Vaginosis a Growing Scourge Among Research Proposal

Excerpt from Research Proposal :

A newer and easy test is the OSOM BVBlue, which mixes a swabbed specimen from the vagina with a reagent. The test yields sialidase activity or presence in the vaginal fluid in 10 minutes. Sialidase is produced by BV pathogens (Mashburn).

pH Level

The most reliable criterion for detecting BV is a pH>4.5 (Mashburn, 2007). A normal pH should, therefore, rule out BV. A pH >4.5 can also indicate trichomoniasis or muco-purulent cervicitis. Vaginal inflammation more strongly suggests trichomonas or muco-purulent cervicitis, in turn associated with gonorrhea or chlamydial trachomatis (Mashburn).

The patient's pH level is 6, indicating BV.

Wet Smears

These are an inexpensive and relatively easy screening procedure for the most common sexually transmitted diseases, such as BV (Iglesias, Alderman & Fox, 2000). The practitioner should be appropriately trained and experienced in using this procedure. Hence, the proper protocol and quality control are needed to insure accurate diagnosis. The wet smear is quite useful and reliable in diagnosing BV because of the presence of clue cells. These are epithelial cells, which have irregular borders, full of bacteria and appear granular. A diagnosis of BV, using wet smear, is made when three of four findings are present. These four are a vaginal pH greater than 4.5; an abnormal and homogeneous vaginal discharge, fishy odor and presence of clue cells (Iglesias, Alderman & Fox).

A study undertaken by Schmidt and Hansen showed that the wet smear criteria are suitable for general practice (Iglesias, Alderman & Fox, 2000). Accuracy, however, depends on the practitioner's level of education, training and experience in conducting the test properly. Another study compared the wet smear with Pap-stained vaginal smear and the Gram-stain smear. It used 107 women, 34 of whom were diagnosed with BV. The study showed that the Gram-stain test correlated well with the diagnosis and the presence of clue cells on wet smears. Vural and co-authors examined wet smears, cervical smears and biopsies of 131 patients for criteria on lower genital inflammation. They found a close correlation between clue cells on wet smear, on examination and with the grade of inflammation on examination (Iglesias, Alderman & Fox).

Data gathered by Judson and Ehret provided evidence that wet smears had a 54-80% sensitive and 96% specific in detecting C. albicans, 50-70% sensitive and 99-100% specific for T. vaginalis, and 72-80% sensitive and 71-95% specific for BV (Iglesias, Alderman & Fox, 2000). Chacko and Rosenfeld's review of the use of wet smears in the diagnosis of cervical infections showed that cultures were more sensitive to the cause of vaginal discharge. Culture techniques are, however, expensive and labor-intensive. The turnaround time can be long and not in routine use in diagnosing the conditions in many health facilities. Faster techniques need to complement wet smears (Iglesias, Alderman & Fox).

The patient was subjected to tests for sexually transmitted infections, inflammation and to speculum examination for vaginal discharge.

Gram Stain Criteria

Federal regulatory agencies now acknowledge that these criteria have partly replaced the wet-mount criteria as the most reliable diagnostic test for BV (Monif, 2001). This shift brought about two significant conceptual changes. It broadened the conditions of inducible odor, the presence of "clue cells,: and Gram Stain confirmation. It also gave less value to the presence of inflammatory cells. The Gram Stain test is considered excellent in documenting bacterial overgrowth. Poly-microbial flora found in women with BV is also called BV flora. BV flora is associated with abnormalities in pregnancy and after delivery, urinary tract infections, secondary fertility, ectopic pregnancies, upper female genital infections, pre-malignant cervical dysplasia and HIV infection. Demographic studies strongly suggest that BV is "one of the most important diseases of the 20th century (Monif)."


The oral regimen for BV consists of 500 mg of metronidazole daily for 7 days (Mashburn, 2007).The recommended intra-vaginal treatment is .75% metronidazole gel daily for 5 days or clindamycin cream 2% once a day for 7 days. Other treatments are 2 grams oral metronidazole as a single dose or ofloxacin 200 orally twice a day. Those who are allergic to metronidazole should be treated with clindamycin. Those with gastrointestinal complications should use intra-vaginal metronidazole, instead. This cream, however, can weaken latex condoms and diaphragms. Another form of contraception should be used as substitute while applying clindamycin vaginal preparations. HIV-positive women are treated the same way as those who are HIV-negative for BV. Oral metronidazole medicines cost much less than the two other recommended regimens (Mashburn).

