title: Elimination of high-risk human papillomavirus type HPV16 infection by 'Praneem' polyherbal tablet in women with early cervical intraepithelial lesions.
abstract: 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.
authors.affiliation: Division of Molecular Oncology, Institute of Cytology and Preventive Oncology (ICMR), Noida, India.
authors.forename: Shirish
authors.initials: S
authors.lastname: Shukla
authors.forename: Alok C
authors.initials: AC
authors.lastname: Bharti
authors.forename: Showket
authors.initials: S
authors.lastname: Hussain
authors.forename: Sutapa
authors.initials: S
authors.lastname: Mahata
authors.forename: Suresh
authors.initials: S
authors.lastname: Hedau
authors.forename: Uma
authors.initials: U
authors.lastname: Kailash
authors.forename: Veena
authors.initials: V
authors.lastname: Kashyap
authors.forename: Suresh
authors.initials: S
authors.lastname: Bhambhani
authors.forename: Meera
authors.initials: M
authors.lastname: Roy
authors.forename: Swaraj
authors.initials: S
authors.lastname: Batra
authors.forename: G P
authors.initials: GP
authors.lastname: Talwar
authors.forename: Bhudev C
authors.initials: BC
authors.lastname: Das
mesh_terms: 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
chemical_list: D000998:Antiviral Agents; D010919:Placebos; D010936:Plant Extracts; C086286:Praneem; D014622:Vaginal Creams, Foams, and Jellies; D011803:Quinine