Which is better metronidazole or clindamycin




















Learn more. Address correspondence to Barbara A. Majeroni, M. Reprints are not available from the author. Diagnosis and clinical manifestations of bacterial vaginosis. Am J Obstet Gynecol. Bacterial vaginosis in pregnancy and preterm birth: evidence from the literature.

J Int Med Res. Hill GB. The microbiology of bacterial vaginosis. Clue cells in predicting infections after abdominal hysterectomy. Obstet Gynecol. Eschenbach DA. Bacterial vaginosis and anaerobes in obstetric-gynecologic infection. Clin Infect Dis. Plasma cell endometritis in women with symptomatic bacterial vaginosis. The preterm prediction study: fetal fibronectin, bacterial vaginosis, and peripartum infection. Gibbs RS. Chorioamnionitis and bacterial vaginosis.

Bacterial vaginosis and intraamniotic infection. The genital flora of women with intraamniotic infection. Vaginal Infection and Prematurity Study Group. J Infect Dis. Premature rupture of membranes and bacterial vaginosis. Association between bacterial vaginosis and preterm delivery of a low-birth-weight infant.

N Engl J Med. The preterm prediction study: significance of vaginal infections. Abnormal bacterial colonization of the genital tract and subsequent preterm delivery and late miscarriage. Fiscella K. Racial disparities in preterm births. The role of urogenital infections. Public Health Rep. Value of wet mount and cervical cultures at the time of cervical cytology in asymptomatic women.

Characteristics of three vaginal flora patterns assessed by gram stain among pregnant women. Vaginal Infections and Prematurity Study Group. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation.

J Clin Microbiol. Bacterial vaginosis: diagnostic and pathogenetic findings during topical clindamycin therapy. Hillier SL. Diagnostic microbiology of bacterial vaginosis.

Bacterial vaginosis in virginal and sexually active adolescent females: evidence against exclusive sexual transmission. Should male consorts of women with bacterial vaginosis be treated? Genitourin Med.

Coinfection with chlamydia and gonorrhoea among pregnant women with bacterial vaginosis. Clindamycin versus metronidazole in the treatment of bacterial vaginosis. Treatment of bacterial vaginosis: a comparison of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream.

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Prevention of premature birth by screening and treatment for common genital tract infections: results of a prospective controlled evaluation. Obstet Gynecol Sep. Concerns about the teratogenic potential of metronidazole have prompted a search for other effective drugs to treat bacterial vaginosis. This randomized, multicenter European trial compared.

This randomized, multicenter European trial compared 1 week of oral metronidazole mg twice daily with 1 week of 2 percent clindamycin vaginal cream once daily in nonpregnant women.

Each group concurrently took a placebo to mimic the opposite treatment. Although women were enrolled, only had complete follow-up evaluations at 25 to 39 days. All others were excluded from the efficacy analysis for reasons such as noncompliance, loss to follow-up, or return visits made at the wrong time. There was no difference in observed follow-up between the treatment groups placebo One month BV recurrence NS 7—10 rates were 3.

Hazard ratios HR for BV recurrence at month were 0. At six months, there was an overall cumulative BV recurrence rate of The unadjusted HR for BV-recurrence for vaginal clindamycin and the vaginal probiotic compared to placebo were 1. When adjusted for adherence to vaginal therapy as previously defined, the HRs for BV recurrence at six months compared to placebo were unchanged at 1. Four hundred and eight women were included in the secondary analysis. The HRs for one and six month BV recurrence, adjusted for adherence to vaginal therapy, are shown in table 4 , and at each time point neither treatment group was superior to placebo.

Self-reported adverse effects are shown in Table 3. These findings suggest that combining first line regimens and achieving broader spectrum antibiotic coverage does not improve the clinical outcome above a standard course of oral metronidazole.

This is the first placebo-controlled RCT to evaluate the effect of combining oral metronidazole with vaginal clindamycin. Metronidazole is active against anaerobes, whereas clindamycin has broader spectrum activity against Gram-positive aerobes and anaerobes. The microbial flora pattern following treatment with clindamycin differs to metronidazole, with greater reduction in Mobiluncus spp and higher frequency of clindamycin-resistant anaerobes [14] , [15] , [16].

Meltzer also confirmed the relative resistance of Mobiluncus spp to metronidazole therapy, and showed their persistence was associated with increased risk of BV recurrence [17]. Based on these data and the polymicrobial nature of BV, one might postulate that higher cure rates could be reached by combining metronidazole and clindamycin.

The combination has the potential to achieve i broader spectrum activity against possible aetiological agents and other BV-associated bacteria that may contribute to symptomatology and sequelae, ii reduction in the selection of macrolide-resistant species, and iii high concurrent vaginal and systemic levels of antibiotic to promote more effective clearance of BV-associated bacteria. Conversely, combination therapy could have resulted in higher rates of adverse effects.

We found no therapeutic benefit from combining first line therapies, but also no increase in adverse symptoms, particularly symptomatic candidiasis, in the combination antibiotic arm. Importantly, ongoing analysis will assist in determining whether any behavioural factors play a significant role in recurrence following treatment. This product demonstrated improved restoration of normal vaginal-flora in two studies in BV-positive women [6] , [7].

