Review question
We assessed the effectiveness in women and the safety in men of concurrent antibiotic treatment for the sexual partners of women treated for bacterial vaginosis (BV).
Background
Bacterial vaginosis (BV) is an infection that has a prevalence between 10% to 50% worlwide. BV results in an imbalance of the normal vaginal flora. Microorganisms associated with BV have been isolated from the normal flora of the male genital tract, and their presence could be related to the recurrence of infection after antibiotic treatment. Therefore, the treatment of sexual partners could offer the advantages of decreasing the recurrence of infection and possibly reducing the burden of the disease.
Trial characteristics
Cochrane researchers searched the available literature up to the 23 July 2016 and included seven trials with 1026 participants. The trials included sexually-active non-pregnant women between 17 and 56 years of age, either single or married, with symptomatic BV. Four studies only included women involved into a monogamous heterosexual relationship and there was no information about this for the remaining trials. Six trials used 5-nitroimidazoles to treat the sexual partner, four trials used metronidazole and two trials used tinidazole; only one study used a lincosamide for treatment. Five trials compared antibiotic versus placebo (854 participants) and two trials compared antibiotic treatment with no intervention (172 participants). Pharmaceutical companies funded four of the included trials.
Key results
Compared with placebo, antibiotic treatment for the sexual partners of women treated for BV had no effects on clinical or symptomatic improvement in women, regardless of the time period over which the trials assessed these outcomes (during the first, between the first and fourth, or after the fourth week). Furthermore, antibiotic treatment of the sexual partner may have no effect on the recurrence of BV up to 12 weeks after treatment, but may increase the frequency of minor adverse events reported by sexual partners. Compared with no intervention, treatment of sexual partners of women with BV may have no effect on decreasing the recurrence rate or over the frequency of clinical or symptomatic improvement between the first and fourth or after the fourth week, respectively.
Quality of evidence
The quality of evidence was high for the outcomes of clinical and symptomatic improvement. The quality of evidence was very low for recurrence due to some limitations regarding risk of bias and imprecision.
High quality evidence shows that antibiotic treatment for sexual partners of women with BV, compared with placebo, does not increase the rate of clinical or symptomatic improvement during the first, between the first and fourth or after the fourth week into the women. Low quality evidence suggests that antibiotic treatment does not led to a lower recurrence rate during the first and fourth or after the fourth week of treatment into the women, but increases the frequency of adverse events reported by sexual partners. Finally, compared with no intervention, antibiotic treatment does not decrease the recurrence rate after the fourth week and does not increase the frequency of clinical or symptomatic improvement between the first and fourth or after the fourth week into the women, respectively.
Bacterial vaginosis (BV) is an infection that has a prevalence between 10% to 50% worlwide. BV results in an imbalance of the normal vaginal flora. Microorganisms associated with BV have been isolated from the normal flora of the male genital tract, and their presence could be related to the recurrence of BV after antibiotic treatment. Therefore, the treatment of sexual partners could decrease the recurrence of infection and possibly the burden of the disease.
To assess the effectiveness in women and the safety in men of concurrent antibiotic treatment for the sexual partners of women treated for BV.
We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (23 July 2016), CENTRAL (1991 to 23 July 2016), MEDLINE (1946 to 23 July 2016), Embase (1974 to 23 July 2016), LILACS (1982 to 23 July 2016), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (23 July 2016), ClinicalTrials.gov (23 July 2016) and the Web of Science™ (2001 to 23 July 2016). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
Randomized controlled trials (RCTs) that compared the concurrent use of any antibiotic treatment with placebo, no intervention or any other intervention by the sexual partners of women treated for BV.
Three review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias in the included studies. We resolved any disagreements through consensus. We assessed the quality of the evidence using the GRADE approach.
Seven RCTs (1026 participants) met our inclusion criteria, and pharmaceutical industry funded four of these trials. Five trials (854 patients) compared any antibiotic treatment of sexual partners with placebo. Based on high quality evidence, antibiotic treatment does not increase the rate of clinical or symptomatic improvement in women during the first week (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.96 to 1.03; 712 participants, four studies; RR 1.06, 95% CI 1.00 to 1.12; 577 patients, three studies, respectively), between the first and fourth week (RR 1.02, 95% CI 0.94 to 1.11; 590 participants, three studies; RR 0.93, 95% CI 0.84 to 1.03; 444 participants, two studies; respectively) or after the fourth week (RR 0.98, 95% CI 0.90 to 1.07; 572 participants, four studies; RR 1.03, 95% CI 0.90 to 1.17; 296 participants, two studies; respectively). Antibiotic treatment does not led to a lower recurrence during the first and fourth week (RR 1.28, 95% CI 0.68 to 2.43; 218 participants, one study; low quality evidence) or after the fourth week of treatment (RR 1.00, 95% CI 0.67 to 1.52; 372 participants, three studies; low quality evidence) in women, but increases the frequency of adverse events (most frequently gastrointestinal symptoms) reported by sexual partners (RR 2.55, 95% CI 1.55 to 4.18; 477 participants, three studies; low quality evidence).
Two trials (172 participants) compared any antibiotic treatment for sexual partners with no intervention. When we compared it with no intervention, the effects of antibiotic treatment on recurrence rate after the fourth week (RR 1.71, 95% CI 0.65 to 4.55; 51 participants, one study), clinical improvement between the first and fourth week (RR 0.93, 95% CI 0.70 to 1.25; 152 participants, two studies) and symptomatic improvement after the fourth week (RR 0.66, 95% CI 0.39 to 1.11; 70 participants, one study) were imprecise and there were no differences between groups. We downgraded the quality of the evidence to low or very low.