Acknowledgements

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The use of oral contraceptive in treatment of endometrial polyps
sized less than 1.5 cm in women aged 20-40 years
Mojgan Barati, Assisstant professor *, Nahid Shahbazian, Assisstant professor *,
Maryam Baghayie nejad, Resident*, Sara Masihi, Assisstant professor *
* Departments of Gynecology and Obstetrics, Imam Khomeini Hospital, Ahvaz
Jundishapur University of Medical Sciences, Ahvaz, Iran
Short title: use of oral contraceptive in treatment of endometrial polyps
Manuscript type: Original
Abstract word Count: 249
Total Manuscript word count: 1168
Conflict of interest statement: We declare that we have no conflict of interest.
Sources of funding: Research deputy, Ahvaz Jundishapur University of Medical Sciences,
Ahvaz, Iran
Corresponding author:
Mojgan Barati,
Gynecology
and
obstetrics
Department,
Imam
Khomeini
Jundishapur University of Medical sciences, Ahvaz, Iran,
Email: brati_m@yhaoo.com
Tel: 09161187090
1
Hospital,
Ahvaz
Abstract
Context: Mucosal polyp is one of the most common cases of postmenopausal
bleeding and menometrorrhagia. Objective: This study outlines the efficacy of oral
contraceptive in the treatment of endometrial polyps (EPs) sized less than 1.5 cm.
Design: a randomized clinical trial from Feb 2010 to 2011. Setting: 50 women who
were referred to obstetrics and gynecology ward of educational hospitals. Patients:
Total of 50 women who are of childbearing age, have asymptomatic EPs smaller
than 1.5 cm, were engaged in this study. Intervention: Oral contraceptives
periodically for 3 months. Main outcome measures: vaginal ultrasonography and
measuring EPs size at beginning of the study and after 3 months. Results: The
mean weight of case and control showed significant difference, but the mean height
and gravidity have no significant difference. Total of 24% in cases fully responded to
treatment, 32% reduction and in 44% no change in size of EPs has been observed,
while in control group the EPs size was reduced in 28%, did not change in 37% and
had increased in 35% of the patients. The mean size of EPs in the control group
before the treatment was no statistically significant (9.5 vs. 8.6 mm, P = 0.297), while
it was statistically significant in the case groups before and after treatment (9.5 vs.
6.3 mm, P <0.05). Conclusion: In the absence of affordable medication and
procedures such as curettage and hysteroscopy, oral contraceptive is not invasive,
cost effective and of course many other studies in this field are needed.
Keywords: oral contraceptive, endometrial polyps (EPs), gravidity, Body mass index
Introduction
Mucosal polyp usually results from localized abnormal growth of endometrial uterine
lining, and is one of the most common cases of postmenopausal bleeding and
2
menometrorrhagia (1- 3). Endometrial polyps (EPs) can be asymptomatic and are
caused by hormonal imbalances, blood pressure, obesity and delayed menopause
(4). Hormonal factors may be involved in the pathogenesis of EPs (5), which are also
shown in patients who are suffering and in endometrial abnormality and exposed to
Tamoxifen (6). Despite the fact that Tamoxifen is an estrogen antagonist, but it
shown the estrogen-like effects on the endometrium tissue (7). A relationship
between endometrial polyps and the use of Tamoxifen has been reported previously
(8, 9). Besides, an association between the growth of benign endometrial polyps and
Tamoxifen treatment has been reported (10).
The multiple EPs were reported in 26% of the postmenopausal women and 15% of
the non-menopausal women (7). This is believed that the reason of EPs is estrogenstimulated (11). Sonohystrography using saline infusion in asymptomatic women
over thirty years of age has been reported the incidence of EPs about 10% (12). The
prevalence of EPs in population studies between 6-32% reported that increases with
increase in the age of patients (13).
Management of EPs using oral progesterone or progesterone-producing IUD are
known as alternatives to hysterectomy in women before the age of menopause
which tend to be pregnant or in women after the age of menopause who are not
been recommended as the candidates suitable for surgery (14-16). Oral
contraceptives are considered as the most common form of contraception due to
ease of use, effective and reversible properties (17). The most common type of oral
contraceptives is containing both estrogen and progesterone, which is naturally
secreted from the ovaries and affect the endometrium.
3
However, according to all advantages of known treatment methods, since entail
higher costs and risks of the surgery and hospitalization and the fact that oral
contraceptive intake reduces the chance of EPs, this study outlines the efficacy of
oral contraceptive in the treatment of EPs sized less than 1.5 cm in women aged 2040 years.
Patients and Methods
Study design and population: This is a randomized clinical trial that was
conducted on 50 women who were of childbearing age, have asymptomatic EPs
smaller than 1.5 cm, and referred to obstetrics and gynecology ward of educational
hospitals of Ahwaz Jundishapur University of Medical Sciences form Feb 2010 to
2011. Patients were randomized in two groups of 25 as case and control. The study
was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical
Sciences, and written informed consent was obtained from all of the parents.
