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A recent study looks at the safety and efficacy of HIFEM and RF combination therapy for fat reduction.
A study published in the Journal of Cosmetic Dermatology recently investigated the structural changes in the subcutaneous tissued brought on by the mixture of radiofrequency (RF) treatment and high intensity focused electromagnetic technology (HIFEM).1
Noninvasive fat tissue reduction is energy dependent and can be achieved in 2 ways: reducing the fat stores or permanently removing adipocytes. These different methods of thermal—RF—and nonthermal—HIFEM—body contouring technologies allow for its combined use.
The prospective single center study’s criteria included a BMI greater of 35.0 kg/m2, with none of the following: pregnancy or breast feeding, injury in the treated area, active participation in any other concurrent therapy, and general contraindications for HIFEM and RF application to the patient.
In total, 5 patients were enrolled, 4 were assigned for active treatments and had a mean of 51.50 ± 6.35 years and a mean BMI of 22.59 ± 3.21 kg/m2. The fifth patient was a control, with an age of 57 years and BMI of 23.60 kg/m2.
Each participant received three 30-minuted abdominal treatments once per week with a device that simultaneously delivered synchronized RF and HIFEM energies (Emsulpt NEO; BTL Industries Inc).
“Based on the patient's physical constitution, [1 or 2] applicators were placed over the treated area and affixed by an elastic fixation belt,” wrote study investigators.
The output power of RF was set to 100% in the active treatments and 5% for sham treatments. The intensity of HIFEM (0%‐100%) in the active group was adjusted according to patient feedback, ending with a maximum tolerable level for the patient. HIFEM intensity in sham treatments was again set to 5%.1
Punch biopsies of adipose tissue were obtained from each patient at baseline, 1 week post treatment, and at the 1-month follow up. Each sample was 4 mm in diameter and 3 samples were collected from each subject, totaling 15 samples. These samples were analyzed by a histopathologist via light microscope (Leica DM1000; Leica Microsystems) and evaluated for the structural changes of fat tissue.
The secondary outcome for the study included documentation of the treatment area by digital photographs, waist circumference, weight measurements, 5‐point Likert scale satisfaction questionnaire, and 10‐point visual analog scale (VAS) therapy comfort questionnaire assessed at baseline, 1 week post procedure, and 1 month follow‐up.
There were no adverse events (AEs) reported during the study and all patients finished treatment. Transient muscle soreness, typically occurring the day after therapy, and erythema that resolved within a few hours were the only document side effects. On a scale of 0 to 10, 0 being no discomfort and 10 being unbearable discomfort, the average score was 0.83.
Histological examination of baseline and control samples revealed healthy round and polygonal shaped unilocular cells. In comparison, the treated samples taken at Week 1 showed visible alternations of the fat cell shape and occasional fat ruptures.
“The evidence of ongoing programmed cell death processed was documented by the presence of pyknotic nuclei manifested by hypercondensation of chromatin and destructive fragmentation of the nucleus,” according to the study investigators.
These findings persisted up to Month 1 and no such changes were found after the administration of sham treatment.
At baseline, both groups showed similar values in adipocyte size, however, post treatment samples showed a significant reduction in size. At Week 1, there was a 33.5% reduction for the treatment group which was sustained at 31.7% during the 1 month follow up.
Additionally, the effective temperature needed to induce structural changes in adipose tissue—43‐45°C—was held during the majority of the treatment time.
Weight fluctuations in the active group were insignificant with −0.2 kg at 1 week and −0.3 kg at 1 month. There was a visible improvement of the abdominal body contour. The average waist circumference reduction in the active cohort was -2.20 cm to -5.4 cm. The control subject did not show improvement. Patients who received therapy with the maximum intensities agreed (4) or strongly agreed (5) with the statement that the appearance of their abdominal area had improved.
The results suggest the efficacy and safety of RF and HIFEM combination therapy. Future research is needed to look at programmed cell death markers for adipocytes and also determine the duration of induced changes in a broader patient sample.
“The results indicate that the simultaneous treatment triggers lipolysis along with fat cell elimination,” study investigators wrote. “The reduced adipocyte size is strong evidence for lipolysis as the adipocytes lose their intracellular content due to the breakdown of triglycerides into glycerol and FFA, which are subsequently liberated into the blood stream.”
1. Goldberg DJ. Deletion of adipocytes induced by a novel device simultaneously delivering Synchronized radiofrequency and HIFEM: Human histological study. Journal of Cosmetic Dermatology. 2021;20(4):1104-1109. doi:https://doi.org/10.1111/jocd.13970