MLM Watch Home Page

Cellasene

Stephen Barrett, M.D.

Cellulite is a term coined in European salons and spas to describe deposits of dimpled fat found on the thighs and buttocks of many women. Widespread promotion of the concept in the United States followed the 1973 publication of Cellulite: Those Lumps, Bumps and Bulges You Couldn't Lose Before, by Nicole Ronsard, owner of a New York City beauty salon that specialized in skin and body care. Cellulite is alleged to be a special type of "fat gone wrong," a combination of fat, water, and "toxic wastes" that the body has failed to eliminate. Alleged "anticellulite" products sold through retail outlets, by mail, and through the Internet have included "loofah" sponges; cactus fibers; special washcloths; horsehair mitts; creams [A] and gels to "dissolve" cellulite; supplements containing vitamins; minerals and/or herbs; bath liquids; massagers; rubberized pants; exercise books; brushes; rollers; body wraps; and toning lotions. Many salons offer treatment with electrical muscle stimulation, vibrating machines, inflatable hip-high pressurized boots, "hormone" or "enzyme" injections, heating pads, and massage. Some operators claim that 5 to 15 inches can be lost in one hour. A series of treatments can cost hundreds of dollars.

"Cellulite" is not a medical term. Medical authorities agree that cellulite is simply ordinary fatty tissue [1]. Strands of fibrous tissue connect the skin to deeper tissue layers and also separate compartments that contain fat cells. When fat cells increase in size, these compartments bulge and produce a waffled appearance of the skin. Many years ago, Neil Solomon, M.D., conducted a double-blind study of 100 people to see whether cellulite differed from ordinary fat. Specimens of regular fat and lumpy fat were obtained by a needle biopsy procedure and given to pathologists for analysis and comparison. No difference between the two was found.

More recently, researchers at Rockefeller Institute used ultrasonography, microscopic examinations, and fat-metabolism studies to see "affected" and unaffected skin areas differed in seven healthy adult subjects (five women, two men; four affected, three unaffected). The researchers concluded: (a) certain characteristics of skin make women more prone than men to develop cellulite; (b) the process is diffuse rather than localized; and (3) there were no significant differences in the appearance or function of the fatty tissue or the regional blood flow between affected and unaffected sites within individuals [2].

Cellasene

An herbal product called Cellasene is being vigorously promoted as a cellulite remedy. The product was developed by an Italian chemist named Gianfranco Merizzi. Its ingredients are evening primrose oil, dried fucus vesiculosis extract, gelatine, fish oil, glycerol, soya oil, grape seed, bioflavonoids, soya lecithin, fatty acids, dried sweet clover extract, dried ginkgo biloba extract, and iron oxide. The product, to be taken twice daily (or three times per day for an "intensive" program) for two months and then once daily for maintenance costs $1.50 to $2.00 per capsule. Here's what one Internet marketer says [followed by my comments in brackets]:

Rexall Sundown, Inc. has been Cellasene's primary marketer in the United States. The company's Web site has claimed:

Cellasene works from within, nutritionally, to help fight cellulite at its source. . . .

Cellasene is a safe, clinically studied formula that works over time at the source of the problem -- below the surface of the skin. This unique formula of plant extracts and other beneficial dietary supplements nourishes connective tissue from within and helps reduce cellulite. The herbal ingredients in Cellasene work to increase blood circulation, reduce fluid buildup, stimulate metabolism and reduce localized fats. CONVENIENT AND EASY TO USE. . . .

You do not need to change your diet and exercise routine for Cellasene to work. It is simple and effortless to incorporate the easy-to-swallow Cellasene softgels into your daily regimen.

On March 15, 1999, during an interview on CNBC-TV, Rexall's chief executive officer claimed that three clinical trials sponsored by the company had demonstrated a 90% success rate, but the results would not be submitted to scientific journals because Rexall did not want to reveal the amounts of each ingredient in its formula [3]. This statement was preposterous because results could published without revealing the exact amounts of each ingredient. Two weeks later, I searched Medline for "cellulite" and "Cellasene" and found no report that any product taken by mouth was proven useful against cellulite.

