Abstract
Introduction:
Cancer cervix is a major health problem responsible for causing a higher mortality rate in women worldwide; the exponential increase in such cases can be reduced by early screening of women. The cytology-based cervical screening had a higher success rate in reducing the incidence of cervical cancer. The present study aimed to evaluate the use of Pap smear screening to find cytological abnormalities and precancerous lesions.
Materials and Methods:
Sexually active women over 21 years of age were enrolled for the study. A detailed history was taken on the preformed proforma, and all were subjected to vaginal examination. Samples for Pap smear were taken with the help of Ayre spatula and immediately spread over a marked grease-free glass slide and dipped into 95% ethyl alcohol fixative for cytological examination.
Results:
Most of the abnormality of the epithelial cells found was in the age range of 31–50 years, and most of them were multiparous. 47.92% of the women had a chief complaint of vaginal discharge, an irregular menstrual cycle in 11.07%, and abdominal pain in 7.83%, while 30.41% were asymptomatic. Women found negative for intraepithelial neoplasia were 82.94%, while 13.36% had an inflammatory smear. 0.92% atypical squamous cells of undetermined significance (ASCUS), 2.78% Low-grade squamous intraepithelial lesion (LSIL) were found, no woman had High-grade squamous intraepithelial lesion (HSIL).
Conclusion:
Pap smear is a simple, cost-effective, non-invasive, and easy to perform tool for early detection of precancerous lesions, and it is evident that every woman above the age of 25–30 years must be recommended for cervical screening.
Keywords: Atypical squamous cells of undetermined significance, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion, Pap smear
Introduction
In the last few decades, cancer cervix has been a major health concern, responsible for causing a higher mortality rate in women worldwide. A larger number of cases have been found worldwide after the successful implementation of screening programs. The number of cervical cancer cases has been significantly reduced in developed nations, but in a developing nation like India, there is a lack of awareness amongst women, and there occurs a problem in running cytology-based screening program, and because of limited resources, all these factors collectively are responsible for causing a high number of cases.[1] Annual numbers of cervical cancer cases reported in India are 1,23,907 and 77,348 have died from the disease as reported in the data by International Agency for Research on Cancer (IARC) information center on HPV and Cancer.[2] Its long pre-invasive phase and proper implementation of screening make it possible to begin treatment well on time to prevent women from getting cervical cancer.[3]
The Papanicolaou (Pap) smear was introduced in 1941; it is widely used for primary screening of cervical epithelial changes for the detection of precancerous lesions. A large scale of screening programs had significantly reduced the mortality rate from cervical cancer. The sensitivity of the Pap test has significantly increased by HPV DNA co-testing.[4]
In India, where a majority of women are not educated, especially those residing in rural areas, are ignorant about their personal hygiene. They are more prone to hazards of suffering from this dreaded disease. Although regular screening has significantly reduced the number of cervical cancer, there is still a need to spread awareness, educate women regarding the signs and symptoms of cancer, and motivate them to visit nearby hospitals more frequently for routine check-ups. Regular follow-up and adequate treatment with proper counseling is needed for those who are found positive for Pap smear. Thus, we need to strengthen our health care sector by including screening at primary health centers. Early detection and robust screening may prevent this disease significantly. To achieve the target of successful elimination of cervical cancer, one can be the primary prevention by HPV vaccination program which aims to prevent cervical cancer by preventing HPV infection, and another could be the secondary prevention by early screening to detect prevalent cervical precancerous lesions[5] The importance of this study is to detect the precancerous lesions and high grade cervical intraepithelial neoplasia (CIN) so that effective treatment can be given in order to prevent them from undergoing invasive cervical cancer treatment. This can bring about a huge awareness regarding the screening for precancerous neoplastic changes in women and enable physicians to intervene and thereby help in treating carcinoma cervix at an early stage. Pap smear testing is easy to perform, economical, and can be done with limited resources in a simple setup for the detection of precancerous cervical intraepithelial lesions, and the present study is an effort to examine Pap smear testing.
Materials and Methods
This study was carried out at the Department of Microbiology in collaboration with the Department of Gynecology at Santosh Medical College and Hospital, Ghaziabad. Two hundred seventeen sexually active women over 21 years of age were included for the study from May 2019 to April 2021. Complete history was taken and recorded for future references on preformed proforma, including menstrual, marital, and sexual history, vaginal discharge, postcoital bleeding, intermenstrual bleeding, education, and occupational history. After that, per speculum vaginal examinations were done by an expert. Women not interested in participation, pregnant, or having a history of malignancy were excluded from the study. Patients were asked to lie down in dorsal lithotomy position; sterile bivalve speculum was inserted into the vagina to examine the posterior and anterior vaginal wall to allow the proper visualization of the cervix.
