When Cellasene made its debut in drugstores across America this March, women eagerly shelled out $40 for a 10-day supply of the heavily advertised pill, which its manufacturer promises will help "eliminate cellulite" in a "natural, safe, effective" way. Doctors, on the other hand, were quick to condemn it. Their problem: no good data to prove either efficacy or safety. Last week Medestea Internazionale, the Italian manufacturer of Cellasene, fought back against the critics. The company and its American distributor, Rexall Sundown, announced the unpublished findings of three studies, which they say prove that Cellasene--a soft-gel capsule made of herbal ingredients--reduced cellulite in about 90 percent of patients who were on the pill eight weeks. One participant, 39-year-old New Yorker Tracy Aron, says the texture of her legs "improved dramatically." The company also claimed that the compound reduced skin thickness and the circumference of hips and thighs. Says Debbie DeSantis, Rexall's VP of product development: "We stand solidly behind the science."
But is the science really there? The new data certainly haven't squelched the critics. The studies are of "exceedingly poor quality," says Dr. Arthur Frank, medical director of George Washington University's Weight Management Program, who reviewed the data on a Web site launched last week (www.scienceoncellasene.com). "They establish nothing." In medical research, the gold standard is a placebo-controlled study in which neither patient nor doctor knows who's getting what. In one of the studies, 15 patients took a placebo, but investigators knew their identities. Critics also say the scope was far too small: 65 women participated in two studies in Italy; just 10 in a pilot study in New York. And doctors question the interpretation of the results. "There is no medical reason that it would work," says Dr. Rod Rohrich, chair of plastic surgery at the University of Texas Southwestern Medical Center.
Gianfranco Merizzi, the Italian chemist who created the pill, claims that Cellasene increases blood supply to cellulite--a commonly used term for the dimpled skin on women's thighs and buttocks--releasing it from under the skin and allowing it to be metabolized for energy. It's possible to target cellulite, Merizzi says, because it's "totally different from fat." Not true, say critics like Dr. Arthur Ship, a professor of plastic surgery at New York's Albert Einstein College of Medicine and senior author of one of the few published studies of cellulite. "As far as we know, there is no difference in the fat," says Ship, and boosting circulation would have no specific effect on cellulite. Critics also question the company's use of thigh circumference as an indicator of cellulite reduction. "It's irrelevant," says Frank.
Because Cellasene is a "dietary supplement," it isn't subject to review by the U.S. Food and Drug Administration. In April, the Center for Science in the Public Interest, an advocacy group, filed a complaint with the Federal Trade Commission, requesting that the company be investigated for deceptive advertising. The FTC won't comment.
Medestea says it has received no reports of adverse effects since the supplement was introduced in Italy six years ago. But Cellasene is a mix of potent herbs that have never been rigorously tested together on a long-term basis. An initial daily dose of the compound (three pills) contains 720 micrograms of iodine. While levels up to 2,000 micrograms are considered safe, the U.S. recommended daily allowance is just 150. Too much iodine can overstimulate the thyroid, causing heart palpitations and weakness. Cellasene also contains ginkgo biloba and sweet clover; both contain blood-thinning agents and could be dangerous in combination with certain prescription drugs.
Rexall announced plans last week to recruit 200 patients for what many doctors say is a long-overdue, double-blind, placebo-controlled study at the University of Miami. But consumers have already spent $5 million on Cellasene. For the critics, that's far too high a price to pay for uncertainty.