Skip to main content
Top
Published in: Archives of Gynecology and Obstetrics 1/2018

01-01-2018 | General Gynecology

The effect of prebiotic vaginal gel with adjuvant oral metronidazole tablets on treatment and recurrence of bacterial vaginosis: a triple-blind randomized controlled study

Authors: Sevil Hakimi, Faranak Farhan, Azizeh Farshbaf-Khalili, Parvin Dehghan, Yousef Javadzadeh, Shamsi Abbasalizadeh, Bagher Khalvati

Published in: Archives of Gynecology and Obstetrics | Issue 1/2018

Login to get access

Abstract

Purpose

Bacterial vaginosis is a change in the normal vaginal bacterial flora that leads to loss of hydrogen peroxide producing lactobacilli and overgrowth of predominantly anaerobic bacteria. The present study was conducted to compare the effects of prebiotic vaginal gel with oral metronidazole tablet and metronidazole tablet alone on treatment and recurrence of bacterial vaginosis.

Methods

The present triple-blind randomized clinical trial was conducted in Sadatmandi Hospital in Robat-Karim town, where 100 patients were randomly divided into intervention (receiving a 5 mg prebiotic vaginal gel applicator plus three 250 mg metronidazole tablets per day for 7 days) and control (receiving a 5 mg placebo vaginal gel applicator and three 250 mg metronidazole tablets per day for 7 days) groups. Then, patients were assessed for bacterial vaginosis on 90 ± 3 day after treatment. Data collected were analyzed in SPSS-21 using Chi square, repeated measures, and student’s t tests at a significance level of P < 0.05.

Results

The results obtained showed no significant difference between the two groups in terms of personal and social characteristics, clinical complaints, or laboratory markers. On the 10th day, healing rate based on Amsel and Nugent criteria was 76% in the intervention group and 30% in the control group [odds ratio (OR) 4.3; 95% confidence interval (CI) 2.7–9.4]. On the 90th day, healing rate was 84% in the intervention group and 62% in the control group (OR 3.7; 95% CI 1.3–8.9).

