Inexpensive, well tolerated: consider calcium supplements for PMS treatment

OB/GYN News, April 15, 2004 by Bruce Jancin

BIG SKY, MONT. -- Calcium supplementation is the most promising and best-supported alternative therapy to date for premenstrual syndrome. Dr. Eric J. Bieber said at a meeting on ob.gyn., gynecologic oncology, and reproductive endocrinology.

That's not necessarily saying all that much. Most of the scanty research on complementary and alternative medicine (CAM) is seriously flawed. But calcium supplementation in the form of two extra-strength Tums twice a day looks like it may have legs, according to Dr. Bieber, editor of the "Textbook of Complementary and Alternative Medicine" and chairman of the division of ob.gyn. at Geisinger Health System in Danville, Pa., which sponsored the meeting.

"The data on calcium are reasonably compelling, in contrast to some of the other natural products. It's cheap therapy--it's easy, well tolerated. ... So it may be something worth trying," he said.

The rationale for calcium supplementation in women with PMS lies in several studies suggesting that PMS patients have altered calcium homeostasis and increased risk of osteoporosis.

Following a couple of favorable pilot studies, investigators at Columbia University in New York organized a randomized, double-blind, placebo-controlled, 3-month prospective clinical trial in which 497 women with moderate to severe PMS received two Tums E-X tablets b.i.d. or placebo. That's 1,500 mg/day of calcium carbonate, or 1,200 mg/day of elemental calcium.

Patients randomized to Tums showed a 48% reduction from baseline in total symptom scores. All four PMS symptom complexes assessed in the trial--pain, water retention, negative affect, and food cravings--decreased to a significantly greater extent in the Tums-treated patients than in the placebo group.

Patients in the placebo arm improved during the course of treatment--the placebo effect looms large throughout CAM research--but the improvement in the Tums group became significantly greater than placebo by 3 months (Am. J. Obstet. Gynecol. 179:444-52, 1998).

A couple of other commonly used CAM therapies worth considering are the fruit or leaves of the chaste tree for PMS and evening primrose oil for cyclic breast tenderness, he continued.

In an impressively large German study, 1,634 women with PMS were given a product derived from the chaste tree, Vitex agnus castus. Overall, 81% of the participants in this open-label study reported being very much improved. But there was no control group, and given the traditionally high placebo response rate to CAM therapies, it's difficult to draw any conclusions from the study.

A better-designed German study prospectively randomized 170 PMS patients to 3 months of chaste berry extract or placebo. In the chaste berry arm, 52% of the women experienced at least a 50% reduction in PMS symptoms from baseline, compared with 24% of those on placebo. There were no adverse events (BMJ 322:134-37, 2001).

"It's a reputable study in a reputable journal. There may be something to this," Dr. Bieber said.

A couple of small Australian and Asian studies, "not great" in quality, suggest that evening primrose oil may be effective for cyclic mastalgia. More important, they showed that side effects are minimal.

Women are going to continue to use herbal preparations, he said.

"We're not going to get them to stop. Our responsibility is to make sure they're not going to hurt themselves with interactions.... I think with chaste berry and evening primrose oil, the risks are low. They may be a reasonable first-line treatment for some patients." Dr. Bieber suggested.

BY BRUCE JANCIN

Denver Bureau