Effect of lyophilized lactobacilli and 0.03 mg estriol (Gynoflor®) on vaginitis and vaginosis with disrupted vaginal microflora: A multicenter, randomized, single-blind, active-controlled pilot study

Gynecologic and Obstetric Investigation

Volumn 70, Issue 4, 2010, Pages 264-272

  Donders, G G G ^a,b   Van Bulck, B ^c   Van De Walle, P ^d   Kaiser, R R ^e   Pohlig, G ^e   Gonser, S ^e   Graf, F ^e  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b Regionaal Ziekenhuis Heilig Hart Tienen   (Belgium)

^c AZ Sint Erasmus   (Belgium)

^d Algemeen Ziekenhuis Jan Palfijn   (Belgium)

^e Medinova Ltd   (Switzerland)

Author keywords

Bacterial vaginal infections; Gynoflor ; Metronidazole

Indexed keywords

ESTRIOL; GYNOFLOR; METRONIDAZOLE; PROBIOTIC AGENT; UNCLASSIFIED DRUG;

ABDOMINAL CRAMP; ADULT; ARTICLE; BELGIUM; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; HEADACHE; HUMAN; LACTOBACILLUS ACIDOPHILUS; LOW DRUG DOSE; MICROFLORA; MULTICENTER STUDY; NAUSEA; PHASE CONTRAST MICROSCOPE; PREMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; VAGINA DISCHARGE; VAGINA FLORA; VAGINITIS;

ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; BACTERIA, AEROBIC; ESTRIOL; FEMALE; FREEZE DRYING; HUMANS; HYDROGEN-ION CONCENTRATION; LACTOBACILLUS; METRONIDAZOLE; MIDDLE AGED; PILOT PROJECTS; PREMENOPAUSE; PROBIOTICS; VAGINA; VAGINOSIS, BACTERIAL;

EID: 78649689963     PISSN: 03787346     EISSN: None     Source Type: Journal    
DOI: 10.1159/000314016     Document Type: Article

References (36)

