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Body Contouring: A Preliminary Report on the Use of the Silhouette® Device for Treating Cellulite
Body Contouring: A Preliminary Report on the Use of the Silhouette ® Device for Treating Cellulite David H. McDaniel, MDa; Jeff Lord, MDb; Keith Ash, MDb; John Newman, MDb; and Mark Zukowski, MD©
Cellulite is a common condition affecting 85% of postadolescent women. Recent advances in aesthetic techniques have initiated a new pursuit into understanding the cause and treatment of this condition. A recently introduced "roller massage therapy" device, Silhouette ®, was selected for evaluation in this study. Three patients were enrolled into this private practice, medical school-affiliated, prospective pilot project. The study objective was to identify whether the Silhouette ® device could generate reproducible reductions in the appearance of cellulite or alter body appearance, specifically in the abdominal, buttock, and thigh regions. A secondary goal was to evaluate the effectiveness of various measuring devices used to quantify cellulite regression. These included serial body weights, percent body fat, relative fat distribution, specific anatomic measurements, diagnostic ultrasound, and serial morphed photographic analysis and laboratory data. Initial results showed that 16 biweekly treatments produced minimal changes in body weight or percent body fat. On average, thigh circumferences increased by 1.7 mm and 8.7 mm in the right and left proximal thighs and decreased by 25 mm and 22 mm in the right and left distal thighs, respectively. Diagnostic ultrasound scans showed trends that may provide further insight into a possible mechanism of action. Relative fat distribution values taken from four selected sites proved the most significant finding with selected treatment sites improving on average from 0.8 to 2.1 units (mean 1.5 units~site).
From the Laser Center of Virginia, a Virginia Beach, VA, Eastern Virginia Medical School, Norfolk, VA; the Department of General Surgery,b Naval Medical Center Portsmouth, Portsmouth, VA; and the Zukowski Center for Cosmetic Plastic Surgery,c Wilmette, IL. The opinions or assertions expressed herein are those of the authors and are not to be construed as official or as reflecting the views of the Department of the Navy, the Department of Defense, or Naval Medical Center Portsmouth, VA. Dr. McDaniel received financial support for this project to partially cover out-of-pocket expenses, staff training and loan of a Silhouette ® device from the Luxar Corporation (ESC Medical Systems), the manufacturer of Silhouette ®. In addition, a resident author (Dr. Lord) received travel expenses and a small honorarium to present data at a private ESC-sponsored symposium.
This technique provided safe yet modest improvement in the appearance of cellulite. The mechanism of this improvement remains unknown. Further research is needed to determine the mechanism of this improvement, its longevity, optimum treatment parameters, and whether maintenance therapy is needed.
Accepted for publication Mar. 31, 1998.
structured weight loss program incorporating diet modification and appropriate exercise is the most time-honored method of maintaining a shapely figure. However, many postpubertal women possess deposits of adipose tissue on the lower extremities and buttocks that are recalcitrant to most forms of exercise and diet modification. 1 Most also have undesirable skin patterns with contour irregularities, known as "cellulite" in Western culture. Many theories about the cause of these subcu-
A
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SURGERY
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Reprint requests: David H. McDaniel, MD, Laser Center of Virginia, 933 First Colonial Rd., Suite 113, Virginia Beach, VA 23454-3101.
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taneous collections of fat have been proposed. Lotti et al. 2 stated that excess dermal glycosaminoglycans resulted in cellulite. Maes and Marenus -3indicated that a subclinical inflammatory process resulting in the persistent activation of proteinases (collagenase and elastase) resulted in cellulite. However, extensive histologic analysis of skin and subcutaneous tissue taken from the thigh and hip regions has shown gender-specific differences in the arrangement of subdermal fibrous septae (retinacula cutis). Men tend to have more tightly organized collagen cross bridges, whereas women and androgen-deficient individuals have a more loosely organized deep dermal substructure with large "standing fat-cell chambers" lacking septal cross bridges. Therefore some classify cellulite not as a pathologic disorder, but rather as a variant of normal gender-dependent anatomy. 4
M a t e r i a l and M e t h o d s
Three patients aged 36, 40, and 50 were enrolled in this pilot study. They exhibited the presence of unwanted cellulite on the abdomen, flanks, thighs, buttocks, and truncal areas severe enough to be closely photographed with a digital imaging system. Informed consent was obtained before treatment. Before treatment and at the completion of all 16 treatments patients underwent fasting laboratory analysis, including cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and chylomicrons. A spot urinary amylase was performed (before treatment, 30 minutes after the first treatment, and after 16 treatments).
