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.
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.


OBJECTIVE
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.


METHODS
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.


METHODS
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).


CONCLUSIONS
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.
Patel
Yamal
Y
Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India.
Gopalan
Sarala
S
Bagga
Rashmi
R
Sharma
Meera
M
Chopra
Seema
S
Sethi
Sunil
S
D000282:Administration, Intravaginal; D000328:Adult; D003022:Clotrimazole / Q000008:administration & dosage / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007434:Intrauterine Devices; D007778:Lactobacillus; D008875:Middle Aged; D017060:Patient Satisfaction; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage*; D011803:Quinine / Q000008:administration & dosage*; D014011:Tinidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D019522:Vaginal Discharge / Q000188:drug therapy; D014627:Vaginitis / Q000188:drug therapy*
D004338:Drug Combinations; D010936:Plant Extracts; C086286:Praneem; D014011:Tinidazole; D011803:Quinine; D003022:Clotrimazole