal administration of antifungals is recommended for vulvovaginal candidiasis. [195][196][197][198][199][200][201][202][203][204][205][206] CQ19: IS A TOPICAL ANTIFUNGAL AGENT RECOMMENDED FOR TINEA VERSICOLOR TREATMENT?…”

Treatment of vulvovaginal candidiasis: a review of the literature

“…Recently, Mendling et al performed a comparative study on 160 patients with VVC in which they compared treatment with clotrimazole vaginal suppositories alone and a combination of 2% clotrimazole cream for external use and clotrimazole vaginal suppositories. They concluded that the combination of both was better than the suppositories alone (19).…”