Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial

Abstract

Background: Trichomonias is the most common non-viral STI among women worldwide and is associated with serious reproductive morbidity, poor birth outcomes and amplified HIV transmission. Single-dose metronidazole therapy has been the treatment of choice for over three decades. There is mounting evidence, however, of high rates of repeat positives following single-dose metronidazole, and among HIVinfected women, bacterial vaginosis (BV) was found to alter treatment efficacy. The purpose of this study was to examine the effectiveness of single-dose metronidazole compared to 7 day-dose metronidazole for the treatment of trichomoniasis among HIV-uninfected, non-pregnant women and to determine if this effect was modified by BV. Methods: This was a randomized, parallel, multi-site, open-label trial of single-dose (2 g one-time) versus 7 day-dose (500 mg twice daily) for the treatment of trichomoniasis. The primary outcome was T. vaginalis infection by arm, per nucleic acid amplification test or culture, four weeks post-completion of treatment, in intentto-treat analyses. This analysis was also stratified by BV status. Findings: Of 623 women randomized, those in the 7 day-dose arm were less likely to be T. vaginalis positive at test-of-cure compared to those in the single-dose arm [34/312 (10.9%) vs. 58/311 (18.6%), p=0·001] [R.R. 0.55 (95% C.I. 0.34–0.70)]. Risk was similar by BV status (p=0·17). Self-reported adherence in both arms was > 95%. Side effects were similar by arm. Interpretation: In this sample of HIV-uninfected, non-pregnant women with trichomoniasis, compared to single-dose, 7 day-dose metronidazole treatment resulted in 45% fewer treatment failures. The 7 day-dose metronidazole should be the preferred treatment for trichomoniasis among women.

Treatment recommendations for trichomoniasis in women

“…Zhen-Zhou Luo and colleagues 4 suggest that false positives from nucleic acid amplification tests (NAAT), re-infection, and nonadherence to treatment could have influenced the results of our study, 3 and suggest that more data are needed before changing treatment recommendations to multidose metronidazole. We disagree.…”

“…Multidose metronidazole has been found to be superior to single-dose metronidazole for the treatment of trichomoniasis in a randomised controlled trial done in women with HIV infection, 1 in a metaanalysis of published comparisons, 2 and in our randomised controlled trial done in women without HIV infection, published in The Lancet Infectious Diseases. 3 The abundance of data indicates that multidose metronidazole should be the first line of treatment for trichomoniasis in women.…”

“…9 If Wolbachia spp were indeed an epileptogenetic factor, larger loads of bacteria released after treatments were done during an onchocerciasis control programme could explain the unknown reason why epilepsy suddenly appeared in a region where onchocerciasis is likely to have been common for centuries. 3 To confirm the role of Wolbachia spp in onchocerciasis-associated epilepsy, anti-wolbachia treatment should be administered in affected areas, therefore preventing the release of bacteria and the subsequent consequences that might ensue after treatment with anti-microfilarial drugs in microfilaria populations with high wolbachia burden.…”

Noncandidal vaginitis: a comprehensive approach to diagnosis and management

“…However, a recent multi-center randomized control trial found the 7-day course of metronidazole to be superior to single-dose metronidazole for the treatment of trichomonas (11% vs 19% trichomonas positive at 4 weeks post-therapy). 49 Hence, 7 days of therapy may be indicated. Tinidazole is slightly more effective than metronidazole but is considerably more expensive than generic metronidazole.…”

Optimal Timing for Trichomonas vaginalis Test of Cure Using Nucleic Acid Amplification Testing

“…This study was a sub-study of a multi-centered randomized trial of two different doses of metronidazole for the treatment of trichomoniasis. Methods have been described elsewhere, 21 but briefly, study participants were recruited from three clinics: Delgado Personal Health Clinic, Crescent Care Health and Wellness Center in New Orleans, LA and the Jefferson County Department of Health (JCDH) -STD Specialty Clinic in Birmingham, AL. These clinics serve mostly African American, low income women, the demographic group most highly affected by T. vaginalis infections.…”