EVALUATION OF CLINICAL EFFICACY OF SINGLE DOSE OF VAGINAL PESSARY SERTACONAZOLE VERSUS CLOTRIMAZOLE IN TREATMENT OF UNCOMPLICATED VAGINAL CANDIDIASIS
Journal Title: Journal of Evolution of Medical and Dental Sciences - Year 2018, Vol 7, Issue 38
Abstract
BACKGROUND Sertaconazole is a new imidazole fungicide introduced for vulvovaginal candidiasis. It has an azole group with benzothiophene that inhibits biosynthesis of ergosterol and brings about a massive leak of cytoplasm with consequent fungal cell death. The objective of this study is to evaluate clinical efficacy of single-dose vaginal pessary Sertaconazole versus Clotrimazole in uncomplicated vaginal candidiasis. MATERIALS AND METHODS Patients attending gynaecological and obstetric OPD with a clinical diagnosis of vaginal candidiasis are studied. Vaginal swabs are taken for microscopy and gram staining examination from patients. Patients in Group 1 receives single-dose vaginal pessary Sertaconazole 300 mg and subjects in Group 2 single-dose vaginal pessary Clotrimazole 500 mg. Patients are evaluated at the end of 7 days and 28 days for symptomatic relief, side effect and mycological clearance. Main Outcome Measures: Primary outcome will be clinical cure. Secondary outcome is mycological cure. Study Design- A prospective, non-randomised, controlled parallel trial. Setting- PESIMSR, a tertiary referral centre, Kuppam. RESULTS In gynaecological group, 27.3% of people in sertaconazole group and 77.3% patients in clotrimazole group had symptoms at the end of 7 days. At the end of 28 days only 15.8% in sertaconazole group had symptoms, while 55.6% patients had persisting symptoms in clotrimazole group. Positive vaginal smear was 36.4% at the end of 7 days of treatment while it was 85.7% in clotrimazole group and the proportion of positive smear in sertaconazole group at the end of 28 days was 15.8% while it was 66.7% in clotrimazole group. On gram staining at the end of 7 days 56.5% patients in sertaconazole group had no organisms on gram staining, while only 13.0% in clotrimazole had no organism on smear examination. After 28 days of treatment with 85.0% in sertaconazole group with no organism on gram staining, while only 33.3% patients in clotrimazole group became free of organisms. In obstetric group at the end of 7 days only 39.1% patients in sertaconazole group had symptoms while 66.3% patients in clotrimazole group and at the end of 28 days 4.8% in sertaconazole group had symptoms, while all patients had persisting symptoms in clotrimazole group. Positive vaginal smear was 54.5% at the end of 7 days of treatment, while it was as high as 95.5% in clotrimazole group. Similarly, the proportion of positive smear in sertaconazole group at the end of 28 days came down to 15.0%, while it was still as high as 50.0% in clotrimazole group. On gram staining 47.8% patients in sertaconazole group had no organisms, while only 9.1% in clotrimazole group had no organisms. After 28 days of treatment with 85.7% in sertaconazole group with no organism on gram staining, while only 28.6% patients in clotrimazole group became free of organisms. CONCLUSION In this study, single-dose Sertaconazole was more effective than Clotrimazole in producing symptomatic and mycological clearance in both obstetric and gynaecological group. Because Sertaconazole was given as a single dose, it has additional advantage of better compliance and less emergence of resistance.
Authors and Affiliations
Sabitha Umapathy Srinivasan, Hemalatha Reddy, Pradeep Shivaraju
Keywords
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- EP ID EP548065
- DOI 10.14260/jemds/2018/933
- Views 54
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