Single dose treatment of vaginal candidosis: randomised comparison of amorolfine (50 mg and 100 mg) and clotrimazole (500 mg) in patients with vulvovaginal candidosis.
A double blind randomised comparative study of single dose treatment with amorolfine vaginal tablets (50 mg and 100 mg) and clotrimazole 500 mg monodose vaginal tablets (open labelled) was undertaken in patients with vaginal candidosis. Vaginitis was demonstrated by both a positive culture and positive findings on microscopic examination of a vaginal smear as well as by the presence of clinical symptoms. 118 patients seen over a 6 month period were randomly allocated to receive one 50 mg vaginal tablet of amorolfine (regimen A, 40 patients), a 100 mg vaginal tablet of amorolfine (regimen B, 38 patients) or a 500 mg tablet of clotrimazole (regimen C, 40 patients). At the assessment one week after the end of therapy the proportion of cured patients was 90% in group A, 94.7% in group B and 92.5% in group C. 4 patients (10%) in group A, 2 (5.2%) in group B and 3 (7.5%) in group C did not respond to the treatment. There was a significant association between Candida glabrata and treatment failure (P less than 0.001) and C. glabrata and carrier state (P less than 0.01). At the assessment 4 weeks after the end of therapy the proportion of cured patients was 80% in group A, 84.2% in group B and 67.5% in group C with a relapse rate of 10% (group A), 10.5% (group B) and 25% (group C). C. glabrata was significantly associated with non-effective overall treatment (P less than 0.05). The relapse rate was significantly associated with positive culture results one week post therapy (P less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
Department of Microbiology, Hospital 12 de Octubre, Madrid, Spain.
A
A
del Palacio
F
F
Sanz
M
M
Garcia-Bravo
C
C
Gimeno
S
S
Cuetara
P
P
Miranda
A
A
R-Noriega
D000282:Administration, Intravaginal; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D003022:Clotrimazole / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000627:therapeutic use*; D013607:Tablets
D000935:Antifungal Agents; D009025:Morpholines; D013607:Tablets; C038974:amorolfine; D003022:Clotrimazole