Bacterial vaginosis is a poorly understood infection that affects one in three women and can bring with it uncomfortable symptoms and, sometimes, long-term health complications. Treatment is often unsuccessful, with 60 percent of B.V. cases recurring within a year, keeping women stuck in a disruptive cycle of going on and off antibiotics.
A study published today shows the results of a novel treatment regimen so effective that an independent safety-monitoring group advised halting the trial early so that all participants could access it.
The key? Treating the women’s male partners.
The findings are “pretty significant for women’s health,” said Dr. Christina Muzny, professor of obstetrics and gynecology at the University of Alabama at Birmingham. She was not involved in the study but coauthored an editorial about its findings in the New England Journal of Medicine. Not only do the study results change how B.V. could be treated going forward, she said, but they also seem to confirm a long-held suspicion among scientists that the condition is actually a sexually transmitted infection.
“Patients and providers are going to need renewed education on B.V.,” Dr. Muzny said.
The Centers for Disease Control and Prevention describe B.V. as a condition that occurs when there is an imbalance of vaginal bacteria, but “we don’t know if it’s one bacteria or a group of bacteria” or what throws off the balance, Dr. Muzny said.
Many women don’t have symptoms; those who do may experience increased discharge, a fishy odor and burning or itching in the vaginal area. Infected patients, whether or not they are symptomatic, are at greater risk of developing other sexually transmitted infections, such as chlamydia or H.I.V., as well as pelvic inflammatory disease. B.V. in pregnant women is also associated with an increased risk of preterm birth.
The standard treatment for B.V. is a weeklong course of antibiotics taken either orally or vaginally, said Dr. Paul Nyirjesy, co-director of the Jefferson Vulvovaginal Health Center in Philadelphia, PA. But its high recurrence rate means patients have to get “treated over and over and over — five, six, 10 times,” which can impact their quality of life and their sex lives. Some patients are put on prolonged regimens of six or seven months to suppress the bacteria, he said, but once they stop treatment, the infection often comes back.
In the study, which was conducted at multiple sexual health and family planning centers in Australia, researchers gave 83 monogamous couples the standard treatment of a seven-day course of antibiotics for the female partner. Meanwhile, 81 other monogamous couples received treatment for the male partner too, which included a seven-day course of oral antibiotics and a topical antibiotic that was applied to the penis. After 12 weeks, 35 percent of women in the partner treatment group had B.V. again compared to 63 percent in the standard treatment group. A majority of men experienced no side effects with the treatment but some reported nausea, headaches or a metallic taste.
Potential risk factors for B.V. recurrence include having an intrauterine device or having sex with an uncircumcised partner. This study found that even among patients with those risk factors, treating both partners reduced recurrence, said Dr. Catriona Bradshaw, the lead author of the study and a clinician at the Melbourne Sexual Health Centre at Monash University.
For decades, reproductive health experts have suspected that B.V. was sexually transmitted. While doing research in central and east Africa over 20 years ago, Dr. Bradshaw found that “recurrence was double or triple in women who had an ongoing sex partner,” she said. It was also more common in people who didn’t use condoms — both signs that suggested the infection was an S.T.I. Several other studies published over the years bolstered that theory, including more recent findings that bacteria in infected women tended to match the bacteria found on penises.
But, in the 1980s and early 1990s, a handful of trials in which men were given antibiotics as a way to reduce B.V. rates failed to reduce recurrence. The results of those studies “were actually taken as evidence that B.V. was not an S.T.I.,” Dr. Bradshaw said. “It was really the nail in the coffin.”
Since then, however, researchers have concluded that those failed studies had significant flaws, said Dr. Nyirjesy. Key among them was that participants only used an oral antibiotic without addressing the bacteria that lived on the penis skin. To date, the new study is the only one that used both oral and topical treatments.
The findings of this study represent a paradigm shift that may even lead to medical bodies, like the C.D.C., changing their treatment guidelines, Dr. Muzny said.
She added: “It’s time for men to take shared responsibility for treating this infection.”
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