Double-blind study with Serocytol^® “Muqueuse urinaire” and “S.R.E.” in patients with urological disorders

Abstract

A double-blind study with Serocytol^® “Muqueuse urinaire” (immune serum against mucosa of the urinary tract) and Serocytol “S.R.E.” (immune serum against reticulo-endothelial system) and placebo was designed for treatment of different bladder diseases (interstitial cystitissui generis, after radiotherapy and in connection with multiple transurethral resections of bladder tumour, cystitis granularis). Twenty-four patients (17 women and 5 men, aged 41–75, with interstitial cystitis, and 2 women, aged 42 and 75, with cystitis granularis) were included in this study. According to the procedure and after breaking the code 13 patients were treated with Serocytol^® and 11 patients with the placebo.

Nine out of 13 patients who were treated with Serocytol^® showed an improvement of their condition. In 1 patient the condition was unchanged. Three patients treated with the active compound dropped out of the study during the treatment phase. In one instance the patient did not appear for further check-up; in another the therapy was discontinued after 3 weeks, and in one case a general exanthema occurred. Of the 11 patients treated with placebo, there was an improvement in 2 patients whereas in 9 cases their status was unchanged.

Serocytol^® and placebo were well tolerated by most of the patients. There were no side effects resulting from the almost daily suppository application over a period of 2 months. No changes in the blood counts, electrolytes, liver and renal function could be found in any of these patients.