In clinical trials, it is standard practice to test the drug in question against a placebo. This is an inert liquid or substance, made to look exactly like the drug under test. In this way, the participants in the trial cannot know whether they are receiving the real drug or an ineffective treatment. The FDA judges whether to approve the given drug by looking at how many more people are helped by the drug. There’s just one problem. Many people react very favorably to placebos, particularly if administered in an impressive modern hospital. It all comes down to belief. If the doctor seems to believe in the treatment and the patient has faith in the doctor, there’s an amplification system. The stronger the belief the “substance” will be effective, the more likely it is to succeed.
In 1955, H.K. Beecher published formal research findings that placebos produced highly satisfactory results in about one-third of all cases. This remains the key work and, in a sense, it is confirmed by most clinical trials which always show a percentage of the participants taking the placebo report improvements. This makes it very difficult to decide whether the drug under test is actually having an effect in its own right or if the same placebo effect also helps some participants feel better no matter what they take or what treatment they receive. As against this, in 2001, Danish researchers reanalyzed the data from 114 clinical trials and found there was little evidence for the placebo effect in large-scale trials that lasted significant periods of time. The power of the mind to heal runs out over time. The best way round this problem is to have a third group of patients who receive no treatment at all. This will help establish what percentage of people get well on their own.
As an aside, a judge recently decided selling a device on the basis of the placebo effect was a fraud. The makers of the Q-Ray Ionized Bracelet were fined for fraud. Charging $200 for something the users could get by taking a sugar pill was considered dishonest. So, when we start talking about erectile dysfunction drugs, we must also be careful since many men have erection problems because of performance anxiety or depression lowering the libido - both of which might respond well to the placebo effect. When we say that Levitra is an effective drug that relieves problems of erectile dysfunction, we are actually saying that the scientific evidence shows this drug to be significantly more effective than the placebo. In other words, when you rule out the psychological effect, Levitra really does produce an erection when you find yourself in a sexually arousing situation. More importantly, it demonstrates this ability in situations where it’s very unlikely the mind would be able to overcome the problem, e.g. where the nerve endings have been damaged by diabetes or following surgery for prostate cancer. We can therefore be reasonably confident that this drug is going to have real benefits in more situations and over longer periods of time.