Evaluation of a vasoactive substance, naftidrofuryl, during the rehabilitation phase after an ischaemic insult.

Sixty-one patients who were undergoing an 8-week course of physical rehabilitation, which started on average 30 days after a cerebrovascular accident, were entered into a controlled double-blind, randomized study of 600 mg naftidrofuryl daily against identical placebo. The following parameters were measured before, and at 4 and 8 weeks after onset of treatment: neurological examinations by a weighted-assessment system, walking ability, and independence in activities of daily living. At the same time, the degree of cerebral lesion and brain atrophy were evaluated by CT scan and the size of the EEG deformations were estimated. During the first 4 weeks of rehabilitation, the placebo patients showed a significant improvement in the neurological symptoms which did not continue during the second period of treatment. On the contrary, the naftidrofuryl patients showed a continuous improvement in the neurological impairment during the whole period of treatment. Thus, at the end of treatment, there was a statistical difference between both groups. An explorative analysis of the most frequent symptoms showed a significant improvement in the naftidrofuryl group in independence in activities of daily living, walking, bladder control and sensory syndrome, whilst the changes in the placebo group were not statistically significant. Another significant change under treatment with naftidrofuryl was found in EEG evaluation which, at the end of the treatment period, showed less moderate and severe pathological alterations. Thus the value of naftidrofuryl treatment in patients with cerebral vascular accidents may be explained by an activation of cerebral metabolism in partially damaged regions of the brain, leading to an improvement in learning ability. In this way the recovery process that occurs during rehabilitation may be accelerated.

RCT Entities:   Population Interventions Outcomes