Cellasene and Endermologie® for Cellulite
Cellasene and Endermologie® for Cellulite
November 2000; Volume 3; 124-128
By Susan T. Marcolina, MD
Eighty-five percent of post-pubertal females have cellulite, a condition characterized by irregular dimpled tissue on the upper outer thighs, lower buttocks, and posterior upper thighs. This dimpling, also known as the "mattress phenomenon" was found by Nurnberger and Muller to be demonstrable in the lateral thigh skin in almost all women using the pinch test. They defined the pinch test as tangentially applied pressure to the skin of the buttocks and lateral thigh. The authors staged cellulite according to pinch test results.1 (See Table 1.)
| Table 1-Staging categories of cellulite | |
| Stage | Characteristics of Thigh and Buttock Skin |
| 0 | Smooth skin when standing or lying; negative pinch test |
| I | Smooth skin standing or lying with positive pinch test demonstrating mattress phenomenon |
| II | Positive mattress phenomenon spontaneously when standing |
| III | Mattress phenomenon spontaneously positive in sitting and lying positions |
| Adapted from: Nurnberger F, Muller G. So-called cellulite: An invented disease. J Dermatol Surg Oncol 1978;4:221-229. |
|
By Madison Avenue aesthetics, cellulite is unattractive. Hence, women’s magazines abound with articles and advertisements featuring products and therapies that will eliminate cellulite. These therapies generally have little scientific validation and are costly, though Endermologie® may have some effectiveness.
Clinical Histopathology of Cellulite
Studies by Nurnberger and Muller, published in 1978, showed a sexual dimorphism in the subcutaneous and connective tissue structure of the thigh. Such differences are demonstrable in fetal skin after the eighth month of gestation and coincide with the time the fetal testicles become hormonally active.2 Rosenbaum et al recently verified these gender-specific differences and examined affected and unaffected areas of thigh in healthy adult volunteers. The authors found no evidence of differences in adipose tissue physiology, blood flow, or biochemistry to account for the anatomic phenomenon of cellulite.3
Etiology
Although cellulite is not related to obesity, excess weight accentuates the condition.4 The dermis is thinner in females than in males and reaches maximal thickness by age 30 with subsequent diminution. With the aging process, the septa of connective tissue between the adipocytes become thinner, the adipocytes hypertrophy, and fat appears within the dermis.1
Cellasene and Endermologie Therapies
Italian chemist Dr. Gianfranco Merizzi introduced his invention, Cellasene, at a Manhattan press conference in March 1999 as the new cure for cellulite. Cellasene is manufactured in Italy by Medestea Internationale and is distributed in the United States by Rexall Sundown.5
LPG Endermologie is a patented machine-assisted massage system developed in France in the 1970s by Louis Paul Guitay. He invented this device for use in remodeling and loosening scar tissue in burn and trauma patients. In the course of its use, physicians noted the improvement in the appearance of cellulite. LPG Endermologie USA (Fort Lauderdale, FL) markets two units, the original Endermologie System 1 and the new Cellu M6®, which offers pulsatile suction and the ability to program and store information about individual treatments.6,7
Endermologie Procedure
LPG Endermologie involves kneading the skin with an electrically powered, hand-held machine containing two rollers. As the rollers exert positive pressure to massage the skin between them, negative pressure from the suction lifts up the skin fold bringing it between the rollers.8 A technician moves the machine over the hips, stomach, legs, and buttocks, which are covered with a nylon stocking to decrease friction and prevent direct skin contact.
Clinical Trials—Cellasene
Medestea Internationale sponsored two clinical studies in Italy.9 The first was an open-label trial performed on 25 healthy female volunteers with a mean age of 38. Circumferential hip, right thigh, and right ankle measurements were taken by tape measure before and after receiving one Cellasene softgel tid for eight weeks.
The data showed that all the women had a reduction in their anthropometric measurements. The ultrasonographic estimates of subdermal thickness also were reduced compared to baseline.
In the second study, a single-blind, placebo-controlled trial, 25 women (mean age 30.9 years) in the treatment group and 15 women (mean age 33.9 years) in the placebo group had the same measurements taken as in the first study. All subjects completed the trial. Diet and physical activity remained constant during both trials. The Cellasene treatment group showed a reduction in hip and thigh circumference and ultrasound measurements showed a slight reduction in subdermal thickness after eight weeks. Neither study was published in a peer-reviewed journal. Problems with the studies include the lack of blinding of the investigators, limitations of reproducibility with tape measurement, and lack of either study evaluating the changes in cellulite appearance.