Mechanical "roller massage therapy" for cellulite is a decade-old technique initially instituted in Europe as "Endermologie®'' (LPG® Systems, Valence, France). 6 This technique as it currently exists has yet to be accepted in the United States as a medical alternative to standard surgical techniques. Traditional liposuction alone, which is an invasive technique, has produced variable results and may result in dimpling. 7 Current devices use one or two variable direction rollers and a suction device capable of 22 inches of Hg that lift up the skin and subcutaneous fat and "massage" it between the rollers. Patients are treated for 24 to 45 minutes biweekly while wearing a body suit or nylon stocking. Thigh measurement reductions on average of 1.85 mm after 12 treatments and 4.98 mm after 20 treatments when administered five times per week have been reported. 6,8,9 However, limited data are available on these "roller massage therapy" techniques for cellulite reduction.
Fixed points on both legs laterally, 25 cm distal to the anterior superior iliac spine, and anteriorly, 10 cm proximal to the superior border of the patella, were marked and underwent high-resolution diagnostic ultrasound evaluation before treatment and at the completion of 16 treatments. In addition, infrared interferometry was used to assess relative fat distribution (RFD) values serially in these same four areas. These values were obtained (before treatment, after eight treatments, after 16 treatments, and 1 month after the completion of 16 treatments) with the Futrex®-5000/XL body composition analyzer (Futrex, Inc., Gaithersburg, MD). All patients underwent serial measurements of weight, percent body fat analysis, and anatomic thigh circumference measurements at the aforementioned sites. Digital and 35 mm photographs were obtained before treatment, after eight treatments, after 16 treatments, and at I and 3 months after the completion of 16 treatments. Photographs were meticulously standardized with the same lighting conditions, magnification, and background used. Images were obtained with a 35 mm camera, and Sony® VX1000 3CCD/digital imaging system and morphed by use of Mirror ® 2000 software (Virtual Eyes, Inc., Kirkland, WA). In addition, the patient with the greatest change in RFD underwent diagnostic magnetic resonance imaging of the right proximal thigh at the completion of the study. All patients underwent 16 treatments, performed twice weekly, with the Silhouette® device (Luxar Corp./ ESC Medical Systems, Bothell, WA).
The purpose of this study was to objectively evaluate the efficacy of this procedure and provide matched photographic documentation of any cellulite improvement if it did in fact occur. In addition, the efficacy of cellulite measurement techniques was evaluated before initiation of a larger case series.
All treatments were performed by the same physician/aesthetician team. Treatments were computer prompted, lasting 36 minutes, and addressed the contour irregularities of the buttock, circumferential thighs, and abdomen inferior to the umbilicus. All patients wore nylon stockings to reduce skin friction during treatment. Patients
The literature is replete with topical therapies for the reduction of cellulite by use of anything from lactic acid to xanthines. Retinoids, herbal compounds, and exothermic herbal packs have also been described in the treatment of cellulite, s Body contouring surgeries including the advent of ultrasound-assisted lipoplasty continue to evolve as treatments for cellulite, particularly in the regions of the abdomen, thighs, and buttocks.
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Volume18, Number3
Figure 1. Diagnostic ultrasound scan (12 MHz, linear array transducer) of the right leg of a patient shows epidermis, dermis, fibrous septae, and subcutaneous tissue. Note the change in depth of the epidermal and dermal regions. A, Before treatment. N, After 16 treatments.
were initially treated starting with a device vacuum setting of number 2 and advanced to number 7 as tolerated. The maximum setting tolerated by patients in this trial was number 7. No treatments occurred below the knees. Patients were encouraged to drink plenty of fluids and continue with their three-times-per-week 30- to 45minute exercise routine, as they had done before the study. Unlike the standard recommended treatment plan associated with this device, in this study patients were not given a specific diet to follow, but rather they were instructed to maintain their same low-fat diet as they had beforehand. The use of diet pills or other modes of weight reduction was prohibited during the study period. The study design attempted to isolate "roller massage therapy" effects on cellulite reduction without the influence of confounding variables. A patient diary was maintained to record bruising, skin irritation, swelling, soreness, desquamation, or any other untoward side effect the patients may have encountered during the study period. Results
All patients reported treatment with the device to be pleasant and equated it with a deep massage. The only adverse effects noted were occasional small, transient 1 to 2 cm bruises. It should be noted that treatment with "roller massage therapy" is safe, and no significant adverse effects occurred during the course of the study. All patients gained weight during the study (3.5 to 8.4 lb)
Body Contourmg: A Preliminary Report on the Use o~ the Silhouette ®Device for Treating Cellulite
Figure 2. Posttreatment Tl-weighted, spin~echo magnetic resonance image (TR/TE = 4 75/18) of the right proximal thigh of the patient in Figure 1. External circular objects represent location markers.
