内科并发症对急性脑卒中患者预后的影响

目的　研究内科并发症对急性脑卒中患者功能恢复和卒中后死亡的影响。方法　对 5 32例急性脑卒中患者出院时 BI、m RS和出院时减少的 NIHSS百分数进行评估 ,并记录其病死率。分析有、无内科并发症两组患者预后的差别。结果　 (1)有并发症的患者出院时减少的 NIHSS百分数低于无并发症者 (P<0 .0 1) ,出院时和出院后6月的日常生活能力差于后者 (P<0 .0 1) ,残疾指数也高于后者 (P<0 .0 1) ;(2 )有并发症者较无并发症者病死率高(P<0 .0 1)。结论　卒中后内科并发症不仅影响急性脑卒中患者的功能恢复 ,而且影响卒中后病死率。     

Functional outcome prediction following intracerebral hemorrhage

The ICH score is a validated method of assessing the risk of mortality and morbidity after intracerebral hemorrhage (ICH). We sought to compare the ability of the ICH score to predict outcome assessed with three of the most widely used scales: the Barthel Index (BI), modified Rankin Scale (mRS), and Glasgow Outcome Score (GOS). All patients with ICH treated at our institution between February 2009 and March 2011 were followed-up at three months using the mRS, GOS, and BI. The ICH score was highly correlated with the three-month mRS (ρ=0.59, p<0.001), BI (ρ=-0.57, p<0.001) and GOS (ρ=0.61, p<0.001). The ICH score also predicted dependency for each measure well, with areas under the curve falling between 0.826 and 0.833. Our results suggest that future clinical studies that use the ICH score to stratify patients may employ any of the three outcome scales and expect good discrimination of disability.     

Stroke initial severity and outcome relative to insurance status in a universal health care system in Switzerland

Background: Socioeconomic status is thought to have a significant influence on stroke incidence, risk factors and outcome. Its influence on acute stroke severity, stroke mechanisms, and acute recanalisation treatment is less known. Methods: Over a 4‐year period, all ischaemic stroke patients admitted within 24 h were entered prospectively in a stroke registry. Data included insurance status, demographics, risk factors, time to hospital arrival, initial stroke severity (NIHSS), etiology, use of acute treatments, short‐term outcome (modified Rankin Scale, mRS). Private insured patients (PI) were compared with basic insured patients (BI). Results: Of 1062 consecutive acute ischaemic stroke patients, 203 had PI and 859 had BI. They were 585 men and 477 women. Both populations were similar in age, cardiovascular risk factors and preventive medications. The onset to admission time, thrombolysis rate, and stroke etiology according to TOAST classification were not different between PI and BI. Mean NIHSS at admission was significantly higher for BI. Good outcome (mRS ≤ 2) at 7 days and 3 months was more frequent in PI than in BI. Conclusion: We found better outcome and lesser stroke severity on admission in patients with higher socioeconomic status in an acute stroke population. The reason for milder strokes in patients with better socioeconomic status in a universal health care system needs to be explained.     

脑卒中后中枢性面瘫闭目乏力与脑卒中预后的关系

目的探讨脑卒中后中枢性面瘫闭目乏力与脑卒中预后的关系。方法观察1年内所有起病7d内的脑卒中患者,入院当天使用拉力测量器测量双眼闭目力量,按测量结果分为中枢性面瘫伴闭目乏力和不伴闭目乏力两组,比较两组入院当天、发病第7、14、21、30天的美国国立卫生院脑卒中量表评分(National Institute of Health stroke scale,NIHSS)以及发病第30、90、180天的Barthel指数(Barthel index,BI)、修正Rankin量表评分(modified Rankin Scale,mRS)。结果入院当天2组的NIHSS无统计学差异,而伴闭目乏力者在脑卒中发病第21和30天的NIHSS较不伴闭目乏力者高(P<0.05)。在脑卒中发病第30、90、180天,伴闭目乏力者的BI≥85的比例比不伴闭目乏力者低;在脑卒中发病第90、180天,伴闭目乏力者的mRS≤2的比例比不伴闭目乏力者低。结论脑卒中后中枢性面瘫伴闭目乏力提示较差的预后。     

