A randomized trial comparing a polyherbal pessary (a complementary and alternative medicine) with Ginlac-V pessary (containing clotrimazole, tinidazole and lactobacilli) for treatment of women with symptomatic vaginal discharge

Abstract

Background: Most women with abnormal vaginal discharge have infection due to candida species, bacterial vaginosis or trichomoniasis and often seek treatment without laboratory confirmation. In this context, a single agent effective against these infections would be useful.

Aim: To compare the efficacy of two such agents: Praneem polyherbal pessary; a complementary and alternative medicine (CAM) with Ginlac-V pessary (containing clotrimazole, tinidazole and lactobacilli) for treatment of abnormal vaginal discharge.

Settings and design: A randomized study in a tertiary care hospital in North India.

Methods: One hundred women were randomized for treatment with either of the two pessaries. Clinical examination and laboratory evaluation was done before and after treatment.

Statistical analysis: Mc-Nemar test and Chi-square test.

Results: Overall, 82% (82/100) reported symptomatic relief; 78% (39/50) with Praneem and 86% (43/50) with Ginlac-V. Only 36% (18/50 in each group) had laboratory-confirmed infection; 18% (18/100) candidosis, 17% (17/100) bacterial vaginosis, 1% (1/100) both; none had trichomoniasis. Among these, symptomatic improvement was seen in 72% (13/18) and laboratory cure in 78% (14/18) with Praneem; symptomatic improvement in 78% (14/18) and laboratory cure in 78% (14/18) with Ginlac-V. Clinical or laboratory criteria could assess treatment efficacy equally. Neither drug was efficacious in candidosis. Ginlac-V was efficacious in bacterial vaginosis (100%) and though Praneem showed a similar trend, it was not statistically significant. Vaginal irritation was more frequent with Praneem (16% vs 4% with Ginlac-V).

Conclusion: Both Praneem and Ginlac-V provided symptomatic relief in most of the women. Either clinical or laboratory criteria could assess treatment efficacy of both drugs. Ginlac-V was efficacious for treating bacterial vaginosis.