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Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study

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Abstract

The purpose of this study was to evaluate the effectiveness of lactobacilli on vaginal health and proinflammatory cytokines. Sixty-seven patients with bacterial vaginosis (BV), 50 with intermediate flora and 42 with normal vaginal flora were enrolled in this double-blind study. The subjects were randomized to receive probiotic lactobacilli vaginal tablets (L. brevis CD2, L. salivarius subsp. salicinius, L. plantarum) or the vaginal pH tablet (active comparator). Cervico-vaginal lavage was collected to measure the concentrations of IL-1β, TNFα and IL-6 by ELISA. Neutral sphingomyelinase activity was also quantified in both arms before and after treatment. The probiotic vaginal tablet was well tolerated and no side effects were reported. The study demonstrated a cure rate of nearly 80 %; i.e., 32 % of the women could restore normal vaginal flora and 47 % had improved Nugent score, whereas 20 % of the subjects did not clear BV in the first follow-up (after 8 days treatment). The pH tablet containing pH lowering compounds induced resolution of BV and restoration of normal vaginal flora in 74 % and 26 %, respectively. The lactobacilli tablet was found to be better than the pH tablet in preventing BV in healthy subjects. A significant reduction in IL-1β and IL-6 vaginal cytokines was observed after treatment with lactobacilli, while the active comparator did not have any effect on local proinflammatory cytokines. Vaginal neutral sphingomyelinase activity was not modified in either group. Vaginal tablets containing lactobacilli can cure BV and reduce vaginal inflammatory response.

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Acknowledgments

The study was funded by CD Pharma India Pvt. Ltd., New Delhi.

The authors thank Mr. S. Ananda Rao, Mr. D. Madusudhan Rao and Ms. Bhavani for technical help.

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Clinical Microbiology & Immunology, National Institute of Nutrition, Hyderabad, 500007, India

    R. Hemalatha

  2. Department of Public Health and Infectious Diseases, Section of Microbiology, Sapienza University, Rome, Italy

    P. Mastromarino

  3. Clinical Division, National Institute of Nutrition, Hyderabad, 500007, India

    B. A. Ramalaxmi

  4. Statistics, National Institute of Nutrition, Hyderabad, 500007, India

    N. V. Balakrishna

  5. National Institute of Nutrition, Hyderabad, 500007, India

    B. Sesikeran

  6. Scientist “E”, National Institute of Nutrition, (Indian Council of Medical Research), Jamai Osmania post, Hyderabad, 500 604, Andhra Pradesh, India

    R. Hemalatha

Authors
  1. R. Hemalatha
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  2. P. Mastromarino
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  3. B. A. Ramalaxmi
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  4. N. V. Balakrishna
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  5. B. Sesikeran
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Corresponding author

Correspondence to R. Hemalatha.

Additional information

Registration status of trial: Clinical Trial Registry India (CTRI), CTRI/2007/091/000022; Registered on 26/12/2007.

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Hemalatha, R., Mastromarino, P., Ramalaxmi, B.A. et al. Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study. Eur J Clin Microbiol Infect Dis 31, 3097–3105 (2012). https://doi.org/10.1007/s10096-012-1671-1

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  • DOI: https://doi.org/10.1007/s10096-012-1671-1

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