Intravenous Magnesium Sulphate for Aneurysmal Subarachnoid Hemorrhage (IMASH)

Wong, George Kwok Chu; Poon, Wai Sang; Chan, Matthew T. V.; Boet, R.; Gin, Tony; Ng, S. Thomas; Zee, Benny

doi:10.1161/strokeaha.109.571125

Cited by 185 publications

(99 citation statements)

References 29 publications

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“…The remaining 24 trials were included in the analysis, including 8,552 patients (Macdonald et al, 2008;Asano et al, 1996;Chou et al, 2008;Gomis et al, 2010;Haley et al, 1993Haley et al, , 1997Hop et al, 2000;Kassell et al, 1996;Ohman and Heiskanen, 1988;Petruk et al, 1988;Pickard et al, 1989;Saito et al, 1998;Shaw et al, 2000;Shibuya et al, 1992;Siironen et al, 2003;Juvela et al, 2005;Springborg et al, 2007;Suzuki et al, 1989;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Westermaier et al, 2010;Wong et al, 2010Wong et al, , 2011. A total of 4,818 patients were randomized to pharmaceutical treatment, and 3,734 patients to placebo.…”

Section: Resultsmentioning

confidence: 99%

“…For blinding, risk of bias was low in 20 studies (Macdonald et al, 2008;Asano et al, 1996;Gomis et al, 2010;Haley et al, 1993Haley et al, , 1997Hop et al, 2000;Kassell et al, 1996;Petruk et al, 1988;Pickard et al, 1989;Shaw et al, 2000;Shibuya et al, 1992;Siironen et al, 2003;Springborg et al, 2007;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Westermaier et al, 2010;Wong et al, 2010), and unclear in four studies (Chou et al, 2008;Ohman and Heiskanen, 1988;Saito et al, 1998;Suzuki et al, 1989). High risk of bias was not observed in any of the studies.…”

Section: Risk Of Bias Assessmentsmentioning

confidence: 96%

“…For clinical outcome, most studies used the Glasgow outcome scale (Macdonald et al, 2008;Asano et al, 1996;Gomis et al, 2010;Haley et al, 1993Haley et al, , 1997Kassell et al, 1996;Ohman and Heiskanen, 1988;Petruk et al, 1988;Pickard et al, 1989;Saito et al, 1998;Shaw et al, 2000;Shibuya et al, 1992;Siironen et al, 2003;Springborg et al, 2007;Westermaier et al, 2010;Wong et al, 2010) or modified Rankin scale (Chou et al, 2008;Hop et al, 2000; Cerebral infarction and outcome after SAH MDI Vergouwen et al (Table 1). One study used a functional activity in daily living scale (Suzuki et al, 1989).…”

Section: Analysesmentioning

confidence: 99%

“…For allocation concealment, risk of bias was low in 13 (Macdonald et al, 2008;Asano et al, 1996;Haley et al, 1993;Hop et al, 2000;Petruk et al, 1988;Pickard et al, 1989;Shaw et al, 2000;Shibuya et al, 1992;Springborg et al, 2007;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Wong et al, 2010) and unclear in 11 studies (Chou et al, 2008;Gomis et al, 2010;Haley et al, 1997;Kassell et al, 1996;Ohman and Heiskanen, 1988;Saito et al, 1998;Siironen et al, 2003;Suzuki et al, 1989;Westermaier et al, 2010) ( Table 1). For blinding, risk of bias was low in 20 studies (Macdonald et al, 2008;Asano et al, 1996;Gomis et al, 2010;Haley et al, 1993Haley et al, , 1997Hop et al, 2000;Kassell et al, 1996;Petruk et al, 1988;Pickard et al, 1989;Shaw et al, 2000;Shibuya et al, 1992;Siironen et al, 2003;Springborg et al, 2007;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Westermaier et al, 2010;…”

