A prospective study was conducted at a tertiary care hospital in Pune city, India over a period of two years between October 2014 and September 2016 on 100 consecutive symptomatic patients diagnosed with vulvovaginal candidiasis. The ethical committee approval was obtained prior to the commencement of the study. Power analysis of the study was done keeping the prevalence of vulvovaginal candidiasis as 66% [4] and an alpha error of 5%, 50 patients in each group were required in order to achieve 80% power. Written informed consent was obtained from all the patients enrolled in the study. The inclusion criteria were symptomatic patients in reproductive age group (18-45 years) with diagnosed candidiasis (on microscopic examination) who agreed to avoid sexual intercourse during the study period and exclusion criteria was pregnant females, recently biopsied or operated cervix, vaginitis due to some other cause, history of previous treatment with antifungal agents within past four weeks, un-controlled diabetes, history of chronic illness, past history of hypersensitivity to imidazole agents, patients on antibiotic/immunosuppressant therapy.

The patients were randomised using the closed envelope technique where in the patients were asked to open a closed sealed opaque envelope once the diagnosis of candidiasis was confirmed and two groups were formed. The microscopic examination was done on the specimens obtained from the posterior fornix by wet mount (bamboo shoots cluster appearance with 10% KOH) and gram stain (presence of pseudopyphaes and positive budding yeasts) techniques. These patients were informed in detail about the study protocol and subsequent follow-ups. Those who consented for the same were included in the study. Group A (n=50) patients were treated with single dose sertaconazole and group B (n=50) patients were treated with multi dosage clotrimazole pessaries. Patients in group A were taught to self insert single dose of 500 mg sertaconazole at bed time and group B were treated using 500 mg clotrimazole pessaries once a day for three days. All the patients were followed up after two weeks of treatment to assess their condition. A local examination was repeated at one, two and four respectively to check for recurrence. All the patients underwent microscopic examination to determine the presence of Candida species. The final evaluation was interpreted in terms of improvement in symptoms i.e., (Pruritis and discharge) when compared to the first visit and decrease in the number of counts on microscopy. There was no lost to follow-up in the present study.

All the collected data was entered in Microsoft Excel Sheet 2007. The data was then transferred and analysed using SPSS ver. 21. Qualitative data was represented in the form of frequency and percentage while quantitative data was represented using Mean±SD. Appropriate statistical tests was applied based on the type and distribution of data. A p-value of <0.05 was taken as level of significance.

As per the demographic parameters, the mean age of the patients was 28.7±5.3 years, body height was 156±4.3 cm and body weight was 63.7±6.8 Kg. The average duration between the appearance of symptoms and consultation was 14.8±7.6 days. Majority of the patients were married (84%) followed by unmarried (13%) and widowed/separated (3%). The prevalence of candidiasis was most amongst the housewife’s accounting for 64.3%. There was no statistically significant difference between both the groups in terms of socio-economic status, literacy rate. The response to the drug administration and clinical and microbiological response is shown in [Table/Fig-1,2]. There was no statistically significant difference in the response between both the drugs. At the end of six weeks, 14% of the patients in group A and 18% of patients in group B had recurrence of symptoms which was not statistically significant (p=0.7578) and thus were treated using oral fluconazole.

Vulvovaginal candidiasis results from overgrowth of various Candida spp. which is usually a normal commensal organism of vagina [1,5,8] and is the second most common cause of vaginitis in the reproductive age group. It has been further uncomplicated (~90%) or complicated (~10%), based on microbiological findings, host factors, and response to therapy. Uncomplicated vulvovaginal candidiasis is usually sporadic or infrequent (≤3 episodes per year) with mild to-moderate symptoms caused by C. albicans, which are responsive to all forms of antifungal therapy, including short-course therapy in immunocompetent women. Complicated Vulvovaginal candidiasis includes severe cases, associated with pregnancy or any concomitant conditions such as immunosuppression or diabetes [8-10].

Approximately 30% of symptomatic women remained undiagnosed after clinical evaluation [11]. The most common symptoms in patients with vulvovaginal candidiasis are severe pruritis and burning like sensation accompanied by whitish discharge. Often these symptoms can give rise to secondary problems such as dyspareunia and dysuria [2,9,10]. Odds FC et al., reported that among the many signs and symptoms of vulvovaginal candidiasis, pruritis and vaginal discharge showed a tendency to be correlated with the numbers of Candida in the vagina [12]. Although it has been described as “cottage cheese-like” in character, the discharge may vary from being watery to homogenously thick [2,11,12]. In present study, most common complaint in subjects of vulvovaginal candidiasis was white discharge (100% cases) followed by pruritis (91%) and dysuria (30%). In a study by Verma K et al., white discharge was seen in all patients, while pruritis and dysuria was seen in 85% and 42% patients respectively [13]. Similar observation was made by Roongpisuthipong A et al., and Wang PH et al., [14,15]. Physical examination usually reveals erythema and swelling of the labia and vulva with normal cervix. Vaginal erythema is present, together with an adherent off-white discharge typically just prior to menses [16]. In addition to clinical symptoms, an accurate diagnosis also depends on the demonstration of Candida in vaginal swabs using vaginal pH measurement, microscopic examination, and/or fungal culture [2,8,10,17].

Acute candidalvulvo-vaginitis can be successfully treated with azole antifungal agents belonging to the azole group due to low level of resistance. These antifungals agents are usually administered as a single dose (fluconazole 150 mg) or as a pessary in a single or three day regimens. In patients with uncomplicated either therapy has shown to be equally efficacious. Topical antimycotic treatment with antifungal drugs is usually the therapy of choice in vulvovaginal candidiasis since oral drugs can have potential adverse effects like gastrointestinal disturbances and hepatotoxicity [18,19]. Various studies have shown that oral fluconazole is as effective as seven days of intravaginal clotrimazole therapy for Candida vaginitis and should be reserved for non-responders [20,21].

Sertaconazole is the first compound to bring a new chemical structure: benzothiophene 3,7- di substituted, together with the already known azole matrix [22]. Its efficacy, tolerability, and safety have been widely demonstrated in previous preclinical and clinical studies [15,23]. Sertaconazole has been shown to have a powerful antifungal activity both in vitro and in vivo on a broad spectrum of fungi, especially on dermatophytes (Trichophyton, Microsporum, Epidermophyton) and pathogenic yeasts (mainly against C. albicans and C. tropicalis) [15]. In a study by Wang PH et al., Dellenbach P et al., and Torres J et al., single dose sertaconzaole was enough in treatment of vulvovaginal candidiasis [15,23,24]. Similar finding was noted in the present study.

Small sample size remains one of the limitations of the present study.

Although sertaconazole and clotrimazole has not shown statistically significant difference, it can be a wise option to prefer sertaconazole with respect to its single dosage regime, convenience and better acceptability in uncomplicated cases of vulvovaginal candidiasis.