Dr. Levine correctly acknowledges that placebo-controlled blinded trials are the epitome of high-quality evidence-based studies. However, one must take exception with his point that the treatment of Peyronie's disease is somehow unique in the field of medicine where adequate trials are not able to be performed because of a laundry list of limitations. The finding of Hellstrom et al. on the use of interferon in Peyronie's disease is a prime example of a high-quality report in the treatment of this disease[1]. Additionally, Dr. Levine incorrectly states that trial assessment of Peyronie's disease is significantly restricted by the fact that patients are reluctant to enter into invasive placebo-controlled trials; there are other clinical trial avenues to explore concerning the role of intralesional injection therapy. Obviously, placebo-controlled trials are preferred, but alternatives exist, for example, a two-armed parallel study using two different active treatments (ie, drug A vs. drug B). Also, a two-armed parallel study using two different concentrations of the same drug is an excellent means of testing drugs in a clinical setting where a placebo is not available or acceptable. Either of these options is preferred over invoking the crutch of “substantial limitations” to adequate trial designs when discussing intralesional injection therapy. Dr. Levine's suggestion that so-called quasi-experimental designs can substitute for more robust controlled trials is in error. By no means is this an acceptable method in intralesional injections, nor in other treatment methods. In fact, the level 4 studies would remain level 4 studies, quasi or not.

Whether or not a hard look at the realistic status of injection therapy is beneficial to practicing urologists or not is a legitimate question. It is a reasonable approach for urologists to make their patients aware of the severe limitations of intralesional injection therapy data. Doing so allows for an ethical and informed consent for intervention. In that light, this publication says in spades that the data really are tenuous. To do anything less is not in our patients’ best interest.

I agree that a quest for an effective nonsurgical treatment for Peyronie's disease is needed. The power of this manuscript demonstrates the current treatments for intralesional therapy are deficient with one exception (α-interferon). The most difficult and most important thing for those who promote intralesional injection therapy is to look at the blemishes that are the current reality. Continuing to promote these treatments without a concerted effort for better science is not in the best interest of the patients nor the field of urology.

Reference

1. Hellstrom WJ, Kendirci M, Matern R, et al.. Single-blind, multicenter, placebo-controlled, parallel study to assess the safety and efficacy of intralesional interferon alpha-2B for minimally invasive treatment for Peyronie's disease. J Urol. 2006;176:394–398

Kevin T. McVary

Department of Urology, Feinberg School of Medicine, Northwestern University, Tarry 16-749, 303 E. Chicago Ave., Chicago, IL 60611, United States

published online 7 November 2006.

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