Efficacy of the combination of 2 g oral tinidazole and acidic buffering vaginal gel in comparison with vaginal clindamycin alone in bacterial vaginosis: a randomized, investigator-blinded, controlled trial.
OBJECTIVE
To evaluate the efficacy of tinidazole (T) (Trimonase, Mipharm, Italy) and an acidic vaginal gel (Miphil) (M) in comparison with vaginal clindamycin (CL) (Cleocin Pharmacia Upjohn) in BV.


METHODS
A multicentre, randomised, investigator-blinded, controlled trial.


METHODS
64 women with BV were enrolled. Thirty-two were allocated to receive oral T 2g, single dose, and 32 were assigned to CL 2% for 7 consecutive days. After week 1, T group were treated with an acidic vaginal gel, 2g every 3 days, for additional 3 weeks, whereas CL group did not received any additional treatment. Patients were evaluated at week 1 and 4. Vaginal pH, the BV-blue test (Gryphus Diagnostics, USA) and the whiff test were performed at baseline and at week 4.


METHODS
Clinical cure rate; normalisation of vaginal pH (pH<4.5); and laboratory cure rate (defined as a clinical cure rate and a negative results of BV-blue and whiff test).


RESULTS
At baseline, vaginal pH values were (mean+/-S.D.) 5.4+/-0.7 and 5.3+/-0.5 in T and CL groups, respectively. Six patients (2 in T group and 4 in CL group) withdrew from the study due to side effects. At week 1, the clinical cure rates were 84% in both T and CL treated group (P=N.S.). At week 4, clinical cure rates were 94% in T+M group and 77% in CL group (P=N.S.). The laboratory cure rates were 81% in T+M group and 59% in CL group (P<0.04). Vaginal pH normalisation (i.e. pH <4.5) was achieved in 78% and in 38% of T+M and CL groups, respectively (P<0.0007).


CONCLUSIONS
In the short term, 2g single oral dose tinidazole was at least as effective as 7-day of vaginal clindamycin. The sequential treatment of tinidazole and acidic vaginal gel was superior to vaginal clindamycin in lowering vaginal pH and achieving a higher laboratory tests normalization rate at 1-month follow-up.
Milani
Massimo
M
R&D Mipharm, Via B. Quaranta 12, 20141 Milan, Italy. massimo.milani@mipharm.it
Barcellona
Eliana
E
Agnello
Antonella
A
D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents; D002021:Buffers; D002981:Clindamycin / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D014011:Tinidazole / Q000008:administration & dosage*; D016896:Treatment Outcome; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D002021:Buffers; D005782:Gels; D014011:Tinidazole; D002981:Clindamycin