Conclusions

Adjuvant treatment with prebiotic vaginal gel improves the efficacy of bacterial vaginosis treatment.
Literature
1.
go back to reference Anukam KC, Reid G (2007) Organisms associated with bacterial vaginosis in Nigerian women as determined by PCR-DGGE and 16S rRNA gene sequence. Afr Health Sci 7(2):68–72PubMedPubMedCentral Anukam KC, Reid G (2007) Organisms associated with bacterial vaginosis in Nigerian women as determined by PCR-DGGE and 16S rRNA gene sequence. Afr Health Sci 7(2):68–72PubMedPubMedCentral
2.
go back to reference Oduyebo OO, Anorlu RI, Ogunsola FT (2009) The effects of antimicrobial therapy on bacterial vaginosis in non-pregnant women. Cochrane Database Syst Rev 3:Cd006055 Oduyebo OO, Anorlu RI, Ogunsola FT (2009) The effects of antimicrobial therapy on bacterial vaginosis in non-pregnant women. Cochrane Database Syst Rev 3:Cd006055
3.
go back to reference Verstraelen H, Verhelst R (2009) Bacterial vaginosis: an update on diagnosis and treatment. Expert Rev Anti-Infect Ther 7(9):1109–1124CrossRefPubMed Verstraelen H, Verhelst R (2009) Bacterial vaginosis: an update on diagnosis and treatment. Expert Rev Anti-Infect Ther 7(9):1109–1124CrossRefPubMed
4.
go back to reference Berek JS, Novak E (2012) Berek & Novak’s gynecology. Wolters Kluwer Health/Lippincott Williams & Wilkins, Philadelphia, United States Berek JS, Novak E (2012) Berek & Novak’s gynecology. Wolters Kluwer Health/Lippincott Williams & Wilkins, Philadelphia, United States
5.
go back to reference Simoes JA, Bahamondes LG, Camargo RP, Alves VM, Zaneveld LJ, Waller DP, Schwartz J, Callahan MM, Mauck CK (2006) A pilot clinical trial comparing an acid-buffering formulation (ACIDFORM gel) with metronidazole gel for the treatment of symptomatic bacterial vaginosis. Br J Clin Pharmacol 61(2):211–217CrossRefPubMed Simoes JA, Bahamondes LG, Camargo RP, Alves VM, Zaneveld LJ, Waller DP, Schwartz J, Callahan MM, Mauck CK (2006) A pilot clinical trial comparing an acid-buffering formulation (ACIDFORM gel) with metronidazole gel for the treatment of symptomatic bacterial vaginosis. Br J Clin Pharmacol 61(2):211–217CrossRefPubMed
6.
go back to reference Pavlova SI, Kilic AO, Kilic SS, So JS, Nader-Macias ME, Simoes JA, Tao L (2002) Genetic diversity of vaginal lactobacilli from women in different countries based on 16S rRNA gene sequences. J Appl Microbiol 92(3):451–459CrossRefPubMed Pavlova SI, Kilic AO, Kilic SS, So JS, Nader-Macias ME, Simoes JA, Tao L (2002) Genetic diversity of vaginal lactobacilli from women in different countries based on 16S rRNA gene sequences. J Appl Microbiol 92(3):451–459CrossRefPubMed
7.
go back to reference Tarnberg M, Jakobsson T, Jonasson J, Forsum U (2002) Identification of randomly selected colonies of lactobacilli from normal vaginal fluid by pyrosequencing of the 16S rDNA variable V1 and V3 regions. Acta Pathol Microbiol Immunol Scand 110(11):802–810CrossRef Tarnberg M, Jakobsson T, Jonasson J, Forsum U (2002) Identification of randomly selected colonies of lactobacilli from normal vaginal fluid by pyrosequencing of the 16S rDNA variable V1 and V3 regions. Acta Pathol Microbiol Immunol Scand 110(11):802–810CrossRef
8.
go back to reference Donders GG (2007) Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol 21(3):355–373CrossRefPubMed Donders GG (2007) Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol 21(3):355–373CrossRefPubMed
9.
go back to reference Aroutcheva A, Gariti D, Simon M, Shott S, Faro J, Simoes JA, Gurguis A, Faro S (2001) Defense factors of vaginal lactobacilli. Am J Obstet Gynecol 185(2):375–379CrossRefPubMed Aroutcheva A, Gariti D, Simon M, Shott S, Faro J, Simoes JA, Gurguis A, Faro S (2001) Defense factors of vaginal lactobacilli. Am J Obstet Gynecol 185(2):375–379CrossRefPubMed
10.
go back to reference Yen S, Shafer MA, Moncada J, Campbell CJ, Flinn SD, Boyer CB (2003) Bacterial vaginosis in sexually experienced and non-sexually experienced young women entering the military. Obstet Gynecol 102(5 Pt 1):927–933CrossRefPubMed Yen S, Shafer MA, Moncada J, Campbell CJ, Flinn SD, Boyer CB (2003) Bacterial vaginosis in sexually experienced and non-sexually experienced young women entering the military. Obstet Gynecol 102(5 Pt 1):927–933CrossRefPubMed
