title: A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss.
abstract: BACKGROUND
  Obesity is a significant public health problem and innovative treatments are needed. The purpose of this pilot study was to assess the preliminary efficacy and safety of a combined treatment of low-level laser therapy (LLLT) and lorcaserin on weight loss, health quality of life (QOL) measures, and cardiovascular risk factors.
  
  
  METHODS
  Forty-five overweight and obese adult participants with a body mass index (BMI) >26.9 and <40 were randomized to receive LLLT, lorcaserin, or a combination of the two therapies. All study participants received treatment for 3 months and were followed for 3 months post-treatment. Participants were recruited from June 2014 through September 2014.
  
  
  RESULTS
  The majority of the 44 participants accrued to this study were female (84 %) with an average age of 43.9 years (range 22 to 64 years). Most participants (93 % LLLT alone, 87 % LLLT + lorcaserin) completed at least 80 % of the LLLT treatments. From baseline to end of treatment, significant reductions in waist circumference were noted for each treatment group (-2.3 ± 4.1 cm, -6.0 ± 7.3 cm, and -4.0 ± 5.5 cm for LLLT, lorcaserin and combination respectively); however, the reduction in body weight was only significant in those receiving lorcaserin and combination treatment (-0.4 ± 1.5 kg, -1.3 ± 1.2 kg and -1.3 ± 1.3 kg). No significant differences were noted between the groups. Self-reported satisfaction was higher in the lorcaserin versus the LLLT group.
  
  
  CONCLUSIONS
  This small pilot demonstrates that when combined with behavioral intervention, Lorcaserin and LLLT may be effective components of a comprehensive approach to the treatment of overweight and obesity in the clinical setting. Further studies with larger sample size and longer duration of treatment and follow-up are needed to further address efficacy.
  Trial registration: NCT02129608. Registered June 15, 2014.
authors.affiliation: Department of Medicine, Clinical Research Office, Clinical Trials Unit, Nicotine Research Program, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA.
authors.forename: Ivana T
authors.initials: IT
authors.lastname: Croghan
authors.affiliation: Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA.
authors.forename: Jon O
authors.initials: JO
authors.lastname: Ebbert
authors.affiliation: Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA.
authors.forename: Darrell R
authors.initials: DR
authors.lastname: Schroeder
authors.affiliation: Department of Medicine, Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA.
authors.forename: Ryan T
authors.initials: RT
authors.lastname: Hurt
authors.affiliation: A New Medspa Clinic, 3135 Superior Drive NW, Suite C, Rochester, MN 55901 USA.
authors.forename: Victoria
authors.initials: V
authors.lastname: Hagstrom
authors.affiliation: Department of Psychiatry and Psychology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA.
authors.forename: Matthew M
authors.initials: MM
authors.lastname: Clark
keywords: Central adiposity; Lorcaserin; Low-level laser therapy; Obesity; Overweight; Weight loss