http://www.ncbi.nlm.nih.gov/pubmed/19093288

J Cosmet Laser Ther. 2008 Dec;10(4):202-9.

Reduction of subcutaneous fat and improvement in cellulite appearance by dual-wavelength, low-level laser energy combined with vacuum and massage.

Lach E.

Boston Surgical Group, Southborough, MA 01772, USA.

In this article, Elliot Lach MD presents the first publication of the clinical results achieved with the new SmoothShapes cellulite treatment device.  Note that Lach is the inventor of the technology and a shareholder in Eleme, the company which makes the device.

In this study of 102 female patients, one thigh was randomized to treatment with the SmoothShapes device and one thigh to massage-alone.  Patients received an average of 14.3 treatments over 4 to 6 weeks.  MRI measurements, thigh circumference measurements and photographs were taken of each patient.  A patient satisfaction questionnaire was completed at the end of the study.  In SmoothShapes treated legs, MRI showed an average decrease in fat thickness of 1.19cm2 from a baseline average of 136.57cm2, which is less than 1% change.  In the control legs, MRI showed an average increase in fat thickness of 3.82cm2 from a baseline average of 133.98 cm2, about a 2% change.  The thigh circumference measurements showed no significant difference between the two SmoothShapes treatment and the control.  While photographs were taken, no grading of the photographs for severity of cellulite was presented.

While the MRI results are statistically significant, a <1% decrease in fat thickness cannot be considered clinically significant.  The increased fat thickness in the massage-only group remains unexplained.  No covariance analysis of weight gain or reduction was provided.  While the title of the article refers to “improvement in cellulite,” no evidence of any improvement in the appearance of cellulite was presented.  While patient satisfaction was reported at 72.6%, a placebo effect cannot be ruled out.  Alternatively, a quantifiable evaluation of cellulite appearance should have been easy to perform, by asking the blinded patient and/or a blinded observer to identify the leg that was treated versus the leg receiving massage only (50% correct responses would result from chance, while 100% correct responses would indicate meaningful improvement in all cases).

In summary, this study failed to show clinically significant reductions in subcutaneous fat or body circumference, nor was improvement in cellulite appearance shown.  One is left to wonder whether the device has any effect at all.