Stroke outcome in patients already taking aspirin

Background Although aspirin (ASA) has been shown to be effective for secondary (but not primary) stroke prevention and to have some beneficial influence on outcome when taken early after stroke onset, studies regarding the impact of prior use of ASA on stroke severity are conflicting. Objectives: To determine whether ASA therapy begun before stroke onset lessens the severity of stroke. Methods: Prospective clinical information was collected for all patients admitted with their first acute ischemic stroke between July 1996 and July 1998. National Institutes of Health Stroke Scale (NIHSS) scores were noted on admission and at discharge. Barthel Index (BI), Modified Rankin Scale (MRS), and Glasgow Outcome Scale (GOS) scores were also noted at discharge. Stroke severity was classified as severe if the NIHSS score was 9 or greater, BI score was 55 or less, the MRS score was 4 or greater, or the GOS score was 3 or greater. Group comparisons were performed by using the X(2) tests. Results: 178 patients were evaluated. Forty-two were taking ASA and 136 were not taking ASA or any other anti-thrombotic drug. There were no differences between the 2 groups in terms of age, gender, baseline hematocrit or blood glucose, history of hypertension, diabetes, atrial fibrillation, smoking, or stroke subtype. There were no significant differences between the 2 groups on any of the scales, either on admission or at discharge. Conclusion: Our data do not suggest that ASA use before stroke onset lessens the severity of first stroke. Until this question is definitively settled, however, it would be prudent to ensure balanced distribution of recent ASA use in acute stroke treatment trials.     

The Eligible study: ultrasound assessment in acute ischemic stroke within 3 hours

BACKGROUND: Aims of the study: to identify with echo color Doppler ultrasound of the supra-aortic vessels and transcranial color-coded duplex sonography (TCCD) various patterns of vessel occlusion within 3 h from stroke onset, to compare each group defined at the admission with clinical findings and outcome, and to study the recanalization process, independent of therapy. METHODS: We enrolled 89 consecutive patients (mean age 68.9 years). Ultrasound evaluation was done within 3 h from stroke onset, and was repeated at 3-6 and 24-36 h, at day 5, and at 3 months. At admission, patients were divided into the following groups: internal carotid artery occlusions and stenoses (<50%, 50-69%, > or =70%, near occlusion), middle cerebral artery stenoses and occlusions, tandem occlusions and T occlusions. Vascular recanalization in each group was evaluated. Subgroups were compared for NIH Stroke Scale (NIHSS) and the outcome measures mortality, Barthel index (BI) and modified Rankin scale (mRS). Favorable outcome was defined as mRS < or =2 and BI > or =90. RESULTS: Each subgroup differed significantly for baseline NIHSS (p < 0.0001), 3-month mortality (p = 0.0235), BI at day 5 (p = 0.0458) and mRS at 3 months (p = 0.0028), even after adjustment for treatment. T and tandem occlusions were the subgroups with the highest NIHSS scores and the poorest outcomes, and the same subgroups had the worst recanalization rates. CONCLUSIONS: TCCD in the acute setting of stroke patients allows identification of the presence and site of clots, prediction of outcome and study of the dynamic process of vessel recanalization, in both the acute phase and follow-up.     

Infarct volume on apparent diffusion coefficient maps correlates with length of stay and outcome after middle cerebral artery stroke