Samples were collected with the help of Ayre spatula, were smeared on a clean, grease-free glass slide by gentle spreading, and then instantly placed into Coplin jar containing 95% ethyl alcohol (fixative). The slides were then sent for cytopathological examination. Cervical cytology results were reported according to the Bethesda System 2014. Pap smear reports were broadly categorized into negative for intraepithelial neoplasia (NILM) and epithelial cells abnormality (ECA). Women found positive for Pap test results, including atypical squamous cells of undetermined significance (ASCUS), lowgrade squamous intraepithelial lesion (LSIL), and high-grade squamous intraepithelial lesion (HSIL) were advised for colposcopic examinations.
The collected data were tabulated and analyzed by using the SPSS software version 22.0 using mean ± standard deviation, percentage, and comparative study was done using the Chi-square test where applicable. Categorical data were presented in percentage (%).
The study was considered and approved by the Institutional Ethics Committee (IEC). All participants were informed about the objectives of the study prior to taking the samples, and written informed consent was obtained from subjects under study.
Results
In our study, very less number of women were aware of the test. The majority of the women enrolled were in the age group of 31–40 years (45.62%). The mean age of the patients was 32.99 ± 8.92 years. All subjects enrolled for the study were married; amongst them, 212 (97.6%) were multiparous, three were primiparous (1.38%), and two women (0.92%) were nulliparous. There is no significant relation seen between parity and the abnormal cytology in the present study. Most of them belonged to low socio-economic strata. During the questionnaire session, women were also asked for any addiction or drug abuse; seven (3.23%) had a history of smoking, 22 (10.14%) had tobacco (chewing), and 33 (15.2%) were addicted to alcohol [Table 1].
Table 1.
Socioeconomical and demographic characteristics of women
| Characteristics | Number (%) |
|---|---|
| Marital Status | |
| Married | 217 (100) |
| Unmarried | Nil |
| Parity Distribution | |
| Nulliparous | 3 (1.38) |
| Primiparous | 2 (0.92) |
| Multiparous | 212 (97.7) |
| Occupation | |
| Not Working | 18 (8.29) |
| Working | 16 (7.38) |
| Farmer | 13 (5.99) |
| Labour | 32 (14.74) |
| Others | 138 (63.60) |
| Addiction | |
| Smoking | 7 (3.23) |
| Tobacco | 22 (10.14) |
| Alcohol | 33 (15.20) |
| No addiction | 155 (71.43) |
| Total | 217 (100) |
The most common clinical findings on examinations were vaginal discharge constituting 47.92%, followed by an irregular menstrual cycle in 11.07%, while the least number of complaints registered were of abdominal pain (17 (7.84%)) followed by frequency in micturition 6 (2.76%). However, 30.41% of the women were asymptomatic as they did not experience any signs and symptoms. On speculum examination, 34.56% of the women had a normal-looking cervix, 13.36% had inflammation, 3.22% had cervical erosion, and 0.92% appeared with vaginal cyst [Graph 1].
Graph 1.
Clinical (per speculum) examination findings
All the women included in the study had undergone cytological examination, of which the majority of thr cases (180 (82.94%)) were benign, comprising negative for intraepithelial lesions or malignancy (NILM); 29 (13.36%) smears were found as inflammatory, ASCUS (2 (0.92%)), six (2.78%) were LSIL. The most important feature of this study that has drawn attention is no HSIL has been found. 23 (10.58%) cases of bacterial vaginosis and six (2.78%) cases of Candida spp. were found in our study [Graph 2]. Of all the smears tested, two (0.92%) of the study population were unsatisfactory in nature. Those were repeated again for cytology to check any abnormality.
Graph 2.
Cytological findings by Pap smear: NILM (negative for intraepithelial lesion or malignancy), ASCUS (atypical squamous cells of undetermined significance), LSIL (low-grade squamous intraepithelial lesion)
Of all the women included in the study, eight (3.69%) were found positive for squamous cell abnormalities. Most of the LSIL cases were found in patients with symptoms of white vaginal discharge and abdominal pain in the age group of 31–40 years. Of all the screened women, 30.41% women were found asymptomatic; amongst them, 9.09% had an inflammatory smear on microscopy, and 3.03% were ASCUS [Table 2].
Table 2.
