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

Authors

Forouzan Bolouri1, Nasrin Moghadami Tabrizi1, Fatemeh Davari Tanha1, Azra Azmoodeh1, Saeed Emami2, Mehraban Falahati3, Somaye Sharifynia3, Maliheh Safavi4, Abbas Shafiee4, Alireza Foroumadi4,*
1Mirza-kouchak Khan Gynecology Hospital, Tehran University of Medical Sciences, Tehran, Iran
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
*Corresponding Author: Faculty of Pharmacy & Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran. Email:[email protected]

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:Bolouri F, Moghadami Tabrizi N, Davari Tanha F, Azmoodeh A, Emami S, et al. Effectiveness of Fluconazole for Suppressive Maintenance Therapy in Patients with RVVC: a Randomized Placebo-Controlled Study. Iran J Pharm Res. 2022;8(4):e128654. doi: 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).

Highlights

Copyright

© 2022, Author(s). This open-access article is available under the Creative Commons Attribution 4.0 (CC BY 4.0) International License (https://creativecommons.org/licenses/by/4.0/), which allows for unrestricted use, distribution, and reproduction in any medium, provided that the original work is properly cited.

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