MANAGEMENT OF ERECTILE DYSFUNCTION WITH PLACEBO ONLY: DOES IT WORK?
Araújo, AC(1); Silva, FG(1); Salvi, F(1); Awad, MC(1); da Silva, EA(1); Vasconcelos, JSP(1); Schiavini, JL(1); Damião, R(1)
(1)Service of Urology. Rio de Janeiro State University. Rio de Janeiro. Brazil.
INTRODUCTION: Placebo controlled randomized clinical trials (RCT) provide the best scientific evidence to medical practice. Several RCT assessed safety and efficacy of phosphodiesterase type 5 inhibitors for erectile dysfunction (ED) and placebo effect (PE) was found to be greater than 30%. We aimed to evaluate the management of ED with placebo only.
MATERIAL AND METHOD: A prospective, controlled, researcher-blind, one-center study was performed. After randomization, 107 patients diagnosed with ED were distributed into 3 groups according to different written information about treatment: G1 was informed to be receiving a substance for ED treatment; G2, an active drug or placebo; G3 was conscious to be using placebo only. All patients received 250 mg starch placebo capsules, on demand for 4 weeks. The efficacy variable was assessed by IIEF, SEAR, QEQ, EDITS and GEAQ questionnaires.
RESULTS: All three groups presented significant improvement of erectile function (G1 32.4%, p=0.022; G2 30.5%, p=0.004; G3 38.2%, p=0.023) as well as intercourse satisfaction (G1 p<0.001; G2 p<0.001; G3 p=0.003). Although group 1 presented significant improvement in the sexual desire domain (p=0.039), this had no impact on overall satisfaction (p=0.132). Self-esteem and overall relationship domains had no improvement in all groups. The quality of erection significantly improved in all groups (G1 p=0.018; G2 p=0.003; G3 p<0.001). Efficacy and satisfaction with therapy presented no significant between-group difference. The mean satisfaction with treatment was greater than 50% in all groups. Erection improvement was reported in 37.8%, 22.2% and 44.1% by groups 1, 2 and 3, respectively.
CONCLUSIONS: Placebo treatment has clinical effects on ED. Medical persuasion for ED therapy has no influence in erectile function, intercourse satisfaction, quality of erection, treatment satisfaction and efficacy. Although medical persuasion seems to improve sexual desire, overall satisfaction is not affected.
