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A Comparison of Butoconazole Nitrate Cream with Econazole Nitrate Cream for the Treatment of Vulvovaginal Candidiasis

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A Comparison of Butoconazole Nitrate Cream with Econazole Nitrate Cream for the Treatment of Vulvovaginal Candidiasis The Journal ofInternational Medical Research 1990; 18: 389 - 399 A Comparison of Butoconazole Nitrate Cream with Econazole Nitrate Cream for the Treatment of Vulvovaginal Candidiasis 2 H. RuCI and M. Vitse 'Belle de Mai Maternity Hospital, Marseille, France; 2Gynaecology and Obstetrics Clinic, Amiens, France In a randomized, single-blind, parallel study the safety and efficacy of 2% butoconazole nitrate cream used for 3 days were compared with those of 1% econazole nitrate cream used for 7 days at night in patients with vulvovaginal candidiasis. Patients in both treatment groups had positive potassium hydroxide smears and fungal cultures, and were similar in age, disease duration and history, obstetric history and contraceptive use. Of the 75 patients enrolled, 63 with a Candida albicans infection were included in the efficacy analyses. Evaluations were made at the start of the study (visit 1), after 10 - 23 days (visit 2) and after 24 - 45 days (visit 3). Both drugs significantly reduced all signs and symptoms, and at visits 2 and 3 the percentages of patients considered microbiologically, clinically and therapeutically cured were consistently higher for butoconazole- than for econazole-treated patients, although differences were not statistically different. Al­ though both drugs were safe and well tolerated, it is concluded that butoconazole because of its much shorter regimen and superior clini­ cal and microbiological performance was the drug of choice. Lors d'une etude parallele randomisee en simple aveugle, I'Innoculte et I'efflcacite du nitrate de butoconazole creme a2% applique pendant 3 jours ont ete comparees acelles du nitrate d'econazole creme a 1% administre la nuit pendant 7 jours a des patientes presentant une candidose vulvo-vaginale. Les deux groupes presentaient des cultures et des frottis a I'hydroxyde de potassium positifs et etaient compar­ abies au point de vue age, duree et evolution de I'infection, antecedents obstetrtcaux et utilisation de contraceptifs. Surles75 patientes traitees, Received for publication 24 May 1990; accepted I June 1990. Address for correspondence: Professor M. Vitse, Chefdu Service de Gynecologie Obstetrique, Clinique de Gynecologie Obstetrique, 80000 Arniens, France. © Copyright 1990 by Cambridge Medical Publications Ltd 389 H. Ruf, M. Vitse 63 presentant une infection a Candida albicans ont ete incluses dans I'analysis d'efficacite. Des evaluations ont ete effectuees au debut de I'etude (visite 1), apres 10 a 23 jours (visite 2), et apres 24 a 45 jours (visite 3)~ Les deux medicaments ont nettement redult tous les signes cliniques et les symptemes, et lors des visites 2 et 3 les pourcentages de patientes considerees comme microbiologiquement, cliniquement et therapeutiquement guertes etaient regulierement plus eleves chez celles traitees avec Ie butoconazole que chez celles traitees avec I'econazole, bien que lesdifferences n'aient pas ete statistiquementsig­ nificatives. Comme les deux produits se sont reveles sans danger et ont ete bien toleres,nous conclusons que Ie butoconazole, acause de son effet beaucoup plus rapide et de ses performances c1iniqueset micro­ biologiques superieures, constitue Ie traitement de cholx, KEY WORDS: Butoconazole; econazole; vulvovaginal candidiasis; Candida albicans. INTRODUCTION In the 1930s douches of mercury bichloride he incidence of vaginal candidiasis, a were used, whereas later gentian violet was T common persistent infection whose the most effective chemical preparation signs and symptoms consist of vulval itch­ available. Since 1955 antifungal agents ing, burning, erythema and vaginal dis­ have come into use! and the synthetic charge, has risen markedly over the past 30 imidazole antimycotics were introduced - 40 years. 1 The species most frequently in the early 1970s, miconazole nitrate, an giving rise to vaginitis is Candida albicans, arylethylimidazole, and clotrimazole, a but C. tropicalis is another common source (poly)aryl-methylimidazole, being the of infection; C. pseudotropicalis, C. krusei, first imidazole derivatives to appear. C. parakrusei, C.stellatoidea and C. guil­ Imidazoles, which act by disrupting the cell liermondii are rarely involved. I membrane systems," have proved to be Less than 50% of the patients who har­ highly effective, providing higher cure rates bour Candida in the vagina have clinical and lower recurrence rates than previous symptoms requiring treatment. Factors treatments, and they also have been suc­ affecting vaginal secretion and thereby the cessful in patients who did not respond to vaginal environment are of prime signifi­ other antifungal