Probiotic therapies are emerging as popular over-the-counter treatments for vaginal candidiasis and BV. As loss of Lactobacillus spp in the vagina is a characteristic of BV, it is thought that lactobacillus-probiotics may support restoration of the normal lactobacillus-dominant state. Several vaginal Lactobacillus spp have host protective characteristics, including hydrogen peroxide, lactic acid and biosurfactant production, antimicrobial activity, and coaggregation with pathogens [18] , [19].

While a considerable number of probiotic studies have been conducted, the lactobacillus species in the probiotics have varied substantially in their characteristics, their ability to colonise the vagina [20] , and adherence to vaginal epithelial cells [21]. A Cochrane review found that only 4 RCTs, including the trial by Parent [7] , met the inclusion criteria for a systematic review [5] , and substantial heterogeneity in products, trial methodologies and outcome measures meant that there was insufficient evidence to establish the role of probiotics in BV.

More recent observational data using prolonged repetitive courses of lactobacillus-probiotics appear to show more promise than short courses [22] , [23] , [24]. Another important advance in the field has been the development of a probiotic containing a human hydrogen-peroxide producing L.

However, large-scale well-designed clinical trials with standardized outcomes to enable direct comparison between probiotics is a priority to advance the field [5]. An important limitation of this trial was that the products and formulations could not be identical in duration and appearance.

Clindamycin ovules are not available in Australia so investigators used the cream. The probiotic could only be obtained as a pessary and the decision was made to match the placebo to this pessary.

Considerable care was therefore taken with concealment of the nature of the vaginal therapy. Participants were not given any trade-names or information to enable them to link a product with its appearance or duration of therapy, and the placebo could not be distinguished from the probiotic. Trial medications were in plain packaging, sealed in opaque boxes and participants were instructed to open their kits at home. No study staff had access to the randomization schedule and the primary and secondary outcome of the trial was the Nugent score, determined by blinded microscopists with no access to any other trial data.

Another important aspect of the trial was that the Nugent method was used to assess the endpoint of BV as it is widely considered to be the most objective diagnostic measure, is relevant and generalizable to clinical trials, and is suited to extended follow-up in the community. The limitation of this approach is that some participants with symptoms of BV, but intermediate flora, were considered as non-recurrent on the basis of the strict Nugent criteria defined primary outcome NS 7—10 ; these cases were counted as recurrent cases in the secondary analysis of abnormal flora.

The use of the Nugent method is therefore likely to result in an under-estimation of the recurrence rate of clinically-evident BV, as a proportion of women with intermediate flora will have BV on the Amsel criteria. Importantly, the aim of this study was not to determine the clinical recurrence rate of BV, but to determine if the recurrence rates differed between treatment groups, and participants with clinically relevant symptoms not captured by the primary outcome measure did not differ between treatment groups.

The strengths of our trial include that it was a large RCT with sufficient power to detect a clinically meaningful difference in efficacy between the treatment groups. The groups were well-balanced for demographic and behavioural characteristics at baseline, and we collected detailed epidemiological data to determine if behavioural characteristics are associated with recurrence, which is the subject of future planned analyses. We applied the gold standard Nugent method to all slides to ensure generalizability of our findings, and have an ongoing quality assurance programme to ensure consistency between our experienced microscopists.

We performed extended follow-up for six months with frequent evaluations which would have detected early non-sustained differences between the arms if they had occurred. High levels of adherence were reported to oral and trial medication.

This trial shows no additional benefit from combining oral metronidazole with vaginal clindamycin cream or a commercially available vaginal- L. Current internationally recommended treatments are delivered as monotherapies, but have not achieved high sustained cure rates whether used for a week or in suppressive or periodic presumptive regimens.

There is a well-recognized need for more effective management of both initial and recurrent BV, both to alleviate symptoms and to reduce its adverse the sequelae. How integral behavioural factors are in the development and recurrence of BV is still not completely understood, and remains an important area of research to advance our management of this common condition. We would like to acknowledge and thank Surbhi Bird Melbourne Sexual Health Centre for her assistance in ensuring the trial medications were packed according to the randomization schedule, Irene and Leonie Horvath Melbourne Sexual Health Centre for assisting with microscopy for the trial, Lyle Gurrin School of Population Health, University of Melbourne for his biostatistical advice, and Philipp Grob and Valda Prasauskas from Medinova for providing the probiotic and placebo that were evaluated in the trial, and for providing comments on the manuscript whilst under preparation.

Browse Subject Areas? Click through the PLOS taxonomy to find articles in your field. Conclusion Combining the recommended first line therapies of oral metronidazole and vaginal clindamycin, or oral metronidazole with an extended-course of a commercially available vaginal- L. Interventions Participants received mg twice daily of oral metronidazole for 7 days, and were randomly assigned to a vaginal intervention placebo, clindamycin, or probiotic.

Outcomes The primary outcome measure was recurrence of BV NS 7—10 within six months, assessed at 1, 2, 3 and 6 months following the intervention by participant self-collected vaginal-smears. Randomization, Allocation concealment, Implementation and Blinding Participants were randomly assigned to one of three study arms in blocks of 15 using a computer-generated sequence. Follow-up and retention At each follow-up, participants were posted a kit containing a questionnaire, self-swabbing instructions, an encased-Dacron swab and glass slide to self-smear.

Download: PPT. Table 1. Numbers analysed Participants were analysed according to their randomized groups.



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