Journal of Cancer Research and Clinical Oncology

, Volume 135, Issue 12, pp 1701–1709 | Cite as

Elimination of high-risk human papillomavirus type HPV16 infection by ‘Praneem’ polyherbal tablet in women with early cervical intraepithelial lesions

  • Shirish Shukla
  • Alok C. Bharti
  • Showket Hussain
  • Sutapa Mahata
  • Suresh Hedau
  • Uma Kailash
  • Veena Kashyap
  • Suresh Bhambhani
  • Meera Roy
  • Swaraj Batra
  • G. P. Talwar
  • Bhudev C. Das
Original Paper

Abstract

Purpose

‘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.

Conclusion

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.

Keywords

Human papillomavirus Low squamous intraepithelial lesions (LSIL) cervical cancer Praneem 

Notes

Acknowledgments

Authors are thankful to untiring efforts of a dedicated team of ICPO Medical Social Workers without which this study would have been impossible. Preparation of Praneem Tablets and a look-alike Placebo under GMP conditions and their supply by M/s Panacea Biotech, New Delhi, and financial support of ICMR (DHR, Govt. of India) is thankfully acknowledged. This article was supported by Indian Council for Medical Research (ICMR); Department of Health Research, Government of India, India.

Conflict of interest statement

None.

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Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Shirish Shukla
    • 1
  • Alok C. Bharti
    • 1
  • Showket Hussain
    • 1
  • Sutapa Mahata
    • 1
  • Suresh Hedau
    • 1
  • Uma Kailash
    • 1
  • Veena Kashyap
    • 2
  • Suresh Bhambhani
    • 2
  • Meera Roy
    • 3
  • Swaraj Batra
    • 4
  • G. P. Talwar
    • 5
  • Bhudev C. Das
    • 1
    • 6
  1. 1.Division of Molecular OncologyInstitute of Cytology and Preventive Oncology (ICMR)NoidaIndia
  2. 2.Division of CytopathologyInstitute of Cytology and Preventive Oncology (ICMR)NoidaIndia
  3. 3.Division of Clinical OncologyInstitute of Cytology and Preventive Oncology (ICMR)NoidaIndia
  4. 4.Department of Obstetrics and GyneLok Nayak HospitalNew DelhiIndia
  5. 5.Talwar Research FoundationNew DelhiIndia
  6. 6.Ambedkar Research Centre for Biomedical ResearchUniversity of DelhiDelhiIndia

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