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Beyond the obvious benefits of extended and continuous
regimen oral contraceptive (OC) use to reduce bleeding, practitioners
and patients are using OCs in this manner to relieve menstruation-related
complaints, such as breast tenderness, bloating, headache, and premenstrual
syndrome or premenstrual dysphoric disorder, as well as medical conditions
such as endometriosis.
Extended Use to Reduce Hormone Withdrawal Symptoms
In a retrospective study by Patsy Sulak and colleagues, women with
hormone withdrawal symptoms were counseled to extend the standard 21/7-day
regimen to 6, 9, or 12 weeks or until breakthrough bleeding or spotting
occurred.1 Reasons for using an extended
OC regimen included decreased symptoms of headache (35 percent), dysmenorrhea
(21 percent), hypermenorrhea (19 percent), and premenstrual symptoms
(13 percent). The remaining 12 percent listed convenience, endometriosis,
and other menstrual-related problems, such as acne. This was the first
large series of extended use of OCs among patients complaining of hormone
withdrawal symptoms. The study yielded 7 years of follow-up data for
292 patients (92 percent of the original 318 patients).
Symptom Improvement and Quality of Life
| FIGURE 4. Symptomatic
with Extended OCs vs. 21/7 Regimen1 |
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As shown in Figure 4, in this nonrandomized series, 86 percent of women
using the extended regimen and 41 percent using the 21/7-day regimen
reported that their symptoms improved. Ninety-four percent of the women
using the extended regimen and 43 percent using the 21/7-day regimen
reported that their overall quality of life improved. A potential limitation
of this uncontrolled series is that a charismatic physician who strongly
supports extended OC regimens supervised the care of these women.
Shortening the Hormone-Free Interval
In the first few years of the study, after an extended cycle of use,
patients were instructed to discontinue pill-taking for the standard
7 days; most elected to do so after a typical cycle of 12 weeks (median
9 weeks). Although extended use of OCs effectively delayed hormone withdrawal
symptoms, subjects often experienced a recurrence of symptoms (headache,
premenstrual symptoms) during the 7-day hormone-free interval. The investigators
subsequently advised patients to shorten the hormone-free interval to
4–5 days, and many avoided withdrawal side effects. The investigators
suggested that this practice may concurrently increase contraceptive
effectiveness via enhanced ovarian follicular suppression.
Drospirenone Extended-Use Trial
In a 6-month prospective, open-label, observational trial conducted
in Germany, 175 women who chose to take an extended regimen of 30 mg
of ethinyl estradiol (EE) and 3 mg of drospirenone (marketed as Yasmin®
in the United States) for 42–126 days were compared with 1,221
women who took the same OC using the standard 21/7-day regimen.2 The
aim of the study was to determine whether taking the OC for an extended
cycle would affect menstrual-related symptoms such as swelling of the
extremities, body weight, breast tenderness, feeling of bloating, acne,
dysmenorrhea, breakthrough bleeding, and withdrawal bleeding.
Effect on Edema, Breast Tenderness, Weight Gain,
and Feeling of Bloating
Of the women using the extended regimen, 49 percent experienced a
reduction in edema and 2 percent experienced an increase in this symptom.
This was in contrast to the women using the 21/7-day regimen, 34 percent
of whom had a decrease and 3 percent had an increase in edema. This
difference was significant between the groups at p < 0.001. Of women
using the extended OC regimen, 50 percent had decreased breast tenderness
and 5 percent had an increase in this symptom. In contrast, among women
using the traditional regimen, 40 percent had decreased breast tenderness
and 7 percent had an increase in this symptom (significant difference
between groups, p = 0.046). Women using the extended regimen experienced
a 0.57-kg mean decrease in weight, whereas those using the standard
regimen had a 0.61-kg mean decrease, a difference that was neither clinically
nor statistically significant between groups. A feeling of bloating
improved among 37 percent of women on the extended regimen and 29 percent
on the 21/7-day regimen, but there was no significant difference between
groups.
Improvement in Skin Problems
At the start of the trial, 35 percent of the women using extended
regimen OCs and 33 percent of women using the 21/7-day regimen reported
moderate to severe skin problems. After 6 months of therapy, only 5
percent of women taking the extended regimen and 8 percent taking the
21/7-day regimen reported these problems. (Statistical testing was not
reported by the authors for this comparison.)
