Study results support adding metronidazole to treatment for PID
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Women who received metronidazole with the CDC-recommended antibiotic regimen of ceftriaxone and doxycycline for pelvic inflammatory disease, or PID, experienced better clinical and microbiologic outcomes than women who received only ceftriaxone and doxycycline, according to a study published in Clinical Infectious Diseases.
“Current CDC guidelines recommend a single intramuscular dose of ceftriaxone and 14 days of doxycycline, with or without the addition of metronidazole for 14 days,” Harold C. Wiesenfeld, MD, CM, professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh, told Healio. “The results of this clinical trial support routinely adding metronidazole to the ceftriaxone and doxycycline regimen for the treatment of women with acute pelvic inflammatory disease.”
Wiesenfeld and colleagues conducted a randomized, placebo-controlled double-blind trial comparing the use of single-dose, 250 mg ceftriaxone and doxycycline for 14 days with or without metronidazole in 233 women with acute PID. Overall, 116 of the patients received metronidazole and 117 received placebo. The primary outcome was clinical improvement at 3 days following enrollment, with additional outcomes at 30 days including clinical cure, adherence, tolerability and the presence of anaerobic organisms in the endometrium.
Adverse events and adherence were similar in each treatment group at 30 days following treatment, according to Wiesenfeld and colleagues. Anaerobic organisms were recovered less frequently from the endometrium in women in the metronidazole group than in the placebo group (8% vs. 21%; P < .05), and cervical Mycoplasma genitalium also was reduced in the metronidazole group (4% vs. 14%; P < .05). Pelvic tenderness also was less common among the women who received metronidazole than among the women who took a placebo (9% vs. 20%; P < .01).
Wiesenfeld noted that tolerability adherence was similar between the metronidazole and placebo groups.
“Clinicians were concerned that adding metronidazole will cause side effects and will result in women not completing the course of prescribed oral antibiotics,” Wiesenfeld said. “The results of this study show that metronidazole was well tolerated and not associated with higher gastrointestinal side effects.”
Wiesenfeld emphasized that one of the study’s limitations was the lack of information on long-term outcomes.
“We were unable to capture important long-term outcomes following PID treatment, such as infertility and ectopic pregnancy,” Wiesenfeld said. “Studies examining long-term outcomes following PID treatment are challenging to conduct and are limited by attrition and other important limitations.”
In an accompanying editorial, Caroline Mitchell, MD, MPH, associate professor of obstetrics, gynecology and reproductive biology and director of the vulvovaginal disorders program at Massachusetts General Hospital, said the findings “support the inclusion of metronidazole in the standard regiment for treatment of PID.”
“These results represent a step forward in the treatment of PID and care for women, but are not necessarily a cause for celebration,” Mitchell wrote.
She noted that recommended therapy for PID “is essentially syndromic management designed to cover [Neisseria] gonorrhoeae and [Chlamydia] trachomatis, which are the classically described pathogens for PID.” But as in other studies, a small proportion of the participants in the current trial tested positive for these pathogens.
“The classic [sexually transmitted infections] represent only 25% to 30% of cases of PID, and these results highlight our lack of consideration for other causes,” she wrote. “What additional screening and prevention strategies are needed to reduce rates of PID? How do [Trichomonas] vaginalis and [Mycoplasma] genitalium contribute to PID? How can we improve and strengthen diagnostic testing, both for improved clinical care and for better epidemiologic classification of cases — especially when some are advocating abandoning the physical exam altogether?
“In an age when some areas of medicine make therapeutic decisions based on sequencing of genetic variants, the syndromic management of PID presents a stark example of how women's health is undervalued and under-researched. We must do better.” – by Eamon Dreisbach
Disclosures: Mitchell reports receiving personal fees from Lupin Pharmaceuticals and Scynexis and research funding from Merck, outside the submitted work. Wiesenfeld reports the study was funded by the NIH. Please see the full study for a list of the other authors’ relevant financial disclosures.
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