Resisting prescribing pressure for sildenafil

doi:10.1016/S0140-6736(07)60162-7

The Lancet

Volume 369, Issue 9559, 3–9 February 2007, Page 344

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The management of erectile dysfunction with placebo only: Does it work?
2009, Journal of Sexual Medicine
Citation Excerpt :
Although ED is associated to several organic disorders, mainly vascular risk factors (diabetes mellitus, obesity, atherosclerotic vascular disease, hyperlipidemia), all patients suffer at least some degree of stress that can affect their biopsychosocial support and could provide them with vulnerability to persuasion [12]. In the last decade, with the revolutionary discovery of effective pharmacotherapy for ED and in addition to an aggressive marketing, oral phosphodiesterase type‐5 inhibitor (iPDE5) has become one of the most common prescribed drugs for men [13,14]. Several randomized clinical trials (RCT) have reproduced the high efficacy of the oral iPDE5 in the management of ED in spite of the occurrence of placebo effect at a rate as high as 50% [15–18].
Randomized clinical trials (RCT) remain the gold standard in providing scientific evidence in medical practice in spite of the significant placebo effect in the treatment of several disorders. Although the first‐line therapy for erectile dysfunction (ED) is oral phosphodiesterase type‐5 inhibitor (iPDE5), the placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%.
To evaluate the role of therapeutic illusion in the oral treatment for ED.
A prospective, controlled, single‐blind, parallel‐group study was performed at single‐center. One hundred and twenty‐three patients with ED were randomly assigned into three groups and received different letters: Group 1 (G1) was informed to be receiving a substance for ED treatment; Group 2 (G2) was informed that they could be receiving an active drug or placebo; Group 3 (G3) was conscious to be using placebo. Starch capsules were dispensed to all patients. Median follow up was 12 weeks.
ED improvement was assessed after 8 weeks of the intervention by the erectile function domain of the International Index of Erectile Function (IIEF) and the Quality of Erection Questionnaire. ED severity was classified by the IIEF erectile function (IIEF‐EF) domain score into five categories: no ED (score of 26–30), mild (22–25), mild to moderate (17–21), moderate (11–16), and severe (6–10). Improvement in IIEF‐EF domain was considered as a change in category of severity.
ED severity improved in all three groups (G1 = 31.7%, P = 0.039; G2 = 36.8%, P = 0.028; G3 = 36.8%, P = 0.002) and no difference was found among groups (P = 0.857). Improvement of quality of erection score was only significant in G2 (P = 0.005) and G3 (P < 0.001).
Written‐suggested therapeutic illusion for patients with ED has no major influence in the outcomes. However, treatment of ED with oral placebo capsules demonstrates clinical effects, improving erectile function and quality of erection. de Araujo AC, da Silva FG, Salvi F, Awad MC, da Silva EA, and Damião R. The management of erectile dysfunction with placebo only: Does it work?

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EditorialResisting prescribing pressure for sildenafil

The management of erectile dysfunction with placebo only: Does it work?

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Resisting prescribing pressure for sildenafil