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Effects of Vitamin E on Stroke: a Systematic Review with Meta-­Analysis and Trial Sequential Analysis

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Effects of Vitamin E on Stroke: a Systematic Review with Meta-­Analysis and Trial Sequential Analysis Open access Review Stroke Vasc Neurol: first published as 10.1136/svn-2020-000519 on 27 October 2020. Downloaded from Effects of vitamin E on stroke: a systematic review with meta- analysis and trial sequential analysis Hong Chuan Loh ,1 Renly Lim,2 Kai Wei Lee,3 Chin Yik Ooi,1 Deik Roy Chuan,1 Irene Looi,1,4 Yuen Kah Hay,5 Nurzalina Abdul Karim Khan 5 To cite: Loh HC, Lim R, Lee KW, ABSTRACT haemorrhage. It usually occurs with one or et al. Effects of vitamin E on There are several previous studies on the association of more clinical signs, lasting for more than 24 stroke: a systematic review vitamin E with prevention of stroke but the findings remain with meta- analysis and trial hours or leading to death, with no apparent controversial. We have conducted a systematic review, 1 sequential analysis. Stroke & cause other than it being of vascular origin. meta- analysis together with trial sequential analysis of Vascular Neurology 2020;0. Globally, 84.4% of all strokes are ischaemic randomised controlled trials to evaluate the effect of doi:10.1136/svn-2020-000519 and 15.6% are haemorrhagic. According vitamin E supplementation versus placebo/no vitamin E on Additional material is to The Global Burden of Diseases, Injuries, ► the risk reduction of total, fatal, non- fatal, haemorrhagic published online only. To view, and ischaemic stroke. Relevant studies were identified and Risk Factors Study, there are 5.5 million please visit the journal online stroke deaths annually around the world and (http:// dx. doi. org/ 10. 1136/ svn- by searching online databases through Medline, PubMed and Cochrane Central Register of Controlled Trials. A total it is the second leading cause of death glob- 2020- 000519). 2 of 18 studies with 148 016 participants were included ally. Stroke- related morbidity remains high. Received 16 July 2020 in the analysis. There was no significant difference in It is estimated that the total annual cost due to Revised 26 August 2020 the prevention of total stroke (RR (relative risk)=0.98, stroke will increase to $240.67 billion by 2030, Accepted 9 September 2020 95% CI 0.92–1.04, p=0.57), fatal stroke (RR=0.96, 95% including both stroke- related medical costs CI 0.77–1.20, p=0.73) and non-fa tal stroke (RR=0.96, and indirect annual costs attributable to loss 95% CI 0.88–1.05, p=0.35). Subgroup analyses were of productivity.3 Thus, proper stroke manage- performed under each category (total stroke, fatal ment and preventive measures are crucial in stroke and non- fatal stroke) and included the following helping to reduce escalating healthcare costs. subgroups (types of prevention, source and dosage of vitamin E and vitamin E alone vs control). The findings in Notwithstanding that both modifiable and non- modifiable risk factors have been widely © Author(s) (or their all subgroup analyses were statistically insignificant. In stroke subtypes analysis, vitamin E showed significant associated with stroke, there is evidence that employer(s)) 2020. Re- use http://svn.bmj.com/ permitted under CC BY- NC. No risk reduction in ischaemic stroke (RR=0.92, 95% CI certain types of diet and nutrition are linked commercial re- use. See rights 0.85–0.99, p=0.04) but not in haemorrhagic stroke with the incidence or prevention of stroke.4 5 and permissions. Published by (RR=1.17, 95% CI 0.98–1.39, p=0.08). However, the trial Vitamin E is a lipid- soluble antioxidant that BMJ. sequential analysis demonstrated that more studies were diminishes the rate of oxidative stress, an 1Clinical Research Center, needed to control random errors. Limitations of this study important component in the pathogenesis of Hospital Seberang Jaya, include the following: trials design may not have provided Ministry of Health Malaysia, atherosclerosis. Oxidised phospholipids and sufficient power to detect a change in stroke outcomes, on September 26, 2021 by guest. Protected copyright. Seberang Jaya, Malaysia other lipid oxidation products (lipid peroxi- 2 participants may have had different lifestyles or health Clinical and Health Sciences, dation) permit build- up of plaque in arteries issues, there were a limited number of studies available for University of South Australia, and cause atherogenesis.6 By scavenging the Adelaide, South Australia, subgroup analysis, studies were mostly done in developed Australia countries, and the total sample size for all included studies reactive oxygen species, modifying vascular 3 7 Department of Pre- Clinical was insufficient to obtain a meaningful result from meta- endothelium vasodilator responsiveness 8 Sciences, Faculty of Medicine analysis. In conclusion, there is still a lack of statistically and reducing platelet aggregation, as well as and Health Sciences, Universiti significant evidence of the effects of vitamin E on the risk preserving cell membranes, vitamin E plays a Tunku Abdul Rahman - Kampus reduction of stroke. Nevertheless, vitamin E may offer Bandar Sungai Long, Kajang, crucial role in inhibiting