WHILE there is a good deal of international agreement that Valium has a quietening effect on spinal cord spasticity (Neill, 1964;Cibeira et al., 1964;Kerr, 1966; Wilson & McKechnie, 1966; Cook & Nathan, 1967;Couvee et al., 1968;Wilson, 1970;Nathan, 1970), it is still not clear how much of this effect is due to (I) suggestion, (2) sedation, (3) action on the spinal cord.In this trial we have attempted to test (I) by Placebo, (2) by comparison with a known sedative, Amy tal, and (3) by exclusion or separation of (I) and (2).
MATERIAL AND METHODSA homogeneous group of patients was tested. All had traumatic lesions of the spinal cord and were four months or more after injury. They were divided into two sub-groups, physiologically complete and incomplete lesions. All had degrees of spasticity varying from the inconvenient to the disabling. All patients were volunteers who had been informed of the purpose of the trial. In order to minimise observer error or bias, assessment of the effect of treatment was made by six observers who each kept a protocol. This was later correlated and submitted for statistical analysis. Sheets for the protocol were distributed to the senior doctor, the patient, a senior physiotherapist-who did not treat the patient-a physio therapist who did, and the junior doctor and ward sister in charge of the patient. All made daily entries on their respective sheets ( -worse, 0 no effect, + better, and + + much better) except the senior doctor and senior physiotherapist who examined the patient once or twice a week. In spite of repeated attempts at obtaining daily entries, lapses of co-operation and changes of staff through illness or holidays left a number of gaps in the evidence collected. They were, however, not sufficiently serious to render the trial useless.For each patient the trial took altogether six weeks, subdivided into three periods of a fortnight each. After three days without any drugs, each patient was given one tablet on the first day, one b.d. on the second day, one t.d.s. on each of the next three days. For the following three days he was given two tablets t.d.s. and for the last three days, three tablets t.d.s.The tablets for each fortnightly period were taken from three identical bottles containing tablets of identical appearance. Placebo, Amy tal 30 mg., and Valium 5 mg. were randomly distributed into bottles I, II and III, none of the participants knowing which contained which. The key was held by the manufacturer's labora tory. A copy was kept in a sealed envelope in the department in case of emergency.The reason for this gradual increase in dosage was that experience had shown very varied responses to Valium in different patients, drowsiness in particular being
