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JOURNAL OF GYNECOLOGIC SURGERY

Mary Ann Liebert, Inc.

Prevention and Treatment of Ovarian Cysts with Oral


Contraceptives: A Prospective Randomized Study
OMUR TASKIN, M.D.,1 DONALD C. YOUNG, D.O.,1 RAKESH MANGAL, M.D.,1 and
ISRAEL ARUH, M.D.2

ABSTRACT

To determine if treatment with low-dose combination oral contraceptives hastened resolu-


tion of ovarian cysts or prevented their occurrence, we conducted a prospective randomized
study of 45 women with ovarian cysts and 50 women without ovarian cysts and divided the
patients into four groups. Group A patients (n = 25) had no cysts and received oral con-
traceptives, group B patients ( = 25) had no cysts and were expectantly managed, group
C patients (n = 25) had cysts and received oral contraceptives, and group D patients (n =
20) had cysts and were observed. All patients were followed with transvaginal ultrasound
examinations every 4 weeks for three cycles, with cyst dimensions and ovarian volumes
recorded. There were no statistically significant changes in the size of the cysts or ovarian
volumes between groups who received oral contraceptives and groups who received expec-
tant management (p > 0.05) Prophylactic treatment with the oral contraceptive did produce
a statistically significant reduction in the incidence of ovarian cyst formation. Cyclic low-
dose oral contraceptives had no effect on resolution of ovarian cysts but did seem to protect
against cyst formation in short-term use. (J GYNECOL SURG 12:21, 1996)

INTRODUCTION

masses are common gynecologic problems that often are first recognized during routine pelvic
Ovarian
of
examination or visualized during diagnostic procedures such as ultrasonography (US). Management
cystic ovarian masses in women of reproductive age remains an unresolved dilemma. ' It is widely ac-
cepted that many of these ovarian cysts are the result of a persistent ovarian follicle or corpus luteum, and
as such, if observed for a period of two menstrual cycles or 60 days, they generally resolve.1-2
As an alternative to observation, low-dose oral contraceptives are widely used in clinical practice to has-
ten resolution when an ovarian cyst is diagnosed, but the efficacy of this treatment is unproven.3 This study
presents results of a prospective trial of cyclic low-dose oral contraceptives in prevention and resolution of
adnexal cystic masses.

MATERIALS AND METHODS

Between February and December 1991, 45 consecutive women age 18-34 years with newly diagnosed
ovarian cysts (46 cm) were included in the study. The study was conducted in a teaching hospital setting,
and the study was approved by the institutional review board. Fifty consecutive women age 19-33 years

'Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.


2SSK Tepecik Maternity Hospital, Izmir, Turkey.

21
22 Taskin et al. Journal of Gynecologic Surgery

Table 1. Classification of Study Patients to Treatment Groups


and Demographic Variables

Treatment

Oral contraceptive No oral contraceptive


No ovarian cyst Group A (n 25)
=
Group B (n =
25)
27.4 4.2a* 26.4 3.2*
Ovarian cyst Group C (n 25)=
Group D (n 20)
=

25.6 4.0* 27.5 3.3*

aAge in years (mean SD).


*p > 0.05 between the study groups.

without ovarian cysts were used to assess the effect of oral contraceptives (OC) on the prevention of ovar-
ian cysts. The patients participated voluntarily in the study and gave informed consent.
The patients were randomized by sequential assignment based on a table of random numbers. All pa-
tients had regular cycles (mean 29 days; range 28-35 days). Women with previous surgery, endometriosis,
pregnancy, masses other than pure cystic (i.e., solid component, papillary projections, irregular cystic cap-
sule, and cysts >6 cm) and medical problems in which OC were contraindicated were excluded from the
study. Patients were further divided into four groups (Table 1): group A patients had no cysts and received
oral contraceptives (n 25), group B patients had no cysts and were observed (n 25), group C patients
= =

