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[Comparison of efficacy of combination of ketokonazol 400 mg + clindamycin 100 mg with ketokonazol 800 mg + clindamycin 100 mg in the treatment of vaginitis due to Candida and bacterial vaginosis]

Author(s): Godinez V, Garibay M, Mirabent F, Perez Calderon A

Affiliation(s): UMAE Hospital de Gineco-Pediatria num. 48, Centro Medico Nacional del Bajio, IMSS, Leon, Guanajuato.

Publication date & source: 2005-06, Ginecol Obstet Mex., 73(6):302-7.

Publication type: Randomized Controlled Trial

OBJECTIVE: To evaluate the effectiveness of the combination of ketoconazol 400 mg + clindamycin 100 mg for 6 days compared to ketoconazol 800 mg + clindamycin 100 mg in Candida vaginitis and bacterial vaginosis. MATERIAL AND METHODS: Patients aged 18-60 years, with clinical diagnosis of Candida vaginitis and vaginosis confirmed by culture of genital secretions were included. Patients were assigned at random to one of two treatment groups: group 1 was given ketoconazol 400 mg + clindamycin 100 mg during six days (K/C6D); group 2 received ketoconazol 800 mg + clindamycin 100 mg for three days + placebo during three days (K/C3D). Patients were evaluated at days 7 and 11 after initiating treatment, at day 11 culture of vaginal secretion was repeated; along with treatment and follow up period patients were asked to report presence of adverse events. RESULTS: Eighty-two patients were included, 41 in K/C6D group and 40 in K/C3D group. C. albicans was found at baseline in 19 patients in K/C6D group and in 15 in K/C3D group; at day 11 was cultured in 2/19 patients (10.52%) and in 2/15 (13.33%) (p = 0.626) respectively; G. vaginalis was cultured at baseline in 25 patients of each group, at day 11 was cultured in 1/25 patients (4.0%) of K/C6D group and in 4/ 25 (16.0%) of K/C3D group (p = 0.174). Clinical cure was found in 36/41 cases (87.8%) of K/C6D group and in 34/40 cases (85.00%) of K/C3D (p = 0.965) group. Only five patients presented adverse events, of which three were related to the treatment. CONCLUSION: Treatment of vaginitis and bacterial vaginosis with anyone of both formulations has the same clinical and microbiological effectiveness, and is well tolerated by the patient. The fact that K/C3D formulation is as effective as K/C6D has the advantage of shortening the treatment time of vaginal infections, and allows a better patient compliance.

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