Calcium carbonate and the premenstrual syndrome: Effects on premenstrual and menstrual symptoms☆,☆☆,★,★★

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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.)

Section snippets

Subjects

Healthy, premenopausal women between the ages of 18 and 45 years were recruited at 12 health centers to participate in a randomized, double-blind, placebo-controlled study. Six centers were located above 40 degrees in latitude (New York, New York; Lyndhurst, Ohio; New Haven, Connecticut; Levittown, New York; Cleveland, Ohio; Salt Lake City, Utah) and 6 were below (Spartanburg, South Carolina; Mobile, Alabama; New Orleans, Louisiana; Houston, Texas; Altamonte, Florida; Miami Beach, Florida).

Results

Seven hundred twenty women were screened. Four hundred ninety-seven patients were enrolled in the study; 466 met criteria for efficacy analysis (1 screening and 1 treatment cycle). Of the 31 patients not included in the efficacy analysis, 17 had insufficient data to analyze, 13 had 1 or 2 treatment cycles that were nonevaluable, and 1 patient had 2 invalid screening cycles and was incorrectly enrolled in the study. Of the remaining 466 patients, 441 patients (95%) completed the trial with 3 out

Comment

PMS afflicts millions of premenopausal women1 and has been described as one of the most common disorders in women. Despite its overwhelming prevalence, clinical investigations exploring its pathophysiologic features have been disappointing. Multiple investigations of basal levels of gonadal steroid hormones, gonadotropins, thyroid, and other hormones have not detected differences between women who have symptoms and those who do not.16 Few therapeutic modalities have proved consistently

Acknowledgements

Members of the Premenstrual Syndrome Study Group include Josef Blankstein, MD, Lyndhurst, Ohio; Roslyn Chosak, MD, New Haven, Connecticut; Leopoldo Grauer, MD, Miami Beach, Florida; Maurice Gunsberger, MD, Levittown, New York; Christopher A. Kaeppel, MD, Houston, Texas; Andrew E. Krupitsky, DO, Altamonte Springs, Florida; Howard G. McQuarrie, MD, Salt Lake City, Utah; George Schneider, MD, New Orleans, Louisiana; John Scott, MD, Spartanburg, South Carolina; Dennis H. Smith, MD, Cleveland, Ohio;

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    ☆

    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.

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    Supported by a grant from SmithKline Beecham Consumer Healthcare.

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    Reprint requests: Susan Thys-Jacobs, MD, St. Luke’s–Roosevelt Hospital Center, 425 West 59th St, Suite 9C, New York, NY 10019.

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