BACKGROUND: Diffusion-weighted MRI (DWI) can depict acute ischemia based on decreased apparent diffusion coefficient (ADC) values. ADC maps, unlike DWI (which have contributions from T2 properties), solely reflect diffusion properties. Recent studies indicate that severity of neurological deficit corresponds with degree of ADC alteration. PURPOSE: To determine whether infarct volume on ADC maps correlates with length of hospitalization and clinical outcome in patients with acute ischemic middle cerebral artery (MCA) stroke. STUDY POPULATION: Forty-five consecutive patients with acute (3 SDs below the average ADC value of a contralateral control region. Infarct volume was correlated with length of hospitalization and 6-month outcome assessed with Glasgow Outcome Scale (GOS), Modified Rankin Score (mRS), Barthel Index (BI) and a dichotomized outcome status with favorable outcome defined as GOS 1, mRS or=95. RESULTS: Infarct volume on ADC maps ranged from 0.2 to 187 cm(3) and was significantly correlated with length of hospitalization (p < 0.001, r = 0.67). Furthermore, ADC infarct volume was significantly correlated with GOS (r = 0.73), mRS (r = 0.68), BI (r = 0.67) and outcome status (r = 0.65) (each p < 0.001). Multiple logistic regression revealed a statistically significant correlation between ADC infarct volume and outcome status (p < 0.05), but none for Canadian Neurological Scale score, age and gender (p >0.05 each). CONCLUSION: Infarct volume measured by using a quantitative definition for infarcted tissue on ADC maps correlated significantly with length of hospitalization (as a possible surrogate marker for short-term outcome) and functional outcome after 6 months. ADC infarct volume may provide prognostic information for patients with acute ischemic MCA stroke.     

代谢综合征对急性脑梗死早期预后的影响

目的 探讨急性脑梗死早期预后的影响因素，分析代谢综合征（metabolic syndrome，MS）是否为急性脑梗死早期预后的独立影响因素。方法 采用前瞻性研究设计，纳入连续性急性脑梗死163例，发病1个月时进行改良Rankin量表（mRS）评分作为结局变量，0=mRS 0～2，1=mRS 3～5；急诊入院时进行美国国立卫生研究院卒中量表(NIHSS)评分、格拉斯哥昏迷量表（GCS）评分；依据病史及辅助检查确定TOAST分型。以性别、年龄、吸烟、饮酒、NIHSS评分、GCS评分、TOAST分型、合并症[感染、心肌梗死（MI）、心衰（HF）]、是否合并MS为自变量作单因素分析。多因素分析采用两分类logistic回归，自变量为多分类时采用变量哑化技术。结果 单因素分析结果发现，性别（P <0.05）、吸烟史（P＜0.05）、NIHSS评分（P <0.01）、GCS评分（P <0.01）、TOAST分型（P <0.01）、感染（P <0.01）、HF（P <0.05）、MS（P <0.01）对早期预后（mRS评分）的影响有统计学差异。多因素分析结果发现，MS（OR 3.869，95%CI 1.542～9.711，P <0.01）、NIHSS评分（OR 19.699，95%CI 2.107～184.134，P <0.01）、TOAST分型（OR 0.188，95%CI 0.067～0.525，P <0.01）、感染（OR 2.950，95%CI 1.202～7.238，P＜0.05）对mRS有统计学差异。结论 MS、NIHSS评分、TOAST分型、感染是预后差的独立危险因素。这对急性脑梗死的预后评价、对MS高危人群实施干预提供了可靠的依据。     

Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST).

OBJECTIVE: To compare the baseline National Institutes of Health Stroke Scale (NIHSS) score and the Trial of Org 10172 in Acute Stroke Treatment (TOAST) stroke subtype as predictors of outcomes at 7 days and 3 months after ischemic stroke. METHODS: Using data collected from 1,281 patients enrolled in a clinical trial, subtype of stroke was categorized using the TOAST classification, and neurologic impairment at baseline was quantified using the NIHSS. Outcomes were assessed at 7 days and 3 months using the Barthel Index (BI) and the Glasgow Outcome Scale (GOS). An outcome was rated as excellent if the GOS score was 1 and the BI was 19 or 20 (scale of 0 to 20). Analyses were adjusted for age, sex, race, and history of previous stroke. RESULTS: The baseline NIHSS score strongly predicted outcome, with one additional point on the NIHSS decreasing the likelihood of excellent outcomes at 7 days by 24% and at 3 months by 17%. At 3 months, excellent outcomes were noted in 46% of patients with NIHSS scores of 7 to 10 and in 23% of patients with scores of 11 to 15. After multivariate adjustment, lacunar stroke had an odds ratio of 3.1 (95% CI, 1.5 to 6.4) for an excellent outcome at 3 months. CONCLUSIONS: The NIHSS score strongly predicts the likelihood of a patient's recovery after stroke. A score of > or =16 forecasts a high probability of death or severe disability whereas a score of < or =6 forecasts a good recovery. Only the TOAST subtype of lacunar stroke predicts outcomes independent of the NIHSS score.     

