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Every year 200,000 breast diseases diagnosed worldwide with benign breast disease presentation in 90% cases. Among benign diseases fibroadenoma accounts 50 % of the entire breast lumps particularly young women. Growing awareness within public has exponentially increased its importance. Here in Pakistan, benign breast disease is the greater part of diagnosis and fibroadenoma is the mainly frequent lesion2. Due to our cultural background, breast diseases usually describe late. This fact may impart this disease as ice berg phenomenon and prevalence reported may be much fewer.
Hazardous factors for benign breast diseases studied to a limited extent. One study in Iran showed that history of full term pregnancy and live child birth could reduce hazard of fibroadenoma. In fact 50% fibroadenoma found in nulliparous women whereas the same situation was 11% within control group. Similarly fibroadenoma was more prevalent in single women that mean 8% of normal women were single whereas 36 % of cases were single. At same moment early marriage (<21 years) measured as another potential hazard of fibroadenoma in married women that means 60% married ladies with fibroadenoma got married before 21 years whereas only 36.9% of control group had early marriage in their reproductive history.In Pakistan most studies are done either on malignancies or whole spectrum of breast diseases. Unfortunately limited work is available here in Pakistan on demographic factors of benign breast diseases in general and fibroadenoma in particular.
Purpose of said trial is to look for relationship of demographic factors as marital status, early marriage and parity via fibroadenoma. Such trial has not been conducted within Pakistan till date. Early marriage and multiparity is quite common in Pakistan and results in changes in hormonal balance within female. As fibroadenoma has connection with exposure of female hormones especially estrogen so early marriage and numeral child births might well be linked with fibroadenoma. These factors are modifiable and hence awareness can be created if there is significant relation to fibroadenoma.
After approval from concerned ethical review committee and written consent as of the entire potential participants, this observational study was planned from 12th July 2015 to 11th January 2016 at Military Hospital Rawalpindi. All subjects are females. Patients selected on consecutive base. Female patients reporting in OPD between ages 18 to 35 years having histopathological diagnosis of fibroadenoma incorporated as cases whereas healthy females reporting with other problems than breast ailments with no prior family record of any breast disease were included as controls. Non-consenting patients or those having any malignancy, pregnancy or family history of any breast diseases are disqualified from trial. Post-menopausal women also not incorporated. After application of inclusion and exclusion criterion, 308 subjects were included in analyses. Model volume calculated using open-epi calculator for case control study.
Fibroadenoma case defined as the entire those patients on histological assessment show nodularity and encapsulation. The epithelial proliferation appears in a single terminal ductal unit and describes duct-like places surrounded by a fibroblastic stroma which may be intracanalicular and pericanalicular. All subjects between 18 to 35 years included and subjects who got married before 21 years grouped as early marriage. Parity defined as women having one or more children. Detailed family, personal and social record was inquired in detail from each subject.
The consenting subjects provided by means of a detailed description of trial. Subjects inquired about previous breast ailments and detailed history was taken. Demographic factors including age, BMI, marital status, age of marriage, smoking, parity, breast feeding and menopausal status recorded and entered on research profroma. All records composed in presence of attendant/chaperon. Control groups also selected keeping in view the inclusion and exclusion criteria. The controls healthy females reporting in OPD with some other condition matched on age and BMI bases with cases.
Data obtained entered and analyzed using Statistical Package for Social Sciences (SPSS) version 16. Mean +/- SD for age calculated. Frequency and percentage of marital status, early marriage and parity for cases and controls was evaluated. Chi-square applied for comparison of frequency and percentage for marital status, early marriage and parity among two groups.
Odds ratio calculated to determine the link between age at marriage and parity by fibroadenoma in both case and control keeping assurance gap of 95% and taking p value of less than 0.05 as significant. Stratification of the data to minimize confounding by controlling age of menarche, breast feeding and use of contraceptive pills was done. Post stratification Chi-square was again applied to compare frequency and percentage of marital status, early marriage and parity among two groups.
