[Comparative double-blind study of the effectiveness and tolerance of baclofen, tetrazepam and tizanidine in spastic movement disorders of the lower extremities].

In a double-blind comparative study, the therapeutic efficacy and safety of three centrally effective antispasmodics (Tetrazepam, Baclofen and Tizanidine) in patients suffering from multiple sclerosis with spastic motor disturbances of the lower extremities was to be examined. 47 patients of either sex at the age of 23 until 63 were allocated to one of the three therapies by means of minimization. The duration of treatment was limited to 35 days at a maximum. The dosage was optimized corresponding to the clinical symptoms. The antispasmodic efficacy and safety of the above-mentioned substances was investigated with well-established parameters and methods. The typical laboratory parameters were determined at the beginning and at the end of the study. -With reference to cloni, spasms and the muscular tonus, no systematic differences were found between the treatment groups. A previously existing clonus could not be altered decisively by the administration of the three antispasmodics, whereas the muscular tonus could comparably be decreased with all therapeutic measures. Statistically significant differences between the treatment groups were not observed. The patients of all three groups recorded a subjective sensation of relief with reference to the symptoms of spasms by the medication. As to the residual urinary volume, no relevant differences and alterations were determinated in the course of the treatment as well. With reference to undesired side effects quantitative and qualitative differences could be established, in which Tetrazepam showed the most favourable benefit/risk ratio.

RCT Entities:   Population Interventions Outcomes