Elimination of high-risk human papillomavirus type HPV16 infection by ‘Praneem’ polyherbal tablet in women with early cervical intraepithelial lesions
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‘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.
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.
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.
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.
KeywordsHuman papillomavirus Low squamous intraepithelial lesions (LSIL) cervical cancer Praneem
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
- Bontkes HJ, de Gruijl TD, Walboomers JM, Schiller JT, Dillner J, Helmerhorst TJ, Verheijen RH, Scheper RJ, Meijer CJ (1999) Immune responses against human papillomavirus (HPV) type 16 virus-like particles in a cohort study of women with cervical intraepithelial neoplasia. II. Systemic but not local IgA responses correlate with clearance of HPV-16. J Gen Virol 80(Pt 2):409–417PubMedGoogle Scholar
- Das BC, Sharma JK, Gopalkrishna V, Das DK, Singh V, Gissmann L, zur Hausen H, Luthra UK (1992) A high frequency of human papillomavirus DNA sequences in cervical carcinomas of Indian women as revealed by Southern blot hybridization and polymerase chain reaction. J Med Virol 36:239–245. doi:10.1002/jmv.1890360402 PubMedCrossRefGoogle Scholar
- Hallez S, Simon P, Maudoux F, Doyen J, Noel JC, Beliard A, Capelle X, Buxant F, Fayt I, Lagrost AC, Hubert P, Gerday C, Burny A, Boniver J, Foidart JM, Delvenne P, Jacobs N (2004) Phase I/II trial of immunogenicity of a human papillomavirus (HPV) type 16 E7 protein-based vaccine in women with oncogenic HPV-positive cervical intraepithelial neoplasia. Cancer Immunol Immunother 53:642–650. doi:10.1007/s00262-004-0501-4 PubMedCrossRefGoogle Scholar
- Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, Zahaf T, Innis B, Naud P, De Carvalho NS, Roteli-Martins CM, Teixeira J, Blatter MM, Korn AP, Quint W, Dubin G (2004) Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 364:1757–1765. doi:10.1016/S0140-6736(04)17398-4 PubMedCrossRefGoogle Scholar
- Satyavati GV, Raina MK, Sharma M (1976) Azadirachta indica. In: Satyavati GV, Raina MK, Sharma M (eds) Medicinal plants of India. Indian Council of Medical Research, New Delhi, p 363Google Scholar
- Schmutterer H (1995) The neem tree: source of unique natural products for integrated pest management, medicine, industry and other purposes. VCH Weinheim, HiedelbergGoogle Scholar
- Sharma R, Mathur A, Chandhiok N, Datey S, Saxena NC, Gopalan S, Sharma S, Mittal S, Sehgal R, Sumandal BK, Chanda A, Salvi V, Mutalik N, Coyaji KJ, Gibsson A, Hazari K, Kalgutkar S, Talwar GP (2009) Phase II clinical trial with Praneem polyherbal tablet for assessment of its efficacy in sympotmatic women with abnormal vaginal discharge. Trans R Soc Trop Med Hyg 103:167–172PubMedCrossRefGoogle Scholar
- Talwar GP, Raghuvanshi P, Mishra R, Banerjee U, Rattan A, Whaley KJ, Zeitlin L, Achilles SL, Barre-Sinoussi F, David A, Doncel GF (2000) Polyherbal formulations with wide spectrum antimicrobial activity against reproductive tract infections and sexually transmitted pathogens. Am J Reprod Immunol 43:144–151. doi:10.1111/j.8755-8920.2000.430303.x PubMedCrossRefGoogle Scholar