(mean 5.7 lb; 2.6 kg). Percent body fat analysis by use of infrared interferometry (Futrex®-5000/XL device) incorporating the Dotson-Davis equation 1° did not change markedly during the study period (0.5% to 1.5%) for all patients. All patient laboratory data remained within normal limits during the study period. Spot urinary amylase values performed decreased in two patients and increased in the third. Thigh circumferences were serially recorded for four regions initially, after eight treatments, after 16 treatments, and 1 month after the completion of 16 treat-
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ments. On average, the right proximal thigh increased 1.7 mm, and the left increased 8.7 mm; the right distal thigh decreased 25 mm, and the left decreased 22 mm. Diagnostic ultrasound scans of the treatment areas were obtained (Figure 1). Skin thickness (epidermis and dermis), a relatively noncompressible tissue in comparison to subcutaneous fat, increased an average 2.3 mm on the right and 0.7 mm on the left. The thickness of the subcutaneous tissue decreased an average of 0.7 mm. To further correlate the ultrasound measurements, a magnetic resonance imaging scan was obtained through the same area on one patient (Figure 2). Comparison of the digital images before and after 16 treatments showed modest "softening" of the skin contour irregularities on all three patients (Figure 3, A and B). Objective blinded grading was performed by four physicians and revealed an average improvement of 57% in the appearance of cellulite. Follow-up 3 months after "mechanical roller massage therapy" ended indicated that the appearance of cellulite remained less than that observed before treatment (Figure 3, C). Fat distribution data were recorded for the right and left lateral and anterior thighs (four values). All patients showed reductions at all treatment sites in the values obtained for RFD. On average, fat distribution values decreased from 0.8 to 2.1 units, for a combined average decrease of 1.5 units per site. The absolute RFD values obtained for the right and left proximal thighs decreased by 1.17 and 2.03 units, respectively. The right and left distal thigh values decreased by 2.13 and 0.83 units, respectively. Discussion
On the basis of this small pilot study, no statistically significant conclusions can be made regarding the reduction of cellulite after use of the Silhouette® device. However, some observations may be made regarding the altered appearance of cellulite and the effectiveness of measuring devices in quantifying a change after treatment with "roller massage therapy." Little insight was gained from the particular laboratory tests evaluated. Percent body fat analyses and serial weights failed to yield useful data in quantifying a change with therapy. The addition of a structured exercise and diet program to the device treatment protocol might produce a measurable difference in one of the aforementioned variables. However, the study design was specifically intended not to alter the patient's
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baseline diet and exercise routines in an attempt to limit confounding variables. By minimizing the "usual" concomitant therapeutic effect (diet modification, exercise, and increased water ingestion) that most patients undergo while receiving "roller massage therapy," the effect of the device could be isolated. Subjective improvements in the photographic images of the cellulite were noted on all patients when pretreatment images were compared with those obtained after 16 treatments. All patients agreed that their cellulite had improved in appearance. When four physicians in a blinded fashion evaluated these same images, all agreed that there were contour changes consistent with "improvement." The combined average improvement was found to be 57%. Thigh circumference data on average revealed increases in proximal thigh circumferences and decreases in distal thigh circumferences. The significance of these data is unknown and limited because of our study size. The weight gain experienced by all subjects may have affected this variable (study ended after the December 1997 holiday period). Ultrasound data reflecting combined epidermal/dermal thickness demonstrated an increase in this parameter over the course of the treatments at all four measurement sites (both legs laterally, 25 cm distal to the anterior superior iliac spine, and anteriorly, 10 cm proximal to the superior border of the patella). A possible explanation for these findings is that the mechanical stimulation of the dermal and subdermal connective tissue matrix produced a subacute inflammatory reaction with resultant dermal edema. This "edema" may have created the observed reduction or softening in the appearance of the cellulite. 11 The permanence of these treatments and the presence of edema or an inflammatory reaction (if any) were not addressed but do provide fertile ground for future studies that should include biopsies. The most quantifiable and readily reproducible finding of the study was the infrared interferometer data on RFD. These values estimate relative body fat, not as a percentage, but as a unit value that can be used as a guide to monitor changes in fat distribution within specified treatment locations. This device uses a near-infrared interactance technique based on technology from the United States Department of Agriculture. The device, with less than a 2% degree of error when compared with standard buoyancy tests, sends a near-infrared signal through the
Vo/umelS, Number3
Figure 3. Dtgital images of a 40-year-old woman, anterior, oblique, and posterior views. A, Before treatment. B, After 16 treatments. Note that softening m the appearance of the cellulite is most noticeable in the oblique projection. C~ Three months after cessation of "mechanical roller massage" therapy, showing that improvement in the appearance of cellulite is maintained.
