Abstract
OBJECTIVE: Previous reports have suggested that disturbances in calcium regulation may underlie
the pathophysiologic characteristics of premenstrual syndrome and that calcium supplementation
may be an effective therapeutic approach. To evaluate the effect of calcium carbonate
on the luteal and menstrual phases of the menstrual cycle in premenstrual syndrome,
a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter
clinical trial was conducted.
STUDY DESIGN: Healthy, premenopausal women between the ages of 18 and 45 years were recruited nationally
across the United States at 12 outpatient centers and screened for moderate-to-severe,
cyclically recurring premenstrual symptoms. Symptoms were prospectively documented
over 2 menstrual cycles with a daily rating scale that had 17 core symptoms and 4
symptom factors (negative affect, water retention, food cravings, and pain). Participants
were randomly assigned to receive 1200 mg of elemental calcium per day in the form
of calcium carbonate or placebo for 3 menstrual cycles. Routine chemistry, complete
blood cell count, and urinalysis were obtained on all participants. Daily documentation
of symptoms, adverse effects, and compliance with medications were monitored. The
primary outcome measure was the 17-parameter symptom complex score.
RESULTS: Seven hundred twenty women were screened for this trial; 497 women were enrolled;
466 were valid for the efficacy analysis. There was no difference in age, weight,
height, use of oral contraceptives, or menstrual cycle length between treatment groups.
There were no differences between groups in the mean screening symptom complex score
of the luteal (P = .659), menstrual (P = .818), or intermenstrual phase (P = .726) of the menstrual cycle. During the luteal phase of the treatment cycle, a
significantly lower mean symptom complex score was observed in the calcium-treated
group for both the second (P = .007) and third (P < .001) treatment cycles. By the third treatment cycle calcium effectively resulted
in an overall 48% reduction in total symptom scores from baseline compared with a
30% reduction in placebo. All 4 symptom factors were significantly reduced by the
third treatment cycle.
CONCLUSIONS: Calcium supplementation is a simple and effective treatment in premenstrual syndrome,
resulting in a major reduction in overall luteal phase symptoms. (Am J Obstet Gynecol
1998;179:444-52.)
Keywords
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Article Info
Publication History
Accepted:
March 11,
1998
Received in revised form:
February 25,
1998
Received:
September 24,
1997
Footnotes
☆From St. Luke’s–Roosevelt Hospital Center, College of Physicians and Surgeons, Columbia University, and the Medical and Regulatory Division, SmithKline Beecham Consumer Healthcare. A complete list of the members of the Premenstrual Syndrome Study Group appears at the end of the article.
☆☆Supported by a grant from SmithKline Beecham Consumer Healthcare.
★Reprint requests: Susan Thys-Jacobs, MD, St. Luke’s–Roosevelt Hospital Center, 425 West 59th St, Suite 9C, New York, NY 10019.
★★0002-9378/98 $5.00 + 0 6/1/90209
Identification
Copyright
© 1998 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