Dysmenorrhea and Bleeding Patterns
After 6 months of therapy, 65 percent of women using the extended
OC regimen and 50 percent using the standard regimen reported an improvement
in dysmenorrhea, whereas 2 and 3 percent, respectively, reported worsening;
these differences were statistically significant in favor of the extended
regimen (p = 0.0016). Breakthrough bleeding occurred in 15 percent of
subjects using the extended regimen and 6 percent using the 21/7-day
regimen. Duration and severity of bleeding were similar between the
two groups, but the number of total withdrawal bleeding episodes was
less in the extended regimen group. (Statistical testing was not reported
by the authors for these comparisons.)
Well-Being
Among women using the extended regimen, 85 percent reported that they
felt better or much better after 6 months and 2 percent felt worse,
compared with 66 and 3 percent, respectively, of women using the standard
regimen (p < 0.0001). Ninety-seven percent of women using the extended
regimen and 91 percent using the 21/7-day regimen said that they would
recommend the preparation.
Oregon Continuous Use Trial
In a randomized study, Kwiecien et al. compared the use of a 20-mg
EE/100-mg levonorgestrel pill (168 days without a pill-free interval)
with standard use (six 28-day cycles).3
Subjects were asked to record subjective side effects on a daily basis.
There were no significant differences between groups in regard to the
incidence of nausea, depression, and premenstrual syndrome. However,
subjects in the continuous group had significantly less bloating (mean
= 0.7 days in the continuous group and 11.1 days in the cyclic group;
p = 0.04) and less menstrual pain (mean = 1.9 days in the continuous
group and 13.3 days in the cyclic group; p < 0.01) than those in
the cyclic group. In addition, continuous users reported approximately
half as many days of headache (mean = 3.1 days in the continuous group
and 9.6 days in the cyclic group) and breast tenderness (mean = 2.6
days in the continuous group and 7.1 days in the cyclic group) as cyclic
users over the 168-day study, although these differences were not statistically
significant.4 Interestingly, although
the number of headache days reported by users of standard cycles remained
about the same during each month of observation, users of the continuous
regimen reported successively fewer headache days for each cycle. Weight
decreased slightly and skin satisfaction was comparable and high in
both groups.
Treatment of Endometriosis-Related Pain
An open-label, 6-month, randomized clinical trial of 90 women with
recurrent moderate or severe pelvic pain after conservative surgery
for endometriosis was conducted in Italy.5
This study compared continuous use of an OC containing 20 mg of EE and
150 mg of desogestrel with oral cyproterone acetate, 12.5 mg/day. Both
drugs substantially reduced dysmenorrhea, deep dyspareunia, and nonmenstrual
pelvic pain scores and significantly improved health-related quality
of life, psychiatric profile, and sexual satisfaction.
In a separate prospective, self-controlled clinical trial of 50 women
who had undergone conservative surgery for endometriosis in the previous
year but continued to experience dysmenorrhea with conventional cyclic
OC use, the same investigators looked at continuous use of an OC containing
20 mg of EE and 150 mg of desogestrel for 2 years.6
They found that continuous use significantly reduced the frequency and
severity of dysmenorrhea, and 80 percent of the women were satisfied
or very satisfied with the treatment.
References
1. Sulak PJ, Kuehl TJ, Ortiz M, Shull BL. Acceptance of altering the
standard 21-day/7-day oral contraceptive regimen to delay menses and
reduce hormone withdrawal symptoms. Am J Obstet Gynecol 2002;186:1142-1149.
2. Sillem M, Schneidereit R, Heithecker R, Mueck AO. Use of an oral
contraceptive containing drospirenone in an extended regimen. Eur
J Contracept Reprod Health Care 2003;8:162-169.
3. Kwiecien M, Edelman A, Nichols MD, Jensen JT. Bleeding patterns
and patient acceptability of standard or continuous dosing regimens
of a low-dose oral contraceptive: a randomized trial. Contraception
2003;67:9-13.
4. Jensen JT. Reducing symptoms through continuous dosing regimens
of low-dose oral contraceptives. Presentation at special symposium on
extended and continuous cycle oral contraceptives, 59th Annual Meeting
of the American Society for Reproductive Medicine, San Antonio, Texas,
October 2003.
5. Vercellini P, DeGiorgi O, Mosconi P, et al. Cyproterone acetate
versus a continuous monophasic oral contraceptive in the treatment of
recurrent pelvic pain after conservative surgery for symptomatic endometriosis.
Fertil Steril 2002;77:52-61.
6. Vercellini P, Frontino G, DeGiorgi O, et al. Continuous use of an
oral contraceptive for endometriosis-associated recurrent dysmenorrhea
that does not respond to a cyclic pill regimen. Fertil Steril
2003;80:560-563.
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