Table 1.
Updated summary of prior male partner treatment trials aimed at reducing recurrent BV
| First author (year) | Location | Sample sizea | Treatment of women | Treatment arm for men | Comparator arm (men) | Primary outcome | Findings |
|---|---|---|---|---|---|---|---|
| Swedberg (1985) [45] | Casper, Wyoming, USA | 64 | Oral MTZ 2g single dose OR | Oral MTZ 2g single dose OR | Standard of care | Culture negative for G. vaginalis and improved vaginal symptoms at 21d |
68% v 64% RR=1.06; 95%CI 0.74–1.52 |
| Oral MTZ 500mg bid 7d | Oral MTZ 500mg bid 7d | ||||||
| Vejtorp (1988) [46] | Denmark | 106 | Oral MTZ 2g on d1 and 3 | Oral MTZ 2g on d1 and 3 | Placebo | Clinically diagnosed BV at 5w |
25% v 29% RR=0.85; 95%CI 0.45–1.61 |
| G. vaginalis at 5w |
26% v 40% RR=0.64; 95%CI 0.37–1.12 |
||||||
| Symptom improvement or cure at 5w |
26% v 40% RR=0.64; 95%CI 0.83–1.29 |
||||||
| Mengel (1989) [47] | Seattle, Washington, USA | 98 | Oral MTZ 2g single dose OR | Oral MTZ 2g single dose OR | Placebo | Symptoms and clinical cure of BV at 2, 5, and 8w; BV on vaginal Gram stain at 2 and 5w | No point estimates reportedb |
| Oral MTZ 500mg bid 7d | Oral MTZ 500mg bid 7d | ||||||
| Moi (1989) [48] | Denmark, Finland, Norway, Sweden | 190 | Oral MTZ 2g on d1 and 3 | Oral MTZ 2g on d1 and 3 | Placebo | Relapse of clinically diagnosed BV at 12w |
21% v 16% RR=1.33; 95%CI 0.73–2.44 |
| Vutyavanich (1993) [49] | Thailand | 133 | Oral TIN 2g single dose | Oral TIN 2g single dose | Placebo | Clinical cure of BV at 4w |
72% v 63% RR=1.13; 95%CI 0.95–1.35 |
| Colli (1997) [50] | Italy | 139 | 2% clindamycin intravaginal cream 7 nights | Oral clindamycin 150mg qid | Placebo | Clinically diagnosed BV recurrence at 12w |
31.9% v 30.0% RR=1.06; 95%CI 0.65–1.75 |
| Schwebke (2021) [51] | Multisite, USA | 214 | Oral MTZ 500mg bid 7d | Oral MTZ 500mg bid 7d | Placebo | BV cure defined as 0–2 Amsel criteria and Nugent score 0–6 at 16w |
81% v 80% Fisher’s exact test p>0.999 |
| Vodstrcilc in progress [52] | Multisite, Australia | Aims to recruit 342 | Oral MTZ 500mg bid 7dd | Oral MTZ 500mg bid and topical clindamycin bid 7d | Standard of care | BV recurrence defined as 3–4 Amsel criteria and Nugent score 4-10 at 12w | in progress |
Adapted from Mehta [53]; “standard of care” indicates female-only treatment; MTZ, metronidazole; TIN, tinidazole; d, days; w, weeks; m, months
aSample size reflects those included in the analysis
bAt 2 and 5w, women who had male sexual partners who received treatment showed less BV on vaginal Gram stain; these women also had fewer vaginal symptoms at 8 weeks
cTrial is currently recruiting (ACTRN12618000219280)
dWomen can receive topical clindamycin 7 nights if MTZ is contraindicated