Fenoverine: a two-step, double-blind and open clinical assessments of its smooth muscle synchronizing effects.

Abstract

A clinical trial on fenoverine was performed in two parts, one double-blind and one open. In the double-blind segment, 69 patients with chronic gastro-intestinal spasmodic conditions were allocated, according to a pre-set randomization table, to receive orally 3 daily doses of fenoverine (100 mg; 35 patients), trimebutine (150 mg; 14 patients) or placebo (20 patients) during an average of 8 days. In the open assay, 60 similar patients were treated during an average of 10 days with 100 mg fenoverine, orally, 3-times daily. Clinical efficacy was evaluated on the grounds of complete or almost complete remission of all symptoms and signs associated with the spasmodic condition. In the double-blind segment, 66% of patients given fenoverine experienced remission, a significantly higher proportion than those who had placebo (40%). The results with trimebutine (71%) could not be statistically differentiated from those of either fenoverine or placebo. In the open segment, 72% of patients experienced remission with fenoverine, thus showing an overall effectiveness in 70% of the total 95 patients who had such treatment. In neither study could a significant influence of spasm localization be shown on the clinical efficacy of fenoverine. Fenoverine also exerted an unexpected, though clinically interesting, anti-emetic action: of the 14 patients reporting vomiting on entry, 12 (86%) responded positively to fenoverine, whereas none responded out of the 3 who had placebo. Possible side-reactions were limited with fenoverine: there were only 17 (18%) complaints, mainly dry mouth, of which 6 were very mild.(ABSTRACT TRUNCATED AT 250 WORDS)