Written by Joyce Smith, BS. Of the 287 participating women with cervical HPV infections, the 72 women treated with BasantTM cream had higher but statistically nonsignificant HPV elimination compared to those treated with placebo.
Human papillomavirus (HPV) is a common infection that is thought to be the cause of most cervical cancers, particularly HPV 16 and HPV 18. 1. Women who are chronically infected with these high risk strains are at increased risk of developing abnormal cervical cells, a condition called cervical dysplasia or intraepithelial neoplasia (CIN) 2. However, according to previous studies, HPV infection was shown to spontaneously regress in 61% of women within 12 months and 91% within 36 months 3. One study showed that cervical dysplasia regressed 74% in 31 out of 42 participating women at 12-month follow-up, while 24% (10/42) progressed to CIN3 (severely abnormal dysplasia) and, in one woman, CIN2 (moderate dysplasia) persisted after 12 months 4. Yet another study showed that at 12 months, 70% of CIN1 (slightly abnormal dysplasia) and 54% of CIN2 lesions spontaneously regressed (p<0.001) 5.
An established body of research has extolled curcumin’s anti-cancer properties. This powerful turmeric polyphenol has proven its anti-cancer prowess in over 100 different cancer cell lines. Conducting a phase 2 randomized placebo-controlled trial 6, Basu et al demonstrated a safe therapeutic intervention for the clearance of established cervical HPV infections and validated previous findings that HPV infections are self-limiting. They investigated the effectiveness of two herbal interventions in eliminating HPV infection from the cervical epithelium of 280 women who were diagnosed with HPV infection, based on Pap smear and HPV tests (PCR), and who had no evidence of high grade cervical dysplasia. The HPV infection was classified as “cervical pre-cancer,” meaning that the HPV infection had not yet progressed to high grade cervical neoplasia. The women were randomized into four groups to receive either BasantTM (a polyherbal vaginal cream containing curcumin, amla extract, reetha, and aloe), a curcumin vaginal capsule, a placebo vaginal cream, or a placebo vaginal capsule. After 30 consecutive days of application, repeat HPV tests, cytology and colposcopy were done to determine the creams effectiveness.
According to modified intention to treat (MITT) analysis, HPV clearance rate in the BasantTM group was 87.7% higher than in the 75.0% clearance rate found in the placebo cream group; but the results were not significant (P=0.08). The curcumin capsule group had an 81.3 % clearance rate which was not significantly higher compared to the 72.5% clearance rate of the placebo capsule group. (P=0.19). Only when compared to the HPV clearance rate of the combined placebo arms (73.3%) did the HPV clearance rate of the Basant TM cream (87.7%) become significant (P=0.03).
Although the Basant group demonstrated a greater (but nonsignificant) rate of clearance for HPV16 and HPV 18 than the placebo group, the combination of curcumin, amla extract, reetha, and aloe may have potential use as a clinical product for treating HPV and preventing cancer. The authors suggest that the synergy among the botanicals in BasantTM may enhance the bioactivity of the product. Also noteworthy is the fact that the BasantTM intervention group experienced significantly more adverse events than the placebo group. Other limitations were the small sample size (due to incomplete recruitment) in the placebo cream group (n=44), and the fact that a combined analysis of the two placebo groups was required to reach significance. Larger future trials are warranted to validate the present findings.
Source: Basu, Partha, Sankhadeep Dutta, Rakiba Begum, Srabani Mittal, Paromita Das Dutta, Alok Chandra Bharti, Chinmay Kumar Panda et al. “Clearance of cervical human papillomavirus infection by topical application of curcumin and curcumin containing polyherbal cream: a phase II randomized controlled study.” Asian Pac J Cancer Prev 14, no. 10 (2013): 5753-5759.
Posted June 19, 2019.
Joyce Smith, BS, is a degreed laboratory technologist. She received her bachelor of arts with a major in Chemistry and a minor in Biology from the University of Saskatchewan and her internship through the University of Saskatchewan College of Medicine and the Royal University Hospital in Saskatoon, Saskatchewan. She currently resides in Bloomingdale, IL.
References:
- Group IMW. Human papillomaviruses. Monographs on the Evaluation of Carcinogenic Risks to Humans. 1995;64.
- Kjaer SK, van den Brule AJ, Paull G, et al. Type specific persistence of high risk human papillomavirus (HPV) as indicator of high grade cervical squamous intraepithelial lesions in young women: population based prospective follow up study. Bmj. 2002;325(7364):572.
- Moscicki AB, Shiboski S, Hills NK, et al. Regression of low-grade squamous intra-epithelial lesions in young women. Lancet. 2004;364(9446):1678-1683.
- Discacciati MG, de Souza CA, d’Otavianno MG, et al. Outcome of expectant management of cervical intraepithelial neoplasia grade 2 in women followed for 12 months. European journal of obstetrics, gynecology, and reproductive biology. 2011;155(2):204-208.
- Ho GY, Einstein MH, Romney SL, et al. Risk factors for persistent cervical intraepithelial neoplasia grades 1 and 2: managed by watchful waiting. Journal of lower genital tract disease. 2011;15(4):268-275.
- Basu P, Dutta S, Begum R, et al. Clearance of cervical human papillomavirus infection by topical application of curcumin and curcumin containing polyherbal cream: a phase II randomized controlled study. Asian Pac J Cancer Prev. 2013;14(10):5753-5759.