A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis.

BACKGROUND: Muscle spasticity is common in multiple sclerosis (MS), occurring in more than 60% of patients. OBJECTIVE: To compare Sativex with placebo in relieving symptoms of spasticity due to MS. METHODS: A 15-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study in 337 subjects with MS spasticity not fully relieved with current anti-spasticity therapy. RESULTS: The primary endpoint was a spasticity 0-10 numeric rating scale (NRS). Intention-to-treat (ITT) analysis showed a non-significant improvement in NRS score, in favor of Sativex. The per protocol (PP) population (79% of subjects) change in NRS score and responder analyses (> or =30% improvement from baseline) were both significantly superior for Sativex, compared with placebo: -1.3 versus -0.8 points (change from baseline, p=0.035); and 36% versus 24% (responders, p=0.040). These were supported by the time to response (ITT: p=0.068; PP: p=0.025) analyses, carer global impression of change assessment (p=0.013) and timed 10-meter walk (p=0.042). Among the subjects who achieved a > or =30% response in spasticity with Sativex, 98, 94 and 73% reported improvements of 10, 20 and 30%, respectively, at least once during the first 4 weeks of treatment. Sativex was generally well tolerated, with most adverse events reported being mild-to-moderate in severity. DISCUSSION AND CONCLUSIONS: The 0-10 NRS and responder PP analyses demonstrated that Sativex treatment resulted in a significant reduction in treatment-resistant spasticity, in subjects with advanced MS and severe spasticity. The response observed within the first 4 weeks of treatment appears to be a useful aid to prediction of responder/non-responder status.

Analyses of prosthetic episodes in trans-tibial amputees.

The prosthetic episodes, i.e. actual processes of provision, identifying number of prostheses, their maintenance, repairs and replacements were analysed for 104 trans-tibial amputees aged 16 and over, over a 10 year period. The purpose of this investigation was to identify how frequently a new prosthesis is actually required for this group of amputees and what are their maintenance requirements. Variations of requirement between the amputee groups of aged 16-60 and over 60 years are also addressed. In the 10 years period of the study the amputees needed an average of 5.04 new prostheses, 6.25 refits, 2.28 major repairs and 17.04 day repairs. The younger amputees, i.e. below the age of 60 years, required significantly more new prostheses (p=0.003), more refit of sockets (p=0.0012) and more day repairs (p=0.01). Traumatic amputees below the age of 60 years needed significantly more day repairs compared to the non-traumatic amputees in the older age group (p=0.003).

Quadriceps muscle injury in trans-femoral amputees.

Two male trans-femoral amputees using modular trans-femoral prostheses lost control and fell to the ground when their prosthetic knees gave way. The semi-automatic knee lock malfunctioned in the first case while the free knee stabilising mechanics gave way in the second case. This resulted in a high tensile force acting on the contralateral quadriceps muscle causing it to rupture. As there are a significant number of patients with both kinds of prostheses it is important to be aware of this possibility so that necessary actions can be taken to minimise its occurrence. Even with the currently available weight activated stance phase control, the prosthetic knee will give way if the knee is flexed more than 20 degrees on weight bearing. Good power and control of hip extensors on the amputation side is needed to control the prosthetic knee joint, especially in the early stage of the walking cycle, i.e., from heel strike to mid-stance. Quadriceps muscle injury in amputees, as far as the authors are aware, has not been reported previously.

Silicone replacement for non-union of the scaphoid. 7 cases followed for 9 (5-18) years.

In the years 1971-1983, 7 patients underwent excision of the scaphoid with replacement by a silicone rubber implant because of painful nonunion of a scaphoid fracture. The patients were reviewed 9 (4.5-18) years postoperatively. All patients returned to work, 2 patients being completely pain-free, 4 having only occasional pain on heavy activity, and 1 having pain on normal activity. The range of motion, power and pinch grip were near-normal in all. Radiographic examination showed progressive dorsal intercalated segment instability with carpal collapse and arthrosis. There was no evidence of fragmentation of, or reaction to the prosthesis. 1 prosthesis was dislocated, and no patient required a revision operation.