Abstract

Background: Prevention of cervical cancer by treatment of precancerous conditions is critical in saving lives and is cost-effective. Turmeric bio-actives have shown potential anticancer activity in vitro, in vivo and in early clinical studies. The activity and safety of non-invasive integrated treatment with antimicrobials and oral turmeric extract was explored clinically in women with Low – grade Squamous Intraepithelial Lesion (LSIL) detected in Papanicolaou (Pap) smears.Methods: Women who attended a cancer screening program and who were detected with LSIL were enrolled for the study. Treatment offered was antimicrobials for associated genital infections followed by oral turmeric extract (Curcuma longa Linn, Haldone®, 600 mg, BD) for 10 weeks. The end points for activity were the degree of abnormality in Pap smears and colposcopy, micrometry in Pap smears and serum IL-6 assays, which were carried out initially, at 4-6, and at 10-11 weeks. Safety was assessed clinically, and with blood and urine tests.Results: Out of 21 enrolled cases, 1 discontinued within 2 weeks, and 3 after 4-6 weeks, due to vaginal irritation. Out of 20 cases treated for 4-10 weeks, LSIL did not progress in any case and 18 showed regression in Pap smear scores (p<0.003; Wilcoxan Rank test); 6 showed Cervical Intraepithelial Neoplasia (CIN 1) by colposcopy initially but none post-treatment. No other significant abnormalities were observed clinically, or biochemically. Manual micrometry of Pap smears (N=17) showed a significant reduction in Nuclear diameters & Nucleus/Cytoplasmic ratio (p<0.03; paired t test). A non-significant reduction in serum IL-6 levels occurred in 5/15 cases. Post-therapy Pap smears showed persistent benefit in 16 women after 6-36 months. Conclusions: Non-invasive integrative therapy with antimicrobials followed by standardised oral turmeric extract for 10 weeks appears to be promising for LSIL management by reversing early carcinogenesis through suppression of inflammation and inhibition of NF-kB pathway.

Highlights

  • When we reported persistence of Low – grade Squamous Intraepithelial Lesion (LSIL) in Pap smears repeated after treatment with antimicrobials in the previous study [8], we further studied the potential of oral Turmeric Oil Extract (TOE) in reversal of the abnormal changes of LSIL

  • Type of study Open labelled exploratory, single arm study on effect of integrated treatment for Low-Grade Cervical Squamous Intraepithelial Neoplasia (LSIL) detected in Pap smears, and confirmed as less than Cervical Intraepithelial Neoplasia (CIN) 2 by colposcopy

  • The scope for secondary prevention of cervical cancer should be expanded from invasive surgical methods to include non-invasive chemoprophylaxis because the number of women who are detected with precancerous Squamous Intraepithelial Lesions (LSIL and High-Grade Squamous Intraepithelial Lesions (HSIL)) is huge, several times larger than cancer cases

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Summary

Introduction

The Pap smear is cheaper than HRHPV test and is more available than colposcopy in most clinics and hospitals in India. It is more useful than VIA for detecting Low-Grade Squamous Intraepithelial. The activity and safety of non-invasive integrated treatment with antimicrobials and oral turmeric extract was explored clinically in women with Low – grade Squamous Intraepithelial Lesion (LSIL) detected in Papanicolaou (Pap) smears. Out of 20 cases treated for 4-10 weeks, LSIL did not progress in any case and 18 showed regression in Pap smear scores (p

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