Objective: To assess the effectiveness of low-level laser therapy (LLLT) for reducing hip, thigh, and abdomen circumference of individuals with body-mass index (BMI) between 30 and 40 kg/m2.
Background: Previous studies demonstrated the effectiveness of LLLT for reducing body circumference in the hips, thighs, and abdomen of nonobese individuals with a BMI <30 kg/m2.
Methods: In this randomized, double-blind sham-controlled study, obese, but otherwise healthy, individuals were randomized to undergo 30-min LLLT (n = 28) or sham treatments (n = 25) three times weekly for 4 weeks. Body measurements were obtained after 2 and 4 weeks of treatment and 2 weeks post-treatment ( ClinicalTrials.gov Identifier: NCT01821352).
Results: After 4 weeks, 20 LLLT-treated subjects (71.43%) achieved ≥7.2 cm decrease in combined measurements versus three sham-treated subjects (12%; p < 0.00005). The mean (standard deviation) decrease in combined measurement for LLLT-treated subjects was 10.52 (7.59) cm (p < 0.0001 vs. baseline) versus 1.80 (3.20) cm for sham-treated subjects. Among subjects with a combined ≥7.2 cm decrease, the mean total decrease 2 weeks post-treatment was 15.21 cm. There were no adverse events.
Conclusions: Based on these results, the device was cleared by the U.S. Food and Drug Administration as a noninvasive esthetic treatment for reduction of circumference of hips, waist, and upper abdomen when applied to individuals with a BMI between 30 and 40 kg/m2.
Keywords: body sculpting; circumference reduction; clinical trial; low-level laser therapy; obesity.