Single-dose tioconazole compared with 3-day clotrimazole treatment in vulvovaginal candidiasis

Abstract

A total of 80 patients were equally randomized to receive a single dose of 6.5% tioconazole ointment or a 3-day course of 100-mg clotrimazole vaginal tablets for the treatment of vulvovaginal candidiasis. Of the 32 evaluable patients treated with tioconazole, 27 (84%) remained asymptomatic 4 weeks posttreatment, compared with 28 of 33 patients (85%) treated with clotrimazole. A total of 34 patients in each group could be evaluated for mycological response based on culture results 1 and 4 weeks after treatment. Twenty patients (59%) who received tioconazole and twenty-one patients (62%) who received clotrimazole remained culture negative 4 weeks after therapy. Of 40 patients who received tioconazole, 12 (30%) experienced local irritation or itching, compared with 2 of 40 patients (5%) treated with clotrimazole (P < 0.01). Single-dose tioconazole ointment was as effective as a 3-day course of clotrimazole tablets, but significantly more patients in the tioconazole-treated group experienced local side effects.The duration of treatment for Candida vaginitis has changed dramatically over the past several years. New high-dose imidazole derivatives have produced excellent short-term cure rates with treatment durations as short as 1 to 3 days (1,3,4,13,16,21). In addition, 4-week follow-up cultures of patients undergoing short-term treatment have not shown a higher incidence of recolonization by Candida organisms compared with cultures from patients undergoing longer periods of treatment (3,13,16,20,21). Shorter courses of therapy also encourage compliance and decrease expense and inconvenience (1,3,12,16).Tioconazole is a new imidazole antifungal agent similar to miconazole and clotrimazole. It has a broad spectrum of activity and is more active than other imidazoles against Candida albicans in vitro (10,11,18). In a randomized study of 109 women with vaginal candidiasis, a 3-day course of treatment with 2% tioconazole vaginal cream produced higher cure rates 7 to 10 days (P = 0.01) and 4 weeks (P < 0.05) after therapy than did clotrimazole vaginal tablets (6).Houang and Lawrence reported a mean vaginal concentration of 21.4 ,ug/ml 24 h after insertion of a single 300-mg ovule of tioconazole in 10 patients with vaginal candidiasis (8). This concentration is significantly higher than the MIC (1.6 to 12.5 ,ug/ml) of tioconazole for C. albicans (10). These studies suggest that a single application of the agent could be clinically effective in the treatment of Candida vaginitis.The study reported here was designed to compare the efficacy and acceptability of a single intravaginal application of 6.5% tioconazole ointment (325 mg) with a 3-day regimen of clotrimazole vaginal tablets in women with vulvovaginal candidiasis.(The study was presented in part at the 23rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Las Vegas, Nev., 24 Before admission to the study, written informed consent was obtained from each patient. A medical history was taken, and a physical and gynecological examination, including a Pa...

Placebo-controlled trial of itraconazole for treatment of acute vaginal candidiasis

“…Mycological cure rates for the various azole derivatives range from 50 to 100% when assessed within 15 days of completion of treatment (16). The mycological cure rates observed in the present study were similar to those of other clinical trials of azole antifungal agents used in the treatment of vulvovaginal candidiasis and were comparable to those from a previous study that we conducted with this patient population (26). It was not surprising to discover that approximately one-third of our patients who received placebo capsules had cultures that were negative for Candida species 1 week following treatment.…”

“…Minor side effects, such as burning, irritation, itching, and dyspareunia, can occur with all topical agents (13). The frequency and severity of side effects depends on many factors, including dose, duration of therapy, and individual susceptibility (12,26). In the present investigation, only one patient treated with clotrimazole reported an untoward effect.…”

“…Short courses of therapy with various topical formulations are highly effective and produce few adverse effects (7,26,31). Oral agents, such as fluconazole, are also well tolerated and are as effective as local treatments (19,25).…”

Comparative Study of Fluconazole and Clotrimazole in the Treatment of Vulvovaginal Candidiasis

“…Highdose imidazole derivatives have produced high cure rates with treatment durations as short as one to three days. [18][19][20] In contrast to ketoconazole, the new oral triazole antifungals are well tolerated and short-course therapy is highly effective.vv Women with vaginal candidiasis express a strong preference for short courses of treatment with oral therapy.P-" The use of fluconazole may enhance patient acceptance as well as compliance.T EXTRACTO Fluconazole es un nuevo agente antifungal oral del tipo triazole con buena accion contra las especies de Candida. En este estudio la efectividad y tolerancia de un tratamiento de tres dfas con fluconazole se compare con tabletas vaginales de c\otrimazole en mujeres no embarazadas con vaginitis por Candida.…”

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

“…tioconazole as a single gel formulation applicaton has proved to be well efficacious and safe for the treatment of vaginal candidiasis. 6 Candida albicans though quite often is the main pathogen seen in vulvovaginal candidiasis, various other candida species have also been isolated such as Candida glabrata, candida tropicalis, Candida krusei etc. 7,8 The reported drug resistance to use of clotrimazole is low and while clotrimazole has been the standard treatment offered, newer medication may also be also as effective.…”