Body Contouring: A Preliminary Report .n #.,e Use of the Silhouette ® Device for Treating Cellulite
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subject's skin and subcutaneous tissue, which then reflects back to the sound head after encountering the fascia. 12 This device was selected for the study on the premise that as changes occur in the cellulite, different values for fat distribution will result, reflecting an increase or decrease in the density of the substance (in this case fat) being monitored. Unlike the ultrasound measurements, which varied markedly just by varying the pressure applied on the skin (without moving the transducer), the interferometer showed minimal variation.
After 16 treatments with the "roller massage therapy" device, modest clinical improvement in the contour outline and skin surface irregularities associated with socalled "cellulite" was demonstrated. Patients and physicians both believed improvement had occurred after treatment. Three months after cessation of therapy, the apparent beneficial effects of "roller massage therapy" remained better than pretreatment levels. Although the cause of this effect remains unknown, possible mechanisms of this treatment include the structural alteration of the dermis-hypodermis interface, which in turn may alter blood microcirculation and lymph circulation. Further radiographic analyses, biopsies, and a larger patient study group are needed to scientifically quantify the changes observed, to define the optimal treatment parameters, and to evaluate the longevity of results to determine the necessity of a maintenance program. Serial photography, thigh measurements, ultrasound scans, magnetic resonance imaging, and infrared interferometry are effective tools for measuring changes associated with "roller massage therapy." The laboratory tests selected and the monitoring of serial weights proved ineffective in this trial. However, additional laboratory tests should be incorporated into future studies, which test for elimination byproducts of lipid breakdown. •
AESTHETIC
References 1. Scherwitz C, Braun-Falco O. So-called cellulite. J Dermatol Surg Oncol 1978;4:230-4.
Conclusion
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We thank Kathy Jordan, Research Manager, Laser Center of Virginia, Virginia Beach, VA, for her assistance in the accumulation and evaluation of data. A special thanks is extended to Alexander Chako, MD, Virginia Beach General Hospital, for his interpretation of the radiology studies. We also thank Ann Shawkey, Aesthetician, Laser Center of Virginia, for her assistance in patient treatments.
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2. Lotti T, Ghersetich MD, Grappone C, Dini G. Proteoglycans in so-called cellulite. Int J Dermatol 1990;29:272-4. 3. Maes D, Marenus K. Modulation of inflammatory reactions in skin. In: Baran R, Maibach H, eds. Cosmetic dermatology. 2nd ed. London: bunitz; (in press), 4. Nurnberger F, Muller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol 1978;4:221-9. 5. Draelos ZD, Marenus KD. Cellulite: etiology and purported treatment. Dermatol Surg 1997;23:1177-81. 6. Marchand JP, Privat Y. A new instrumental method for the treatment of cellulite. Medecine au Feminin (in French). 1991;39:25-34. 7. Coleman WP, Hanke CW, AIt TH, Asken S. Liposuction. In: Coleman WP, Hanke CW, AIt TH, Asken S, eds. Cosmetic surgery of the skin: principles and practice. Philadelphia: BC Decker Inc., 1991;213-38. 8. Vergereau R. Use of mechanical skin fold rolling in cosmetic medicine. J Cosmet Med Dermatol Surg (in French). 1995;85:49-53, 9. Kinney BM. External fatty tissue massage (the "endermologie" and "silhouette" procedures). Plas Reconstr Surg 1997;100:1903-4. 10. Conway JM, Norris KH, Bodwell CE. A new approach for the estimation of body composition: infrared interactance. Am J Clin Nutrition 1984;40:1123-30. 11. Curri SB, Bombardelli E. Local lipodystrophy and districtual microcirculation: proposed etiology and therapeutic management. Cosmet Toilet 1994;109:51-65. 12. Conway JM, Norris KH. Non-invasive body composition in humans by near-infrared interactance. In: Ells KJ, Yasumura S, Morgan WD, editors. In vivo body composition studies. London: Institute of Physical Sciences in Medicine; 1987:163-70.