11.
go back to reference Fethers KA, Fairley CK, Morton A, Hocking JS, Hopkins C, Kennedy LJ, Fehler G, Bradshaw CS (2009) Early sexual experiences and risk factors for bacterial vaginosis. J Infect Dis 200(11):1662–1670CrossRefPubMed Fethers KA, Fairley CK, Morton A, Hocking JS, Hopkins C, Kennedy LJ, Fehler G, Bradshaw CS (2009) Early sexual experiences and risk factors for bacterial vaginosis. J Infect Dis 200(11):1662–1670CrossRefPubMed
12.
go back to reference Bradshaw CS, Walker SM, Vodstrcil LA, Bilardi JE, Law M, Hocking JS, Fethers KA, Fehler G, Petersen S, Tabrizi SN, Chen MY, Garland SM, Fairley CK (2014) The influence of behaviors and relationships on the vaginal microbiota of women and their female partners: the WOW health study. J Infect Dis 209(10):1562–1572CrossRefPubMed Bradshaw CS, Walker SM, Vodstrcil LA, Bilardi JE, Law M, Hocking JS, Fethers KA, Fehler G, Petersen S, Tabrizi SN, Chen MY, Garland SM, Fairley CK (2014) The influence of behaviors and relationships on the vaginal microbiota of women and their female partners: the WOW health study. J Infect Dis 209(10):1562–1572CrossRefPubMed
13.
go back to reference Schwebke JR, Desmond RA, Oh MK (2004) Predictors of bacterial vaginosis in adolescent women who douche. Sex Transm Dis 31(7):433–436CrossRefPubMed Schwebke JR, Desmond RA, Oh MK (2004) Predictors of bacterial vaginosis in adolescent women who douche. Sex Transm Dis 31(7):433–436CrossRefPubMed
14.
go back to reference Morris M, Nicoll A, Simms I, Wilson J, Catchpole M (2001) Bacterial vaginosis: a public health review. BJOG Int J Obstet Gynaecol 108(5):439–450CrossRef Morris M, Nicoll A, Simms I, Wilson J, Catchpole M (2001) Bacterial vaginosis: a public health review. BJOG Int J Obstet Gynaecol 108(5):439–450CrossRef
15.
go back to reference Jafarzadeh H, Ivanbagha R, Hasanzadeh D, Sorush Barhaghi MH, Sayyah Melli M, Mohamad Poorasl A (2011) Comparsion of the effect of lactobacillus acidophilus suppository and metronidazol vaginal tablet on bacterial vaginosis. Hayat 17(3):5–14 Jafarzadeh H, Ivanbagha R, Hasanzadeh D, Sorush Barhaghi MH, Sayyah Melli M, Mohamad Poorasl A (2011) Comparsion of the effect of lactobacillus acidophilus suppository and metronidazol vaginal tablet on bacterial vaginosis. Hayat 17(3):5–14
16.
go back to reference Gellar M, Nelson A (2004) Diagnosis and treatment of recurrent and persistent vaginitis. Womens Health Gynecol 4:137–146 Gellar M, Nelson A (2004) Diagnosis and treatment of recurrent and persistent vaginitis. Womens Health Gynecol 4:137–146
17.
go back to reference Sobel JD, Ferris D, Schwebke J, Nyirjesy P, Wiesenfeld HC, Peipert J, Soper D, Ohmit SE, Hillier SL (2006) Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosis. Am J Obstet Gynecol 194(5):1283–1289. doi:10.1016/j.ajog.2005.11.041 CrossRefPubMed Sobel JD, Ferris D, Schwebke J, Nyirjesy P, Wiesenfeld HC, Peipert J, Soper D, Ohmit SE, Hillier SL (2006) Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosis. Am J Obstet Gynecol 194(5):1283–1289. doi:10.​1016/​j.​ajog.​2005.​11.​041 CrossRefPubMed
20.
go back to reference Gibson GR, Roberfroid MB (1995) Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr 125(6):1401–1412PubMed Gibson GR, Roberfroid MB (1995) Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr 125(6):1401–1412PubMed
21.
go back to reference Aghajani A, Pourahmad R, Mahdavi Adeli H (2011) The effect of prebiotics on probiotic yogurt containing Lactobacillus casei. J Food Technol Nutr 8(4):73–82 Aghajani A, Pourahmad R, Mahdavi Adeli H (2011) The effect of prebiotics on probiotic yogurt containing Lactobacillus casei. J Food Technol Nutr 8(4):73–82
22.
