Vaginal Tablets of Metronidazole (750 mg) plus Miconazole Nitrate (200 mg) versus Oral Metronidazole (2 g) for Bacterial Vaginosis: A Randomized Controlled Trial

Manopchai  Thamkhantho; Chenchit  Chayachinda; Chanita  Lertaroonchai

doi:10.33192/Smj.2021.83

Authors

Manopchai Thamkhantho Unit of Gynaecologic Infectious Diseases and Female Sexually Transmitted Infections Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Chenchit Chayachinda Unit of Gynaecologic Infectious Diseases and Female Sexually Transmitted Infections Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Chanita Lertaroonchai Unit of Gynaecologic Infectious Diseases and Female Sexually Transmitted Infections Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University

DOI:

https://doi.org/10.33192/Smj.2021.83

Keywords:

bacterial vaginosis, metronidazole, vaginal tablet

Abstract

Objective: To compare the cure rates, side effects, satisfaction, and recurrence rates of bacterial vaginosis (BV) in women having vaginal tablets of metronidazole (750 mg) plus miconazole (200 mg)—the “NPF group”—versus oral metronidazole (2 g)—the “MET group.”

Materials and methods: This September 2019–March 2020 trial enrolled symptomatic women aged 18–45 years diagnosed with BV based on Amsel’s criteria. Excluded were women who were immunocompromised; allergic to metronidazole or miconazole; had BV episodes during the preceding 3 months; or had abnormal vaginal bleeding. After randomization with a ratio 1:1, another vaginal swab was done for Nugent scoring. Two weeks later, the evaluation using Amsel’s criteria and Nugent scores was repeated. Also, symptom resolution, side effects and satisfaction were evaluated. Symptomatic resolution referred to 75% improvement in discharge, irritation, itching, odor, and coital pain. At one and three months, subjective symptomatic recurrence was assessed by telephone.

Results: Data on 70 participants were analyzed (NPF, N=34; MET, N=36). Their average age was 32.3±7.9 years (NPF, 34.1±8.1; MET, 30.6±7.3). Without statistical significance, NPF had higher symptom resolution (67.7% vs 58.3%; P=0.420), cure rate by Amsel criteria (82.4% vs 77.8%; P=0.632), and cure rate by Nugent scoring (35.3% vs 16.9%; P=0.075). Both groups reported high satisfaction (NPF, 8.5±1.4; MET, 7.9±2.0; P=0.125). Side effects were comparable, including appetite loss, metallic taste, nausea, and dizziness.

Conclusion: For BV treatment, both vaginal ovules containing metronidazole (750 mg) plus miconazole nitrate (200 mg) and oral metronidazole (2 g) show comparable efficacy and side effects.

References

1. Chayachinda C, Thamkhantho M, Chalermchockcharoenkit A, Neungton C, Thipmontree W. Characteristics of Clients at the Siriraj Female STD Clinic during 2011-2015. Siriraj Medical Bulletin 2018;11:182-9.
2. Srinivasan S, Fredricks D. The human vaginal bacterial biota and bacterial vaginosis. Interdiscip perspect Infect Dis 2008:750479.
3. Hill G. The microbiology of bacterial vaginosis. Am J Obstet Gynecol 1993;169:450-54.
4. Haggerty CL, Hillier SL, Bass DC, Ness RB, Evaluation PID, Clinical Health study i. Bacterial vaginosis and anaerobic bacteria are associated with endometritis. Clin Infect Dis 2004;39:990-5.
5. Sharma H, Tal R, Clark NA, Segars JH. Microbiota and pelvic inflammatory disease. Semin Reprod Med 2014;32:43-9.
6. Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS 2008;22:1493-501.
7. Cherpes TL, Meyn LA, Krohn MA, Lurie JG, Hillier SL. Association between acquisition of herpes simplex virus type 2 in women and bacterial vaginosis. Clin Infect Dis 2003;37:319-25.
8. Nardis C, Mosca L, Mastromarino P. Vaginal microbiota and viral sexually transmitted diseases. Ann Ig 2013;25:443-56.
9. Workowski KA, Bolan GA, Centers for Disease C, Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015;64:1-137.
10. Lugo-Miro VI, Green M, Mazur L. Comparison of different metronidazole therapeutic regimens for bacterial vaginosis. A meta-analysis. JAMA 1992;268:92-5.
11. Brandt M, Abels C, May T, Lohmann K, Schmidts-Winkler I, Hoyme U. Intravaginally applied metronidazole is as effective as orally applied in the treatment of bacterial vaginosis, but exhibits significantly less side effects. European Journal of Obstetrics & Gynecology and Reproductive Biology 2008;141:158-62.
12. Chaithongwongwatthana S, Limpongsanurak S, Sitthi-Amorn C. Single hydrogen peroxide vaginal douching versus single-dose oral metronidazole for the treatment of bacterial vaginosis: a randomized controlled trial. J Med Assoc Thai 2003;86:S379-84.
13. Mitchell C, Hitti J, Agnew K, Fredricks D. Comparison of oral and vaginal metronidazole for treatment of baterial vaginosis in pregnancy: impact on fastidiuos bacteria. BMC Infectious Diseases 2009;9.
14. Australian Sexual Health Alliance. Bacterial vaginosis. Australian STI management guidelines for use in primary care2018.
15. Peixoto F, Camargos A, Duarte G, Linhares I, Bahamondes L, Petracco A. Efficacy and tolerance of metronidazole and miconazole nitrate in treatment of vaginitis. International Journal of Gynecology and Obstetrics 2008;102:287-92.
16. Regidor P, Ozyurt E, Toykuliyeva M, et al. Treatment and prevention of trichomoniasis, bacterial vaginosis and candidiasis with a new 7-day regime containing metronidazole and miconazole in a single vaginal pessary. International Journal of Medical Device and Adjuvant Treatments 2018;1:e118.
17. Sobel J, Kaur N, Woznicki N, et al. Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses. Infection and Drug Resistance 2019;12:2297-307.
18. Aguin T, Akins R, Sobel J. High-dose vaginal maintenance metronidazole for recurrent bacterial vaginosis: a pilot study. Sexually Transmitted Diseases 2014;41:290-1.
19. Mohammadzadeh F, Dolatian M, Jorjani M, Alavi Majd H. Diagnostic value of Amsel's clinical criteria for diagnosis of bacterial vaginosis. Glob J Health Sci 2014;7:8-14.
20. Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 1991;29:297-301.
21. Verwijs M, Agaba S, Darby A, van de Wijgert J. Impact of oral metronidazole treatment on the vaginal microbiota and correlates of treatment failure. American Journal of Obstetrics and Gynecology 2020;222:157.
22. Tachawatcharapunya S, Chayachinda C, Parkpinyo N. The prevalence of bacterial vaginosis in asymptomatic pregnant women during early third trimester and the pregnancy complications. Thai Journal of Obstetrics and Gynaecology 2017;25:96-103.
23. British Association for Sexual Health and HIV. British Association for Sexual Health and HIV national guideline for the management of vulvovaginal candidiasis (2019). 2019.