Volume18, Number3
Cellulite is a common condition affecting 85% of postadolescent women. Recent advances in aesthetic techniques have initiated a new pursuit into understanding the cause and treatment of this condition. A recently introduced "roller massage therapy" device, Silhouette ®, was selected for evaluation in this study. Three patients were enrolled into this private practice, medical school-affiliated, prospective pilot project. The study objective was to identify whether the Silhouette ® device could generate reproducible reductions in the appearance of cellulite or alter body appearance, specifically in the abdominal, buttock, and thigh regions. A secondary goal was to evaluate the effectiveness of various measuring devices used to quantify cellulite regression. These included serial body weights, percent body fat, relative fat distribution, specific anatomic measurements, diagnostic ultrasound, and serial morphed photographic analysis and laboratory data. Initial results showed that 16 biweekly treatments produced minimal changes in body weight or percent body fat. On average, thigh circumferences increased by 1.7 mm and 8.7 mm in the right and left proximal thighs and decreased by 25 mm and 22 mm in the right and left distal thighs, respectively. Diagnostic ultrasound scans showed trends that may provide further insight into a possible mechanism of action. Relative fat distribution values taken from four selected sites proved the most significant finding with selected treatment sites improving on average from 0.8 to 2.1 units (mean 1.5 units~site).
From the Laser Center of Virginia, a Virginia Beach, VA, Eastern Virginia Medical School, Norfolk, VA; the Department of General Surgery,b Naval Medical Center Portsmouth, Portsmouth, VA; and the Zukowski Center for Cosmetic Plastic Surgery,c Wilmette, IL. The opinions or assertions expressed herein are those of the authors and are not to be construed as official or as reflecting the views of the Department of the Navy, the Department of Defense, or Naval Medical Center Portsmouth, VA. Dr. McDaniel received financial support for this project to partially cover out-of-pocket expenses, staff training and loan of a Silhouette ® device from the Luxar Corporation (ESC Medical Systems), the manufacturer of Silhouette ®. In addition, a resident author (Dr. Lord) received travel expenses and a small honorarium to present data at a private ESC-sponsored symposium.
This technique provided safe yet modest improvement in the appearance of cellulite. The mechanism of this improvement remains unknown. Further research is needed to determine the mechanism of this improvement, its longevity, optimum treatment parameters, and whether maintenance therapy is needed.
Accepted for publication Mar. 31, 1998.
structured weight loss program incorporating diet modification and appropriate exercise is the most time-honored method of maintaining a shapely figure. However, many postpubertal women possess deposits of adipose tissue on the lower extremities and buttocks that are recalcitrant to most forms of exercise and diet modification. 1 Most also have undesirable skin patterns with contour irregularities, known as "cellulite" in Western culture. Many theories about the cause of these subcu-
A
AESTHETIC
SURGERY
JOURNAL
Reprint requests: David H. McDaniel, MD, Laser Center of Virginia, 933 First Colonial Rd., Suite 113, Virginia Beach, VA 23454-3101.
70/1/90775
~
MAY/JUNE
| g98
t77
taneous collections of fat have been proposed. Lotti et al. 2 stated that excess dermal glycosaminoglycans resulted in cellulite. Maes and Marenus -3indicated that a subclinical inflammatory process resulting in the persistent activation of proteinases (collagenase and elastase) resulted in cellulite. However, extensive histologic analysis of skin and subcutaneous tissue taken from the thigh and hip regions has shown gender-specific differences in the arrangement of subdermal fibrous septae (retinacula cutis). Men tend to have more tightly organized collagen cross bridges, whereas women and androgen-deficient individuals have a more loosely organized deep dermal substructure with large "standing fat-cell chambers" lacking septal cross bridges. Therefore some classify cellulite not as a pathologic disorder, but rather as a variant of normal gender-dependent anatomy. 4
M a t e r i a l and M e t h o d s
Three patients aged 36, 40, and 50 were enrolled in this pilot study. They exhibited the presence of unwanted cellulite on the abdomen, flanks, thighs, buttocks, and truncal areas severe enough to be closely photographed with a digital imaging system. Informed consent was obtained before treatment. Before treatment and at the completion of all 16 treatments patients underwent fasting laboratory analysis, including cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and chylomicrons. A spot urinary amylase was performed (before treatment, 30 minutes after the first treatment, and after 16 treatments).
