"If men had cramps," snapped a colleague the other day, "they'd have found a cure centuries ago."
Menstraul cramps, "the curse of Eve," and a thousand other more or less inept euphemisms, are, self-evidently, as old as humanity. But the body of scientific literature on the subject has not increased appreciably since that venerable oath-maker Hippocrates first referred to a woman's "agitated blood seeking escape from the womb."
Primitive men variously regarded menstruating women as endowed with supernatural powers for good or evil - averting storms, blighting crops, even stopping clocks.By the tenets of orthodox Jewry, a menstruating woman is regarded as unclean. Women in India are isolated when menstruating.
Even today, reputable gynecologists will tell patients their dysmenorrhea (menstrual cramps) results from "your ambivalence about being a woman." Or, as related recently by a young Jewish woman with no religious training and little ethnic background, "because your grandparents believed it unclean." Cramps may be treated with sympathy and narcotics, and sometimes "the pill," a Hobson's choice at best, but it's a basic given that "it's all in your head."
Even today, in the most liberated of environments, the mention of the subject in mixed company will elicit reactions ranging from embarrassed snickers to hostile suspicion of any female taking sick leave because of the "you know, er, uh, that time of the month."
Nevertheless, dysmenorrhea accounts for more lost workdays among women than any other single cause, an estimated 100 million or so workdays a year in the United States. Estimates indicated that perhaps 50 to 70 percent of all women have some menstrual discomfort much of the time. Dysmenorrhea is sometimes accompanied by weakness and dizziness, nausea, headaches and such acute cramping that the victim is rendered effectively nonfunctional for one to three days out of every month.
It was in light of that statistic that family practitioner Penny Wise Budoff asked to speak several years ago at a conference on the medical problems of women in industry, began researching the single most common medical problem of women in industry.
She found practically nothing.And because of that she changed the direction of her career, contributed to her profession, stands to improve the quality of life for millions of women and might even become as great a feminist heroine as Margaret Sanger.
Budoff was appalled, she recalls now, and challenged. In 1974, she said, there were just eight scientific articles on dysmenorrhea in the entire world body of scientific literature.
She began her own research, culminating about two weeks ago with publication - as the lead article in the prestigious Journal of the American Medical Association - of the results. Corroborating two similar studies made in Europe, but generally ignored here, her study made two basic findings: first, the implication and identification of a physiological, rather than psychological, cause of primary spasmodic dysmenorrhea and second, the promise of significant relief through use of a safe, non-narcotic, nonsteroidal medication - mefenamic acid. As Ponstel, it has been marketed in this country for some years as an analgesic for use - by prescription - in treating mild to moderate arthritis pain. Similar drugs are marketed in several other countries, in some cases (Japan, for one) as an over-the-counter preparation.
What Budoff found, partly through assiduous research, and partly as a result of her own studies, was evidence of a cause-and-effect relationship between dysmenorrhea and the overproduction of entities in the blood called prostaglandins, hormone-like substances which govern the activity of the body's organs.
These ubiquitous messengers of the body cause, for example blood vessels to constrict or dilate. Or they cause uterine contractions in women in labor or during menstruation . (There have been studies of their use for inducing natural abortions as well.) But when too many are produced - especially two specific types - the result appears to be primary spasmodic dysmenorrhea, the kind of pain that usually occur with the onset of a woman's period and recurs cyclically.
Dr. Budoff also established that a family of analgesics known as fenamates, including mefenamic acid (Ponstel) had been found to inhibit not only the production of prostaglandins (as does simple aspirin) but also the activity of prostaglandins already produced in the body.
Her "double blind-crossover" test was conducted with 46 women over period of six months, using a placebo for half the women and Ponstel for the other half and then reversing the medications. She found that "mefenamic acid was consistently superior to placebo in reducing the frequency of the symptoms of spasmodic dysmenorrhea," and that "the results showed significantly greater relief of pain, weakness-dizziness and nausea."
In sum, Budoff found: "In 44 women (two withdrew) with primary spasmodic dysmenorrhea, mefenamic acid produced highly significant relief of the frequency and severity of their symptoms."
Budoff, who is a family practitioner at the State University of New York at Stony Brook on Long Island, may have made something of a tactical blunder when she called the article to the attention of a TV science editor in New York, though she notes that the study had been completed some two years before the article was published.
Her subsequent local TV appearance provoked a flood of response and a flurry of national interest. As a result, she is, almost predictably, under attack in some quarters, charged vaguely with self-promotion or overtly helping to commercialize a pharmaceutical product, a big no-no for doctors.
Ironically, she said last week, when she approached Warner-Lambert (the pharmaceutical company that makes Ponstel), with her then untested theory that "one of your drugs might alleviate menstrual cramps," the initial response was a bored-sounding "Oh?" (Read: "Yeah, so?")
"Gee, guys," she recalled she responded, in effect, "I don't want any money, but I do think your product would be useful . . . just let me try to test it . . ."
The company agreed, then, to provide the drug - but no funds - for a five-month "open-label" study she made at her own expense.
Her results, using no placebos or control groups, were promising enough for the pharmaceutical house to make her one of its "outside clinical investigators," a spokesman for Warner-Lambert said, permitting the study described in the AMA Journal. Now the company will ask FDA permission to offer the drug for treatment of dysmenorrhea as well as arthritis, a less complicated procedure than seeking approval of a totally new drug.
And, if the promise of the drug is upheld in wider use, the manufacturers clearly have a product which will be in high demand and, therefore, unquestionably profitable.
What is curious is this: Consider that the body of medical evidence pointing to the fenamates as useful for treatment of dysmenorrhea has been available to the medical community for some time. And consider that Lydia Pinkham thoroughly demonstrated the profits in preparations for "female complaints" more than 100 year ago.
Why, then, did it take so long?
If men had cramps . . .? CAPTION: Picture, Penny Wise Budoff: Her research points out the effectiveness of an already-on-the-market analgesic. Copyright (c) 1979, by Burton Berinsky