Objective-To determine the efficacy of oral nimodipine in reducing cerebral infarction and poor outcomes (death and severe disability) after subarachnoid haemorrhage.Design-Double blind, placebo controlled, randomised trial with three months of follow up and intention to treat analysis. To have an 80% chance with a significance level of 0-05 of detecting a 50% reduction in an incidence of cerebral infarction of 15% a minimum of 540 patients was required.Setting-Four regional neurosurgical units in the United Kingdom.Patients-In all 554 patients were recruited between June 1985 and September 1987 out of a population of 1115 patients admitted with subarachnoid haemorrhage proved by the results of lumbar puncture or computed tomography, or both. The main exclusion criterion was admission to the neurosurgical units more than 96 hours after subarachnoid haemorrhage. There were four breaks of code and no exclusions after entry. One patient was withdrawn and in 130 treatment was discontinued early. All patients were followed up for three months and were included in the analysis, except the patient who had been withdrawn.Interventions-Placebo or nimodipine 60 mg was given orally every four hours for 21 days to 276 and 278 patients, respectively. Treatment was started within 96 hours after subarachnoid haemorrhage.End points -Incidence of cerebral infarction and ischaemic neurological deficits and outcome three months after entry.Measurements-Demographic and clinical data, including age, sex, history of hypertension and subarachnoid haemorrhage, severity ofhaemorrhage according to an adaptation of the Glasgow coma scale, number and site of aneurysms on angiography, and initial findings on computed tomography were measured at entry. Deterioration, defined as development of a focal sign or fall of more than one point on the Glasgow coma scale for more than six hours, was investigated by using clinical criteria and by computed tomography, by lumbar puncture, or at necropsy when appropriate. All episodes of deterioration and all patients with a three month outcome other than a good recovery were assessed by a review committee.Main results-Demographic and clinical data at entry were similar in the two groups. In patients given nimodipine the incidence of cerebral infarction was 22% (61/278) compared with 33% (92/276) in those given placebo, a significant reduction of 34% (95% confidence interval 13 to 50%). Poor outcomes were also significantly reduced by 40% (95% confidence interval 20 to 55%) with nimodipine (20%
OBJECTIVE Adults with GH deficiency complain frequently of low energy levels, emotional lability and mental fatigue resulting in a low perceived quality of life (QOL). Body composition is altered with increased fat mass and decreased lean body mass and muscle strength is reduced. The aims of this study were to determine the effects of replacement GH treatment on: (a) body composition and muscle strength and (b) QOL, using specifically selected and adapted measures. DESIGN A 12‐month study (double‐blind placebo‐controlled for the first 6 months and open for the second 6 months) of GH replacement injections (0.125 iu/kg/week for the first month and 0.25 iu/kg/week for the following 5 months of each study period) in GH deficient adults on QOL, body composition and muscle strength. This was followed by an open study of a further 12 months' GH treatment assessing QOL and muscle strength. Finally, QOL was assessed after up to 3 years of GH replacement treatment. PATIENTS Thirty of the 32 adult patients with GH deficiency enrolled completed the initial 12‐month study (10 male, mean age 33.5 years, mean (SD) stimulated serum GH response 3.0 mU/l (2.86)). Nineteen patients then opted to continue GH treatment. Of these, 13 patients were available for assessment after a further 12 months' and 24 months' treatment. MEASUREMENTS Health‐related QOL was assessed using 2 specifically adapted scales for adults with GH deficiency: the Life Fulfilment Scale and the Impact Scale. In addition 4 other self‐rating questionnaires were used: Nottingham Health Profile, Hospital Anxiety and Depression Scale, Self Esteem Scale and Mental Fatigue Scale. Body composition was assessed by DEXA and quadriceps muscle strength by measuring maximum voluntary contractions. RESULTS In the initial 12 months' placebo‐controlled study perceived energy levels increased after 6 and 12 months of GH treatment (P<0.01 compared with baseline) in the patients receiving GH for the full 12‐month period. There were no changes in energy levels throughout the study in the group receiving placebo for the first 6 months. Also small improvements in impact scores were found after 6 months of GH treatment (P<0.05) but this was not sustained at 12 months. In both GH and placebo groups life fulfilment worsened after 6 months, but then improved to baseline values after 12 months. In the patients who persisted with GH replacement, energy levels continued to improve (at 2 years, P<0.01 compared with baseline) but then fell (at 3 years, P = NS compared with baseline). A similar pattern was observed in emotional reaction scores. However, improvements in self‐esteem were maintained (at 3 years, P<0.05 compared with baseline). Body composition altered favourably over the initial 12‐month study period with a significant increase in lean mass and decrease in fat mass in both groups after 6–12 months of GH. There were no changes in muscle strength in either group during the initial 12‐month study. However, in the patients who were available for assessment after a further 12 months ...
The management of acute traumatic cerebrospinal fluid (CSF) fistulae is still a matter of debate and hinges about what is perceived to be the risk of subsequent intracranial infection. We have therefore carried out a retrospective analysis of 160 cases of traumatic CSF leaks to assess the incidence, cumulative risk and prognosis of intracranial infection. The overall incidence of meningitis in this group before surgical dural repair was 30.6% (49/160), the cumulative risk exceeded 85% at 10 years follow-up and the meningitis was fatal in 4.1% (2/49). The recurrence of CSF leakage after initial spontaneous cessation was 7% and meningitis was recurrent in 30.6% (15/49). Prophylactic antibiotics had reduced the risk of meningitis from 61 to 34%. The commonest pathogen was pneumococcus and the CSF leakage had stopped within 7 days in 60% of those who developed meningitis and in 50% of those who did not develop meningitis. Meningitis is still a serious complication of post-traumatic CSF fistulae and is potentially fatal despite modern therapeutic agents.
A retrospective study of 1000 patients who had undergone supratentorial neurosurgery and with prolonged follow-up revealed an overall postoperative incidence of epilepsy of 17%. The incidence varied with different pathologies but anticonvulsants given prophylactically in a randomized trial did not significantly alter the incidence. Routine anticonvulsant prophylaxis cannot be recommended.
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