Why do different criteria for 'cure' yield different conclusions in comparing two treatments for bacterial vaginosis?
OBJECTIVE
The objective of this study was to determine why different criteria for response to treatment of bacterial vaginosis (BV) led to markedly different conclusions about treatment efficacy in a randomized trial comparing metronidazole gel versus metronidazole/nystatin ovules.


METHODS
We compared the impact of two treatment regimens on individual components of Amsel and Nugent criteria at follow-up visits 14, 42, and 104 days after initiating treatment.


RESULTS
Compared with gel, ovules more effectively eliminated amines, clue cells, and Gardnerella, Prevotella, or Mobiluncus morphotypes from vaginal fluid, thus achieving cure based on "usual" criteria (absence of BV by Amsel or Nugent criteria), but did not more effectively restore Lactobacillus morphotypes or lower vaginal pH, thus not meeting Federal Drug Administration (FDA) criteria for cure.


CONCLUSIONS
Because early vaginal recolonization by lactobacilli was poor after both gel and ovules, FDA draft criteria for cure missed marked differences in treatment efficacies against Gardnerella, clue cells, and amines. Cure defined more "usually" may give more useful information.
Thomas
Katherine K
KK
University of Washington, Department of Medicine, Seattle, Washington 98104, USA.
Sanchez
Sixto
S
Garcia
Patricia J
PJ
Holmes
King K
KK
D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D004359:Drug Therapy, Combination; D005260:Female; D005782:Gels; D006801:Humans; D008795:Metronidazole / Q000627:therapeutic use*; D009761:Nystatin / Q000627:therapeutic use*; D018579:Patient Selection; D016896:Treatment Outcome; D016585:Vaginosis, Bacterial / Q000175:diagnosis / Q000188:drug therapy*
D000890:Anti-Infective Agents; D005782:Gels; D009761:Nystatin; D008795:Metronidazole