A prospective study to compare the efficacy and safety of tioconazole and clotrimazole vaginal gel in patients suffering from vulvovaginal candidiasis

Abstract

Background: Vulvo vaginal candidiasis is an extremely common gynaecological condition. While clotrimazole has been the mainstay of treatment of this pathology, newer medications are now available. The study aims to compare the efficacy, compliance and safety of tioconazole single dose intravaginal gel application and clotrimazole vaginal gel for 3 days in patients suffering from vulvovaginal candidiasis.

Methods: A prospective, multicentric, open label, randomized, controlled, parallel group clinical trial of 220 women with 110 in each group for the evaluation of the effects of tioconazole vaginal gel in patients suffering from candidial vaginitis. Patients were divided into two groups; Group I received tioconazole vaginal gel as topical single dose therapy administered by the treating doctor and Group II received clotrimazole vaginal gel self-administered by the patient for three days. Response to therapy in both groups was studied and compared.

Results: At the end of day 7, mean score of vaginal discharge quantity had a fall of 93.3% and 92.3% in tioconazole and clotrimazole group respectively but difference was statistically insignificant. Microbiological cure rate in both the groups was similar. Reduction of vaginal irritation, vaginal itching, vaginal burning, pain in the vulval area, pain during urination or during sexual intercourse, vaginal erythema, tenderness and swelling were also comparable in both the groups.

Conclusions: Tioconazole gel single dose intravaginal application is as effective as clotrimazole gel three day intravaginal application. tioconazole is safe, well accepted and tolerated by the patients and will be useful in the treatment of vulvovaginal candidiasis.