Key result
Disclosing atenolol-induced erectile dysfunction increases its incidence tenfold versus blinded administration.
Why the study?
Does patient knowledge of beta-blocker side effects increase the reported incidence of erectile dysfunction in men with newly diagnosed cardiovascular disease?
RCT (n=96)
Blinded
Randomised
Does patient knowledge of beta-blocker side effects increase the reported incidence of erectile dysfunction in men with newly diagnosed cardiovascular disease?
Answers are grounded in this paper and cite their sources.
Patient knowledge and prejudice regarding beta-blocker side effects significantly increases the reported incidence of erectile dysfunction, demonstrating a strong nocebo effect.
AIMS: Patients with cardiovascular diseases frequently complain of erectile dysfunction especially when treated with beta-blockers. In order to assess whether the effect of beta-blockers on erectile dysfunction is in part related to patient knowledge of the drug side effects, 96 patients (all males, age 52+/-7 years) with newly diagnosed cardiovascular disease and not suffering from erectile dysfunction entered a two phase, single cross over study. METHODS AND RESULTS: During the first phase of the study patients received atenolol 50mg o.d. (A), 32 patients were blinded on the drug given (group A), 32 were informed on the drug given but not on its side effects (group B) and 32 took A after being informed on its side effects on erectile function (group C). After 3 months the incidence of erectile dysfunction was 3.1% in the group A, 15.6% in group B and 31.2% in group C (P<0.01). All patients reporting ED entered the second phase of the study and were randomised to receive Sildenafil 50mg and placebo in a cross over study. Sildenafil citrate and placebo were equally effective in reversing erectile dysfunction in all but one patient reporting ED with Atenolol. CONCLUSION: Our results show that the knowledge and prejudice about side effects of beta-blockers can produce anxiety, that may cause erectile function.
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Antonello Silvestri (2003) conducted an RCT in Cardiovascular disease (n=96). Atenolol with information on side effects vs. Atenolol blinded to drug or informed of drug without side effect information was evaluated on Incidence of erectile dysfunction (p=<0.01). Informing patients about the erectile dysfunction side effects of atenolol increased its incidence to 31.2%, compared to 3.1% in patients blinded to the drug (P<0.01).
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