Q&A

Metronidazole gel ineffective for minimally abnormal Pap

J Fam Pract. 2003 January;52(1):12-31
By
Catherine Smith, MD
Lili Church, MD
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  • BACKGROUND: Is metronidazole vaginal gel effective in the management of the minimally abnormal Papanicolaou smear? Gardnerella vaginalis infection, or bacterial vaginosis, has been suggested in a number of studies as a cofactor for the development of cervical intraepithelial neoplasia and as being associated with an increased relative risk of developing cervical intraepithelial neoplasia. Bacterial vaginosis also has been linked with acute and chronic inflammatory changes of the cervix. Metronidazole is often used in the treatment of bacterial vaginosis and thus may be helpful in the management of the minimally abnormal Papanicolaou (Pap) smear.
  • POPULATION STUDIED: The population consisted of women 18 years or older undergoing routine Pap smear screening in an outpatient primary care setting who were found to have minimally abnormal cytology (defined as limited by inflammation, benign or reactive cellular changes).
  • STUDY DESIGN AND VALIDITY: After completing a thorough medical and behavioral questionnaire, 145 patients meeting inclusion criteria were randomized in a single blind fashion to the treatment or control group. Treatment consisted of 0.75% metronidazole vaginal gel in 1 filled applicator, used once daily for 5 days. The control group received no treatment. Pap smears were repeated 3 to 4 months after the initial screening, and patients completed a follow-up questionnaire. Patients’ medical providers and pathologists evaluating cytologic studies were blinded to the group assignments.
  • OUTCOMES MEASURED: The main outcome measure was defined as a normal Pap smear at follow-up examination after 3 to 4 months.
  • RESULTS: Of the 145 women initially enrolled, 31 (21%) were lost to follow-up. Follow-up Pap smear cytology reverted to normal in 61 of the remaining 114 patients, including 54% (n=37) of the control group and 44% (n=24) of the treatment group (difference not statistically significant). The final sample size of 114 patients provided an 80% power to detect a 25% difference in resolution rates. Subgroup analysis of specific initial cytologic findings on the screening Pap smears and of patient characteristics failed to yield any subgroup for which metronidazole treatment was beneficial, including cytology limited by inflammation.
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PRACTICE RECOMMENDATIONS

Empiric treatment of women with minimally abnormal Papanicolaou smears (limited by inflammation, benign, or reactive cellular changes) with 0.75% metronidazole vaginal gel is ineffective in yielding a higher rate of reversion to normal cytology when compared with no treatment.

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