2.4. Data Extraction
After completing the screening process, we commenced the data extraction
step. Four investigators extracted data. Three main categories of data
were extracted: 1) baseline characteristics of the included studies and
clinico-demographic information of the research subjects, 2) efficacy
endpoints, and 3) safety outcomes. Efficacy endpoints included clinical
cure rate at 9-12 and 21-30 days, Nugent cure rate at 9-12 and 21-30
days, patient self-reported absence of vaginal odor at 9-12 and 21-30
days, patient self-reported absence of vaginal discharge at 9-12 and
21-30 days, resolution of Amsel criteria (pH, Whiff test, clue cells
>20%, and vaginal discharge)26 and
administration of rescue therapy. Safety outcomes included patients with
≥1 adverse event (AE), patients with ≥1 treatment-related AE, patients
with ≥1 severe AE, patients with ≥1 serious AE, urinary tract infection,
vulvovaginal candidiasis, treatment-related vulvovaginal candidiasis and
patients who stopped treatment due to an AE. Clinical cure was defined
as absence of Amsel criteria. Nugent cure was defined was Nugent score
≤3 when a score of ≥7 was identified at baseline.