CRAIG T. KOJIMA / CKOJIMA@STARBULLETIN.COM Josephine Nicolo is the nurse practitioner for a recent study about hormone replacement therapy and is going to be counseling patients in the study. Nicolo worked Saturday with patient Ethel Kunishige.

Hormone study subjects
weigh newfound risks

265 Hawaii women took part in
research called off as unsafe

---

By Mary Vorsino
mvorsino@starbulletin.com

Vivian Tsuji began hormone replacement therapy 25 years ago to ward off osteoporosis.

Now, at 60, Tsuji is tapering off the post-menopausal treatment of estrogen and progestin on advice from her doctors after a national study linked the therapy with an increased risk of breast cancer, heart attacks and strokes.

At 35, when she first began post-menopause, "my hot flashes were enough to be uncomfortable. For the short term, it (the therapy) was to help relieve the symptoms."

Today, she is osteopenic, which means that she has borderline osteoporosis. But she says that she "probably would have been far worse off" if she had not done the hormone therapy.

Tsuji, who recently underwent surgery for an abnormal lump in her breast, is one of several thousand women in Hawaii and roughly 6 million women nationwide who have been prescribed the treatment and who now must reassess whether its benefits outweigh its risks.

"The increased risk (of cardiovascular problems) is the opposite of what they thought they were going to find. ... You don't know who's on it. I would suggest the same advice as (my doctor) has -- to seriously consider" whether the treatment is right for them.

Last week, participants in a nationwide estrogen-progestin study, including 265 Hawaii women, were abruptly told to stop taking the drugs because of the increased health risks. (Some of the women in the study were actually taking placebos.)

Tsuji was among another 3,500 Hawaii women also being tracked by the study's researchers to monitor post-menopausal symptoms and the effects of hormone therapy and its alternatives.

Dr. Santosh Sharma, a professor at the University of Hawaii medical school and a co-investigator for the study here, said about 25 percent of the 265 women in the Hawaii study have called or come in to the center, based at the Kuakini Medical Center, to be told whether they were on a placebo or on the hormone drug treatment.

Josephine Nicolo, nurse practitioner with the project, has not only been examining the 265 women since its inception eight years ago, but is also counseling them.

"Most of our participants that I've spoken to thus far are really excited.

"This (study) was for their daughters and granddaughters and other women."

She said none of the women she has talked to so far have been overly concerned about the results.

Sharma said there are a number of alternatives to hormone replacement therapy that may be more tuned to a specific symptom.

But "there's no one treatment for all," like the estrogen and progestin combination is.

The therapy has been known to relieve common post-menopausal symptoms -- hot flashes, insomnia, mood swings, night sweats and, in some cases, depression -- and for some women means a profound difference to their lifestyle, said Dr. Rick Williams, an obstetrician-gynecologist at the Women's Clinic in Pearl City.

Williams said he had a patient who had such fierce hot flashes that her clothes would be drenched in sweat three to four times a day.

"Women like that are going to need something, and they will choose estrogen or whatever gets the job done."

The Women's Health Initiative study's principal investigator, Dr. J. David Curb of the UH medical school, said the study's findings are only the start of a "very complex picture."

"We need to be careful not to go too fast on this one."

Williams agreed: "The situation with hormone replacement therapy a decade ago was that most women should take it because of the believed benefits.

"Now it's swung. Most women shouldn't take it but some women still should.

"It's a quality of life issue."

Like many obstetrician-gynecologists in Hawaii, Williams has been inundated with phone calls from concerned patients on the treatment. He recommends that patients on the hormone treatment "assess the degree of (their) problem.

"It's not going to come down to black-and-white cases. (It's going to take) a lot of participation from the patient and a lot of the patient's responsibility for which way they're going to go."

Other doctors agree.

Dr. Laura Weldon Hoque, medical director of Kapiolani Medical Center for Women & Children's breast center, said, "There are many people who are on it for very vague indications."

She said that women should "feel strongly one way or the other" about whether to take the hormone replacement.

The 265 women in the study will continue to be monitored for three more years, the duration of the study's time frame. Another arm of the study, which monitors women taking estrogen-only therapy for post-menopausal symptoms, has not been cut short.

As for Tsuji, she said she is happy to be off the therapy but "not bitter at all that I was put on."