In this case-control study, a total of 308 patients incorporated, out of them 156(50.6%) found to be cases of fibroadenoma, they diagnosed on histopathology and 152(49.4%) control casess who presented in OPD some other problems. All patients were female.
Age distribution in cases and controls is shown in table 1. The minimum age in both groups 18 years and maximum age in both groups 35 years. The mode and median of both groups found to be same that is 22 years and 23 years respectively. No noteworthy difference between the means of two groups as depicted by student t test (p-value = 0.544).
The distribution of body mass index in both groups is given in table. Minimum BMI in both groups was 18 whereas maximum was 35.5 in case and 35 in control group. Median and mode of both groups was 24. Mean BMI of case group was 23.628±2.776 and mean BMI of control group was 23.642±2.751. The scrutiny shows that there was no significant (P-value = 0.756) difference in both groups on the basis of BMI.
In case group, 79(50.6%) patients unmarried and 77(49.4%) married whereas in control group 53 (34.9%) unmarried and 99(65.1%) married. Chi-square test used for scrutiny and it show significant association as revealed in table 2 (p-value=0.005). Odds ratio calculated and it also confirmed a significant relationship between marital status and case group (OR = 1.919 CI 95 % 1.212-3.030).
Analysis showed that in case group, out of 77 patients who married, 38(49.4%) had age less than 21 years at time of their marriage and 39(51.6%) patients had age over 21 years, whereas in control group out of 99 patients who married, 47(47.5%) less than 21 years old at time of their marriage and 52(52.5%) women more than 21 years old at time of marriage. Chi-square test used for analysis and result showed significant association as revealed in table 2 (p-value=0.805). The odds ratio did not show statistically noteworthy relation among early marriage and growth of fibroadenoma (OR=0.928 CI 95% 0.511-1.683).
Analysis for parity showed that case group had 107(68.6%) nulliparous patients and 49(31.4%) patients had children. In control group 69(45.4%) women were nulliparous and 83(54.6%) had children. Chi-square test applied for scrutiny and it showed significant link as shown in table 2 (p-value=0.000). Odds ratio calculated and it also confirmed a significant relationship between nulliparous women and case group (OR = 2.627 CI 95 % 1.650-4.182).
To minimize effect of confounding factors of use of oral contraceptive use, early menarche and breast feeding binary logistic deterioration used keeping assurance gap of 95 % and is given in table 3. The odds ratio adjusted for oral contraceptive use, menarche and breast feeding of marital status is significant (OR=1.807 CI 95% 1.074-3.039 p-value=0.026).
Similarly parity was adjusted for oral contraceptive use, menarche and breast feeding using binary logistic regression shown in table 3. The odds ratio adjusted after stratification of confounding factors was significant (OR=2.372 CI 95% 1.398-4.024 p-value=.001).
Data stratification was done using multinomial regression for age at marriage and after adjusting of oral contraceptive use, menarche and breast feeding, corrected odds ratio for early marriage and case group is noteworthy (OR 1.851 CI 95% 1.025-3.342 p-value=0.041).
Increasing awareness about breast diseases and easy access to information has resulted in frequent visits on the way to clinics and be depicted as greater than before incidence of breast diseases over last decade. Spectrum of breast diseases ranges from inflammatory and benign diseases to malignant ailments. Benign lumps more frequent than malignant cancers responsible for 75% of the entire breast biopsies in Pakistan. Among benign breast diseases fibroadenoma found in 66% of cases21, 2. It is the first study being carried out in Pakistan evaluating relationship of marital status, early marriage and parity by fibroadenoma.
As fibroadenoma is more common between second and third decade of life so our study inhabitants ranged between 18 to 35 years, both groups matched on basis of age and no noteworthy difference noted (p-value=0.544). Similarly both groups also matched depending on basis of BMI to nullify its effect on overall result (p-value=0.756).