Use of the Barthel index and modified Rankin scale in acute stroke trials.

BACKGROUND AND PURPOSE: The Barthel Index (BI) and the Modified Rankin Scale (MRS) are commonly used scales that measure disability or dependence in activities of daily living in stroke victims. The objective of this study was to investigate how these scales were used and interpreted in acute stroke trials. METHODS: We identified from MEDLINE the major efficacy trials with neuroprotective drugs, thrombolytic drugs, and anticoagulants in acute ischemic stroke published between January 1995 and December 1998. We selected those trials that used the BI and/or MRS as outcome parameters. RESULTS: Fifteen trials fulfilling the inclusion criteria were identified. The BI was used in 13 and the MRS in 8. In 4 trials mean and median scores of the BI were used, and in 1 trial median scores of the MRS were compared. Primary end points included the BI in 7, the MRS in 6, and both the BI and MRS in 3. With regard to the BI, a variety of sum scores between 50 and 95 were used as cutoff scores to define favorable outcome. Favorable outcome on the MRS was defined as either 3, or BI <60.     

Autonomic function may mediate the neuroprotection of remote ischemic postconditioning in stroke: A randomized controlled trial

ObjectivesTo evaluate the effect of remote ischemic postconditioning (RIPostC) on the prognosis of acute ischemic stroke(AIS) patients and investigate the mediating role of autonomic function in the neuroprotection of RIPostC.Materials and Methods132 AIS patients were randomized into two groups. Patients received four cycles of 5-min inflation to a pressure of 200 mmHg(i.e., RIPostC) or patients’ diastolic BP(i.e., shame), followed by 5 min of deflation on healthy upper limbs once a day for 30 days. The main outcome was neurological outcome including the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Barthel index(BI). The second outcome measure was autonomic function measured by heart rate variability(HRV).ResultsCompared with the baseline, the post-intervention NIHSS score was significantly reduced in both groups (P<0.001). NIHSS score was significantly lower in the control group than intervention group at day 7.[RIPostC:3(1,5) versus shame:2(1,4); P=0.030]. mRS scored lower in the intervention group compared with the control group at day 90 follow-up(RIPostC:0.5±2.0 versus shame:1.0±2.0;P=0.016). The goodness-of-fit test revealed a significant difference between the generalized estimating equation model of mRS and BI scores of uncontrolled-HRV and controlled-HRV(P<0.05, both). The results of bootstrap revealed a complete mediation effect of HRV between group on mRS[indirect effect: −0.267 (LLCI = −0.549, ULCI = −0.048), the direct effect: −0.443 (LLCI = −0.831, ULCI = 0.118)].ConclusionThis is the first human-based study providing evidence for a mediation role of autonomic function between RIpostC and prognosis in AIS patients. It indicated that RIPostC could improve the neurological outcome of AIS patients. Autonomic function may play a mediating role in this association.Trial registrationThe clinical trials registration number for this study is NCT02777099 (ClinicalTrials.gov Identifier)     

Hypoglycemic encephalopathy: a case series and literature review on outcome determination