The patient's oral treatment consists of 2 grams of metronidazole as a single dose or 400 mg metronidazole twice daily for seven days. She may substitute intra-veginal metronidazole or clindamycin cream in case of intolerance for oral metronidazole. She is advised against vaginal douching and the use of genital shower gels or soaps and bath antiseptics.

Recurrence of BV

As high as 70% of women treated for BV experience a recurrence within 9 months after initial diagnosis (Mashburn, 2007). Realizing the problem, the 2006 Center for Disease Control guidelines recommend consultation with a specialist. Another recommendation is diagnosis by Gram stain as the gold standard technique, followed by a 10-to-14-day regimen of oral metronidazole 500 mg twice a day. One more regimen is vaginal metronidazole .075% cream once daily for 10 days and then twice a week for 4 to 6 months. Studies showed that the twice-a-week application for 6 months sustained a clinical cure (Mashburn).


Relapse does occur after termination of even extended therapy, however (Mashburn, 2007). Furthermore, long-term use of vaginal metronidazole enhances vulvovaginal candidiasis infection. The use of nystatin and metronidazole combined is recommended following evidence of significantly lower recurrence in the combination treatment even up to 104 days after treatment. Tinidazole has also been recommended. It is a derivative of nitroimidazole with a higher peak of concentration and longer half-life than metronidazole. A case report found that treatment with tinidazole 500 mg twice daily for two weeks on a woman with refractory BV made her asymptomatic for 10 months. A 2-gram single-dose tinidazole was likewise effective on non-recurrent BV. Tinidazole also produced fewer gastrointestinal side effects than metronidazole. Recolonization of the vagina with lactobacilli is still under study for recurrent BV and has not been recommended (Mashburn).

Sexual Transmission

Australian researchers found that BV recurs because of sexual transmission (Kerr, 2006). High rates of recurrence were found among first-line therapy users of oral metronidazole, according to Carolina S. Bradshaw of the University of Melbourne and the Melbourne Sexual Health Center at The Alfred Hospital. This was the conclusion reached by the study undertaken by Dr. Bradshaw and her team on 121 respondents with BV symptoms. The respondents took 400 mg of metronidazole twice a day for seven days for the test. The team reported in the June 1st issue of The Joural of Infectious Diseases that 58% of the respondents had a recurrence and 69% at the 12th month of follow-up. The research team determined that the risk factors were a past history of BV, a regular sexual partner and a female sex partner. Dr. Bradshaw suspected an unknown and unresponsive virus or bacterium that disturbs vaginal immunity and kills protective lactobacilli. Current treatment did not treat the cause of the infection either in the woman or the sexual partner. In addition, there is substantial evidence that BV is transmitted between women. The team's position was that the definite cause of BV has not been established and practitioners only assume that it will respond to antibiotics. Dr. Bradshaw also said that new therapies were being developed. One of these is probiotics, which contain lactobacillus species (Kerr).

Efficacy of Human Lactobacilli

A recent study was conducted to determine if supplementary lactobacilli could improve cure rate after a vaginal clindamycin treatment and increase time of relapse (Larsson, Stray-Pedersen & Larsen, 2008). The study used the Amsel criteria on 100 respondents with BV who were asked to use the treatment and vaginal gelatine capsules or placebo. The gelatine capsules contained 109 freeze-dried lactobacilli. These were applied for 10 days during their menstrual cycles. The respondents were regularly menstruating women 18 years old and older. They had normal gynecological conditions, neither pregnant nor breast feeding at the time of the study and had no signs of other genital tract problems. Results showed that supplementation did not improve the effectiveness of BV therapy in the first month of treatment. But it increased the time of relapse up to 6 months during which the women were free of BV (Larsson, et al.).

There is loss or reduction of lactobacilli in BV, which increases overgrowth of harmful bacteria (Larsson, et al., 2008). BV can also adversely affect pregnancy, so that treatment in early pregnancy is needed to reduce the chances of preterm deliveries. In a follow-up study on the efficacy of oral and vaginal metronidazole showed that only 48% of the respondents were BV-free in the 12 months after therapy. The presence of sufficient lactic-acid-producing bacilli maintains the normal bacterial environment of the vagina and maintains a low pH…

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