had an ovarian cyst and received oral contraceptives, and group D patients had cysts and received expec-
tant management (n =
20).
Thepatients who were diagnosed with ovarian cysts were randomized to one of the treatments without
knowledge of the size and volume of the cysts. The initial measurements were made known only at the end
of the study, and the ultrasonographer was blinded to the patient's group. The OC-treated patients had cyclic
low-dose oral contraceptives (30 pug ethinyl estradiol and 0.3 mg norgestrel) beginning with the first cycle
following US. All patients were followed with transvaginal US (by Toshiba, 5 MHz probe) examinations
every 4 weeks and at the end of the second and third month just after menses by the same physician, who
was unaware of which therapy the patient was receiving. Cyst volumes were recorded and compared with
the previous volume recorded at the beginning of study. The volumes of the cysts were estimated by the
measurement of the long, short, and anteroposterior dimensions, and the volumes were calculated by the
prolate ellipsoid formula: [length height (cm) width (cm) 0.5 volume in mL] before and at the end
=

of the third month.4 In the patients with no ovarian cysts, the ovarian volume was within the normal range
(<11 mL).5
The volumes and number of women with residual cysts were analyzed statistically between each group
with paired Student's /-test and Chi-square test. A p value of <0.05 was considered significant.

RESULTS

A total of 95 women were included in the study. There ages were 27.4 4.2 years in group A, 26.4
3.2 years in group B, 25.6 4.0 years in group C, and 27.5 3.3 years in group D. There was no differ-
ence between the groups with or without cyst in number, size, and volume of the cysts at the initial exam-
ination. The mean cyst volumes were 22.5 7.8 mL in group C and 20.2 6.0 mL in group D in the be-
ginning of study, and they were found to be 14.8 9.2 mL and 9.6 4.3 mL, respectively, at the end of
the third month (Table 2). The differences between these volumes were both significant compared with the
volumes at the beginning of therapy, although there was no significance between the volumes measured at
the end of the third month. The difference between the number of patients whose cysts were resolved was
not statistically significant in groups that received oral contraceptives and expectant therapy (p > 0.05).
In groups A and B (which were free of ovarian cysts at the beginning of the study) 3 women in group
A and 9 women in group B (and at the second month, 5 women in group A and 11 in group B) had cysts
with a mean volume of 2.8 1.8 mL and 4.4 3.4 mL, respectively. The difference between the volumes
and the number of women with cysts at the end of the third month was significant (p < 0.05). The cysts
Volume 12, Number 1, 1996 Treatment of Ovarian Cysts with Oral Contraceptives 23

Table 2. Number of Patients with Residual Cysts (>3 cm) and Cyst
Volumes Before and After Management

No. ofpatients
Cyst volume with residual cysts

Before After
management management (+) ()

Group A 0 2.8 1.8a 3* 22


Group B 0 4.4 3.4 9* 16
GroupC 22.5 7.9 12.8 9.2** 12* 13
Group D 20.2 6.2 9.6 4.3** 10* 10

aMean SD.
*p > 0.05 between the study groups (groups A, B, groups C, D) by Chi-square
tests.
**p < 0.05 compared with pretreatment baseline measurements by paired Mest.

that werelarger than 3^ cm and failed to regress in groups C and D (n 8) were either aspirated under
=

transvaginal ultrasound guidance (n 3) or underwent surgery (n 5). The aspiration cytology was neg-
= =

ative for carcinoma in all patients. Two women in the surgical group had endometriomas, and the others
were diagnosed with corpus luteum cysts.

