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Combo no better than monotherapy for BV: from a congress of the international society for sexually transmitted diseases research.

QUEBEC CITY--Oral metronidazole was not more effective for bacterial vaginosis when combined with clindamycin or a probiotic, according to a study of data involving 450 women.

"Bacterial vaginosis is the most common cause of infections in women worldwide," said Dr. Catriona Bradshaw of the University of Melbourne.

Current ` treatments are not highly effective, and up to 50%-60% of women have recurrent bacterial vaginosis (BV) after treatment.

Dr. Bradshaw and her colleagues examined whether a combination of oral and vaginal therapy could be more effective.

Data on the efficacy of vaginal probiotics for BV are limited, said Dr. Bradshaw. But the growing awareness of and interest in probiotics helped drive the study, she said.

Dr. Bradshaw and her associates randomized 150 women to each of three treatments: oral metronidazole plus vaginal clindamycin, oral metronidazole plus a vaginal probiotic, or oral metronidazole plus a placebo.

The women ranged in age from 18 to 50 years. All of them had bacterial vaginosis, and none of them were HIV positive.

There were no significant demographic or behavioral differences among the three groups of women, said Dr. Bradshaw, who presented the findings at the meeting.

Overall, 382 (85%) of the women had baseline Nugent scores of 7-10--which is considered highly positive for bacterial vaginosis--on a scale of 0-10.

In the intent-to-treat population, the cumulative 6-month BV recurrence rate was 28%.

The hazard ratio for BV recurrence at 6 months post treatment was 1.09 for the clindamycin group and 1.03 for the probiotic group, compared with 1.00 for the placebo group, Dr. Bradshaw noted.

The cumulative 6-month recurrence rate for abnormal vaginal flora was 54%, and the hazard ratio for the recurrence of abnormal flora was 1.01 for the clindamycin group and 0.97 for the probiotic group, compared with 1.0 for the placebo group.

The self-reported adherence to vaginal therapy in the clindamycin, probiotic, and placebo groups was 88%, 77%, and 78%, respectively, and to oral metronidazole was more than 90% for all three study arms, according to Dr. Bradshaw

The most common self-reported side effect was vaginal itching or soreness, reported by approximately one-third of the patients in each treatment group.

"The implications for clinicians are to keep an open mind about BV and to keep an eye on the literature to look for improved therapies," she said. Also, clinicians should inform patients about the limitations of current therapies. 'A lot of women are quite disappointed when their BV comes back," she said.


Major Finding: After 6 months of treatment, the hazard ratio for BV recurrence was 1.09 for the clindamycin group and 1.03 for the probiotic group, compared with 1.00 for the placebo group when each of these treatments was combined with oral metronidazole.

Data Source: A randomized, double-blind placebo-controlled trial of 450 women aged 18-50 years.

Disclosures: Dr. Bradshaw said she had no relevant financial disclosures.
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Title Annotation:WOMEN'S HEALTH
Author:Splete, Hedi
Publication:Internal Medicine News
Date:Sep 1, 2011
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