Efficacy and tolerability of two intravaginal formulations containing clindamycin plus clotrimazole in women with vaginal infections: A pilot study

Abstract

Aims: To compare the effectiveness and tolerability of soft gelatine capsule versus Extended-release tablet containing clindamycin with clotrimazole in vaginal infections. Subjects and Methods: Following baseline vaginal examination, 66 women having clinical diagnosis of vaginal infection were randomized to receive three doses [once daily] of an immediate release (SG-group) or an extended release combination of clindamycin with clotrimazole (ER-group) and followed up for assessing resolution of clinical and microbiological evidence of vaginal infection by 8 th day; maintenance of clinical and microbiological cure at 29 th day; and occurrence of side effects. Results were presented using descriptive statistics. Qualitative data was analyzed by Fischer’s Exact test Unpaired t-test was used for quantitative data. Results: 27 women from SG-group and 30 women from ER-group completed the study. In SG-group, 69.23% had complete cure and 7.69% had partial remission at 8 th day of which 88.89% maintained remission, while in ER-group 73.68% women had a complete cure of which 85.71% maintained remission on 29 th day. Delayed remission was observed in 25% women from SG-group and 60% women from ER-group, while none of the women experienced intolerable adverse effects. Conclusion: Both formulations containing clindamycin plus clotrimazole were effective, as empiric therapy, in inducing and maintaining microbiological as well as clinical remission in women with clinical diagnosis of vaginal infection to a similar extent but should not to be recommended for cases specifically identified to have trichomoniasis. An adequately powered study using a larger population should be conducted to further explore differences between these two formulations.