Data on clinical long-term outcome after the acute phase of hypoglycemic encephalopathy (HE) using validated outcome scales is currently unavailable. Here we report the results of a systematic literature search for studies on HE and data on long-term outcome in patients with HE admitted to three Charité hospitals between January 2005 and July 2010. HE was defined as coma/stupor and blood glucose levels?<50?mg/dl on admission, persistence of coma/stupor for?≥24?h despite normalization of blood glucose levels, and exclusion of any other cause of coma/stupor. Outcome was assessed using the modified Rankin scale (mRS), Glasgow Outcome Scale (GOS), and Barthel index (BI). Fifteen patients were included, with a mean age of 60?years (range 29-79). Two were lost to follow-up. Of the remaining 13 patients, six had died (46 %). In the seven survivors, the median mRS score was 0 (range 0-5), median GOS score was 5 (range 2-5), and median BI was 100 (range 0-100). MRIs made in the acute phase were available for three patients and revealed no obvious relation between lesion size or pattern and clinical outcome. To our knowledge, this is the first case series using validated clinical scoring systems to determine clinical long-term outcome after HE. The results suggest that mortality is high, but long-term survival with little or no disability is possible and can be observed in the majority of survivors. Risk of death or poor outcome does not seem to be related to MRI features in the acute phase but rather to other presumably medical factors.     

中西医结合卒中单元的疗效和卫生经济学评价

目的探讨中西医结合卒中单元治疗急性缺血性脑卒中的临床疗效和卫生经济学价值。方法随机选取符合入选标准的260例急性缺血性脑卒中(风痰瘀阻症)患者,分为实验组(中西医结合卒中单元组)和对照组(常规治疗组),两组均为130例。采用美国国立卫生院卒中量表(NIHSS)评分、Barthe1指数(BI)、改良的Rankin量表(mRS)为疗效观察指标;住院时间、住院费用、药品费用、检查和治疗费用为卫生经济学指标。比较NIHSS评分每减少1分、BI评分每增加5分、mRS评分每减少1分,患者每人每天所花费的住院费用。结果①与对照组比较,实验组治疗后14 d时NIHSS、BI、mRS改善程度明显优于对照组(P0.05)。实验组14 d后NIHSS评分下降主要在构音和运动功能方面优于对照组(P0.001);实验组BI评分提高主要在用厕、吃饭、移动、行走、穿衣、上楼、洗浴方面优于对照组(P0.01),实验组mRS(0~2)分的患者近期残障功能的改善优于对照组(P0.01)。②住院期间,两组患者的住院费用和检查费用差异无统计学意义(P0.05);实验组的平均住院时间和药品费用明显低于对照组(P0.01),治疗费用高于对照组(P0.001)。③NIHSS评分每减少1分,BI评分每增加5分,MRS评分每减少1分,实验组所需费用均较对照组少。结论中西医结合卒中单元治疗急性缺血性脑卒中更具有社会效益和经济效益。     

Using the Barthel Index and modified Rankin Scale as Outcome Measures for Stroke Rehabilitation Trials; A Comparison of Minimum Sample Size Requirements

ObjectivesUnderpowered trials risk inaccurate results. Recruitment to stroke rehabilitation randomised controlled trials (RCTs) is often a challenge. Statistical simulations offer an important opportunity to explore the adequacy of sample sizes in the context of specific outcome measures. We aimed to examine and compare the adequacy of stroke rehabilitation RCT sample sizes using the Barthel Index (BI) or modified Rankin Scale (mRS) as primary outcomes.MethodsWe conducted computer simulations using typical experimental event rates (EER) and control event rates (CER) based on individual participant data (IPD) from stroke rehabilitation RCTs. Event rates are the proportion of participants who experienced clinically relevant improvements in the RCT experimental and control groups. We examined minimum sample size requirements and estimated the number of participants required to achieve a number needed to treat within clinically acceptable boundaries for the BI and mRS.ResultsWe secured 2350 IPD (18 RCTs). For a 90% chance of statistical accuracy on the BI a rehabilitation RCT would require 273 participants per randomised group. Accurate interpretation of effect sizes would require 1000s of participants per group. Simulations for the mRS were not possible as a clinically relevant improvement was not detected when using this outcome measure.ConclusionsStroke rehabilitation RCTs with large sample sizes are required for accurate interpretation of effect sizes based on the BI. The mRS lacked sensitivity to detect change and thus may be unsuitable as a primary outcome in stroke rehabilitation trials.     

