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Improvement of abnormal vaginal flora in Ugandan women by self-testing and short use of intravaginal antimicrobials

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Abstract

The vaginal composition of African women is more often lactobacillus-deficient compared to that of women from other areas around the world. Lactobacillus-deficient microflora is a known risk factor for serious health problems, such as preterm birth, cervix cancer, and entrapment of human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). The aim of this study was to assess the effect of local vaginal antibiotic or antiseptic treatment on abnormal vaginal flora (AVF), aerobic vaginitis (AV), and bacterial vaginosis (BV) among women in rural, semi-urban, and urban areas in Uganda, as compared to placebo. In a double-blind, placebo-controlled, randomized trial, 300 women presenting for outpatient routine, follow-up, or medical care at Mulago Hospital in Kampala, Uganda, were enrolled to receive 6 days of treatment with vaginal rifaximin (RFX), dequalinium chloride (DQC), or placebo if they had an increased vaginal pH of >4.5 as determined by self-testing. At initial visit and at control visit after 4 weeks, a smear was taken for blinded wet mount microscopy to determine AVF, BV, AV, and Candida severity scores. As compared to placebo, both RFX or DQC treatments dramatically diminished BV prevalence and severity from the initial to follow-up visit: the BV score declined from 2.5 to 1.6 (p < 0.0001) and from 2.5 to 1.9 (p < 0.0001), respectively. Similarly, strong improvements in the AV score were seen in both treatment regimens: moderate and severe AV declined from AV scores of 6.3 to 3.6 (p = 0.003) and from 6.6 to 4.1 (p < 0.004), respectively. Also, women with AVF (deceased or absent lactobacilli) showed similar improvements when compared with placebo. Women with normal flora and Candida at the initial visit showed less Candida after 4 weeks in the group treated with DQC (p = 0.014). Even after a short duration of intravaginal treatment with local non-absorbable antiseptics or antibiotics produced significant, lasting improvements in the vaginal microbiome composition of women with disturbed vaginal microflora. As African women have high prevalences of BV, AV, and AVF, this approach could improve their odds to prevent health-compromising complications. Further studies assessing direct health outcomes are needed to substantiate this.

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Acknowledgments

The authors sincerely thank the collaborating nurses and midwives at Mulago University Hospital, Kampala, for their ever-lasting efforts to motivate and help the patients with the questionnaires and practical organization of the study visits.

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Authors and Affiliations

  1. Femicare vzw, Clinical Research for Women, Gasthuismolenstraat 31, 3300, Tienen, Belgium

    G. Donders & G. Bellen

  2. Department of Obstetrics and Gynaecology, University Hospital Antwerpen, Antwerp, Belgium

    G. Donders

  3. Department of Obstetrics and Gynaecology, General Hospital H Hart Tienen, Tienen, Belgium

    G. Donders

  4. Department of Obstetrics and Gynaecology, Gasthuisberg University Hospital, Leuven, Belgium

    F. Donders

  5. Site Management Clinical Research, Faculty of Medicine, Janssens Pharma, Beerse, Belgium

    J. Pinget

  6. Pharmacist, De Haan, Belgium

    I. Vandevelde

  7. Department of Surgery, Gasthuisberg University Hospital, Leuven, Belgium

    T. Michiels

  8. Department of Obstetrics and Gynaecology, Mulago University Hospital, Kampala, Uganda

    J. Byamughisa

Authors
  1. G. Donders
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  2. G. Bellen
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  3. F. Donders
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  4. J. Pinget
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  5. I. Vandevelde
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  6. T. Michiels
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  7. J. Byamughisa
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Corresponding author

Correspondence to G. Donders.

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Funding

No official grant was obtained for this study. Femicare, a non-profit organization based in Tienen, Belgium, provided the lab support and covered the travel and accommodation fees of the co-investigators. Both study products and their corresponding placebos were kindly donated by Alfa Wasserman and Medinova, respectively.

Conflict of interest

None of the authors has any competing interests to disclose. Prof. G. Donders was a scientific consultant for both Alfa Wasserman, Bologna, Italy, and Medinova, Zürich, Switzerland.

Ethical approval

Protocol revised and approved by Kampala University Hospital Ethical Committee.

Informed consent

Every patient received information and signed written informed consent in full accordance with Good Clinical Practice (GCP), all applicable subject privacy requirements, and the guiding principles of the Declaration of Helsinki.

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Donders, G., Bellen, G., Donders, F. et al. Improvement of abnormal vaginal flora in Ugandan women by self-testing and short use of intravaginal antimicrobials. Eur J Clin Microbiol Infect Dis 36, 731–738 (2017). https://doi.org/10.1007/s10096-016-2856-9

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  • DOI: https://doi.org/10.1007/s10096-016-2856-9

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