Sulak PJ, Kuehl TJ, Ortiz M, Shull BL
American Journal of Obstetrics and Gynecology. 2002;186(6):1142-1149
Site: Scott & White Clinic, Texas A & M University, Temple, Texas
Objective: To measure acceptance and use of shortening the hormone-free interval in combination oral contraceptive pills (OCs) to reduce the frequency and severity of hormone withdrawal symptoms.
Methods: This was a retrospective review of patients on OCs with unwanted hormone withdrawal symptoms who were counseled by 1 gynecologist (PJS) about altering their standard 21/7 regimen. All patients used a monophasic 30 to 35 mcg pill and underwent an initial counseling visit between 1993 and 2000. Patients were free to choose how long to stay on active pills; they were given a simple menstrual calendar to record spotting or bleeding. They were also instructed to record hormone-free days and were asked to rate their quality of life on a scale of 0 to 10.
Results: Of 318 women counseled on extending the number of active pills, 292 (92%) had documented follow-up. The primary reason for extending the number of active pills was to decrease symptoms of headache (35%), dysmenorrhea (21%), hypermenorrhea (19%), and premenstrual symptoms (13%). The remaining 12% cited convenience, endometriosis, or perimenstrual acne.
Twenty-five patients (9%), chose not to change their regimen after counseling, mostly because they preferred to have regular periods. Of 267 patients who initiated an extended regimen, 57 discontinued OCs, 38 returned to a standard regimen, and 172 were extending use at the last follow-up. Forty-six percent of the women continued extended use for at least 5 years.
There were multiple reasons for discontinuing the OC, the most common of which were worsening of side effects (42%) and desire for pregnancy (23%).
Most of the 38 women who returned to the usual 21/7 OC regimen did so because of unscheduled bleeding or spotting. In the 172 women who continued an extended OC regimen, the pattern of active pill use showed remarkable variation: a mean of 12 +/- 12 weeks of active pills, with a median of 9 weeks and a range of 104 weeks. The typical pill-free interval was 6 +/- 2 days.
Not surprisingly, the quality-of-life measure was significantly better (P < .00001) in the women who continued an extended OC regimen, compared with those who discontinued the pill or returned to the standard regimen. No unintended pregnancies or serious complications were observed in these women.
Conclusions: A majority of women with hormone withdrawal symptoms on OCs will initiate a regimen of extended active pills, often with a shortened hormone-free interval, to reduce the frequency and severity of associated symptoms.
Commentary: The principal investigator (PJS) admits to a potential bias: "the counseling of all patients by a single physician who has a strong belief that monthly menses are unnecessary and, in fact, create a multitude of problems for many women." Although the women were apparently informed of this bias, it is unclear whether the author's admitted "clinical practice pattern since 1993" was intended as a research project from the beginning. In any case, Institutional Review Board approval was obtained for a retrospective review of her database.
When combination OCs were first introduced, the placebo pills were added to provide a withdrawal bleed that would mimic menstruation. This was reassuring to sexually active women worried about pregnancy and was seemingly more "natural." However, many women continued to have dysmenorrhea and a variety of symptoms -- most markedly during the placebo week.
Gynecologists have known for years that menses could be delayed by omitting the sugar pills, and many a new bride has taken advantage of this possibility. Of course, continuous OC therapy -- pseudo-pregnancy -- has long been employed in the treatment of endometriosis.
Sixty-four percent of women with unwanted hormone withdrawal symptoms felt much better when skipping the placebo pills; this offers hope to many women who have problems with the pill. In this study, each woman was free to adjust the number of active pill days and pill-free intervals to suit herself; thus, this does not permit any general recommendation about an "ideal regimen." Indeed, it is possible that the sense of "control" associated with fine-tuning the regimen might in itself be therapeutic. This hypothesis could be tested in a prospective trial.
No significant short-term adverse effects were reported. However, recent reports showing increased incidence of breast cancer, myocardial infarction, and cardiovascular events in patients taking continuous estrogen-progestin HRT for more than 4 years should raise concerns about the long-term use of this type of regimen, particularly since OCs contain 4-6 times the amount of estrogen and progestin as HRT. The low incidence of these adverse events in young women will make it difficult to show an association, but it is not unreasonable to discourage patients with significant risk factors from this therapy.