侧支循环状态与再灌注治疗预后的关系及CTA侧支循环评分的预测价值

目的 探讨急性缺血性卒中患者基线侧支循环状态与再灌注治疗预后的关系,并比较阿尔伯特早期卒中计划评分(ASPECTS)、多期CTA评分(mCTAs)和软脑膜侧支评分(rLMCs)的预测价值.方法收集87例接受再灌注治疗的急性缺血性卒中患者的临床资料.采用ASPECTS、mCTAs和rLMCs评分评定基线侧支循环情况.根据...     

Preliminary findings of the effects of autonomic dysfunction on functional outcome after acute ischemic stroke

Background and purpose

Impaired autonomic function is common in the acute poststroke phase but little is known about its effects on functional outcome after acute ischemic stroke. This study sought to investigate the impact of autonomic dysfunction by Ewing's classification on functional outcome 2 months after acute ischemic stroke.

Methods

34 consecutive acute ischemic stroke patients within 7 days after onset were enrolled. On admission, autonomic function was assessed by Ewing's battery tests. Stroke severity was assessed by the National Institutes of Health Stroke Scale (NIHSS), autonomy in activities of daily living by the Barthel Index (BI), and global disability by the modified Rankin Scale (mRS). BI and mRS were also evaluated 2 months after ischemic stroke onset.

Results

On admission, eight patients were diagnosed as minor autonomic dysfunction and 26 patients as relatively severe autonomic dysfunction. The prevalence of relatively severe autonomic dysfunction in ischemic stroke patients was 76.5%. There were no significant differences in baseline characteristics between the minor and severe autonomic dysfunction groups. 2 months after stroke onset, the mean BI score of patients with minor autonomic dysfunction and severe autonomic dysfunction increased from 76.3 ± 15.3 on admission to 95.0 ± 7.1, 66.5 ± 15.2 on admission to 74.8 ± 15.9 respectively. The mean BI score after 2-month stroke onset and the change in BI from admission to 2-month outcome (delta BI) in patients with severe autonomic dysfunction were lower than those in patients with minor autonomic dysfunction (all P < 0.05).

Conclusions

Autonomic dysfunction occurs in acute stroke patients. Relatively severe autonomic dysfunction is related to an unfavorable functional outcome in patients with acute ischemic stroke.     

Measuring outcomes as a function of baseline severity of ischemic stroke

BACKGROUND: The spectrum of neurological impairments following acute ischemic stroke is broad. The initial stroke severity predicts responses to treatment and outcomes after ischemic stroke. While clinical trials are using baseline severity as an enrollment criterion or a stratified variable, adjustment of outcome measures as a function of initial impairments has not been done. METHODS: We developed a responder analysis that defines favorable outcomes at 90 days as influenced by the baseline National Institutes of Health Stroke Scale (NIHSS). Favorable outcome was defined as a modified Rankin Scale (mRS) score of 0 if the baseline NIHSS score was <8, mRS score of 0-1 if the NIHSS score was 8-14, and mRS score of 0-2 if the NIHSS score was >14. The concept stemmed from the data of two European rtPA trials. The analysis is a predefined secondary endpoint in a trial testing abciximab. We also used the analysis to reexamine the Trial of Org 10172 in Acute Stroke Treatment data. RESULTS: The responder analysis did not change the overall results of any of the 3 previous trials, but it did give information about differences in responses among subgroups of patients. Evidence about the potential utility of tPA for treatment of patients with mild stroke appeared from the analysis of the second European trial of rtPA. The analysis also provided a hint of efficacy of abciximab. CONCLUSIONS: The responder analysis appears to be a potentially useful way to evaluate outcomes of patients enrolled in clinical trials in stroke. The results of the analysis have clinical relevance and can further explain differences in responses to therapies. In addition, the analysis allows for improved comparisons of results among clinical trials.     

