Professional Documents
Culture Documents
Contraceptive Users
PATRICIA J. SULAK, MD, ROGER D. SCOW, MD, CHERYL PREECE, MS,
MARK W. RIGGS, PhD, AND THOMAS J. KUEHL, PhD
Objective: To measure the timing, frequency, and severity of Oral contraceptives (OCs), the most common method of
hormone-related symptoms in oral contraceptive (OC) users, reversible birth control, are used by approximately 80%
specifically to compare active-pill with hormone-free inter- of women in the United States at some time during their
vals. reproductive years.1 Despite the continuous reduction
Methods: Using daily diaries, women recorded pelvic in hormone content since OC introduction almost 40
pain, bleeding, headaches, analgesic use, nausea or vomit- years ago, side effects continue to affect compliance.2 4
ing, bloating or swelling, and breast tenderness during
The most commonly reported side effects are nausea
active-pill intervals and hormone-free intervals. Participants
and vomiting, breakthrough bleeding and spotting,
either had no prior OC use, had taken OCs and were
headaches, bloating or swelling, and breast tender-
restarting, or had been taking OCs continuously for 12
ness.57
months or longer.
Although women are prescribed OCs as treatment for
Results: Two hundred sixty-two women, 26 with no pre-
vious OC use, 43 prior users, and 193 current users, provided
menorrhagia or dysmenorrhea, the long-term success
daily records of hormone-related symptoms. Subjects with rates of current low-dose OCs in managing those com-
no prior OC use and prior users restarting were similar in no mon menstrual disorders is not known. There is also a
recent OC use, and because of the small sample, they were lack of information comparing symptoms in new-start
pooled for analysis as new-start OC users. Current users had OC users with long-term users during the 21 days of
patterns of symptoms that were more frequent during hor- hormone-containing pills and the 7-day hormone-free
mone-free intervals than during the three active-pill weeks. interval. If problems are a result of the 7-day hormone
These included pelvic pain (70% versus 21%, P < .001), withdrawal, knowledge of the types and severity of
headaches (70% versus 53%, P < .001), use of pain medica- complaints could lead to specific interventions.
tion (69% versus 43%, P < .001), bloating or swelling (58% In this study, we examined prospectively hormonal
versus 19%, P < .001), and breast tenderness (38% versus symptomatology in women currently using or newly
16%, P < .001). Similar patterns were seen in new-start OC initiating OCs to assess frequency, timing, and severity
users after the first cycle. Among new-start OC users, men- of complaints during each of the 21 days of active pills
strual flow patterns, headache, bloating or swelling, and compared with the 7 days of hormone-free pills.
breast-tenderness symptoms decreased during the three cy-
cles to approach those levels of current users.
Conclusion: Almost all symptoms assessed were signifi- Materials and Methods
cantly worse during the 7-day hormone-free interval than
during the 21 days of hormone-containing pills. (Obstet Women who requested OCs were recruited from the
Gynecol 2000;95:261 6. 2000 by The American College of obstetrics and gynecology practice of Scott and White
Obstetricians and Gynecologists.) Clinic from November 1996 to August 1997 and were
eligible for participation if they had no prior OC use,
had used OCs previously but not in the prior 3 months,
or were current users of OCs for 12 months or more.
From the Departments of Obstetrics and Gynecology, Biostatistics, Women not currently using OCs were considered new
Pathology, and Medical Biochemistry and Genetics, Scott and White starts because they were never users or were not taking
Clinic and Memorial Hospital, Texas A&M University Health Science OCs for a minimum of 3 months before enrollment. All
Center College of Medicine, Temple, Texas.
Supported by a grant from Scott, Sherwood, and Brindley Foundation, patients used a combination low-dose OC of 21 active
Temple, Texas. pills containing 35 g or less of ethinyl estradiol (E2)
VOL. 95, NO. 2, FEBRUARY 2000 Sulak et al Oral Contraceptive Symptoms 263
2, there were similar results (25% versus 8%, respec-
tively; P .001). During weeks 3 and 4, the prevalence
of breast tenderness was comparable (P .78 and P
.38, respectively). Breast tenderness began to increase in
the week before the hormone-free interval in current
users, with a peak during the hormone-free interval,
similar to the pattern for bloating or swelling. Current
users had more frequent breast tenderness during hor-
mone-free intervals than the active-pill weeks (38%
versus 16%, P .001).
Discussion
We documented that hormone-related symptoms some-
times varied between new starts and long-term users of
Figure 3. Percentage of subjects with bloating or swelling by cycle OCs, and between active-pill and hormone-free weeks.
day for current users (A) and new starts (B). In current OC users of more than 12 months, headaches
were more common during hormone-free intervals
compared with the active-pill weeks, probably because
iting, bloating or swelling, and breast tenderness. There of the estrogen withdrawal effect on the vasculature
was an increased prevalence of nausea or vomiting in from declining estrogen levels during hormone-free
new starts compared with current users. During the intervals. Menstrual migraines have occurred in spon-
first recorded cycle, 54% of new starts experienced taneous cycles in women not using OCs, during de-
nausea or vomiting compared with 32% of current users creased estrogen immediately before and during men-
(P .01). As seen in Figure 3, there was an increase in ses.9 12
the prevalence of bloating or swelling during the hor- The prevalence of pelvic pain and analgesic use was
mone-free interval in both groups for all cycles com- greatest during hormone-free intervals. Approximately
pared with the weeks of active-hormone pills (58% 70% of women in the two monitored cycles in current
versus 19%, P .0001 in all cycles). The bloating or users documented some degree of pelvic pain during
swelling begins in the active week before the hormone- the hormone-free interval compared with a prevalence
free interval. As seen in Figure 4, breast tenderness was of 1123% during active-pill weeks. The prevalence of
encountered more commonly in new starts compared moderate to severe pain was 2729% during the hor-
with current users. During week 1 of the first recorded mone-free week compared with 2 6% during active-pill
cycle, 22% of new starts had breast tenderness com- weeks in cycles 1 and 2 of current users.
pared with 9% of current users (P .01). During week Evaluation of menstrual flow showed expected re-
sults. Moderate to heavy menstrual flow was noted less
in current users than new starts, which is important
when counseling those who have been prescribed OCs
for menorrhagia, emphasizing the importance of ex-
plaining that significant reduction in flow might take
several months. Breast tenderness and bloating or
swelling were more likely during hormone-free inter-
vals, an increased prevalence that began in the last few
days of active pills before hormone-free intervals. Those
symptoms before hormone-free intervals might corre-
late with serum E2 levels. Combination low-dose OCs
with 35 g or less of ethinyl E2 do not produce
complete ovarian suppression.1315 Studies have docu-
mented serum FSH and 17-E2 levels suppressed at the
beginning of 7-day hormone-free intervals, but gradu-
ally increasing over the next few days. No significant
differences between FSH levels on day 7 of hormone-
Figure 4. Percentage of subjects with breast tenderness by cycle day free intervals were found compared with controls in the
for current users (A) and new starts (B). normal follicular phase of the ovarian cycle, suggesting
VOL. 95, NO. 2, FEBRUARY 2000 Sulak et al Oral Contraceptive Symptoms 265
21. Thornton MH, Bello SM, Israel R. Treatment. In: Stenchever MA, Received May 3, 1999.
Mishell DR Jr, eds. Atlas of clinical gynecology. Vol III. Reproduc- Received in revised form August 2, 1999.
tive endocrinology. Norwalk, Connecticut: Appleton & Lange, Accepted August 12, 1999.
1999:14.116.