A pilot clinical trial comparing an acid-buffering formulation (ACIDFORM gel) with metronidazole gel for the treatment of symptomatic bacterial vaginosis.
OBJECTIVE
To compare the effectiveness of an acid-buffering formulation gel (ACIDFORM) with metronidazole gel in the treatment of symptomatic bacterial vaginosis (BV).


METHODS
After a confirmed diagnosis of BV according to the criteria established by Nugent and Amsel, 30 nonpregnant women were enrolled in a randomized, double-blind clinical study. The women were randomly assigned to receive either 5 g ACIDFORM gel (n = 13) or 10% metronidazole gel (n = 17) intravaginally once daily for five consecutive days. Participants were evaluated in two follow-up visits (7-12 days and 28-35 days after treatment). Therapeutic success was defined as the presence of less than three of Amsel's criteria. If three or more criteria were present at first or second follow-up visit, the woman was excluded from the study and treated orally with metronidazole. Nugent scores were recorded at each visit but these were not used to define cure.


RESULTS
At the first follow-up visit, 15 (88%) of the women in the metronidazole group were cured compared with only three (23%) in the ACIDFORM group (P < 0.001). The remaining 12 women (10 of the ACIDFORM group and two of the metronidazole group) were considered as failure and were treated orally with metronidazole. At the second follow-up visit, two of the ACIDFORM-treated women and six of the metronidazole-treated women presented recurrent BV. Four women in the ACIDFORM group and one in the metronidazole group reported occasional burning and itching during product use.


CONCLUSIONS
ACIDFORM gel was significantly less effective than high-dose metronidazole gel for the treatment of symptomatic BV.
Simoes
Jose A
JA
Department of Obstetrics and Gynaecology, School of Medicine, Universidade Estadual de Campinas (UNICAMP), Campinas, SP, Brazil.
Bahamondes
Luis G
LG
Camargo
Rodrigo P S
RP
Alves
Valeria M N
VM
Zaneveld
Lourens J D
LJ
Waller
Donald P
DP
Schwartz
Jill
J
Callahan
Marianne M
MM
Mauck
Christine K
CK
D000282:Administration, Intravaginal; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004812:Epidemiologic Methods; D005260:Female; D005782:Gels / Q000627:therapeutic use*; D006801:Humans; D008795:Metronidazole / Q000627:therapeutic use*; D012008:Recurrence; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies; D016585:Vaginosis, Bacterial / Q000175:diagnosis / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D005782:Gels; D014622:Vaginal Creams, Foams, and Jellies; D008795:Metronidazole