Long-term health-related quality of life after decompressive hemicraniectomy in stroke patients with life-threatening space-occupying brain edema

Background

Although randomized clinical trials have reported significant improvement in mortality and functional outcome as measured with modified Rankin Scale (mRS) or Barthel index (BI) in stroke patients with space-occupying anterior circulation infarctions treated with hemicraniectomy, many clinicians are still concerned about the long-term health-related quality of life (HRQoL).

Aim

Assessment of HRQoL after hemicraniectomy to holistically reevaluate clinical outcome.

Methods

Eleven patients (6 men, 5 women; mean age 48 (SD 5.8) years) were examined at 9–51 months after hemicraniectomy. Test batteries comprised NIH stroke scale, BI, mRS, neuropsychological tests (Visual Object and Space Perception Battery and clock test), and HRQoL-scales (Short Form 36 Health Survey (SF-36), Nottingham Health Profile (NHP), Questions on Life Satisfaction, Hospital Anxiety and Depression Scale and EQ-5D).

Results

Median values for NIHSS, BI and mRS were 11.5, 55 and 3.5. In HRQoL-scales, subscales related to physical mobility and functioning were consistently severely impaired, while subscales related to psychological well-being were impaired to a lesser extent. Mean scores for physical functioning and physical role were 10.5 and 12.5 in the SF-36, and 61.3 and 43.3 for physical mobility and energy in the NHP; emotional role and mental health scored 63.3 and 66.4 (SF-36), scores for emotional reaction and social isolation were 18.9 and 16.0 (NHP), respectively.

Conclusion

Although, physical components of HRQoL are highly impaired, these stroke patients achieved a satisfying level of psychological well-being which was endorsed by a nearly unanimous retrospective appraisal of life-saving hemicraniectomy.     

Placebo treatment in acute stroke trials : benefit or harm to patients?

BACKGROUND AND PURPOSE: Some stroke patients and their families express reservations about participating in trials of experimental therapies for acute stroke. Among many reasons given for this is the concern that by participating, patients may be deprived of some component of routine care. We sought to determine the effect on outcome of participating in a clinical stroke trial while being treated with placebo. METHODS: Prospective clinical information was collected for all patients admitted with acute ischemic stroke between July 1995 and July 1996. A subgroup of these patients was enrolled in a clinical trial of acute stroke therapy and had been randomly assigned to the placebo group. The control group was selected from concurrent stroke patients who were not enrolled in any clinical trial. The National Institutes of Health Stroke Scale (NIHSS) was performed on admission and on day 7 after admission. The Glasgow Outcome Scale (GOS) was also performed at discharge. Stroke severity was classified as "severe" if NIHSS was >/=9 or GOS >/=3. Group comparisons were performed with chi(2) tests. RESULTS: One hundred twenty-six patients were evaluated. Forty-seven were placebo patients, and 79 were selected as control subjects. There were no significant differences between the groups with respect to age, sex, hematocrit, blood glucose level, history of hypertension, diabetes, smoking, or initial NIHSS. In addition, there was no difference between groups in terms of the frequency of baseline stroke subtype. Among our controls, 55 patients (70%) were on antithrombotic treatment during hospitalization, whereas none of our placebo patients were on any antithrombotic treatment. For the GOS at follow-up, a good outcome was attained by 76% of the control subjects and 72% of placebo patients (not significant). A severe NIHSS (>9) at follow-up, however, was documented in 15% of controls and 59% of placebo patients (P<0.001). There was a trend toward a higher ("worse") mean follow-up NIHSS among placebo patients (mean NIHSS, 11) versus controls (mean NIHSS, 6) (P=0.09). CONCLUSIONS: Patients enrolled in the placebo arms of some acute clinical stroke trials have similar functional outcomes but more severe neurological deficits at 1 week than did a control group. These findings might be partially explained by the withholding of antithrombotic medication and the exclusion criteria inherent in most trials. Vigilance is required to ensure that all patients participating in stroke studies be guaranteed optimal known medical therapy.