go back to reference Hosseini Kangelani A (2013) Functional foods, prebiotics and probiotics. In: Paper presented at the National Congress of Food Science and Technology, Shiraz Hosseini Kangelani A (2013) Functional foods, prebiotics and probiotics. In: Paper presented at the National Congress of Food Science and Technology, Shiraz
23.
go back to reference Rastall RA (2010) Functional oligosaccharides: application and manufacture. Annu Rev Food Sci Technol 1:305–339CrossRefPubMed Rastall RA (2010) Functional oligosaccharides: application and manufacture. Annu Rev Food Sci Technol 1:305–339CrossRefPubMed
24.
go back to reference Roberfroid MB (2001) Prebiotics: preferential substrates for specific germs? Am J Clin Nutr 73(2 Suppl):406s–409sPubMed Roberfroid MB (2001) Prebiotics: preferential substrates for specific germs? Am J Clin Nutr 73(2 Suppl):406s–409sPubMed
25.
go back to reference Rousseau V, Lepargneur JP, Roques C, Remaud-Simeon M, Paul F (2005) Prebiotic effects of oligosaccharides on selected vaginal lactobacilli and pathogenic microorganisms. Anaerobe 11(3):145–153CrossRefPubMed Rousseau V, Lepargneur JP, Roques C, Remaud-Simeon M, Paul F (2005) Prebiotic effects of oligosaccharides on selected vaginal lactobacilli and pathogenic microorganisms. Anaerobe 11(3):145–153CrossRefPubMed
26.
go back to reference Coste I, Judlin P, Lepargneur JP, Bou-Antoun S (2012) Safety and efficacy of an intravaginal prebiotic gel in the prevention of recurrent bacterial vaginosis: a randomized double-blind study. Obstetr Gynecol Int 2012:147867 Coste I, Judlin P, Lepargneur JP, Bou-Antoun S (2012) Safety and efficacy of an intravaginal prebiotic gel in the prevention of recurrent bacterial vaginosis: a randomized double-blind study. Obstetr Gynecol Int 2012:147867
27.
go back to reference Bohbot JM, Vicaut E, Fagnen D, Brauman M (2010) Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol 2010:1–6CrossRef Bohbot JM, Vicaut E, Fagnen D, Brauman M (2010) Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol 2010:1–6CrossRef
28.
go back to reference Fethers KA, Fairley CK, Hocking JS, Gurrin LC, Bradshaw CS (2008) Sexual risk factors and bacterial vaginosis: a systematic review and meta-analysis. Clin Infect Dis 47(11):1426–1435CrossRefPubMed Fethers KA, Fairley CK, Hocking JS, Gurrin LC, Bradshaw CS (2008) Sexual risk factors and bacterial vaginosis: a systematic review and meta-analysis. Clin Infect Dis 47(11):1426–1435CrossRefPubMed
29.
go back to reference Spiegel CA, Amsel R, Holmes KK (1983) Diagnosis of bacterial vaginosis by direct gram stain of vaginal fluid. J Clin Microbiol 18(1):170–177PubMedPubMedCentral Spiegel CA, Amsel R, Holmes KK (1983) Diagnosis of bacterial vaginosis by direct gram stain of vaginal fluid. J Clin Microbiol 18(1):170–177PubMedPubMedCentral
30.
go back to reference Borghei MS, Saatian M, Mohammadyari F (2010) Diagnostic value of Pap smear test in screening of bacterial vaginosis. Med Sci J Islam Azad Univ 20(3):189–193 Borghei MS, Saatian M, Mohammadyari F (2010) Diagnostic value of Pap smear test in screening of bacterial vaginosis. Med Sci J Islam Azad Univ 20(3):189–193
31.
go back to reference Emery S, Tomlinson M, Hansen I (2012) P51 patient-reported effects of vaginal lactose as a prebiotic for bacterial vaginosis. Sex Transm Dis 88(Suppl 1):A27 Emery S, Tomlinson M, Hansen I (2012) P51 patient-reported effects of vaginal lactose as a prebiotic for bacterial vaginosis. Sex Transm Dis 88(Suppl 1):A27
Metadata
Title
The effect of prebiotic vaginal gel with adjuvant oral metronidazole tablets on treatment and recurrence of bacterial vaginosis: a triple-blind randomized controlled study
Authors
Sevil Hakimi
Faranak Farhan
Azizeh Farshbaf-Khalili
Parvin Dehghan
Yousef Javadzadeh
Shamsi Abbasalizadeh
Bagher Khalvati
Publication date
01-01-2018
Publisher
Springer Berlin Heidelberg
Published in
Archives of Gynecology and Obstetrics / Issue 1/2018
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI
https://doi.org/10.1007/s00404-017-4555-x

Other articles of this Issue 1/2018

Archives of Gynecology and Obstetrics 1/2018 Go to the issue

Acknowledgement to Referees

Acknowledgement to reviewers