—Dr. Trost Commentary and Key Take Home Points—
This current study evaluates the use of two different injection treatments for men with early phase Peyronie’s Disease. This study was performed by an experienced group of researchers in Italy. This is important to recognize though, as the gold-standard injection treatment (Xiaflex) is more difficult to use in Europe because it is often not covered by insurance (and therefore patients need to pay out of pocket for the treatment). Because of this, some groups are looking at alternative treatments such as hyaluronic acid or verapamil.
The current study had several important limitations. The first is that there was not a control group. For “acute phase” studies, a control group is mandatory, since the disease will fluctuate quite a bit without any treatment in this early time period. The other main limitation is that hyaluronic acid was compared against verapamil. The issue with verapamil is that it is considered the least effective of the main 3 injectables (Xiaflex, interferon, verapamil; hyaluronic acid is also used – more common outside the US), and in the only randomized controlled study performed of verapamil, it failed to do any better statistically than placebo. So, this is a major limitation. The outcomes also only showed a roughly 10 and 5 degree difference in curvature, which was similar to the rate of improvement in placebo in the original Xiaflex studies (which were the largest and best performed studies of injectable therapies to date). So, my conclusion is that hyaluronic acid would require more study (including a placebo arm) before being considered as a viable therapy for PD.
- A total of 244 patients were included and treated with either intralesional hyaluronic acid (125 men) or verapamil (119 men).
- Median curvature of the participants was 35 degrees.
- Patients were treated with one injection weekly for 8 weeks in total
- Final assessments were performed after 3 months
- Curvature decreased by 9.5 degrees in the hyaluronic acid group
- Curvature decreased by 4.5 degrees in the verapamil group
- The authors concluded that hyaluronic acid represents a viable treatment option – however we would disagree slightly and would suggest that it’s too preliminary to suggest that this represents a viable option without a study that includes a viable control group and compares outcomes directly between groups.