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    • Viagra or Placebo: Surprising Results From a New Study

      It's been known for years that PDE5 inhibitors, Viagra, Cialis, Levitra, improve erectile function in men. However, a surprising number of men in a double-blind, controlled study of sildenafil (Viagra) responded well - better than expected - to placebo as opposed to the active drug. These men reported improved erectile function as measured by International Index of Erectile Function (IIEF)–Erectile Function Domain (EFD) scores.



      Methods


      Placebo-treated participants in the intent-to-treat population of 42 double-blind, placebo-controlled, flexible-dose, sildenafil studies were included. A participant was classified as a placebo responder if the International Index of Erectile Function-EFD score was ≥26 at the last visit.


      Outcomes

      Variables assessed were:

      • age (<45, 45–64, ≥65 years),
      • race,
      • body mass index,
      • co-morbidities (cardiovascular disease/hypertension, diabetes mellitus, depression),
      • date the last study dose was taken,
      • study completion date,
      • ED etiology (psychogenic, organic, mixed),
      • history of cigarette smoking,
      • ED duration, baseline IIEF-EFD score (≤10, 11–16, ≥17),
      • and treatment duration.



      Results


      • A total of 4,360 men were included; 13.5% were responders.
      • Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds = 20.2, P < .0001), were younger than 45 years (odds = 7.3, P < .0001), had mild ED (baseline IIEF-EFD ≥17; odds >100, P < .0001), and did not have diabetes (odds = 4.5, P < .0001).
      • The likelihood of a placebo response decreased as ED duration increased (odds = 0.74, P < .0001).
      • The frequency of common adverse events was similar between placebo responders and non-responders.



      Conclusions


      Certain demographics, co-morbidities, and condition characteristics predicted the odds of a placebo response in sildenafil clinical studies of ED. Underlying reasons behind a placebo response warrant further evaluation. The strong role psychological factors play in ED presentation, even in cases with an underlying organic foundation, can not be overlooked.

      "Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo," Journal of Sexual Medicine, In press, May 2018, https://www.jsm.jsexmed.org/action/s...xm.2018.03.089

      This article was originally published in forum thread: Viagra or Placebo: Surprising Results From a New Study
      Comments 4 Comments
      1. Vince Carter's Avatar
        Vince Carter -
        Having experienced that there's a real part of ED that can be in your head, reliance on the drugs, etc etc
      1. Will Brink's Avatar
        Will Brink -
        Does not surprise me at all. Vast majority of ED is psychogenic in nature in my view.
      1. FeelingLost's Avatar
        FeelingLost -
        I would have not done well in that test. Suffering from the side effects from low dose Cialis (stuffy nose and chronic lower back pain)
        I have tested the big three over the last 3 months and tried to find just how low a dose I could use.
        My findings suck for me. If I want a stiffy once or twice a week I must suffer with lower back pain 24/7 Nose spray keeps the stuffy nose away.
        Nothing has worked on the lower back pain other than stop taking it.
      1. nestol's Avatar
        nestol -
        wow but i do know that some ED is psychological. i mean guys married to ugly woman who wouldn't have ED? lol
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