Benign Breast Disease in Makkah, Saudi Arabia: A Retrospective Analytical Cross-Sectional Study

Introduction The most frequent reason for visiting breast clinics is benign breast disease (BBD), which accounts for 90% of all breast-related presentations globally. It is widespread among women of childbearing age, peaking between the ages of 30 and 50. However, owing to the lack of studies on BBD compared with breast cancer in Saudi Arabia, this study aimed to assess the common patterns of BBD and factors associated with the frequency of fibroadenoma (FA) occurrence. Methodology A retrospective analytical study was carried out at Al-Noor Specialist Hospital, Makkah, Saudi Arabia, from May to August 2022. The sample was all patients who attended the breast and endocrine unit from January 2015 to December 2020. Results This study included 222 of 367 patients who had BBD. Of them, 42.3% were aged 31-45 years, with a mean age of 36.71 ± 12.48 years. The mean body mass index (BMI) was 26.45 ± 6.69 kg/m2, and the mean tumor size was 4.22 ± 4.9 mm. Conclusion Fibroadenoma among BBD types is the most common lesion in the studied population. This study established the baseline pattern of BBD in a specialized hospital in Makkah.


Introduction
The most frequent reason for visiting breast clinics is benign breast disease (BBD), which accounts for 90% of all breast-related presentations globally [1,2]. BBD is widespread among women of childbearing age, peaking between the ages of 30 and 50 [3]. It is a range of histological entities that includes nonproliferative lesions, atypical hyperplasia, and proliferative lesions without atypia [4]. Although BBD is frequently benign, some cases do develop into cancer [1]. The patient's medical history, clinical examination, and imaging modalities are all used to make the diagnosis [5].
Early menarche, regular short menstrual cycles, oral contraceptives, hormonal replacement therapy, nulliparity, pregnancy at an older age, and having a high postmenopausal body mass index (BMI) are risk factors linked to a higher risk of breast cancer, whereas having a high premenopausal BMI and nursing for a long time is linked to a lower risk [6][7][8][9]. Patients with BBD frequently exhibit mastalgia, a palpable tumor, and nipple discharge, necessitating biopsy in addition to targeted diagnostic imaging such as mammography, ultrasound, and magnetic resonance imaging (MRI) [5]. Up to 30% of women diagnosed with BBD will eventually need therapy [1].
Although some forms of BBD are linked to the development of later breast cancer, non-proliferative lesions with atypical hyperplasia are 3.9-13-fold more likely than proliferative lesions without atypia (1.3-1.9-fold greater risk) [10]. Between 70% and 79% of breast lumps in Uganda, Trinidad, and Nigeria are BBD, the majority of which are fibroadenoma (FA) and fibrocystic change (FCC) [11].
Similarly, the most common BBD in Saudi Arabia is FA, followed by FCC [12][13][14]. Owing to the lack of studies on BBD compared with breast cancer in Saudi Arabia, this study aimed to assess the common patterns of BBD and their demographic distribution at Al-Noor Specialist Hospital, Makkah, Saudi Arabia. It also aimed to assess the factors associated with the frequency of FA occurrence.

Study design, setting, and time
This retrospective cross-sectional study was carried out at Al-Noor Specialist Hospital, Makkah, Saudi Arabia, from May to August 2022.

Study population
The inclusion criteria were patients between 18 and 80 years who presented to the breast and endocrine unit of Al-Noor Specialist Hospital because of a breast complaint (mass, pain, swelling, and discharge) or for a screening mammogram from 2015 to 2020. The exclusion criteria were patients with malignancy, incomplete data, and pregnant or lactating women.

Sample size
The sample comprised all patients who attended the breast and endocrine unit from January 2015 to December 2020 and met the inclusion criteria.

Ethical considerations
Ethical approval for the study was obtained from the Institutional Review Board (IRB) of Al-Noor Specialist Hospital, Makkah, Saudi Arabia.

Data analysis
Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 26 (IBM SPSS Statistics, Armonk, NY, USA). The chi-squared test (χ 2 ) was applied to qualitative data expressed as numbers and percentages to examine the relationship between the variables. The Mann-Whitney U test was used to analyze non-parametric variables and quantitative data presented as mean and standard deviation (mean ± SD). A p-value of less than 0.05 was regarded as statistically significant.

Results
This study included 222 patients who had BBD. Of them, 42.3% were aged 31-45 years, with a mean age of 36.71 ± 12.48 years. The mean BMI was 26.45 ± 6.69 kg/m 2 , and the mean tumor size was 4.22 ± 4.9 mm. Of the participants, 92.3% were women, and 82.4% had Saudi nationality. Only 8.6% had chronic diseases, of whom 26.3% had iron deficiency anemia. Almost half of the participants (50.9%) were taking medications ( Table 1). The most frequent diagnosis was FA (55.4%) ( Table 2).     Figure 1 illustrates that 55.4% of the studied patients were diagnosed with FA. Additionally, FA was significantly higher among patients aged under 30 years (p ≤ 0.05) (Figure 2). Table 4 shows a significantly higher rate of FA among patients in their 30s (p ≤ 0.05).

Discussion
The present study was carried out to investigate the patterns of BBD and its associated risk factors in Makkah. Our findings showed that among the 222 participants, FA was the most common BBD, followed by FCC, abscesses, and gynecomastia. Furthermore, the prevalence of FA was higher in young women than in other subjects.
In this study, FA was highly prevalent in the third decade, with a mean age of 33.55 years, similar to the research of Razik et al. [18] and higher than the study of Albasri [12]. However, other variables, such as residence in Saudi Arabia and chronic diseases, were not significantly associated with FA, which disagrees with the study of Razik et al. [18].
The similarity of our result with those mentioned above is consistent with national studies regardless of the level of care. Our research was carried out in a specialized center, whereas the study of Albasri [12] was in a tertiary hospital, the study of Razik et al. [18] was a multicentric study, and Jamal [13] was in a teaching hospital.
In our study, FCC was the second most commonly reported lesion, accounting for 15.3% of all BBD types. This finding is in line with the findings of Albasri [12], Alamri et al. [19], and Amr et al. [20]. They found an FCC frequency of 23.4%, 18.8%, and 21.1%, respectively.
In our cohort, abscesses were the third most commonly reported BBD type, accounting for 8.1%, which is comparable to the study of Alamri et al. (5.9%) [19] and higher than the study of Ahmad Mohammed (0.8%) [21]. In the present study, benign phylloid tumor was found in 4.1% of the study population, while Aslam et al. [17] and Masciadri and Ferranti [22] reported a lower rate. Other BBD types, such as gynecomastia, epithelial hyperplasia, lipoma, and mastitis, were found to be low in our cohort; similar rates were also reported in the studies of Albasri [12] and Razik et al. [18].

Limitations
The study has some limitations, notably its retrospective design and sample size affected by poor recording systems, which limited data collection to a five-year period. The lower rate of benign breast disease in our study compared with the Makkah population may result from many variables such as the distribution of patients across city hospitals. However, other reasons could explain our findings such as a lack of awareness of such conditions, hesitancy to seek medical care due to social difficulties, and ignorance of these issues.

Conclusions
In conclusion, fibroadenoma is the most common lesion of benign breast disease in the studied population. This study established the baseline pattern of benign breast disease in a specialized hospital in Makkah, which provides valuable information to local physicians.

Additional Information Disclosures
Human subjects: Consent was obtained or waived by all participants in this study. The Institutional Review Board (IRB) of Al-Noor Specialist Hospital, Makkah, Saudi Arabia, issued approval H-02-K-076-0222-664. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue.

Conflicts of interest:
In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.