Mechanical "roller massage therapy" for cellulite is a decade-old technique initially instituted in Europe as "Endermologie®'' (LPG® Systems, Valence, France). 6 This technique as it currently exists has yet to be accepted in the United States as a medical alternative to standard surgical techniques. Traditional liposuction alone, which is an invasive technique, has produced variable results and may result in dimpling. 7 Current devices use one or two variable direction rollers and a suction device capable of 22 inches of Hg that lift up the skin and subcutaneous fat and "massage" it between the rollers. Patients are treated for 24 to 45 minutes biweekly while wearing a body suit or nylon stocking. Thigh measurement reductions on average of 1.85 mm after 12 treatments and 4.98 mm after 20 treatments when administered five times per week have been reported. 6,8,9 However, limited data are available on these "roller massage therapy" techniques for cellulite reduction.
Fixed points on both legs laterally, 25 cm distal to the anterior superior iliac spine, and anteriorly, 10 cm proximal to the superior border of the patella, were marked and underwent high-resolution diagnostic ultrasound evaluation before treatment and at the completion of 16 treatments. In addition, infrared interferometry was used to assess relative fat distribution (RFD) values serially in these same four areas. These values were obtained (before treatment, after eight treatments, after 16 treatments, and 1 month after the completion of 16 treatments) with the Futrex®-5000/XL body composition analyzer (Futrex, Inc., Gaithersburg, MD). All patients underwent serial measurements of weight, percent body fat analysis, and anatomic thigh circumference measurements at the aforementioned sites. Digital and 35 mm photographs were obtained before treatment, after eight treatments, after 16 treatments, and at I and 3 months after the completion of 16 treatments. Photographs were meticulously standardized with the same lighting conditions, magnification, and background used. Images were obtained with a 35 mm camera, and Sony® VX1000 3CCD/digital imaging system and morphed by use of Mirror ® 2000 software (Virtual Eyes, Inc., Kirkland, WA). In addition, the patient with the greatest change in RFD underwent diagnostic magnetic resonance imaging of the right proximal thigh at the completion of the study. All patients underwent 16 treatments, performed twice weekly, with the Silhouette® device (Luxar Corp./ ESC Medical Systems, Bothell, WA).
The purpose of this study was to objectively evaluate the efficacy of this procedure and provide matched photographic documentation of any cellulite improvement if it did in fact occur. In addition, the efficacy of cellulite measurement techniques was evaluated before initiation of a larger case series.
All treatments were performed by the same physician/aesthetician team. Treatments were computer prompted, lasting 36 minutes, and addressed the contour irregularities of the buttock, circumferential thighs, and abdomen inferior to the umbilicus. All patients wore nylon stockings to reduce skin friction during treatment. Patients
The literature is replete with topical therapies for the reduction of cellulite by use of anything from lactic acid to xanthines. Retinoids, herbal compounds, and exothermic herbal packs have also been described in the treatment of cellulite, s Body contouring surgeries including the advent of ultrasound-assisted lipoplasty continue to evolve as treatments for cellulite, particularly in the regions of the abdomen, thighs, and buttocks.
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Volume18, Number3
Figure 1. Diagnostic ultrasound scan (12 MHz, linear array transducer) of the right leg of a patient shows epidermis, dermis, fibrous septae, and subcutaneous tissue. Note the change in depth of the epidermal and dermal regions. A, Before treatment. N, After 16 treatments.
were initially treated starting with a device vacuum setting of number 2 and advanced to number 7 as tolerated. The maximum setting tolerated by patients in this trial was number 7. No treatments occurred below the knees. Patients were encouraged to drink plenty of fluids and continue with their three-times-per-week 30- to 45minute exercise routine, as they had done before the study. Unlike the standard recommended treatment plan associated with this device, in this study patients were not given a specific diet to follow, but rather they were instructed to maintain their same low-fat diet as they had beforehand. The use of diet pills or other modes of weight reduction was prohibited during the study period. The study design attempted to isolate "roller massage therapy" effects on cellulite reduction without the influence of confounding variables. A patient diary was maintained to record bruising, skin irritation, swelling, soreness, desquamation, or any other untoward side effect the patients may have encountered during the study period. Results
All patients reported treatment with the device to be pleasant and equated it with a deep massage. The only adverse effects noted were occasional small, transient 1 to 2 cm bruises. It should be noted that treatment with "roller massage therapy" is safe, and no significant adverse effects occurred during the course of the study. All patients gained weight during the study (3.5 to 8.4 lb)
Body Contourmg: A Preliminary Report on the Use o~ the Silhouette ®Device for Treating Cellulite
Figure 2. Posttreatment Tl-weighted, spin~echo magnetic resonance image (TR/TE = 4 75/18) of the right proximal thigh of the patient in Figure 1. External circular objects represent location markers.
