Minimally Abnormal Papanicolaou Smears
Background: The purpose of this study was to compare the efficacy of 0.75% metronidazole vaginal gel with no treatment in patients who have had a minimally abnormal Papanicolaou smear.
Methods: One hundred forty-five patients whose initial Papanicolaou smears were limited by inflammation or benign cellular changes, reactive cellular changes, or atypical squamous cells of undetermined significance that did not favor a neoplastic process were randomized to 5 days of treatment with 0.75% metronidazole vaginal gel or to a control group receiving no treatment. Papanicolaou smears were repeated after 3 to 4 months.
Results: Cytologic findings of the follow-up Papanicolaou smears were normal in 61 of 114 (54%) of patients. Sixty-two percent (n = 37) of the Papanicolaou smears in the control group converted to normal on follow-up, whereas 44% (n = 24) of the Papanicolaou smears in the treatment group converted to normal (P = .07). Only one follow-up Papanicolaou smear worsened to low-grade squamous intraepithelial lesion. In no subgroup was treatment effective.
Conclusions: Empiric treatment for an asymptomatic, minimally abnormal Papanicolaou smear with 0.75% metronidazole vaginal gel before a repeated cytologic examination did not improve the rate of reversion to normal cytologic findings.
More than 50 million Papanicolaou smears are performed annually in the United States. Of these, approximately 2.5 million are reported as having low-grade cytologic abnormalities. Since the standardization of cervical cytologic reporting by the Bethesda system, a great many Papanicolaou smears have been classified as minimally abnormal. Findings include benign cellular changes, reactive cellular changes associated with inflammation, atypical squamous cells of undetermined significance (ASCUS), and low-grade squamous intraepithelial lesions (LSIL).
Although the evaluation and management of high-grade squamous intraepithelial lesions or carcinoma are clear, there is a lack of consensus among physicians about the most appropriate approach for the minimally abnormal Papanicolaou smear. Some clinicians empirically prescribe a topical or systemic antimicrobial therapy, such as povidone-iodine gels or douches, sulfa vaginal cream, metronidazole vaginal gel, or oral antibiotics. Papanicolaou smears are then repeated in 3 to 6 months. Other clinicians recommend evaluations with slide preparations of the vagina and cultures of the cervix in women with inflammation. In contrast, some experts advocate simply monitoring patients with mildly abnormal cervical findings with serial Papanicolaou smears and performing colposcopy if subsequent Papanicolaou smears continue to show mild abnormalities or worsening cytologic findings. Still, others promote immediate colposcopic examinations and biopsy for all women with minimally abnormal Papanicolaou smears.
There is currently no accepted standard of care for women with minimally abnormal Papanicolaou smears.
Recent data have shown an association between Papanicolaou smears with inflammation and bacterial vaginosis. Bacterial vaginosis, the most common cause of vaginal symptoms in adolescent and adult women, is characterized by an overgrowth of anaerobic and gram-negative bacteria in the vagina, Gardnerella vaginalis in particular. Up to 50% of cases are asymptomatic. The reported prevalence of bacterial vaginosis varies widely, ranging from 5% to 25% of college students and from 10% to 30% of typical obstetric populations, to more than 60% of patients visiting sexually transmitted disease clinics. In a study of premenopausal women with cytologic findings showing cervical inflammatory changes, 43% were found to be infected with G vaginalis.
Other studies have found inflammatory epithelial changes on cytologic examination to be significantly associated with clue cells in rehydrated wet smears and bacterial vaginosis. In addition, Eltabbakh et al found a statistically significant association between bacterial vaginosis and Papanicolaou smears with inflammation and ASCUS. Interestingly, data also suggest an association between bacterial vaginosis and cervical intraepithelial neoplasia (CIN). Platz-Christensen et al found that patients who had clue cells representing bacterial vaginosis on a Papanicolaou smear were more likely to develop CIN.
Recognizing the common finding of bacterial vaginosis in women of reproductive age and the association of bacterial vaginosis in Papanicolaou smears with inflammation, ASCUS, and CIN, we believed it seemed reasonable to treat bacterial vaginosis empirically in the patient who has a minimally abnormal Papanicolaou smear. For these patients, revision to normal cytologic findings with inexpensive drug therapy represents time and cost savings when compared with further evaluation entailing slide preparations, cultures, and colposcopy for the patient who continues to produce abnormal Papanicolaou smears. In only one published study were patients with initial atypical smears randomized to receive antibiotic therapy before a repeated cytologic examination. Triple sulfa cream, the drug used for treatment in the above study, failed to show superior results compared with placebo. A retrospective observational study, however, found that in patients with inflammatory atypia on Papanicolaou smears, rate of reversion to normal cytologic findings improved significantly after treatment with 0.75% metronidazole vaginal gel.
The purpose of this study was to compare the efficacy of 0.75% metronidazole vaginal gel with no treatment in asymptomatic patients who have had a minimally abnormal Papanicolaou smear. We hypothesized that the Papanicolaou smears of patients with minimally abnormal cytologic findings who apply 0.75% metronidazole vaginal gel will more likely convert to normal than will those of patients in the control group. In addition, we examined possible relations of continued abnormal Papanicolaou smears with demographic and behavioral characteristics.