Correlation of Pap smear findings with symptoms
| Clinical Finding Number (%) | NILM 180 (82.94) | Inflammation 29 (13.36) | ASCUS 2 (0.92) | LSIL 6 (2.78) | HSIL (0) |
|---|---|---|---|---|---|
| Asymptomatic 66 (30.41) | 58 | 6 | 2 | 0 | 0 |
| Pain in Abdomen 17 (7.84) | 14 | 0 | 0 | 3 | 0 |
| Vaginal Discharge 104 (47.92) | 81 | 20 | 0 | 3 | 0 |
| Frequency of Micturition 6 (2.76) | 5 | 1 | 0 | 0 | 0 |
| Irregular Menstrual Cycle 24 (11.07) | 22 | 2 | 0 | 0 | 0 |
| Total 217 | 180 | 29 | 2 | 6 | 0 |
Discussion
It has been found that in the last few decades, cervical cancer cases has been increased exponentially because of prevention programs that have been poorly implemented. The most effective screening method for cervical cancer is Pap smear, but due to lack of awareness in the general population, it is very low. According to recent guidelines, cervical screening is recommended at the age of 25 to 65 years (HPV testing in combination with cytology) every five years or cytology alone every three years;[6] however, those women who did not have their first smear till the age of 45 might have more serious implications[7] because the persisting infection has a higher chance to get converted into cervical intraepithelial lesions (CIN) if left undetected and untreated at an early stage.[8,9]
Our study has shown an unsatisfactory cytology report in 0.92%, which might have been due to sampling or technical error which is comparable to the Vaghela et al.[10] as they reported 4.8%. However, such unsatisfactory cases had been repeated again and further included in the total number of cases.
47.92% of the women were found with chief complaints of vaginal discharge, almost similar to other studies[11,12] but considerably higher than the 14.5% reported by Patel et al.[13]
In our study, 13.36% of the participants had inflammation, which is significantly lower than another study, where 42.66% inflammation was reported.[11] We have found 23 (10.58%) cases of bacterial vaginosis and six (2.78%) cases with Candida spp. infection, whereas Marconi et al.[14] found 23 (30.1%) bacterial vaginosis cases in their study, and Salih et al.[12] reported 67 (33.5%) women with Candida spp., which is considerably higher than this study. By studying these data, much geographical heterogeneity in cervical abnormalities hs been observed; such large variations could have been the result of immunity level, self-hygiene dwelling inhabitants, and literacy rate, which has a profound effect on causing such infections.
In our study, ASCUS in 0.92%, LSIL in 2.7%, and no HSIL have been found, which is different in comparison to Verma et al.,[15] where ASCUS in 1%, LSIL in 5.5%, and HSIL in 2.5% have been observed; this was in sharp contrast to the study done by Kang et al.,[16] in which higher percentage of HSIL (46.7%) and LSIL (13.5%) have been reported. In our study, LSIL was found in a larger proportion (1.88%) in the age group of (31–40) years, while Sachan et al.[11] reported a large number of abnormal cytology (5.57%) in the age group of 40–60 years.
According to several studies conducted in India, the prevalence of cytological abnormality is high. The difference in the prevalence of epithelial cells abnormality and inflammatory changes could have been the result of diverse cultures, ages at marriage, cohabitation, sexual activity, the incidence of related infections, and improper execution of cervical screening programs.
In our study, women addicted to alcohol were found positive for abnormal cytology in six (16.21%), which is showing similarity to another study, where it had been reported 16.7%.[17] This might indicate that alcohol may be one of the important factors; however, more study is required to prove such associations of alcohol in cervical abnormality.
In the present study, higher number of LSIL has been observed in younger women in whom it may lead to cancer cervix if no proper treatment has been provided at an early stage. However, no HSIL was observed in any age group, and this might suggest an active host immune response that has prevented the conversion of low-grade to high-grade lesions. This highlights the need to follow up the screening program to understand the factors responsible for the transformation of abnormal cells to high-grade lesions and eventually lead to invasive carcinoma cervix. There is a need to provide a huge platform for a regular Pap smear screening program, which can be successfully implemented by creating awareness among women on cervix cancer and the importance of early detection by regular screening and for clinicians to ensure and provide prompt and adequate treatment.
Future Directions of the Study
Health care camps for regular screening should be organized by local area authorities with better infrastructure and funding; to increase the coverage in the primary health centers for active participation to maximize the reach in the community. Pap smear, along with HPV DNA testing, may improve the detection of cervical cancer.
Conclusion
In a country like India, where a large proportion of women generally visits gyne clinic during their pregnancy or some serious health issues, they barely go for routine check-up. Thus, clinicians need to motivate those women for regular screening. In the last few decades, this screening tool has shown significant results in developed countries so that the mortality rate has been reduced considerably, and thus, it should be included as a routine procedure. Pap smear, along with HPV DNA co-testing, increases the sensitivity of detection. Hence, there is a need to educate women for regular screening even if they are not experiencing any symptoms, as this will pave the way to reduce the incidence of cervix carcinoma. This study highlights the fact that regular screening is important for women to prevent them from undergoing carcinoma cervix as prevention is better than cure.
Limitations of the Study
Women of reproductive age group attending outpatient department were enrolled for the study. For a more robust screening, women of post-menopausal age should be considered, which may have a different effect on cervical cytology findings.
Ethical approval
The study was considered and approved by the Institutional Ethics Committee (IEC).
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
Acknowledgement
We are immensely grateful to all the technical and supportive staff for their substantial contribution, without which this study would not have been possible.
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