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(R), Mipharm, Italy) and an acidic vaginal gel (Miphil(R)) (M) in comparison with vaginal clindamycin (CL) (Cleocin(R) Pharmacia Upjohn) in BV. Design: A multicentre, randomised, investigator-blinded, controlled trial. Population and methods: 64 women with BV were enrolled. Thirty-two were allocated to receive oral T 2 g, 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, 2 g 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. Main outcomes measures: 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, 2 g 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 I-month follow-up. (C) 2003 Published by Elsevier Science Ireland Ltd.