Bacterial vaginosis is focus of new research
A check of the next patient’s file indicates a repeat visit for treatment of bacterial vaginosis (BV). What is your next step?
If you are puzzled, you are not alone. Recurrent bacterial vaginosis is a difficult clinical condition that is not uncommon, says Jack Sobel, MD, professor of medicine and infectious diseases at Wayne State University in Detroit. According to the Centers for Disease Control and Prevention (CDC), bacterial vaginosis is the most common vaginal infection in women of childbearing age.1
Sobel now is heading a multicenter Phase III clinical study to demonstrate the safety and effectiveness of tinidazole (Tindamax, Presutti Laboratories, Rolling Meadows, IL) for the potential treatment of BV. Other sites participating in the company-sponsored study include Medical University of South Carolina in Charleston; Magee-Womens Hospital in Pittsburgh; Duke University in Durham, NC; Medical College of Georgia in Augusta; Drexel University in Philadelphia; Louisiana State University in New Orleans; and University of Washington in Seattle.
"BV has been difficult to treat because although we know the organisms associated with it, we do not understand the cause of the infection," says Jane Schwebke, MD, professor of medicine in the division of infectious diseases at the University of Alabama at Birmingham who is heading a single-site investigation of the drug funded by the National Institute of Allergy and Infectious Diseases (NIAID). "If we could blame it on a particular bacteria, it would be much easier to treat."
Common symptoms of BV include a fishlike odor or a thin white or gray vaginal discharge. Some women may note burning during urination or itching around the outside of the vagina. About half of women with BV may be asymptomatic.2
Clinicians can diagnose BV by using clinical or Gram stain criteria. Clinical criteria include the presence of clue cells on microscopic examination; a homogeneous, white, noninflammatory discharge that coats the vaginal walls; a pH reading of greater than 4.5 on vaginal fluid; and a fishy odor of vaginal discharge before or after addition of 10% potassium hydroxide (also known as the "whiff test").
In most cases, BV causes no complications. However, the infection can give rise to some serious risks, including increasing a woman’s susceptibility to HIV infection if she is exposed to the virus.3
Pregnant women with BV more often have babies who are born early or with low birth weight.4
Look at options
The CDC’s 2002 treatment guidelines list the following drugs for treatment of BV:
- metronidazole (Flagyl, G.D. Searle, Chicago; also generic versions), 500 mg orally twice a day for seven days;
- clindamycin cream 2% (Cleocin, Pharmacia Corp., Peapack, NJ), one full applicator (5 g) intravaginally at bedtime for seven days;
- metronidazole gel 0.75% (MetroGel vaginal gel, 3M, St. Paul, MN), one full applicator (5 g) intravaginally twice a day for five days.
Alternate regimens include:
- metronidazole, 2 g orally, in a single dose;
- clindamycin, 300 mg orally twice a day for seven days;
- clindamycin ovules (Cleocin Vaginal Ovules, Pharmacia Corp.) 100 mg, intravaginally, once at bedtime, for three days.5
Another treatment option has been added since the publication of the CDC guidelines: clindamycin phosphate (Clindesse) vaginal cream, 2%, a single-dose cream. The new drug, manufactured by KV Pharmaceutical Co. in St. Louis and marketed through its Ther-Rx subsidiary, received Food and Drug Administration approval in December.
The multisite trial of tinidazole will evaluate a dosing regimen of 2 g of the drug once daily for two days and 1 g of the drug once a day for five days. The NIAID-funded investigation will compare a seven-day regimen of 500 mg metronidazole, taken twice daily, with two different seven- day dosing regimens of tinidazole — 500 mg and 1 g — taken twice daily. Tinidazole is approved for treatment of trichomoniasis, giardiasis, intestinal amebiasis, and amebic liver abscess.
With metronidazole, the standard treatment for the disease, the cure rate is only about 70%, and recurring infection is a problem, notes Schwebke.
"We’re interested to see if tinidazole, shown to be better tolerated with fewer sides effects, can be given in higher doses to achieve a greater cure rate," she states. "Even a small increase in the cure rate for such a prevalent disease, with so many public health implications, could be of great benefit."
References
- Centers for Disease Control and Prevention. National Center for HIV, STD and TB Prevention. Bacterial Vaginosis. Updated Feb. 25, 2005. Accessed at: www.cdc.gov/std/BV/STDFact-Bacterial-Vaginosis.htm.
- Secor RM. Bacterial vaginosis: common, subtle, and more serious than ever. Clinician Reviews 2001; 11:59-68.
- Taha TE, Hoover DR, Dallabetta GA, et al. Bacterial vaginosis and disturbances of vaginal flora: Association with increased acquisition of HIV. AIDS 1998; 12:1,699-1,706.
- Guise JM, Mahon SM, Aickin M, et al. Screening for bacterial vaginosis in pregnancy. Am J Prev Med 2001; 20(3 Suppl):62-72.
- Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines — 2002. MMWR 2002; 51(RR06):1-80.
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