Background: The purpose of this study was to compare the efficacy of 0.75% metronidazole vaginal gel with no treatment in patients who have had a minimally abnormal Papanicolaou smear.
Methods: One hundred forty-five patients whose initial Papanicolaou smears were limited by inflammation or benign cellular changes, reactive cellular changes, or atypical squamous cells of undetermined significance that did not favor a neoplastic process were randomized to 5 days of treatment with 0.75% metronidazole vaginal gel or to a control group receiving no treatment. Papanicolaou smears were repeated after 3 to 4 months.
Results: Cytologic findings of the follow-up Papanicolaou smears were normal in 61 of 114 (54%) of patients. Sixty-two percent (n = 37) of the Papanicolaou smears in the control group converted to normal on follow-up, whereas 44% (n = 24) of the Papanicolaou smears in the treatment group converted to normal (P = .07). Only one follow-up Papanicolaou smear worsened to low-grade squamous intraepithelial lesion. In no subgroup was treatment effective.
Conclusions: Empiric treatment for an asymptomatic, minimally abnormal Papanicolaou smear with 0.75% metronidazole vaginal gel before a repeated cytologic examination did not improve the rate of reversion to normal cytologic findings.
More than 50 million Papanicolaou smears are performed annually in the United States. Of these, approximately 2.5 million are reported as having low-grade cytologic abnormalities. Since the standardization of cervical cytologic reporting by the Bethesda system, a great many Papanicolaou smears have been classified as minimally abnormal. Findings include benign cellular changes, reactive cellular changes associated with inflammation, atypical squamous cells of undetermined significance (ASCUS), and low-grade squamous intraepithelial lesions (LSIL).
Although the evaluation and management of high-grade squamous intraepithelial lesions or carcinoma are clear, there is a lack of consensus among physicians about the most appropriate approach for the minimally abnormal Papanicolaou smear. Some clinicians empirically prescribe a topical or systemic antimicrobial therapy, such as povidone-iodine gels or douches, sulfa vaginal cream, metronidazole vaginal gel, or oral antibiotics. Papanicolaou smears are then repeated in 3 to 6 months. Other clinicians recommend evaluations with slide preparations of the vagina and cultures of the cervix in women with inflammation. In contrast, some experts advocate simply monitoring patients with mildly abnormal cervical findings with serial Papanicolaou smears and performing colposcopy if subsequent Papanicolaou smears continue to show mild abnormalities or worsening cytologic findings. Still, others promote immediate colposcopic examinations and biopsy for all women with minimally abnormal Papanicolaou smears.
There is currently no accepted standard of care for women with minimally abnormal Papanicolaou smears.
Recent data have shown an association between Papanicolaou smears with inflammation and bacterial vaginosis. Bacterial vaginosis, the most common cause of vaginal symptoms in adolescent and adult women, is characterized by an overgrowth of anaerobic and gram-negative bacteria in the vagina, Gardnerella vaginalis in particular. Up to 50% of cases are asymptomatic. The reported prevalence of bacterial vaginosis varies widely, ranging from 5% to 25% of college students and from 10% to 30% of typical obstetric populations, to more than 60% of patients visiting sexually transmitted disease clinics. In a study of premenopausal women with cytologic findings showing cervical inflammatory changes, 43% were found to be infected with G vaginalis.
Other studies have found inflammatory epithelial changes on cytologic examination to be significantly associated with clue cells in rehydrated wet smears and bacterial vaginosis. In addition, Eltabbakh et al found a statistically significant association between bacterial vaginosis and Papanicolaou smears with inflammation and ASCUS. Interestingly, data also suggest an association between bacterial vaginosis and cervical intraepithelial neoplasia (CIN). Platz-Christensen et al found that patients who had clue cells representing bacterial vaginosis on a Papanicolaou smear were more likely to develop CIN.
Recognizing the common finding of bacterial vaginosis in women of reproductive age and the association of bacterial vaginosis in Papanicolaou smears with inflammation, ASCUS, and CIN, we believed it seemed reasonable to treat bacterial vaginosis empirically in the patient who has a minimally abnormal Papanicolaou smear. For these patients, revision to normal cytologic findings with inexpensive drug therapy represents time and cost savings when compared with further evaluation entailing slide preparations, cultures, and colposcopy for the patient who continues to produce abnormal Papanicolaou smears. In only one published study were patients with initial atypical smears randomized to receive antibiotic therapy before a repeated cytologic examination. Triple sulfa cream, the drug used for treatment in the above study, failed to show superior results compared with placebo. A retrospective observational study, however, found that in patients with inflammatory atypia on Papanicolaou smears, rate of reversion to normal cytologic findings improved significantly after treatment with 0.75% metronidazole vaginal gel.
The purpose of this study was to compare the efficacy of 0.75% metronidazole vaginal gel with no treatment in asymptomatic patients who have had a minimally abnormal Papanicolaou smear. We hypothesized that the Papanicolaou smears of patients with minimally abnormal cytologic findings who apply 0.75% metronidazole vaginal gel will more likely convert to normal than will those of patients in the control group. In addition, we examined possible relations of continued abnormal Papanicolaou smears with demographic and behavioral characteristics.
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