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A Randomized Controlled Trial

Katherine Esposito, MD; Francesco Giugliano, MD; Carmen Di Palo, MD; Giovanni Giugliano, MD; Raffaele Marfella, MD, PhD; Francesco D'Andrea, MD; Massimo D'Armiento, MD; Dario Giugliano, MD, PhD

JAMA. 2004;291:2978-2984.

Context  Healthy lifestyle factors are associated with maintenance of erectile function in men.

Objective  To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men.

Design, Setting, and Patients  Randomized, single-blind trial of 110 obese men (body mass index 30) aged 35 to 55 years, without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF). The study was conducted from October 2000 to October 2003 at a university hospital in Italy.

Interventions  The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.

Main Outcomes Measures  Erectile function score, levels of cholesterol and tryglycerides, circulating levels of interleukin 6, interleukin 8, and C-reactive protein, and endothelial function as assessed by vascular responses to L-arginine.

Results  After 2 years, body mass index decreased more in the intervention group (from a mean [SD] of 36.9 [2.5] to 31.2 [2.1]) than in the control group (from 36.4 [2.3] to 35.7 [2.5]) (P<.001), as did serum concentrations of interleukin 6 (P = .03), and C-reactive protein (P = .02). The mean (SD) level of physical activity increased more in the intervention group (from 48 [10] to 195 [36] min/wk; P<.001) than in the control group (from 51 [9] to 84 [28] min/wk; P<.001). The mean (SD) IIEF score improved in the intervention group (from 13.9 [4.0] to 17 [5]; P<.001), but remained stable in the control group (from 13.5 [4.0] to 13.6 [4.1]; P = .89). Seventeen men in the intervention group and 3 in the control group (P = .001) reported an IIEF score of 22 or higher. In multivariate analyses, changes in body mass index (P = .02), physical activity (P = .02), and C-reactive protein (P = .03) were independently associated with changes in IIEF score.

Conclusion  Lifestyle changes are associated with improvement in sexual function in about one third of obese men with erectile dysfunction at baseline.

Author Affiliations: Center for Obesity Management (Drs Esposito and Di Palo), Division of Metabolic Diseases (Drs D. Giugliano and Marfella), Departments of Urology (Drs F. Giugliano and D'Armiento), and Plastic and Reconstructive Surgery (Drs G. Giugliano and D'Andrea), and Center of Excellence in Cardiology (Drs Esposito, Marfella, and D. Giugliano), Second University of Naples, Naples, Italy.

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