DISCUSSION

Ovarian cysts, which arebelieved to be the persistence of an ovarian follicle or corpus luteum, are a com-
mon gynecologic problem in reproductive age females. The use of OC is advocated by many authors for
faster resolution of the cysts.3 OC are presumed to hasten the resolution of these cysts presumably by sup-
pression pituitary gonadotropin release or direct effects on the ovaries.6 The other proposed advantages
of
of OC are their beneficial effects in protection of ovarian cyst development and ovarian malignancies.7
Derman8 reported this protective effect as more pronounced for corpus luteum cysts (78% reduction) and
estimated that approximately 28 operations for ovarian cysts were avoided among every 100,000 women
who take OC.
In contradiction to these reports, a case report by Cailloute and Koehler9 revealed that functional ovar-
ian cysts occurred in women who took multiphasic OC and raised the question of an association between
these two events. In a follow-up study, Grimes and Hughes10 failed to confirm the postulated association
between the events.
In a series of 286 patients, Spanos1 ' found complete resolution of cysts with the use of various doses of
estrogen/progestin combinations. Although this treatment regimen has been widely accepted in clinical prac-
tice, controlled studies have failed to show the efficacy of this therapy on cystic ovarian masses once they
are found.3
Although various types and dosages of combination OC have been used, we used low-dose OC (<35
/xg) to avoid the side effects associated with higher-dose formulations. The time interval used for the ther-
apy was 12 weeks because functional cysts usually resolve spontaneously within two menstrual cycles or
8 weeks. Spellacy et al.12 demonstrated lower FSH response to a GnRH challenge in women taking 50 ptg
estrogen preparations as compared with lower-dose pills. Because the degree of FSH suppression (as as-
sessed with GnRH stimulation testing) correlates directly with estrogen concentration in OC pills, we have
followed the patients for 3 months to ensure complete suppression. There was no statistical difference in
resolution of ovarian cysts between the end of the second and third month.
In our study, no differences were seen between OC use and expectant therapy in the groups with ovar-
ian cysts (p > 0.05), whereas the use of OC in normal women was found to be effective over expectant
management in protection against cyst formation (p < 0.05). In a field study of 6382 patients, Friedman
and Wheeler13 found a lower frequency of ovarian cyst formation with low-dose OC use.
Our study failed to demonstrate any significant effect of OC over expectant management in the rsolu-
24 Taskin et al. Journal of Gynecologic Surgery

tion of ovarian cysts, although we did demonstrate the beneficial effects of oral contraceptives in protec-
tion against ovarian cyst formation. Obviously, the sample size of this study may be a factor to avoid gen-
eralizing the results, since a total of 196 patients was required to have a power of 0.80. Still, our results are
within the limits that have been published previously on the same subject. Additional research to reveal the
pathogenesis of ovarian cyst formation is needed to evaluate possible treatment modalities, such as new OC
formulations and the use of GnRH analogs.

REFERENCES

1. Bird CC, McElin T, Victor T. Benign neoplasms of ovary. In: Sciarra J, ed. Gynecology and obstetrics. Philadelphia:
Harper & Row, 1988:35.
2. Drogemueller W. Benign gynecologic lesions. In: Drogemueller W, Herbst AL, Mishel DR, eds. Comprehensive
gynecology. St. Louis: CV Mosby Company 1987:467.
3 Steinkamf M, Hammond K, Blackwell R. Hormonal treatment of functional ovarian cysts: A randomized, prospec-
tive study. Frtil Steril 1990;54:775.
4. Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol 1991 ;34:433.
5. Munn C, Linsey KC, Wetzner SM, Baer JE. Ovary volume in young and premenopausal adults: US determination.
Radiology 1986;159:731.
6. Fuller ME. Oral contraceptive therapy for differentiating ovarian cysts. Postgrad Med 1971;50:143.
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1987;294:1518.
8. Derman R. Oral contraceptives, assessment of benefits. J Reprod Med 1986;31:879.
9. Cailloute JC, Koehler AL. Phasic contraceptive pills and functional ovarian cysts. Am J Obstet Gynecol
1987;156:1538.
10. Grimes DA, Hughes JM. Use of multiphasic oral contraceptives and hospitalization of women with functional ovar-
ian cysts in the United States. Obstet Gynecol 1989:73:1037.
11. Spanos WJ. Preoperative hormonal therapy of cystic adnexal masses. Am J Obstet Gynecol 1973; 116:551.
12. Spellacy WN, Kalra PS, Buhi WC, et al. Pituitary and ovarian responsiveness to a graded gonadotropin-releasing
factor stimulation test in women using low estrogen or a regular type of contraceptive. Am J Obstet Gynecol
1980:137:109.
13. Friedman AJ, Wheeler JM. Incidence of ovarian cyst formation in women taking ethynodiol diacetate, 1 mg with
ethinyl estradiol, 35 p.g. J Reprod Med 1991;36:328.
Address reprint requests to:
Omur Taskin, M.D.
Department of Obstetrics and Gynecology
Innu University School of Medicine
Malatya, Turkey

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