Effectiveness of Fluconazole for Suppressive Maintenance Therapy in Patients with RVVC: a Randomized Placebo-Controlled Study

2Department of Medicinal Chemistry and Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran

3Department of Parasitology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran

4Faculty of Pharmacy & Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran

IJ Pharmaceutical Research:Vol. 8, issue 4; 307-313

Published online:Nov 20, 2010

Article type:Research Article

Received:Mar 01, 2009

Accepted:Jun 01, 2009

How to Cite:Forouzan BolouriNasrin Moghadami TabriziFatemeh Davari TanhaAzra AzmoodehSaeed EmamiMehraban FalahatiSomaye SharifyniaMaliheh SafaviAbbas ShafieeAlireza Foroumadiet al.Effectiveness of Fluconazole for Suppressive Maintenance Therapy in Patients with RVVC: a Randomized Placebo-Controlled Study.Iran J Pharm Res.8(4):e128654.https://doi.org/10.22037/ijpr.2010.827.

Abstract

Recurrent vulvovaginal candidiasis (RVVC) is seen in 5% of women with Candida vaginitis. Use of fluconazole as prophylactic treatment has been suggested for RVVC. The aim of the present study was to evaluate the efficacy of fluconazole suppressive therapy in RVVC patients, as a randomized, placebo-controlled, double-blind prophylactic study. Among the 330 women with acute symptomatic vulvovaginal candidiasis referred to Mirza-kouchak Khan gynecology hospital, 64 eligible subjects with RVVC were enrolled. Then, all of them were treated with fluconazole (150 mg orally every 3 days, for three doses). This was followed by microscopical and clinical examination. Next, patients were randomly divided into two groups. In the fluconazole group (n = 32), patients received fluconazole 150 mg, per week for 6 months and in the control group (n = 32) they received placebo. All the patients were revisited on a monthly basis and at the end of treatment, as well as 3 and 6 months after treatment. At the end of treatment, the frequency of positive culture in fluconazole group was significantly lower than the placebo group (25% vs. 62.5%, P = 0.05). Furthermore, the rate of clinical recurrence was significantly lower in the fluconazole group,with respect to the placebo group (18.8% vs. 50%, P = 0.017). However, following band 6 months after treatment, patients who received fluconazole maintenance therapy had a non-significant differences, compared to the placebo group, based on the rate of clinical recurrence or the frequency of positive cultures. Resistance to fluconazole (MIC ≥ 64) was comparable between groups. Despite the fact that fluconazole is well tolerated by the patients, suppressive treatment with fluconazole in RVVC patients had an insufficient effect on prevention from recurrence of clinical signs and the improvement of vaginal mycological status in long term (3-6 months after treatment).

Keywords

Fluconazole

Suppressive therapy

Recurrent vulvovaginal candidiasis (RVVC)

Randomized clinical study

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Author(s):

Forouzan Bolouri:[PubMed][Scholar]
Nasrin Moghadami Tabrizi:[PubMed][Scholar]
Fatemeh Davari Tanha:[PubMed][Scholar]
Azra Azmoodeh:[PubMed][Scholar]
Saeed Emami:[PubMed][Scholar]
Mehraban Falahati:[PubMed][Scholar]
Somaye Sharifynia:[PubMed][Scholar]
Maliheh Safavi:[PubMed][Scholar]
Abbas Shafiee:[PubMed][Scholar]
Alireza Foroumadi:[PubMed][Scholar]