Inclusion criteria: all women who are of childbearing age, have asymptomatic EPs
smaller than 1.5 cm, aged 20 to 40 years, and the EPs randomly determined by
vaginal ultrasound methods were entered to this study.
Exclusion criteria: patients with history of oral contraceptive intake, infertility, pelvic
pain, liver disease, thrombo-embolism, Diabetes, hypertension, uterine fibroma and
adenomyosis, infertility due to non-uterine causes, other uterine abnormalities and
during the study if complications of oral contraceptive such as dizziness, decreased
vision, obsess, and suspected for malignancies or cancers were excluded from the
study.
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Drugs: The oral contraceptive was used in tablet form of LD type with a composition
of levonorgestrol 0.15 mg and ethynil estradiol 0.03 mg (Abureihan CO. Tehran,
Iran).
Intervention: Oral contraceptives were administered to patients in case group
periodically for 3 months (21 tablets, one each night that starts from the 5th day of
menstrual period). The patients in control group were undergone to non-hormonal
preventive method also for 3 months.
Method: all the patients in case and control group were admitted to vaginal
ultrasonography in the beginning of the study and the EPs size were measured.
Then they were undergone to oral contraceptive intake in case group and barrier
preventive method in control group for 3 months.
The second vaginal
ultrasonography and the EPs size measurement were done after that 3 months
period and the obtained EPs sizes were compared.
Statistical analysis: data were analyzed using SPSS 17.0. The descriptive statistics
were observed and matched in both groups. The mean sizes of EPs before and after
intervention were compared using paired t-test. The p-value less than 0.05
considered as significant.
Results
There was no significant difference between case and control groups in term of
mean age (29 ± 3.94 vs. 27.32 ± 4.18, P= 0.155) (Figure 1). The mean weight and of
case and control patients showed significant difference, but the mean height of two
groups has no significant difference (Table 1). The most predominant gravidities in
case and control groups were observed in second (32 vs. 28) and third (28 vs. 32)
5
type, respectively (Figure 2). Total of 24% in cases fully responded to treatment,
32% reduction and in 44% no change in size of EPs has been observed. In control
group the EPs size was reduced in 28%, did not change in 37% and had increased
in 35% of the patients (Figure 3). The mean gravidity in case and control groups has
not statistically significant difference (1.3 vs. 1.8, P = 0.1). The mean size of EPs in
the control group before the treatment was no statistically significant (9.5 vs. 8.6 mm,
P = 0.297), while it was statistically significant in the case groups before and after
treatment (9.5 vs. 6.3 mm, P <0.05).
Discussion
This study outlines the efficacy of oral contraceptive in the treatment of EPs sized
less than 1.5 cm especially in women aged 20-40 years. However, the use of oral
contraceptives helps in treatment of the EPs. Dreisler and colleagues were reported
the asymptomatic EPs were presented in 82% of cases, the risk of EPs Increases
with age and taking oral contraceptives decrease the chance of EPs (13).
In the present study also we demonstrated that the size of EPs significantly reduced
when taking oral contraceptives, but in our study 48% of cases and 56% in the
control group were asymptomatic, which was lower than the Dreisler et al study.
Another study showed that EPs have more positive relationship with BMI > 25 kg /
m2 and hormonal therapy has negative correlation with the use of oral contraceptive
(13).The present study was similar in the context that showed significant differences
and an inverse correlation between BMI and EPs.
In a study that conducted by the wary and colleagues in 2003, approximately 75% of
women with EPs are cured with hormonal therapy (17), hence, In the present study,
24% of patients in case group had complete remission, 32% had reduction and in
6
44% had no change in EPs size. Besides, in control group the EPs size was reduced
in 28%, did not change in 37% and had increased in 35% of the patients.
Conclusion
According to the study, which appears to use the oral contraceptive in the absence
of affordable medication and procedures such as curettage and hysteroscopy, is not
invasive, cost effective and of course many other studies in this field are needed.
Acknowledgements:
This study was a MD thesis (Ref.No: U-89146) and supported by the research
deputy of Jundishapur University of Medical Sciences. The authors would like to
thank Research Consulting center (RCC) for their participation in manuscript
revision.
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Tables and Figures
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Table 1: Comparing the demographic data of endometrial polyps (EPs) between
case and control groups
Variables
Case group
Control group
P-values
29 ± 3.94
27.32 ± 4.18
0.155
Weight (Kg), mean ± SD
68.7 ± 7.26
63.92 ± 6.57
0.007
Height (Cm), mean ± SD
162 ±3.9
159 ±2.7
0.687
BMI (kg/m2),mean ± SD
26.2 ± 2.93
26.32 ± 2.34
0.167
Before treatment
9.5 ± 3.1
8.6 ± 3.01
0.297
After treatment
6.3 ± 4.5
8.3 ± 1.23
0.000
1.3 ± 1.03
1.8 ± 1.23
0.167
Age (year), mean ± SD
EPs size
Gravidity
Figure 1: The age distribution of case and control groups
Figure 2: The frequencies of gravity in case and control groups
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Figure 3: The various degrees of improvements in endometrial polyps (EPs) size
and condition
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