agents. cance in host susceptibility and the occur­ Extensive clinical trials have been car­ rence of symptoms; some of the most im­ ried out comparing topical clotrimazole, portant predisposing factors are pregnancy, miconazole and econazole, all of which are the hormone pattern that exists just prior to available as a cream or as vaginal tablets, menstruation, use of oral contraceptives or for the treatment of vaginal candidiasis. broad-spectrum antibiotics, and diabetes This method of treatment has the advantage mellitus.' that systemic absorption from the vaginal After identifying the cause of vaginal mucosa is negligible (ranging from 0.017% candidiasis, therapy consists of the topical to 0.09% of the applied dose per litre of application of candidacidal agents to plasma) after topical application in either destroy vulvovaginal Candida infections. animals" or humans.' 390 Butoconazole vs econazole in vulvovaginal candidiasis Since many women frequently discon­ treatment periods, with a minimal recur­ tinue treatment as soon as they feel better, rence of infection after the treatment has they tend to suffer relapses of the disease ended: 8 days after completion oftreatment and there are also women who, for what­ negative fungal cultures were obtainedfrom ever predisposing factors, suffer from re­ 98% of patients who had been treated with current vulvovaginal candidiasis. The ideal 2% butoconazole nitrate vaginal creamonce approach, therefore, would be to have a daily for 6 days and use of a 1% butocon­ short-term treatment that would quickly azole nitrate cream resulted in negative eliminate the Candida organism. Treat­ cultures from 91% ofpatients. 12 When treated ment has traditionally involved a 14-day with 2% miconazole nitrate, 83% of pa­ regimen; however, an increase in the dos­ tients were culture-negative after 8 days. age has allowed shorter periods of treat­ Even after 30 days negative cultures were ment and studies have shown that 7 - 10 found in 80% of those treated with either days' treatment can result in equivalent 1% or 2% butoconazole cream and in 68% curerates5andevenshortertreatmentperi­ of the miconazole treatment group, with ods have been reported to be successful.v" rapid relief of clinical symptoms accompa­ Econazole nitrate, an imidazole anti­ nying the microbiological cure. A cream fungal agent introduced in the mid 1970s, is containing 2% butoconazole nitrate applied structurally very similar to miconazole." to the vagina for only 3 days gave results Applied as a I% vaginal cream it has been that were practically identical to those compared with 100 mg clotrimazole vagi­ achieved after 7 days' treatment with a 2% nal tablets, eachused once daily for 7 days.? miconazole nitrate cream." A comparison These two fungicides when followed up for of 2% butoconazole nitrate cream treat­ 1 month were equivalent in their mycologi­ ment for 3 days with 200 mg/day clotrima­ cal cure rates and in relieving the clinical zole vaginal tablets given for 3 days showed symptoms related to vulvovaginal candidi­ that the butoconazole cream was at least as asis. effective as the clotrimazole vaginal tab­ Butoconazole nitrate (Femstar" ) devel­ lets." oped specifically as an anticandidal agent, The purpose of the present study was to is a new potent vaginal antifungal agent assess the safety and efficacy ofa 2% buto­ based on l-tphenylbutyljimidazole.'? conazole nitrate cream applied to the va­ In animal studies, butoconazole has gina for 3 days and to compare it with a 1% displayed a greater affinity for C. albicans econazole nitrate cream used for 7 days. than for dermatophytes10 and in vivo assays comparing it with known agents have PATIENTS AND METHODS indicated its marked superiority in Patients combating C. albicans. II In experimentally Patients exhibiting the objective signs and induced Candida infections in animals, bu­ symptoms compatible with vulvovaginal toconazole was distinctly superior to mi­ candidiasis were eligible. To be included in conazole and clotrimazole, both in terms of the trial it was necessary to demonstrate quickly clearing infections and preventing conidia and filaments ofCandida by micro­ relapse. 10 scopic examinationofvaginal material mixed In humans, butoconazole has provided with potassiumhydroxide and also to detect consistently high cure rates even after short growth of Candida on an appropriate my­ cobiotic medium. Women with trichomonads or clue cells Femstar" is the registered tradename of Syntex detected using wet mount microscopy were Laboratories, Inc, USA. not eligible for the study, since these 391 H. Ruf, M. Vitse findings indicated the presence of Tricho­ gator to identify the presence ofthe pseudo­ monas vaginalis and Gardnerella vaginalis. hyphae of Candida, which were detected Also excluded were women with any gy­ using low- and high-magnification micros­ naeco- logical abnormality requiring treat­
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