Lis-Balchin performed a parallel, placebo-controlled, two-month clinical study of Cellasene in 21 women. Seven of the 11 treatment subjects gained weight, as did eight placebo subjects. Only three of the women in the Cellasene group had improvement in cellulite appearance vs. two in the placebo group.10
Rexall Sundown and Medestea Internationale sponsored a 20-week, double-blind, placebo-controlled clinical study of 200 women at the University of Miami; this study concluded in February 2000. The university released a statement that the results were inconclusive "due to subject nonadherence with and significant deviations from the protocol requirements."11
Clinical Trials—Endermologie
In an open-label clinical pilot study, Ersek studied 22 women between the ages of 22-48.12 Each study patient was prescribed 14 LPG Endermologie sessions (45 min each) once or twice per week with a trained LPG technician. Measurements of the circumference of waist, hips, thighs, knees, and calves for each patient were taken and averaged into a mean. Patients’ weights also were recorded. Identical weight and circumference measurements were collected for each patient at sessions 1, 7, and 14. A mean body circumference loss was determined for each of the five parameters measured above. These parameters were averaged into a mean index of overall loss.
The 22 patients in this study completing at least seven treatments experienced a mean index of overall loss of 1.38 cm. Of these 22 patients, 19 exhibited a weight loss of 0.612 kg during this time period, while two showed a mean weight gain of 0.655 kg. Despite the weight gain, they still had a mean index of overall loss in body circumference of 1.15 cm.
For the six patients completing all 14 Endermologie treatments, their mean index of overall loss was 2.84 cm with an average weight loss of 0.321 kg.12
Chang et al continued this study using 85 patients, 46 of whom completed at least seven sessions while 39 completed all 14 sessions. Although the study results varied widely, a general correlation was noted between body circumference loss and weight loss for patients who completed seven and 14 sessions, with greater improvement seen in those completing the 14-treatment course.8
Dabb used Endermologie for the reduction of cellulite in 24 small-volume liposuction patients treated over a two-year period. Each patient had a medical evaluation and participated in an exercise and nutrition program. Each had one or more sessions of small volume liposuction, followed by a series of Endermologie treatments limited to the area involved in the liposuction. Periodic body composition analyses assessed compliance with diet and exercise regimens.
Of the 24 patients who completed the study, 22 patients reported satisfaction with attainment of treatment goals. The two patient treatment failures gained weight and were noncompliant with their original dietary and exercise regimens.13
Formulation
Cellasene features what Medestea terms Lipovascolen, a proprietary blend of natural herbal extracts, each listed in Table 2.
| Table 2-Herbal ingredients of Cellasene | ||
| Herbal Ingredients |
Botanical Name |
Portion of Plant Used |
| Borage seed oil | Borago officinalis | Seeds |
| Bladderwrack | Fucus vesiculosis | Thallus |
| Sweet clover extract |
Melilotus officinalis | Leaves and flowering tips |
| Ginkgo biloba extract |
Ginkgo biloba |
Leaves |
| Grape seed extract | Vitis vinifera | Seeds |
| Soya lecithin | Glycine max | Seeds |
| www.cellasene.com/pages/product.htm. Accessed July 14, 2000. | ||
Dosage
The manufacturer recommends taking three Cellasene softgels per day for eight weeks followed by one softgel daily for another eight weeks.14 A minimum of 14 Endermologie sessions (35 min each, once or twice weekly) is recommended, followed by once monthly maintenance sessions.6,8,12
Adverse Effects
Cellasene is marketed as a food supplement so there is limited information about the proportions of component herbs it contains. Each softgel contains 240 µg of iodine, derived from bladderwrack (Fucus vesiculosis) extract.
The German Commission E bladderwrack monograph specifies that ingestion of an iodine dosage over 150 µg/d may induce latent hyperthyroidism or exacerbate existing hyperthyroidism.15 Bladderwrack has been reported to accumulate cadmium and lead in various plant parts because of heavy metal content of seawater. Conz et al reported the case of an 18-year-old who consumed a product containing Fucus vesiculosis for weight loss and presented with acute renal failure, which resolved within one year after discontinuation of this product.16
The coumarin derivatives in sweet clover extract can potentiate the effects of warfarin anticoagulants and should not be used in patients on this medication. Ginkgo biloba also has anticoagulant effects as its ginkgolide components are potent inhibitors of platelet-activating factor.17
The results and experiences of Endermologie treatment for patients are technician dependent. If the vacuum pressure exerted with the device is too great, petechiae, ecchymoses, and pain can result.18
Cost
Cellasene retails for approximately $40 for a two-week supply.14 Each 35- to 45-minute Endermologie session costs between $80-$100.12
Regulation
Cellasene is marketed as an over-the-counter dietary supplement. In July 2000, the Federal Trade Commission (FTC) filed a lawsuit in federal district court charging Rexall Sundown, Inc. with making false and unsubstantiated claims in marketing Cellasene.19 The FTC alleges that statements from the product label, such as as Cellasene "helps eliminate cellulite" and "fights cellulite from the inside," are unsubstantiated. In addition, the FTC alleges that Rexall Sundown falsely represented that it had clinical evidence establishing efficacy of Cellasene. The FTC will seek full refunds for U.S. consumers that could exceed $54 million.19
Endermologie was licensed by the FDA as an approved device for "temporary improvement in the appearance of cellulite" in April 1998. In March 2000, the FDA approved the device for an additional indication of a temporary reduction in the circumferential body measurements of cellulite treated areas. The advisory committee based their recommendations for approval on studies done by Ersek, Chang, and Dabb.8,12,13
Conclusion
Cellulite and its unattractive appearance are a nuisance to many women. There is insufficient clinical evidence, however, to support the use of Cellasene to treat cellulite.