Section: Risk Of Bias Assessmentsmentioning

confidence: 99%

“…In the sensitivity analysis that only included studies with a low risk of bias, as assessed on the items 'allocation concealment' and 'blinding,' 13 studies were included with 3,831 patients (Macdonald et al, 2008;Asano et al, 1996;Haley et al, 1993;Hop et al, 2000;Petruk et al, 1988;Pickard et al, 1989;Shaw et al, 2000;Shibuya et al, 1992;Springborg et al, 2007;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Wong et al, 2010). The pooled RR for cerebral infarction was 0.70 (95% CI: 0.56 to 0.88) and for poor outcome 0.78 (95% CI: 0.67 to 0.90) (figures not shown).…”

Section: Sensitivity Analysesmentioning

confidence: 99%

See 4 more Smart Citations

Lower incidence of cerebral infarction correlates with improved functional outcome after aneurysmal subarachnoid hemorrhage

Vergouwen

Etminan

Ilodigwe

et al. 2011

J Cereb Blood Flow Metab

126

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Despite an undisputed association between vasospasm and delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage (SAH), there is debate if this association implies causality. It has been suggested that cerebral infarction is a better outcome measure than vasospasm in clinical trials and observational studies. To further investigate the relationship between infarction and outcome, we performed a systematic review and meta-analysis of all randomized, double-blind, placebo-controlled trials that studied the efficacy of pharmaceutical preventive strategies in SAH patients, and had both cerebral infarction and clinical outcome as outcome events. Effect sizes were expressed in (pooled) risk ratio (RR) estimates with corresponding 95% confidence intervals (CIs). Sensitivity analyses were performed for studies with a low risk of bias and for those who reported outcome at 3 months after SAH. Twenty-four studies including 8,552 patients were included. Pharmaceutical treatments decreased the incidence of both cerebral infarction (RR: 0.83; 95% CI: 0.74 to 0.93) and of poor functional outcome (RR: 0.92; 95% CI: 0.86 to 0.98). The sensitivity analyses did not change the results essentially. These data suggest that the previously observed association between cerebral infarction and functional outcome implies causality, and that cerebral infarction is a better outcome measure than vasospasm in clinical trials and observational studies.

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Section: Resultsmentioning

confidence: 99%

Section: Risk Of Bias Assessmentsmentioning

confidence: 96%

Section: Analysesmentioning

confidence: 99%

Section: Risk Of Bias Assessmentsmentioning

confidence: 99%

Section: Sensitivity Analysesmentioning

confidence: 99%

See 3 more Smart Citations

Lower incidence of cerebral infarction correlates with improved functional outcome after aneurysmal subarachnoid hemorrhage

Vergouwen

Etminan

Ilodigwe

et al. 2011

J Cereb Blood Flow Metab

126

View full text Add to dashboard Cite

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Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients

