Effect of intralesional interferon-alpha 2b combined with oral vitamin E for treatment of early stage Peyronie's disease: a randomized and prospective study.

OBJECTIVES: To compare the efficacy and safety of intralesional interferon-alpha 2b combined with oral vitamin E or intralesional interferon-alpha 2b alone or oral vitamin E alone for the treatment of Peyronie's disease.

METHODS: From January 2000 to March 2002, a total of 30 consecutive men with Peyronie's disease were randomized prospectively into three different treatment groups. All the patients were assessed objectively with penile duplex Doppler ultrasonography for plaque size, location, and presence of calcification before and after treatment. Subjective data were obtained by querying about the improvement in penile pain and by using the "global efficacy question" for the assessment of the quality of sexual intercourse at the end of the study. A total of 5.0 x 10(6) U of interferon-alpha 2b was given once per week directly into the plaque for a period of 12 weeks. Patients received 400 IU of vitamin E orally twice daily for 6 months.

RESULTS: At the 6-month follow-up visit, we did not find any statistically significant changes in the objective parameters when compared with the initial findings in each group or among the three groups (P >0.05). We did not observe any clinically significant improvement in the subjective parameters among the three groups (P >0.05). However, all patients who were treated with interferon-alpha 2b experienced brief flu-like side effects.

CONCLUSIONS: Our findings indicate that 5 million units of intralesional interferon-alpha 2b injection therapy either alone or in combination with vitamin E does not appear to be clinically effective in the management of early stage Peyronie's disease compared with only oral vitamin E.