OBJECTIVES: To compare efficacy, safety and patient preference of a single oral dose of 150 mg fluconazole with a single intravaginal dose of 1200 mg miconazole in vaginal candidosis. To investigate the effect of treatment on Candida colonization of throat and rectum. DESIGN: Double-blind, double-dummy, parallel, randomized trial. Ninety-nine patients with symptomatic and mycologically verified candidosis were given 150 mg fluconazole with an intravaginal dummy, or 1200 mg miconazole with an oral dummy. Patients with an inadequate short-term response were given a second dose. RESULTS: At each visit a patient self assessment and an investigators' global assessment were recorded, and cultures were set up. Adverse events were recorded and laboratory tests were performed. Clinical cure or improvement (investigators' assessment) was obtained in 100% (short-term) and 95% (long term) of the fluconazole group and in 94% and 90%, respectively, of the miconazole group. Patients considered the treatment excellent or good in 81% (short-term) and 88% (long-term) in the fluconazole group and in 84% and 76%, respectively, of the miconazole group. Mycological cure was achieved in 98% (short-term) and 73% (long-term) of the fluconazole group and in 96% and 82% respectively in the miconazole group. The differences in results were not significant. Both treatments significantly reduced the number of positive rectal cultures: neither treatment had a significant effect on throat cultures. Four percent of the patients preferred intravaginal therapy. CONCLUSION: A single dose fluconazole is as safe and effective as a single dose of miconazole.
RCT Entities:
OBJECTIVES: To compare efficacy, safety and patient preference of a single oral dose of 150 mg fluconazole with a single intravaginal dose of 1200 mg miconazole in vaginal candidosis. To investigate the effect of treatment on Candida colonization of throat and rectum. DESIGN: Double-blind, double-dummy, parallel, randomized trial. Ninety-nine patients with symptomatic and mycologically verified candidosis were given 150 mg fluconazole with an intravaginal dummy, or 1200 mg miconazole with an oral dummy. Patients with an inadequate short-term response were given a second dose. RESULTS: At each visit a patient self assessment and an investigators' global assessment were recorded, and cultures were set up. Adverse events were recorded and laboratory tests were performed. Clinical cure or improvement (investigators' assessment) was obtained in 100% (short-term) and 95% (long term) of the fluconazole group and in 94% and 90%, respectively, of the miconazole group. Patients considered the treatment excellent or good in 81% (short-term) and 88% (long-term) in the fluconazole group and in 84% and 76%, respectively, of the miconazole group. Mycological cure was achieved in 98% (short-term) and 73% (long-term) of the fluconazole group and in 96% and 82% respectively in the miconazole group. The differences in results were not significant. Both treatments significantly reduced the number of positive rectal cultures: neither treatment had a significant effect on throat cultures. Four percent of the patients preferred intravaginal therapy. CONCLUSION: A single dose fluconazole is as safe and effective as a single dose of miconazole.
Authors: Isabel Del-Cura González; Francisca García-de-Blas González; Teresa Sanz Cuesta; Jesús Martín Fernández; Justo M Del-Alamo Rodríguez; Rosa A Escriva Ferrairo; M Del Canto De-Hoyos Alonso; Laura Balsalobre Arenas; Ricardo Rodríguez Barrientos; Elisa Ceresuela Wiesmann; Cristina De-Alba Romero; Yolanda Ginés Díaz; Ana Pastor Rodríguez-Moñino; Blanca Gutiérrez Teira; Marta Sánchez-Celaya Del Pozo; Jesús Fernández Horcajuelo; María J Rojas Giraldo; Paulino Cubero González; Rocío A Vello Cuadrado; Beatriz López Uriarte; Jeannet Sánchez Yepes; Yolanda Hernando Sanz; M José Iglesias Piñeiro; Susana Tudanca Hernández; Fernando Gallardo Alonso; Ana I González González; Alicia Simón Fernández; Carmen Carballo; Ana Rey López; Fernanda Morales; Dolores Martínez López Journal: BMC Public Health Date: 2011-01-31 Impact factor: 3.295
Authors: Hayley J Denison; Julia Worswick; Christine M Bond; Jeremy M Grimshaw; Alain Mayhew; Shakila Gnani Ramadoss; Clare Robertson; Mary Ellen Schaafsma; Margaret C Watson Journal: Cochrane Database Syst Rev Date: 2020-08-24