Jiang¹,

et al. 2018

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IMPORTANCE Chronic subdural hematoma (CSDH) is a trauma-associated condition commonly found in elderly patients. Surgery is currently the treatment of choice, but it carries a significant risk of recurrence and death. Nonsurgical treatments remain limited and ineffective. Our recent studies suggest that atorvastatin reduces hematomas and improves the clinical outcomes of patients with CSDH.OBJECTIVE To investigate the safety and therapeutic efficacy of atorvastatin to nonsurgically treat patients with CSDH. DESIGN, SETTING, AND PARTICIPANTSThe Effect of Atorvastatin on Chronic Subdural Hematoma (ATOCH) randomized, placebo-controlled, double-blind phase II clinical trial was conducted in multiple centers in China from February 2014 to November 2015. For this trial, we approached 254 patients with CSDH who received a diagnosis via a computed tomography scan; of these, 200 (78.7%) were enrolled because 23 patients (9.1%) refused to participate and 31 (12.2%) were disqualified.INTERVENTIONS Patients were randomly assigned to receive either 20 mg of atorvastatin or placebo daily for 8 weeks and were followed up for an additional 16 weeks. MAIN OUTCOMES AND MEASURESThe primary outcome was change in hematoma volume (HV) by computed tomography after 8 weeks of treatment. The secondary outcomes included HV measured at the 4th, 12th, and 24th weeks and neurological function that was evaluated using the Markwalder grading scale/Glasgow Coma Scale and the Barthel Index at the 8th week.RESULTS One hundred ninety-six patients received treatment (169 men [86.2%]; median [SD] age, 63.6 [14.2] years). The baseline HV and clinical presentations were similar between patients who were taking atorvastatin (98 [50%]) and the placebo (98 [50%]). After 8 weeks, the HV reduction in patients who were taking atorvastatin was 12.55 mL more than those taking the placebo (95% CI, 0.9-23.9 mL; P = .003). Forty-five patients (45.9%) who were taking atorvastatin significantly improved their neurological function, but only 28 (28.6%) who were taking the placebo did, resulting in an adjusted odds ratio of 1.957 for clinical improvements (95% CI, 1.07-3.58; P = .03). Eleven patients (11.2%) who were taking atorvastatin and 23 (23.5%) who were taking the placebo underwent surgery during the trial for an enlarging hematoma and/or a deteriorating clinical condition (hazard ratio, 0.47; 95% CI, 0.24-0.92; P = .03). No significant adverse events were reported.CONCLUSIONS AND RELEVANCE Atorvastatin may be a safe and efficacious nonsurgical alternative for treating patients with CSDH.

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Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke

et al. 2021

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IMPORTANCEThe underenrollment of women in randomized clinical trials represents a threat to the validity of the evidence supporting clinical guidelines and potential disparities in access to novel treatments. OBJECTIVE To determine whether women were underenrolled in contemporary randomized clinical trials of acute stroke therapies published in 9 major journals after accounting for their representation in underlying stroke populations.DATA SOURCES MEDLINE was searched for acute stroke therapeutic trials published between January 1, 2010, and June 11, 2020.STUDY SELECTION Eligible articles reported the results of a phase 2 or 3 randomized clinical trial that enrolled patients with stroke and/or transient ischemic attack and examined a therapeutic intervention initiated within 1 month of onset.DATA EXTRACTION Data extraction was performed by 2 independent authors in duplicate. Individual trials were matched to estimates of the proportion of women in underlying stroke populations using the Global Burden of Disease database. MAIN OUTCOMES AND MEASURESThe primary outcome was the enrollment disparity difference (EDD), the absolute difference between the proportion of trial participants who were women and the proportion of strokes in the underlying disease populations that occurred in women. Random-effects meta-analyses of the EDD were performed, and multivariable metaregression was used to explore the associations of trial eligibility criteria with disparity estimates. RESULTSThe search returned 1529 results, and 115 trials (7.5%) met inclusion criteria. Of 121 105 randomized patients for whom sex was reported, 52 522 (43.4%) were women. The random-effects summary EDD was −0.053 (95% CI, −0.065 to −0.040), indicating that women were underenrolled by 5.3 percentage points. This disparity persisted across virtually all geographic regions, intervention types, and stroke types, apart from subarachnoid hemorrhage (0.117 [95% CI, 0.084 to 0.150]). When subarachnoid hemorrhage trials were excluded, the summary EDD was −0.067 (95% CI, −0.078 to −0.057). In the multivariable metaregression analysis, an upper age limit of 80 years as an eligibility criterion was associated with a 6-percentage point decrease in the enrollment of women.CONCLUSIONS AND RELEVANCE Further research is needed to understand the causes of the underenrollment of women in acute stroke trials. However, to maximize representation, investigators should avoid imposing age limits on enrollment.

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Intravenous Magnesium Sulphate for Aneurysmal Subarachnoid Hemorrhage (IMASH)

Cited by 185 publications

References 29 publications

Lower incidence of cerebral infarction correlates with improved functional outcome after aneurysmal subarachnoid hemorrhage

Lower incidence of cerebral infarction correlates with improved functional outcome after aneurysmal subarachnoid hemorrhage

Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients

Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke

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