BACKGROUND AND OBJECTIVES:Low-level laser therapy (LLLT) has been shown to induce cellular reactions in nonphotosynthetic cells however skepticism remains regarding efficacy at the clinical level. The purpose of this study was to evaluate the efficacy of LLLT independent of liposuction. Additionally, a weight loss supplement (Curva™, Santa Barbra Medical Innovations, Santa Barbra, CA) was evaluated. This clinical trial evaluates the effectiveness of the Erchonia EML Laser (Zerona™ System, Santa Barbra Medical Innovations) for non-invasive fat reduction and body contouring in a split-body clinical evaluation. MATERIALS AND METHODS:Five subjects were enrolled and completed the study. Subjects had a body mass index (BMI) of less than or equal to 29 kg/m(2) and satisfied the set inclusion criteria. Participants were randomly assigned to receive low-level laser treatments on one side of the body three times per week for 2 weeks. One group took the weight loss supplement and was also treated with the laser. Subject satisfaction questionnaires, physician blinded photo evaluation, circumference measurements and ultrasound measurements were utilized to evaluate efficacy. RESULTS:Circumference measurements revealed no statistically significant reduction at either 7 days or 1 month post-treatment. One month following treatment the greatest circumference reduction overall was 0.5 ± 0.3 inches. Ultrasound measurements also did not reveal statistically significant reduction in fat layer thickness (P > 0.5). Evaluation by three blinded dermatologists resulted in average correct photo identification of 51.1%. Results reflect little clinical difference between post-treatment and baseline images. Three subjects recording a "dissatisfied" rating on satisfaction questionnaires and all subjects reported the effects of the treatment were less than expected. Subjects who took the weight loss supplement had no greater circumference reduction or identifiable clinical outcome. CONCLUSIONS: This small study demonstrates to the authors that there needs to be more evidence to show clinical circumferential reduction before LLLT can be recommended as an effective therapeutic option.
RCT Entities:
BACKGROUND AND OBJECTIVES: Low-level laser therapy (LLLT) has been shown to induce cellular reactions in nonphotosynthetic cells however skepticism remains regarding efficacy at the clinical level. The purpose of this study was to evaluate the efficacy of LLLT independent of liposuction. Additionally, a weight loss supplement (Curva™, Santa Barbra Medical Innovations, Santa Barbra, CA) was evaluated. This clinical trial evaluates the effectiveness of the Erchonia EML Laser (Zerona™ System, Santa Barbra Medical Innovations) for non-invasive fat reduction and body contouring in a split-body clinical evaluation. MATERIALS AND METHODS: Five subjects were enrolled and completed the study. Subjects had a body mass index (BMI) of less than or equal to 29 kg/m(2) and satisfied the set inclusion criteria. Participants were randomly assigned to receive low-level laser treatments on one side of the body three times per week for 2 weeks. One group took the weight loss supplement and was also treated with the laser. Subject satisfaction questionnaires, physician blinded photo evaluation, circumference measurements and ultrasound measurements were utilized to evaluate efficacy. RESULTS: Circumference measurements revealed no statistically significant reduction at either 7 days or 1 month post-treatment. One month following treatment the greatest circumference reduction overall was 0.5 ± 0.3 inches. Ultrasound measurements also did not reveal statistically significant reduction in fat layer thickness (P > 0.5). Evaluation by three blinded dermatologists resulted in average correct photo identification of 51.1%. Results reflect little clinical difference between post-treatment and baseline images. Three subjects recording a "dissatisfied" rating on satisfaction questionnaires and all subjects reported the effects of the treatment were less than expected. Subjects who took the weight loss supplement had no greater circumference reduction or identifiable clinical outcome. CONCLUSIONS: This small study demonstrates to the authors that there needs to be more evidence to show clinical circumferential reduction before LLLT can be recommended as an effective therapeutic option.