(mean 5.7 lb; 2.6 kg). Percent body fat analysis by use of infrared interferometry (Futrex®-5000/XL device) incorporating the Dotson-Davis equation 1° did not change markedly during the study period (0.5% to 1.5%) for all patients. All patient laboratory data remained within normal limits during the study period. Spot urinary amylase values performed decreased in two patients and increased in the third. Thigh circumferences were serially recorded for four regions initially, after eight treatments, after 16 treatments, and 1 month after the completion of 16 treat-
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ments. On average, the right proximal thigh increased 1.7 mm, and the left increased 8.7 mm; the right distal thigh decreased 25 mm, and the left decreased 22 mm. Diagnostic ultrasound scans of the treatment areas were obtained (Figure 1). Skin thickness (epidermis and dermis), a relatively noncompressible tissue in comparison to subcutaneous fat, increased an average 2.3 mm on the right and 0.7 mm on the left. The thickness of the subcutaneous tissue decreased an average of 0.7 mm. To further correlate the ultrasound measurements, a magnetic resonance imaging scan was obtained through the same area on one patient (Figure 2). Comparison of the digital images before and after 16 treatments showed modest "softening" of the skin contour irregularities on all three patients (Figure 3, A and B). Objective blinded grading was performed by four physicians and revealed an average improvement of 57% in the appearance of cellulite. Follow-up 3 months after "mechanical roller massage therapy" ended indicated that the appearance of cellulite remained less than that observed before treatment (Figure 3, C). Fat distribution data were recorded for the right and left lateral and anterior thighs (four values). All patients showed reductions at all treatment sites in the values obtained for RFD. On average, fat distribution values decreased from 0.8 to 2.1 units, for a combined average decrease of 1.5 units per site. The absolute RFD values obtained for the right and left proximal thighs decreased by 1.17 and 2.03 units, respectively. The right and left distal thigh values decreased by 2.13 and 0.83 units, respectively. Discussion
On the basis of this small pilot study, no statistically significant conclusions can be made regarding the reduction of cellulite after use of the Silhouette® device. However, some observations may be made regarding the altered appearance of cellulite and the effectiveness of measuring devices in quantifying a change after treatment with "roller massage therapy." Little insight was gained from the particular laboratory tests evaluated. Percent body fat analyses and serial weights failed to yield useful data in quantifying a change with therapy. The addition of a structured exercise and diet program to the device treatment protocol might produce a measurable difference in one of the aforementioned variables. However, the study design was specifically intended not to alter the patient's
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baseline diet and exercise routines in an attempt to limit confounding variables. By minimizing the "usual" concomitant therapeutic effect (diet modification, exercise, and increased water ingestion) that most patients undergo while receiving "roller massage therapy," the effect of the device could be isolated. Subjective improvements in the photographic images of the cellulite were noted on all patients when pretreatment images were compared with those obtained after 16 treatments. All patients agreed that their cellulite had improved in appearance. When four physicians in a blinded fashion evaluated these same images, all agreed that there were contour changes consistent with "improvement." The combined average improvement was found to be 57%. Thigh circumference data on average revealed increases in proximal thigh circumferences and decreases in distal thigh circumferences. The significance of these data is unknown and limited because of our study size. The weight gain experienced by all subjects may have affected this variable (study ended after the December 1997 holiday period). Ultrasound data reflecting combined epidermal/dermal thickness demonstrated an increase in this parameter over the course of the treatments at all four measurement sites (both legs laterally, 25 cm distal to the anterior superior iliac spine, and anteriorly, 10 cm proximal to the superior border of the patella). A possible explanation for these findings is that the mechanical stimulation of the dermal and subdermal connective tissue matrix produced a subacute inflammatory reaction with resultant dermal edema. This "edema" may have created the observed reduction or softening in the appearance of the cellulite. 11 The permanence of these treatments and the presence of edema or an inflammatory reaction (if any) were not addressed but do provide fertile ground for future studies that should include biopsies. The most quantifiable and readily reproducible finding of the study was the infrared interferometer data on RFD. These values estimate relative body fat, not as a percentage, but as a unit value that can be used as a guide to monitor changes in fat distribution within specified treatment locations. This device uses a near-infrared interactance technique based on technology from the United States Department of Agriculture. The device, with less than a 2% degree of error when compared with standard buoyancy tests, sends a near-infrared signal through the
Vo/umelS, Number3
Figure 3. Dtgital images of a 40-year-old woman, anterior, oblique, and posterior views. A, Before treatment. B, After 16 treatments. Note that softening m the appearance of the cellulite is most noticeable in the oblique projection. C~ Three months after cessation of "mechanical roller massage" therapy, showing that improvement in the appearance of cellulite is maintained.
