Treatment of localized fat and gynoid lipodystrophy with combination therapy: multipolar radiofrequency, red LED, pneumatic endermologie, and cavitational ultrasound

Received on: 29 June 2012
Approved on: 2 September 2012
This study was carried out at the authors’ private
practices in Rio de Janeiro (RJ) and
Guaxupé (MG), Brazil.
Financial support: None
Conflicts of interest: LMG Lasers (MG, Brazil),
Brazil supplied the study materials.

Abstract

Introduction: A new combination therapy combines four different technologies for the treatment of localized fat and gynoid lipodystrophy. Objectives: To evaluate the efficacy and safety of this new treatment modality. Methods: Female patients (n = 21, aged 24-39) were treated with four different technologies from April to December 2011: cavitational ultrasound, multipolar radiofrequency, endermologie with pneumatic system, and LED. Eight 40-minute sessions were carried out on a weekly basis. The patients were evaluated before and after the eight treatment sessions with laboratory measurements of total cholesterol, triglycerides, creatinine, glucose, AST and ALT; and weight, waist circumference, and degree of patient satisfaction measurements. Results: The laboratory controls of the 21 patients remained within normal limits. On average, the treated patients lost 1.62 kg, presented a 2.85 cm reduction in their waist circumference, and rated their satisfaction with the treatment as 6.83 out of 10 grade in the evaluation scale. None of the patients presented systemic signs or symptoms as a result of the treatment. Conclusion: The method proved to be safe and effective in the treatment of localized fat and gynoid lipodystrophy.

Keywords: LIPODYSTROPHY, COMBINED MODALITY THERAPY, CELLULITIS

INTRODUCTION

The pressure to have a body shape that is within the current beauty standards has been increasing over the years, meaning that localized fat and gynoid lipodystrophy (cellulite) are relevant social problems. Men and women often go to extremes to achieve the "perfect" body, so physicians must correctly and sensibly educate patients about the real therapeutic possibilities and develop treatment programs based on the various methods currently available. Techniques that use radiofrequency, infrared radiation, cavitational or non-cavitational ultrasound, infusion of substances in the adipose tissue, and other non-invasive procedures have been studied.1

Combining four technologies into a single application is a new non-invasive, modern, and safe therapy to treat gynoid lipodystrophy and localized fat.2 Cavitational ultrasound has often been used to treat renal calculus and musculoskeletal disorders.3 Radiofrequency is used to stimulate collagen contraction beyond the fat septa.4 In turn, red light emitting diodes (LEDs) promote photobiomodulation, while endermologie helps improve lymph drainage.5,6,7

Fat Metabolism
The metabolic route of hydrolyzed fat has been extensively researched over the past decade, and today there is ample knowledge about it. Adipocytes are primarily composed of 20% cholesterol and 80% triglycerides. Triglycerides are composed of fatty acids and glycerol. After cavitation, part of the adipocyte''''''''s contents comes into contact with enzymes in the interstitial fluid and is metabolized.8 The fatty acid that appears after lipolysis binds to albumin, enters the circulatory system, and reaches the liver, where it is excreted through bile. In turn, glycerol, which is water soluble, is dissolved in plasma that is subsequently eliminated by the liver.9 The cholesterol present in the body can have different destinations. In order to be conveyed in the blood, it is esterified into fatty acid molecules – which increases its hydrophobicity – and then encased by a lipoprotein.10

Cavitation
Stable cavitation is a physical phenomenon produced by ultrasonic low-frequency waves (20-70kHz) and high amplitudes. 11 It produces microbubbles of vacuum containing a high level of energy. During the cavitation process, these microbubbles grow in size and implode, producing a shockwave among adipocytes. Since adipocytes'''''''' membranes are very thin and cannot resist the shock, they rupture(Figure 1). 12,13

Radio Frequency
Multipolar radiofrequency is applied using three or more electrodes.14 The transit of electrons occurs in both directions, and poles sometimes behave as positive and sometimes as negative. Since electrons will never exhibit bipolar behavior (i.e. leave a single pole and reach two other poles), an intense alternation of polarity and parity takes place, with the electric current''''''''s origin and destination points constantly varying. This process causes the energy delivered to the skin surface to be homogeneous and well distributed. This type of technology has a dermal- epidermal concomitant action.15

(Figure 2 and 3) present schematic drawings that show multipolar- type radiofrequency: three or more electrodes arranged symmetrically and working together with alternating polarity between them, resulting in the homogeneous heating of different layers of the skin.

LEDs
Light emitting diodes (LEDs) are devices composed of interconnected solid semiconductors that generate light. They provide a reliable, high-potency, narrow-bandwidth source of light that illuminates a given surface homogeneously, which is very important in medical use. 5,16,17 The present study used a 650 nm red LED wavelength due to its photobiomodulation function, which is effective in the production and maintenance of fibroblasts, which in turn is key for collagen remodeling.