Endermologie appears to offer a promising alternative of care for body remodeling, in conjunction with diet and exercise, and it may be an adjunct to liposuction. Its effects may vary with operator proficiency. The clinical studies to date show a wide range of results.
Recommendation
Given the dearth of any blinded, placebo-controlled trials that demonstrate its efficacy in the reduction of cellulite, coupled with the concerns about long-term, significant iodine consumption, Cellasene should be avoided.
Endermologie may be an effective adjunct to an overall fitness program including weight loss, regular exercise, and a low-fat diet for the reduction of cellulite. More studies within a carefully controlled research setting must be performed, however, before our patients spend the time and incur the expense of treatment.
Dr. Marcolina is a board-certified internist and geriatrician in Issaquah, WA.
References
1. Nurnberger F, Muller G. So-called cellulite: An invented disease. J Dermatol Surg Oncol 1978;4:221-229.
2. Abramovich DR, Rowe P. Fetal plasma testosterone levels at mid-pregnancy and at term: Relationship to fetal sex. J Endocrinol 1973;56:621-622.
3. Rosenbaum M, et al. An exploratory investigation of the morphology and biochemistry of cellulite. Plast Reconstr Surg 1998;101:1934-1939.
4. Draelos ZD, Marenus KD. Cellulite: Etiology and purported treatment. Dermatol Surg 1997;23:1177-1181.
5. Reuters Health Information. Cellulite "cure" questioned. Available at: http://www.mdchoice.com/news.asp?rowid=185920&title=Cellulite+%22cure%22+questioned. Accessed July 8, 2000.
6. Cellulite USA: Frequently asked questions. Available at: www.celluliteusa.com/endermologiefaq.htm. Accessed July 16, 2000.
7. Endermoletter. The Endermologie Newsletter. Fort Lauderdale, FL: LPG USA; 1999.
8. Chang P, et al. Noninvasive mechanical body contouring: (Endermologie) a one-year clinical outcome study update. Aesthetic Plast Surg 1998;22:145-153.
9. Summary of the Cellasene clinical studies. Available at: www.scienceoncellasene.com/pages/pilotst.htm. Accessed July 12, 2000. Available on request from American Health Consultants: [email protected].
10. Lis-Balchin M. Parallel placebo-controlled clinical study of a mixture of herbs sold as a remedy for cellulite. Phytother Res 1999;13:627-629.
11. Singer G. Cellasene trial invalid. Sun-Sentinel. June 22, 2000.
12. Ersek RA, et al. Noninvasive mechanical body contouring: A preliminary clinical outcome study. Aesthetic Plast Surg 1997;21:61-67.
13. Dabb RW. A combined program of small-volume liposuction, endermologie and nutrition: A logical alternative. Aesthetic Surg J 1999;September-October:
388-393.
14. Cellasene. Available at: www.cellasene.com. Accessed July 14, 2000.
15. Blumenthal M, et al, eds. The Complete German
Commission E Monographs. Austin, TX: American Botanical Council; 1998:35.
16. Conz PA, et al. Fucus vesiculosus: A nephrotoxic alga? Nephrol Dial Transplant 1998;13:526-527.
17. Lamant V, et al. Inhibition of the metabolism of platelet activating factor (PAF-acether) by three specific antagonists from Ginkgo biloba. Biochem Pharmacol 1987;36:2749-2752.
18. Collis N, et al. Cellulite treatment: A myth or reality: A prospective randomized, controlled trial of two therapies, endermologie and aminophylline cream. Plast Reconstr Surg 1999;104:1110-1114.
19. Federal Trade Commission. Rexall Sundown charged by FTC with making false and unsubstantiated claims for "Cellasene." Available at: http://www.ftc.gov/opa/2000/07/rexall.htm. Accessed October 4, 2000.
November 2000; Volume 3; 124-128
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