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.