Abstract
Objective: We sought to compare the efficacy of metronidazole gel vs. triple-sulfa cream in the treatment of bacterial vaginosis (BV).
Methods: In a double-blinded study, 247 women with symptomatic BV were randomly assigned to receive either 5 g of 0.75% metronidazole gel twice daily for 5 days or triple-sulfa cream twice daily for 5 days. There were 205 (96 treated with metronidazole and 109 treated with triple-sulfa) evaluable patients to compare efficacy at the final visit. Approximately 60% of these patients had been previously treated for BV, reflecting the recurrent nature of the disease in this patient population.
Results: At the first (12–16 days) return visit, 81/103 (79%) patients in the metronidazole group were cured compared with 80/113 (71%) patients in the triple-sulfa cream group (P = 0.333). At the final (28–35 days) return visit, 63/96 (66%) in the 96 metronidazole group remained cured compared with only 51/109 (47%) in the triple-sulfa group (P = 0.02). An intent-to-treat analysis similarly showed that the cure rate with metronidazole was superior to triple-sulfa (P ≤ 0.02). The clinical diagnosis demonstrated a high correlation (88%) with the diagnosis made by an independent assessment by Gram's stain. The side effects reported by the patients using metronidazole gel were infrequent and mild and were similar to those reported with triple-sulfa.
Conclusions: Metronidazole gel is a safe, effective, and well-tolerated treatment for BV.
Full Text
The Full Text of this article is available as a PDF (484.8 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Amsel R., Totten P. A., Spiegel C. A., Chen K. C., Eschenbach D., Holmes K. K. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983 Jan;74(1):14–22. doi: 10.1016/0002-9343(83)91112-9. [DOI] [PubMed] [Google Scholar]
- Bailey R. K., Voss J. L., Smith R. F. Factors affecting isolation and identification of Haemophilus vaginalis (Corynebacterium vaginale). J Clin Microbiol. 1979 Jan;9(1):65–71. doi: 10.1128/jcm.9.1.65-71.1979. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Beard C. M., Noller K. L., O'Fallon W. M., Kurland L. T., Dockerty M. B. Lack of evidence for cancer due to use of metronidazole. N Engl J Med. 1979 Sep 6;301(10):519–522. doi: 10.1056/NEJM197909063011003. [DOI] [PubMed] [Google Scholar]
- Bistoletti P., Fredricsson B., Hagström B., Nord C. E. Comparison of oral and vaginal metronidazole therapy for nonspecific bacterial vaginosis. Gynecol Obstet Invest. 1986;21(3):144–149. doi: 10.1159/000298944. [DOI] [PubMed] [Google Scholar]
- Biswas M. K. Bacterial vaginosis. Clin Obstet Gynecol. 1993 Mar;36(1):166–176. doi: 10.1097/00003081-199303000-00022. [DOI] [PubMed] [Google Scholar]
- Blackwell A. L., Fox A. R., Phillips I., Barlow D. Anaerobic vaginosis (non-specific vaginitis): clinical, microbiological, and therapeutic findings. Lancet. 1983 Dec 17;2(8364):1379–1382. doi: 10.1016/s0140-6736(83)90920-0. [DOI] [PubMed] [Google Scholar]
- Boeke A. J., Dekker J. H., van Eijk J. T., Kostense P. J., Bezemer P. D. Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial. Genitourin Med. 1993 Oct;69(5):388–392. doi: 10.1136/sti.69.5.388. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Greaves W. L., Chungafung J., Morris B., Haile A., Townsend J. L. Clindamycin versus metronidazole in the treatment of bacterial vaginosis. Obstet Gynecol. 1988 Nov;72(5):799–802. [PubMed] [Google Scholar]
- Hillier S. L., Lipinski C., Briselden A. M., Eschenbach D. A. Efficacy of intravaginal 0.75% metronidazole gel for the treatment of bacterial vaginosis. Obstet Gynecol. 1993 Jun;81(6):963–967. [PubMed] [Google Scholar]
- Hillier S., Krohn M. A., Watts D. H., Wolner-Hanssen P., Eschenbach D. Microbiologic efficacy of intravaginal clindamycin cream for the treatment of bacterial vaginosis. Obstet Gynecol. 1990 Sep;76(3 Pt 1):407–413. [PubMed] [Google Scholar]
- Livengood C. H., 3rd, Thomason J. L., Hill G. B. Bacterial vaginosis: diagnostic and pathogenetic findings during topical clindamycin therapy. Am J Obstet Gynecol. 1990 Aug;163(2):515–520. doi: 10.1016/0002-9378(90)91187-h. [DOI] [PubMed] [Google Scholar]
- Livengood C. H., 3rd, Thomason J. L., Hill G. B. Bacterial vaginosis: treatment with topical intravaginal clindamycin phosphate. Obstet Gynecol. 1990 Jul;76(1):118–123. [PubMed] [Google Scholar]
- Lugo-Miro V. I., Green M., Mazur L. Comparison of different metronidazole therapeutic regimens for bacterial vaginosis. A meta-analysis. JAMA. 1992 Jul 1;268(1):92–95. [PubMed] [Google Scholar]
- McCarthy L. R., Mickelsen P. A., Smith E. G. Antibiotic susceptibility of Haemophilus vaginalis (Corynebacterium vaginale) to 21 antibiotics. Antimicrob Agents Chemother. 1979 Aug;16(2):186–189. doi: 10.1128/aac.16.2.186. [DOI] [PMC free article] [PubMed] [Google Scholar]
- McDonald H. M., O'Loughlin J. A., Vigneswaran R., Jolley P. T., McDonald P. J. Bacterial vaginosis in pregnancy and efficacy of short-course oral metronidazole treatment: a randomized controlled trial. Obstet Gynecol. 1994 Sep;84(3):343–348. [PubMed] [Google Scholar]
- Nugent R. P., Krohn M. A., Hillier S. L. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991 Feb;29(2):297–301. doi: 10.1128/jcm.29.2.297-301.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Pheifer T. A., Forsyth P. S., Durfee M. A., Pollock H. M., Holmes K. K. Nonspecific vaginitis: role of Haemophilus vaginalis and treatment with metronidazole. N Engl J Med. 1978 Jun 29;298(26):1429–1434. doi: 10.1056/NEJM197806292982601. [DOI] [PubMed] [Google Scholar]
- Piot P., Van Dyck E., Godts P., Vanderheyden J. A placebo-controlled, double-blind comparison of tinidazole and triple sulfonamide cream for the treatment of nonspecific vaginitis. Am J Obstet Gynecol. 1983 Sep 1;147(1):85–89. doi: 10.1016/0002-9378(83)90090-x. [DOI] [PubMed] [Google Scholar]
- Roe F. J. Toxicologic evaluation of metronidazole with particular reference to carcinogenic, mutagenic, and teratogenic potential. Surgery. 1983 Jan;93(1 Pt 2):158–164. [PubMed] [Google Scholar]
- Rustia M., Shubik P. Induction of lung tumors and malignant lymphomas in mice by metronidazole. J Natl Cancer Inst. 1972 Mar;48(3):721–729. [PubMed] [Google Scholar]
- Schmitt C., Sobel J. D., Meriwether C. Bacterial vaginosis: treatment with clindamycin cream versus oral metronidazole. Obstet Gynecol. 1992 Jun;79(6):1020–1023. [PubMed] [Google Scholar]