Combined oral contraceptive pill-exposure alone does not reduce the risk of bacterial vaginosis recurrence in a pilot randomised controlled trial

Vodstrcil, Lenka A; Plummer, Erica L; Fairley, Christopher K; Tachedjian, Gilda; Law, Matthew; Hocking, Jane S; Worthington, Karen; Grant, M; Okoko, Nita; Bradshaw, Catriona S

doi:10.1038/s41598-019-39879-8

Cited by 26 publications

(35 citation statements)

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“…However, reviews of the early partner treatment trials also highlighted the significant issues that render their findings inconclusive [10,18,19]. Since the publication of these partner-treatment trials, an increasing body of epidemiological data shows women with a regular partner are more likely to experience post-treatment recurrence compared to women with no partner or a new posttreatment partner [8,20,21], and microbiological data supports transmission or exchange of BV-associated bacteria (henceforth referred to as BV-organisms) during sexual activity [22][23][24][25][26][27]. Notably, BV-organisms are more prevalent in the sub-preputial space (under the foreskin) and distal urethra of male partners of females with BV than without BV [22,26], and recently, the composition of the meatal microbiota was shown to be particularly predictive of incident BV in female partners [24].…”

Section: Background and Rationalementioning

confidence: 99%

Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

et al. 2020

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Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

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Section: Background and Rationalementioning

confidence: 99%

Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

et al. 2020

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“…We previously conducted the Strategies to Prevent BV (STOPBV) study, a pilot randomised controlled trial (RCT) investigating the use of the combined (estrogen and progesterone) oral contraceptive pill (COCP) to reduce BV recurrence following antibiotic treatment. While COCP‐exposure did not improve BV‐cure in the pilot RCT, we found that sex with an ongoing RSP and reporting a history of BV were both significantly associated with BV recurrence 16 . If there is a beneficial effect of hormonal contraceptives on the VM in sexually active women, hormonal contraceptives would be a readily available and acceptable intervention for women globally.…”

Section: Introductionmentioning

confidence: 65%

“…This study used prospectively collected specimens derived from the STOPBV study, an open‐label pilot RCT of COCP‐use following first‐line antibiotics to determine the impact on BV recurrence 16 . There was no patient engagement in the study development.…”

Section: Methodsmentioning

confidence: 99%

“…Epidemiologically, BV recurrence is more common in women with a regular sexual partner (RSP) and in those whose male partners inconsistently use condoms, indicating that sexual exchange of BV‐associated bacteria may contribute to recurrence 15,16 . Conversely, hormonal contraceptive use is associated with a 30% reduced risk of recurrent BV by meta‐analysis (pooled effect size = 0.69, 95% CI 0.59 to 0.91) 17 .…”

Section: Introductionmentioning

confidence: 99%

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Sex is associated with the persistence of non‐optimal vaginal microbiota following treatment for bacterial vaginosis: a prospective cohort study

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Plummer

Murray

et al. 2020

BJOG

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Objective Determine the associations between factors and sexual practices and the composition of the vaginal microbiome (VM) of women treated for bacterial vaginosis (BV). Design Prospective cohort study. Setting The Melbourne Sexual Health Centre, Melbourne, Australia. Population Seventy‐five reproductive‐age women diagnosed with clinical BV, treated with first‐line antibiotics and followed for up to 6 months. Methods Women self‐collected vaginal swabs and completed questionnaires at enrolment, the day following antibiotics and monthly for up to 6months until BV recurrence or no BV recurrence (n = 430 specimens). Bacterial composition was determined using 16S rRNA gene amplicon sequencing. The effects of ongoing factors on VM composition (utilising 291 monthly specimens) were assessed using generalised estimating equations population‐averaged models, which accounted for repeated measures within individuals. Main outcome measures The relative abundance of vaginal bacterial taxa. Results Women who reported ongoing sex with a regular sexual partner (RSP) had a VM comprised of increased relative abundance of non‐optimal BV‐associated bacteria (Adjusted co‐efficient [Adjusted co‐eff] = 11.91, 95% CI 3.39to20.43, P = 0.006) and a decreased relative abundance of optimal, Lactobacillus species (Adjusted co‐eff = −12.76, 95% CI −23.03 to −2.49, P = 0.015). A history of BV was also associated with a decreased relative abundance of Lactobacillus spp. (Adjusted co‐eff = −12.35, 95% CI −22.68, P = 0.019). The relative abundance of Gardnerella, Atopobium and Sneathia spp. increased following sex with an RSP. Conclusions Sex with an untreated RSP after BV treatment was associated with a VM comprised of non‐optimal BV‐associated bacteria. BV treatment approaches may need to include partner treatment if they are to achieve a sustained optimal VM associated with improved health outcomes. Tweetable abstract Sex drives a return to a ‘non‐optimal’ vaginal microbiota after antibiotics for bacterial vaginosis.

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“…In contrast to some studies,9 we found no association between hormonal contraceptive use and persistent BV. A recent randomised controlled pilot study by Vodstrcil et al found no difference in the rate of BV recurrence between women randomised to combined oral contraception or non-hormonal contraception,26 suggesting protective associations may be limited in the context of recurrence.…”

Section: Discussionmentioning

confidence: 99%

Risk and protective factors associated with BV chronicity among women in Rakai, Uganda

et al. 2019

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ObjectivesTo assess risk and protective factors associated with bacterial vaginosis (BV) chronicity ascertained by Nugent score criteria.MethodsA longitudinal cohort study included 255 sexually experienced, postmenarcheal women who provided weekly self-collected vaginal swabs for up to 2 years. Vaginal swabs were scored using Nugent criteria and classified as normal (≤3), intermediate (4–6) and Nugent-BV (≥7). Detailed behavioural/health information were assessed every 6 months. A per-woman longitudinal summary measure of BV chronicity was defined as the percentage of each woman’s weekly vaginal assessments scored as Nugent-BV over a 6-month interval. Risk and protective factors associated with BV chronicity were assessed using multiple linear regression with generalised estimating equations.ResultsAverage BV chronicity was 39% across all follow-up periods. After adjustment, factors associated with BV chronicity included baseline Nugent-BV (β=35.3, 95% CI 28.6 to 42.0) compared with normal baseline Nugent scores and use of unprotected water for bathing (ie, rainwater, pond, lake/stream) (β=12.0, 95% CI 3.4 to 20.5) compared with protected water sources (ie, well, tap, borehole). Women had fewer BV occurrences if they were currently pregnant (β=−6.6, 95% CI −12.1 to 1.1), reported consistent condom use (β=−7.7, 95% CI −14.2 to 1.3) or their partner was circumcised (β=−5.8, 95% CI −11.3 to 0.3).ConclusionsFactors associated with higher and lower values of BV chronicity were multifactorial. Notably, higher values of BV chronicity were associated with potentially contaminated bathing water. Future studies should examine the role of waterborne microbial agents in the pathogenesis of BV.

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Combined oral contraceptive pill-exposure alone does not reduce the risk of bacterial vaginosis recurrence in a pilot randomised controlled trial

Cited by 26 publications

References 41 publications

Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

Sex is associated with the persistence of non‐optimal vaginal microbiota following treatment for bacterial vaginosis: a prospective cohort study

Risk and protective factors associated with BV chronicity among women in Rakai, Uganda

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