Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis

Summary

Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age. Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and homogenous and has a fishy smell especially after intercourse. It is of importance to treat women with BV, as this condition is associated with serious risks, such as an increased risk of preterm birth in pregnant women, and particular vulnerability to the acquisition of sexually transmitted disease (STD). The pathophysiology of BV consists of changes in the microbiologic composition of the vaginal flora. The treatment of choice for BV is oral metronidazole for 7 days. Although the available antibiotic therapies produce good results in the short term, symptomatic BV persists or recurs at 3 months in up to 50% to 70% of patients, with long-term recurrence approaching 85%. An alternative treatment option may be a vaginal acid gel which aims to optimize the vaginal milieu. The aim of this pilot study is to assess the efficacy of Gynofit® vaginal gel (lactic acid and glycogen) compared to oral metronidazole in the treatment of BV.

Timeline

Start

2014-06

Primary completion

2020-03-19

Completion

2020-03-19

Publications

• Background Schwebke JR. Gynecologic consequences of bacterial vaginosis. Obstet Gynecol Clin North Am. 2003 Dec;30(4):685-94. doi: 10.1016/s0889-8545(03)00086-x.
• Background Hill GB. The microbiology of bacterial vaginosis. Am J Obstet Gynecol. 1993 Aug;169(2 Pt 2):450-4. doi: 10.1016/0002-9378(93)90339-k.
• Background Saunders S, Bocking A, Challis J, Reid G. Effect of Lactobacillus challenge on Gardnerella vaginalis biofilms. Colloids Surf B Biointerfaces. 2007 Apr 1;55(2):138-42. doi: 10.1016/j.colsurfb.2006.11.040. Epub 2006 Dec 9.
• Results Wilson JD, Shann SM, Brady SK, Mammen-Tobin AG, Evans AL, Lee RA. Recurrent bacterial vaginosis: the use of maintenance acidic vaginal gel following treatment. Int J STD AIDS. 2005 Nov;16(11):736-8. doi: 10.1258/095646205774763081.
• Results Andersch B, Forssman L, Lincoln K, Torstensson P. Treatment of bacterial vaginosis with an acid cream: a comparison between the effect of lactate-gel and metronidazole. Gynecol Obstet Invest. 1986;21(1):19-25. doi: 10.1159/000298923.
• Results Holley RL, Richter HE, Varner RE, Pair L, Schwebke JR. A randomized, double-blind clinical trial of vaginal acidification versus placebo for the treatment of symptomatic bacterial vaginosis. Sex Transm Dis. 2004 Apr;31(4):236-8. doi: 10.1097/01.olq.0000118423.20985.e7.
• Results Boeke AJ, Dekker JH, van Eijk JT, Kostense PJ, Bezemer PD. Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial. Genitourin Med. 1993 Oct;69(5):388-92. doi: 10.1136/sti.69.5.388.
• Tidbury F, Brulhart G, Muller G, Pavicic E, Weidlinger S, Eichner G, von Wolff M, Stute P. Effectiveness and tolerability of lactic acid vaginal gel compared to oral metronidazole in the treatment of acute symptomatic bacterial vaginosis: a multicenter, randomized-controlled, head-to-head pilot study. BMC Womens Health. 2025 Jan 6;25(1):7. doi: 10.1186/s12905-024-03513-1.

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