Background:Human Papillomavirus (HPV) testing is recommended by WHO as the test of choice for cervical cancer screening. Till date there is no effective treatment directed towards clearance of HPV. The infected women are followed up till they clear infection or develop neoplasias. This is programmatically challenging.In-vitro studies observed anti-HPV properties of curcumin and demonstrated curcumin induced inhibition of HPV-E6/E7 transcription and restoration of expression of p53, Rb, PTPN13, inhibited by E6/E7.
Aim:The present four-arm, double-blind, randomized phase-II trial was designed to evaluate the efficacy of BasantTM, a polyherbal cream containing extracts of curcumin (along with reetha, amla and aloe vera) and the efficacy of curcumin gelatine capsules to clear cervical HPV infections.
Methods:Non-pregnant women between 30-60 years were tested for HPV. HPV-detection in cervical samples was done by PCR using MY-09/11 L1 consensus primers. Women positive for any HPV were subjected to colposcopy and biopsy to rule out high-grade cervical neoplasias. HPV-positive women without high-grade lesions (N=287) were randomized to four arms to be treated with BasantTM vaginal cream, placebo vaginal cream, curcumin vaginal capsules and placebo vaginal capsules respectively. All subjects used one application of designated formulation daily for 30 consecutive days except during menstruation. They were recalled within one month of last application for repeat HPV test, cytology and colposcopy.
Results:HPV clearance rate in BasantTM arm (87.7%) was significantly higher than placebo (73.3%). Curcumin alone also caused higher but not statistically significant clearance rate (81.3%) than placebo. Type-specific clearance of HPV types 16 and 18 also showed similar patterns. Vaginal irritation and itching was significantly higher after BasantTM application but not after curcumin capsules. No serious adverse event was noted.
Conclusions:Curcumin is effective in achieving HPV clearance when applied locally on cervix. Phase-III trial is justified based on these findings.