Abstract
Applying Lugol’s iodine solution to the cervix followed by colposcopic assessment is an established standard test to identify low grade/high grade squamous intraepithelial lesions (LSIL/HSIL). Here, we assessed the performance of Lugol’s iodine test during colposcopy using a standardized protocol with 5% acetic acid followed by 5% Lugol’s iodine solution and recording the most severe acetowhite (MSAWL) and iodine-negative (MSINL) lesions in a prospective cohort of consecutive women referred to our specialized colposcopy unit. The primary study endpoint was the sensitivity/specificity of MSINL for the detection of LSIL/HSIL. Secondary endpoints were the time to first appearance of the MSINL, MSINL staining intensity, and fading of MSINL. Three hundred and twenty women were included. The sensitivity and specificity of MSINL for the detection of LSIL/HSIL was 81.4 (95%—confidence interval (CI) 77.3–85.0)% and 29.5 (24.2–35.5)%, respectively. Ninety-six MSINL were identified exclusively by Lugol’s iodine test (no pathology, n = 46; LSIL, n = 29; HSIL, n = 21) (number needed to biopsy to identify one additional LSIL/HSIL = 1.9). In 17/320 (5.3%) patients, the clinical management was changed based on the result of Lugol’s iodine test. Video analysis showed an instant appearance of the MSINL within 10 s in 100% of cases. Intensity of MSINL significantly correlated with the presence/absence of LSIL/HSIL (Spearman rank order correlation; p < 0.0001). Fading of iodine-induced staining intensity over time was not observed. Thus, Lugol’s iodine showed moderate sensitivity and poor specificity, but changed clinical management in 5% of cases when used in addition to acetic acid.
Highlights
Cervical dysplasia is an important health issue affecting women of all ages [1,2]
Several strategies have been developed for the prevention and early detection of cervical dysplasia, among them human papilloma virus (HPV) vaccination, HPV testing, and cervical cytology using Papanicolaou smears [1,7,8,9]
We performed a prospective cohort study and found that Lugol’s iodine test had a sensitivity and specificity for detecting LSIL/high-grade squamous intraepithelial lesions (HSIL) of 81.4% and 29.5%, respectively, and led to a clinical management change in 5% of patients when used in addition to acetic acid (AA)
Summary
Detecting and removing high-grade squamous intraepithelial lesions (HSIL) before they develop into invasive cervical cancer is the main goal of cervical cancer screening and an important goal of medical care of women worldwide [3,4]. Both cervical neoplasia and cervical cancer have profound impacts on the health and quality of life of affected women [5,6]. We performed a prospective study with a uniform definition of each colposcopy step and an adequate number of patients and aimed to define for the first time the validity of Lugol’s iodine test in women with suspected cervical dysplasia. The goal of our study was to provide evidence-based data on Lugol’s iodine test, allowing colposcopists to make an informed and rational use of this test in their clinical practice
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