Elimination of high-risk human papillomavirus type HPV16 infection by 'Praneem' polyherbal tablet in women with early cervical intraepithelial lesions.
OBJECTIVE
'Praneem', a polyherbal formulation developed by us, has successfully completed Phase II efficacy study for treatment of abnormal vaginal discharge due to reproductive tract infections that act as co-factors for HPV persistence. In the present study we evaluated potential anti-HPV activity of Praneem in women infected with high risk HPV type 16.


METHODS
Twenty women molecularly diagnosed positive for HPV16 infection without or with low grade squamous intraepithelial lesion (LSIL) or inflammation were assigned to receive intra-vaginal, topical application of either Praneem tablet or placebo for 30 days excluding the days of menstrual period and were evaluated for persistence of HPV infection using HPV L1 consensus and HPV type 16-specific PCR as primary outcome.


RESULTS
One course of Praneem treatment resulted in elimination of HPV in 6 out of 10 (60%) cases. A repeat treatment of four patients with persisting HPV infection resulted in clearance of HPV in two additional cases resulting in an overall 80% clearance of HPV 16 as against a spontaneous clearance of 10% (1/10) seen in the placebo arm. The elimination of HPV DNA was found to be accompanied by marked improvement in clinical symptoms and cytological abnormalities of Praneem-treated patients.


CONCLUSIONS
Our results showed for the first time that a 30-day intra-vaginal application of the Praneem can result in elimination of HPV infection from the uterine cervix.
Shukla
Shirish
S
Division of Molecular Oncology, Institute of Cytology and Preventive Oncology (ICMR), Noida, India.
Bharti
Alok C
AC
Hussain
Showket
S
Mahata
Sutapa
S
Hedau
Suresh
S
Kailash
Uma
U
Kashyap
Veena
V
Bhambhani
Suresh
S
Roy
Meera
M
Batra
Swaraj
S
Talwar
G P
GP
Das
Bhudev C
BC
D000328:Adult; D000465:Algorithms; D000998:Antiviral Agents / Q000008:administration & dosage; D005260:Female; D052162:Human papillomavirus 16 / Q000502:physiology; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications / Q000188:drug therapy*; D010919:Placebos; D010936:Plant Extracts / Q000008:administration & dosage*; D011803:Quinine / Q000008:administration & dosage*; D012307:Risk Factors; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000209:etiology / Q000821:virology; D014622:Vaginal Creams, Foams, and Jellies; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000188:drug therapy* / Q000209:etiology / Q000821:virology
D000998:Antiviral Agents; D010919:Placebos; D010936:Plant Extracts; C086286:Praneem; D014622:Vaginal Creams, Foams, and Jellies; D011803:Quinine