Endermologie
Endermologie promotes real-time lymphatic drainage. The pressure exerted externally on the skin is decreased, while the internal pressure increases, leading to the hyperoxygenation of tissues and an intense removal of toxins due to the increased vascularization and better restoration of the cellular metabolic exchange.18,19 This process generates a "mobile fold" of the skin, the size of which varies according to the adjustment of the vacuum''''''''s negative pressure, and creates a massaging and pumping effect in the lymphatic system.18,19

Combination Therapy
The combination of technologies has been progressively demonstrating interesting clinical results. The combination of elements such as ultrasound, radiofrequency, LED, and endermologie appears to act synergistically in the treatment of cellulite and localized fat. Thus, the application of radio frequency associated with endermologie increases the temperature of the fat tissue, which becomes turgid. The cavitational ultrasound delivers a better lipolysis performance in turgid tissues compared to flabby and loose membranes. Damaged fat is later eliminated through the liver and lymphatic routes. All those technologies combined produce good results, and require fewer sessions than their isolated application.

OBJECTIVE
The objective of this clinical study was to evaluate the safety and efficacy of combining these four technologies to treat cellulite and gynoid lipodystrophy.

METHODS

A prospective study was carried out from April to December 2011, with 21 female patients (skin types II to V, aged 24-39), according to the guidelines of the Declaration of Helsinki. After receiving nutritional counseling, the patients were instructed not to carry out physical activity during the study period. The device used in the study was manufactured in South Korea (Powershape Platform, registered in the Brazilian national health surveillance agency ANVISA under the number 80520090001). The ultrasound device''''''''s handpiece (S-Cavity) had a 36.5 kHz frequency and a maximum potency of 100W. The multipolar radiofrequency device''''''''s handpiece (S-Body) had a 1mHz frequency and a potency of 100W. The red LED had a 650nmwavelength.Thevacuum''''''''s negative pressure was 600mmHg and the endermologie process was carried out using a patented pneumatic system. Eight 40- minute applications were carried out at weekly intervals. Standardized photographs were taken at the beginning of each session. The S-Body handpiece was applied with level-2 and - 3 vacuum, and level-10 radiofrequency intensity. The temperature was kept at 40-42°C (measured by infrared thermometer) and the radiofrequency potency was lowered and kept constant for 20 minutes. Subsequently, the S-cavity device was used in the same parts of the body, with the ultrasound set at level 5 and a continuous pulse applied in circular movements, for an average of 20 minutes.

The following measures were evaluated before and after the eight treatment sessions: patient''''''''s weight (with a calibrated scale), waist circumference (with a standard metric tape), degree of satisfaction (questionnaire with a 1-10scale), and laboratory measurements of total cholesterol, triglycerides, creatinine, fasting glucose, AST, and ALT.

Side effects reported by patients during the sessions were caused by the high temperature from the S-Body handpiece and the whizzing sound from the S-Cavity handpiece. All patients had medical and nutrition follow-up. The procedure was carried out by a functional physiotherapist and was overseen by a physician.

RESULTS

Safety
None of the 21 patients treated had signs or systemic symptoms such as malaise, gastrointestinal, circulatory, otological, or neurological symptoms. No cases of burns were observed during the application procedures. Laboratory tests remained within levels considered safe, as illustrated in Table 1.

Effectiveness
The treated patients lost on average 1.62 kg, had an average reduction of 2.85 cm in their waist circumference, and rated their satisfaction as 6.83 on average(out of 10) (Figures 4 and 5). No patients presented signs or systemic symptoms as a result of the treatment (Table 2).

DISCUSSION

The analysis of the data has shown that even in cases in which there was no weight loss, a significant decrease in waist circumference was verified. Although attributed subjectively and difficult to assess, the patient satisfaction index was considerably positive; while no patient reported 100% satisfaction, all observed results of the treatment. That is an expected behavior in non-invasive methods.

According to Table 1, cholesterol and triglyceride levels, as well as their proportions, remained close to the baseline. At no stage of the treatment were increased levels of serum lipids observed. Also, there were no significant alterations in blood glucose, AST, ALT or creatinine levels. As for the whizzing sound described during the sessions, it ceased completely after the end of treatment. No patients reported alterations in hearing acuity or whiz sound after the treatment.

Table 2 shows that the reduction in measurements was more important than the weight loss, however all patients experienced a reduction in measurements, regardless of the amount of weight they lost. That shows that there was a clear decrease in the adipose panniculus in the sites treated, which corroborates with the study''''''''s objective: to assess the outcome of the proposed treatment for localized fat.

CONCLUSION

This study analyzed the effects of a new combined technique for treating adipose tissue disorders such as gynoid lipodystrophy and localized fat. The results have shown that the technique is safe, effective, and well tolerated in non-invasive bodily procedures. In particular, the authors believe that the ideal patients for this type of procedure are those with localized fat and cellulite, rather than those seeking to lose weight. This technique would also be an option for treating patients who are advised not to have surgical treatment. Laboratory analysis showed that no significant alterations of serum fats, blood glucose levels, or liver function are caused by this procedure. It is always worth highlighting that a comprehensive patient history that describes previous diseases, accompanied by a detailed physical examination and an analysis of the patient''''''''s level of expectations, are vital for success and to avoid patient dissatisfaction.

