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Randomized Controlled Trial
. 2023 May 9;23(1):241.
doi: 10.1186/s12905-023-02303-5.

Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial

Jonathan D C Ross  1 , Clare Brittain  2 , Jocelyn Anstey Watkins  3 , Joe Kai  4 , Miruna David  5 , Mara Ozolins  2 , Louise Jackson  6 , Zainab Abdali  6 , Trish M Hepburn  7 , Frances Griffiths  3   8 , Alan Montgomery  2 , Jane Daniels  2 , Alice Manley  1 , Gillian Dean  9 , Lindsay K Armstrong-Buisseret  2
Affiliations
Randomized Controlled Trial

Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial

Jonathan D C Ross et al. BMC Womens Health. .

Abstract

Background: Bacterial vaginosis is a common and distressing condition for women. Short-term antibiotic treatment is usually clinically effective, but recurrence is common. We assessed the effectiveness of intravaginal lactic acid gel versus oral metronidazole for treating recurrent bacterial vaginosis.

Methods: We undertook an open-label, multicentre, parallel group, randomised controlled trial in nineteen UK sexual health clinics and a university health centre. Women aged ≥ 16 years, with current bacterial vaginosis symptoms and a preceding history of bacterial vaginosis, were randomised in a 1:1 ratio using a web-based minimisation algorithm, to 400 mg twice daily oral metronidazole tablets or 5 ml once daily intravaginal lactic acid gel, for 7 days. Masking of participants was not possible. The primary outcome was participant-reported resolution of symptoms within 2 weeks. Secondary outcomes included time to first recurrence of symptoms, number of recurrences and repeat treatments over 6 months and side effects.

Results: Five hundred and eighteen participants were randomised before the trial was advised to stop recruiting by the Data Monitoring Committee. Primary outcome data were available for 79% (204/259) allocated to metronidazole and 79% (205/259) allocated to lactic acid gel. Resolution of bacterial vaginosis symptoms within 2 weeks was reported in 70% (143/204) receiving metronidazole versus 47% (97/205) receiving lactic acid gel (adjusted risk difference -23·2%; 95% confidence interval -32.3 to -14·0%). In those participants who had initial resolution and for whom 6 month data were available, 51 of 72 (71%) women in the metronidazole group and 32 of 46 women (70%) in the lactic acid gel group had recurrence of symptoms, with median times to first recurrence of 92 and 126 days, respectively. Reported side effects were more common following metronidazole than lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively).

Conclusions: Metronidazole was more effective than lactic acid gel for short-term resolution of bacterial vaginosis symptoms, but recurrence is common following both treatments. Lactic acid gel was associated with fewer reported side effects.

Trial registration: ISRCTN14161293 , prospectively registered on 18th September 2017.

Keywords: Bacterial vaginosis; Lactic acid; Metronidazole; Recurrence; Sexual health; Side effects.

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Conflict of interest statement

JDCR reports personal fees from GSK Pharma and Bayer pharma, and ownership of shares in GSK Pharma and AstraZeneca Pharma; and is lead author of the UK and European Guidelines on Pelvic Inflammatory Disease; is a Member of the European Sexually Transmitted Infections Guidelines Editorial Board. He is associate editor of Sexually Transmitted Infections journal. He is an officer of the International Union against Sexually Transmitted Infections (treasurer), and a chair of trustees for the Sexually Transmitted Infections Research Foundation. CB, JAW, JK, MD, MO, LJ, ZA, TH, FG, AMo, JD, AMa, GD and LAB report no conflict of interests.

Figures

Fig. 1
Fig. 1
Flowchart of the VITA trial. a Prescribed lactic acid gel as refused allocated study treatment.b Ineligible as taking warfarin, prescribed lactic acid gel instead.c No study treatment given as participant received medication to treat thrush.d Preferred metronidazole after being randomised to lactic acid gel.e Included as one of the two withdrawn before Week 2 in the next box down.f Includes outcomes obtained from Week 2 questionnaire where a date of resolution was given without an answer to the ‘Have your bacterial vaginosis symptoms cleared’ question, and primary outcome collected by phone. Also includes outcomes obtained from 3 month questionnaire asking about resolution by Week 2.g At least one data item entered on questionnaire. h At least one data item entered on questionnaire or obtained by telephone
See this image and copyright information in PMC

References

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