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      A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss

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          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.

          Conclusion

          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 Registry Information

          Trial registration: NCT02129608. Registered June 15, 2014.

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          Most cited references32

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          Systematic reviews in health care: Assessing the quality of controlled clinical trials.

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            Multicenter, placebo-controlled trial of lorcaserin for weight management.

            Lorcaserin is a selective serotonin 2C receptor agonist that could be useful in reducing body weight. In this double-blind clinical trial, we randomly assigned 3182 obese or overweight adults (mean body-mass index [the weight in kilograms divided by the square of the height in meters] of 36.2) to receive lorcaserin at a dose of 10 mg, or placebo, twice daily for 52 weeks. All patients also underwent diet and exercise counseling. At week 52, patients in the placebo group continued to receive placebo but patients in the lorcaserin group were randomly reassigned to receive either placebo or lorcaserin. Primary outcomes were weight loss at 1 year and maintenance of weight loss at 2 years. Serial echocardiography was used to identify patients in whom valvulopathy (as defined by the Food and Drug Administration) developed. At 1 year, 55.4% of patients (883 of 1595) receiving lorcaserin and 45.1% of patients (716 of 1587) receiving placebo remained in the trial; 1553 patients continued into year 2. At 1 year, 47.5% of patients in the lorcaserin group and 20.3% in the placebo group had lost 5% or more of their body weight (P<0.001), corresponding to an average loss of 5.8+/-0.2 kg with lorcaserin and 2.2+/-0.1 kg with placebo during year 1 (P<0.001). Among the patients who received lorcaserin during year 1 and who had lost 5% or more of their baseline weight at 1 year, the loss was maintained in more patients who continued to receive lorcaserin during year 2 (67.9%) than in patients who received placebo during year 2 (50.3%, P<0.001). Among 2472 patients evaluated at 1 year and 1127 evaluated at 2 years, the rate of cardiac valvulopathy was not increased with the use of lorcaserin. Among the most frequent adverse events reported with lorcaserin were headache, dizziness, and nausea. The rates of serious adverse events in the two groups were similar. In conjunction with behavioral modification, lorcaserin was associated with significant weight loss and improved maintenance of weight loss, as compared with placebo. (Funded by Arena Pharmaceuticals; ClinicalTrials.gov number, NCT00395135.) 2010 Massachusetts Medical Society
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              A prospective study of obesity and risk of coronary heart disease in women.

              We examined the incidence of nonfatal and fatal coronary heart disease in relation to obesity in a prospective cohort study of 115,886 U.S. women who were 30 to 55 years of age in 1976 and free of diagnosed coronary disease, stroke, and cancer. During eight years of follow-up (775,430 person-years), we identified 605 first coronary events, including 306 nonfatal myocardial infarctions, 83 deaths due to coronary heart disease, and 216 cases of confirmed angina pectoris. A higher Quetelet index (weight in kilograms divided by the square of the height in meters) was positively associated with the occurrence of each category of coronary heart disease. For increasing levels of current Quetelet index (less than 21, 21 to less than 23, 23 to less than 25, 25 to less than 29, and greater than or equal to 29), the relative risks of nonfatal myocardial infarction and fatal coronary heart disease combined, as adjusted for age and cigarette smoking, were 1.0, 1.3, 1.3, 1.8, and 3.3 (Mantel-extension chi for trend = 7.29; P less than 0.00001). As expected, control for a history of hypertension, diabetes mellitus, and hypercholesterolemia--conditions known to be biologic effects of obesity--attenuated the strength of the association. The current Quetelet index was a more important determinant of coronary risk than that at the age of 18; an intervening weight gain increased risk substantially. These prospective data emphasize the importance of obesity as a determinant of coronary heart disease in women. After control for cigarette smoking, which is essential to assess the true effects of obesity, even mild-to-moderate overweight increased the risk of coronary disease in middle-aged women.
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                Author and article information

                Contributors
                1-507-266-1944 , croghan.ivana@mayo.edu
                ebbert.jon@mayo.edu
                schroedd@mayo.edu
                hurt.ryan@mayo.edu
                Drvicky911@gmail.com
                clark.matthew@mayo.edu
                Journal
                BMC Obes
                BMC Obes
                BMC obesity
                BioMed Central (London )
                2052-9538
                29 September 2016
                29 September 2016
                2016
                : 3
                : 42
                Affiliations
                [1 ]Department of Medicine, Clinical Research Office, Clinical Trials Unit, Nicotine Research Program, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA
                [2 ]Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA
                [3 ]Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA
                [4 ]Department of Medicine, Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA
                [5 ]A New Medspa Clinic, 3135 Superior Drive NW, Suite C, Rochester, MN 55901 USA
                [6 ]Department of Psychiatry and Psychology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905 USA
                Article
                122
                10.1186/s40608-016-0122-4
                5043601
                27708788
                cf6ec40a-cc25-42bb-8731-d727c8183724
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 22 December 2015
                : 26 August 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000054, National Cancer Institute;
                Award ID: CA178927
                Funded by: FundRef http://dx.doi.org/10.13039/100006108, National Center for Advancing Translational Sciences;
                Award ID: TR000135
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2016

                central adiposity,lorcaserin,low-level laser therapy,obesity,overweight,weight loss

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