`PMS Escape' escapes scientific rigor

"The first clinically-tested nutritional product to effectively manage disturbances in mood, appetite and memory associated with premenstrual syndrome." So read the marketing materials for PMS Escape, a Kool-Aid-like powdered drink mix launched in the greater Boston area in March. Sales have already reached nearly $200,000 in New England alone. The product's national debut is slated for later this year.

Unfortunately for the women who have already shelled out 810 for an 8-packet box of the stuff, the only published "clinical test" conducted involved a mere 24 women. Granted, the study suggested that drinking the beverage helped ease depression and other symptoms of PMS to some degree. But it was much too small to serve as "clinical proof."

For one thing, PMS is particularly difficult to study because symptoms such as depression often vary from cycle to cycle and are influenced by other things in a woman's life, such as stress at work. Proving that a product aimed at managing PMS symptoms is effective would require numerous studies involving large numbers of women. "The beverage needs to be tested in a multicenter trial," notes Raja Sayegh, MD, who headed the research at Massachusetts General Hospital in Boston.

Another problem is that the label of PMS Escape states "this special blend of simple and complex carbohydrates has been designed to affect serotonin production." Some research suggests that levels of serotonin, a brain chemical that plays a role in moods and depression, fall during the week or so before the onset of menstruation, and that this drop may be responsible for the symptoms of PMS.

The theory is backed by Judith Wurtman, PhD, a Massachusetts Institute of Technology researcher who helped conduct the 24-woman study. She also is the scientific founder and director of InterNutria, the company that makes PMS Escape. Dr. Wurtman believes that PMS Escape "works" by boosting levels of serotonin.

But the notion that serotonin levels influence symptoms of PMS is not engraved in scientific stone. Even if it were, serotonin levels were not measured in the 24 women participating in the one and only clinical test of PMS Escape. So it is not at all clear that the product has the physiologic effect Dr. Wurtman expects.

PMS Escape is marketed as a dietary supplement, so it is not subject to the same federal regulations as foods. But when we showed the Nutrition Facts panel from PMS Escape to officials at the Food and Drug Administration, they assured us that if the product were sold as a food, it would be in violation of the Nutrition Labeling and Education Act. That's because the product label states it contains no "refined sugars" (see first line highlighted in blue).

According to federal regulations, food manufacturers must state the amount of total sugars--"refined" or otherwise. If the makers of PMS Escape followed this rule, it would be clear that the product contains sugar in the form of dextrose. Indeed, because ingredients are listed in order of predominance and dextrose is the first ingredient on the list (see second line highlighted in blue), the actual amount of total sugars in the product is no doubt quite high.

Ironically, a brochure enclosed with the product recommends that women with PMS "avoid beverages containing sugar. . . ."

Nutrition Facts
Serving Size: 1 packet (50g)
Servings Per Container: 8

Amount Per Serving

Calories 188 Calories from Fat 0

% Daily Value[a]

Total Fat 0g 0%
Cholesterol 0mg 0%
Sodium 0mg 0%
Total Carbohydrate 47g 9%
Refined Sugars 0g 0%
Protein 0g 0%
Vitamin B-6 25% Vitamin C 100%
Calcium 5% Magnesium 5%
a Percent Daily Values are based on a 2,000 calorie diet.


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