Tuesday, June 24, 2003

By Karen Hoffmann, Post-Gazette Staff Writer

As many women eagerly await federal approval of a new birth control pill that would give them "that time of the month" just four times a year, a group of researchers is urging caution because no studies have been done on the long-term effects of suppressing menstruation.

More info   To understand how the Pill works, it's helpful to know something about a woman's cycle. When the pituitary gland in the brain secretes luteinizing hormone (LH), an egg is released from the ovary and the lining of the uterus thickens in preparation for pregnancy. The synthetic estrogen and progestin in the Pill suppress ovulation by stopping the pituitary gland from releasing the luteinizing hormone. The Pill also keeps the lining of the uterus from thickening, providing an additional protection against pregnancy. Some women should not use oral contraceptives. The Pill raises the risk of blood clots and stroke, especially in women over 35 and smokers. Participants are being recruited for a study at the Magee-Womens Research Institute that will explore whether an experimental birth control pill can help eliminate monthly periods, premenstrual syndrome symptoms and painful periods. In the study, led by Dr. Mitchell Creinin, the drug is taken for an entire year, with no scheduled withdrawal bleeding. It contains lower hormone doses than current birth control pills. Participants will receive free birth control and exams for a year, and will be compensated. Candidates must be healthy women between 18 and 49 with regular periods who are either interested in starting oral contraceptives or are currently taking them. For details, contact the Family Planning Research Office at 412-641-5496.

This fall, the Food and Drug Administration is expected to approve Seasonale, an extended cycle oral contraceptive developed by Barr Laboratories that includes the same hormonal mix as regular birth control pills. It is taken for 84 straight days instead of 21, cutting the number of periods women have each year from 13 to 4.

At a conference of the Society for Menstrual Cycle Research held in Pittsburgh June 5-7, women's health experts said that not enough is known about the effects of suppressing periods.

"I am concerned about the release of Seasonale because I do not believe we have the data to argue that it is entirely safe," said Dr. Ingrid Johnston-Robledo of the department of psychology at State University of New York in Fredonia, who organized a symposium on menstrual suppression at the conference. "At the same time, it may be safer than manipulating one's own birth control pills without guidance or endorsement from one's health-care provider."

Studies on menstrual suppression have not adequately addressed breast or endometrial safety or the effects on bone density, said Dr. Christine Hitchcock, a researcher at the Centre for Menstrual Cycle and Ovulation Research at the University of British Columbia.

"There is a serious flaw in all of these studies," said Hitchcock, namely that they don't include a control group of women who aren't on birth control pills.

"There is also a selection bias in the studies because the majority of women were current users of [the Pill], which automatically means that they are people who are able to tolerate oral contraceptives," she said. "That doesn't say anything about the changes a woman not currently taking any oral contraceptives can expect."

Suppressing menstruation is not a new idea.

For years, doctors have quietly told women that by taking the contraceptives' "active pills" without a break they can avoid their period if it's expected to occur during a vacation, honeymoon or other important event. And some doctors encourage women to take the pill continuously if their periods trigger migraines or if they suffer from the severe menstrual pain caused by endometriosis.

Local researcher Dr. Mitchell Creinin has long believed that women don't need a monthly period. He is leading a study on an experimental birth control pill to see if it helps eliminate monthly periods, the symptoms of premenstrual syndrome and painful periods.

He suggests that all his patients go on the pill continuously. "I recommend it to anyone who wants it," said Creinin, director of family planning in the obstetrics and gynecology department of the University of Pittsburgh and Magee-Womens Hospital.

But the society came to a different consensus. In a statement last week, the society conceded that menstrual suppression may be useful for women with severe menstrual cycle problems, but wrote, "We do not believe that continuous oral contraceptive use should be prescribed to all menstruating women out of a rejection of a normal, healthy menstrual cycle."

A look at history

Supporters of menstrual suppression point to history. Before the 1900s, women had far fewer periods because they began menstruating later, were pregnant more often and spent more time breast-feeding. Creinin said he is taken aback when women tell him they want monthly periods because they are natural.

"What's natural," he said, "is for women to have one to two periods a year and to either be breast-feeding or pregnant the rest of the time. Monthly periods are an artifact of modern contraception."

Early contraceptive research had shown that daily injections of progesterone could cause women to stop menstruating for as long as the shots were given.

But when fertility experts Drs. John Rock and Gregory Pincus developed the birth control pill in the 1950s, they designed it to mimic nature's monthly cycle, hoping that if it appeared "natural," it would be more readily accepted by women, as well as by the Catholic Church.

Women on the pill generally take "active" pills, containing hormones, for 21 days and sugar pills for the last seven days of their cycle, during which they experience withdrawal bleeding. This usually involves a lighter flow than a normal period.

Since the withdrawal bleeding was not created for biological reasons, many people wonder why it is still there at all.

In 1999, Dr. Elsimar Coutinho, professor of gynecology, obstetrics and human reproduction at Federal University of Bahia School of Medicine in Brazil, and Dr. Sheldon Segal of the Population Council in New York, cowrote "Is Menstruation Obsolete?"

Segal wrote of the original Portuguese edition, "Elsimar Coutinho's take-home message for his readers was that from a medical point of view, menstruation has no beneficial effects for anyone, and for many women it is harmful to their health."

A protective effect

Research shows that oral contraceptives protect women from developing ovarian and uterine cancers.

Women on the pill experience a 30 percent to 40 percent decrease in ovarian cancer risk, said Dr. Roberta Ness, a researcher at Pitt's Graduate School of Public Health, who spoke at the conference. Once they stop taking the pill, they remain protected for more than 20 years.

Ness says that ovulation itself is harmful. "When a woman ovulates, the egg bursts through the ovarian epithelium [the cells that line the ovaries], and a wound is created," she said.

In other words, ovulation inflames the lining of the ovary, and Ness's research suggests that such inflammation is linked to ovarian cancer.

Though much is still unknown, one drawback to taking the pill continuously that researchers are well aware of is breakthrough bleeding and spotting, though this effect decreases with time and is more of an inconvenience than a medical problem.

The debate on menstrual suppression has been a hot topic on the Web site for the online Museum of Menstruation, www.mum.org

When site founder Harry Finley, a graphic designer in Washington D.C., posed a question to visitors: "Would you stop menstruating if you could?" women responded with passionate arguments on both sides.

Though many women feel a strong connection to their periods and wouldn't stop having them even if they could, Finley told New Scientist magazine that women responded roughly 5 to 1 in favor of stopping menstruating.

Said one respondent: "Periods -- normal? I don't think so. Period."

Karen Hoffmann can be reached at khoffmann@post-gazette.com or 412-263-1994.

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