1. Reid G, Bruce AW, McGroarty JA, et al: Is there a role for lactobacilli in prevention of urogenital and intestinal infections? Clin Microbiol Rev 1990;3:335-344.
2. Sobel JD, Cook RL, Redondo-Lopez V: Lactobacilli: a role in controlling the vaginal microflora?; in Horowitz BJ, Mardh PA (eds): Vaginitis and Vaginosis. New York, Wiley-Liss, 1991, pp 47-53.
3. Boris S, Suarez JE, Vazquez F, et al: Adherence of human vaginal lactobacilli to vaginal epithelial cells and interaction with uropathogens. Infect Immun 1998;66:1985-1989.
4. Rösch BU, Stanek G: Endogenous and exogenous factors affecting the vaginal flora. Ann Med 1993;1:48-53.
5. Lauritzen C, Graf F, Mucha M: Wiederherstellung des physiologischen Vaginalmilieus mit Döderlein-Keimen und Oestriol. Frauenarzt 1984;4:5-8.
6. Parent D, Bossens M, Bayot D, et al: Therapy of bacterial vaginosis using exogenouslyapplied Lactobacilli acidophili and a low dose of estriol. Arzneimittelforschung 1996;46:68-73.
7. Feiks A, Grünberger W: Therapie der atrophen Kolpitis - Ist eine Reduktion der Östrogendosis bei lokaler Anwendung möglich? Gynäkol Rundsch 1991;31:268-271.
8. Kanne B, Jenny J: Lokale Anwendung von schwachdosiertem Östriol und lebensfähigen Döderlein-Keimen in der Postmenopause. Gynäkol Rundsch 1991;31:7-13.
9. Kanne B, Beyerle-Müller HL, Patz B, et al: The antibiotic activity of the Doederlein flora in the local treatment of vaginal infections with viable Döderlein bacteria and estriol. Jatros Gynäkologie 1986;2:40-44.
10. Ozkinay E, Terek MC, Yayci M, et al: The effectiveness of live lactobacilli in combination with low-dose estriol (Gynoflor) to restore the vaginal flora after treatment of vaginal infections. BJOG 2005;112:234-240.
11. Donders GG, Vereecken A, Bosmans E, et al: Definition of a type of abnormal vaginal flora that is distinct from bacterial vaginosis: aerobic vaginitis. Br J Obstet Gynecol 2002;109:34-43.
12. Amsel R, Totten PA, Spiegel CA, et al: Nonspecific vaginitis: diagnostic criteria and microbial and epidemiological associations. Am J Med 1983;74:14-22.
13. Donders GG, Bosmans E, Dekeersmaecker A, et al: Pathogenesis of abnormal vaginal bacterial flora. Am J Obstet Gynecol 2000;182:872-878.
14. Rezeberga D, Lazdane G, Kroica J, Sokolova L, Donders GG: Placental histological inflammation and reproductive tract infections in a low risk pregnant population in Latvia. Acta Obstet Gynecol Scand 2008;87:360-365.
15. Donders GG, Van Calsteren C, Bellen G, Reybrouck R, Van den Bosch T, Riphagen I, Van Lierde S: Predictive value for preterm birth of abnormal vaginal flora, bacterial vaginosis and aerobic vaginitis during the first trimester of pregnancy. BJOG 2009;110:1315-1324.
16. Donders GG, Spitz B, Vereecken A, Van Bulck B, Cornelis A, Dekeersmaeker A, Klerckx P, Londers L, Caudron J: The ecology of the vaginal flora at first prenatal visit is associated with preterm delivery and low birth weight. Open Inf Dis J 2008;2:45-51.
17. Donders GG, Van Calsteren C, Bellen G, Reybrouck R, Van den Bosch T, Riphagen I, Van Lierde S: Abnormal vaginal flora and cervix length as risk factors for preterm birth. Ultrasound Obstet Gynecol 2009; in press.
18. Tempera G, Abbadessa G, Bonfiglio G, et al: Topical kanamycin: an effective therapeutic option in aerobic vaginitis. J Chemother 2006;18:409-414.
19. Tempera G, Bonfiglio G, Cammarata E, Corsello S, Cianci A: Microbiological/clinical characteristics and validation of topical therapy with kanamycin in aerobic vaginitis: a pilot study. Int J Antimicrob Agents 2004;24:85-88.
20. Brandt M, Abels C, May T, Lohmann K, Schmidts-Winkler I, Hoyme UB: Intravaginally applied metronidazole is as effective as orally applied in the treatment of bacterial vaginosis, but exhibits significantly less side effects. Eur J Obstet Gynecol Reprod Biol 2008;141:158-162.
21. Donders GG: Microscopy of the bacterial flora on fresh vaginal smears. Infect Dis Obstet Gynecol 1999;7:126-127.
22. Donders GG: Wet smear compared with Gram stain diagnosis in asymptomatic pregnant women. Obstet Gynecol 2001;97:482.
23. Donders GG, Desmyter J, Vereecken A: Vaginitis. N Engl J Med 1998;338:1548.
24. Hillier SL, Krohn MA, Nugent RP, et al: Characteristics of three vaginal flora patterns assessed by Gram stain among pregnant women. Am J Obstet Gynecol 1992;166:938-944.
25. Wei LJ, Lachin JM: Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J Am Stat Assoc 1984;79:653-661.
26. Thall PF, Geurts T B P: Analysis of recurrent events: nonparametric methods for random interval count data. J Am Stat Assoc 1988;83:339-347.
27. Lachin JM: Some large-sample distributionfree estimators and tests for multivariate partially incomplete data from two populations. Stat Med 1992;11:1151-1170.
28. Lachin JM: Distribution-free marginal analyses of repeated measures. Drug Information J 1996;30:1017-1028.
29. Cohen J: Statistical Power Analysis for the Behavioral Sciences. New York, Academic Press, 1969.
30. Colditz GA, Miller JN, Mosteller F: Measuring gain in the evaluation of medical technology: the probability of a better outcome. Int J Technol Assess Health Care 1988;4:637-642.
31. Hillier SL, Lipinski C, Briselden AM, et al: Efficacy of intravaginal 0.75% metronidazole gel for the treatment of bacterial vaginosis. Obstet Gynecol 1993;81:963-967.
32. Schmitt C, Sobel JD, Meriwether C: Bacterial vaginosis: treatment with clindamycin cream versus oral metronidazole. Obstet Gynecol 1992;79:1020-1023.
33. Blackwell AL, Phillips I, Fox AR, et al: Anaerobic vaginosis (non-specific vaginitis): clinical, microbiological and therapeutic findings. Lancet 1983;17:1379-1382.
34. Pheifer TA, Forsyth PS, Durfee MA, et al: Nonspecific vaginitis: role of Haemophilus vaginalis and treatment with metronidazole. N Engl J Med 1978;298:1429-1434.
35. Larsson PG: Treatment of bacterial vaginosis. Int J STD AIDS 1992;3:239-247.
36. Martindale W: Metronidazole; in Reynolds JEF (ed): The Extra Pharmacopoeia. London, Royal Pharmaceutical Society, 1996, pp 621-625.