formation of athero- 9 Malaysia some benefits in the prevention of ischaemic stroke and sclerosis. Therefore, for populations in which 4Medical Department, Hospital additional well- designed randomised controlled trials atherosclerosis in major intracranial arteries Seberang Jaya, Ministry of are needed to arrive at a definitive finding. PROSPERO accounts for a high prevalence of stroke, such Health Malaysia, Seberang Jaya, registration number: CRD42020167827. as African- American, Asian (Chinese, Japa- Malaysia 10 5School of Pharmaceutical nese, South Korean, Indian) and Hispanic, Sciences, Universiti Sains INTRODUCTION vitamin E supplementation may aid in stroke Malaysia, Minden, Malaysia Stroke is defined as rapidly developing focal prevention. (or global) disturbance of cerebral func- Previous prospective cohort studies Correspondence to Dr. Nurzalina Abdul Karim Khan; tion, including cerebral infarction, intrac- have indicated association between a high nurza@ usm. my erebral haemorrhage and subarachnoid intake of vitamin E and the prevention of Loh HC, et al. Stroke & Vascular Neurology 2020;0. doi:10.1136/svn-2020-000519 1 Open access Stroke Vasc Neurol: first published as 10.1136/svn-2020-000519 on 27 October 2020. Downloaded from cardiovascular disease (CVD).11–13 A community study Study selection (Aric Study) also hypothesised that vitamin E may protect All articles obtained via the database searches were against atherosclerosis and thus prevent stroke.14 From a imported into Endnote programme X9 version, merged subgroup analysis of a cancer prevention study, patients and any duplicate publications were removed. Titles and with hypertension showed a reduction in the risk of abstracts were screened independently by three investiga- ischaemic stroke with vitamin E supplementation. Addi- tors (HCL, CYO, DRC). Full-text articles were retrieved and tionally, similar results were also found in hypertensive independently reviewed by the same investigators to assess patients with diabetes.15 eligibility. We also manually performed reverse- forward To date, there have been several systematic reviews and citation of the identified studies. Any disagreements were meta- analyses of studies investigating the association of resolved by consensus. We included randomised controlled vitamin E with stroke prevention.16–20 However, the results trials (RCT) comparing the effect of vitamin E supplemen- are inconsistent. The discrepancy in the outcomes is tation on the incidences of stroke and its subtypes. Studies mainly due to the pathological subtypes of stroke, namely were excluded if there was no access to full text, and/or ischaemic stroke and haemorrhagic stroke. In addi- there were multiple papers reporting on the same trial (we tion, we added quality assessment on all of the included chose either the original paper or the one with the most studies since the previous systematic reviews had either relevant information or outcomes). no quality assessment or incomplete quality assessment. Furthermore, we also included trial sequential analysis Data extraction (TSA) because previously there had not been any quanti- Two investigators (HCL and RL) independently reviewed tative attempt to summarise the precise effect of vitamin and extracted relevant data from each of the included arti- E on prevention of stroke. Hence, the objective of this cles using a standard data extraction template. Extracted systematic review and meta-analysis with TSA was to assess data included the following variables: study characteris- the effect of vitamin E on stroke prevention based on a tics (first author, trial’s name, publication year, country sufficient sample size and with adequate reliability of the and study design), baseline characteristics of the study conclusions. population, type of prevention, trial duration, interven- tion and trial outcome measures (number of total stroke, fatal stroke, non-fatal stroke, ischaemic stroke and haem- METHODS orrhagic stroke). All discrepancies and disagreements This study was registered with PROSPERO and the were resolved through consensus. local National Medical Research Register (NMRR-20- 1197-55340) and performed according to the Preferred Data syntheses Reporting Items for Systematic Reviews and Meta- Analyses The results were pooled if comparable outcome data guidelines.21 were available from two or more studies. Meta-analysis 22 was performed with Review Manager software using a http://svn.bmj.com/ Literature search random- effects model to produce the study risk ratio and Two investigators (HCL and KWL) independently their respective 95% CIs with a two‐sided p value of <0.05 searched through three major citation databases, namely considered as statistically significant. Statistical heteroge- Medline, PubMed, as well as Cochrane Central Register neity between studies was assessed using the I2 index (low of Controlled Trials, and included all relevant arti- was <25%, moderate 25%–50% and high >50%), and the cles published from inception to 12 February 2020. We sources of heterogeneity were explored if present.23 In limited our search to English language articles and studies addition, a leave- one- out meta- analysis was performed as on September 26, 2021 by guest.
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