Body Contouring: A Preliminary Report .n #.,e Use of the Silhouette ® Device for Treating Cellulite
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subject's skin and subcutaneous tissue, which then reflects back to the sound head after encountering the fascia. 12 This device was selected for the study on the premise that as changes occur in the cellulite, different values for fat distribution will result, reflecting an increase or decrease in the density of the substance (in this case fat) being monitored. Unlike the ultrasound measurements, which varied markedly just by varying the pressure applied on the skin (without moving the transducer), the interferometer showed minimal variation.
After 16 treatments with the "roller massage therapy" device, modest clinical improvement in the contour outline and skin surface irregularities associated with socalled "cellulite" was demonstrated. Patients and physicians both believed improvement had occurred after treatment. Three months after cessation of therapy, the apparent beneficial effects of "roller massage therapy" remained better than pretreatment levels. Although the cause of this effect remains unknown, possible mechanisms of this treatment include the structural alteration of the dermis-hypodermis interface, which in turn may alter blood microcirculation and lymph circulation. Further radiographic analyses, biopsies, and a larger patient study group are needed to scientifically quantify the changes observed, to define the optimal treatment parameters, and to evaluate the longevity of results to determine the necessity of a maintenance program. Serial photography, thigh measurements, ultrasound scans, magnetic resonance imaging, and infrared interferometry are effective tools for measuring changes associated with "roller massage therapy." The laboratory tests selected and the monitoring of serial weights proved ineffective in this trial. However, additional laboratory tests should be incorporated into future studies, which test for elimination byproducts of lipid breakdown. •
AESTHETIC
References 1. Scherwitz C, Braun-Falco O. So-called cellulite. J Dermatol Surg Oncol 1978;4:230-4.
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We thank Kathy Jordan, Research Manager, Laser Center of Virginia, Virginia Beach, VA, for her assistance in the accumulation and evaluation of data. A special thanks is extended to Alexander Chako, MD, Virginia Beach General Hospital, for his interpretation of the radiology studies. We also thank Ann Shawkey, Aesthetician, Laser Center of Virginia, for her assistance in patient treatments.
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2. Lotti T, Ghersetich MD, Grappone C, Dini G. Proteoglycans in so-called cellulite. Int J Dermatol 1990;29:272-4. 3. Maes D, Marenus K. Modulation of inflammatory reactions in skin. In: Baran R, Maibach H, eds. Cosmetic dermatology. 2nd ed. London: bunitz; (in press), 4. Nurnberger F, Muller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol 1978;4:221-9. 5. Draelos ZD, Marenus KD. Cellulite: etiology and purported treatment. Dermatol Surg 1997;23:1177-81. 6. Marchand JP, Privat Y. A new instrumental method for the treatment of cellulite. Medecine au Feminin (in French). 1991;39:25-34. 7. Coleman WP, Hanke CW, AIt TH, Asken S. Liposuction. In: Coleman WP, Hanke CW, AIt TH, Asken S, eds. Cosmetic surgery of the skin: principles and practice. Philadelphia: BC Decker Inc., 1991;213-38. 8. Vergereau R. Use of mechanical skin fold rolling in cosmetic medicine. J Cosmet Med Dermatol Surg (in French). 1995;85:49-53, 9. Kinney BM. External fatty tissue massage (the "endermologie" and "silhouette" procedures). Plas Reconstr Surg 1997;100:1903-4. 10. Conway JM, Norris KH, Bodwell CE. A new approach for the estimation of body composition: infrared interactance. Am J Clin Nutrition 1984;40:1123-30. 11. Curri SB, Bombardelli E. Local lipodystrophy and districtual microcirculation: proposed etiology and therapeutic management. Cosmet Toilet 1994;109:51-65. 12. Conway JM, Norris KH. Non-invasive body composition in humans by near-infrared interactance. In: Ells KJ, Yasumura S, Morgan WD, editors. In vivo body composition studies. London: Institute of Physical Sciences in Medicine; 1987:163-70.
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