Our study concluded that there is a statistically noteworthy relationship among unmarried women and growth of fibroadenoma (p-value=0.005). In other words unmarried women had approximately two times more risk of developing fibroadenoma as compared to controls of same age and BMI. Our findings were consistent with study carried out by Bidgoli SA et al which showed that only 8% of controls were unmarried whereas 36% of cases were married (OR = 6.64)5. However in a similar study Arjitha MB et al showed that fibroadenoma was prevalent in 62% of married women. Similarly a study conducted by Amruthavalli BV et al showed that married women were more likely to develop benign breast diseases.
In fibroadenoma cases, 38 patients got married before the age of 21 years and in control group 47 women had married before the age of 21 years. There appears to be no significant relationship between early marriage and fibroadenoma (p-value=.805). On the contrary, study conducted in Iran showed that 60% of married women who had fibroadenoma got married before 21 years whereas in control group only 36.9 % were married before 21 years.
It was inferred from our study that nulliparous women had statistically significant relationship with fibroadenoma (p-value=0.000). It means that nulliparous women had approximately 2.6 times greater odds of developing fibroadenoma than control group. A study conducted by Nelson ZC et al in China, showed that with increasing number of births the chances of fibroadenoma decrease exponentially. Similarly Bridgoli SA and colleagues showed that nulliparous women had 8 times more chance of getting fibroadenoma. A studied conducted in Kurnool also showed that nulliparous young female have more chances of developing fibroadenoma. A Cohort study conducted in Shanghai identified a decreasing risk of fibroadenoma with increasing number of live child births. Previous studies did not show any significant association between parity and fibroadenoma.
Reproductive background of female is related to the development of fibroadenoma and it is primarily due to endogenous female hormonal exposure. Estrogen being a steroid hormone exerts its effects by synthesizing proteins and inducing proliferation of cells. In benign breast diseases the cell differentiation and apoptosis is averted probably by steroid hormones. The function of estrogen and the cellular response are thought to be impaired due to unknown causes hence resulting in breast lumps of benign diseases as fibroadenoma. It is possible early pregnancy induce cellular proliferation and differentiation of mammary epithelium which in turn act to prevent development of fibroadenoma.
Various confounding factors were also studied which included age at menarche, use of oral contraceptive pills , breast feeding and smoking. The studied factors were stratified using logistic regression model and multinominal regression model. The major confounder in our study was early age at menarche (OR= 2.5), rest of the confounding factors did not have any statistically significant effect. One study in China showed that cases of fibroadenoma had early menarche as compared to controls. Similarly a study conducted in India showed that women with early menarche had more fibrocystic changes in their breasts. On the contrary various studies did not find any significant relation between early menarche and benign breast diseases. The use of contraceptive pills did not have any significant relationship with development if benign lumps in various studies although previously they were thought to have protective function5. Similarly breast feeding once attributed to have a protective effect did not show any relationship with development of fibroadenoma. Smoking had inverse relation with fibroadenoma in studies.
The major limitation in our study was the recall bias as patient had to recall about exposure of associated factors. The case selection was based on consecutive convenient sampling and was not randomized. Since the study was carried out in a tertiary care hospital so generalization to the whole population may be done cautiously. There is a problem with diagnosis in studies of fibroadenomas, because some fibroadenomas go undetected and may regress with time and hence may be included in control group instead which could have affected the whole result introducing observation bias.
Fibroadenoma is the most common breast lump present in Pakistani female population in pre-menopausal age. Its development has been found, in our study, to be directly related to the endogenous female hormonal exposure. Unmarried women are more likely to develop fibroadenoma as compared to married females of same age and BMI. Those women who got married in their early age (<21years) did not show any increased risk of developing fibroadenoma. Similarly nulliparous women have more odds of developing benign lumps as compared to females who had one or more full term pregnancies.
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