[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].

Abstract

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.

• Authors: Victor Godínez, Miguel Garibay, Felio Mirabent, Araceli Pérez Calderón
• Journal: Ginecologia y obstetricia de Mexico (Ginecol Obstet Mex) Vol. 73 Issue 6 Pg. 302-7 (Jun 2005) ISSN: 0300-9041 [Print] Mexico
• Vernacular Title: Comparación de la eficacia de la combinación ketoconazol 400 mg + clindamicina 100 mg, con ketoconazol 800 mg + clindamicina 100 mg en vaginitis por Candida y vaginosis bacteriana.
• PMID: 16309036 (Publication Type: Comparative Study, English Abstract, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Antifungal Agents
• Clindamycin
• Ketoconazole

Topics

• Adolescent
• Adult
• Anti-Bacterial Agents (administration & dosage)
• Antifungal Agents (administration & dosage)
• Candidiasis (drug therapy)
• Clindamycin (administration & dosage)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Ketoconazole (administration & dosage)
• Middle Aged
• Vaginitis (drug therapy, microbiology)
• Vaginosis, Bacterial (drug therapy)