References

1 . Goldman MP. Cellulite a review of currents treatments . Cosmet Dermatol. 2002; 15:17-20

2 . Lucas MRA. Association of multipolar radiofrequency with vacuum massage and pulsed cavitational ultrasound. South Am J Aesthet Med. 2011; 07: 08-11

3 . Palumbo P, Cinque B, Miconi G, La Torre C, Zoccali G, Vrentzos N, et al. Biological effects of low frequency high intensity ultrasound application on ex vivo human adipose tissue. Int J Immunopathol Pharmacol. 2011;24(2):411-22

4 . Boisnic S, Branchet MC. Ex vivo human skin evaluation of localized fat reduction and anti-aging effect by TriPollar radio frequency treatments. J Cosmet Laser Ther. 2010;12(1):25-31

5 . Sousa AP, Santos JN, Reis JAJR, Ramos TA, Souza J, Cangussú MC, et al. Effect of LED phototherapy of three distinct wavelengths on fibroblasts on wound healing: a histological study in a rodent model. Photomed Laser Surg. 2010;28(4):547-52

6 . Chang P, Wiseman J, Jacoby T, Salisbury AV, Ersek RA. Noninvasive mechanical body contouring (Endermologie): a one-year clinical outcome study update. Aesthetic Plast Surg. 1998; 22(2): 145-53

7 . Huang PJ, Huang YC, Su MF, Yang TY, Huang TY, Huang JR, et al. In vitro observations on the influence of copper peptide aids for the LED photoirradiation of fibroblast collagen synthesis. Photomed Laser Surg. 2007;25(3):183-90

8 . van Hees AM, Jocken JW, Essers Y, Roche HM, Saris WH, Blaak EE. Adipose triglyceride lipase and hormone-sensitive lipase protein expression in subcutaneous adipose tissue is decreased after an isoenergetic low-fat high-complex carbohydrate diet in the metabolic syndrome. Metabolism. 2012 Apr 30. [Epub ahead of print]

9 . Enjoji M, Yasutake K, Kohjima M, Nakamuta M. Nutrition and nonalcoholic Fatty liver disease: the significance of cholesterol. Int J Hepatol. 2012;2012:925807

10 . Weber K, Erben RG. Differences in triglyceride and cholesterol metabolism and resistance to obesity in male and female vitamin D receptor knockout mice. J Anim Physiol Anim Nutr (Berl). 2012 Apr 30. [Epub ahead of print]

11 . Scandurra S. Analysis and overwiew about the innovative metod the " stable cavitation" for treatment of localized adiposity and aedema-fibrosclerotic panniculopaty. Use of generator at "cavitation" dominance. Monitoring and follow-up of blood and urin parameters on 3 groups of 7 patients each. Plast Aesthetic Surg. 2005: 1-9

12 . Neira R, Arroyave J, Ramirez H, Ortiz CL, Solarte E, Sequeda F, et al. Fat liquefication: Effect of low-level laser energy on adipose tissue. Plast Reconstr Surg. 2002; 110(3): 912-22

13 . Zhou Y, Yang K, Cui J, Ye JY, Deng CX. Controlled permeation of cell membrane by single bubble acoustic cavitation. J Control Release. 2012; 157(1): 103-11

14 . Royo de la Torre J, Moreno-Moraga J, Muñoz E, Cornejo Navarro P.Multisource, Phase-controlled Radiofrequency for Treatment of Skin Laxity: Correlation Between Clinical and In-vivo Confocal Microscopy Results and Real-Time Thermal Changes. J Clin Aesthet Dermatol. 2011;4(1):28-35

15 . Mlosek RK, Wozniak W, Malinowska S, Lewandowski M, Nowicki A. The effectiveness of anticellulite treatment using tripolar radiofrequency monitored by classic and high-frequency ultrasound. J Eur Acad Dermatol Venereol. 2012;26(6):696-703

16 . Lee SY, You CE, Park MY. Blue and red light combination LED phototherapy for acne vulgaris in patients with skin phototype IV. Lasers Surg Med. 2007;39(2):180-8

17 . Weiss RA, McDaniel DH, Geronemus RG, Weiss MA, Beasley KL, Munavalli GM, et al. Clinical experience with light-emitting diode (LED) photomodulation. Dermatol Surg. 2005;31(9 Pt 2):1199-205

18 . Shack RB. Endermologie: taking a closer look. Aesthet Surg J. 2001;21(3):259-60

19 . Latrenta GS, Mick SL.Endermologie after external ultrasound-assisted lipoplasty (EUAL) versus EUAL alone. Aesthet Surg J. 2001;21(2):128-35