Near the end of May, apparently in response to criticism in the media [4], Rexall released various details on two of the studies and posted them to its Science on Cellasene Web site. The first study was performed on 25 healthy female volunteers whose hip and thigh and ankle circumference were measured before and after eight weeks of daily consumption of the product. Although differences between the initial and final measurements were reported, no control group was used, so that it would not be possible to tell whether any changes were related to taking the products or to measurement variations. In addition, neither individual measurements nor weights were reported, so that it is not possible to judge from the data whether the reductions were related to weight loss, whether coincidental or otherwise.

The second study compared 25 people who took the product with 15 people who took a placebo for eight weeks. According to the report, the average weight of both groups varied little but average hip and thigh circumference and skin thickness (measured with an ultrasound test) decreased. However, the experimental design was so seriously flawed that the findings should not be regarded as valid. The participants were not told whether they were receiving Cellasene or the placebo, but the investigators knew who was in each group because only the Cellasene group had blood drawn for testing. This could have influenced the way the measurements were performed, as well as the participants' motivation. No data were given to demonstrate whether the measurement process was accurate or whether the appearance or feel of the women's skin had changed [4]. In addition, although measurements were made at the experiment's beginning, midpoint, and end, the midpoint measurements were not reported on Rexall's Web site.

It seems to me that a valid test should involve: (a) more participants, (b) a longer initial investigative period plus monthly follow-up measurements for at least a year, (c) standardization of the measurement technique, (d) measurements taken by at least three investigators, (e) blinding of the investigators about who received the Cellasene and who did not, (f) measuring several times a week to see whether measurements tend to change or remain constant, (g) weekly ratings of the appearance of the skin by both the participants and the experimenters, and (h) release of the individual data in addition to the group averages. I have suggested these points to Rexall's chief executive officer [5].

A spokesperson for Cellasene's Italian manufacturer stated that a study involving 200 women would be done at the University of Miami with results expected in the Fall of 1999 [4]. In June 2000, however, the lead researcher study stated that the $400,000 study could not be completed because some of the participants had not come to the testing site to be measured [6]. In the interim a British researcher reported finding no difference in hip and thigh measurements between 11 women taking Cellasene and 8 women using a placebo [7 ]. In July 2000, the FTC charged Rexall Sundown, Inc., with making false and unsubstantiated claims for Cellasene [8]. In December 2000, a class-action suit was filed in Florida federal court, charging Rexall with false and deceptive practices and unjust enrichment. [9]. The same law firm filed a simlar suit in Florida state court.

The Bottom Line

The amount of fat in the body is determined by the individual's eating and exercise habits, but the distribution of fat in the body is determined by heredity. In most cases, reduction of a particular part can be accomplished only as part of an overall weight-reduction program.

References

  1. Fenner L. Cellulite: Hard to budge pudge. FDA Consumer 14(4):5-9, 1980.
  2. Rosenbaum M and others. An exploratory investigation of the morphology and biochemistry of cellulite. Plastic and Reconstructive Surgery 101:1934-1939, 1998.
  3. DeSantos D. Interview on Power Lunch, CNBC-TV, March 15, 1999.
  4. Srinivasan K. Feds want the skinny on cellulite pill's claims. Associated Press. May 28, 1999.
  5. Barrett S. Email message to D. DeSantis, June 2, 1999.
  6. Murawski J. Anti-cellulite drug's test results were jilted. Palm Beach Post, June 27, 2000.
  7. Lis-Balchin M. Parallel placebo-controlled clinical study of a mixture of herbs sold as a remedy for cellulite. Phytotherapy Research 13:627-629, 1999.
  8. Rexall Sundown Charged By FTC with Making False and Unsubstantiated Claims for "Cellasene." FTC news release, July 20, 2000.
  9. Theresa Haney and Janet Villa, on behalf of themselves and all others similarly situated, plaintiffs, v. Rexall Sundown, Inc., and unidentified subsidiaries 1 through 13, defendants. Filed in United States District Court Southern District of Florida, December 2000.

Rexall Information Index ||| More on "Cellulite Removers"
MLM Watch Home Page

This article was revised on December 28, 2000.